Sekisan 3.54 mg/ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Sekisan 3.54 mg/ml syrup
cloperastine fendizoate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Leaflet contents:
- What Sekisan is and what it is used for
- What you need to know before taking Sekisan
- How to take Sekisan
- Possible side effects
- Storage of Sekisan
- Contents of the pack and other information
1. What Sekisan is and what it is used for
Cloperastine, the active substance in this medicine, is an antitussive 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, in adults and children from 2 years of age.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before starting to take Sekisan
Do not take Sekisan if:
- You are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6).
- You are allergic to allergy medications (antihistamines).
- You are taking medicines for the treatment of depression.
- You are pregnant, think you might be pregnant, or are breastfeeding.
- Children under 2 years of age must not take this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Sekisan:
- If you have high intraocular pressure.
- If you have been diagnosed with prostate enlargement (hypertrophy).
- If you have difficulty urinating.
- If you have high blood pressure (hypertensive).
- If you have heart problems.
- If you have a muscle degenerative disorder called myasthenia gravis.
- If you have any type of gastric or intestinal obstruction, including peptic ulcer.
- If you have chronic cough due to smoking, lung conditions, or asthma.
- If your cough persists after 7 days of treatment.
Children
This medicine is contraindicated in children under 2 years of age.
Other medicines and Sekisan
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Sekisan may interact with other medicines such as:
- Medicines used to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
- Medicines for depression and medicines used to treat Parkinson's disease, as they may enhance the adverse effects of this medicine.
- Expectorant and mucolytic medicines used to clear excess mucus and phlegm, because when taken simultaneously with a cough medicine such as Sekisan, they may prevent the elimination of excess mucus and cause choking.
Taking Sekisan with food, drinks, and alcohol
During treatment with Sekisan, you must not consume 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is contraindicated during pregnancy and breastfeeding.
Driving and using machines
Sekisan may cause drowsiness at usual doses. If this occurs, refrain from driving or operating dangerous machinery.
Sekisan contains sucrose, propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), propylene glycol (E-1520), ethanol, and sodium
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 4.5 g of sucrose per 10 ml dose.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medicine contains 26.25 mg of propylene glycol (E-1520) in each dose unit (10 ml), equivalent to 2.625 mg/ml.
This medicine contains 3.3 mg of alcohol (ethanol) in each dose unit (10 ml), equivalent to 0.33 mg/ml (0.033% w/v). The amount in 10 ml (single 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 contained in this medicine does not produce any perceptible effect.
This medicine contains less than 23 mg of sodium (1 mmol) per 10 ml; therefore, it is essentially “sodium-free”.
3. How to take Sekisan
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
In adults and adolescents over 12 years of age: 10 ml, three times a day.
In children:
Between 7 and 12 years: 5 ml, twice a day.
Between 5 and 6 years: 3 ml, twice a day.
Between 2 and 4 years: 2 ml, twice a day.
Sekisan is contraindicated in children under 2 years of age.
Shake the bottle before use.
This medicine is taken orally.
Measure the amount of medicine to be taken using the dosing cup provided in the package.
If you take more Sekisan than you should
Symptoms of overdose include: Excitation and difficulty breathing.
If you have taken more Sekisan than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service 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 a missed dose.
This treatment is symptomatic; do not take it if you do not have a cough. If your cough returns, take the medicine as indicated in section 3. How to take Sekisan.
4. Possible adverse effects
Like all medicines, Sekisan may cause adverse effects, although not everyone experiences them.
The most commonly occurring adverse effects, although infrequent, are: drowsiness and dry mouth.
The following adverse effects may occur:
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 of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Sekisan
The active substance in 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-sodium carboxymethylcellulose, mono-stearate of polyethylene glycol 2000, methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216), banana flavouring (containing propylene glycol (E-1520) and ethanol), and purified water.
Presentation of the product and contents of the pack
Sekisan is presented as a white syrup with a characteristic banana flavouring odour. It is supplied in an amber-coloured PET bottle of 120 ml and 200 ml with a child-resistant closure. A graduated dosing cup with multiple measurement markings is included in the package.
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 most recent revision of this leaflet: June 2014
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.