Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution

⚠ 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 Guaifenesin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Guaifenesin

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for BENYLIN® Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution contains guaifenesin which is a type of medicine called an expectorant. It helps to relieve chesty (productive) coughs by loosening phlegm (mucus), making it easier to cough up and the cough more productive.

What you need to know before you take it

e this medicine Do NOT take this medicine ■ if you are allergic to guaifenesin or any of the

ingredients of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: ■ have had a cough for more than 7 days or your cough recurs or is accompanied by a fever, rash or persistent headache. ■ have a persistent cough that may be caused by asthma. ■ have a cough which brings up a lot of mucus (phlegm). ■ suffer from liver or kidney problems. ■ are taking alcohol.

Children The safety and efficacy of guaifenesin in children aged under 12 years have not yet been established.

Interference with laboratory tests If you are undergoing urine tests it is important to tell the doctor or nurse you are taking, or have recently taken, this medicine as it can affect some results.

Taking other medicines Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. ■ It is not recommended that you take this medicine with other cough medicines intended to stop you from coughing (antitussives or cough suppressants) as they may interfere with the action of this medicine.

Taking with food and drink You can take this medicine with or without food or drink.

Pregnancy and breast-feeding ■ If you are pregnant or breast-feeding, think you may

be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine should not be used during pregnancy unless advised by a doctor. ■ Do not take this medicine if you are breast-feeding until you speak with a doctor or pharmacist.

Driving and using machines This medicine is not expected to affect your ability to drive or operate machinery. However, if you do feel unwell, do not drive or use machinery.

Important information on some of the other ingredients in this medicine ■ This medicinal product contains 381 mg of alcohol

(ethanol) in each 10 ml dose which is equivalent to 38.1 mg/ml. The amount in 10 ml of this medicine is equivalent to 9.5 ml beer or 3.8 ml wine. ■ The small amount of alcohol in this medicine will not have any noticeable effects. ■ Ponceau 4R (E124) – red colouring – may cause allergic reactions. ■ This medicinal product contains less than 1 mmol sodium (23 mg) per 10 ml dose, that is to say essentially 'sodium-free'. ■ Glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. ■ This medicinal product contains 10 mg of benzoate salt in each 10 ml dose. ■ 2003.5 mg propylene glycol in each 10 ml dose. If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine. ■ Macrogol glycerol hydroxystearate 40 may cause stomach upset and diarrhoea.

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How to take it

this medicine 4 Possible side-effects Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. ■ This solution is for oral use only. ■ Do not use more than the stated dose shown. Age

Dose

Adults and adolescents over 12 years Elderly

Take two 5 ml spoonfuls (total of 10 ml) 4 times a day As for adults

Children under 12 years

Do not give

Patients with liver Speak to a doctor or or kidney problems pharmacist ■ Do NOT take more than 4 doses (40 ml) in

24 hours. ■ Contact a doctor if your symptoms worsen or do not improve within 7 days.

If you take too much of this medicine If anyone has too much, contact a doctor or your nearest Accident and Emergency Department taking this leaflet and pack with you. If you take too much of this medicine you may develop kidney stones. Symptoms may include: ■ Upset stomach, nausea and drowsiness.

If you forget to take this medicine You should only take this medicine as required following the dosage instructions carefully. If you forget to take a dose, take the next dose when needed. Do not take a double dose to make up for the forgotten dose. Do not take more than 4 doses (40 ml) in 24 hours.

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

If you experience any of the following STOP using the medicine and seek medical help immediately: ■ Allergic reactions including skin rashes (which may

be severe and include blistering and peeling of the skin) and itching. ■ Difficulty in breathing, swelling of the face, neck, tongue or throat (anaphylactic reaction).

Other effects that may occur include: ■ Nausea or vomiting.

■ Stomach pain and diarrhoea.

Reporting of side effects If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also report sideeffects 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.

Possible side effects

. 5. How to store this medicine. 6. Contents of the pack and other information.

How to store it

this medicine ■ Keep this medicine out of the sight and reach of

children.

■ Do not store this medicine above 25°C.

■ Store in the original container in order to protect

from light. Do not use if bottle seal is broken when purchased. ■ Do not use this medicine after the expiry date which is stated on the bottle and outer carton after 'EXP'. The expiry date refers to the last day of that month. ■ Use within 4 weeks of opening. ■ 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 to protect the environment.

Contents of the pack and other information

What this medicine contains:

The active substance is guaifenesin. Each ml of oral solution contains 20 mg of guaifenesin. Each 10 ml of oral solution contains 200 mg of guaifenesin. The other ingredients are: Xanthan gum, sodium chloride, saccharin sodium, ammonium glycyrrhizate, citric acid, sodium citrate, macrogol glycerol hydroxystearate 40, levomenthol, raspberry flavour (includes ethanol), glycerol, macrogol 1500, propylene glycol (E1520), ethanol, purified water, sodium benzoate (E211), Ponceau 4R (E124), caramel (E150) (for further information on some of the ingredients see Section 2).

What this medicine looks like and contents of the pack BENYLIN® Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution is a clear to slightly opalescent red solution for oral use only. It is available in a 150 ml brown glass bottle fitted with a plastic child resistant cap. Marketing Authorisation holder: McNeil Products Ltd, High Wycombe, Buckinghamshire, HP12 4EG, UK. Manufacturer: Delpharm Orleans, 5 avenue de Concyr, Orleans Cedex 2, 45071, France. This package leaflet was revised in March 2023. BENYLIN® is a registered trade mark. McNeil Products Limited 2023 ©

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Frequently asked questions about Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution

How do I take Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution?

Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution comes as oral solution containing 100mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution?

The active substance in Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution is guaifenesin.

Are there equivalent medicines to Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution?

Medicines with the same active substance, strength and form include: Benylin Mucus Cough Max Honey & Lemon Flavour 100 mg/5 ml Syrup, Boots Chesty Cough Relief 100 mg/5ml Oral Solution, Boots Mucus Cough Relief 100mg/5ml Oral Solution. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution, 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 Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution 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.

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: Guaifenesin (30 medicines)
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

Benylin Mucus Cough Max Menthol Flavour 100 mg/ 5 ml Oral Solution is indicated to help loosen phlegm and thin bronchial secretions associated with productive cough, for use in adults and adolescents over 12 years.

4.2. Posology and method of administration

Posology

Adults and adolescents over 12 years:

10 ml (200 mg guaifenesin) 4 times a day.

Maximum daily dose: 40 ml (800 mg guaifenesin)

Paediatric population

The safety and efficacy of Benylin Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution in children under 12 years of age has not yet been established.

No data are available.

Elderly:

As per adults.

Hepatic/renal impairment

Caution should be exercised in severe hepatic and severe renal impairment (see Section 5.2).

If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

Method of administration

Oral

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions, unless directed by a physician.

A persistent cough may be a sign of a serious condition. If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.

Caution should be exercised when using the product in the presence of severe renal or severe hepatic impairment.

The concomitant use of cough suppressants is not recommended.

This medicinal product contains 10 mg of benzoate salt in each 10 ml dose.

This medicinal product may contain very trace amounts of glucose. Patients with rare glucose galactose malabsorption should not take this medicine.

This medicinal product contains 381 mg of alcohol (ethanol) in each 10 ml dose which is equivalent to 38.1 mg/ml. The amount in 10 ml of this medicine is equivalent to 9.5 ml beer or 3.8 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This product contains Ponceau 4R (E124) red colouring which may cause allergic reactions.

This medicinal product contains less than 1 mmol sodium (23 mg) per 10 ml dose, that is to say essentially 'sodium-free'.

This medicinal product contains 2003.5 mg propylene glycol in each 10 ml dose. While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

This medicinal product contains macrogol glycerol hydroxystearate 40. It may cause stomach upset and diarrhoea.

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

If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid 5-HIAA) and vanillylmandelic acid (VMA).

Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.

No interaction studies have been performed which revealed an interaction with guaifenesin.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of guaifenesin in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Benylin Mucus Cough Max Menthol Flavour 100 mg/5 ml Oral Solution is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding

Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of guaifenesin in newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.

4.7. Effects on ability to drive and use machines

Guaifenesin has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

Anaphylaxis has been reported.

The undesirable effects have been reported spontaneously during post- marketing use. Due to limited clinical trial data, a frequency cannot be estimated from the available data and is therefore classified as “not known”.'

The following side effects may be associated with the use of guaifenesin:

SOC

Frequency Category

Adverse Event Term

Immune System Disorders

Not Known

Hypersensitivity reactions including pruritus and urticaria

Rash

Anaphylactic reaction

Gastrointestinal Disorders

Not Known

Gastrointestinal discomfort, nausea, vomiting

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

Symptoms and signs

The symptoms and signs of overdose may include gastro-intestinal discomfort, nausea and drowsiness.

When taken in excess, guaifenesin may cause renal calculi.

Management

Treatment should be symptomatic and supportive.

💬 Ask about this leaflet

Ask anything about Benylin Mucus Cough Max Menthol flavour 100 mg/5 ml Oral Solution. 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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