Benylin Mucus Cough Plus Decongestant syrup – patient leaflet, side effects, dosage

1 What the medicine is and what it is used for

Benylin Mucus Cough plus Decongestant Syrup is a medicine which is used to relieve chesty coughs, help clear the stuffy, blocked up feeling in your nose and sinuses and reduce catarrh. The syrup contains pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion and guaifenesin, which is an expectorant that helps to loosen the mucus in your throat and chest.

This medicine is for use by adults and children aged 12 years and over.

2 What you need to know before taking this

Medicine

This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your

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doctor or pharmacist.

Do not take this medicine…

• If you have ever had a bad reaction to any of the

ingredients of this medicine (listed in section 6).

If you have high blood pressure or heart disease.

• If you are taking beta blockers (used to treat high blood

pressure).

• If you have diabetes.
• If you have an overactive thyroid gland.
• If you have glaucoma (increased pressure in the eye).
• If you have phaeochromocytoma (a rare tumour which

affects your heart rate and blood pressure).

• If you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure
• If you are taking, or have taken in the last two

weeks, drugs for depression known as Monoamine

Oxidase Inhibitors (MAOIs) or Reversible Inhibitors of

Monoamine Oxidase (RIMAs).

• If you are taking stimulants or appetite suppressants

or drugs used to treat congestion and asthma

(Sympathomimetic drugs).

• If you have had a cough for a few weeks, or a cough

which brings up any blood or a lot of mucus that may be caused by asthma or emphysema.

• If you are taking any other cough and cold medicine.
• For a child under 12 years old.

If any of these apply to you, get advice from a doctor or pharmacist without taking Benylin Mucus Cough plus

Decongestant Syrup.

Talk to your doctor or pharmacist...

• If you have kidney or severe liver problems.
• If you have blocked arteries or veins (occlusive

vascular disease).

• If you have alcohol dependence.

• If you are being treated for a thyroid disorder.
• If you have difficulty passing water and / or an enlarged

prostate (which may mean you need to pass water more often).

• If your cough keeps re-occurring or you have a cough

with a fever, rash or persistent headache.

• If you are taking any other medicines, including:
• Antihypertensives (drugs used to treat high blood

pressure such as guanethidine, methyldopa, adrenergic neurone blockers debrisoquine, bretylium and

betanidine).

• Tricyclic antidepressants (used to treat mood disorders).
• Moclobemide (used to treat mood disorders).

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• Cardiac glycosides (drugs used to control heart

rhythms or contractions such as digoxin).

• Ergot alkaloids (drugs used to treat migraine such as

ergotamine and methysergide).

• Oxytocin (drug used to help contractions during

childbirth).

• Anticholinergic drugs (drugs used to treat cramps and

spasms such as atropine).

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

! If you experience the following, stop

taking this medicine immediately and

contact your doctor:

• A feverish generalised erythema associated with pustules

(see section 4).

• Sudden severe headaches, nausea, vomiting,

confusion, fits, visual disturbances.

• Sudden abdominal pain or rectal bleeding may occur

with this medicine, due to inflammation of the colon

(ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking this medicine and contact your

doctor or seek medical attention immediately (see

section 4).

• Reduction of blood flow to your optic nerve may occur

with this medicine. If you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately (see section 4).

If you are pregnant or 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.

Special warnings about this medicine

Cases of posterior reversible encephalopathy syndrome (PRES)

and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine.

PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using Benylin Mucus Cough plus Decongestant Syrup immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section4 "Possible side effects" for symptoms)

Some of the ingredients can cause problems

• Each 5 ml of this medicine contains 3 g of sucrose. 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 medicine.

• This medicine contains less than 1 mmol sodium

(23 mg) per 5 ml, that is to say essentially

‘sodium-free’.

• This medicine contains 0.02 mg benzyl alcohol in each

5 ml. Benzyl alcohol may cause allergic reactions.

Ask you doctor or pharmacist for advice if you are

pregnant or breast-feeding, or

if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called ‘‘metabolic acidosis’’).

• This medicine contains 190 mg of alcohol (ethanol)

in each 5 ml dose. The amount in a 5 ml dose of this medicine is equivalent to less than 5 ml beer or 2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

• Methyl hydroxybenzoate and propyl hydroxybenzoate

may cause allergic reactions such as skin rash; this may happen after a few days.

• The colourings Ponceau 4R (E124) and Sunset Yellow

(E110) in this medicine may cause allergic reactions.

3 How to take this medicine

Check the table that follows to see how

much medicine to take.

• For oral use only.
• Always shake the bottle thoroughly before use.
• Do not take more medicine than the label tells you to.
• Do not overfill the spoon.

There is a double-ended

spoon in the pack.

Children under 12 years

Do not give to children under 12 years.

Adults and children over 12 years

If anyone has too much

If anyone has taken too much contact a doctor or your nearest Accident and Emergency Department (Casualty)

taking this leaflet and pack with you.

If you forget to take the medicine

If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4

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hours ago. Do not take a double dose.

4 Possible side-effects

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 immediate

medical help:

• Reduced blood flow to the heart which can cause

angina (discomfort or pain in the chest, neck, back, jaw, shoulders or arms), or heart attack.

• Stroke (weakness of the face, arms or legs, or speech

problems).

• Sudden onset of fever, reddening of the skin, or many

small pustules (possible symptoms of Acute Generalized

Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with this medicine (see section 2).

• Sudden onset of severe headache, nausea, vomiting,

confusion, fits, visual disturbances.

• Swelling of the face, lips, mouth, tongue or throat which

may cause difficulty in swallowing or breathing.

• Allergic reactions including skin rashes such as hives

(which may be severe and include blistering and peeling of the skin) and itching.

• Hallucinations or paranoid delusions (seeing or hearing

things that are not there, irrational thoughts or feelings).

• Inflammation of the colon due to insufficient blood

supply (ischaemic colitis). Symptoms may include sudden abdominal pain or rectal bleeding.

If you experience any of the following, stop

using the medicine and talk to your doctor:

• Trouble passing water (especially in men with prostate

problems).

Other effects which may occur include:

Very Common (may affect more than 1 in 10

people)

• Headache

Common (may affect up to 1 in 10 people)

• Difficulty sleeping, nervousness or dizziness
• Dry mouth or nausea

Other effects which may occur but it is

unknown how often

• serious conditions affecting blood vessels in the brain

known as posterior reversible encephalopathy syndrome (PRES)

and reversible cerebral vasoconstriction syndrome (RCVS)

• Anxiety, restlessness, irritability, feeling jittery or

feelings of extreme happiness

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• A fast or irregular heartbeat or an increased awareness

of the heartbeat (palpitations)

• Sleep disturbances
• Stomach pain, diarrhoea or vomiting
• Pain when passing water
• High blood pressure
• Drowsiness
• Reduced blood flow to the optic nerve (Ischaemic optic

neuropathy)

• Tingling or numbness of hands or feet (Pins and needles)
• A tremor or shakiness

Stop using Benylin Mucus Cough plus Decongestant Syrup immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES)

and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset
• feeling sick
• vomiting
• confusion
• seizures changes in vision

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.

5 Storing this medicine

Do not store above 25ºC.

Do not refrigerate.

Keep the product out of the sight and reach of children.

Keep the container in the outer carton.

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.

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.

6 Further information

What’s in this medicine?

The active ingredients in Benylin Mucus Cough plus

Decongestant Syrup are: 100 mg Guaifenesin and 30 mg

Pseudoephedrine hydrochloride in each 5 ml spoonful.

Other ingredients are: Sucrose, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), ethanol (alcohol), Ponceau 4R (E124), flavouring (wild cherry (sodium, benzyl alcohol) and menthol), Sunset

Yellow (E110) and purified water.

What the medicine looks like

Benylin Mucus Cough plus Decongestant Syrup is a clear

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orange-red cherry flavoured liquid available in 100 ml glass bottle.

Marketing Authorisation holder: McNeil Products

Ltd, 50 - 100 Holmers Farm Way, High Wycombe,

Buckinghamshire, HP12 4EG, UK.

Manufacturer: Delpharm Orléans, 5 avenue de Concyr,

45071 Orléans, Cedex 2, France.

This leaflet was last revised in April 2024.

Benylin is a registered trade mark.

McNeil Products Limited 2024 ©