Strepsils lozenges for sucking, mint flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Strepsils sugar-free pastilles with mint flavour
2,4-dichlorobenzyl alcohol, amylmetacresol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always follow exactly the instructions for use of this medicine as contained in this leaflet or as directed by your doctor or pharmacist.
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Keep this leaflet. 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 side effects, talk to your doctor or pharmacist, even if they are side 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.
Contents of the leaflet:
- 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 over.
You should consult a doctor if symptoms worsen or do not improve after 2 days.
2. What you need to know before taking Strepsils
Do not take Strepsils
- If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, or any of the other components 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 your symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you should consult a doctor.
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.
Do 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 use of machines
The effect of this medicine on the ability to drive or operate machinery is negligible or none.
Strepsils contains sucrose, glucose, wheat starch, sulfur dioxide, and fragrances containing allergens
This medicine contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 1.38 g of sucrose and 1.10 g of glucose per lozenge.
This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free" and is very unlikely to cause problems if you have coeliac disease.
One lozenge contains no more than 22.04 micrograms of gluten.
If you have a wheat allergy (other than coeliac disease), you should not take this medicine.
This medicine contains fragrances containing benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol, and linalool.
Benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol, and linalool may cause allergic reactions.
This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sulfur dioxide (E-220).
This medicine contains terpenes from levomenthol which, in excessive doses, may cause seizures in young children (under 6 years of age), although at the doses and by the route of administration used in this medicine, absorption and activity of terpenes are very low.
3. How to take Strepsils
Follow exactly the instructions for use of Strepsils provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
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 to be used 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 persist for more than 2 days, worsen, or are accompanied by high fever, headache, nausea or vomiting, consult your doctor as soon as possible.
If you take more Strepsils than you should
In case of overdose or accidental ingestion of large quantities, you may experience gastrointestinal discomfort. 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, indicating the medicine 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 will experience them.
Adverse effects with unknown frequency (cannot be estimated from available data): allergic reactions (hypersensitivity) such as redness (urticaria), itching or skin rash, burning or swelling of the mouth or throat (angioedema), difficulty breathing (bronchospasm), hypotension with fainting.
Adverse effects with unknown frequency (cannot be estimated from 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 (paresthesia) or burning mouth (glosodynia).
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 through 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 shown 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 or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. 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 Strepsils
The active substances are 0.6 mg of amylocresol and 1.2 mg of 2,4-dichlorobenzyl alcohol.
The other components (excipients) are: xylitol, fresh mint flavour (containing d-limonene and linalool), levomenthol, spearmint flavour (containing benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol and linalool), eucalyptus oil (containing d-limonene), sucrose, liquid glucose (containing wheat starch and sulphur dioxide (E-220)).
Appearance of the product and contents of the pack
Strepsils are circular tablets, white to pale yellow in colour, with a mint flavour and the Strepsils logo imprinted on both sides.
Each pack contains 16 or 24 lozenges. Not all pack sizes may be marketed.
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 revision of this leaflet: November 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/