Strepsils lozenges lemon flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Strepsils lemon flavoured lozenges
2,4-dichlorobenzyl alcohol, amylmetacresol
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine provided in this leaflet or those given by your doctor or pharmacist.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.
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You should consult your doctor if you worsen or do not improve after 2 days.
Leaflet contents:
- What Strepsils is and what it is used for.
- What you need to know before taking Strepsils.
- How to take Strepsils.
- Possible side effects.
- How to store Strepsils.
- Contents of the pack and other information.
1. What Strepsils is and what it is used for
Strepsils belongs to a group of medicines called antiseptics.
It is used for the local symptomatic relief of mild mouth and throat infections without fever in adults and children aged 6 years and older.
You should consult a doctor if your condition worsens or does not improve after 2 days.
2. What you need to know before starting to take Strepsils
Do not take Strepsils
- If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, or any of the other ingredients of this medicine (listed in section 6).
- If you are under 6 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Strepsils.
If symptoms persist for more than 2 days, worsen, or are accompanied by high fever, headache, nausea, or vomiting, you should consult your doctor as soon as possible.
Do not exceed the maximum recommended dose.
Use of Strepsils with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You should not take other oropharyngeal antiseptics (medicines for mild throat infections such as Strepsils) while taking this medicine, although interactions are not expected.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is negligible or none.
Strepsils contains isomalt, liquid maltitol, sodium, and fragrances containing allergens.
This medicine contains isomalt (E-953) and liquid maltitol (E-965). If your doctor has advised you that you have an intolerance to certain sugars, consult him before taking this medicine.
It may produce a mild laxative effect because it contains 1.830 g of isomalt and 0.458 g of liquid maltitol per lozenge.
Calorific value: 2.3 kcal/g of isomalt/liquid maltitol.
This medicine contains less than 23 mg of sodium (1 mmol) per lozenge; therefore, it is essentially "sodium-free".
This medicine contains fragrances with benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool.
Benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool may cause allergic reactions.
3. How to take Strepsils
Follow exactly the administration instructions for Strepsils contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults: 1 tablet every 2 or 3 hours as needed, up to a maximum of 8 tablets in 24 hours.
Children
Children from 6 years of age: 1 tablet every 2 or 3 hours as needed, up to a maximum of 4 tablets in 24 hours.
Not intended for use in children under 6 years of age.
How to take Strepsils:
For oropharyngeal use, to be dissolved in the mouth.
Allow one lozenge to dissolve slowly in the mouth.
Do not swallow, chew, or bite.
If symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you should consult your doctor.
If you take more Strepsils than you should
In case of overdose or accidental ingestion of large quantities, gastrointestinal discomfort may occur. In the event of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91.562.04.20, stating the medication and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Strepsils may produce adverse effects, although not everyone experiences them.
Adverse effects with frequency not known (cannot be estimated from the available data): allergic reactions (hypersensitivity) such as redness (urticaria), itching or skin swelling (rash), burning or swelling of the mouth or throat (angioedema), difficulty breathing (bronchospasm), hypotension with fainting.
Adverse effects with frequency not known (cannot be estimated from the available data): abdominal pain, nausea or oral discomfort which may present as throat irritation, swelling of the mouth or throat, tingling sensation in the mouth (paraesthesia), or burning sensation in the mouth (glossodynia).
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Strepsils
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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 must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to a pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Strepsils
The active substances are 0.6 mg of amylmetacresol and 1.2 mg of 2,4-dichlorobenzyl alcohol.
The other components (excipients) are: lemon flavour (contains benzyl alcohol, citral, citronellol, d-limonene, geraniol and linalool), sodium saccharin (E-954), tartaric acid, isomalt (E-953) and liquid maltitol (E-965).
Appearance of the product and contents of the pack
Strepsils are circular tablets, white to pale yellow in colour, lemon-flavoured, with the Strepsils logo imprinted on both sides.
Each pack contains 24 lozenges.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reckitt Benckiser Healthcare, S.A.
Paseo de Gracia, 9, 08007, Barcelona, Spain
Manufacturer
RB NL Brands B.V.
Schiphol Blvd 207, 1118 BH Schiphol, The Netherlands
Date of the most recent review of this leaflet: November 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/