Description
Strepsils Honey & Lemon is a medicated antiseptic throat lozenge designed for adults and children aged 6 and older. It helps relieve mild sore throats that are not accompanied by fever.

Each lozenge contains a dual antiseptic formula to help reduce bacteria in the mouth and throat:
• Amylmetacresol – 0.6 mg
• 2,4-Dichlorobenzyl alcohol – 1.2 mg

Other ingredients include: honey, tartaric acid, peppermint essential oil, lemon essential oil, glucose–sucrose syrup, quinoline yellow, and flavorings containing citral, d-limonene, geraniol, and linalool.
Excipients of note: glucose, sucrose, wheat starch (contains gluten), sulfites (E220).

Who Can Use It?
• Children 6+
• Teenagers
• Adults
Not permitted during pregnancy or breastfeeding.

Dosage & Directions

• Dissolve 1 lozenge slowly in the mouth, 3 to 6 times per day.
• Do not exceed 6 lozenges per day.
• Take between meals.
• Do not chew, crush, or swallow whole.
• Allow 2 to 3 hours between doses.
• Maximum treatment duration: 5 days. Longer use can disrupt the natural oral flora.
• Do not double the dose if you forget a dose.

Contraindications

Do not use if:
• You are allergic to any ingredient in Strepsils Honey & Lemon.
• You are allergic to wheat.
• You have fructose intolerance, glucose–galactose malabsorption, or sucrase–isomaltase deficiency.
• The patient is a child under 6 years (choking risk + risk of convulsions due to terpene derivatives).
• You are pregnant or breastfeeding.

Warnings & Precautions

Use with caution if:
• You have a history of epilepsy, due to the presence of terpenes.
• You follow a low-sugar diet, are diabetic, or follow a ketogenic diet — each lozenge contains 2.45 g of glucose/sucrose.

Strepsils Honey & Lemon is considered very low in gluten, unlikely to affect celiac patients.

If symptoms do not improve within 3 days, or if they worsen, consult a doctor.

Avoid using with other products containing antiseptics unless approved by a pharmacist or doctor.

Possible Side Effects

Allergic reactions may occur, especially in people sensitive to amylmetacresol, benzyl alcohol, gluten, terpenes, or sulfites.

Symptoms may include:
• Skin reactions (rash, hives)
• Swelling of the face or throat (angioedema)
• Breathing difficulty (bronchospasm)
• Severe allergic reaction or loss of consciousness

Stop use immediately and seek urgent medical care if any of these occur.

Packaging:
Box of 24 lozenges

Please read the following full disclosure before purchasing or taking this product.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

ANSM – Updated: 17/12/2021

1. NAME OF THE MEDICINAL PRODUCT

STREPSILS HONEY LEMON, lozenge

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Amylmetacresol ...................................................................................... 0.6000 mg
2,4-Dichlorobenzyl alcohol .................................................................... 1.2000 mg

Per lozenge of 2.6 g.

Each lozenge contains 2.4 g of sugar.

Excipients with known effect:
• Glucose (0.98 g per lozenge)
• Sucrose (1.44 g per lozenge)
• Wheat starch (containing gluten) (not more than 19.52 micrograms of gluten per lozenge)
• Flavouring containing citral, d-limonene, geraniol and linalool
• Sulfites – sulfur dioxide (E220)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Lozenge.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Indicated in adults and children over 6 years for mild sore throat without fever.

4.2 Posology and method of administration

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

Adults and children over 6 years
1 lozenge, 3 to 6 times daily, spaced 2 to 3 hours apart.
Do not exceed 6 lozenges in 24 hours.

Children under 6 years
Contraindicated (see section 4.3).

Method of administration
Oral use.
Slowly dissolve the lozenge in the mouth without chewing or swallowing it whole.
Preferably take the lozenge away from mealtimes.

4.3 Contraindications

• Hypersensitivity to the active substances or any of the excipients listed in section 6.1
• Children under 6 years

4.4 Special warnings and precautions for use

Warnings
• Treatment must not exceed 5 days, as prolonged use may disrupt the normal microbial flora of the oral cavity, with a risk of bacterial or fungal proliferation.

Precautions
• If symptoms persist beyond 3 days, or if fever appears, consult a doctor.
• Contains 0.98 g glucose and 1.44 g sucrose per lozenge. Patients with fructose intolerance, glucose–galactose malabsorption or sucrase–isomaltase deficiency must not use this medicine.
• Contains a very low gluten content (from wheat starch). Considered “gluten-free” and unlikely to cause issues in coeliac disease. Patients with wheat allergy (different from coeliac disease) must not take this medicinal product.
• Contains flavourings with citral, d-limonene, geraniol, and linalool — substances that may cause allergic reactions.
• Contains sulfites, which may rarely cause severe hypersensitivity reactions and bronchospasm.

4.5 Interactions with other medicinal products

No clinically significant interactions known to date.

4.6 Fertility, pregnancy and lactation

Pregnancy
Animal data are insufficient regarding reproductive toxicity.
There are no or limited data on use in pregnant women.
Use is not recommended during pregnancy or in women of childbearing potential not using contraception.

Breastfeeding
No adequate data on excretion of the active substances or metabolites in breast milk.
A risk to newborns/infants cannot be excluded.
STREPSILS must not be used during breastfeeding.

Fertility
No data available regarding effects on fertility.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Adverse reactions are listed by System Organ Class and frequency (MedDRA classification).
Frequency categories: very common, common, uncommon, rare, very rare, not known.

Immune system disorders
• Frequency: Not known – Hypersensitivity¹

¹Hypersensitivity reactions may include rash, angioedema, urticaria, bronchospasm, and hypotension with syncope.

Reporting of suspected adverse reactions: via ANSM and the Regional Pharmacovigilance Centres: www.signalement-sante.gouv.fr

4.9 Overdose

Symptoms
Serious adverse effects are unlikely. Gastrointestinal discomfort may occur.

Management
Symptomatic treatment.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Local antiseptic
(R: Respiratory system)
Combination of two local antiseptics.

5.2 Pharmacokinetic properties

2,4-Dichlorobenzyl alcohol is metabolised in the liver to hippuric acid, excreted in urine.
No available data on metabolism and excretion of amylmetacresol.

5.3 Preclinical safety data

No harmful effects on pregnancy or fetal development observed in studies in rabbits.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Honey, tartaric acid, peppermint essential oil (d-limonene), lemon essential oil (citral, d-limonene, geraniol, linalool), quinoline yellow, sucrose–glucose solution, wheat starch (gluten), sulfites (sulfur dioxide E220).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

(Not all presentations may be marketed.)

• Blisters (PVC/PVDC/Aluminium): boxes of 6, 8, 12, 24, or 36 lozenges
• Polypropylene tube: box of 10 lozenges

6.6 Special precautions for disposal

Dispose of unused product or waste according to local regulations.

7. MARKETING AUTHORISATION HOLDER

RECKITT BENCKISER HEALTHCARE France
38 Rue Victor Basch
CS 11018
91305 MASSY CEDEX

8. MARKETING AUTHORISATION NUMBERS

• 34009 336 450 1 4 – 6-lozenge blister
• 34009 363 776 1 5 – 8-lozenge blister
• 34009 336 451 8 2 – 12-lozenge blister
• 34009 332 266 1 9 – 24-lozenge blister
• 34009 385 121 8 2 – 36-lozenge blister
• 34009 395 600 6 9 – 10-lozenge tube (PP)

9. DATE OF FIRST AUTHORISATION / RENEWAL

To be completed by the MAH.

10. DATE OF REVISION OF THE TEXT

To be completed by the MAH.

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION

Not applicable.

PRESCRIPTION / DISPENSING CONDITIONS

Non-prescription medicinal product.