Package Leaflet: Information for the User

Cetirizine pensa 10 mg Film-Coated Tablets

Cetirizine dihydrochloride

Read this leaflet carefully before you start taking this medicinebecause 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

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

3. How to take Cetirizine pensa

4. Possible side effects

5. Storage of Cetirizine pensa

6. Contents of the pack and additional information

The active ingredient of Cetirizina Pensa is cetirizine dihydrochloride.

Cetirizina Pensa is an antihistamine medication.

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

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

-relief of chronic urticaria.

Do not use Cetirizina pensa:

-If you have a severe kidney disease (severe renal insufficiency with a 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 principles of other medications).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCetirizina pensa.

If you have 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 problems or prostate or bladder problems), please consult your doctor.

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

No notable 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, there are no available safety data when taking together higher doses of cetirizine and alcohol. 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 if you should interrupt taking Cetirizina 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 old, as this formulation does not allow for the necessary dose adjustment.

Other medications and Cetirizina pensa:

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

Taking Cetirizina 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 intend to become pregnant, consult your doctor before using this medication.

Cetirizina Pensa should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause any harm to the fetus. However, the medication should only be administered if necessary and after consulting with your doctor.

Cetirizine passes into breast milk. A risk of adverse reactions in infants cannot be ruled out. Therefore, do not take Cetirizina pensa during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that Cetirizina pensa produces attention impairments, decreased reaction capacity, and ability to drive at the recommended dose. If you intend to drive, perform potentially hazardous activities, or operate machinery, do not exceed the recommended dose. You must closely observe your response to the medication.

Important information about some of the components of Cetirizina pensa:

Cetirizina pensa coated tablets contain lactose; if your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

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 must be swallowed with a glass of liquid.

The tablets can be divided into 2 equal doses.

Adults and adolescents over 12 years old

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

Children between 6 and 12 years old

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

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, 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 Cetirizine Pens is too weak or too strong, consult 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 Cetirizine Pens than you should

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

If you forgot to take Cetirizine Pens

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

If you interrupt treatment with Cetirizine Pens

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

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

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

The following side effects are rare or very rare, but you should stop taking the medicine 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 may start soon after taking the medicine for the first time, or they may start later.

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

• Drowsiness (drowsiness)
• Vertigo, 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
• Pruritus (itching on the skin), 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 quickly)
• 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), nystagmus (uncontrolled eye movement)
• Angioedema (severe allergic reaction that causes swelling of the face or throat), drug rash
• Difficulty or inability to urinate (bedwetting, pain, and/or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurring thoughts or obsession with suicide), nightmares
• Amnesia, memory deterioration
• Dizziness (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria after treatment discontinuation
• Joint pain
• Rash with blisters containing pus
• Hepatitis (inflammation of the liver)

Communication of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this 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 after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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

Cetirizine pensa composition:

The active ingredient is cetirizine dihydrochloride. A 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).

Product appearance and packaging content:

Coated tablets, cylindrical, biconvex, scored, white in color, and marked with the code “C”.

Packaging with 20 tablets.

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

Last review date of this leaflet: January 2021

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