1. WHAT IS CETIRIZINE SANDOZ 10 mg, scored film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: PIPERAZINE DERIVATIVES - ATC code: R06AE07.
Cetirizine dihydrochloride is the active substance in CETIRIZINE SANDOZ.
CETIRIZINE SANDOZ is an anti-allergy medicine.
In adults and children aged 6 years and over, CETIRIZINE SANDOZ is indicated:
Forthe treatment of nasal and ocular symptoms of seasonal or perennial allergic rhinitis,
forthe treatment of symptoms of urticaria.
2. WHAT YOU SHOULD KNOW BEFORE TAKING CETIRIZINE SANDOZ 10 mg, scored film-coated tablet
If your doctor has told you that you are intolerant to certain sugars, contact your doctor before taking this medicine.
Never take CETIRIZINE SANDOZ 10 mg scored film-coated tablet:
-ifyou are allergic (hypersensitive) to cetirizine dihydrochloride or hydroxyzine or piperazine derivatives (related substances in other medicines) or to any of the other ingredients in this medicine, mentioned in section 6.
ifyou have severe kidney disease (severe renal insufficiency with a creatinine clearance of less than 10 ml/min).
Warnings and precautions
Talk to your doctor or pharmacist before taking CETIRIZINE SANDOZ 10 mg, scored film-coated tablet
If you have kidney failure, ask your doctor for advice; if necessary, you should take a lower dose. The appropriate dosage will be determined by your doctor.
If you have epilepsy or are at risk of seizures, ask your doctor for advice.
If you have difficulty in urinating, ask your doctor for advice.
No interactions have been described that would have a particular effect when cetirizine (used in normal doses) is taken together with alcohol (up to the blood concentration of 0.5 per thousand corresponding to a glass of wine). However, no data are available with larger doses of cetirizine and alcohol. As with any other antihistamine, it is nevertheless recommended that alcohol be avoided during treatment.
If you need to have tests done to diagnose the allergy (e.g. skin test), you should stop taking this medicine at least 3 days before the test as it may affect the results.
Ask your doctor what to do before you have the allergy test.
This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
Other medicines and CETIRIZINE SANDOZ 10 mg, scored film-coated tablet
Tell 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.
CETIRIZINE SANDOZ 10 mg, scored film-coated tablet with food and drink
Food intake does not significantly affect the absorption of cetirizine.
Pregnancy and Nursing
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicineor pharmacist before taking this medicine.
As with other drugs, the use of CETIRIZINE SANDOZ should be avoided during pregnancy.
Accidental use during pregnancy is not expected to affect the fetus. However, as a precautionary measure, continued use should be avoided.
CETIRIZINE SANDOZ should not be taken during breast-feeding because of its passage into breast milk.
Athletes
Not applicable.
Driving and Use of Machinery
Clinical studies have not shown any impairment of alertness, reaction time or ability to drive after administration of CETIRIZINE SANDOZ at the recommended doses.
If you are likely to drive or operate potentially dangerous machinery, you should not exceed the recommended dose. Your response to cetirizine therapy should be carefully evaluated before use.
In some sensitive patients, the concomitant use of alcohol or other central nervous system depressants may result in decreased attention or responsiveness.
CETIRIZINE SANDOZ 10 mg, scored film-coated tablet contains lactose.
3. HOW DO I TAKE CETIRIZINE SANDOZ 10 mg, scored film-coated tablet?
Always take this medicine exactly as your doctor or pharmacist has instructed. Check with your doctor or pharmacist if you are not sure.
How and when should you take CETIRIZINE SANDOZ?
These instructions should be followed unless your doctor has given you different instructions on how to use CETIRIZINE SANDOZ.
Follow these instructions, otherwise CETIRIZINE SANDOZ may not be completely effective.
The tablets should be swallowed with a drink.
Adults and adolescents over 12 years of age :
10 mg once daily, or 1 tablet.
Children 6 to 12 years of age:
The use of this drug is not recommended in children under 6 years of age as this form does not allow for dosage adjustment in this age group.
5 mg twice daily, i.e. half a tablet twice daily.
Moderate to Severe Renal Impairment:
In patients with moderate to severe renal impairment, the dose will be reduced to 5 mg once daily or every other day depending on the severity of renal impairment (creatinine clearance).
If you think the effect of CETIRIZINE SANDOZ is too weak or too strong, consult your doctor.
Duration of treatment:
The duration of treatment depends on the type, duration and your symptoms and is determined by your doctor.
If you have taken more CETIRIZINE SANDOZ 10 mg, scored film-coated tablet than you should have:
Contact your doctor if you think you have taken more CETIRIZINE SANDOZ tablets than you should. Your doctor will decide what action, if any, to take.
In the event of an overdose, the side effects described below may appear with increased intensity. Undesirable effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, agitation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor and urinary retention have been reported.
If you forget to take CETIRIZINE SANDOZ 10 mg, scored film-coated tablet:
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking CETIRIZINE SANDOZ 10 mg, scored film-coated tablet:
If you have any further questions about using this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, but they do not always occur in everyone.
The following side effects are rare or very rare; however, if they occur, you should stop your treatment immediately and consult your doctor:
- ·Allergic reactions, including severe reactions and angioedema (severe allergic reaction causing swelling of the face and throat).
These reactions may occur immediately or after a delay in taking the medication.
Common adverse reactions (may occur in up to 1 in 10 patients)
- ·Drowsiness,
- ·Dizziness, headache,
- ·Pharyngitis, rhinitis (in children),
- ·Diarrhea, nausea, dry mouth,
- ·Fatigue.
Uncommon side effects (may occur in up to 1 in 100 patients)
- ·Agitation,
- ·Paraesthesia (abnormal tactile sensation in the skin),
- ·Abdominal pain,
- ·Pruritus (itching), rash,
- ·Asthenia (severe fatigue), malaise.
Rare adverse reactions (may occur in up to 1 in 1,000 patients)
- ·Allergic reactions, sometimes severe (very rare),
- ·Depression, hallucinations, aggression, confusion, insomnia,
- ·Convulsions, abnormal movements,
- ·Tachycardia (rapid heartbeat),
- ·Abnormalities in liver function,
- ·Urticaria,
- ·Edema (swelling),
- ·Weight gain.
Very rare side effects (may occur in up to 1 in 10,000 patients)
- ·Thrombocytopenia (decrease in blood platelets),
- ·Tics (repeated involuntary muscle contractions),
- ·Syncope, dyskinesia (involuntary movements), dystonia (abnormally prolonged muscle contraction), tremors, dysgeusia (taste alteration),
- ·Blurred vision, accommodation disorders (difficulty seeing clearly), oculogyric seizures (uncontrolled circular eye movements),
- ·Angioedema (severe allergic reaction causing swelling of the face and throat), fixed erythema pigmentosum,
- ·Urine elimination disorders (bedwetting, pain).
Undesirable effects of undetermined frequency (frequency of occurrence cannot be estimated on the basis of available data)
- ·Amnesia, memory impairment,
- ·Increased appetite,
- ·Suicidal ideation,
- ·Dizziness,
- ·Difficulty urinating.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres
By reporting adverse reactions, you contribute to providing more information on the safety of the medicine.
5. HOW TO USE CETIRIZINE SANDOZ 10 mg, scored film-coated tablet
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box and blister. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
Do not dispose of any medicine in the sewer or in the household waste. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What CETIRIZINE SANDOZ 10 mg, scored film-coated tablet contains
The active substance is :
Cetirizine dihydrochloride............................................................................................... 10 mg
For one scored film-coated tablet.
The other components are:
Core: Lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Film coating: OPADRY WHITE (lactose monohydrate, titanium dioxide (E171), hypromellose (E464), macrogol 4000).
What CETIRIZINE SANDOZ 10 mg, scored film-coated tablet is and what it contains
This medicine is presented as scored film-coated tablets. Box of 15 tablets.
Marketing authorisation holder
SANDOZ
49 AVENUE GEORGES POMPIDOU
92593 LEVALLOIS-PERRET CEDEX
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