Introduction

Cetirizine Cinfa 10 mg film-coated tablets

Dihydrochloride of cetirizine

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

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

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

The active ingredient of Cetirizina Cinfa is dihydrochloride of cetirizine.

Cetirizina Cinfa is an antihistamine medication.

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

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

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

Do not take Cetirizina Cinfa

If you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10 ml/min).
If you are allergic to dihydrochloride of cetirizine or 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 take Cetirizina Cinfa.

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 problems 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 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 available safety data when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is recommended to avoid taking cetirizine with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should interrupt taking cetirizine 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 Cinfa

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

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

Cetirizine 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 your doctor.

Cetirizine is excreted in breast milk. A risk of adverse reactions in infants cannot be ruled out. Therefore, do not take cetirizine during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that cetirizine produces attention alterations, reaction ability decrease, and driving ability 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.

If you are a sensitive patient, you may find that the simultaneous use of alcohol or other central nervous system depressants affects your attention and reaction ability in addition.

Cetirizina Cinfa contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

3. How to Take Cetirizina Cinfa

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 tablet can be divided into equal doses.

Adults and adolescents over 12 years old

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

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

Use in children between 6 and 12 years old

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

Other forms of this medication may be more 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, 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.

Treatment duration

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 Cinfa 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. It is recommended to bring the leaflet and 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, dilated pupil, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremor, and urinary retention have been reported.

If you forgot to take Cetirizina Cinfa

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

If you interrupt treatment with Cetirizina Cinfa

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

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

4. Possible Adverse Effects

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 (a 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).
Dizziness, headache.
Pharyngitis, rhinitis (in children).
Diarrhea, nausea, dry mouth.
Fatigue.

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

Restlessness.
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 the 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 the 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 urinary bladder).
Pruritus (intense itching) and/or urticaria after treatment suspension.
Joint pain.
Rash with blisters containing pus.
Hepatitis (inflammation of the liver).

Reporting 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.

5. Conservation of Cetirizina Cinfa

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.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the 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.

6. Contents of the packaging and additional information

Cetirizine Cinfa Composition

The active ingredient is dihydrochloride of cetirizine. A coated tablet contains 10 mg of dihydrochloride of cetirizine.
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 packaging

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

Presented in PVC-PVDC/Aluminum blisters. Each package contains 20 tablets.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra)-Spain

Last review date of this leaflet:October 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your 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