DRILL ALLERGY CETIRIZINE 10MG TABLETS 7

NOTICE

ANSM - Last updated: 13/06/2017

Name of the medicinal product

DRILL ALLERGY CETIRIZINE 10 mg tablet to suck

Cetirizine dihydrochloride

framed

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

You should always use 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 3 days.

What is in this leaflet?

1. What is DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck and in which cases it is used?

2. What should be known before taking DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck?

3. How to take DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck?

4. What are the possible side effects?

5. How to store DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck?

6. Package contents and other information.

1. WHAT IS DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck AND WHAT IS IT USED FOR?

Cetirizine dihydrochloride is the active substance in DRILL ALLERGY CETIRIZINE.

DRILL ALLERGY CETIRIZINE is an antiallergic drug.

In adults and adolescents over 12 years of age, DRILL 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 DRILL ALLERGY CETIRIZINE 10 mg, sucked tablet?

Do not take DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck:

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

· if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medication mentioned in section 6, to hydroxyzine or to piperazine derivatives (related substances contained in other medicines.

Warnings and Precautions

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.

Talk to your doctor or pharmacist before taking DRILL ALLERGY CETIRIZINE .

children

Not applicable.

Other medicines and DRILL ALLERGY CETIRIZINE 10 mg, sucked tablet

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

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

DRILL ALLERGY CETIRIZINE 10 mg, sucking tablet with food and beverages

Food intake does not significantly affect the absorption of cetirizine.

Pregnancy and breast feeding

As with other medicines, the use of DRILL 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.

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

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

Driving and using machines

Clinical studies did not demonstrate impaired vigilance, reaction time, or ability to drive after administration of DRILL 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.

DRILL ALLERGY CETIRIZINE 10 mg, sucking tablet contains

Not applicable.

3. HOW TO TAKE DRILL ALLERGY CETIRIZINE 10 mg, sucked tablet?

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.

How and when should you take DRILL ALLERGY CETIRIZINE?

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

Follow these instructions, otherwise DRILL 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 DRILL 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.

If you take more DRILL ALLERGY CETIRIZINE 10 mg tablet to suck you should not have

Immediately consult your doctor or pharmacist.

Contact your doctor if you think you have taken more DRILL ALLERGY CETIRIZINE tablets than you 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.

If you forget to take DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck

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

If you stop taking DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck

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.

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 DRILL ALLERGY CETIRIZINE 10 mg, tablet to suck. Your doctor will assess the severity and decide what to do if necessary.

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 DRILL ALLERGY CETIRIZINE 10 mg, sucked 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 and blister 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 DRILL ALLERGIE CETIRIZINE 10 mg contains: tablet to suck

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

· The other ingredients are: Betdex (contains glucose), povidone, sodium cyclamate, powdered cellulose, monosodium citrate, microcrystalline cellulose, magnesium stearate, apple flavor (contains maltodextrin).

What is DRILL ALLERGIE CETIRIZINE 10 mg tablets and contents of the pack

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

Marketing Authorization Holder

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Marketing Authorization Operator

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

Maker

LOSAN PHARMA GmbH

OTTO-HAHN-STRASSE 13

79395 NEUENBURG

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).

Health Education Advice

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.

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.

VIDAL OF THE FAMILY

DRILL ALLERGIE