- Approval Id
- 41eab11053fa627c
- Drug Approval Emc Name
- Benylin Herbal Cough & Cold Sugar Free Syrup
- Drug Name
- Benylin Herbal Cough & Cold Sugar Free Syrup
- Company Name
- McNeil Products Ltd
- Company Address
- 50-100 Holmers Farm Way, High Wycombe, HP12 4EG, UK
- Company Medical Info Direct Line
- 0808 238 9999 (freephone)
- Company Medical Info Email
- consumer-gb@kenvue.com
- Legal Category
- General Sales List
- Authorisation Holder
- McNeil Products Limited
50 – 100 Holmers Farm Way,
High Wycombe,
Buckinghamshire,
HP12 4EG,
UK
- Authorisation Number
- THR 15513/0186
- Authorisation Date
- 21 February 2024
- Instruction Authorisation Holder
- McNeil Products Limited
50 – 100 Holmers Farm Way,
High Wycombe,
Buckinghamshire,
HP12 4EG,
UK
- Instruction Authorisation Number
- THR 15513/0186
- Instruction Authorisation Date
- 21 February 2024
- Instruction Composition
- 2.5 ml of syrup contains 20 mg of dry extract from Pelargonium root (\*Pelargonium sidoides\* DC and/or \*Pelargonium reniforme\* Curt., radix); (DER 4-25:1), extraction solvent: ethanol 11% (m/m)
2.5 ml of syrup also contains 893 mg of sorbitol (E 420) and 893 mg of maltitol (E 965) (see section 4.4 'Special warnings and precautions for use').
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Syrup
Dark red liquid with a characteristic odour and a sweet taste.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve symptoms associated with the common cold such as coughs, sore throat and blocked or runny nose. Based on traditional use only.4.2 Posology and method of administration
Posology
Start at first signs of common cold.
\*Children between 6 and 12 years of age:\*
Using the measuring spoon provided take 2.5 ml, 2-times per day.
\*Adolescents over 12 years of age, adults, and elderly:\*
Using the measuring spoon provided take 2.5 ml, 3-times per day.
The use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
Do not use for more than 10 days.
Method of administration
For oral use only.
Shake the bottle before use.
If the symptoms worsen or persist longer than 1 week during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic or renal disease.4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children under 6 years of age has not been established due to lack of adequate data.
Hepatotoxicity and hepatitis cases were reported in association with the administration of the medicinal product. In case signs of hepatotoxicity occur (such as fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine), the administration of the medicinal product should be stopped immediately, and a medical doctor should be consulted.
If symptoms worsen, or do not improve after one week, a doctor or qualified healthcare practitioner should be consulted.
If fever, shortness of breath or blood in the sputum occurs, a doctor or qualified healthcare practitioner should be consulted.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None reported.4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, dizziness has been reported. Affected patients should not drive or operate machinery.4.8 Undesirable effects
In very rare cases serious hypersensitivity reactions with swelling of the face, dyspnoea and decrease in blood pressure have been reported.
Hepatotoxicity (including hepatitis, liver dysfunction of different origin) has been reported. Dizziness and flushed skin have also been reported. The frequency is not known.
Gastrointestinal complaints (such as diarrhoea, epigastric discomfort, nausea or vomiting, dysphagia), mild nasal and gingival bleeding and hypersensitivity reactions (e.g. Dermatitis, rash, rash erythematous, exanthema, urticaria, pruritus of skin and mucous membranes) have been reported. The frequency was very rare.
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
No case of overdose has been reported.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.5.3 Preclinical safety data
A bacterial reverse mutation assay (Ames test) indicated that the Pelargonium root dry extract in the product was not mutagenic.
Adequate tests on reproductive toxicity and carcinogenicity have not been performed.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Extract:
Maltodextrin
Syrup:
Sorbitol, liquid
Maltitol, liquid
Potassium sorbate
Citric acid anhydrous
Purified water6.2 Incompatibilities
None.6.3 Shelf life
3 years
After first opening: 3 months.6.4 Special precautions for storage
Store in the original container. This medicinal product does not require any special temperature storage conditions.6.5 Nature and contents of container
100 ml brown glass bottle with white PE screw cap. A measuring spoon made from polypropylene, graduated with 2.5 ml and 5 ml, is placed in cardboard box.6.6 Special precautions for disposal and other handling
No special requirements
Any unused product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
2.5 ml of syrup contains 20 mg of dry extract from Pelargonium root (\*Pelargonium sidoides\* DC and/or \*Pelargonium reniforme\* Curt., radix); (DER 4-25:1), extraction solvent: ethanol 11% (m/m)
2.5 ml of syrup also contains 893 mg of sorbitol (E 420) and 893 mg of maltitol (E 965) (see section 4.4 'Special warnings and precautions for use').
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Syrup
Dark red liquid with a characteristic odour and a sweet taste.
## Clinical Particulars
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve symptoms associated with the common cold such as coughs, sore throat and blocked or runny nose. Based on traditional use only.4.2 Posology and method of administration
Posology
Start at first signs of common cold.
\*Children between 6 and 12 years of age:\*
Using the measuring spoon provided take 2.5 ml, 2-times per day.
\*Adolescents over 12 years of age, adults, and elderly:\*
Using the measuring spoon provided take 2.5 ml, 3-times per day.
The use in children under 6 years of age is not recommended (see section 4.4 'Special warnings and precautions for use').
Do not use for more than 10 days.
Method of administration
For oral use only.
Shake the bottle before use.
If the symptoms worsen or persist longer than 1 week during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic or renal disease.4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children under 6 years of age has not been established due to lack of adequate data.
Hepatotoxicity and hepatitis cases were reported in association with the administration of the medicinal product. In case signs of hepatotoxicity occur (such as fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine), the administration of the medicinal product should be stopped immediately, and a medical doctor should be consulted.
If symptoms worsen, or do not improve after one week, a doctor or qualified healthcare practitioner should be consulted.
If fever, shortness of breath or blood in the sputum occurs, a doctor or qualified healthcare practitioner should be consulted.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
None reported.4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, dizziness has been reported. Affected patients should not drive or operate machinery.4.8 Undesirable effects
In very rare cases serious hypersensitivity reactions with swelling of the face, dyspnoea and decrease in blood pressure have been reported.
Hepatotoxicity (including hepatitis, liver dysfunction of different origin) has been reported. Dizziness and flushed skin have also been reported. The frequency is not known.
Gastrointestinal complaints (such as diarrhoea, epigastric discomfort, nausea or vomiting, dysphagia), mild nasal and gingival bleeding and hypersensitivity reactions (e.g. Dermatitis, rash, rash erythematous, exanthema, urticaria, pruritus of skin and mucous membranes) have been reported. The frequency was very rare.
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
No case of overdose has been reported.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.5.3 Preclinical safety data
A bacterial reverse mutation assay (Ames test) indicated that the Pelargonium root dry extract in the product was not mutagenic.
Adequate tests on reproductive toxicity and carcinogenicity have not been performed.
## Pharmaceutical Particulars
6.1 List of excipients
Extract:
Maltodextrin
Syrup:
Sorbitol, liquid
Maltitol, liquid
Potassium sorbate
Citric acid anhydrous
Purified water6.2 Incompatibilities
None.6.3 Shelf life
3 years
After first opening: 3 months.6.4 Special precautions for storage
Store in the original container. This medicinal product does not require any special temperature storage conditions.6.5 Nature and contents of container
100 ml brown glass bottle with white PE screw cap. A measuring spoon made from polypropylene, graduated with 2.5 ml and 5 ml, is placed in cardboard box.6.6 Special precautions for disposal and other handling
No special requirements
Any unused product or waste material should be disposed of in accordance with local requirements.
