CERCHIO 10 mg Tablets

Зміст інструкції

1. CERCHIO 10 mg tablets
   1. What is Cerchio and what is it used for
   2. What you need to know before you take Cerchio
   3. How to take Cerchio
   4. Possible side effects
   5. How to store Cerchio
   6. Contents of the pack and other information
2. CERCHIO 10 mg/ml oral drops, solution
   1. What is Cerchio and what is it used for
   2. What you need to know before you take Cerchio
   3. How to take Cerchio
   4. Possible side effects
   5. How to store Cerchio
   6. Contents of the pack and other information

CERCHIO 10 mg tablets

Cetirizine dihydrochloride

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

1. What is Cerchio and what is it used for

Cetirizine dihydrochloride is the active ingredient of Cerchio.
Cerchio is an antihistamine drug.
In adults and children aged 6 years and over, Cerchio 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 Cerchio

Do not take Cerchio

• if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
• 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 Cerchio.
If you are a patient with renal insufficiency, ask your doctor for advice; if necessary, you must 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 convulsions, you must ask your
doctor.
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 Cerchio with alcohol.
If you need to have an allergy test, ask your doctor if you need to stop taking Cerchio
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 Cerchio
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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

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.
Cerchio 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 must be
taken only if necessary and on the advice of a doctor.
Cetirizine passes into breast milk. A risk of undesirable effects in
breastfed infants cannot be excluded. Therefore, you should not take Cerchio during breastfeeding
unless you have contacted your doctor.

Driving and using machines
Clinical studies have not shown impairment of attention, alertness and
ability to drive after taking Cerchio at the recommended dose.
You must carefully observe your response to the drug after taking Cerchio if you
intend to drive, engage in potentially dangerous activities or operate machinery.
You must not exceed the recommended dose.

Cerchio tablets contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Cerchio tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Cerchio

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

Adults and adolescents starting from 12 years
The recommended dose is 10 mg (1 tablet) once a day.

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 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 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 Cerchio 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 disorders and is
established by the doctor.

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

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

If you stop taking Cerchio
If you stop treatment with Cerchio, 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 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, 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 1000 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 10000 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), nightmare
• 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
• Pustular rash
• Hepatitis (inflammation of the liver)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Cerchio

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 Cerchio 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 Cerchio and contents of the pack
White, round tablet, with a score line.
Pack with 20 divisible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15

• 20143 – Milan

Manufacturer:

• VAMFARMA S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO).
• DOPPEL Farmaceutici S.r.l., Via Volturno, 48 - 20089 Quinto de’ Stampi, Rozzano (MI).

CERCHIO 10 mg/ml oral drops, solution

Cetirizine dihydrochloride

Generic medicine
Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Cerchio is and what it is used for
• 2. What you need to know before you take Cerchio
• 3. How to take Cerchio
• 4. Possible side effects
• 5. How to store Cerchio
• 6. Contents of the pack and other information

1. What is Cerchio and what is it used for

Cetirizine dihydrochloride is the active ingredient of Cerchio. Cerchio is an antihistamine medicine.
In adults and paediatric patients from 2 years of age, Cerchio 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 Cerchio

Do not take Cerchio

• if you have a severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
• 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 Cerchio.
If you are a patient with kidney failure, ask your doctor for advice; if necessary, you must 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 convulsions, you must ask your
doctor.
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 Cerchio with alcohol.
If you need to have an allergy test, ask your doctor if you should stop taking Cerchio
for a few days before the test. This medicine may alter the results of the allergy test.

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

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

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.
Cerchio should be avoided during pregnancy. Accidental use of the drug by a
pregnant woman does not produce any harmful effects on the foetus, however the medicine must be
taken only 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
children breastfed with breast milk. Therefore, you should not take Cerchio 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 after taking Cerchio at the recommended dose.
You must carefully observe your response to the drug after taking Cerchio if you
intend to drive, engage in potentially dangerous activities or operate machinery.
You should not exceed the recommended dose.

Cerchio oral drops, solution contains:

• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216);these ingredients may cause allergic reactions (including delayed reactions).
• 350 mg of propylene glycol per 20 drops.
• less than 1 mmol (23 mg) of sodium per 20 drops, i.e. essentially ‘sodium-free’.

3. How to take Cerchio

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any 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 must be considered, especially for administration to children, that the
volume of water to which the drops are added must be proportional to the amount of water
that the patient is able to drink. 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 the upright position, then invert it again and continue counting the
drops.

Adults and adolescents from 12 years:
The recommended dose is 10 mg (20 drops) once a day.

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

Use in children aged between 2 and 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 or pharmacist who may adjust the
dose accordingly.
If your child has 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 Cerchio 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 your doctor.

If you take more Cerchio than you should
If you think you have taken an overdose of Cerchio, 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. Adverse events such as confusion, diarrhea, dizziness, fatigue,
headache, malaise, pupillary dilation, itching, restlessness, sedation, drowsiness,
stupor, abnormal and rapid heart rate, tremors and urinary retention have been reported.

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

If you stop taking Cerchio
If you stop taking Cerchio, itching (intense tingling) and/or urticaria may rarely recur.
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 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, 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 (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, dyskinesia (involuntary movements), dystonia (prolonged abnormal muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculorotation (uncontrolled circular eye 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), nightmare
• Amnesia, 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
• Joint pain
• Pustular rash
• 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 Cerchio

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 bottle after
“EXP”. The expiry date refers to the last day of that month.
The period of validity after first opening of the bottle is 15 months (record the date of first
opening in the designated space on the package).
Do not use the medicine after 15 months from the first opening of the bottle. This date refers to the
product in intact packaging, correctly stored.
This medicine does not require any particular storage conditions.

6. Contents of the pack and other information

What Cerchio contains
The active ingredient is cetirizine dihydrochloride. 1 ml (corresponding to 20 drops) contains 10 mg of
cetirizine dihydrochloride. One drop contains 0.5 mg of cetirizine dihydrochloride.
The other ingredients are: glycerol 85%, propylene glycol, sodium saccharin, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, sodium acetate trihydrate, glacial acetic acid,
purified water.

Description of the appearance of Cerchio and contents of the pack
Cerchio is supplied as a clear and colourless liquid.
Pack with a bottle containing 20 ml of solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15

• 20143 – Milan.

Manufacturer

• ABC Farmaceutici S.p.A., Canton Moretti, 29 - 10090 San Bernardo d’Ivrea (TO).
• VAMFARMA S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO).