CETIRIZINA 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Cetirizina Teva 10 mg film-coated tablets
   1. What is Cetirizina Teva and what is it used for
   2. What you need to know before you take Cetirizina Teva
   3. How to take Cetirizina Teva
   4. Possible side effects
   5. How to store Cetirizina Teva
   6. Contents of the pack and other information
2. Cetirizina Teva 10 mg film-coated tablets
   1. What is Cetirizina Teva and what is it used for
   2. What you need to know before you take Cetirizina Teva
   3. How to take Cetirizina Teva
   4. Possible side effects
   5. How to store Cetirizina Teva
   6. Contents of the pack and other information

Medical prescription required (RR)(valid only for packs of 20, 28, 30, 50 and 100)

Cetirizina Teva 10 mg film-coated tablets

Cetirizine dihydrochloride

Generic medicine

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Cetirizine dihydrochloride is the active ingredient of Cetirizina Teva. Cetirizina Teva is an
antihistamine medicine.
In adults and children aged 6 years and over, 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 you take Cetirizina Teva

Do not take Cetirizina Teva

• 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 piperazine derivatives (active ingredients of other closely related medicines);
• if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Warnings and precautions
Consult your doctor or pharmacist before taking Cetirizina Teva.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you will need to take a
lower dose. The new dose will be determined by your doctor.
If you have difficulty urinating (problems with the spinal cord, prostate or bladder), ask your
doctor for advice.
If you are an epileptic patient or a patient at risk of seizures, you should ask your
doctor for advice.
No clinically significant interactions have been observed between alcohol (at a blood level
of 0.5 per mille (g/l) corresponding to a glass of wine) and cetirizine used at the recommended
doses. However, no data are available on the safety of the product when higher doses of cetirizine and alcohol are taken together. Therefore, as with all antihistamines, it is
recommended to avoid taking Cetirizina Teva with alcohol.
If you need to have an allergy test, ask your doctor if you need to stop taking Cetirizina
Teva for a few days before the test. This medicine may alter the results of the allergy test.

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 Cetirizina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
Cetirizina Teva should be avoided in pregnant women. Accidental use of the drug by
a pregnant woman does not produce any harmful effects on the fetus. However, the
medicine should only be taken if necessary and on the advice of a doctor.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizina Teva during
breastfeeding unless you have contacted your doctor.

Driving and using machines
Clinical studies have shown no evidence of impairment of attention,
vigilance and the ability to drive after taking cetirizine dihydrochloride at the recommended
dose.
You should carefully observe your response to the medicine after taking Cetirizina Teva if
you intend to drive, perform potentially dangerous activities or use machinery. You should not
exceed the recommended dose.

Cetirizina Teva contains lactose
If your doctor has told you that you are intolerant to certain sugars, ask your doctor before
taking this medicine.

Cetirizina 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 following exactly the instructions of 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 can be divided into equal doses.

Instructions for use
If your treatment with Cetirizina Teva involves dividing the tablets, you should
preferably do as follows.
Place the tablet on a hard, flat surface (such as a table top or plate) with the
score line facing upwards. Then press simultaneously with your fingers (index fingers or
thumbs) briefly but firmly on the outer edges to the right and left of the score line, as
shown in the figure below.

Adults and adolescents from 12 years of age
The recommended dose is 10 mg (1 tablet) once a day.
Other forms of this medicine may be more suitable for children; ask your doctor or
pharmacist.

Use in children aged between 6 and 12 years
The recommended dose is 5 mg (half a tablet) twice a day. Other forms of this
medicine may be more suitable for children; ask your doctor or pharmacist.

Patients with impaired renal function
In patients with moderate renal impairment, the recommended dose is 5 mg once a day.
If you suffer from a severe kidney disease, consult your doctor or pharmacist, who may adjust your
dose accordingly.
If your child suffers from a kidney disease, consult your doctor or pharmacist who may 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 is
established by the doctor.

If you take more Cetirizina Teva than you should
If you believe you have taken an overdose of Cetirizina Teva, inform your doctor.
The doctor will decide what measures to take, if necessary.
After an overdose, the side effects described below may occur with increased
intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness,
stupor, abnormal fast heartbeat, tremors and urinary retention have been reported.

If you forget to take Cetirizina Teva
Do not take a double dose to make up for a missed dose.

If you stop taking Cetirizina Teva
If you stop treatment with Cetirizina Teva, itching
(intense tingling) and/or hives may rarely reappear.
If you have any doubts about the use of this medicine, ask 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 should stop taking the medicine and inform your doctor immediately if you notice the appearance ofallergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes 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 (somnolence),
• 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
• Pruritus (itchy 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
• Convulsions
• Tachycardia (fast heartbeat)
• 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 (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculorotation (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
• Abnormal urine elimination (involuntary bladder emptying during nighttime sleep, pain and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available data)

• Increased appetite
• Suicidal ideation (recurring concerns or suicidal thoughts), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Intense itching and/or urticaria following discontinuation of treatment
• Joint pain
• Blistering rash containing pus

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the blister after
“Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cetirizina Teva contains

• The active ingredient is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.

Description of the appearance of Cetirizina Teva and contents of the pack
The film-coated tablet is white to off-white in colour, round, biconvex, with a
score line on one side and approximately 6.5 mm in diameter.
Blisters in PVC/PVDC/aluminium.
Cetirizina Teva is available in blisters of 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 Milano

Manufacturer
Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren-Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Cetiriva
France: CETIRIZINE TEVA SANTE 10 mg, film-coated divisible tablet
Italy: Cetirizina Teva 10 mg
Spain: Cetirizina Tevagen 10 mg film-coated tablets EFG
Sweden: Cetirizine Teva, 10 mg, film-coated tablet
United Kingdom: Cetirizine 10 mg Film-Coated Tablets
SOP (valid only for packs of 7, 14, 15)

Cetirizina Teva 10 mg film-coated tablets

Cetirizine dihydrochloride

Generic medicine

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse after 3 days.

Contents of this leaflet

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

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

Cetirizine dihydrochloride is the active ingredient of Cetirizina Teva. Cetirizina Teva is an
antihistamine medicine.
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 you take Cetirizina Teva

Do not take Cetirizina Teva

• 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 piperazine derivatives (active ingredients of other closely related medicines);
• if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min).

Warnings and precautions
Consult your doctor or pharmacist before taking Cetirizina Teva.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you will need to take a
lower dose. The new dose will be determined by your doctor.
If you have difficulty urinating (problems with the spinal cord, prostate or bladder), ask your
doctor for advice.
If you are an epileptic patient or a patient at risk of seizures, you should ask your
doctor for advice.
No clinically significant interactions have been observed between alcohol (at a blood level
of 0.5 per mille (g/l) corresponding to a glass of wine) and cetirizine used at the recommended
doses. However, no safety data are available when higher doses of cetirizine and alcohol are taken
together. Therefore, as with all antihistamines, it is
recommended to avoid taking Cetirizina Teva with alcohol.
If you need to have an allergy test, ask your doctor if you need to stop taking Cetirizina
Teva for a few days before the test. This medicine may alter the results of the allergy test.

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 Cetirizina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
Cetirizina Teva should be avoided in pregnant women. Accidental use of the drug by
a pregnant woman does not produce any harmful effects on the fetus. However, the
medicine should only be taken if necessary and on the advice of a doctor.
Cetirizine passes into breast milk. Therefore, you should not take Cetirizina Teva during
breastfeeding unless you have contacted your doctor.

Driving and using machines
Clinical studies have shown no evidence of impairment of attention,
vigilance and the ability to drive after taking cetirizine dihydrochloride at the
recommended dose.
You should carefully observe your response to the medicine after taking Cetirizina Teva if
you intend to drive, perform potentially dangerous activities or use machinery. You should not
exceed the recommended dose.

Cetirizina Teva contains lactose
If your doctor has told you that you are intolerant to certain sugars, ask your doctor before
taking this medicine.

Cetirizina 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 following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets must be swallowed with a glass of liquid.
The tablet can be divided into equal doses.

Instructions for use
If your treatment with Cetirizina Teva involves dividing the tablets, you should preferably do as follows.
Place the tablet on a hard, flat surface (such as a table top or a plate) with the
notch facing upwards. Then press simultaneously with your fingers (index fingers or
thumbs) briefly but firmly on the outer edges to the right and left of the notch, as
shown in the figure below.

Adults and adolescents starting from 12 years
The recommended dose is 10 mg (1 tablet) once a day.
Other forms of this medicine may be more suitable for children; consult your doctor or
pharmacist.

Use in children aged between 6 and 12 years
The recommended dose is 5 mg (half a tablet) twice a day.
Other forms of this medicine may be more suitable for children; consult your doctor or
pharmacist.

Patients with impaired renal function
In patients with moderate renal impairment, the recommended dose is 5 mg once a day.
If you suffer from a severe kidney disease, consult your doctor or pharmacist, who may adjust your
dose accordingly.
If your child suffers from a kidney disease, consult your doctor or pharmacist who may 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. If you have
doubts, consult your doctor or pharmacist.

If you take more Cetirizina Teva than you should
If you believe you have taken an overdose of Cetirizina Teva, inform your doctor.
The doctor will decide what measures to take, if necessary.
After an overdose, the side effects described below may occur with increased
intensity. Adverse effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness,
stupor, abnormal fast heartbeat, tremors and urinary retention have been reported.

If you forget to take Cetirizina Teva
Do not take a double dose to make up for a missed dose.

If you stop taking Cetirizina Teva
If you stop treatment with Cetirizina Teva, itching
(intense tingling) and/or hives may rarely reappear.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects are rare or very rare. However, you should stop taking the medicine and immediately inform your doctor if you notice the appearance ofallergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes 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 patients)

• Drowsiness (somnolence),
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itchy skin), rash
• Asthenia (extreme fatigue), malaise

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

• Allergic reactions, some severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Convulsions
• Tachycardia (fast heartbeat)
• Abnormal liver function
• Urticaria
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low platelet count in the blood)
• Tic (habitual spasm)
• Syncope, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculorotation (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption
• Abnormal urine elimination (involuntary bladder emptying during nighttime sleep, pain and/or difficulty urinating)

Side effects with unknown frequency(frequency cannot be estimated based on available data)

• Increased appetite
• Suicidal ideation (recurring concerns or suicidal thoughts), nightmares
• Amnesia, memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Intense itching and/or urticaria following discontinuation of treatment
• Joint pain
• Blistering rash containing pus

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 which is stated on the package and on the 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 in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cetirizina Teva contains

• The active ingredient is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171), hypromellose (E464) and macrogol.

Description of the appearance of Cetirizina Teva and contents of the pack
The film-coated tablet is white to off-white in colour, round, biconvex, with a
score line on one side and approximately 6.5 mm in diameter.
Blisters in PVC/PVDC/aluminium.
Cetirizina Teva is available in blisters of 7, 14 and 15 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 Milano

Manufacturer
Merckle GmbH Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren-Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Cetiriva
France: CETIRIZINE TEVA SANTE 10 mg, film-coated divisible tablet
Italy: Cetirizina Teva 10 mg
Spain: Cetirizina Tevagen 10 mg film-coated tablets EFG
Sweden: Cetirizine Teva, 10 mg, film-coated tablet
United Kingdom: Cetirizine 10 mg Film-Coated Tablets