CETIRIZINE CINFA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Cetirizine Cinfa 10 mg Film-Coated Tablets EFG

Dihydrochloride of cetirizine

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 pack

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

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

The active substance of Cetirizine Cinfa is dihydrochloride of cetirizine.

Cetirizine Cinfa is an antiallergic medicine.

This medicine is indicated in adults and children from 6 years for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• relief of urticaria.

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

Do not take Cetirizine Cinfa

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

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Cinfa.

• If you have kidney insufficiency, consult your doctor; if necessary, a lower dose will be taken. Your doctor will determine the new dose.
• If you have problems urinating (such as spinal cord or prostate or bladder problems), please consult your doctor.
• If you are an epileptic patient or a patient at risk of convulsions, consult your doctor.

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

If you are going to have an allergy test, consult your doctor if you should stop taking cetirizine 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, as this formulation does not allow for the necessary dose adjustment.

Other medicines and Cetirizine Cinfa

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

Taking Cetirizine Cinfa with food, drinks and alcohol

Food does not affect the absorption of cetirizine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The use of cetirizine should be avoided in pregnant women. Accidental use of the medicine in pregnant women should not produce any harmful effect on the fetus. However, the medicine should only be administered if necessary and after consulting your doctor.

Cetirizine is excreted in breast milk. A risk of adverse reactions in breastfed infants cannot be excluded. Therefore, you should not take cetirizine during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine produces alterations in attention, decreased reaction capacity and ability to drive at the recommended dose.

If you intend to drive, perform potentially hazardous activities or use machinery, do not exceed the recommended dose. You should closely observe your response to the medicine.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants may further affect your attention and reaction capacity.

Cetirizine Cinfa contains lactose

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

3. How to take Cetirizine Cinfa

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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 once a day as 1 tablet.

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Use in children between 6 and 12 years

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

Other forms of this medicine may be more suitable for children: ask your doctor or pharmacist.

Patient 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 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 Cetirizine Cinfa 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 medicine and the amount taken. It is recommended to bring the leaflet and the packaging to the healthcare professional.

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, abnormally fast heart rate, tremor, and urinary retention have been reported.

If you forget to take Cetirizine Cinfa

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

If you stop taking Cetirizine Cinfa

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

If you have any further questions on the use of this product, 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 should stop taking the medicine and tell your doctor immediately if you notice any of them:

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

These reactions can start soon after taking the medicine for the first time, or they can 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 skin sensation).
• Abdominal pain.
• Itching (skin itching), rash.
• Asthenia (extreme fatigue), malaise.

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

• Allergic reactions, some serious (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 people).

• Thrombocytopenia (low blood platelet count).
• Tics (spasms).
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged and abnormal muscle contraction), tremor, dysgeusia (taste disorder).
• Blurred vision, accommodation disorders (difficulty fixing gaze), ocular gyration (uncontrolled circular eye 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 the 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 completely empty the urinary bladder).
• Itching (intense itching) and/or urticaria after stopping treatment.
• Joint pain.
• Blistering rash.
• Hepatitis (inflammation of the liver).

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 and Health Products Agency's website (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Cinfa

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 after EXP. The expiry date refers to the last day of the month shown.

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 Cinfa

• The active substance is dihydrochloride of cetirizine. One film-coated tablet contains 10 mg of dihydrochloride of cetirizine.
• The other ingredients 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 pack contents

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

They are presented in PVC-PVDC/Aluminum blisters. Each pack contains 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)-Spain

Date of last revision of this leaflet:October 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)

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/66605/P_66605.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66605/P_66605.html