Clofend

Package leaflet: Information for the patient

CLOFEND 7.08 mg/ml oral suspension

L-Cloperastine fendizoate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
U se this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Clofend is and what it is used for

Clofend contains the active substance L-cloperastine fendizoate, which belongs to a group of
medicines called antitussives that suppress cough by acting on the central nervous system.
This medicine is indicated for the treatment of cough.
Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking Clofend

Do not take Clofend

• if you are allergic to L-cloperastine fendizoate or to any of the other ingredients of this medicine (listed in section 6);
• if the person taking this medicine is a child aged between 0 and 2 years (very early infancy).

Warnings and precautions
Talk to your doctor or pharmacist before taking Clofend.
Use with caution is advised.

• if you suffer from high pressure inside the eye (increased intraocular pressure or glaucoma);
• if you suffer from benign enlargement of the prostate (prostatic hypertrophy);
• if you have difficulty urinating (bladder obstruction);
• if you are taking other medicines, see “Other medicines and Clofend”.

Children
This medicine is contraindicated in children aged between 0 and 2 years (see section “Do not take Clofend”).
Other medicines and Clofend
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking the following medicines:

• medicines that act by depressing or stimulating the central nervous system;
• alcohol;
• antihistamines, used to treat allergies, anti-serotonergic agents, used mainly to treat depression and severe forms of headache (migraine), muscle relaxants such as papaverine (papaverine-type), used to reduce muscle contraction, because L-cloperastine may enhance their effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking this medicine during the first three months of pregnancy. During later months of pregnancy, take Clofend only if clearly needed and under direct medical supervision.
Avoid taking Clofend while breastfeeding.
Driving and using machines
When taken as directed, this medicine does not impair the ability to drive vehicles or operate machinery.
Clofend contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. These may cause allergic reactions (including delayed reactions).
Clofend contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml dose, i.e. essentially ‘sodium-free’.

3. How to take Clofend

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Please read the following instructions carefully before taking Clofend:

• to open the bottle, press the cap downwards and unscrew to the left;
• to close the bottle, screw the cap fully to the right.

To measure the medicine, use the provided graduated oral syringe (2-3-5 ml).
In adults, the recommended dose is 5 ml, three times daily.
Use in children
In children, the dose should be reduced according to age:

• between 2 and 4 years: the recommended dose is 2 ml, twice daily.
• between 4 and 7 years: the recommended dose is 3 ml, twice daily.
• between 7 and 15 years: the recommended dose is 5 ml, twice daily.

Duration of treatment: 7 days. If no noticeable improvement occurs, consult your doctor.
Children under 2 years of age: Clofend must not be used in children under 2 years of age; see “What you need to know before taking Clofend”.
If you take more Clofend than you should
After taking an excessive dose of this medicine, symptoms of excessive stimulation (overstimulation) may occur. Drowsiness may also occur.
Your doctor will determine the most appropriate treatment based on your symptoms.
In case of accidental ingestion/overdose of Clofend, contact your doctor immediately or go to the nearest hospital.
If you forget to take Clofend
Do not take a double dose to make up for the missed dose.
Take the next dose at the scheduled time.
If you have any doubts about how to use 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 possible side effects are:

• stomach and intestinal problems (gastrointestinal disturbances), mild and temporary.

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

• dry mouth.

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

• hypersensitivity reactions including severe, rapidly occurring allergic reactions (anaphylactic/anaphylactoid reaction),
• urticaria,
• erythema.

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 through the national reporting system at the following website:
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 Clofend

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month and to the product in its original, unopened packaging.
The product should be used within 6 weeks after first opening the bottle. Any remaining medicine should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clofend contains

• The active substance is L-cloperastine fendizoate. 100 ml of suspension contains 708 mg of L-cloperastine fendizoate (equivalent to 400 mg of cloperastine hydrochloride).
• The other components are: xanthan gum, macrogol stearate, xylitol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, banana flavour, Sodium hydroxide, deionized water.

Description of the appearance of Clofend and contents of the pack
Yellow glass bottle with child-resistant cap containing a suspension with a fruity smell and sweet, pleasant taste. 200 ml oral suspension. Marketing Authorization Holder
FIDIA Farmaceutici S.p.A. – Via Ponte della Fabbrica 3/A – 35031 Abano Terme (PD) – Italy
Manufacturer
Marco Viti Farmaceutici S.p.A. – Via Tarantelli, 13/15 - 22076 Mozzate (CO)