Package Leaflet: Information for the User

Cetirizine ratiopharm 10 mg Film-Coated Tablets

cetirizine dihydrochloride

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

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Cetirizine ratiopharm

3. How to take Cetirizine ratiopharm

4. Possible side effects

5. Storage of Cetirizine ratiopharm

6. Contents of the pack and additional information

Cetirizine dihydrochloride is the active ingredient of Cetirizina ratiopharm.

Cetirizina ratiopharm is an antihistamine medication.

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

• For the relief of nasal and ocular symptoms caused by seasonal and perennial allergic rhinitis.
• For the relief of urticaria.

Do not take Cetirizina ratiopharm

• if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10 ml/min).
• if you know that you are allergic to cetirizine dihydrochloride or to any of the other components of this medication (described in section 6), or to hydroxyzine or to piperazine derivatives (closely related active principles of other drugs),

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizina 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 seizures, 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 available data on the safety when administered at higher doses with alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina ratiopharm with alcohol.

If you have planned allergy tests, consult your doctor if you should stop taking Cetirizina ratiopharm several days before the test. This medication may alter the results of allergy tests.

Children

Do not administer this medication to children under 6 years old because the tablet formulation does not allow for the necessary dose adjustments..

Taking Cetirizina ratiopharm with other medications

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

Taking Cetirizina ratiopharm with food and drinks

Food does not affect the absorption of Cetirizina ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Cetirizina ratiopharm should be avoided in pregnant women. Accidental use of the medication by a pregnant woman will not cause any harmful effects on the fetus. However, this medication should only be administered if necessary and after consulting a doctor.

Cetirizine passes into breast milk. The risk of secondary effects in breastfed infants cannot be ruled out. Therefore, you should not take Cetirizina ratiopharm during breastfeeding unless your doctor advises you otherwise.

Driving and operating machines

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

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

Cetirizina ratiopharm contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Cetirizina ratiopharm contains sodium

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

Follow exactly the administration instructions of this medication indicated 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 a day.

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 tablet) twice a day.

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

Patients with renal insufficiency

Patients with moderate renal insufficiency are recommended to take 5 mg once a day.

If you suffer from severe kidney disease, contact your doctor or pharmacist to adjust your dose appropriately.

If your child suffers from severe kidney disease, contact your doctor or pharmacist to adjust the dose appropriately for your child's needs.

If you feel that the effect of Cetirizina ratiopharm is very weak or very strong, contact your doctor.

Treatment duration

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

If you take more Cetirizina ratiopharm than you should

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

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, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, abnormal heart rate, tremors, and urinary retention.

In case of overdose or accidental ingestion, consult the Toxicological Information Service at phone: 91 562 04 20.

If you forgot to take Cetirizina ratiopharm

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Cetirizina ratiopharm

Rarely, itching and/or urticaria may recur if you stop taking Cetirizina ratiopharm.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following medicines 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 facial or throat inflammation)

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

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

• Drowsiness (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 skin sensations)
• Abdominal pain
• Pruritus (skin itching), rash
• Asthenia (extreme fatigue),unpleasantness

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 (very 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 blood)
• Tics (habitual spasmodic movements)
• 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 facial or throat swelling, medication-related rash)
• Abnormal urination (bedwetting, pain, and/or difficulty urinating)

Side effects of unknown frequency(cannot be estimated based on available data):

• Increased appetite
• Suicidal thoughts (recurring thoughts or concern about suicide), nightmares
• Amnesia, memory failure
• Dizziness (sensation of rotation or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria after discontinuation
• Extremity pain
• Rash with pus-filled blisters
• Hepatitis (liver inflammation)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of the medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the blister, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of Cetirizina ratiopharm

• The active ingredient is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components 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 packaging

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

Cetirizina ratiopharm is available in blister packs containing 2, 7, 10, 14, 20, 20x1, 30, 50, 90, 100, or 100 x 1 film-coated tablets.

Not all package sizes may be marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing:

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Manufacturing Responsible Parties:

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 - Blaubeuren (Germany)

This medicine is authorized in the member states of the European Economic Area with the following names:

BelgiumCetirizine Teva 10 mg film-coated tablets

NorwayCetirizin ratiopharm 10 mg tablets

PortugalAllertek

SpainCetirizina ratiopharm 10 mg film-coated tablets EFG

Last review date of this leaflet: February 2021

Further detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/