Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Pelargonium reniforme, Pelargonium sidoides may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2. What you need to know before you take Benylin Herbal Cough & Cold Sugar Free Syrup 3. How to take Benylin Herbal Cough & Cold Sugar Free Syrup 4. Possible side effects 5. How to store Benylin Herbal Cough & Cold Sugar Free Syrup 6. Contents of the pack and other information
Other medicines and Benylin Herbal Cough & Cold Sugar Free Syrup
Tell your doctor, qualified healthcare practitioner or pharmacist if you are taking, have recently taken or might take any other medicines, including any medicines obtained without a prescription.
511U363
634
Driving and using machines
e Benylin Herbal Cough & Cold Sugar Free Syrup
Some people have felt dizzy when taking this medicine. If you feel dizzy, do not drive or use machines.
Important information about the ingredients in your medicine
Do not use Benylin Herbal Cough & Cold Sugar Free Syrup
Benylin Herbal Cough & Cold Sugar Free Syrup contains 625.1 mg of sorbitol (E 420) and 893 mg of maltitol (E 965) per 2.5 ml dose.
other ingredients in this medicine (listed in section 6). ■ if you are pregnant or breast feeding. ■ if you are under 6 years of age. ■ if you have liver or kidney problems.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
■ if you are allergic to Pelargonium root or to any of the
Warnings and precautions Talk to your doctor or qualified healthcare practitioner immediately: ■ if fever, shortness of breath or blood in your phlegm occurs. ■ If signs of hepatotoxicity or other liver problems occur (such as hepatitis, fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain, nausea and vomiting or dark urine). The use of the medicinal product should be stopped immediately. Talk to your doctor, qualified healthcare practitioner or pharmacist if you feel worse, or do not feel better after one week.
Children and adolescents
This medicine is not for use in children under 6 years of age.
Benylin Herbal Cough & Cold Sugar Free Syrup For oral use only.
Always take this medicine exactly as described in this leaflet or as your doctor, qualified healthcare practitioner or pharmacist has told you. Check with your doctor, qualified healthcare practitioner or pharmacist if you are not sure. Start taking at the first signs of a common cold. Shake the bottle before use. Always use the enclosed measuring spoon provided which is graduated with 2.5 ml and 5 ml. After each use, wash the spoon and dry it.
LARGEST TEXT SIZE
14.00 pt
AVE. TEXT SIZE
7 pt
4.00 pt
SMALLEST TEXT SIZE
FONTS USED
Gotham-Black Gotham-Bold NimbusSanLOT-Bla NimbusSanLOT-Bol NimbusSanLOT-Reg NimbusSanLOT-RegIta TransatBlack
Interstate-LightCondensed
PPK
JJEXT_00270_V2
Leaflet
148 x 210 mm
WHITE PAPER
leaflet_148x210 – production file
Colours represented with a diagonal line have been modified to aid PDF approval. LITHO OFFSET LITHO OFFSET
REPRESENTATION:
PANTONE 362 C Black
634
19-11-2021
Date 19-02-2024
English
402890629_r13 Job / Version No.
Languages
N/A Old Component / Item Code
EMEA_2022_00070211_000 ArtWorks ID
511U363 New Component / Item Code
Product / Eurocode / Mat. ID Code 90354800
CHILD
Project Name / Design GB Benylin Herbal Cough & Cold SF Syrup Pelargonium 100ml_PIL_NPI_3673
turn over
The recommended dose is:
Adults, the elderly, and children aged 12 years and over: Using the measuring spoon provided, take 2.5 ml of syrup three times daily.
Children between 6 and 12 years of age: Using the measuring spoon provided, take 2.5 ml of syrup two times daily. Do not take more than the leaflet tells you to.
Not for use in children under 6 years of age. Not to be used for more than 10 days. You must talk to a doctor or qualified healthcare practitioner if you feel worse, or do not feel better after one week.
If you take more Benylin Herbal Cough & Cold Sugar Free Syrup than you should
If you take more Benylin Herbal Cough & Cold Sugar Free Syrup than the recommended dose, talk to your doctor, qualified healthcare practitioner, pharmacist or contact your nearest hospital casualty department. Take this leaflet with you.
If you forget to take Benylin Herbal Cough & Cold Sugar Free Syrup
Do not take a double dose to make up for a forgotten dose, but continue to take your next dose at the usual time. If you have any further questions on the use of this medicine, ask your doctor, qualified healthcare practitioner or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In very rare cases serious hypersensitivity reactions with
swelling of the face, difficulty breathing and decrease in blood pressure have been reported. If these effects occur, stop taking this medicine and seek medical advice immediately. This medicine may cause hepatitis or other liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain or unusual tiredness), stop taking this medicine immediately and seek medical advice immediately. The following side effects have been very rarely reported:
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Very rare side effects
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).
■ diarrhoea
■ stomach pain or discomfort ■ nausea or vomiting
■ swallowing difficulties
■ bleeding from nose and/or gums
■ allergic reactions such as dermatitis, rash and itching
The following other side effects have been reported. The frequency of them occurring is not known ■ dizziness
■ flushed skin
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or qualified healthcare practitioner. This includes any
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.
Benylin Herbal Cough & Cold Sugar Free Syrup Keep this medicine out of the sight and reach of children. Store in the original container. This medicine does not require any special temperature storage conditions. Any unused medicine must be discarded after 3 months of first opening the bottle. Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month.
What Benylin Herbal Cough & Cold Sugar Free Syrup contains
The other ingredients are: Maltodextrin (from extract), sorbitol (E 420) and maltitol (E 965), potassium sorbate, citric acid anhydrous, purified water.
What Benylin Herbal Cough & Cold Sugar Free Syrup looks like and contents of the pack
Benylin Herbal Cough & Cold Sugar Free Syrup is a dark red liquid filled in 100 ml brown glass bottles. The bottle is closed with white polyethylene (PE) screw cap. The package also includes a measuring spoon which is graduated with 2.5 ml and 5 ml. Traditional Herbal Registration Holder McNeil Products Limited, High Wycombe, Buckinghamshire, HP12 4EG, UK. Manufacturer Phytopharm Klęka S.A., Klęka 1, 63-040 Nowe Miasto nad Wartą, Poland. This leaflet was last prepared in February 2024. If you are partially sighted or blind and require an alternative format of the leaflet, please email [email protected] or call 0808 238 9999.
©
McNeil Products Limited 2024
Benylin Herbal Cough & Cold Sugar Free Syrup comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Benylin Herbal Cough & Cold Sugar Free Syrup is pelargonium reniforme, pelargonium sidoides.
This leaflet reproduces the patient information leaflet approved for Benylin Herbal Cough & Cold Sugar Free Syrup, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe hepatic or renal disease.
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.
None reported.
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.
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.
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.
No case of overdose has been reported.
Ask anything about Benylin Herbal Cough & Cold Sugar Free Syrup. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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