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Package Insert: Information for the Patient

Cetirizine Sandoz 10 mg Film-Coated Tablets

Cetirizine dihydrochloride

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, 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 package insert. See section 4.

1.What is Cetirizine Sandoz and for what it is used

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

3.How to take Cetirizine Sandoz

4.Possible side effects

5.Storage of Cetirizine Sandoz

6. Contents of the pack and additional information

Cetirizine dihydrochloride is the active ingredient of Cetirizina Sandoz.

Cetirizina Sandoz is an antihistamine medication.

Cetirizina Sandoz is indicated in adults and children aged 6 years and above for:

• relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis,
• relief of chronic urticaria (idiopathic chronic urticaria).

Do not take Cetirizina Sandoz

• if you have a severe kidney disease (severe renal insufficiency with a creatinine clearance below 10ml/min),

• if you are allergic to cetirizine dihydrochloride, to hydroxyzine, to piperazine derivatives (principles closely related to other medications) or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Cetirizina Sandoz.

If you have problems urinating (such as spinal cord or prostate problems, or bladder problems), please consult your doctor.

If you have kidney insufficiency, please consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.

If you are an epileptic patient or a patient at risk of seizures, consult your doctor.

If you are scheduled to undergo an allergy test, consult your doctor if you should stop taking cetirizine a few days beforethe same. Thismedication may affect the results of your allergy tests.

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 normal doses. 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 cetirizine with alcohol.

Children

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

Taking Cetirizina Sandoz with other medications

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

Taking Cetirizina Sandoz with food and drinks

Foods do 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 or pharmacist before using this medication.

Cetirizine should be avoided in pregnant women. Accidental use of the medication in pregnant women should not cause anyharmfuleffects on the fetus.However, the medication should only be administered if necessary and after consulting with the doctor.

Cetirizine passes into 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 thatcetirizineproduces attention impairments, decreased reaction capacity, and ability to drive at the recommended dose.

You should carefully observe your response to the medication after taking cetirizine if you intend to drive, perform potentially hazardous activities or use machinery. Do not exceed the recommended dose.

Cetirizina Sandozcontains lactose

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

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 this medication 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 Sandoz than you should

If you have taken more Cetirizina Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

After an overdose, the adverse reactions described below may occur with greater intensity. Adverse reactions such as confusion, diarrhea, dizziness, fatigue, headache, weakness, dilated pupils, tingling, irritation, sedation, drowsiness, stupor, abnormal increase in heart rate, tremors, and urinary retention have been reported.

If you forgot to take Cetirizina Sandoz

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

If you interrupt treatment with Cetirizina Sandoz

In rare cases, 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Cetirizina Sandoz and seek medical help immediately if you experience any of the symptoms described below:

• swelling of the mouth, face, and/or throat,
• difficulty breathing (chest tightness or wheezing),
• sudden drop in blood pressure leading to dizziness or shock.

These symptoms may be signs of allergic reactions, anaphylactic shock, and angioedema. These reactions may start immediately after the first dose of this medicine or may start later.

The following scheme contains other side effects that have been reported, listed according to their frequency.

Frequent(may affect up to 1 in 10 people):

• fatigue
• dry mouth, nausea, diarrhea
• dizziness, headache
• drowsiness (drowsiness)
• pharyngitis (sore throat), rhinitis (swelling and irritation inside the nose)

Rare(may affect up to 1 in 100 people):

• agitation
• abdominal pain
• asthenia (extreme fatigue), malaise (feeling or being unwell in general)
• paresthesia (strange sensations in the skin)
• pruritus (itching), rash

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

• tachycardia (heart beats too quickly)
• edema (swelling)
• altered liver function
• weight gain
• seizures
• aggressiveness, confusion, depression, hallucination, insomnia
• urticaria (hives)

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

• thrombocytopenia (low platelet count in the blood, which manifests as bleeding or bruising that appears more easily than normal)
• accommodation disorders (difficulty focusing), blurred vision, oculogyric crisis (eyes have an uncontrolled circular movement)
• syncope, tremor, dysgeusia (taste disorder), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions)
• tics (habitual spasms),
• abnormal urination (bedwetting, pain, and/or difficulty urinating)
• drug rash

Unknown frequency(the frequency cannot be estimated from the available data)

• amnesia, memory deterioration
• increased appetite
• vertigo (sensation of rotation or movement)
• urinary retention (inability to completely empty the urinary bladder)
• nightmares
• hepatitis (inflammation of the liver)
• joint pain
• eruption with blisters containing pus,
• pruritus (intense itching) and/or urticaria after stopping treatment
• suicidal thoughts (recurring or obsessive thoughts of suicide).

If you experience any of these symptoms, stop taking the medicine and consult your doctor.

Reporting of 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 leaflet. You can also report them directly through theSpanish 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.

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 and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cetirizine Sandoz

Each tablet contains 10 mg of cetirizine dihydrochloride.

• The active ingredient is cetirizine dihydrochloride.
• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.

Coating:hypromellose, lactose monohydrate, titanium dioxide (E171) and macrogol 4000.

Appearance of the product and contents of the package

White, coated, oblong, scored tablets.

It is presented in a PVC/Al blister pack, in packs of: 7, 10, 14, 20, 21, 28, 30, 50, 60, 98 and 100 and 50 (50x1) coated tablets in a single dose.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-allee 1,

39179 Barleben,

Germany

This medicine is authorized in themember states of the European Economic Area withthe following names:

Austria:Cetirizin Sandoz 10 mg - Filmtabletten

Hungary:Cetirizin 1A Pharma 10 mg filmtabletta

Italy:Cetirizine Sandoz

Portugal:CETIRIZINA SANDOZ

Slovakia:Cetirizine Sandoz 10 mg

Slovenia:Cetirizin Lek 10 mgfilmsko obložene tablete

United Kingdom:Cetirizine Hydrochloride 10mg tablets

Last review date of this leaflet: February 2019

For detailed and updated information on this medicine, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/