The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: ascorbic acid, amylmetacresol, 2,4-dichlorobenzyl alcoholOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

← Back to all medicines

Strepsils Orange with Vitamin C 100mg

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Ascorbic acid, Amylmetacresol, 2,4-dichlorobenzyl alcohol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Ascorbic acid, Amylmetacresol, 2,4-dichlorobenzyl alcohol

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

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. Ascorbic acid provides a source of Vitamin C which may be beneficial during infection when Vitamin C levels are believed to fall.

What you need to know before you take it

e this medicine This medicine is recommended for adults, children (over 6 years old) and the elderly. Children under 6 years old should not use this medicine. Do not take this medicine if you:

are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, Vitamin C or any of the other ingredients shown in Section 6
are under 6 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 (1.44 g per lozenge) and glucose (0.97 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 also contains sunset yellow (E110) and Ponceau 4R (E124), which may cause allergic reactions.
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 19.36 micrograms of gluten. If you have wheat allergy (different from coeliac disease) you should not take this medicine.
This medicine contains 3 mg propylene glycol in each Lozenge.
This medicine contains less than 1 mmol sodium (23 mg) per lozenge, that is to say essentially 'sodium-free'.

Pharmacode Reads This Way

Package Leaflet: Information for the user STREPSILS Orange with Vitamin C 100mg Lozenges 2,4-Dichlorobenzyl alcohol Amylmetacresol Vitamin C (Ascorbic acid / Sodium ascorbate)

This medicine contains fragrance with Citral, Citronellol, d-Limonene, Geraniol and Linalool which may cause allergic reactions.
This medicine contains Sulphur Dioxide (E220) 0.124ppm per lozenge (present in liquid glucose), which may rarely cause severe hypersensitivity reactions and bronchospasm.

How to take it

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, Children (over 6 years old) and the elderly – One lozenge to be dissolved slowly in the mouth every 2 – 3 hours up to a maximum of 12 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 6 years take this medicine. Remember that young children can choke on lozenges. 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.

How to store it

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.

Contents of the pack and other information

What this medicine contains The active substances are: 2,4-Dichlorobenzyl alcohol 1.2mg, Amylmetacresol 0.6mg, Vitamin C 100mg (Ascorbic acid / Sodium ascorbate) The other ingredients are: Menthol, Tartaric acid, Orange flavour (containing Citral, Citronellol, d-Limonene, Geraniol and Linalool), Propylene glycol, Sunset yellow (E110), Ponceau 4R (E124) (containing Sodium), Liquid Glucose (containing wheat starch (containing gluten), Sulphites- Sulphur Dioxide (E220)), Liquid Sucrose. What this medicine looks like An orange circular lozenge. Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited, Slough, SL1 3UH Manufacturer: Reckitt Benckiser Healthcare International Limited, Nottingham, NG90 2DB Licence Number: PL 00063/0391 Date of preparation: January 2021

TR2085401

0000000

Top Front

N/A TDD1022/6

N/A

PRINTING READS This Way

CUSTOMER INFO: Minimum Point Size = 9.00pt

1.3.1 Package Leaflet – Clean 1 Strepsils Orange with Vitamin C ZVQZ6 eCTD

Page 1

Frequently asked questions about Strepsils Orange with Vitamin C 100mg

What is the active substance in Strepsils Orange with Vitamin C 100mg?

The active substance in Strepsils Orange with Vitamin C 100mg is ascorbic acid, amylmetacresol, 2,4-dichlorobenzyl alcohol.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Strepsils Orange with Vitamin C 100mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Strepsils Orange with Vitamin C 100mg without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: ascorbic acid, amylmetacresol, 2,4-dichlorobenzyl alcohol
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Amylmetacresol (8 medicines), Ascorbic acid (13 medicines), Ascorbic acid, amylmetacresol, 2,4-dichlorobenzyl alcohol (1 medicine)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For the symptomatic relief of mouth and throat infections.

4.2. Posology and method of administration

Posology

Use the lowest dose for the shortest duration necessary to relieve symptoms.

Adults:

One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Children over 6 years old:

As above for adults.

Elderly:

There is no need for dosage reduction in the elderly.

Children under 6 years old:

Not suitable for children under 6 years (see section 4.4).

Method of administration

For oral administration. To be dissolved slowly in the mouth.

4.3. Contraindications

Hypersensitivity to any of the ingredients.

4.4. Special warnings and precautions for use

Not to be given to children under 6 years

If symptoms persist, have not improved, or have worsened after 3 days, consult a doctor or health care professional.

Important information about some of the ingredients of this medicine:

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 19.36 micrograms of gluten.

If you have wheat allergy (different from coeliac disease) you should not take this medicine.

This medicine contains 3 mg propylene glycol in each Lozenge.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

This medicine contains fragrance with Citral, Citronellol, d-Limonene, Geraniol and Linalool. Citral, Citronellol, d-Limonene, Geraniol and Linalool may cause allergic reactions.

This medicine contains glucose (0.97g per lozenge) and sucrose (1.44g per lozenge). This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

This medicine contains sulphites – Sulphur dioxide (E220) which may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine contains colouring agents (Ponceau 4R (E124) and Sunset Yellow (E110)), which may cause allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

No clinically significant interactions are known.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of amylmetacresol, 2,4-dichlorbenzyl alcohol and ascorbic acid.

As with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.

Breast-feeding

Ascorbic acid or metabolites are excreted in human milk, but at therapeutic doses of the product no effects on breastfed newborns / infants are anticipated. It is unknown whether 2,4-dichlorobenzyl alcohol, amylmetacresol or metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded.

Fertility

No data are available regarding the effects on fertility.

4.7. Effects on ability to drive and use machines

No or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The list of the following adverse effects relates to those experienced with 2,4-dichlorobenzyl alcohol and amylmetacresol at OTC doses, in short term use..

Adverse events which have been associated with 2,4-dichlorobenzyl alcohol and amylmetacresol are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivityab1

Gastrointestinal Disorders

Not known

Glossodyniaab, oral discomfortab

a2,4-dichlorobenzyl alcohol bamylmetacresol

1 Hypersensitivity reactions may include rash, urticaria and angioedema, which may include swelling of the face, neck, throat or tongue that could affect breathing.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9. Overdose

Overdosage should not present a problem other than gastrointestinal discomfort.

Treatment should be symptomatic.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

⚠ Not the same combination. This medicine contains Ascorbic acid, Amylmetacresol, 2,4-dichlorobenzyl alcohol. The products below do not contain exactly the same set of active substances — they are not direct substitutes.

⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.

VITAMINA C - RICHTER 500 mg over the counter partial — not the same combinationACIDUM ASCORBICUM · taken by mouth
VITAMINA C ARENA 750 mg prescription partial — not the same combinationACIDUM ASCORBICUM · injection / infusion
ADDITIVA VITAMIN C 1000 mg over the counter partial — not the same combinationACIDUM ASCORBICUM · taken by mouth
VITAMINA C BÉRES 100 mg/ml over the counter partial — not the same combinationACIDUM ASCORBICUM · taken by mouth
VITAMINA C ZENTIVA 100 mg/ml prescription partial — not the same combinationACIDUM ASCORBICUM · injection / infusion
VITAMINA C GALENIKA 100 mg/ml prescription partial — not the same combinationACIDUM ASCORBICUM · injection / infusion

Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako