SEKISAN 3.54 mg/ml SYRUP

Introduction

Leaflet: information for the patient

Sekisan 3.54 mg/ml syrup

cloperastine fendizoate

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet:

1. What Sekisan is and what it is used for
2. What you need to know before taking Sekisan
3. How to take Sekisan
4. Possible side effects

5 Conservation of Sekisan

1. Package contents and additional information

1. What Sekisan is and what it is used for

Cloperastine, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex. Sekisan is a medicine indicated for the treatment of non-productive forms of cough, such as irritative cough or nervous cough for adults and children from 2 years old.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before taking Sekisan

Do not take Sekisanif:

• You are allergic (hypersensitive) to the active ingredient or to any of the other components of this medicine (listed in section 6).
• You are allergic to allergy medicines (antihistamines).
• You are taking medicines for the treatment of depression.
• You are pregnant or think you may be pregnant or are breastfeeding.
• Children under 2 years old cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sekisan:

• If you have high intraocular pressure.
• If you have been told you have prostate hypertrophy.
• If you have difficulty urinating.
• If you are hypertensive.
• If you have heart problems.
• If you have a degenerative muscle disease called myasthenia gravis.
• If you have any type of gastric or intestinal obstruction, including ulcers.
• If you have chronic cough due to smoking, lung problems, or asthma.
• If the cough persists after 7 days of treatment.

Children

Children under 2 years old cannot take this medicine, it is contraindicated.

Other medicines and Sekisan

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Sekisan may interact with other medicines such as:

• Medicines to help you sleep (sedatives, opioid analgesics, barbiturics, hypnotics, or benzodiazepines).
• Medicines for depression and medicines for the treatment of Parkinson's disease because they may potentiate the adverse effects of this medicine.
• Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medicine like Sekisan may prevent the elimination of excess mucus and produce choking.

Taking Sekisan with food, drinks, and alcohol

During treatment with Sekisan, do not drink alcohol as it may increase the effects of alcohol.

Taking this medicine with food and drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is contraindicated in pregnancy and breastfeeding.

Driving and using machines

Sekisan may cause drowsiness at usual doses. If so, refrain from driving and operating hazardous machinery.

Sekisan contains sucrose, propyl hydroxybenzoate (E-216), methyl hydroxybenzoate (E-218), propylene glycol (E-1520), ethanol, and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 4.5 g of sucrose per 10 ml dose.

It may cause allergic reactions (possibly delayed) because it contains methyl hydroxybenzoate (E-218) and propyl hydroxybenzoate (E-216).

This medicine contains 26.25 mg of propylene glycol (E-1520) in each unit dose (10 ml), equivalent to 2.625 mg/ml.

This medicine contains 3.3 mg of alcohol (ethanol) in each unit dose (10 ml), equivalent to 0.33 mg/ml (0.033% p/v). The amount in 10 ml (unit dose) of this medicine is equivalent to less than 0.083 ml of beer or 0.034 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml; it is essentially "sodium-free".

3. How to take Sekisan

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

In adults and adolescents over 12 years old: 10 ml, 3 times a day.

In children:Between 7 and 12 years old: 5 ml, 2 times a day.

Between 5 and 6 years old: 3 ml, 2 times a day.

Between 2 and 4 years old: 2 ml, 2 times a day.

Sekisan is contraindicated in children under 2 years old.

Shake the bottle before use.

This medicine is taken orally.

Measure the amount of medicine to be taken with the measuring cup included in the package.

If you take more Sekisan than you should

The symptoms of overdose are: excitement and difficulty breathing.

If you have taken more Sekisan than you should, consult your doctor or pharmacist immediately or call the poison control center at 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Sekisan

Do not take a double dose to make up for forgotten doses.

This treatment is symptomatic; if you do not have a cough, do not take it, and if it returns, take the medicine as indicated in section 3. How to take Sekisan.

4. Possible side effects

Like all medicines, Sekisan can cause side effects, although not everyone gets them.

The most common side effects, although rare, are: drowsiness and dry mouth.

Side effects that may occur are:

Uncommon (may affect up to 1 in 100 patients): drowsiness, dry mouth (at high doses), movement disorders, tremors, and dizziness.

Very rare (may affect up to 1 in 10,000 patients): allergic reaction, urticaria.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Sekisan

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Sekisan

The active ingredient of Sekisan is Cloperastine fendizoate. Each ml of syrup contains 3.54 mg of cloperastine fendizoate (equivalent to 2 mg of cloperastine hydrochloride).

The other components (excipients) are: sucrose, microcrystalline cellulose-carboxymethylcellulose sodium, macrogol 2000 monoester, methyl hydroxybenzoate (E-218), propyl hydroxybenzoate (E-216), banana essence (contains propylene glycol (E-1520) and ethanol), and purified water.

Appearance of the product and package contents

Sekisan is presented as a white syrup with a characteristic banana essence odor. It is presented in a 120 and 200 ml amber PET bottle with a child-resistant closure. The package includes a graduated measuring cup with several measurements.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almirall, S.A. General Mitre, 151 08022 – Barcelona (Spain).

Manufacturer:

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61 08740 Sant Andreu de la Barca - Barcelona (Spain).

Local representative:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Date of the last revision of this leaflet:June 2014

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.