Cetirizine Sandoz 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Cetirizine Sandoz 10 mg film-coated tablets EFG

Cetirizine dihydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Cetirizine Sandoz is and what it is used for
2. What you need to know before taking Cetirizine Sandoz
3. How to take Cetirizine Sandoz
4. Possible side effects
5. How to store Cetirizine Sandoz
6. Contents of the pack and other information

1. What Cetirizina Sandoz is and what it is used for

Cetirizine dihydrochloride is the active substance in Cetirizina Sandoz.

Cetirizina Sandoz is an antiallergic medicine.

Cetirizina Sandoz is indicated in adults and children aged 6 years and older for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis,
• relief of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizine Sandoz

Do not take Cetirizine Sandoz

• if you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min),

• if you are allergic to cetirizine dihydrochloride, hydroxyzine, piperazine derivatives (active substances closely related to other medicines), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Cetirizine Sandoz.

If you have difficulty urinating (such as spinal cord or prostate problems, or bladder issues), please consult your doctor.

If you have renal insufficiency, please consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

If you are an epileptic patient or a patient at risk of seizures, consult your doctor.

If you are scheduled to undergo an allergy test, consult your doctor whether you should stop taking cetirizine a few days before the test. This medicine may affect the results of your allergy tests.

No clinically significant interactions have been observed between alcohol (with a blood level of 0.5 per mille (g/l), corresponding to one glass of wine) and the use of cetirizine at normal doses. However, safety data are not available when higher doses of cetirizine and alcohol are taken together.

Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

Children

Do not give this medicine to children under 6 years of age, as this formulation does not allow for the necessary dose adjustment.

Taking Cetirizine Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking Cetirizine Sandoz with food and drink

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Cetirizine should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with the doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take cetirizine while breastfeeding unless advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine causes disturbances in attention, reduced reaction ability, or impaired driving skills at the recommended dose.

You should carefully observe your response to the medicine after taking cetirizine if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizine Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Cetirizina Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablets must be swallowed with a glass of liquid.

The tablet may be divided into equal doses.

Adults and adolescents over 12 years of age:

The recommended dose is 10 mg once daily as 1 tablet.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Use in children between 6 and 12 years of age:

The recommended dose is 5 mg twice daily as half a tablet twice daily.

Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.

Patients with renal impairment

Patients with moderate renal impairment are recommended to take 5 mg once daily.

If you suffer from severe renal disease, please contact your doctor or pharmacist, who can appropriately adjust the dose.

If your child suffers from renal disease, please contact your doctor or pharmacist, who can adjust the dose according to your child's needs.

If you notice that the effect of this medicine is too weak or too strong, consult your doctor.

Duration of treatment:

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

If you take more Cetirizina Sandoz than you should

If you have taken more Cetirizina Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount used.

After an overdose, the adverse reactions described below may occur with greater intensity. Adverse effects reported include confusion, diarrhea, dizziness, fatigue, headache, weakness, pupillary dilation, tingling, irritation, sedation, somnolence, stupor, abnormally increased heart rate, tremor, and urinary retention.

If you forget to take Cetirizina Sandoz

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

If you stop taking Cetirizina Sandoz

In rare cases, itching (intense pruritus) and/or urticaria may reappear if you stop taking cetirizine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Cetirizine Sandoz and seek immediate medical help if you experience any of the symptoms listed below:

• swelling of the mouth, face and/or throat,
• difficulty breathing (tightness in the chest or wheezing),
• sudden drop in blood pressure leading to fainting or shock.

These symptoms may be signs of allergic reactions, anaphylactic shock, and angioedema. These reactions may begin immediately after the first dose of this medicine or may start later.

The table below lists other adverse effects that have been reported, categorized by frequency.

Common (may affect up to 1 in 10 people):

• fatigue
• dry mouth, nausea, diarrhea
• dizziness, headache
• somnolence (drowsiness)
• pharyngitis (sore throat), rhinitis (swelling and irritation inside the nose)

Uncommon (may affect up to 1 in 100 people):

• agitation
• abdominal pain
• asthenia (extreme fatigue), malaise (feeling generally unwell)
• paresthesia (abnormal sensations in the skin)
• pruritus (itching), rash

Rare (may affect up to 1 in 1,000 people):

• tachycardia (rapid heartbeat)
• edema (swelling)
• altered liver function
• weight gain
• seizures
• aggression, confusion, depression, hallucination, insomnia
• urticaria (hives)

Very rare (may affect up to 1 in 10,000 people):

• thrombocytopenia (low platelet levels in the blood, manifested by bleeding or bruising more easily than normal)
• accommodation disorders (difficulty focusing), blurred vision, oculogyration (eyes making uncontrolled circular movements)
• syncope, tremor, dysgeusia (taste disturbance), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions)
• tics (habitual spasms)
• abnormal urination (bedwetting, pain and/or difficulty urinating)
• drug-related rash

Frequency not known (frequency cannot be estimated from available data):

• amnesia, memory impairment
• increased appetite
• vertigo (sensation of spinning or movement)
• urinary retention (inability to completely empty the bladder)
• nightmares
• hepatitis (inflammation of the liver)
• joint pain
• blistering rash containing pus
• pruritus (intense itching) and/or urticaria after discontinuation of treatment
• suicidal thoughts (recurrent thoughts or obsession with suicide).

If you experience any of these symptoms, stop taking the medicine and consult your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Sandoz

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Cetirizine Sandoz

Each tablet contains 10 mg of cetirizine dihydrochloride.

• The active substance is cetirizine dihydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica.

Coating: hypromellose, lactose monohydrate, titanium dioxide (E171) and macrogol 4000.

Appearance of the product and contents of the pack

Film-coated white, oblong tablets, scored on one side.

Presented in PVC/Al blisters, in pack sizes of: 7, 10, 14, 20, 21, 28, 30, 50, 60, 98 and 100 and 50 (50x1) film-coated tablets in unit dose packs.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Cetirizin Sandoz 10 mg - Filmtabletten

Hungary: Cetirizin 1A Pharma 10 mg filmtabletta

Italy: Cetirizine Sandoz

Portugal: CETIRIZINA SANDOZ

Slovakia: Cetirizine Sandoz 10 mg

Slovenia: Cetirizin Lek 10 mg filmsko obložene tablete

United Kingdom: Cetirizine Hydrochloride 10mg tablets

Date of the most recent review of this leaflet: February 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/