Cetirizine Teva
Italy
Table of Contents
Prescription only medicine (RR) (valid only for packs of 20, 28, 30, 50 and 100)
Package leaflet: Information for the user
Cetirizine Teva 10 mg film-coated tablets
Cetirizine dihydrochloride
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
- Keep this leaflet. 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. Do not give it to others, 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, consult your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Cetirizine Teva is and what it is used for
- What you need to know before taking Cetirizine Teva
- How to take Cetirizine Teva
- Possible side effects
- How to store Cetirizine Teva
- Contents of the pack and other information
1. What Cetirizina Teva is and what it is used for
Cetirizine hydrochloride is the active substance in Cetirizina Teva. Cetirizina Teva is an antiallergic medicinal product.
In adults and children from 6 years of age, Cetirizina Teva is indicated:
- for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the treatment of urticaria.
2. What you need to know before taking Cetirizine Teva
Do not take Cetirizine Teva
- if you are allergic to cetirizine hydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines);
- if you have severe kidney disease (severe renal impairment with creatinine clearance less than 10 ml/min).
Warnings and precautions
Consult your doctor or pharmacist before taking Cetirizine Teva.
If you have renal impairment, consult your doctor; if necessary, you will need to take a lower dose. Your doctor will determine the new dose.
If you have difficulty urinating (spinal cord, prostate or bladder problems), consult your doctor.
If you are an epileptic patient or at risk of seizures, you should consult your doctor.
No clinically significant interactions have been observed between alcohol (at a blood level of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine when used at recommended doses. 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 with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizine Teva a few days before the test. This medicine may affect the results of allergy testing.
Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.
Other medicines and Cetirizine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizine Teva with food and drink
Food does not affect the absorption of Cetirizine Teva.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Cetirizine Teva should be avoided in pregnant women. 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 on medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizine Teva during breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have shown no evidence of impaired attention, alertness, or driving ability after taking cetirizine hydrochloride at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizine Teva if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizine Teva contains lactose
If your doctor has told you that you are intolerant to certain sugars, consult your doctor before taking this medicine.
Cetirizine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.
3. How to take Cetirizina Teva
Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet may be divided into equal doses.
Instructions for use
If your treatment with Cetirizina Teva requires splitting the tablets, you should preferably follow these steps:
Place the tablet on a hard, flat surface (such as a table top or plate) with the score line facing upwards. Then press briefly but firmly with your fingers (index fingers or thumbs) on the outer edges to the right and left of the score line, as shown in the figure below.
Adults and adolescents aged 12 years and older
The recommended dose is 10 mg (1 tablet) once daily.
Other formulations of this medicine may be more suitable for children; consult your doctor or pharmacist.
Use in children aged 6 to 12 years
The recommended dose is 5 mg (half a tablet) twice daily.
Other formulations of this medicine may be more suitable for children; consult your doctor or pharmacist.
Patients with renal impairment
In patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you have severe kidney disease, consult your doctor or pharmacist, who will adjust your dose accordingly.
If your child has kidney disease, consult your doctor or pharmacist, who will adjust the dose according to your child’s needs.
If you feel that the effect of Cetirizina Teva 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 Teva than you should
If you think you have taken an overdose of Cetirizina Teva, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the adverse effects described below may occur with increased intensity. Adverse effects reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heartbeat, tremors, and urinary retention.
If you forget to take Cetirizina Teva
Do not take a double dose to make up for the forgotten dose.
If you stop taking Cetirizina Teva
If you stop treatment with Cetirizina Teva, itching (intense pricking 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 gets them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
contact your doctor immediately if you notice allergic reactions, including severe reactions and
angioedema (a severe allergic reaction causing swelling of the face or throat).
These reactions may occur immediately after taking the medicine or later on.
Common side effects (may affect up to 1 in 10 people)
- Drowsiness (drowsy feeling),
- Dizziness, headache
- Pharyngitis, rhinitis (in children)
- Diarrhoea, nausea, dry mouth
- Fatigue
Uncommon side effects (may affect up to 1 in 100 people)
- Agitation
- Paresthesia (abnormal skin sensation)
- Abdominal pain
- Itching (itchy skin), skin rash
- Asthenia (extreme tiredness), malaise
Rare side effects (may affect up to 1 in 1,000 people)
- Allergic reactions, some severe (very rare)
- Depression, hallucinations, aggression, confusion, insomnia
- Seizures
- Tachycardia (increased heart rate)
- Abnormal liver function
- Urticaria
- Edema (swelling)
- Weight gain
Very rare side effects (may affect up to 1 in 10,000 people)
- Thrombocytopenia (low platelet count in the blood)
- Tic (habitual spasm)
- Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
- Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes with uncontrolled circular movements)
- Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
- Abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty in urinating)
Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Increased appetite
- Suicidal ideation (recurring suicidal thoughts or concerns), nightmares
- Amnesia, memory impairment
- Vertigo (sensation of spinning or movement)
- Urinary retention (inability to completely empty the bladder)
- Itching (intense pricking sensation) and/or urticaria following discontinuation of treatment
- Joint pain
- Skin rash with pus-filled blisters
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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Cetirizina Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any 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 Teva contains
- The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.
Description of the appearance of Cetirizina Teva and pack contents
The film-coated tablet is white to off-white, round, biconvex, with a score line on one side and approximately 6.5 mm in diameter.
Blister packs made of PVC/PVDC/aluminium.
Cetirizina Teva is available in blisters containing 20, 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturer
Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Cetiriva
France: CETIRIZINE TEVA SANTE 10 mg, comprimé pelliculé sécable
Italy: Cetirizina Teva 10 mg
Spain: Cetirizina Tevagen 10 mg comprimidos recubiertos con película EFG
Sweden: Cetirizine Teva, 10 mg, filmdragerad tablett
United Kingdom: Cetirizine 10 mg Film-Coated Tablets
SOP (valid only for packs of 7, 14, 15)
Package leaflet: Information for the user
Cetirizine Teva 10 mg film-coated tablets
Cetirizine dihydrochloride
Generic medicine
Please 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 side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.
Contents of this leaflet
- What Cetirizine Teva is and what it is used for
- What you need to know before taking Cetirizine Teva
- How to take Cetirizine Teva
- Possible side effects
- How to store Cetirizine Teva
- Contents of the pack and other information
1. What Cetirizina Teva is and what it is used for
Cetirizine dihydrochloride is the active substance in Cetirizina Teva. Cetirizina Teva is an antiallergic medicinal product.
In adults and children from the age of 6 years, Cetirizina Teva is indicated:
- for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis;
- for the treatment of urticaria.
2. What you need to know before taking Cetirizine Teva
Do not take Cetirizine Teva
- if you are allergic to cetirizine hydrochloride or to any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances in other closely related medicines);
- if you have severe kidney disease (severe renal impairment with creatinine clearance below 10 ml/min).
Warnings and precautions
Consult your doctor or pharmacist before taking Cetirizine Teva.
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 difficulty urinating (spinal cord, prostate or bladder problems), seek medical advice.
If you are an epileptic patient or at risk of seizures, you should seek medical advice.
No clinically significant interactions have been observed between alcohol (at a blood level of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses. 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 with alcohol.
If you are due to have an allergy test, ask your doctor whether you should stop taking Cetirizine Teva a few days before the test. This medicine may affect the results of allergy testing.
Children
Do not give this medicine to children under 6 years of age, because the tablet formulation does not allow for the necessary dose adjustments.
Other medicines and Cetirizine Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizine Teva with food and drink
Food does not affect the absorption of Cetirizine Teva.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Cetirizine Teva should be avoided in pregnant women. 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 on medical advice.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizine Teva during breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have shown no evidence of impaired attention, alertness, or ability to drive following administration of cetirizine hydrochloride at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizine Teva if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Cetirizine Teva contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.
Cetirizine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially 'sodium-free'.
3. How to take Cetirizina Teva
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 swallowed with a glass of liquid.
The tablet may be divided into equal doses.
Instructions for use
If your treatment with Cetirizina Teva requires splitting the tablets, you should preferably follow the steps below.
Place the tablet on a hard, flat surface (such as a table top or a plate) with the score line facing upwards. Then press briefly but firmly with your fingers (index fingers or thumbs) on the outer edges to the right and left of the score line, as shown in the figure below.
Adults and adolescents aged 12 years and older
The recommended dose is 10 mg (1 tablet) once daily.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.
Use in children aged 6 to 12 years
The recommended dose is 5 mg (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
In patients with moderate renal impairment, the recommended dose is 5 mg once daily.
If you suffer from severe kidney disease, consult your doctor or pharmacist, who will adjust your dose accordingly.
If your child suffers from kidney disease, consult your doctor or pharmacist, who will adjust the dose according to your child’s needs.
If you feel that the effect of Cetirizina Teva is too weak or too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration, and progression of your symptoms. If you have any doubts, consult your doctor or pharmacist.
If you take more Cetirizina Teva than you should
If you think you have taken an overdose of Cetirizina Teva, inform your doctor.
Your doctor will decide what measures to take, if necessary.
After an overdose, the adverse effects described below may occur with increased intensity. Adverse effects reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal rapid heartbeat, tremors, and urinary retention.
If you forget to take Cetirizina Teva
Do not take a double dose to make up for the missed dose.
If you stop taking Cetirizina Teva
If you stop treatment with Cetirizina Teva, itching (intense pricking sensation) and/or urticaria may rarely reappear.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects are rare or very rare. However, you must stop taking the medicine and
contact your doctor immediately if you notice any signs of allergic reactions, including severe
reactions and angioedema (a severe allergic reaction causing swelling of the face or throat).
These reactions may occur immediately after taking the medicine or later.
Common side effects (may affect up to 1 in 10 people)
- Drowsiness (sleepiness),
- Dizziness, headache
- Pharyngitis, rhinitis (in children)
- Diarrhoea, nausea, dry mouth
- Fatigue
Uncommon side effects (may affect up to 1 in 100 people)
- Agitation
- Paresthesia (abnormal skin sensation)
- Abdominal pain
- Itching (itchy skin), skin rash
- Asthenia (extreme fatigue), malaise
Rare side effects (may affect up to 1 in 1,000 people)
- Allergic reactions, some severe (very rare)
- Depression, hallucinations, aggression, confusion, insomnia
- Seizures
- Tachycardia (increased heart rate)
- Abnormal liver function
- Urticaria (hives)
- Edema (swelling)
- Weight gain
Very rare side effects (may affect up to 1 in 10,000 people)
- Thrombocytopenia (low platelet count in the blood)
- Tic (habitual spasm)
- Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
- Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes with uncontrolled circular movements)
- Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
- Abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty in urinating)
Side effects with unknown frequency (frequency cannot be determined from the available data)
- Increased appetite
- Suicidal ideation (recurring suicidal concerns or thoughts), nightmares
- Amnesia, memory impairment
- Vertigo (sensation of spinning or movement)
- Urinary retention (inability to completely empty the bladder)
- Itching (intense pricking sensation) and/or urticaria following discontinuation of treatment
- Joint pain
- Skin rash with pus-filled blisters
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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Cetirizina Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Teva contains
- The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
- The other ingredients are monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.
Description of the appearance of Cetirizina Teva and package contents
The film-coated tablet is white to almost white, round, biconvex, with a score line on one side and approximately 6.5 mm in diameter.
Blister packs made of PVC/PVDC/aluminum.
Cetirizina Teva is available in blister packs containing 7, 14 or 15 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren-Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Cetiriva
France: CETIRIZINE TEVA SANTE 10 mg, comprimé pelliculé sécable
Italy: Cetirizina Teva 10 mg
Spain: Cetirizina Tevagen 10 mg comprimidos recubiertos con película EFG
Sweden: Cetirizine Teva, 10 mg, filmdragerad tablett
United Kingdom: Cetirizine 10 mg Film-Coated Tablets