Prospect: information for the patient

Sekisan 3.54 mg/ml syrup

cloperastina fendizoate

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

-Keep this prospect, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

-You should consult a doctor if you worsen or do not improve after 7 days.

1.What is Sekisan and what it is used for

2.What you need to know before starting to take Sekisan

3.How to take Sekisan

4.Possible adverse effects

5Storage of Sekisan

6.Contents of the package and additional information

Thecloperastina,theactiveingredientofthismedication,isanantitussivethatinhibitsthereflexofthelungs.Sekisanisamedicationindicatedforthetreatmentofproductiveformsofcough,irritativeornervouscoughinadultsandchildren2yearsofageorolder.

Youshouldconsultadoctorifyoudonotimproveafter7daysoftreatment.

Do not take Sekisan if:

-You are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication (listed in section 6).

-You are allergic to allergy medications (antihistamines).

-You are taking medications for depression treatment.

-You are pregnant or think you may be pregnant or breastfeeding.

-Children under 2 years old cannot take this medication.

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 gastrointestinal or intestinal obstruction, including ulcers.
• If you have chronic cough due to smoking, respiratory problems, or asthma.
• If the cough persists after 7 days of treatment.

Children

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

Other medications and Sekisan

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

Sekisan may interact with other medications such as:

-Sleeping medications (sedatives, analgesic opioids, barbiturates, hypnotics, or benzodiazepines).

-Depression medications and Parkinson's disease medications because they may potentiate the adverse effects of this medication.

-Expectorants and mucolytics used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medication like Sekisan may prevent the elimination of excess mucus and cause choking.

Taking Sekisan with food, drinks, and alcohol

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

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy and lactation

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

This medication is contraindicated in pregnancy and lactation.

Driving and operating machinery

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

Sekisan contains saccharose, parahydroxybenzoic acid propyl ester (E-216), parahydroxybenzoic acid methyl ester (E-218), propylene glycol (E-1520), ethanol, and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

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

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

The small amount of alcohol contained in this medication does not produce any perceptible effect.

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

Followexactlytheinstructionsfortheadministrationofthemedicationasindicatedinthisprospectusorasprescribedbyyourdoctororpharmacist.Incaseofdoubt,askyourdoctororpharmacist.

Therecommendeddoseis:

Inadultsandadolescents12yearsofageand:10ml,3timesaday.

Inchildren:Between7and12yearsofage:5ml,2timesaday.

Between5and6yearsofage:3ml,2timesaday.

Between2and4yearsofage:2ml,2timesaday.

Sekisaniscontraindicatedinchildrenunder2yearsofage.

Shakethecontainerbeforeuse.

Thismedicationistobetakenbymouth.

Measuretheamountofmedicationtobetakenwiththedosagecupincludedinthecontainer.

IfyoutakemoreSekisanthanyoushould

Thesymptomsofoverdoseare:Excitementanddifficultybreathing.

IfyouhavetakenmoreSekisanthanyoushould,consultyourdoctororpharmacistimmediatelyorcallthepoisoncontrolcenterat915620420indicatingthemedicationandtheamounttaken.

IfyouforgettotakeSekisan

Donottakeadoubledosetomakeupforthemisseddose.

Thistreatmentissymptomaticifyoudonottakethemedicationandifitreturns,takethemedicationasindicatedinsection3.DonottakeSekisan.

Likeallmedicines,Sekisanmayproduceadverseeffects,althoughnotallpeoplewillexperiencethem.

The adverse effects that may occur, although they are rare, are: drowsiness and dry mouth.

Theadverseeffectsthatmaybeproducedare:

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

VeryRare(mayaffectupto1in10,000patients):allergicreaction,urticaria.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medicine.

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition ofSekisan

The active principle of Sekisan is Cloperastina fendizoate. Each ml of syrup contains 3.54 mg of cloperastina fendizoate (equivalent to 2 mg of cloperastina chloride).

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

Appearance of the product and contents of the packaging

Sekisan is presented in the form of a white-colored syrup with a characteristic banana essence odor. It is presented in an amber-colored PET bottle of 120 and 200 ml with a child-resistant closure. The carton includes a graduated dosing cup with various measurements.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

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

Responsible for manufacturing:

Industrias Farmacéuticas Almirall, S.A.

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

Local representative:

Laboratorios ERN, S.A.

C/Perú, 228

08020 Barcelona, Spain

Revision date of thisleaflet:June 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.