CETIRIZINE TEVA 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Cetirizine Teva 1 mg/ml Oral Solution EFG

Cetirizine Dihydrochloride

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 and other information

1. What Cetirizine Teva 1 mg/ml Oral Solution is and what it is used for.
2. What you need to know before you take Cetirizine Teva 1 mg/ml Oral Solution.
3. How to take Cetirizine Teva 1 mg/ml Oral Solution.
4. Possible side effects
5. Storage of Cetirizine Teva 1 mg/ml Oral Solution.
6. Contents of the pack and further information

1. What Cetirizine Teva 1 mg/ml Oral Solution is and what it is used for

The active substance of Cetirizine Teva is cetirizine dihydrochloride.

Cetirizine Teva is an antiallergic medicine.

Cetirizine Teva is indicated in adults and children from 2 years:

• for the relief of symptoms of seasonal and perennial allergic rhinitis and conjunctivitis;
• for the relief of urticaria.

2. What you need to know before you take Cetirizine Teva 1 mg/ml Oral Solution

Do not take Cetirizine Teva 1 mg/ml:

• If you have severe kidney disease that requires dialysis
• If you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine or to any piperazine derivative (closely related active substances).

Warnings and precautions

Consult your doctor or pharmacist before taking Cetirizine Teva 1 mg/ml.

If you have kidney failure, 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 and 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 Teva 1 mg/ml with alcohol.

If you are going to have an allergy test, consult your doctor if you should stop taking Cetirizine Teva 1 mg/ml a few days before the test. This medicine may affect the results of your allergy tests.

Using Cetirizine Teva 1 mg/ml with other medicines

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

Using Cetirizine Teva 1 mg/ml with food and drinks:

Food does not affect the absorption of Cetirizine Teva 1 mg/ml.

Pregnancy and breastfeeding

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

The use of Cetirizine Teva 1 mg/ml should be avoided in pregnant women. Accidental use of the medicine in pregnant women does not produce any harmful effect on the fetus. However, the medicine should only be administered if necessary and after consulting a doctor.

Cetirizine Teva 1 mg/ml is excreted in breast milk. A risk of adverse reactions in breast-fed infants cannot be excluded. Therefore, you should not take Cetirizine Teva 1 mg/ml during breastfeeding, unless you have consulted your doctor.

Driving and using machines

Clinical studies have not shown evidence that cetirizine dihydrochloride causes 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.

Cetirizine Teva contains methylparahydroxybenzoate, propylparahydroxybenzoate, propylene glycol, sodium, and sorbitol

This medicine contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (possibly delayed)

This medicine contains 494 mg of propylene glycol in 10 ml of oral solution.

This medicine contains less than 1 mmol of sodium (23 mg) in 10 ml of oral solution, which is essentially 'sodium-free'.

This medicine contains 4.5 g of sorbitol in 10 ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the person cannot break down fructose, consult your doctor before you (or your child) take this medicine. Sorbitol may cause gastrointestinal upset and a mild laxative effect.

3. How to take Cetirizine Teva 1 mg/ml Oral Solution

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The solution can be taken as is.

Adults and adolescents from 12 years

The recommended dose is 10 mg once daily as 10 ml of oral solution (2 full measuring spoons).

Use in children between 6 and 12 years

The recommended dose is 5 mg twice daily, as 5 ml (one full measuring spoon) twice daily.

Use in children between 2 and 6 years

The recommended dose is 2.5 mg twice daily as 2.5 ml of the oral solution (half a measuring spoon) twice daily.

Patients with renal failure

It is recommended that patients with moderate renal failure take 5 mg once daily.

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 Teva 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 Teva than you should

If you think you have taken an overdose of cetirizine, inform your doctor. Your doctor will decide what measures should be taken if necessary. It is recommended to bring the package and leaflet to the healthcare professional.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

After an overdose, the adverse effects described below may occur with greater intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, discomfort (feeling unwell), pupil dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormally fast heart rate, tremor, and urinary retention (difficulty emptying the bladder) have been reported.

If you forget to take Cetirizine Teva

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

If you stop taking Cetirizine Teva

Rarely, itching (pruritus) and/or urticaria (hives) may reappear if you stop taking Cetirizine Teva.

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 must 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, lips, mouth, or throat, which can cause difficulty breathing or swallowing; urticaria).

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

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

• Somnolence (drowsiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
• Cold symptoms in the nose (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Abnormal skin sensation (paresthesia)
• Abdominal pain
• Itching (pruritus), rash
• Asthenia (extreme fatigue), discomfort (feeling unwell)

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

• Allergic reactions, some severe (very rare)
• Depression, hallucination, aggression, confusion, insomnia
• Seizures
• Abnormally fast heart rate (tachycardia)
• Abnormal liver function
• Hives (urticaria)
• Swelling (edema)
• Weight gain

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

• Low blood platelet count (thrombocytopenia)
• Tics (involuntary muscle contractions)
• Fainting (syncope), involuntary movements (dyskinesia), prolonged abnormal muscle contraction (dystonia), tremor, taste disturbance (dysgeusia)
• Blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (eyes have an uncontrolled circular 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 with frequency not known(frequency cannot be estimated from the available data)

• Increased appetite
• Recurring or obsessive thoughts of suicide (suicidal thoughts), nightmares
• Amnesia (memory loss), memory impairment
• Feeling of spinning or movement (vertigo)
• Inability to empty the urinary bladder completely (urinary retention)
• Intense itching (pruritus) and/or urticaria after treatment discontinuation
• Joint pain, muscle 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 via the Spanish Medicines Agency website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cetirizine Teva 1 mg/ml Oral Solution

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

Do not transfer to another container.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

The shelf life after first opening is 3 months.

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 further information

Composition of Cetirizine Teva

The active substance is cetirizine dihydrochloride. 10 ml (equal to two measuring spoons) contain 10 mg of cetirizine dihydrochloride.

The other ingredients are: glycerol, propylene glycol, sorbitol (E-420), methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium acetate, acetic acid, sodium saccharin, banana flavor (contains propylene glycol), and purified water.

Appearance and pack contents

Cetirizine Teva 1 mg/ml is a clear, colorless solution with a banana odor.

Each pack consists of a carton with a bottle containing 75 ml, 150 ml, or 200 ml oral solution and a 5 ml plastic measuring spoon, graduated to 2.5 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura 11 Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid (Spain)

Manufacturer

TEVA CZECH INDUSTRIES S.R.O.

Ostravská 29,

Opava-Komárov 74770

CZECH REPUBLIC

Pharmachemie B.V.

Swensweg 5, P.O. Box 552,

NL-2003 RN Haarlem

THE NETHERLANDS

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Cetirizine Teva 1 mg/ml drank/solution buvable/Lösung zum Einnehmen

Spain: Cetirizina Teva 1 mg/ml solución oral EFG

Netherlands: Cetirizine 2HCl 1 mg/ml PCH, drank

Date of last revision of this leaflet:July 2024

Detailed and up-to-date 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 up-to-date information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67271/P_67271.html