CETIRIZINE SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Cetirizine Sandoz 10 mg Film-Coated Tablets EFG

Cetirizine Dihydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Cetirizine dihydrochloride is the active substance of Cetirizine Sandoz.

Cetirizine Sandoz is an antiallergic medicine.

Cetirizine Sandoz is indicated in adults and children aged 6 years and above for:

• relief of symptoms of seasonal and perennial allergic rhinitis and
• relief of chronic idiopathic urticaria.

2. What you need to know before you take Cetirizine Sandoz

Do not take Cetirizine Sandoz

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

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

Warnings and precautions

Consult your doctor before taking Cetirizine Sandoz.

If you have problems with urination (such as spinal cord or prostate problems, or bladder problems), please consult your doctor.

If you are a patient with 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 convulsions, consult your doctor.

If you are scheduled to undergo an allergy test, consult your doctor if you should discontinue 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 thousand (g/l), corresponding to a 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 take any other medicines.

Taking Cetirizine Sandoz with food and drinks

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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Cetirizine should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effects on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

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

Driving and using machines

Clinical studies have not shown evidence that cetirizine produces an alteration of the attention, reduction of the capacity of reaction and the ability to drive 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 use machinery. Do not exceed the recommended dose.

Cetirizine Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Cetirizine Sandoz

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed with a glass of liquid.

The tablet can be divided into equal doses.

Adults and adolescents over 12 years:

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:

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.

Patient with renal insufficiency

It is recommended that patients with moderate renal insufficiency take 5 mg once daily.

If you suffer from severe kidney disease, please contact your doctor or pharmacist, who may adjust the dose accordingly.

If your child suffers from kidney disease, please contact your doctor or pharmacist, who may 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 Cetirizine Sandoz than you should

If you have taken more Cetirizine Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 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 such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormally fast heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Sandoz

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

If you stop taking Cetirizine Sandoz

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

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

4. Possible side effects

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

Stop taking Cetirizine Sandoz and seek medical help immediately if you experience any of the following symptoms:

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

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

The following scheme contains other side effects that have been reported, listed by frequency.

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

• fatigue
• dry mouth, nausea, diarrhea
• dizziness, headache
• sleepiness (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 unwell in general)
• paresthesia (strange sensations in the skin)
• pruritus (itching), rash

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

• tachycardia (heart beats too fast)
• edema (swelling)
• abnormal 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 count in the blood, which is manifested by bleeding or bruising that appears more easily than normal)
• accommodation disorders (difficulty focusing), blurred vision, oculogyration (the eyes have an uncontrolled circular movement)
• syncope, tremor, dysgeusia (taste disorder), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions)
• tics (habitual spasms),
• abnormal urine elimination (bedwetting, pain and/or difficulty urinating)
• drug rash

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage temperature.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal product in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicinal product. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cetirizine Sandoz

Each tablet contains 10 mg of cetirizine dihydrochloride.

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

Core of the tablet:microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.

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

Appearance of the product and pack size

White, oblong, film-coated tablets with a score line on one side.

Available in PVC/Al blister packs in packs of: 7, 10, 14, 20, 21, 28, 30, 50, 60, 98, and 100 and 50 (50x1) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

This medicine is authorised 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 last revision of this leaflet: February 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/