CETIRIZINE PENSA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Pensa 10 mg Film-Coated Tablets EFG

Cetirizine Dihydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Cetirizine Pensa is and what it is used for
2. What you need to know before taking Cetirizine Pensa
3. How to take Cetirizine Pensa
4. Possible side effects
5. Storage of Cetirizine Pensa
6. Package Contents and Additional Information

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

The active ingredient of Cetirizine Pensa is cetirizine dihydrochloride.

Cetirizine Pensa is an antiallergic medication.

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

-relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

-relief of chronic urticaria.

2. What you need to know before taking Cetirizine Pensa

Do not use Cetirizine 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 components of this medication (listed in section 6), to hydroxyzine, or to piperazine derivatives (closely related active substances to other medications).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cetirizine Pensa.

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

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

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

No significant interactions have been observed between alcohol (with a blood level of 0.5 per thousand, corresponding to a glass of wine) and the use of cetirizine at the recommended dose. However, safety data are not available when taking higher doses of cetirizine and alcohol together. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Pensa with alcohol.

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

Children

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

Other medications and Cetirizine Pensa:

Tell your doctor or pharmacist if you are using or have recently used, or may need to use any other medication.

Taking Cetirizine Pensa with food and beverages:

Food does not affect the absorption of cetirizine.

Pregnancy and Breastfeeding:

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

The use of Cetirizine Pensa should be avoided in pregnant women. Accidental use of the medication in pregnant women should not produce any harmful effects on the fetus. However, the medication should only be administered if necessary and after consulting 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 Pensa during breastfeeding, unless you consult your doctor.

Driving and Using Machines

Clinical studies have not shown evidence that Cetirizine Pensa causes alterations in attention, decreased reaction capacity, and ability to drive at the recommended dose. If you plan to drive, perform potentially hazardous activities, or use machinery, do not exceed the recommended dose. You should closely observe your response to the medication.

Important information about some of the components of Cetirizine Pensa:

Cetirizine Pensa film-coated tablets contain lactose; if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Cetirizine Pensa

Follow the administration instructions of this medication exactly as 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 tablets can be divided into 2 equal doses.

Adults andadolescents over12 years:

The recommended dose is 10 mg once a day as 1 tablet.

Childrenbetween6and12 years:

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

Patient withrenal insufficiency:

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

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

If your child has 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 Cetirizine Pensa is too weak or 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 Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested. After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, weakness, pupil dilation, tingling, irritation, sedation, somnolence, stupor, abnormal heart rate increase, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Pensa

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

If you stop taking Cetirizine Pensa

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

These reactions can start soon after taking the medication for the first time or may start later.

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

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

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

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

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

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

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

• Thrombocytopenia (low platelet count in blood)
• Tics (spasms)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), ocular gyration (eyes have an uncontrolled circular movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurring or obsessive thoughts of suicide), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to fully empty the urinary bladder)
• Itching (intense itching) and/or urticaria after stopping treatment
• Joint pain
• Blistering rash
• Hepatitis (liver inflammation)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cetirizine Pensa

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

Do not use this medication after the expiration date stated on the package after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cetirizine Pensa:

The active ingredient 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 package contents:

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

Packages 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 last revision of this package leaflet: January 2021

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