Cetirizina teva 1 mg/ml solucion oral efg

Package Leaflet: Information for the User

Cetirizine Teva 1 mg/ml Oral Solution EFG

Cetirizine dihydrochloride

Read this 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. Do 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.

The active ingredient of Cetirizina Teva is cetirizine dihydrochloride.

Cetirizina Teva is an antihistamine medication.

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

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

Do not take Cetirizina Teva 1 mg/ml:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cetirizina Teva 1 mg/ml.

If you are a patient with kidney 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 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 taking together higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Teva 1 mg/ml with alcohol.

If you are scheduled to undergo an allergy test, consult your doctor if you should interrupt taking Cetirizina Teva 1 mg/ml a few days before the test. This medication may affect the results of your allergy tests.

Use of Cetirizina Teva 1 mg/ml with other medications

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

Use of Cetirizina Teva 1 mg/ml with food and beverages:

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

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Cetirizina Teva 1 mg/ml should be avoided in pregnant women. Accidental use of the medication in pregnant women does not cause any harmful effects on the fetus. However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizina Teva 1 mg/ml is excreted in breast milk.Cannot be ruled out a risk of adverse reactions in infants.Therefore, do not take Cetirizina Teva 1 mg/ml during breastfeeding, unless you consult your doctor.

Driving and operating machinery

Clinical studies have not shown evidence that cetirizine dihydrochloride produces attention impairments, reaction ability decrease, and ability to drive at the recommended dose.

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

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

This medication contains methylparahydroxybenzoate and propylparahydroxybenzoate that may cause allergic reactions (possibly delayed)

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

This medication contains less than 1 mmol of sodium (23 mg) in 10 ml of oral solution, which is especially "sodium-free".

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The solution can be taken as such.

Adults and adolescents 12 years and older

The recommended dose is 10 mg once a day as 10 ml of oral solution (2 full teaspoons).

Use in children between 6 and 12 years

The recommended dose is 5 mg twice a day, as 5 ml (one full teaspoon) twice a day.

Use in children between 2 and 6 years

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

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 Cetirizina Teva is too weak or too strong, consult your doctor.

Treatment duration

The treatment duration will depend on the type, duration, and course of your symptoms and will be determined by your doctor.

If you take more Cetirizina Teva than you should

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

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

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

If you forgot to take Cetirizina Teva

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

If you stop taking Cetirizina Teva

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

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

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

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 (sore throat), rhinitis (runny nose, nasal congestion) (in children)
• Common cold symptoms in the nose (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Restlessness
• Abnormal skin sensation (paresthesia)
• Abdominal pain
• Itching on the skin (pruritus), rash
• Extreme fatigue, discomfort (feeling unwell)

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

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

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

• Low platelet count in the blood (thrombocytopenia)
• Tics (habitual spasms)
• Syncope (fainting), involuntary movements (dyskinesia), prolonged abnormal muscle contraction (dystonia), tremor, disgeusia (taste disorder)
• Blurred vision, accommodation disorders (difficulty focusing), ocular crises (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, or difficulty urinating)

Side effects of unknown frequency(frequency cannot be estimated from available data)

• Increased appetite
• Recurring thoughts or obsession with suicide (suicidal thoughts), nightmares
• Amnesia (memory loss), memory deterioration
• Sensation of spinning or movement (vertigo)
• Inability to completely empty the urinary bladder (urinary retention)
• Intense itching (pruritus) and/or urticaria after treatment suspension
• Joint pain, muscle pain
• Blistering rash with pus
• Hepatitis (liver inflammation)

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 Pharmacovigilance of Medicines for Human Use website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not transfer to another container.

Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Expiration after the first opening is 3 months.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Cetirizina Teva

The active ingredient is cetirizine dihydrochloride 10 ml (equivalent to two teaspoons) contains 10 mg of cetirizine dihydrochloride.

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U

c/ Anabel Segura 11 Edificio Albatros B, 1st floor

Alcobendas 28108 Madrid (Spain)

Responsible for manufacturing

TEVA CZECH INDUSTRIES S.R.O

Ostravská 29,

Opava-Komárov 74770

REPUBLIC OF CZECH

Pharmachemie B.V.

Swensweg 5, P.O. Box 552,

NL-2003 RN Haarlem

NETHERLANDS

This medicine is authorized in the member states of the European Economic Area with 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 last review of this leaflet:July2024

Detailed and updated information on this medicine 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 on this medicine by scanning with your 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