Cloel 708 mg/100 ml oral suspension

Cloperastine fendizoate
Generic medicinal product

Contains: para-hydroxybenzoates

Active substance: cloperastine fendizoate. 100 ml of suspension contains 708 mg of cloperastine fendizoate (equivalent to 400 mg of cloperastine hydrochloride).
Excipients: xanthan gum, polyoxyethylene stearate, xylitol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (may cause allergic reactions, including delayed-type reactions), banana flavor, deionized water.
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What Cloel is and what it is used for:
Cloel is a cough suppressant medicinal product containing cloperastine fendizoate as the active substance.
The medicine is used to relieve cough.

Consult a doctor if the patient’s condition does not improve or worsens after a short period of treatment.

Do not take Cloel:
- if the patient is allergic to cloperastine fendizoate or any other ingredient of the medicine.
- Cloel is generally contraindicated during pregnancy.
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Warnings and precautions: Consult a doctor or pharmacist before taking Cloel.
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Other medicines and Cloel: Tell your doctor or pharmacist about any medicines the patient is taking, has recently taken, or plans to take.

Do not take the following medicines together with Cloel:
- antihistamines (medicines used to treat allergies);
- sedatives (medicines with a calming effect).

Taking Cloel with alcohol: Alcohol consumption may increase the risk of undesirable side effects of the medicine.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult a doctor or pharmacist before taking this medicine.
Cloel must not be taken during the first trimester of pregnancy. During the remaining period of pregnancy, it may be taken only if clearly necessary and under strict medical supervision.

Driving and using machines: Cloel may rarely cause drowsiness; therefore, special care is required when driving vehicles or operating machinery that requires concentration.

Method of administration:
Always take the medicine according to the instructions or as advised by your doctor or pharmacist. Consult a doctor or pharmacist if you are unsure.
- Shake the bottle well before use.
- Use the 2-3-5 ml measuring cup included in the package.
- Do not exceed the recommended dose.

Recommended dose:
Adults:5 ml three times daily
Use in children and adolescents:

- Children aged 2–4 years: 2 ml twice daily

- Children aged 4–7 years: 3 ml twice daily

- Children aged 7–15 years: 5 ml twice daily

If you take more Cloel than recommended:
Seek immediate medical advice – contact your doctor or go to the nearest hospital.
In case of overdose, gastric lavage should be performed immediately; calmness should be maintained to reduce signs of excessive agitation. If necessary, a benzodiazepine (a psychiatric medicine) should be used.

If you miss a dose of Cloel: Do not take a double dose to make up for a missed dose.

If you stop taking Cloel: Consult a doctor or pharmacist if you are unsure about stopping this medicine.

Possible side effects:
- Very high doses may cause dry mouth and mild drowsiness, which disappear quickly after dose reduction. Follow the instructions to reduce the risk of undesirable side effects.

Report any side effects to your doctor or pharmacist.

Storage of Cloel:
- Keep out of the reach of children.
- Do not use the medicine after the expiry date stated on the package; the expiry date refers to the last day of the indicated month.
- Do not dispose of medicines via household waste or wastewater. Ask a pharmacist how to dispose of medicines no longer required. These measures help protect the environment.
- Dispensing conditions: pharmaceutical product, Group III, available without prescription

Manufacturer:
Aesculapius Farmaceutici S.r.l. – Via Cefalonia, 70-25124 Brescia