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BENYLIN CHILDRENS CHESTY COUGHS, CALCOUGH SIXPLUS - patient leaflet, side effects, dosage

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Patient leaflet - BENYLIN CHILDRENS CHESTY COUGHS, CALCOUGH SIXPLUS

Now read this whole leaflet carefully before you use this medicine.

Keep the leaflet: you might need it again.

1 what the medicine is and what it is used for

CalCough Six Plus 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.

2 what you need to know before giving 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.

X Do not use this medicine…

  • ■ If your child has ever had a bad reaction to this product or any of the ingredients.

  • ■ If your child is taking any other cough and cold medicine.

  • ■ If your child is under 6 years old.

If any of these apply, get advice from a doctor or pharmacist without using CalCough Six Plus.

! 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 your doctor or pharmacist.

!If you are pregnant or breast-feeding

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 sorbitol liquid. This should be taken into account in patients with an intolerance to some sugars.

  • ■ This medicine may have a laxative effect and has a calorific value of 13.2 kcal per 10 ml dose.

  • ■ This medicine contains 14.94 mg sodium per 10 ml dose. To be taken into consideration by patients on a controlled sodium diet.

3 how to use 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.

There is a single-ended spoon in this pack.

i Children under 6 years old

This medicine is not recommended for children under 6 years old.

i Children 6 – 12 years

Age

Dose

Children 6–12 years

Two 5ml 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 taken 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 of the skin) 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, or 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

The following details are applicable for Malta:

ADR Reporting

The Medicines Authority

Post-Licensing Directorate

203 Level 3, Rue D'Argens

GZR-1368 Gzira

Website:

e-mail:

By reporting side effects, you can help provide more information on the safety of this medicine.

5 how to store this medicine

Do not store this product above 25°C.

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.

6 contents of the pack and other information

What’s in this medicine?

The active ingredient in 5 ml of CalCough Six Plus 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 and water.

What the medicine looks like

CalCough Six Plus is a clear colourless syrup, available in 125 ml glass bottles.

Marketing Authorisation holder: McNeil Products Ltd, High Wycombe, Buckinghamshire, HP12 4EG, UK.

Manufacturer: Delpharm Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised September 2020.

CalCough 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.