Polaramine allergy antihistamine tablets

Polaramine allergy antihistamine tablets View larger

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Polaramine allergy antihistamine tablets dexchlorpheniramine

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Used for : conjunctivitis, hay fever, urticaria, runny nose, rhinitis

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For warnings, precautions for use and against-indications, please refer to the manual of Polaramine.

Description Polaramine

This medicine contains an antihistamine, dexchlorpheniramine. It is indicated for the symptomatic treatment of allergic manifestations such as rhinitis (eg hay fever, perennial rhinitis ...), conjunctivitis (eye inflammation), urticaria.
Adults and children over 6 years.

Directions for use and dosage of Polaramine

Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
Adults and children over 12 years: 1 tablet 3-4 times daily.
Children 6 to 12 years: 1/2 tablet 2 or 3 times a day.

Method and route of administration
ORAL
The tablets are to be swallowed with a glass of water.

Frequency and timing of the drug must be administered
They should be spaced at least 4 hours.
Given the drowsiness effect of this drug, it is best to start treatment one evening.

Duration of treatment
Treatment duration should be short.

What to do in case of overdose
In case of overdose or accidental poisoning, stop treatment immediately and prevent a doctor.

Composition Polaramine

Qualitative and quantitative composition
Maleate dexchlorpheniramine ............................................... ........... 2.00 mg

Excipients: Lactose monohydrate, maize starch, pre-gelatinized maize starch, magnesium stearate.
For a scored tablet

Introducing Polaramine

Box of 20 tablets

Warnings about medications

Attention allergy medication Polaramine antihistamine tablets is not a product like any other. Read the package leaflet before ordering. Do not let the drug out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency for Medicines Safety and Health Products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug allergy antihistamine tablets Polaramine

VIDAL OF THE FAMILY

POLARAMINE tablet

Hypo-allergenic

dexchlorpheniramine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

POLARAMINE 2 mg: scored tablet (white); box of 20.
-

Laboratory

COMPOSITION (summary)
p cp
Dexchlorpheniramine maleate 2 mg
Lactose 83 mg

INDICATIONS (summary)
This drug is an antihistamine antiallergic. It also has sedative and atropine effects.
It is used in the treatment of various allergic manifestations: allergic rhinitis or conjunctivitis , urticaria .
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This drug has atropine effects. It can cause acute glaucoma in susceptible persons: red, hard and painful eyes, with blurred vision. An emergency consultation with an ophthalmologist is necessary.
Because of the presence of an antihistamine with sedative and atropine properties, precautions are necessary in patients with hepatic or renal insufficiency and in the elderly, particularly in the case of chronic constipation, prostatic adenoma , tendency to dizziness or drops in blood pressure.
Avoid alcoholic beverages: increased risk of drowsiness.
This medicine may cause drowsiness in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving or using hazardous machines is not recommended.
DRUG INTERACTIONS (summary)
Tell your doctor or pharmacist if you are taking any other medicines that have atropine or sedative effects (tranquillizers, sleeping pills, some cough or pain medications containing opioids , antidepressants , neuroleptics, etc.).
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
The effect of this medication during pregnancy is not well known: only your doctor can evaluate the possible risk of its use in your case.
In case of termination of pregnancy, monitoring of the newborn may be necessary.

Breastfeeding:
This medication passes weakly into breast milk: as a precaution, it is not recommended during breast-feeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
The catch must be spaced at least 4 hours apart.
It is recommended to privilege the catches in the evening, due to the sedative effect of the drug.

Usual dosage:

  • Adult and child over 12 years: 1 tablet, 3 or 4 times a day.
  • Children from 6 to 12 years: ½ tablet, 2 or 3 times a day.
TIPS (summary)
This medication works on the manifestations of allergy but does not eliminate the cause. If symptoms persist or worsen, do not hesitate to consult your doctor.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness.
Atropine effects: dry mouth, difficulty in accommodation , blocked urine, constipation, palpitations .
Orthostatic hypotension , dizziness , tremors, restlessness.
Allergic reaction .
Abnormal blood count .


GLOSSARY (summary)


accommodation
"Focus" of the eye, allowing clear vision close up. Presbyopia is the most common disorder of accommodation; some drugs such as atropine may cause passenger accommodation problems.


adenoma of the prostate
Increase in the volume of the prostate gland located under the bladder of man. This increase in volume is benign, has no relationship to cancer, but can interfere with the passage of urine into the urethra through the gland.
Symptoms that suggest the presence of a prostate adenoma are:
  • difficulty urinating (slowness, weakness of the spray);
  • the need to get up several times at night to urinate;
  • urges to urinate imperiously and difficult to control.
Some drugs, especially atropinics, may have the undesirable effect of aggravating the discomfort and may lead to a total blockage of the bladder evacuation. They are therefore contraindicated or should be used cautiously in men with the symptoms described above.


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even 60o) is a better antiseptic than alcohol at 90o.


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication, or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


antidepressants
Medication that works against depression. Some antidepressants are also used to combat obsessive-compulsive disorder, generalized anxiety, certain rebellious pain, enuresis, etc.
Depending on their mode of action and adverse effects, antidepressants are divided into different families: imipraminic antidepressants, serotonin reuptake inhibitors, selective or non-selective MAOIs. Finally, other antidepressants do not belong to any of these families, because they possess original properties.
The mode of action of antidepressants has two main aspects: the relief of moral suffering and the fight against inhibition which removes all will to action from the depressed. There may be a time lag between these two effects: moral suffering may persist, while the capacity for action reappears. During this short period, the risk of suicide in some depressed people can be increased. The physician takes it into account in its prescription (possible association with a tranquillizer) and it must imperatively be respected.


antihistamine
Medication that opposes different effects of histamine. Two main types exist: antihistamines type H1 (antiallergic) and antihistamines type H2 (gastric antiulcer). Some antihistamines of type H1 are sedative, others do not alter vigilance.


atropine
Medication with effects similar to those of atropine. Atropinics fight spasms and diarrhea. Adverse effects of atropinic drugs include: thickening of bronchial secretions, dry mouth and mucous membranes, constipation, risk of urine blockage and acute glaucoma in susceptible persons, accommodation disorders, abnormal sensitivity to light by dilation of the pupil. Taking several atropine medicines increases the risk of adverse effects. In the event of overdose or accidental ingestion, the following signs may also appear: red and warm skin, fever, acceleration of breathing, fall or, on the contrary, elevated blood pressure, agitation, hallucinations, poor coordination of movements. Emergency care should be given to your doctor or, if not available, call 15, 112 or an emergency medical service.
In addition to atropine and its derivatives, other drugs have atropine effects: imipraminic antidepressants, some antihistamines, antispasmodics, antiparkinsonian and neuroleptic.


conjunctivitis
Inflammation of the conjunctiva, due to foreign body, allergy, infection or irritant.


glaucoma
Disease characterized by increased pressure of the fluids contained in the eye (intraocular hypertension).
This general term covers two totally different affections:
  • Open angle glaucoma or chronic glaucoma is the most common; it is generally symptom-free, detected by the measurement of intraocular tension in the ophthalmologist. It does not cause acute seizures, and treatment relies primarily on beta-blocking eye drops. People with open-angle glaucoma should not use cortisone derivatives without prior ophthalmologic advice.
  • Closed-angle glaucoma or acute glaucoma is more rare. Between seizures, intraocular tension is normal. But the inadvertent use of atropine medicines (especially eye drops) causes an acute crisis of intraocular hypertension which can permanently damage the retina in a few hours. It is an ophthalmological emergency that is recognized by a brutally red eye, horribly painful, hard as a glass ball, and whose vision becomes blurred.
The angle in question in these two affections is the irido-corneal angle. It is indeed between the iris and the cornea that is located the system of evacuation of the liquids of the eye. A slightly open (closed) angle exposes a total obstruction of the evacuation system. This obstruction can occur when the iris is opened to the maximum (mydriasis) under the effect of an atropinic drug: the iris then comes to be attached to the cornea.
Contraindications for atropine medicines are limited to those who have already had closed-angle glaucoma or have been detected by an ophthalmologist. Those who suffer from chronic open angle glaucoma are not affected by these contraindications.


Orthostatic hypotension
Reduced blood pressure when changing from elongated to standing. Due mostly to drugs, orthostatic hypotension results in dizziness with risk of fall, especially in the elderly. These disturbances can be prevented by avoiding sudden changes of position: sit for a few moments at the edge of the bed before standing, slowly rising from a seat, keeping a support before moving.
Wearing compression stockings, which prevents blood from flowing back to the legs while standing, is also used to treat orthostatic hypotension.


hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


neuroleptics
Family of medicines used in the treatment of certain nervous disorders or various symptoms: digestive disorders, menopausal disorders, etc.


blood count
The count measures the number of red blood cells (red blood cells), white blood cells (leukocytes) and platelets in the blood. The blood formula specifies the percentage of different white blood cells: neutrophils, eosinophils, basophils, lymphocytes, monocytes.
Abbreviation: NFS.


opiates
A chemical family that includes opium and its derivatives. In addition to drugs such as opium or heroin, the opiate family includes morphine (strong analgesic), codeine (antitussive and analgesic) and many other substances.


palpitations
Abnormal perception of irregular heartbeat.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


rhinitis
Inflammation or infection of the nose and nasal cavities. Rhinitis can have an infectious origin (bacteria or virus) or an allergic origin. Allergic rhinitis includes seasonal rhinitis (hay fever) and perennial rhinitis, which are often persistent during the year (eg due to mites, animal hair or chemical agents) .


sedatives
  • Quiets, calms down.
  • Medication belonging to different families: anxiolytics, hypnotics, analgesics, antitussives, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.


symptoms
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.


dizziness
Symptom that can mean an impression of loss of balance (common sense) or, more strictly, a sense of rotation on oneself or the environment (medical sense).

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 26/07/2017

Name of the medicinal product

POLARAMINE 2 mg, scored tablet

Dexchlorpheniramine maleate

framed

Please read this leaflet carefully before you start taking this medicine because it contains important information for you.

You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should contact your doctor if you experience no improvement or feel less well after treatment.

What is in this leaflet?

1. What is POLARAMINE 2 mg, scored tablet and in which cases it is used?

2. What information should I take before taking POLARAMINE 2 mg scored tablet?

3. How to take POLARAMINE 2 mg tablet scored?

4. What are the possible side effects?

5. How to store POLARAMINE 2 mg scored tablet?

6. Package contents and other information.

1. WHAT IS POLARAMINE 2 mg scored tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group - ATC code: ANTIHISTAMINIC FOR SYSTEMIC USE

(R. Respiratory system)

(D. Dermatology)

This medication contains an antihistamine, dexchlorphenamine.

It is indicated in the symptomatic treatment of allergic manifestations such as:

· rhinitis (eg hay fever, non-seasonal rhinitis ...),

· conjunctivitis (inflammation of the eye),

· urticaria

In adults and children over 6 years of age.

2. BEFORE YOU TAKE POLARAMINE 2 mg tablet scored?

Never take POLARAMINE 2 mg scored tablet:

· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.

· If you have difficulty urinating from prostatic or other sources,

· If you have some forms of glaucoma (increased pressure in the eye),

· For children under 6 years due to the pharmaceutical form

This medication is GENERALLY NOT RECOMMENDED unless your doctor advises otherwise, in case of breast-feeding.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Warnings and Precautions

Talk to your doctor or pharmacist before taking POLARAMINE 2 mg scored tablet.

This medication only treats the manifestations of your allergy. Their origin must be sought.

If symptoms persist or worsen, SEEK YOUR DOCTOR.

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

In case of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he can adapt the dosage.

Taking this medication requires a MEDICAL ADVICE in the elderly:

· predisposed to constipation, dizziness or drowsiness,

· having prostate disorders;

PREVENT YOUR DOCTOR before taking this antihistamine.

Refrain from alcoholic beverages or medication containing alcohol during the course of treatment.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.

Children and Youth

Not applicable.

Other medicines and POLARAMINE 2 mg, scored tablet

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

This medicine contains dexchlorphenamine. Other medicines contain it. Do not combine them in order not to exceed the maximum recommended doses ( see Dosage ).

POLARAMINE 2 mg, scored tablet with food, beverages and alcohol

Not applicable.

Pregnancy and breast feeding

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.

Pregnancy

It is possible to take this medication during the first two trimesters of your pregnancy. Use during the 3rd trimester should only be considered if necessary and limited to one-time use.

At the end of pregnancy, abuse of this drug may cause adverse effects in the newborn.

feeding

This drug passes into breast milk. It is therefore not recommended for breastfeeding women.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Attention is drawn, especially to vehicle drivers and machine users, on the possibilities of drowsiness or decreased vigilance associated with the use of this medication.

This is exacerbated by the use of alcoholic beverages or alcohol-containing medications.

It is best to start this treatment one night.

POLARAMINE 2 mg scored tablet contains lactose

3. HOW TO TAKE POLARAMINE 2 mg scored tablet?

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.

Adult and child over 12 years: 1 tablet, 3 to 4 times a day.

Children from 6 to 12 years: 1/2 tablet, 2 or 3 times a day.

Method and route of administration

Oral use.

The tablets should be swallowed with a glass of water.

Frequency of Administration

They must be spaced at least 4 hours apart.

Given the sleepiness effect of this medication, it is best to start treatment one night.

Duration of treatment

The duration of treatment should be short.

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.

If you take more POLARAMINE 2 mg tablets than you should have

Immediately consult your doctor or pharmacist.

If you forget to take POLARAMINE 2 mg, scored tablet

Not applicable.

If you stop taking POLARAMINE 2 mg, scored tablet

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· Some side effects require STOPPING IMMEDIATELY TREATMENT AND WARNING A DOCTOR:

o Allergic reactions:

§ rash type (erythema, eczema, purpura, urticaria);

§ angioedema (urticaria with sudden swelling of the face and neck, which can cause respiratory discomfort);

§ anaphylactic shock;

o Significant decrease in white blood cells in the blood, which may be manifested by the onset or recurrence of fever with or without signs of infection;

o Abnormal decrease in platelets in the blood, which can result in nose bleeds or gums.

· Other side effects may include:

o Drowsiness, decreased vigilance, more marked at the beginning of treatment.

o Memory or concentration disorders, dizziness (more common in the elderly),

o Motor incoordination, tremors,

o Confusion, hallucinations,

o Dry mouth, visual disturbances, urine retention, constipation, palpitations, low blood pressure.

· More rarely, signs of excitement (agitation, nervousness, insomnia) may occur.

Declaration of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE POLARAMINE 2 mg scored tablet?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton after {EXP}. The expiry date refers to the last day of that month.

No special storage conditions.

Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What POLARAMINE 2 mg contains, scored tablet

· The active substance (s) is (are):

Dexchlorpheniramine Maleate ............................................... .......................................... 2 mg

For a scored tablet

· The other components are: lactose monohydrate, corn starch, pregelatinized maize starch, magnesium stearate

What is POLARAMINE 2 mg, scored tablet and contents of the pack

This medication is in the form of a scored tablet. Box of 20, 28 or 30.

Not all pack sizes may be marketed.

Marketing Authorization Holder

BAYER HEALTHCARE SAS

220 avenue de la Recherche

59120 LOOS

LA FRANCE

Marketing Authorization Operator

BAYER HEALTHCARE SAS

33 rue de l'Industrie

74240 GAILLARD

LA FRANCE

Maker

SCHERING-PLOUGH LABO NV

INDUSTRIEPARK 30,

2220 HEIST-OP-DEN-BERG

Belgium

Or

AESICA PHARMACEUTICALS GMBH

ALFRED-NOBEL-STRASSE 10

40789 MONHEIM

GERMANY

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

Other

Detailed information on this medicine is available on the ANSM website (France).

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