Cetirizine Teva 1 mg/ml oral solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cetirizine Teva 1 mg/ml oral solution EFG

Cetirizine dihydrochloride

Read the entire leaflet carefully before you start using this medicine, as 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. Do 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 the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Cetirizine Teva 1 mg/ml oral solution is and what it is used for.
2. What you need to know before taking Cetirizine Teva 1 mg/ml oral solution.
3. How to take Cetirizine Teva 1 mg/ml oral solution.
4. Possible side effects
5. How to store Cetirizine Teva 1 mg/ml oral solution.
6. Contents of the pack and other 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 of age:

• for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;
• for the relief of urticaria.

2. What you need to know before taking Cetirizine Teva 1 mg/ml oral solution

Do not take Cetirizine Teva 1 mg/ml:

• If you have severe kidney disease requiring dialysis
• 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 any piperazine derivative (active substances closely related to other drugs).

Warnings and precautions

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

If you are a patient with renal impairment, consult your doctor; if necessary, you will be prescribed a lower dose. Your doctor will determine the new dose.

If you have difficulty urinating (such as spinal cord disorders, prostate problems, or bladder issues), 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 (at a blood level of 0.5 per thousand (g/l), equivalent to one glass of wine) and cetirizine 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 Teva 1 mg/ml with alcohol.

If you are scheduled to undergo allergy testing, consult your doctor about whether you should stop taking Cetirizine Teva 1 mg/ml several days before the test. This medicine may affect the results of your allergy tests.

Use of Cetirizine Teva 1 mg/ml with other medicines

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

Use of Cetirizine Teva 1 mg/ml with food and drink:

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 become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Cetirizine Teva 1 mg/ml should be avoided in pregnant women. Accidental use of the medicine during pregnancy does not produce any harmful effects on the fetus. However, the medicine should only be administered if necessary and after consultation with your doctor.

Cetirizine Teva 1 mg/ml is excreted in breast milk. A risk of adverse reactions in breastfed infants cannot be ruled out. Therefore, you should not take Cetirizine Teva 1 mg/ml during breastfeeding unless advised by your doctor.

Driving and use of machines

Clinical studies have not shown evidence that cetirizine dihydrochloride causes impairment of attention, reduced reaction capacity, or reduced 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.

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 informed you (or your child) that you have an intolerance to certain 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 discomfort and a mild laxative effect.

3. How to take Cetirizine Teva 1 mg/ml oral solution

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

The solution can be taken undiluted.

Adults and adolescents aged 12 years and older

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

Use in children between 6 and 12 years of age

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

Use in children between 2 and 6 years of age

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

Patients with renal impairment

Patients with moderate renal impairment are advised 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 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 packaging and the leaflet to the healthcare professional.

You may also call the Toxicology Information Service at telephone number 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 reported include confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupil dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormally increased heart rate, tremor, and urinary retention (difficulty completely emptying the bladder).

If you forget to take Cetirizine Teva

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

If you stop taking Cetirizine Teva

In rare cases, pruritus (intense itching) and/or urticaria (hives) may reappear if you stop taking Cetirizine Teva.

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 experiences them.

The following adverse 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 (a severe allergic reaction causing swelling of the face, lips, mouth, or throat, which may cause difficulty breathing or swallowing; hives).

These reactions may begin soon after taking the medicine for the first time, or they may start later.

Frequent adverse effects (may affect up to 1 in 10 patients)

• Drowsiness (drowsiness)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (runny nose, nasal congestion) (in children)
• Cold-like nasal symptoms (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

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

Rare adverse effects (may affect up to 1 in 1,000 patients)

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

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Low platelet levels in blood (thrombocytopenia)
• Spasmodic habits (tics)
• Syncope (fainting), involuntary movements (dyskinesia), prolonged abnormal muscle contractions (dystonia), tremor, dysgeusia (taste disturbance)
• Blurred vision, accommodation disorders (difficulty focusing vision), oculogyric crisis (eyes have uncontrolled circular movement)
• Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced rash
• Difficulty or lack of control when urinating (bedwetting, pain and/or difficulty urinating)

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Increased appetite
• Recurrent thoughts or obsession about suicide (suicidal thoughts), nightmares
• Amnesia (memory loss), memory impairment
• Sensation of spinning or movement (dizziness)
• Inability to completely empty the urinary bladder (urinary retention)
• Intense itching (pruritus) and/or hives after discontinuation of treatment
• Joint pain, muscle pain
• 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 they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse 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 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.

The shelf life after first opening is 3 months.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cetirizine Teva

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

The other components are: glycerol, propylene glycol, sorbitol (E-420), methyl 4-hydroxybenzoate (E-218), propyl 4-hydroxybenzoate (E-216), sodium acetate, acetic acid, sodium saccharin, banana flavour (containing propylene glycol), and purified water.

Appearance of the medicinal product and contents of the pack

Cetirizine Teva 1 mg/ml is a clear, colourless solution with a banana odour.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U
c/ Anabel Segura 11 Edificio Albatros B, 1st floor
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 medicinal product is authorised in the European Economic Area member states under the following names:

Belgium: Cetirizine Teva 1 mg/ml drank/solution buvable/Lösung zum Einnehmen
Spain: Cetirizina Teva 1 mg/ml oral solution EFG
Netherlands: Cetirizine 2HCl 1 mg/ml PCH, drank

Date of the most recent review of this leaflet: July 2024

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