Stamidix

Package leaflet: Information for the user

Stamidix 10 mg tablets

Cetirizine dihydrochloride
Equivalent medicine
Please read all of 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 they have the same symptoms as yours, because 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 Stamidix is and what it is used for
2. What you need to know before taking Stamidix
3. How to take Stamidix
4. Possible side effects
5. How to store Stamidix
6. Contents of the pack and other information

1. What Stamidix is and what it is used for

Stamidix contains the active substance cetirizine dihydrochloride and belongs to the piperazine derivative class, which are second-generation antihistamines.
Stamidix is an antiallergic medicinal product.
In adults and children from 6 years of age, Stamidix 10 mg tablets are indicated:

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

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Stamidix

Do not take Stamidix

• 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 Stamidix.
If you have kidney impairment, consult your doctor; a lower dose may be needed. Your doctor will determine the appropriate dose.
Consult your doctor if you have problems urinating (such as in conditions involving spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, consult your doctor before taking this medicine.
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine administered 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 Stamidix together with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Stamidix a few days before the test. This medicine may interfere with 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 Stamidix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Stamidix should be avoided during pregnancy. Accidental use of the medicine during pregnancy does not cause 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 excluded. Therefore, you should not take Stamidix 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 Stamidix at the recommended dose.
However, you should carefully observe how you react to the medicine after taking Stamidix if you intend to drive, perform potentially hazardous activities, or operate machinery.
Do not exceed the recommended dose.

Stamidix contains lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Stamidix contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Stamidix

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 aged 12 years and older
The recommended dose is 10 mg once daily (i.e. one tablet once daily).
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Use in children aged between 6 and 12 years
The recommended dose is 5 mg twice daily (i.e. 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 or pharmacist, who may adjust the dose accordingly.
If your child has kidney disease, contact your doctor or pharmacist, who will adjust the dose according to the child's needs.

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

If you take more Stamidix than you should
If you think you have taken more Stamidix than you should, inform your doctor.
Your doctor will decide which measures to take, if necessary.
After an overdose, the undesirable effects described below may occur with increased intensity. Reported adverse effects 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 Stamidix
Do not take a double dose to make up for the forgotten dose.

If you stop taking Stamidix
If you stop treatment with Stamidix, 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 may develop later.

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

• Drowsiness (need to sleep)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (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
• Itching (itchy skin), skin rash
• Asthenia (extreme fatigue), malaise (feeling unwell)

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

• Allergic reactions, some severe (very rare)
• Aggressiveness, confusion, depression (low mood), hallucinations (seeing or hearing things that are not there), insomnia
• Seizures (involuntary shaking movements)
• Tachycardia (rapid heartbeat)
• Abnormal liver function (abnormal liver functioning)
• Urticaria (itchy skin rash)
• 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 (loss of consciousness), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (taste disturbances)
• 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 (skin rash)
• 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 (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)
• Itching (intense pricking sensation) and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Generalized pustular eruption (skin rash with pus-filled blisters)
• Hepatitis (liver inflammation)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Stamidix

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 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 Stamidix contains

• The active substance is cetirizine hydrochloride. One tablet contains 10 mg of cetirizine hydrochloride.
• The other components are: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, sodium starch glycolate.

Description of the appearance of Stamidix and package contents
Tablets: blister pack containing 20 tablets
Marketing Authorization Holder
IDI Farmaceutici S.r.l. – Via dei Castelli Romani nn. 83/85 – Pomezia (RM)
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10090 San Bernardo d’Ivrea (TO)

Package leaflet: information for the user

Stamidix 10 mg/ml oral drops, solution

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, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Stamidix is and what it is used for

Stamidix contains the active substance cetirizine dihydrochloride and belongs to the piperazine derivatives class, which are second-generation antihistamines.
Stamidix is an antiallergic medicinal product.
In adults and children from 2 years of age, Stamidix 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 Stamidix

Do not take Stamidix

• 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 Stamidix.

• If you have kidney impairment, consult your doctor; a lower dose may be needed. Your doctor will determine the appropriate 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, 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 safety when higher doses of cetirizine and alcohol are taken simultaneously.
Therefore, as with all antihistamines, it is recommended to avoid taking Stamidix together with alcohol.
If you are scheduled for an allergy test, ask your doctor whether you should stop taking Stamidix a few days before the test. This medicine may alter the results of allergy testing.
The use of this medicine is not recommended in neonates and children under 2 years of age.
Other medicines and Stamidix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Stamidix with food and drink
Food does not affect the absorption of Stamidix.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Stamidix 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 excluded. Therefore, you should not take Stamidix during breastfeeding unless advised by your doctor.
Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or ability to drive vehicles after taking Stamidix at the recommended dose.
You should carefully observe your response to the medicine after taking Stamidix if you intend to drive, perform potentially hazardous activities, or operate machinery.
Do not exceed the recommended dose.
Stamidix oral drops, solution contains methyl parahydroxybenzoate (E128) and propyl
parahydroxybenzoate (E216), which may cause allergic reactions (including delayed reactions).
Stamidix oral drops, solution contains propylene glycol.
This medicine contains 350 mg of propylene glycol (E1520) per 1 ml.
If the child is under 5 years of age, speak with your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor (see also section “Pregnancy and breastfeeding”).
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor.
Your doctor may carry out additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Stamidix

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The drops should be poured onto a spoon or diluted in water and taken orally.
If using dilution, especially when administering to children, consider that the volume of water used to dilute the drops should be proportionate to the amount of liquid the patient is able to swallow.
The diluted solution must 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 (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 will adjust the dose according to the child's needs.

If you feel that the effect of Stamidix is too weak or too strong, inform your doctor.

Treatment duration
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 Stamidix than you should
If you think you have taken more Stamidix than you should, inform your doctor.
The doctor will decide what measures to take, if necessary.
After an overdose, the following undesirable effects may occur with increased intensity. Reported side effects include confusion, diarrhoea, 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 Stamidix
Do not take a double dose to make up for the forgotten dose.

If you stop treatment with Stamidix
If you stop treatment with Stamidix, itching (intense prickling) 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 immediately contact your doctor 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 at a later time.

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

• Drowsiness
• 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 of which severe (very rare)
• Aggression, confusion, depression (low mood), hallucinations (seeing or hearing things that are not there), insomnia
• Seizures (involuntary shaking movements)
• Tachycardia (fast heartbeat)
• Abnormal liver function (abnormal liver functioning)
• Urticaria (itchy skin rash)
• Edema (swelling)
• Weight gain

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

• Anaphylactic shock
• 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-induced fixed 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 worries or suicidal thoughts), nightmares
• Amnesia (loss of memory), 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)
• Generalized pustular exanthema (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 Stamidix

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 more than 15 months after first opening the bottle.
This medicine requires no 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 Stamidix contains

• The active substance is cetirizine dihydrochloride. 1 ml (equivalent to 20 drops) contains 10 mg of cetirizine dihydrochloride.
• The other components are: glycerol 85%, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid, purified water.

Description of the appearance of Stamidix and contents of the pack
Oral drops, solution: 20 ml bottle.
Marketing Authorization Holder
IDI Farmaceutici S.r.l. – Via dei Castelli Romani nn. 83/85 – Pomezia (RM)
Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10090 San Bernardo d’Ivrea (TO)