Tezastin

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEZASTIN 10 mg film-coated tablets

Cetirizine dihydrochloride
Equivalent medicine
Please 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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Tezastin is and what it is used for

Cetirizine dihydrochloride is the active substance in Tezastin. Tezastin is an antiallergic medicine.
In adults and children aged 6 years and older, Tezastin 10 mg film-coated tablets are indicated:

• for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• for the treatment of urticaria.

2. What you should know before taking Tezastin

Do not take Tezastin:

• if you have severe kidney disease requiring dialysis;
• 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 substances of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tezastin.
If you are a patient with renal impairment, consult your doctor; if necessary, you should take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have problems urinating (in conditions such as spinal cord injury or bladder or prostate problems).
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 blood levels of 0.5 per mille (g/l), corresponding to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Tezastin together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Tezastin a few days before the test. This medicine may alter 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 Tezastin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tezastin with food and drink
Food does not affect the absorption of Tezastin.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Tezastin should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce harmful effects on the fetus; however, the medicine should be taken only if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Tezastin while breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles after taking Tezastin at the recommended dose. However, you should carefully observe your response to the medicine after taking Tezastin if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.
Tezastin film-coated tablets contain 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 Tezastin

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 taken with a glass of liquid.
The tablet may be divided into two equal parts.
Adults and adolescents from 12 years of age
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.
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
For patients with moderate renal impairment, the recommended dose is 5 mg (half a tablet) once daily.
If you have severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
If the child has kidney disease, contact the doctor or pharmacist, who will adjust the dose according to the child's needs.
If you feel that the effect of Tezastin 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 condition and will be determined by your doctor.
If you take more Tezastin than you should
If you think you have taken an overdose of Tezastin, inform your doctor.
The doctor will decide which measures to take if necessary.
After an overdose, the undesirable effects described below may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupil dilation, itching, restlessness, sedation, somnolence (drowsiness), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).
If you forget to take Tezastin
Do not take a double dose to make up for the forgotten dose.
If you stop taking Tezastin
If you stop treatment with Tezastin, itching (intense pruritus) 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 everyone experiences them.
The following side effects are rare or very rare. However, you must stop taking the medicine and inform your
doctor immediately if you notice any of the following:

• Allergic reactions, including severe reactions and angioedema (a serious 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 (need to sleep)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paraesthesia (abnormal skin sensation)
• Abdominal pain
• Pruritus (itchy skin), skin rash
• Asthenia (extreme tiredness), malaise (feeling unwell)

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

• Allergic reactions, some of which are severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Seizures
• Tachycardia (increased heart rate)
• Abnormal liver function
• Urticaria
• Oedema (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 (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrolled circular movements)
• Angioedema (serious 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 urinating)

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

• Increased appetite
• Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
• Amnesia (memory loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalised exanthematous pustulosis (skin eruption with pus-filled blisters)
• Hepatitis (inflammation of the liver)

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 Tezastin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Tezastin contains

• The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Coating: Opadry II white (composed of hypromellose, titanium dioxide (E171), polydextrose (E1200), talc, maltodextrin, medium-chain triglycerides).

Description of the appearance of Tezastin and package contents
White, oval, film-coated tablet with a score line.
Pack sizes: 20 and 7 tablets in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)

Manufacturer

• Doppel Farmaceutici S.r.l. - Via Volturno, 48 - 20089 Quinto de' Stampi - Milano
• Vamfarma S.r.l. - Via Kennedy, 5 - 26833 Comazzo (Lo)

PATIENT LEAFLET: INFORMATION FOR THE USER

TEZASTIN 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic medicine
Please 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 may 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

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

1. What Tezastin is and what it is used for

Cetirizine dihydrochloride is the active substance in Tezastin. Tezastin is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, Tezastin 10 mg/ml oral drops, solution 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 Tezastin

Do not take Tezastin:

• if you have severe kidney disease requiring dialysis;
• 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 substances in other closely related medicines).

Warnings and precautions
Consult your doctor or pharmacist before taking Tezastin.
If you are a patient with renal impairment, consult your doctor; if necessary, you must take a lower dose.
Your doctor will determine the new dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you must consult your doctor.
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 used at the recommended doses. However, there are no available data on the safety of concomitant intake of higher doses of cetirizine and alcohol.
Therefore, as with all antihistamines, it is recommended to avoid taking Tezastin and alcohol at the same time.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Tezastin a few days before the test. This medicine may alter the results of allergy testing.

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

Tezastin with food and drinks
Food does not affect the absorption of Tezastin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Tezastin 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.
A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you must not take Tezastin while breastfeeding unless advised by your doctor.

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

Tezastin oral drops, solution contains methylparahydroxybenzoate, propylparahydroxybenzoate, propylene glycol and sodium.
Tezastin oral drops, solution contains methylparahydroxybenzoate and propylparahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
Tezastin oral drops, solution contains 350 mg of propylene glycol per 10 mg dose (20 drops).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Tezastin

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The drops should be poured into a spoon or diluted in water and taken orally.
If using dilution, especially when administering to children, consider that the volume
of water to which the drops are added must be proportionate to the amount of liquid the patient is able
to swallow. The diluted solution should be taken immediately.
When counting drops, the bottle must be held vertically (upside down).
If the flow of drops stops and the correct amount has not been dispensed, return the bottle
to an upright position, then turn it upside down again and continue counting the drops.

Adults and adolescents from 12 years of age
The recommended dose is 10 mg (20 drops) once daily.

Use in children aged 6 to 12 years
The recommended dose is 5 mg (10 drops) twice daily.

Use in children aged 2 to 6 years
The recommended dose is 2.5 mg (5 drops) twice daily.

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg (i.e. 10 drops) once daily.
If you suffer from severe kidney disease, contact your doctor or pharmacist, who may adjust the dose accordingly.
If the child suffers from kidney disease, contact the doctor or pharmacist, who may adjust the dose based on the child's needs.

If you feel that the effect of Tezastin 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 determined by
your doctor.

If you take more Tezastin than you should
If you think you have taken an overdose of Tezastin, 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 events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence (need to sleep), stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).

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

If you stop taking Tezastin
If you stop treatment with Tezastin, itching (intense pruritus) 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.
The following side effects are rare or very rare. However, you must stop taking the medicine and inform your doctor immediately if you notice any of the following:

• 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 (need to sleep)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (stuffy nose, runny nose) (in children)
• Diarrhoea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paraesthesia (abnormal skin sensations)
• Abdominal pain
• Itching (pruritic skin), skin rash
• Asthenia (extreme tiredness), malaise (feeling unwell)

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

• Allergic reactions, some of which are severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Seizures
• Tachycardia (increased heart rate)
• Abnormal liver function
• Urticaria (hives)
• Oedema (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 (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
• Angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption
• Abnormal urination (involuntary emptying of the bladder during sleep, pain and/or difficulty urinating)

Side effects with unknown frequency (frequency cannot be determined from the available data)

• Increased appetite
• Suicidal ideation (recurring suicidal thoughts or concerns), nightmares
• Amnesia (loss of memory), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Itching (intense pruritus) and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalised acute exanthematous pustulosis (skin eruption with pus-filled blisters)
• Hepatitis (inflammation of the liver)

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 Tezastin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use after 6 months from the first opening of the bottle.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Tezastin contains

• The active substance is cetirizine dihydrochloride. 1 ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
• The other components are glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Tezastin and contents of the pack
Tezastin oral drops are supplied in a pack containing an amber glass bottle of 20 ml with a dropper.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Epifarma S.r.l. – Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1- 29016 Cortemaggiore (PC)