CETIRIZINE RATIOPHARM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine ratiopharm 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 package leaflet

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

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

Cetirizine dihydrochloride is the active substance of Cetirizine ratiopharm.

Cetirizine ratiopharm is an antiallergic medicine.

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

• For the relief of symptoms of seasonal and perennial allergic rhinitis and urticaria.

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

Do not take Cetirizine ratiopharm

• if you have severe renal impairment (severe renal failure with creatinine clearance below 10 ml/min).
• if you know that you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (described in section 6), or to hydroxyzine or piperazine derivatives (closely related active substances of other medicines),

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine ratiopharm.

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

If you have problems eliminating urine (such as spinal cord problems or prostate or bladder problems), consult your doctor.

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

No clinically significant interactions have been observed between alcohol (blood alcohol levels of 0.5 per thousand (g/l) corresponding to a glass of wine) and cetirizine used at the recommended doses. However, there are no data available on safety when administered at higher doses with alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine ratiopharm with alcohol.

If you are going to undergo allergy testing, consult your doctor if you should stop taking Cetirizine ratiopharm several days before the test. This medicine may alter the results of allergy tests.

Children

Do not give this medicine to children under 6 years of age because the tablet formulation does not allow for the necessary dose adjustments.

Taking Cetirizine ratiopharm with other medicines

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

Taking Cetirizine ratiopharm with food and drinks

Food does not affect the absorption of Cetirizine ratiopharm.

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 ratiopharm should be avoided in pregnant women. Accidental use of the medicine by a pregnant woman will not produce any harmful effect on the fetus. However, this medicine should only be administered if necessary and after medical advice has been obtained.

Cetirizine passes into breast milk. The risk of side effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine ratiopharm during breastfeeding unless your doctor advises you to do so.

Driving and using machines

In clinical studies, no clinical evidence of decreased attention, alertness, and ability to drive has been observed after taking cetirizine dihydrochloride at the recommended doses.

You should see your individual response after taking Cetirizine ratiopharm if you are going to drive, perform hazardous activities, or work with machines. Do not exceed the recommended dose.

Cetirizine ratiopharm contains lactose

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

Cetirizine ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Cetirizine ratiopharm

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 (1 tablet) once daily.

Other pharmaceutical forms may be suitable for children; ask your doctor or pharmacist.

Children between 6 and 12 years:

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

Other pharmaceutical forms may be suitable for children; ask your doctor or pharmacist.

Patients with renal insufficiency

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

If you suffer from severe kidney disease, contact your doctor or pharmacist so that they can adjust the dose accordingly.

If your child suffers from severe kidney disease, contact your doctor or pharmacist so that they can adjust the dose accordingly to your child's needs.

If you feel that the effect of Cetirizine ratiopharm is too weak or too strong, contact 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 ratiopharm than you should

If you think you have taken an overdose of Cetirizine ratiopharm, consult your doctor. Your doctor will decide what measures, if any, should be taken.

After an overdose, the following adverse effects may occur with greater intensity. The following adverse effects have been described: confusion, diarrhea, dizziness, fatigue, headache, feeling unwell, pupil dilation, pruritus, agitation, sedation, somnolence, stupor, abnormally rapid heartbeats, tremors, and urinary retention.

In case of overdose or accidental ingestion, consult the Toxicology Information Service telephone: 91 562 04 20.

If you forget to take Cetirizine ratiopharm

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

If you stop taking Cetirizine ratiopharm

Rarely, pruritus (intense itching) and/or urticaria may reappear if you stop taking Cetirizine ratiopharm.

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

4. Possible side effects

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

The following side effects are rare or very rare, but you must stop taking the medicine and inform your doctor immediately if you notice any of them:

• Allergic reactions including severe reactions and angioedema (serious allergic reaction that causes swelling of the face or throat)

These reactions can start when you start taking the medicine or may start later.

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

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal sensations in the skin)
• Abdominal pain
• Pruritus (itching), rash
• Asthenia (extreme fatigue), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Seizures
• Tachycardia (abnormally rapid heartbeats)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low platelet count in the blood)
• Tics (involuntary habits)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremors, dysgeusia (altered taste)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (uncontrolled circular eye movements)
• Angioedema (serious reactions that cause swelling of the face or throat, drug-related rash
• Abnormal urine elimination (bedwetting, pain and/or difficulty urinating)

Side effects of unknown frequency(cannot be estimated from the available data):

• Increased appetite
• Suicidal thoughts (recurring thoughts or concerns about suicide), nightmares
• Amnesia, memory failure
• Vertigo (sensation of rotation or movement)
• Urinary retention (inability to complete emptying of the urinary bladder)
• Pruritus (intense itching) and/or urticaria after discontinuation
• Limbs pain
• Blistering rash
• Hepatitis (liver inflammation)

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 through the Spanish Medicines Monitoring System website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine ratiopharm

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizine ratiopharm

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are:

Core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate,

Coating: titanium dioxide (E-171), hypromellose (E464), macrogol 400.

Appearance of the product and contents of the pack

White to off-white film-coated tablet with a score line on one side.

Cetirizine ratiopharm is available in blister packs containing 2, 7, 10, 14, 20, 20x1, 30, 50, 90, 100, or 100x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid

Manufacturers:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 - Blaubeuren (Germany)

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

Belgium Cetirizine Teva 10 mg film-coated tablets

Norway Cetirizin ratiopharm 10 mg tablets

Portugal Allertek

Spain Cetirizina ratiopharm 10 mg film-coated tablets EFG

Date of last revision of this leaflet: February 2021

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/