Cerchio

Patient Information Leaflet

CERCHIO 10 mg 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 they have the same symptoms as you, because 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 Cerchio is and what it is used for
2. What you need to know before taking 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 Cerchio is and what it is used for

Cetirizine dihydrochloride is the active substance in Cerchio.
Cerchio is an antiallergic medicinal product.
In adults and children aged 6 years and older, 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 taking Cerchio

Do not take Cerchio

• if you have severe kidney disease (severe renal failure with creatinine clearance below 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 substances of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cerchio.
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 problems 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 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 taking higher doses of cetirizine together with alcohol. Therefore, as with all antihistamines, it is recommended to avoid concomitant use of Cerchio with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Cerchio for 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 Cerchio
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Cerchio 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 be taken only if necessary and on medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be ruled out. Therefore, you should not take Cerchio during 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 Cerchio at the recommended dose.
You should carefully observe your response to the medicine after taking Cerchio if you intend to drive, engage in potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

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

Cerchio tablets contain 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 exactly as instructed 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.
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 or pharmacist, who can adjust the dose accordingly.
If your child has kidney disease, contact your doctor or pharmacist, who can 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 condition and is determined by your doctor.
If you take more Cerchio than you should
If you think you have taken an overdose of Cerchio, inform your doctor.
Your 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, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal and rapid heart rate, tremors and urinary retention.
If you forget to take Cerchio
Do not take a double dose to make up for a forgotten dose.
If you stop taking Cerchio
If you stop treatment with Cerchio, 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 serious 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 people)

• Drowsiness
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

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

• Agitation
• Paresthesia (abnormal skin sensations)
• Abdominal pain
• Itching (pruritic skin), 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
• Seizures
• Tachycardia (rapid heartbeat)
• 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)
• Tics (habitual spasms)
• Syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyration (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 sleep, pain and/or difficulty urinating)

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

• Increased appetite
• Suicidal thoughts (recurrent suicidal concerns or thoughts), nightmares
• Amnesia, 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
• Joint pain
• Skin rash with pustule-filled blisters
• Hepatitis (liver inflammation)

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 Cerchio

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 after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Cerchio contains

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

Description of the appearance of Cerchio and package contents
White, round tablet with a score line.
Pack containing 20 divisible tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 – Milan
Manufacturers:

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

Package leaflet: information for the patient

CERCHIO 10 mg/ml oral drops, solution

Cetirizine dihydrochloride
Generic 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 their symptoms are the same as yours, because it could 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 Cerchio is and what it is used for
2. What you need to know before taking 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 Cerchio is and what it is used for

Cetirizine dihydrochloride is the active substance in Cerchio. Cerchio is an antiallergic medicinal product.
In adults and pediatric patients aged 2 years and older, 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 should know before taking Cerchio

Do not take Cerchio

• if you have severe kidney disease (severe renal failure with creatinine clearance below 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 substances of other closely related medicines).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cerchio.
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 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 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 taking higher doses of cetirizine together with alcohol. Therefore, as with all antihistamines, it is recommended to avoid concomitant use of Cerchio with alcohol.
If you need to undergo an allergy test, ask your doctor whether you should stop taking Cerchio for a few days before the test. This medicine may alter the results of allergy testing.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Cerchio 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 Cerchio during 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 Cerchio at the recommended dose.
You should carefully observe your individual response to the medicine after taking Cerchio, especially if you intend to drive, perform potentially hazardous activities, or operate machinery. Do not exceed the recommended dose.

Cerchio oral drops, solution contains:

• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216); these components 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 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
proportional 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 between 6 and 12 years:
The recommended dose is 5 mg (10 drops) twice daily.
Use in children aged between 2 and 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 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 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 determined by your doctor.
If you take more Cerchio than you should
If you think you have taken an overdose of Cerchio, inform your doctor.
Your doctor will decide what 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, pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal and rapid heartbeat, tremors and urinary retention.
If you forget to take Cerchio
Do not take a double dose to make up for the forgotten dose.
If you stop taking Cerchio
If you stop treatment with Cerchio, itching (intense prickling) and/or urticaria may rarely reappear.
If you have any questions about using 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 may develop later.

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

• Drowsiness
• Dizziness, headache
• Pharyngitis, rhinitis (in children)
• Diarrhea, 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 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
• Seizures
• Tachycardia (rapid heartbeat)
• 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, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
• Blurred vision, accommodation disorder (difficulty focusing), oculogyration (eyes with uncontrolled circular movements)
• Angioedema (severe 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 thoughts (recurrent concerns or thoughts about suicide), nightmares
• Amnesia, 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
• Joint pain
• Skin rash with pustules
• 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 Cerchio

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 bottle after "EXP". The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 15 months (record the date of first opening in the designated space on the carton).
Do not use the medicine more than 15 months after first opening the bottle. This timeframe applies to the product kept in its original, undamaged packaging and stored correctly.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Cerchio 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 85%, propylene glycol, sodium saccharin, methyl
p-hydroxybenzoate, propyl p-hydroxybenzoate, 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, colourless liquid.
Pack containing one bottle with 20 ml of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 – Milan.
Manufacturers

• ICE S.p.A., Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO).
• VAMFARMA S.r.l., Via Kennedy, 5 - 26833 Comazzo (LO).