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 Guaifenesin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Benylin Children's Chesty Coughs is a medicine which is used to help relieve chesty coughs in children. It contains guaifenesin (an expectorant) to help loosen mucus (phlegm) from the lungs and make it easier to cough up. The medicine is for use in children aged 6-12 years.
ing this medicine to your child This medicine is suitable for most children but a few children should not use it. If you are in any doubt, talk to your doctor or pharmacist.
Do not use this medicine… ■ If your child has ever had a bad reaction to this
product or any of the ingredients. See section 6 for full list of ingredients. ■ If your child is taking any other cough and cold medicine. ■ If your child is aged under 6 years. If any of these apply, get advice from a doctor or pharmacist without using Benylin Children's Chesty Coughs.
Talk to your doctor or pharmacist… ■ If your child suffers from liver or kidney
problems. ■ If your child has a persistent cough such as occurs with asthma, has asthma, is suffering from an asthma attack or a cough that produces a lot of mucus (phlegm). If any of these apply now or in the past, talk to a doctor or pharmacist.
If you are pregnant or breast-feeding
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. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. ■ This medicinal product contains 33.04 mg sodium per 10 ml, equivalent to 1.65% of the WHO recommended maximum daily intake of 2 g sodium for an adult. ■ This medicine contains 25.2 mg benzoate salt in each 10 ml. ■ This medicine contains 0.1 mg benzyl alcohol in each 10 ml. Benzyl alcohol may cause allergic reactions. Ask your 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 Check the table below to see how much medicine to take. ■ For oral use only.
■ Do not give more than the stated dose shown below.
Children under 6 years old This medicine is not recommended for children under 6 years old.
The following advice is included in case an older child or adult is taking the medicine. ■ If you are pregnant or breast-feeding, only use this medicine on the advice of your doctor.
Some of the ingredients can cause problems ■ This medicine contains 5.05 g sorbitol in each
10 ml. 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
turn over
Children 6 – 12 years Age
Dose
Children 6 – 12 years
Two 5 ml spoonfuls four times a day.
■ Do not give more than 4 doses in 24 hours. ■ If symptoms persist or worsen, talk to your
doctor or pharmacist. ■ Do not give to a child under 12 years of age for more than 5 days without consulting your doctor. ■ If your child's cough comes back or is accompanied by a high temperature, rash or a headache that does not go away, stop using this medicine and talk to your doctor or pharmacist.
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 give the medicine You should only give this medicine as required following the dosage instructions above carefully. If you forget to give a dose, give the next dose when needed. Do not give a double dose.
4 Possible side-effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them. If your child experiences any of the following stop using the medicine and seek immediate help: ■ Allergic reactions including skin rashes (which may be severe and include blistering and peeling), hives and itching. Other effects that may occur include: ■ Stomach pain or discomfort, diarrhoea, vomiting and nausea. Reporting of side-effects If your child experiences 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
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.
this medicine Do not store this product above 25oC. Discard the bottle 4 months after opening, even if there is syrup remaining. Store in the original package. Keep the product out of the sight and reach of children. Do not use after the end of the month shown as an expiry date on the packaging. 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.
What's in this medicine? The active ingredient in 5 ml of Benylin Children's Chesty Coughs is: 50 mg Guaifenesin. Other ingredients are: Glycerol, sorbitol liquid (E420), carmellose sodium, sodium citrate, sodium saccharin, sodium benzoate (E211), citric acid monohydrate, strawberry flavour (containing benzyl alcohol) and water.
This leaflet was last revised in August 2022. Benylin is a registered trade mark.
7 Information about treating cough and cold in children It's normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Most colds get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Because colds are caused by viruses, not bacteria, antibiotics don't help. Here are simple steps to help your child who has a cough or cold. ■ If they are hot/feverish: Increase the amount of fluid
your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children. (Paracetamol is not for children under 2 months. Ibuprofen is not for children under 3 months.)
■ For coughs: Although it is distressing to hear your
child cough, in fact coughing serves a purpose. It helps clear phlegm on the chest and mucus from the nose. Give the child plenty of warm clear fluids to drink.
■ To help with breathing: Plain saline nose drops,
available from your pharmacy, can help babies with blocked noses who are having trouble feeding.
McNeil Products Limited 2022 ©
What the medicine looks like Benylin Children's Chesty Coughs is a clear colourless syrup, available in 125 ml, glass bottles. Product Licence holder: McNeil Products Ltd, High Wycombe, Buckinghamshire, HP12 4EG, UK. Manufacturer: Delpharm Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.
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The active substance in Benylin Children's Chesty Coughs is guaifenesin.
Medicines with the same active substance, strength and form include: Robitussin Chesty Cough Medicine. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Benylin Children's Chesty Coughs, 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.
BENYLIN Children's Chesty Coughs is an expectorant for the symptomatic relief of acute productive (chesty) coughs.
Posology
Adults and children aged 12 years and over:
Not applicable.
Children aged 6 to 12 years:
10 ml syrup four times daily.
Maximum daily dose: 40 ml syrup (400 mg guaifenesin)
Not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child's condition deteriorates during treatment.
Children under 6 years:
Benylin Children's Chesty Coughs is contraindicated in children under the age of 6 years (see section 4.3).
Method of administration
For oral use
Do not exceed the stated dose.
Keep out of the sight and reach of children.
BENYLIN Children's Chesty Coughs is contraindicated in individuals with known hypersensitivity to the product, or any of its components.
Not to be used in children under the age of 6 years.
Ask a doctor before use if your child suffers from chronic cough, if he/she has asthma or is suffering from an acute asthma attack.
Stop use and ask a healthcare professional if your child's cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache.
Do not give with a cough suppressant.
Caution should be exercised in the presence of severe renal or severe hepatic impairment.
Not more than 4 doses should be given in any 24 hours.
Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
This medicine contains 5.05g sorbitol in each 10 ml dose.
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 hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
This medicinal product contains 33.04 mg sodium per 10 ml dose, equivalent to 1.65% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicine contains 25.2 mg benzoate salt in each 10 ml dose.
This medicine contains 0.1 mg benzyl alcohol in each 10 ml dose. Benzyl alcohol may cause allergic reactions. This medicine must be used with caution in patients with renal or hepatic impairment, or in patients who are pregnant or breast-feeding, because of the risk of accumulation and toxicity (metabolic acidosis).
If urine is collected within 24 hours of a dose of BENYLIN Children's Chesty Coughs a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
This product has been formulated specifically for children, and would therefore not normally be taken during 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 Children's Chesty Coughs is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
Guaifenesin is excreted in breast milk in small amounts. There is insufficient information on the effects of Guaifenesin in breastfed newborns/infants. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from BENYLIN Children's Chesty Coughs 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.
Guaifenesin has no or negligible influence on the ability to drive or operate machinery.
The safety of guaifenesin is based on available data from clinical trials and adverse drug reactions (ADRs) identified during post-marketing experience.
The frequencies are provided according to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000
Not known (cannot be estimated from the available data)
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.
Adverse Drug Reactions Identified during Clinical Trials, Epidemiology studies and Post-Marketing Experience with Guaifenesin. Frequency Category estimated from Clinical Trials or Epidemiology Studies
Body system (SOC)
Incidence
Adverse Event Preferred Term
Immune system disorders
Not known
Hypersensitivity reactions (hypersensitivity, pruritus and urticaria)
Rash
Gastrointestinal disorders
Not known
Abdominal pain upper
Diarrhoea
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.
Symptoms
The effects of acute toxicity from guaifenesin may include gastrointestinal discomfort, nausea and drowsiness. When taken in excess, guaifenesin may cause renal calculi.
Management
Treatment should be symptomatic and supportive.
Ask anything about Benylin Children’s Chesty Coughs. 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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