CETIRIZINE PENSA 10 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cetirizina pensa 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, 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, and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

The active substance of Cetirizina Pensa is cetirizine dihydrochloride.

Cetirizina Pensa is an antiallergy medicine.

Cetirizina Pensa is indicated in adults and children from 6 years of age for:

• relieving nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

• relieving chronic urticaria.

2. What you need to know before starting to take Cetirizina pensa

Do not use Cetirizina pensa:

• If you have severe kidney disease (severe renal insufficiency with creatinine clearance below 10 ml/min).
• If you are allergic to cetirizine, to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances closely related to other medicines).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cetirizina pensa.

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

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

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

No interactions likely to have a notable impact have been observed between alcohol (with a blood level of 0.5 per mille, corresponding to one glass of wine) and cetirizine used at the recommended dose. 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 Cetirizina pensa with alcohol.

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

Children

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

Other medicines and Cetirizina pensa:

Inform your doctor or pharmacist if you are using or have recently used, or might need to use, any other medicine.

Taking Cetirizina pensa with food and drinks:

Food does not affect the absorption of cetirizine.

Pregnancy and lactation:

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

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

Cetirizine passes into breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, Cetirizina Pensa should not be taken during breastfeeding unless advised by your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina pensa causes disturbances in attention, reduced reaction capacity, or impaired ability to drive at the recommended dose. If you intend to drive, perform potentially hazardous activities, or operate machinery, you should not exceed the recommended dose. You must closely monitor your response to the medication.

Important information about some of the components of Cetirizina pensa:

Cetirizina pensa film-coated tablets contain lactose; if your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Cetirizina pensa

Follow exactly the instructions for use of this medicine provided 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 tablets may be divided into two equal doses.

Adults and adolescents over 12 years of age:

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

Children between 6 and 12 years of age:

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

Patients with renal impairment:

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

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

If your child has kidney 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 Cetirizina pensa 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 pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone: 91 562 04 20, indicating the medicine and the amount ingested. After an overdose, the adverse effects 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 pensa

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

If you stop taking Cetirizina pensa

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

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

4. Possible adverse effects

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

The following adverse 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 (a severe allergic reaction causing swelling of the face or throat).

These reactions may begin soon after taking the medicine for the first time, or they may begin later.

Frequent adverse effects (may affect up to 1 in 10 patients)

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

Uncommon adverse effects (may affect up to 1 in 100 patients)

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

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Tachycardia (heart beating too fast)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Thrombocytopenia (low platelet levels in blood)
• Tics (spasms)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contractions), tremor, dysgeusia (taste disturbance)
• Blurred vision, accommodation disorders (difficulty focusing vision), ocular rotation (eyes have uncontrolled circular movement)
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Increased appetite
• Suicidal thoughts (recurring thoughts or obsession about suicide), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the urinary bladder)
• Pruritus (intense itching) and/or urticaria after discontinuation of treatment
• Joint pain
• Blistering rash containing pus
• Hepatitis (inflammation of the liver)

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 via 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 pensa

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizina pensa:

The active substance is cetirizine dihydrochloride. One tablet contains 10 mg of cetirizine dihydrochloride.

The other components are: lactose monohydrate, povidone (E-1201), crospovidone, magnesium stearate (E-470b), talc (E-553b), hypromellose (E-464), macrogol 400 and titanium dioxide (E-171).

Appearance of the product and contents of the pack:

Film-coated tablets, cylindrical, biconvex, scored, white in colour and marked with the code "C".

Packs containing 20 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra) - Spain

Date of the most recent revision of this leaflet: January 2021

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