Sotrizol

PACKAGE LEAFLET: INFORMATION FOR THE USER

SOTRIZOL

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

Contents of this leaflet

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

1. What Sotrizol is and what it is used for

Cetirizine dihydrochloride is the active substance of Sotrizol.
Sotrizol is an antiallergic medicinal product.
In adults and children from 6 years of age, Sotrizol 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 need to know before taking Sotrizol

Do not take Sotrizol

• 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 Sotrizol.
If you are a patient with renal insufficiency, consult your doctor; if necessary, you should 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 injuries 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 SOTRIZOL together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Sotrizol 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 Sotrizol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Sotrizol 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 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 should not take Sotrizol while breastfeeding unless you have consulted your doctor.

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

Sotrizol film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Sotrizol

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.
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
For patients with moderate renal impairment, the recommended dose is 5 mg once daily. If you have severe
kidney disease, contact your doctor, who may adjust the dose accordingly.
If your child has kidney disease, contact the doctor, who may adjust the dose according to the child's needs.
If you feel that the effect of Sotrizol 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 Sotrizol than you should
If you think you have taken an overdose of Sotrizol, inform your doctor. The doctor will decide which 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,
pruritus, 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 Sotrizol
Do not take a double dose to make up for the missed dose.
If you stop taking Sotrizol
If you stop treatment with Sotrizol, pruritus (intense itching) 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 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 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 or runny nose) (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 (feeling unwell)

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 (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), drug eruption (fixed drug eruption, i.e. drug allergy)
• Abnormal urination (involuntary emptying of the bladder during sleep, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal ideation (suicidal thoughts or concerns, recurrent), nightmares
• Amnesia (memory loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Itching (intense pricking sensation) and/or urticaria occurring after stopping treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalized acute exanthematous pustulosis (skin eruption with pustules containing pus)
• 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

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. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.

6. Package contents and other information What Sotrizol contains

SOTRIZOL film-coated tablets

• The active substance in Sotrizol is Cetirizine dihydrochloride.
• Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The excipients are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 6000.

Description of the appearance of Sotrizol and pack contents
Film-coated tablet with a score line. The tablets can be divided into two equal parts.
Pack size: 20 tablets.
Marketing Authorization Holder and Manufacturer
Dymalife Pharmaceutical srl – Via Bagnulo, n°95 - 80063 Piano di Sorrento NA
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Via Fratta Rotonda Vado Largo, n.1, 03012 Anagni (FR)

PACKAGE LEAFLET: INFORMATION FOR THE USER

SOTRIZOL

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

Contents of this leaflet:

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

1. What Sotrizol is and what it is used for

Cetirizine dihydrochloride is the active substance in Sotrizol.
Sotrizol is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, Sotrizol 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 Sotrizol

Do not take Sotrizol

• 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
Talk to your doctor or pharmacist before taking Sotrizol.
If you have kidney impairment, consult your doctor; if necessary, you should take a lower dose. Your doctor will determine the appropriate 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 concomitant intake of SOTRIZOL with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Sotrizol a few days before the test. This medicine may alter the results of allergy testing.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Sotrizol should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not cause 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 ruled out. Therefore, you should not take Sotrizol while breastfeeding unless you have consulted your doctor.

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

Sotrizol oral drops, solution contains methyl para-hydroxybenzoate (E218), propyl para-hydroxybenzoate (E216), propylene glycol (E1520), and sodium
This medicine contains methyl para-hydroxybenzoate (E218) and propyl para-hydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
This medicine contains 350 mg of propylene glycol (E1520) per ml.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Sotrizol

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 dilution is used, especially when administering to children, consider that the volume of water to which the drops are added should be proportionate to the amount of liquid the patient can ingest. 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 the 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 (10 drops) once daily.
If you have severe kidney disease, contact your doctor, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor, who may adjust the dose based on the child's needs.

If you feel that the effect of Sotrizol 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 Sotrizol than you should
If you think you have taken an overdose of Sotrizol, inform your doctor. The 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, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupil 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 Sotrizol
Do not take a double dose to make up for a missed dose.

If you stop taking Sotrizol
If you stop treatment with Sotrizol, 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 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 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 on.

Common side effects (may affect up to 1 in 10 people)

• Somnolence (feeling sleepy)
• 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
• Paresthesia (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 severe (very rare)
• Depression, hallucinations, aggression, confusion, insomnia
• Seizures
• Tachycardia (fast heartbeat)
• Abnormal liver function
• Urticaria (hives)
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (low level of platelets 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 (allergic reaction to the medicine)
• 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 loss), memory impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Pruritus (intense itching) and/or urticaria occurring after stopping treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalized pustular eruption (skin rash 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 Sotrizol

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 on the bottle. 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. Contents of the pack and other information What Sotrizol contains SOTRIZOL oral drops, solution
   • The active substance in Sotrizol 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 excipients are: glycerol, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Sotrizol and contents of the pack
Oral drops, solution; bottle containing 20 ml of clear, colourless solution.
Marketing Authorisation Holder and Manufacturer
Dymalife Pharmaceutical srl – Via Bagnulo, n° 95 - 80063 Piano di Sorrento NA
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. Via Fratta Rotonda Vado Largo, n.1, 03012 Anagni (FR)