Cetirizine CINFA 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cetirizina Cinfa 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 you should not give it to others, even if they have the same symptoms as you, because it could 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 Cinfa is and what it is used for
2. What you need to know before taking Cetirizina Cinfa
3. How to take Cetirizina Cinfa
4. Possible adverse effects
5. How to store Cetirizina Cinfa
6. Contents of the pack and other information

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

The active substance in Cetirizina Cinfa is cetirizine dihydrochloride.

Cetirizina Cinfa is an antiallergic medicinal product.

This medicine is indicated in adults and children aged 6 years and older 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 Cetirizina Cinfa

Do not take Cetirizina Cinfa

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

• If you have renal insufficiency, consult your doctor; if necessary, you will receive a lower dose. Your doctor will determine the new dose.
• If you have difficulty urinating (such as spinal cord, 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 concentration of 0.5 per mille (g/l), equivalent 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 cetirizine with alcohol.

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

Children

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

Other medicines and Cetirizina Cinfa

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

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 plan to become pregnant, consult your doctor before using this medicine.

The use of cetirizine should be avoided in pregnant women. Accidental use of the medicine in pregnant women is not expected to cause harmful effects 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 advised by your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine causes impairment of 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 should closely monitor 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.

Cetirizina Cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Cetirizine Cinfa

Follow exactly the instructions for use of this medicine as given 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 tablet may be divided into equal doses.

Adults and adolescents over 12 years of age

The recommended dose is 10 mg once daily 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 of age

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

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

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 suffers from 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 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and container to the healthcare professional.

After an overdose, the adverse effects described below may occur with increased 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 Cetirizine Cinfa

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

If you stop taking Cetirizine Cinfa

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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can 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 experience any of them:

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

These reactions may occur soon after first taking the medicine, or may develop 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 (skin 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, hallucinations, 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 show uncontrolled circular movement).
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash.
• Difficulty or loss of bladder control (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 with suicide), nightmares.
• Amnesia, memory impairment.
• Vertigo (sensation of spinning or movement).
• Urinary retention (inability to completely empty the urinary bladder).
• Intense pruritus (itching) and/or urticaria after stopping treatment.
• Joint pain.
• Pustular rash (rash with pus-filled blisters).
• 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 Cinfa

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.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Cetirizina Cinfa

• The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are: monohydrate lactose, povidone (E-1201), crospovidone, magnesium stearate (E-470b), talc (E-553b), hypromellose (E-464), macrogol 400 and titanium dioxide (E-171).

Appearance of the medicine and contents of the pack

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

Presented in PVC-PVDC/Aluminium blisters. Each pack contains 20 tablets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra)-Spain

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. 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