STAMIDIX 10 mg Tablet

Зміст інструкції

1. Stamidix 10 mg tablets
   1. What is Stamidix and what is it 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
2. Stamidix 10 mg/ml oral drops, solution
   1. What is Stamidix and what is it 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

Stamidix 10 mg 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 Stamidix is and what it is used for
• 2. What you need to know before you take 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 is Stamidix and what is it used for

Stamidix contains the active ingredient cetirizine dihydrochloride and belongs to the category of piperazine derivatives, which are second-generation antihistamines.
Stamidix is an antiallergic medicine.
In adults and children from 6 years of age, Stamidix 10 mg tablets is 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 a 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 are a patient with kidney failure, ask your doctor for advice; if necessary, you should take a lower dose.
The new dose will be defined by your doctor.
Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or
bladder or prostate problems).
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 (for blood levels of 0.5 per
mille (g/l) corresponding to a glass of wine) and cetirizine used at recommended doses. However, no data
are available on safety when higher doses of cetirizine and alcohol are taken
simultaneously. Therefore, as with all antihistamines, it is recommended to avoid the simultaneous
intake of Stamidix and alcohol.
If you need to have an allergy test, ask your doctor if you should stop taking Stamidix 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 Stamidix
Tell 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 significantly affect the absorption of Stamidix.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
Stamidix should be avoided during pregnancy. 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. It is not possible to exclude a risk of adverse effects in breastfed infants.
Therefore, you should not take Stamidix during breastfeeding unless you have
contacted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and the 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 vehicles, engage in potentially dangerous activities or use machines.
You should not exceed the recommended dose.
Stamidix contains lactose; if your doctor has diagnosed you with intolerance to some sugars, contact
him/her before taking this medicine.
Stamidix contains less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially “sodium-free”.

3. How to take Stamidix

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The tablets should be taken with a glass of liquid.
The tablet can be divided into 2 equal parts.

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

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once a day.
If you suffer from severe kidney disease, contact your doctor or pharmacist who may adjust the dose of
accordingly.
If your child suffers from kidney disease, contact your doctor or pharmacist who may adjust the dose
based on the child's needs.
If you feel that the effect of Stamidix is too weak or strong, tell your doctor.

Duration of treatment
The duration of treatment depends on the type, duration and course of your disorders and is established by the
doctor.

If you take more Stamidix than you should
If you think you have taken more Stamidix than you should, tell your doctor.
The doctor will decide what measures to take if necessary.
After an overdose, the undesirable effects described below may appear with increased
intensity. Undesirable effects such as confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupil dilation, itching, restlessness, sedation, drowsiness
(need to sleep), stupor, abnormal and rapid heart rate, tremors and urinary retention (difficulty in
completely emptying the bladder) have been reported.

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

If you stop taking Stamidix
If you stop taking Stamidix, itching (intense tingling) and/or
urticaria 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 tell your doctor immediately if you notice the appearance of:

• allergic 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 (feeling sleepy)
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (blocked 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), rash
• Asthenia (extreme fatigue), malaise (feeling unwell)

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

• Allergic reactions, some severe (very rare)
• Aggressiveness, confusion, depression (low mood), hallucinations (seeing or hearing things that are not there), insomnia
• Convulsions (involuntary shaking movements)
• Tachycardia (fast heartbeat)
• Abnormal liver function (abnormal liver function)
• Urticaria (itchy rash)
• 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)
• Tics (habitual spasm)
• Syncope (loss of consciousness), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption (skin rash)
• Abnormal urination (involuntary bladder emptying during sleep, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal ideation (recurring thoughts or concerns about suicide), nightmare
• Amnesia (memory loss), 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
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalized pustulosis (skin rash with pus-filled blisters)
• Hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister. 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 Stamidix contains

• The active ingredient is cetirizine dihydrochloride. One tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, sodium starch glycolate

Description of the appearance of Stamidix and contents of the pack
Divisible tablets: pack of 20 tablets

Marketing Authorisation 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)

Stamidix 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic medicine

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, 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 Stamidix is and what it is used for
• 2. What you need to know before you take 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 is Stamidix and what is it used for

Stamidix contains the active ingredient cetirizine dihydrochloride and belongs to the category of piperazine derivatives, which are second-generation antihistamines.
Stamidix is an anti-allergic medicine.
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 a 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 ingredients of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Stamidix.

• If you are a patient with kidney failure, ask your doctor for advice; if necessary, you may need to take a lower dose. The new dose will be defined by your doctor;
• Ask your doctor for advice if you have problems with urination (in conditions such as spinal cord injury or bladder or prostate problems);
• 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 (for blood levels 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 safety when higher doses of cetirizine and alcohol are
taken simultaneously.
Therefore, as with all antihistamines, it is recommended to avoid the simultaneous intake of Stamidix
with alcohol.
If you need to have an allergy test, ask your doctor if you should stop taking Stamidix for a few
days before the test. This medicine may alter the results of the allergy test.
The use of the medicine is not recommended in newborns and children under 2 years of age.

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

Stamidix with food, beverages
Food does not affect the absorption of Stamidix.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice 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 on the advice of a doctor.
Cetirizine passes into breast milk. It is not possible to exclude a risk of adverse effects in breastfed
infants. Therefore, do not take Stamidix during breastfeeding unless you have
contacted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and the 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 vehicles, engage in potentially dangerous 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 1ml.
If the child is less than 5 years of age, talk to your doctor or pharmacist before giving 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 perform further checks during therapy.
This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially “sodium-free”.

3. How to take Stamidix

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The drops must be poured into a spoon or diluted in water and taken orally.
If dilution is used, it should be considered, especially for administration to children, that the volume
of water to which the drops are added must be proportionate to the amount of water the patient is able to
ingest.
The diluted solution must be taken immediately.
When counting the drops, the bottle must be held vertically (inverted).
If the flow of drops stops and if the correct amount has not been dispensed, return the bottle to
an upright position, then invert it again and continue counting the drops.

Adults and adolescents aged 12 years and over
The recommended dose is 10 mg (20 drops) once a day

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

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

Patients with renal impairment
For patients with moderate renal impairment, the recommended dose is 5 mg as 10 drops once
a day.
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 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
the 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 undesirable effects described below may appear with increased
intensity. Undesirable effects such as confusion, diarrhea, dizziness, fatigue, headache, malaise (feeling unwell), pupil dilation, itching, restlessness, sedation, drowsiness
(need to sleep), stupor, abnormal and rapid heart rate, tremors and urinary retention (difficulty
emptying the bladder) have been reported.

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

If you stop taking Stamidix
If you stop taking Stamidix, itching (intense tingling) and/or
urticaria (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 everybody gets 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 of:

• Allergic 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
• Dizziness, headache
• Pharyngitis (sore throat), rhinitis (nasal congestion, 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), rash
• Asthenia (extreme fatigue), malaise (feeling unwell)

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

• Allergic reactions, some severe (very rare)
• Aggression, confusion, depression (low mood), hallucinations (seeing or hearing things that are not there), insomnia
• Convulsions (involuntary shaking movements)
• Tachycardia (fast heartbeat)
• Abnormal liver function (abnormal liver function)
• Urticaria (itchy 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)
• Tics (habitual spasm)
• Syncope (fainting), dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrolled circular movements)
• Angioedema (a severe allergic reaction that causes swelling of the face or throat), fixed drug eruption (allergy to the medicine)
• Abnormal urine elimination (involuntary bladder emptying during nocturnal sleep, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal ideation (recurring concerns or suicidal thoughts), nightmare
• Amnesia (memory loss), cognitive impairment
• Vertigo (sensation of spinning or movement)
• Urinary retention (inability to completely empty the bladder)
• Intense itching and/or urticaria following discontinuation of treatment
• Arthralgia (joint pain), myalgia (muscle pain)
• Acute generalized pustular exanthem (skin rash with blisters containing pus)
• Hepatitis (inflammation of the liver)

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 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 which is stated on the package and the bottle.
The expiry date refers to the last day of that month.
Do not use after 15 months from the first opening of the bottle.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Stamidix contains

• The active ingredient is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: glycerol 85%, propylene glycol, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, trisodium citrate dihydrate, glacial acetic acid, purified water.

Description of the appearance of Stamidix and contents of the pack
Oral drops, solution: bottle of 20 ml.

Marketing Authorisation 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)