Sinarest Nasal

Generic Name: oxymetazoline nasal (ox ee me TAZ oh leen)

Brand Names: Afrin, Afrin Nasal Sinus, Allerest 12 Hour Nasal Spray, Duramist Plus, Duration, Four-Way Nasal Spray, Genasal, Neo-Synephrine 12 Hour, Nostrilla, NRS Nasal, NTZ Long Acting Nasal, Oxyfrin, Oxymeta-12, Sinarest Nasal, Sinex Long-Acting, Twice-A-Day

What is Sinarest Nasal (oxymetazoline nasal)?

Oxymetazoline is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. The nasal formulation acts directly on the blood vessels in your nasal tissues. Constriction of the blood vessels in your nose and sinuses leads to drainage of these areas and a decrease in congestion.

Oxymetazoline nasal is used to treat congestion associated with allergies, hay fever, sinus irritation, and the common cold.

Oxymetazoline nasal may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sinarest Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Do not use more of this medication than is recommended on the package or by your doctor.

Who should not use Sinarest Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. This could cause a very dangerous drug interaction with serious side effects.

Before taking this medication, tell your doctor if you have

• 
  

  high blood pressure;

  
  


• 
  

  any type of heart disease, hardening of the arteries, or irregular heart beats;

  
  


• 
  

  thyroid problems;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  an enlarged prostate or difficulty urinating; or

  
  


• 
  

  liver or kidney disease.

  
  

You may not be able to use oxymetazoline nasal, or you may require a lower dose or special monitoring during your therapy if you have any of the conditions listed above.

It is not known whether oxymetazoline nasal will harm an unborn baby. Do not use oxymetazoline nasal without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of oxymetazoline nasal. Do not use this medication without first talking to your doctor if you are breast-feeding a baby. If you over 60 years of age, you may be more likely to experience side effects from oxymetazoline nasal. You may require a lower dose of this medication.

How should I use Sinarest Nasal (oxymetazoline nasal)?

Use oxymetazoline nasal exactly as directed by your doctor, or follow the instructions that accompany the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To apply the nasal spray, keep your head upright, spray, then sniff hard for a few minutes after administering a dose.

To apply the nasal drops, lie on a bed on your back with your head hanging over the edge. Insert the drops and remain in this position for several minutes. Gently turn your head from side to side.

Do not allow the tip of the container to touch the inside of your nose or any other surface. This spreads the infection.

Also, to prevent the spread of infection, do not share this medication with anyone else.

Discard this medication bottle after use. Do not save it for reuse.

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful. Oxymetazoline nasal should not be used more often than twice a day (every 12 hours).

Do not use oxymetazoline nasal for longer than 3 to 5 days. Longer use could cause damage to your nasal tissue and lead to chronic congestion. If your symptoms do not improve, see your doctor.

Store oxymetazoline nasal at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an oxymetazoline nasal overdose include extreme tiredness, sweating, dizziness, a slow heartbeat, and coma.

What should I avoid while taking Sinarest Nasal (oxymetazoline nasal)?

Never use this medication in larger doses or more often than is recommended. Too much oxymetazoline nasal could be very harmful.

Sinarest Nasal (oxymetazoline nasal) side effects

If you experience any of the following serious side effects, stop using oxymetazoline nasal and seek emergency medical attention:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  seizures;

  
  


• 
  

  unusual behavior or hallucinations; or

  
  


• 
  

  an irregular or fast heartbeat.

  
  

More commonly, you may experience some sneezing or burning, stinging, dryness, or irritation of the nose. These side effects are usually mild and temporary.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sinarest Nasal (oxymetazoline nasal)?

Do not use oxymetazoline nasal if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

Although drug interactions between topical nasal decongestants and drugs taken by mouth are not expected, they can occur. Rarely, oxymetazoline nasal may interact with the following medicines:

• 
  

  furazolidone (Furoxone);

  
  


• 
  

  guanethidine (Ismelin);

  
  


• 
  

  indomethacin (Indocin);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  bromocriptine (Parlodel);

  
  


• 
  

  caffeine in cola, tea, coffee, chocolate and other products;

  
  


• 
  

  theophylline (Theo-Dur, Theochron, Theolair, others);

  
  


• tricyclic antidepressants such as amitriptyline (Elavil, Endep), doxepin (Sinequan), and nortriptyline (Pamelor);


• other commonly used tricyclic antidepressants, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil);


• phenothiazines such as chlorpromazine (Thorazine), thioridazine (Mellaril), and prochlorperazine (Compazine); and


• other commonly used phenothiazines, including fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), and trifluoperazine (Stelazine).

Drugs other than those listed here may also interact with oxymetazoline nasal. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Sinarest Nasal resources

• Sinarest Nasal Side Effects (in more detail)
• Sinarest Nasal Use in Pregnancy & Breastfeeding
• Sinarest Nasal Drug Interactions
• Sinarest Nasal Support Group
• 0 Reviews for Sinarest Nasal - Add your own review/rating

• Sinarest Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Afrin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sinarest Nasal with other medications

• Nasal Congestion

Where can I get more information?

• Your pharmacist has additional information about oxymetazoline nasal written for health professionals that you may read.

See also: Sinarest Nasal side effects (in more detail)

Yeast-Vite

1. Name Of The Medicinal Product

Yeast-Vite

2. Qualitative And Quantitative Composition

Caffeine EP 50.0 MG

Nicotinamide 1.75 MG

Thiamine Hydrochloride (Vitamin B1) 0.167 MG

Riboflavin (Vitamin B2) 0.167 MG

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the relief of fatigue and drowsiness.

2. The maximum daily dose will supply the recommended daily amount of Vitamins B1, B2 and Nicotinamide.

4.2 Posology And Method Of Administration

Adults and Children aged 12 years and over

2 tablets every 3 – 4 hours as required.

Do not exceed 12 tablets in any period of 24 hours.

Not to be given to children under 12 years of age, except on medical advice.

The Elderly

The normal adult dose should be taken.

4.3 Contraindications

Known sensitivity to caffeine. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Label Warnings

Do not exceed the stated dose.

If symptoms persist, consult your doctor.

Keep out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Caffeine may enhance the action of Ergotamine. High doses may cause tremor and palpitations. Patients should avoid excessive intake of coffee or tea.

Other drugs which may have their action altered by caffeine are idrocilamide, mexiletine, ciprofloxacin, enoxacin, pipemidic acid, fluvoxamine, phenylpropanolamie, phenytoin, clozapine, lithium, theophylline, pentobarbital, diazepam and methoxsalen.

4.6 Pregnancy And Lactation

Consult a doctor before using if you are pregnant or breast-feeding. Caffeine may cause irritability to the breast-fed baby, therefore nursing mothers should use with caution.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

High doses of caffeine may cause tremor and palpitations.

4.9 Overdose

Any symptoms of over dosage would be related to the caffeine content. Mild over dosage leads to nausea, headache and insomnia; Major over dosage causes restlessness, excitement, muscle tremor, tinnitus, tachycardia and extrasystoles. Later there may be scintillating scotoma (blind or partially blind areas in the visual fields).

In mild to moderate over dosage, no particular treatment is indicated. In major over dosage the stomach should be emptied either by inducing emesis or by intubation and lavage. Stimulation of the nervous system may be controlled by administration, intravenously if necessary, of a tranquilliser.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Caffeine is a mild stimulant.

The maximum daily dose of product will supply the recommended daily amount of vitamins B1, B2 and nicotinamide.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dried Yeast (1973)

Powdered Clove

Colloidal Anhydrous Silica

Micro Crystalline Cellulose

Lactose

Dispersed Brown 16658 (E124, E104, E132)

Maize Starch

Magnesium Stearate

6.2 Incompatibilities

Iodine, silver salts, tanning, strong caustic alkali.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Store at or below 25°C in a dry place.

6.5 Nature And Contents Of Container

a) Polypropylene securitainer, with polythene closure and polyether wad, containing 50 or 100 tablets.

b) Cylindrical, white (HDPE) bottle with a laminate membrane neck seal. A polypropylene screw cap and polyether wad, containing 50 or 100 tablets.

c) Cylindrical, white (HDPE) bottle, with an orange child resistant tamper evident lined closure. The bottle is fitted with a polyether wad and contains 50 or 100 tablets.

d) Blister packs comprising 25µ hard temper aluminium foil with 250µ opaque PVC film containing 12, 24 or 48 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0081

9. Date Of First Authorisation/Renewal Of The Authorisation

19 June 2002

10. Date Of Revision Of The Text

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable

clotrimazole Topical

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.

• Clotrim Antifungal


• Cruex Prescription Strength


• Lotrimin


• Lotrimin AF


• Mycelex

In Canada

• Canesten


• Clotrimaderm


• Desenex


• Myclo-Derm


• Neo-Zol

Available Dosage Forms:

• Lotion


• Solution


• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For clotrimazole

Clotrimazole topical preparations are used to treat fungus infections on the skin.

clotrimazole is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using clotrimazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clotrimazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to clotrimazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

clotrimazole has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, clotrimazole is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking clotrimazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using clotrimazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fentanyl


• Tacrolimus


• Trimetrexate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of clotrimazole

Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.

Keep clotrimazole away from the eyes.

When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over clotrimazole unless you have been directed to do so by your doctor.

To help clear up your infection completely, it is very important that you keep using clotrimazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using clotrimazole every day for several weeks or more. If you stop using clotrimazole too soon, your symptoms may return. Do not miss any doses .

Dosing

The dose of clotrimazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of clotrimazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, lotion, and solution):
  
  • Fungal infections (treatment):
    
    • Adults and children—Use two times a day, morning and evening.
    
    
  
  

Missed Dose

If you miss a dose of clotrimazole, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using clotrimazole

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.

clotrimazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of clotrimazole

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More clotrimazole Topical resources

• Clotrimazole Topical Use in Pregnancy & Breastfeeding
• Clotrimazole Topical Support Group
• 2 Reviews for Clotrimazole Topical - Add your own review/rating

• clotrimazole topical Concise Consumer Information (Cerner Multum)


• Anti-Fungal Liquid Concise Consumer Information (Cerner Multum)


• Clotrimazole-3 Concise Consumer Information (Cerner Multum)


• Femcare Concise Consumer Information (Cerner Multum)


• Gyne-Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Mycelex Prescribing Information (FDA)

Compare clotrimazole Topical with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor
• Vaginal Yeast Infection

Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets

Pronunciation: SOE-dee-um bye-KAR-bo-nate/SIT-rik AS-id/sye-METH-i-kone
Generic Name: Sodium Bicarbonate/Citric Acid/Simethicone
Brand Name: EZ Gas II

Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets are used for:

Relieving indigestion, heartburn, sour stomach, upset stomach, or gas.

Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets are an antacid and antiflatulent combination. It works by neutralizing stomach acid, which helps relieve upset stomach. It also breaks up gas bubbles, which makes gas easier to eliminate.

Do NOT use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets if:

• you are allergic to any ingredient in Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets


• you have appendicitis or a blockage of your bowel or esophagus


• you are on a low-salt diet

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets:

Some medical conditions may interact with Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of stomach or intestinal bleeding


• if you have congestive heart failure, swelling, liver problems, kidney problems, a decrease in the amount of urination, or rectal bleeding from an unknown cause


• if you have pregnancy-induced high blood pressure

Some MEDICINES MAY INTERACT with Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aluminum salts (eg, aluminum hydroxide) because the risk of bone or muscle pain, mental or mood changes, and seizures may be increased


• Anorexiants (eg, phentermine) or sympathomimetics (eg, pseudoephedrine) because the risk of their side effects may be increased by Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets


• Lithium because its effectiveness may be decreased by Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets:

Use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets by mouth with or without food.


• Place half of the contents of 1 packet on the back of the tongue and wash down with a half ounce (15 mL) of water. Repeat with the remaining contents of the packet.


• If you take azole antifungals (eg, itraconazole, ketoconazole), cephalosporins (eg, cefdinir), iron (eg, ferrous sulfate), or tetracyclines (eg, doxycycline), ask your doctor or pharmacist how to take it with Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets.


• If you miss taking a dose of Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets.

Important safety information:

• Do NOT take more than the recommended dose or use more frequently than prescribed without checking with your doctor.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets has sodium in it. Include this when you count your daily intake of sodium.


• Use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets with caution in the ELDERLY; they may be more sensitive to its effects.


• Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets should not be used in CHILDREN younger than 6 years old without first checking with your doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets while you are pregnant. It is not known if Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets are found in breast milk. If you are or will be breast-feeding while you use Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; headache; irritability; muscle rigidity; nausea; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion, possibly leading to coma; muscle twitching or tremors; nausea; numbness or tingling in the face or extremities; seizures; vomiting.

Proper storage of Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets:

Store Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets out of the reach of children and away from pets.

General information:

• If you have any questions about Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets, please talk with your doctor, pharmacist, or other health care provider.


• Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sodium Bicarbonate/Citric Acid/Simethicone Effervescent Granule Packets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Sodium Bicarbonate/Citric Acid/Simethicone resources

• Sodium Bicarbonate/Citric Acid/Simethicone Use in Pregnancy & Breastfeeding
• Sodium Bicarbonate/Citric Acid/Simethicone Drug Interactions
• Sodium Bicarbonate/Citric Acid/Simethicone Support Group
• 1 Review for Sodium Bicarbonate/Citric Acid/Simethicone - Add your own review/rating

Compare Sodium Bicarbonate/Citric Acid/Simethicone with other medications

• Gas
• Indigestion

Quinoderm 10% / 0.5% w / w Cream

1. Name Of The Medicinal Product

Quinoderm 10% / 0.5% w/w Cream

2. Qualitative And Quantitative Composition

Benzoyl Peroxide, hydrous	10.0% w/w
Potassium Hydroxyquinoline Sulphate	0.5% w/w

Excipients: Also includes cetostearyl alcohol, approx 0.825% w/w

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Quinoderm Cream is a creamy white astringent vanishing cream. It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne vulgaris, acneform eruptions, folliculitis.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, children and the elderly

By gentle massage over all the affected area two or three times daily.

4.3 Contraindications

Acne rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness.

In a few isolated cases, overreaction to Quinoderm Cream may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for 12 hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzoyl Peroxide is an oxidising agent. Hence, Quinoderm Cream should not be used at the same time as other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Quinoderm Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Skin & Subcutaneous Tissue Disorders

Local irritation or inflammation may result; in such cases use should be interrupted or frequency reduced. Itch or rash may occur in which instance treatment should cease and a Physician or Pharmacist consulted.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Group: Peroxides, Benzoyl Peroxide

ATC Code: D10AE01

Potassium Hydroxyquinoline Sulphate – not known.

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulphate in a specially formulated bland water-miscible base make this preparation valuable in the treatment of acne vulgaris, acneform eruptions and folliculitis.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid,

White Soft Paraffin,

Edetic Acid,

Sodium Dihydrogen Phosphate Dihydrate ,

Maize Starch,

Cetostearyl Alcohol

Sodium Cetostearyl Sulphate

Macrogol 40 Castor Oil

Purified Water.

6.2 Incompatibilities

Any topical agent that would react with an oxidising agent

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25ºC. Do not refrigerate.

6.5 Nature And Contents Of Container

Quinoderm Cream is available in heat sealed low density polyethylene tubes with flush fitting cap containing 25 g, 40g and 50 g of product. Each tube is cartoned and contains a patient information leaflet.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Ferndale Pharmaceuticals Ltd,

12 York Place,

Leeds,

LS1 2DS,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 20685/0022

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 2004

10. Date Of Revision Of The Text

05 November 2010

11 DOSIMETRY

n/a

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

n/a

Florinef Acetate

Generic Name: fludrocortisone (FLOO droe KOR ti sone)

Brand Names: Florinef Acetate

What is Florinef Acetate (fludrocortisone)?

Fludrocortisone is in a class of drugs called steroids. Fludrocortisone prevents the release of substances in the body that cause inflammation.

Fludrocortisone is used to treat conditions in which the body does not produce enough of its own steroids, such as Addison's disease, and salt-losing adrenogenital syndrome.

Fludrocortisone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Florinef Acetate (fludrocortisone)?

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Before taking fludrocortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking fludrocortisone. Vaccines may not work as well while you are taking a steroid.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

What should I discuss with my healthcare provider before taking Florinef Acetate (fludrocortisone)?

You should not use this medication if you are allergic to fludrocortisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

Other medical conditions you should tell your doctor about before taking fludrocortisone include:

• 
  

  liver disease (such as cirrhosis);

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a history of malaria;

  
  


• 
  

  tuberculosis;

  
  


• 
  

  osteoporosis;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  herpes infection of the eyes;

  
  


• 
  

  stomach ulcers, ulcerative colitis, or diverticulitis;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  high blood pressure

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take fludrocortisone.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fludrocortisone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Florinef Acetate (fludrocortisone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using fludrocortisone.

Do not stop using fludrocortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication. Store fludrocortisone at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, weight gain, feeling short of breath, confusion, uneven heart rate, increased thirst or urination, leg discomfort, and muscle pain or weakness.

What should I avoid while taking Florinef Acetate (fludrocortisone)?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with fludrocortisone. Vaccines may not work as well while you are taking a steroid.

Florinef Acetate (fludrocortisone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  problems with your vision;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath;

  
  


• 
  

  severe depression, unusual thoughts or behavior, seizure (convulsions);

  
  


• 
  

  bloody or tarry stools, coughing up blood;

  
  


• 
  

  pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  sleep problems (insomnia), mood changes;

  
  


• 
  

  acne, dry skin, thinning skin, bruising or discoloration;

  
  


• 
  

  slow wound healing;

  
  


• 
  

  increased sweating;

  
  


• 
  

  headache, dizziness, spinning sensation;

  
  


• 
  

  nausea, stomach pain, bloating; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Florinef Acetate (fludrocortisone)?

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• 
  

  aspirin (taken on a daily basis or at high doses);

  
  


• 
  

  amphotericin B (Fungizone);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  an anabolic steroid such as oxymetholone (Anadrol-50), nandrolone (Durabolin, others), and others; or

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there may be other drugs that can interact with fludrocortisone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Florinef Acetate resources

• Florinef Acetate Side Effects (in more detail)
• Florinef Acetate Use in Pregnancy & Breastfeeding
• Drug Images
• Florinef Acetate Drug Interactions
• Florinef Acetate Support Group
• 1 Review for Florinef Acetate - Add your own review/rating

• Florinef Acetate Monograph (AHFS DI)


• Florinef Acetate Advanced Consumer (Micromedex) - Includes Dosage Information


• Fludrocortisone Prescribing Information (FDA)


• Fludrocortisone MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Florinef Acetate with other medications

• Addison's Disease
• Adrenogenital Syndrome
• Dysautonomia
• Postural Orthostatic Tachycardia Syndrome

Where can I get more information?

• Your pharmacist can provide more information about fludrocortisone.

See also: Florinef Acetate side effects (in more detail)

Selexid Tablets

Selexid Tablets

Pivmecillinam hydrochloride

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.


• In this leaflet Selexid Tablets will be called Selexid.

In this leaflet:

• 1. What Selexid is and what it is used for


• 2. Before you take Selexid


• 3. How to take Selexid


• 4. Possible side effects


• 5. How to store Selexid


• 6. Further information

What Selexid Is And What It Is Used For

Selexid belongs to a group of medicines called penicillins. It is a type of antibiotic.

Selexid works by killing germs (bacteria) that cause infections.

If the infection is not treated germs can continue to grow in your body. The infection will make you feel very unwell, and could even be life-threatening.

Selexid is used to treat:

• Infections of the bladder or tubes leading from the kidneys (urinary tract infections).


• Infections caused by a bacteria called Salmonella (salmonellosis).

Before You Take Selexid

Do not take Selexid

• If you are allergic (hypersensitive) to pivmecillinam or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.


• If you are allergic (hypersensitive) to other antibiotics. Such antibiotics include penicillin or cephalosporins.


• If you know that your food pipe has become narrow.


• If you know that you have any blockages in your digestive system.


• If you know you have any condition that may reduce the amount of a substance called carnitine in your body. Such conditions include primary carnitine deficiency or kidney dialysis.

Do not give this medicine to a baby under three months old.

Take special care with Selexid

Before you take Selexid tell your doctor:

• If you have problems with your kidneys.


• If you know that you have a condition called porphyria.


• If you are taking other medicines used to treat epilepsy, called valproic acid or valproate.


• If you are taking another antibiotic called pivampicillin.


• If you have recently taken a course of Selexid.


• If you have been taking Selexid for a long time already.

If you take Selexid for a long time your doctor may take regular blood tests. This is to check if your kidneys and liver are working properly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• Methotrexate: for arthritis or psoriasis. You may need to take a different dose of methotrexate.


• Probenecid: for gout. This may increase the effect of Selexid.


• Valproic acid or valproate: for epilepsy.


• Any other antibiotic: for treating an infection. This may increase the effect of Selexid.

Taking Selexid with food and drink

Tablets must be swallowed whole during or immediately after a meal with at least half a glass of water, while sitting or standing.

It is important to take your medicine with plenty of liquid. This will stop you getting mouth ulcers or ulcers in your food pipe. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before taking Selexid:

• If you are pregnant, or think you are pregnant.


• If you are breast-feeding.

Tell your doctor if you become pregnant while taking this medicine.

Driving and using machines

Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

How To Take Selexid

Always use Selexid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Selexid to take

Your doctor will tell you how many tablets to take, or give to your child. Your doctor will tell you how many times each day to take your medicine.

You should take the medicine at equally spaced times in the day.

Remember to always swallow the tablets whole during or immediately after a meal and with at least half a glass of water, while sitting or standing.

It is very important to take all the medicine your doctor has told you to take.

Urinary Tract Infections:

Adults and children weighing more than 40 kg:

• Acute infection:
  
  The usual starting dose is 2 tablets taken immediately. Then take one tablet every 8 hours. Continue until you have taken all 10 tablets in the pack.


• Repeated infection:
  
  The usual dose is 6-8 tablets each day. Take two tablets 3 or 4 times each day.

For other type of infections or for children weighing less than 40 kg:

Your doctor will prescribe the right dose for you.

If you take more Selexid than you should

Tell your doctor straight away. You may need to stop taking this medicine.

You may be sick, or feel sick, or get an upset stomach.

If you forget to take Selexid

If you forget to take your medicine, take it as soon as you remember. If you can, take it during or immediately after a meal, but always take it with half a glass of water, while sitting or standing. Then take the next dose at the usual time.

If you stop taking Selexid

It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise you may feel ill again.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

Selexid Tablets Side Effects

Like all medicines, Selexid can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• 
  You have difficulty breathing.
  


• 
  Your face or throat swell.
  


• 
  Your skin develops a severe rash or areas of sudden swelling.
  

Other possible side effects:

Common side effects are digestive and skin problems.

Very rare side effects are allergic reactions, blood problems, and liver problems.

Digestive problems:

• Being sick (vomiting).


• Feeling sick (nausea).


• Indigestion.


• Stomach pain.


• Diarrhoea. This may be because your bowel is inflamed (colitis).


• Trouble chewing or swallowing your food. This may be due to mouth ulcers or ulcers in your food pipe from taking the tablets with insufficient fluids.

Skin problems:

• Rash.


• Hives (urticaria).


• Itching skin (pruritus).

Liver problems:

• Yellowing of the skin or eyes.


• Unusually dark urine.


• Small changes in blood test results. Your doctor can explain this more.

Blood problems:

• Bruising or bleeding more easily.


• Getting a fever or infections more often.

Changes to certain cells found in your blood may cause these symptoms.

Other problems:

• Muscle weakness or muscle loss.


• Tiredness or lack of energy.

Not enough of a substance called carnitine in your body may cause these symptoms.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Selexid

• Keep out of the reach and the sight of children.


• Do not use the tablets after the expiry date on the carton. The expiry date is the last day of that month.


• Store below 25°C in a dry place.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

Further Information

What Selexid contains

• The active ingredient is pivmecillinam hydrochloride.
  
  Selexid contains 200 milligrams of pivmecillinam hydrochloride in each tablet.


• The other ingredients are cellulose microcrystalline, hydroxypropylcellulose, magnesium stearate, hypromellose, simethicone and synthetic paraffin.

What Selexid looks like and contents of the pack

Selexid is a white tablet. There is a picture of a lion on one side of the tablet. The other side has 137 written on it.

Selexid comes in blister packs of 10 tablets.

Marketing Authorisation Holder / Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

UK

Manufacturer:

Recipharm Strängnäs AB

Mariefredsvägen 35

S-645 41 Strängnäs

Sweden

This leaflet was last revised in November 2009.

This leaflet was last approved in January 2010.

Registered Trade Mark

LEO

023719-02

063339