Cetirizine Sandoz

Package leaflet: Information for the patient

Cetirizine Sandoz 10 mg film-coated tablets

Cetirizine dihydrochloride
For prescription-only packs:
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

For non-prescription packs:
Read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

1. What Cetirizine Sandoz is and what it is used for
2. What you need to know before taking Cetirizine Sandoz
3. How to take Cetirizine Sandoz
4. Possible side effects
5. How to store Cetirizine Sandoz
6. Contents of the pack and other information

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

Cetirizina Sandoz contains the active substance cetirizine dihydrochloride.
Cetirizina Sandoz is an antiallergic medicine.
In adults and children aged 6 years and older, Cetirizina Sandoz is indicated

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis
• for the treatment of chronic urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizina Sandoz

Do not take Cetirizina Sandoz

• if you have severe kidney disease (severe renal failure with creatinine clearance less than 10 ml/min);
• if you are allergic to cetirizine dihydrochloride, hydroxyzine, piperazine derivatives (active substances of other closely related medicines), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cetirizina Sandoz.
If you have kidney impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you have problems with urination (such as spinal cord injury, prostate enlargement, or bladder problems), consult your doctor.
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
If you are scheduled to undergo an allergy test, ask your doctor whether you should stop taking Cetirizina Sandoz a few days before the test. This medicine may affect the results of your allergy test.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine taken at recommended doses. However, safety data are not available when higher doses of cetirizine and alcohol are taken simultaneously.
Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Sandoz together with alcohol.

Children
Do not give this medicine to children under 6 years of age, because the tablet formulation does not allow for the necessary dose adjustment.

Other medicines and Cetirizina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Cetirizina Sandoz with food and drink
Food does not affect the absorption of Cetirizina Sandoz.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Cetirizina Sandoz should be avoided during pregnancy.
Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus. However, the medicine should only be taken if necessary and under medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizina Sandoz while breastfeeding unless you have consulted your doctor.

Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or driving ability after taking Cetirizina Sandoz at the recommended dose.
However, you should carefully observe your response to the medicine after taking Cetirizina Sandoz if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cetirizina Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Cetirizina Sandoz

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets should be taken with a glass of liquid.
The tablet may be divided into two equal doses.

Adults and adolescents aged 12 years and older
The recommended dose is 10 mg once daily as 1 tablet.

Use in children aged between 6 and 12 years
The recommended dose is 5 mg twice daily, as half a tablet twice daily.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Patients with renal impairment
For patients with impaired kidney function, the recommended dose is 5 mg once daily.
If you suffer from severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
If your child suffers from kidney disease, contact your doctor or pharmacist, who may adjust the dose according to the child's needs.

If you feel that the effect of Cetirizina Sandoz is too weak or too strong, inform 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 Cetirizina Sandoz than you should
If you think you have taken an overdose of Cetirizina Sandoz, inform your doctor.
Your doctor will decide which measures to take, if necessary.
After an overdose, the adverse reactions listed below may occur with increased intensity.
Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heart rhythm, tremors, and urinary retention.

If you forget to take Cetirizina Sandoz
Do not take a double dose to make up for the forgotten dose.

If you stop taking Cetirizina Sandoz
If you stop treatment with Cetirizina Sandoz, itching (intense prickling sensation) and/or urticaria may rarely reappear.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Cetirizina Sandoz and seek immediate medical help if you experience symptoms such as:

• swelling of the mouth, face and/or throat
• difficulty breathing (tightness in the chest or wheezing)
• sudden drop in blood pressure leading to fainting or shock. These symptoms may be signs of an allergic reaction, anaphylactic shock or angioedema. These reactions may occur immediately after taking the medicine or even after repeated doses.

The following section lists additional side effects by frequency:
Common (may affect up to 1 in 10 people):

• fatigue
• dry mouth, nausea, diarrhoea
• dizziness, headache
• somnolence (drowsiness)
• pharyngitis (sore throat), rhinitis (nasal symptoms such as runny nose)

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

• agitation
• abdominal pain
• asthenia (extreme tiredness), feeling of weakness or general malaise
• paraesthesia (abnormal skin sensation)
• pruritus (itchy skin), rash

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

• tachycardia (fast heartbeat)
• oedema (swelling)
• altered liver function
• weight gain
• seizures
• aggression, confusion, depression, hallucinations, insomnia
• urticaria (hives)

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

• thrombocytopenia (low platelet count in the blood, leading to bleeding or bruising more easily than normal)
• accommodation disorder (difficulty focusing), blurred vision, oculogyria (involuntary circular eye movements)
• syncope, tremor, dysgeusia (altered taste), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions)
• tic (habitual spasm)
• abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty urinating)
• fixed drug eruption

Frequency not known (frequency cannot be estimated from the available data):

• memory loss, memory impairment
• increased appetite
• vertigo (sensation of spinning or movement)
• urinary retention (inability to completely empty the bladder)
• nightmares
• hepatitis (inflammation of the liver)
• joint pain
• skin eruptions with pus-filled blisters
• pruritus (intense itching) and/or urticaria after discontinuation
• suicidal ideation (recurring thoughts of self-harm or suicide). If you feel this way, stop taking the tablets and consult your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetirizina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after the word EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cetirizina Sandoz contains
Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.

• The active substance is cetirizine dihydrochloride.
• The other components are:
  • Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, anhydrous colloidal silica.
  • Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

Description of the appearance of Cetirizina Sandoz and package contents
Cetirizina Sandoz is presented as white, oval-shaped, film-coated tablets with a break line on one side.
PVC blisters sealed with an aluminum foil containing 7, 10, 14, 20, 30, 40, 50, 60, 80, 100 and 100 (100x1) unit doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 - 39179 Barleben – Germany

This medicinal product has been authorized in EEA member states under the following names:
Austria: Cetirizin Sandoz 10 mg - Filmtabletten
Hungary: Cetirizin 1A Pharma 10 mg filmtabletta
Italy: Cetirizina Sandoz 10 mg compresse rivestite con film
Portugal: Cetirizina Sandoz
Slovakia: Cetirizine Sandoz 10 mg
Slovenia: Cetirizin Lek 10 mg filmsko obložene tablete
Spain: Cetirizina Sandoz 10 mg comprimidos recubiertos con película EFG
United Kingdom: Cetirizine dihydrochloride 10mg tablets