10MG TABLETS 7 ALAIRGIX CETITRIZINE

10MG TABLETS 7 ALAIRGIX CETITRIZINE View larger

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Alairgix Cetirizine 10mg Tablets 7 on sale in our pharmacy bio, is indicated for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the treatment of symptoms of chronic urticaria (CIU).

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10MG TABLETS 7 ALAIRGIX CETITRIZINE

For warnings, precautions for use and cons-indications, see the instructions for use.

Description Alairgix Cetirizine 10mg Tablets 7

This drug is an anti-allergic antihistamine. Unlike older antihistamines, it has no atropine-like effects or, in most cases, sedation. It is used in the treatment of various allergic diseases: allergic rhinitis or conjunctivitis, urticaria.

Using advice from Alairgix Cetirizine 10mg Tablets 7

Oral use.

Dosage:

  • Adults and adolescents over 12 years: 1 tablet once daily.
  • Moderate to severe renal impairment: In patients with moderate to severe renal impairment, the dose will be respectively reduced to 5 mg once daily and 5 mg once every two days.


Place the tablet on the tongue and allow to melt before swallowing.

The tablet can also be dissolved in a liquid before being swallowed.

If you think the effect is too weak or too strong, consult your doctor.

Composition Alairgix Cetirizine 10mg Tablets 7

The active substance is cetirizine dihydrochloride. A lozenge containing 10 mg of cetirizine dihydrochloride.

The other ingredients are:

Betadex, povidone, sodium cyclamate, powdered cellulose, monosodium citrate, microcrystalline cellulose, magnesium stearate, flavor apple HR 290107.

Precaution of use

Do not take Cetirizine Alairgix 10mg Tablets 7 in the following cases:
if you have a severe kidney disease (severe renal failure with creatinine clearance below 10 ml / min);
if you are allergic to the active substance or to any of the other ingredients (excipients), to hydroxyzine or to piperazine derivatives (related substances contained in other medicines).

Take special care with Cetirizine 10mg Alairgix 7 Tablets:

  • If you have kidney disease, talk to your doctor; if necessary, you will take a lower dose. The new dose will be determined by your doctor.
  • If you have epilepsy or if you are at risk of convulsions, consult your doctor.
  • It is not likely to interact described to have a particular effect in the event of concomitant cetirizine (used at normal doses) and alcohol (at the blood level of 0.5 per mille corresponding to one glass wine). As with other antihistamine, it is nevertheless recommended to avoid taking alcohol during treatment.


Taking other medicines:
- If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
- Due to the profile of cetirizine, no interactions with other drugs are expected.

Introducing Alairgix Cetirizine 10mg Tablets 7

Box 7 lozenges.

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

VIDAL OF THE FAMILY

ALAIRGIX

Hypo-allergenic

cetirizine

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

PRESENTATIONS (summary)

ALAIRGIX: tablet to suck (apple aroma); box of 7.
-

French Pharmaceutical Cooperation Laboratory

COMPOSITION (summary)
p cp
Cetirizine dihydrochloride 10 mg

INDICATIONS (summary)
This drug is an antihistamine antiallergic. Unlike older antihistamines, it has no atropine effects and, in most cases, has no sedative effect.
It is used in the treatment of various allergic manifestations: allergic rhinitis or conjunctivitis , urticaria .
CONTRAINDICATIONS (summary)
This medication should not be used in patients with severe renal impairment .
WARNING (Contents)
This medication is over-the-counter. In the absence of medical advice, it should be used only in adults and children over 12 years of age, in the event of recurrence of symptoms already diagnosed by a physician and previously treated with a medicinal product containing the same substance (cetirizine).
Precautions are necessary in case of epilepsy or a history of convulsions .
Although there is no clear interaction with alcohol, avoid drinking alcohol during treatment.
This medication may, in rare cases, lead to decreased vigilance. Be sure to occasionally take the first shot that you bear it well, before driving or using a dangerous machine.
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.

Breastfeeding:
This drug passes weakly into breast milk. However, it is best not to use it without medical advice during breastfeeding.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets can be sucked or dissolved in a glass of water.

Usual dosage:

  • Adult and child over 12 years: 1 tablet per day.
In case of renal insufficiency , dose adjustment may be necessary.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Cetirizine acts on the manifestations of allergy but does not eliminate the cause. If symptoms persist after 3 days of treatment, consult your doctor.
POSSIBLE ADVERSE EFFECTS (summary)
Drowsiness, fatigue, dizziness , headache and more rarely, dryness of the mouth, disturbances of accommodation .
Other adverse effects were also observed:
  • uncommon: nausea, diarrhea, restlessness, tingling of the extremities, rash;
  • rarely: convulsions, confusion, tachycardia , increased transaminases ;
  • very rare: tremor, taste disturbance, edema of angioedema , decreased number of blood platelets.


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.


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.


antecedent
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


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 crisis 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.


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to excessive pain or stimulation of the brain: fever, poisoning, lack of oxygen, brain damage. Convulsions may be due to an epileptic seizure or high fever in young children.


epilepsy
A chronic seizure disorder associated with abnormal electrical activity of a group of brain cells. Its manifestations, varying in intensity, range from the sudden drop in attention (absences, or small evil) to loss of consciousness accompanied by abnormal muscle movements (convulsions, or great evil). Partial epilepsy, as its name implies, does not concern the whole body: the jerky movements only touch one or more muscle groups.


renal failure
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.


edema
Accumulation of water or lymph causing localized swelling.


angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.


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) .


sedative
  • 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.


tachycardia
Accelerating the rhythm of the heartbeat. It may be due to fever, hyperthyroidism, heart disease, certain medications, and so on.


transaminases
Enzymes dosed in the blood, which rate rises during some hepatitis. They are included in blood tests as SGOT and SGPT or ASAT and ALAT.


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).

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NOTICE

ANSM - Last update: 23/08/2012

Name of the medicinal product

ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet

Cetirizine dihydrochloride

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.

· However, given its indication in the treatment of symptoms of chronic urticaria, medical advice is recommended to help you use it well, at least the first time.

· If symptoms persist after 3 days of treatment, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.

· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.

DO NOT LEAVE THIS MEDICINE FOR CHILDREN.

Review summary

In this notice :

1. WHAT IS ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable suckable tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable?

3. HOW TO TAKE ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable suckable tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

Cetirizine dihydrochloride is the active substance of ALAIRGIX ALLERGY CETIRIZINE.

ALAIRGIX ALLERGY CETIRIZINE is an antiallergic drug.

Therapeutic indications

In adults and adolescents over the age of 12, ALAIRGIX ALLERGY CETIRIZINE is indicated:

· for the treatment of nasal and ocular symptoms of seasonal or perennial allergic rhinitis,

· for the treatment of symptoms of chronic urticaria (idiopathic chronic urticaria).
A medical opinion is recommended for idiopathic chronic urticaria.

2. BEFORE YOU TAKE ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable?

List of information needed before taking the medication

Not applicable.

Cons-indications

Never take ALAIRGIX ALLERGY CETIRIZINE 10 mg tablet to be sucked in the following cases:

· if you have severe kidney disease (severe renal insufficiency with a creatinine clearance of less than 10 ml / min);

· if you are allergic to the active substance of ALAIRGIX ALLERGY CETIRIZINE or to any of the other ingredients (excipients), to hydroxyzine or to piperazine derivatives (related substances contained in other medicines).

Precautions for use; special warnings

Take special care with ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet:

If you have kidney failure, seek advice from your doctor; if necessary, you should take a lower dose. The appropriate dosage will be determined by your doctor.

If you are an epileptic or if you are at risk of seizures, ask your doctor for advice.

There is no description of any interaction that may have a particular effect in the concomitant use of cetirizine (used in normal doses) and alcohol (up to a blood concentration of 0.5 per thousand corresponding to a glass of wine). As with any other antihistamine, it is nevertheless recommended to avoid taking alcohol during treatment.

Interaction with other medicines

Taking other medicines:

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Due to the profile of cetirizine, no interaction with other drugs is expected.

Interactions with food and beverages

Food and drinks

Food intake does not significantly affect the absorption of cetirizine.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

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

As with other medicines, the use of ALAIRGIX ALLERGY CETIRIZINE should be avoided during pregnancy.

Accidental use during pregnancy should not affect the fetus. However, it is preferable as a precautionary measure to avoid further treatment.

ALAIRGIX ALLERGY CETIRIZINE should not be taken during breast-feeding because of its passage through breast milk.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines:

Clinical studies did not demonstrate impaired vigilance, reaction time or ability to drive after administration of ALAIRGIX ALLERGY CETIRIZINE at recommended doses.

If you are likely to drive a vehicle or handle a potentially hazardous tool or machine, you should not exceed the recommended dose. You should carefully evaluate your response to cetirizine treatment beforehand.

In some susceptible patients, concomitant use of alcohol or other central nervous system depressants may result in decreased attention or ability to respond.

List of excipients with known effect

Not applicable.

3. HOW TO TAKE ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

How and when should you take ALAIRGIX ALLERGY CETIRIZINE

These instructions should be followed unless your doctor has given you different instructions on how to use ALAIRGIX ALLERGY CETIRIZINE.

Follow these instructions, otherwise ALAIRGIX ALLERGY CETIRIZINE may not be completely effective.

Dosage

Adults and adolescents over 12 years:

10 mg once daily or 1 tablet.

Moderate to severe renal impairment:

In patients with moderate to severe renal impairment, the dose will be reduced to 5 mg once daily and 5 mg once every two days.

If you think the effect of ALAIRGIX ALLERGY CETIRIZINE is too weak or too strong, talk to your doctor.

Administration mode

Oral use.

Place the tablet on the tongue and let it melt before swallowing.

Instruction for good use:

1. Detach a square from the blister along the pre-cut line.

2. Remove the protective film.

3. Grasp the tablet.

4. Place the tablet on the tongue and allow to dissolve.

The tablet can also be dissolved in a little water before being swallowed.

Duration of treatment

The duration of treatment depends on the type, duration and your symptoms and is determined by your doctor.

Symptoms and Instructions for Overdose

If you take more ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet you should not have:

Contact your doctor if you think you have taken more tablets of ALAIRGIX ALLERGY CETIRIZINE than it should. Your doctor will decide, if necessary, what to do.

In case of overdose, the side effects described below may occur with an increased intensity. Side effects such as confusion, diarrhea, dizziness, tiredness, headache, feeling sick, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, abnormal increase in heart rate, tremors and urinary retention have been reported.

Instructions for omission of one or more doses

If you forget to take ALAIRGIX ALLERGY CETIRIZINE 10 mg tablet to suck breakable:

Do not take a double dose to make up for a missed dose.

Risk of withdrawal syndrome

If you stop taking ALAIRGIX ALLERGY CETIRIZINE 10 mg tablet to suck breakable:

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

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable is likely to have undesirable effects although not everyone is subject.

Since commercialization, the following adverse reactions have been reported. Their frequency was defined as: (Frequent: 1 in 100 to 1 in 10, uncommon: 1 in 1000 to 1 in 100, rare: 1 in 10,000 to 1 in 1,000, very rare: less than 1 out of 10,000).

· Blood and lymphatic system disorders:
Very rare: thrombocytopenia (decreased blood platelets)

· General condition disorders:
Common: fatigue

· Cardiac disorders:
Rare: tachycardia (heartbeat too fast)

· Eye disorders:
Very rare: disorders of accommodation, blurred vision, oculogyre crises (uncontrolled circular movements of the eyes)

· Gastrointestinal disorders:
Common: dry mouth, nausea, diarrhea
Uncommon: abdominal pain.

· General disorders and administration site conditions:
Uncommon: asthenia (extreme fatigue), malaise,
Rare: swelling (subcutaneous swelling)

· Immune system disorders:
Rare: allergic reactions, sometimes severe (very rare)

· Hepatobiliary disorders:
Rare: abnormal liver function (increased liver enzymes)

· investigations:
Rare: weight gain

· Nervous system disorders:
Common: vertigo, headache
Uncommon: paresthesia (abnormal sensation in the skin)
Rare: convulsions, abnormal movements
Very rare: syncope, tremor, dysgeusia (altered taste)

· Psychiatric disorders:
Common: somnolence
Uncommon: restlessness
Rare: aggressiveness, confusion, depression, hallucination, insomnia
Very rare: tic

· Renal and urinary disorders:
Very rare: difficulty passing urine

· Respiratory disorders:
Common: pharyngitis, rhinitis

· Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: edema, fixed pigmented erythema.

If you develop any of the side effects listed above, please tell your doctor. At the first signs of allergic reaction, stop taking ALAIRGIX ALLERGY CETIRIZINE. Your doctor will assess the severity and decide what to do if necessary.

If you experience any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use ALAIRGIX ALLERGY CETIRIZINE 10 mg, suckable tablet after the expiry date stated on the carton and blister.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What contains ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck breakable?

The active substance of ALAIRGIX ALLERGY CETIRIZINE is cetirizine dihydrochloride. One tablet to be sucked contains 10 mg of cetirizine dihydrochloride.

The other components are:

Betadex, povidone, sodium cyclamate, powdered cellulose, monosodium citrate, microcrystalline cellulose, magnesium stearate, apple flavor HR 290107.

Pharmaceutical form and content

What is ALAIRGIX ALLERGY CETIRIZINE 10 mg, tablet to suck scored and contents of the outer packaging?

This medication is in the form of a tablet to be sucked. Box of 7 tablets.

The tablet may be divided into equal doses.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN-AUVERT

77020 MELUN CEDEX

exploiting

FRENCH PHARMACEUTICAL COOPERATION

PLACE LUCIEN AUVERT

77020 MELUN CEDEX

Maker

LOSAN PHARMA GMBH OTTO-HAHN-STRASSE

13 - D-79395 NEUENBURG

GERMANY

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

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable.

Other

ADVICE / HEALTH EDUCATION

a) What is an allergy, what is an allergic reaction?

Allergy is an overreaction of our body to substances it considers harmful: allergens. Allergens are the factors and substances triggering allergy and associated disorders.

During repeated and intensive contacts of our body with the allergen, an allergic reaction is triggered.

The allergic reaction refers to all symptoms appearing a few minutes or hours after exposure to allergens. These allergens come from plants, animal hair, food, dust mites, molds or are substances of occupational origin.

This allergic reaction causes the release in the body of substances such as the histamine responsible for the disorders felt.

Like any allergic disease, it is important to consult a doctor at least once. IT SHALL DETERMINE IN PARTICULAR THE NEED TO CARRY OUT AN ALLERGOLOGICAL BALANCE SHEET.

b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis, localized acute urticaria?

Allergic rhinitis results in the following symptoms: successive sneezing, colorless nasal discharge, nasal obstruction (stuffy nose), itching and tingling of the nose. It may be accompanied by irritations of both eyes (tearing, redness), throat and nose.

We distinguish:

· Seasonal allergic rhinitis or hay fever : occur every year in the same season, when the concentration of pollen increases in the air. These allergies due to pollen are very common and usually manifest for the first time during adolescence. They are repeated every year at the same time, depending on the presence of the responsible pollen (s). However, you are not allergic to all pollens, but to one or more of them only.

· Perennial allergic rhinitis occurs throughout the year and most often depends on domestic allergens such as dust mites, dust, mold, and domestic animals.

· Allergic conjunctivitis is characterized by tearing and tingling of both eyes.

· The localized acute urticaria results in plaques with itching, redness, edema (swelling).

c) Some practical tips

Removing the allergen (is foreclosure) is the measure of choice to suppress or reduce the symptoms of allergy.

For household allergens: measures to reduce the presence of allergens are essential:

· The mattress should be completely surrounded by a plastic dust mite cover as well as the pillows. The bed base, unless it is in slats or metal, shall be surrounded by a plastic. All bedding should be washed twice a month at 60 ° C if possible.

· The room should be ventilated and cleaned regularly.

· On the floor, you will avoid bed runs and carpets.

· Avoid pets.

During the pollen season it is possible to reduce the exposure to pollen:

· In your garden, diversify the plantations avoiding the most allergenic species (cypress, thuja, birch ...),

· Avoid lawn mowing yourself during the pollen season,

· Garde preferably with glasses and a protective mask.

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