Monday, 8 October 2012

Idasal




Idasal may be available in the countries listed below.


Ingredient matches for Idasal



Xylometazoline

Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Idasal in the following countries:


  • Spain

International Drug Name Search

Sunday, 7 October 2012

NaFrinse Daily/Acidulated


Generic Name: fluoride topical (FLOR ide TOP i kal)

Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N


What is NaFrinse Daily/Acidulated (fluoride topical)?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.


Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.


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


What is the most important information I should know about NaFrinse Daily/Acidulated (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


Do not eat, drink, or rinse your mouth for 30 minutes after using a fluoride topical. Do not swallow fluoride topical. Spit it out after use. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I discuss with my healthcare provider before using NaFrinse Daily/Acidulated (fluoride topical)?


Fluoride topical should not be used if the level of fluoride in the drinking water is greater than 0.7 parts per million (ppm).

Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.


If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.


Talk to your doctor and dentist before using fluoride topical if you are pregnant. Talk to your doctor and dentist before using fluoride topical if you are breast-feeding. The use of fluoride is particularly important in children to protect against tooth decay. The American Dental Association's Council on Dental Therapeutics recommends the use of fluoride by children up to 13 years of age. The American Academy of Pediatrics recommends fluoride supplementation in children until the age of 16 years old. Do not allow a child to swallow fluoride topical or serious overdose symptoms could result.

How should I use NaFrinse Daily/Acidulated (fluoride topical)?


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


Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.


Swish this medication in your mouth without swallowing. Then spit it out.


Do not eat, drink, or rinse your mouth for 30 minutes after using fluoride topical. Store fluoride topical at room temperature away from moisture and heat.

What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use 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 nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).


Overdose symptoms may result if you swallow large amounts of fluoride while using it.


What should I avoid while using NaFrinse Daily/Acidulated (fluoride topical)?


Do not swallow fluoride topical. Spit it out after use.

NaFrinse Daily/Acidulated (fluoride topical) 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 if you have any of the following side effects:

  • discolored teeth;




  • weakened tooth enamel; or




  • any changes in the appearance of your teeth.



Less serious side effects may include:



  • stomach upset;




  • headache; or




  • weakness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect NaFrinse Daily/Acidulated (fluoride topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More NaFrinse Daily/Acidulated resources


  • NaFrinse Daily/Acidulated Side Effects (in more detail)
  • NaFrinse Daily/Acidulated Use in Pregnancy & Breastfeeding
  • 0 Reviews for NaFrinse Daily/Acidulated - Add your own review/rating


  • APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information

  • EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer)

  • Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prevident 5000 Booster Prescribing Information (FDA)

  • Prevident 5000 Dry Mouth Prescribing Information (FDA)

  • Prevident 5000 Enamel Protect Prescribing Information (FDA)

  • Prevident 5000 Sensitive Prescribing Information (FDA)



Compare NaFrinse Daily/Acidulated with other medications


  • Prevention of Dental Caries


Where can I get more information?


  • Your pharmacist can provide more information about fluoride topical.

See also: NaFrinse Daily/Acidulated side effects (in more detail)


Tuesday, 2 October 2012

Histex Pd 12


Generic Name: carbinoxamine (car bi NOX a meen)

Brand Names: Palgic


What is Histex Pd 12 (carbinoxamine)?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Carbinoxamine is used to treat sneezing, runny nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.


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


What is the most important information I should know about Histex Pd 12 (carbinoxamine)?


Always ask a doctor before giving a cold or allergy medicine to a child. Do not give this medication to a child younger than 2 years old. Deaths have been reported in children under 2 years old who had received carbinoxamine, although it has not been determined that carbinoxamine was the cause of these deaths. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Do not use carbinoxamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine before the MAO inhibitor has cleared from your body. Carbinoxamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of carbinoxamine.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.


What should I discuss with my healthcare provider before taking Histex Pd 12 (carbinoxamine)?


Always ask a doctor before giving a cold or allergy medicine to a child. Do not give this medication to a child younger than 2 years old. Deaths have been reported in children under 2 years old who had received carbinoxamine, although it has not been determined that carbinoxamine was the cause of these deaths. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Do not use carbinoxamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to carbinoxamine, or if you are breast-feeding.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take carbinoxamine:



  • glaucoma;




  • a stomach ulcer;




  • a blockage in your stomach or intestines;




  • an enlarged prostate or urination problems;




  • overactive thyroid;




  • heart disease, high blood pressure; or




  • asthma.




FDA pregnancy category C. It is not known whether carbinoxamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether carbinoxamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take Histex Pd 12 (carbinoxamine)?


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.


Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children.

Carbinoxamine can be taken with or without food.


Take the medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of carbinoxamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.


Store carbinoxamine 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, skip the missed dose and take the medicine at the next regularly scheduled time. 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 extreme drowsiness, confusion, blurred vision, dry mouth, hallucinations, fainting, and seizure (convulsions).


What should I avoid while taking Histex Pd 12 (carbinoxamine)?


Carbinoxamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of carbinoxamine. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine.

Histex Pd 12 (carbinoxamine) 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. Stop using carbinoxamine and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;




  • urinating less than usual or not at all;




  • wheezing, tightness in your chest;




  • fast or pounding heartbeat; or




  • pale skin, easy bruising or bleeding.



Less serious side effects may include:



  • drowsiness, dizziness;




  • lack of coordination;




  • upset stomach;




  • stuffy nose, chest congestion;




  • sleep problems (insomnia);




  • feeling restless or excited (especially in children);




  • dry mouth or nose; or




  • blurred vision.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Histex Pd 12 (carbinoxamine)?


Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbinoxamine.

This list is not complete and there may be other drugs that can interact with carbinoxamine. 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 Histex Pd 12 resources


  • Histex Pd 12 Side Effects (in more detail)
  • Histex Pd 12 Use in Pregnancy & Breastfeeding
  • Drug Images
  • Histex Pd 12 Drug Interactions
  • Histex Pd 12 Support Group
  • 2 Reviews for Histex Pd2 - Add your own review/rating


  • Histex Pd 12 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Carbinoxamine Prescribing Information (FDA)

  • Arbinoxa Prescribing Information (FDA)

  • Carbinoxamine Maleate Monograph (AHFS DI)

  • Histex CT Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Histex Pd Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Palgic Prescribing Information (FDA)

  • Palgic MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Histex Pd 12 with other medications


  • Allergic Reactions
  • Allergic Urticaria
  • Conjunctivitis, Allergic
  • Dermatographism
  • Hay Fever
  • Vasomotor Rhinitis


Where can I get more information?


  • Your pharmacist can provide more information about carbinoxamine.

See also: Histex Pd2 side effects (in more detail)


Tofranil


Generic Name: imipramine (im IP ra meen)

Brand Names: Tofranil, Tofranil-PM


What is Tofranil (imipramine)?

Imipramine is in a group of drugs called tricyclic antidepressants. Imipramine affects chemicals in the brain that may become unbalanced.


Imipramine is used to treat symptoms of depression.


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


What is the most important information I should know about Tofranil (imipramine)?


Do not use imipramine if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.



Video: Treatment for Depression







Treatments for depression are getting better everyday and there are things you can start doing right away.





Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What should I discuss with my healthcare provider before taking Tofranil (imipramine)?


Do not use this medication if you are allergic to imipramine, or if you have recently had a heart attack. Do not use imipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take imipramine before the MAO inhibitor has cleared from your body.

Before taking imipramine, tell your doctor if you are allergic to any drugs, or if you have:



  • heart disease;




  • a history of heart attack, stroke, or seizures;




  • bipolar disorder (manic-depression);



  • kidney or liver disease;


  • overactive thyroid;




  • diabetes (imipramine may raise or lower blood sugar);




  • adrenal gland tumor (pheochromocytoma);




  • glaucoma; or




  • problems with urination.



If you have any of these conditions, you may not be able to use imipramine, or you may need a dosage adjustment or special tests during treatment.


You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.


Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.


This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Imipramine 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. Do not give this medication to anyone younger than 18 years old without the advice of a doctor.

How should I take Tofranil (imipramine)?


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. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.


If you need to have any type of surgery, tell the surgeon ahead of time that you are taking imipramine. You may need to stop using the medicine for a short time.


Do not stop using imipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 3 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment. Store imipramine 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, skip the missed dose and take the medicine at the next regularly scheduled time. 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. An overdose of imipramine can be fatal.

Symptoms of an imipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, sweating, muscle stiffness, swelling, shortness of breath, blue lips or fingernails, feeling light-headed, fainting, seizure (convulsions), or coma.


What should I avoid while taking Tofranil (imipramine)?


Avoid drinking alcohol. It can cause dangerous side effects when taken together with imipramine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by imipramine.


Grapefruit and grapefruit juice may interact with imipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.


Imipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Imipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Tofranil (imipramine) 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 new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.


Call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heart rate;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, problems with vision, speech, or balance;




  • feeling short of breath, even with mild exertion;




  • swelling, rapid weight gain;




  • confusion, hallucinations, or seizure (convulsions);




  • easy bruising or bleeding, unusual weakness;




  • restless muscle movements in your eyes, tongue, jaw, or neck;




  • urinating more or less than usual;




  • extreme thirst with headache, nausea, vomiting, and weakness;




  • skin rash, bruising, severe tingling, numbness, pain, or muscle weakness.



Less serious side effects may be more likely to occur, such as:



  • nausea, vomiting, stomach pain, loss of appetite;




  • constipation or diarrhea;




  • dry mouth, unpleasant taste;




  • weight changes;




  • weakness, lack of coordination;




  • feeling dizzy, drowsy, or tired;




  • nightmares;




  • blurred vision, headache, ringing in your ears;




  • breast swelling (in men or women); or




  • decreased sex drive, impotence, or difficulty having an orgasm.



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 Tofranil (imipramine)?


Before taking imipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).


Before taking imipramine, tell your doctor if you are currently using any of the following drugs:



  • cimetidine (Tagamet);




  • clonidine (Catapres);




  • guanethidine (Ismelin);




  • methylphenidate (Concerta, Ritalin, Daytrana); or




  • heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).



If you are using any of these drugs, you may not be able to use imipramine, or you may need dosage adjustments or special tests during treatment.


There are many other medicines that can interact with imipramine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.



More Tofranil resources


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


  • Tofranil MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tofranil Advanced Consumer (Micromedex) - Includes Dosage Information

  • Tofranil Prescribing Information (FDA)

  • Imipramine Professional Patient Advice (Wolters Kluwer)

  • Imipramine Prescribing Information (FDA)

  • Imipramine Hydrochloride Monograph (AHFS DI)

  • Tofranil-PM Prescribing Information (FDA)

  • Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Tofranil with other medications


  • ADHD
  • Depression
  • Interstitial Cystitis
  • Night Terrors
  • Pain
  • Panic Disorder
  • Primary Nocturnal Enuresis


Where can I get more information?


  • Your pharmacist has information about imipramine written for health professionals that you may read.

See also: Tofranil side effects (in more detail)


Monday, 1 October 2012

Woodward's Gripe Water





1. Name Of The Medicinal Product



Woodward's Gripe Water- Alcohol Free & Sugar Free.


2. Qualitative And Quantitative Composition



Terpeneless Dill Seed Oil 2.3mg/5ml; Sodium Hydrogen Carbonate 52.5mg/5ml.



3. Pharmaceutical Form



Oral solution.



4. Clinical Particulars



4.1 Therapeutic Indications



For the symptomatic relief of distress associated with wind in infants up to one year old.



4.2 Posology And Method Of Administration



For oral use.



Adults including the elderly: not applicable.



Children 1-6 months: one 5ml spoonful.



Children 6-12 months: two 5ml spoonsful.



Children under 1 month: not to be used.



These doses may be given during or after each feed or up to six times in 24 hours.



4.3 Contraindications



Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists.



4.4 Special Warnings And Precautions For Use



If symptoms persist, medical advice should be sought. Keep all medicines out of the reach of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



None known.



4.6 Pregnancy And Lactation



Not applicable.



4.7 Effects On Ability To Drive And Use Machines



Not applicable.



4.8 Undesirable Effects



None known.



4.9 Overdose



Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe overdosing, medical advice should be sought immediately.



Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia and tachypnoea. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur.



The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patients circulatory and central nervous system are necessary.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Sodium hydrogen carbonate has a well established antacid action. Dill seed oil is a widely used aromatic carminative especially for use in the treatment of flatulence in children.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



Not applicable.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Glycerol;



Antifoam M Compound



Polysorbate 80



Maltitol Liquid;



Sodium Methyl Parahydroxybenzoate



Sodium Propyl Parahydroxybenzoate



Disodium Edetate



Purified Water.



6.2 Incompatibilities



None known.



6.3 Shelf Life



18 months unopened.



14 days after opening.



6.4 Special Precautions For Storage



Do not store above 25°C.



6.5 Nature And Contents Of Container



Clear, soda-lime-silica Type III pharmaceutical grade glass bottle with an expanded polyethylene wadded cap containing 150 of product.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Seton Products Limited, Tubiton House, Oldham, Lancashire, OL1 3HS.



8. Marketing Authorisation Number(S)



PL 11314/0139.



9. Date Of First Authorisation/Renewal Of The Authorisation



30/11/99



10. Date Of Revision Of The Text



March 2004