Patient leaflet - Strepsils Menthol lozenges
1. What this medicine is and what it is used for
This medicine contains two antiseptic ingredients for use in throat medications. These are used for the symptomatic relief of mouth and throat infections. These ingredients are both mild antiseptics which kill the bacteria associated with mouth and throat infections. The action of sucking the lozenge allows the active ingredients to work in the area of the discomfort and also helps lubricate and soothe the painful area. This helps relieve the soreness and discomfort of mouth and throat infections.
2. What you need to know before you take this medicine
This medicine is recommended for adults, children (over 12 years old) and the elderly. Children under 12 years old should not use this medicine.
Do not take this medicine if you:
are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, or any of the other ingredients shown in Section 6.
- are under 12 years old.
Warnings and precautions
Tell your doctor or pharmacist if you:
- are taking or have recently taken any other medicines, including medicines obtained without a prescription. • suffer or are suffering from any other throat problems
Pregnancy and breast-feeding
Check with your pharmacist or your doctor before taking this medicine if you think you are pregnant, are pregnant or are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients in this medicine •This medicine contains sucrose (1.38 g per lozenge) and glucose (1.10 g per lozenge). •This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. •This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘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 wheat allergy (different from coeliac disease) you should not take this medicine. •This medicine contains 1.89 mg propylene glycol in each lozenge •This medicine contains fragrance with Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Linalool (all present in Spearmint flavour), Linalool and d-limonene (present in Cool Mint Sensation flavour) and d-limonen (present in Eucalyptus oil). Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool may cause allergic reactions.
•This medicine contains Sulphites – Sulphur Dioxide (E220) (present in liquid glucose) which may rarely cause severe hypersensitivity reactions and bronchospasm.
3. How to take this medicine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. This medicine is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Adults and elderly – One lozenge to be dissolved slowly in the mouth every 2 – 3 hours up to a maximum of 12 lozenges in 24 hours
Children 12 to 16 years old – One lozenge to be dissolved slowly in the mouth every 2 – 3 hours up to a maximum of 8 lozenges in 24 hours
Remove one lozenge from the foil blister packaging.
Replace the foil blister back into the cardboard carton.
Place lozenge into the mouth allowing it to dissolve slowly.
Dissolve one lozenge slowly in the mouth every 2 – 3 hours.
It is not recommended that children under 12 years use this medicine. If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or pharmacist. If you take more of this medicine than you should
You may experience stomach discomfort.
Do not take any more of this medicine and consult your doctor or pharmacist. If you forget to take this medicine
Do not take a double dose to make up for a forgotten lozenge. Continue to use this medicine normally. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any hypersensitivity to this medicine i.e. itching, burning sensation and/or discomfort of the mouth, difficulty in breathing, swelling of the face, neck, tongue or throat and rash (severe allergic reactions) stop taking this medicine and consult your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month and the year. Do not store above 25°C Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What this medicine contains:
The active substances are: 2,4-Dichlorobenzyl alcohol 1.2mg and Amylmetacresol 0.6mg The other ingredients are: Xylitol, cool mint sensation flavour (contains propylene glycol), Levomenthol, Spearmint, Eucalyptus Oil, Liquid Sucrose, Liquid Glucose (containing wheat starch (containing Gluten) and Sulphites – Sulphur Dioxide (E220)), fragrance allergens -Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool. What this medicine looks like
A white to pale yellow coloured lozenge with a characteristic taste of cool mint and the Strepsils brand icon pressed on both sides.
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (UK) Limited, Slough, SL1 3UH
Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham, NG90 2DB Licence Number: PL 00063/0469
Date of preparation: December 2020
CUSTOMER INFO:
1.3.1 Package Leaflet - Clean
Strepsils Cool 0117278 eCTD Page 1
TR2085779
B
83.6mm to centre of
mark
Reckitt Benckiser 0003 PL 00063-0469 Addition of Reel Fed of leaflet Top Front Top Back
Package Leaflet: Information for the user Strepsils Menthol 1.2mg/0.6mg Lozenges
- This medicine contains Sulphites – Sulphur Dioxide (E220) (present in liquid glucose) which may rarely cause severe hypersensitivity reactions and bronchospasm.
- How to take this medicine
2,4-Dichlorobenzyl alcohol
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. This medicine is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Amylmetacresol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without prescription. However, you still need to take Strepsils Menthol 1.2mg/0.6mg Lozenges carefully to get the best results from it. Strepsils
Adults and elderly – One lozenge to be dissolved slowly in the mouth every 2 – 3 hours up to a maximum of 12 lozenges in 24 hours
Menthol 1.2mg/0.6mg Lozenges will be referred to as this medicine throughout this leaflet. • Keep this leaflet. You may need to read it again.
Children 12 to 16 years old – One lozenge to be dissolved slowly in the mouth every 2 – 3 hours up to a maximum of 8 lozenges in 24 hours
Ask your pharmacist if you need more information or advice.
Remove one lozenge from the foil blister packaging.
If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Replace the foil blister back into the cardboard carton.
Place lozenge into the mouth allowing it to dissolve slowly.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days. What is in this leaflet:
Dissolve one lozenge slowly in the mouth every 2 – 3 hours.
It is not recommended that children under 12 years use this medicine. If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or pharmacist. If you take more of this medicine than you should
1.What this medicine is and what it is used for
2.What you need to know before you take this medicine
3.How to take this medicine
You may experience stomach discomfort.
4.Possible side effects
Do not take any more of this medicine and consult your doctor or pharmacist. If you forget to take this medicine
5.How to store this medicine
6.Contents of the pack and other information
Do not take a double dose to make up for a forgotten lozenge. Continue to use this medicine normally. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
- 4. Possible side effects
- 1. What this medicine is and what it is used for
This medicine contains two antiseptic ingredients for use in throat medications. These are used for the symptomatic relief of mouth and throat infections. These ingredients are both mild antiseptics which kill the bacteria associated with mouth and throat infections. The action of sucking the lozenge allows the active ingredients to work in the area of the discomfort and also helps lubricate and soothe the painful area. This helps relieve the soreness and discomfort of mouth and throat infections.
- 2.
What you need to know before you take this medicine
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any hypersensitivity to this medicine i.e. itching, burning sensation and/or discomfort of the mouth, difficulty in breathing, swelling of the face, neck, tongue or throat and rash (severe allergic reactions) stop taking this medicine and consult your doctor or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This medicine is recommended for adults, children (over 12 years old) and the elderly. Children under 12 years old should not use this medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
- 5. How to store this medicine
Do not take this medicine if you:
- are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, or any of the other ingredients shown in Section 6.
- are under 12 years old.
Warnings and precautions
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month and the year. Do not store above 25°C Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Tell your doctor or pharmacist if you:
- are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- suffer or are suffering from any other throat problems
Pregnancy and breast-feeding
- 6. Contents of the pack and other information
Check with your pharmacist or your doctor before taking this medicine if you think you are pregnant, are pregnant or are breastfeeding.
What this medicine contains:
The active substances are: 2,4-Dichlorobenzyl alcohol 1.2mg and Amylmetacresol 0.6mg The other ingredients are: Xylitol, cool mint sensation flavour (contains propylene glycol), Levomenthol, Spearmint, Eucalyptus Oil, Liquid Sucrose, Liquid Glucose (containing wheat starch (containing Gluten) and Sulphites – Sulphur Dioxide (E220)), fragrance allergens - Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool.
Ask your doctor or pharmacist for advice before taking any medicine. Important information about some of the ingredients in this medicine • This medicine contains sucrose (1.38 g per lozenge) and glucose (1.10 g per lozenge). • This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. • This medicine contains only very low levels of gluten (from wheat starch). It is regarded as ‘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 wheat allergy (different from coeliac disease) you should not take this medicine.
72.5mm from first bar to bottom
What this medicine looks like
A white to pale yellow coloured lozenge with a characteristic taste of cool mint and the Strepsils brand icon pressed on both sides.
Marketing Authorisation Holder:
This medicine contains 1.89 mg propylene glycol in each lozenge • This medicine contains fragrance with Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Linalool (all present in Spearmint flavour), Linalool and d-limonene (present in Cool Mint Sensation flavour) and d-limonen (present in Eucalyptus oil). Benzyl Alcohol, Cinnamyl Alcohol, Citral, Citranellol, d-Limonene, Eugenol and Linalool may cause allergic reactions.
Reckitt Benckiser Healthcare (UK) Limited, Slough, SL1 3UH
Manufacturer
Reckitt Benckiser Healthcare International Limited, Nottingham, NG90 2DB Licence Number: PL 00063/0469
Date of preparation: December 2020
TDD1022/6
PRINTING
READS
This Way
CUSTOMER INFO:
1.3.1 Package Leaflet - Clean
Strepsils Cool 0117278 eCTD Page 2
TR2204988
B