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Boots Chesty Cough & Congestion Relief Oral Solution

Document: leaflet ALMUS PHARMACEUTICALS_PL 00014-0555 change

Leaflet for Almus Chesty Cough Linctus with Decongestant (Yellow card update May 2015)

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Information for the user

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Chesty Cough Linctus with Decongestant (Guaifenesin, Pseudoephedrine Hydrochloride)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Pseudoephedrine, a decongestant, which acts to relieve a blocked nose. It also contains Guaifenesin, an expectorant, which acts to loosen and relieve phlegm on the chest.

It can be used to relieve the symptoms of a chesty cough, catarrh and a blocked nose without causing drowsiness.

For children, simple treatments should be tried first before you give this medicine. Further information on “Treating coughs and colds in children” is provided at the end of this leaflet.

Before you take this medicine

This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

X Do not take:

•    If you are allergic to any of the ingredients in this medicine (see "What is in this medicine”)

•    If you are allergic to other decongestants

•    If you have severe kidney problems

•    If you have heart or blood vessel disease, including poor circulation in your hands or feet

•    If you have high blood pressure (including that due to a tumour near your kidney)

•    If you have diabetes

•    If you have an overactive thyroid

•    If you have raised pressure in the eye (glaucoma)

•    If you are taking any of these medicines:

-    Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them in the last 14 days

-    Medicines called beta-blockers (normally for heart problems)

-    Other decongestants

-    Other medicines to stop you coughing

•    If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose)

•    If you are a man with prostate problems

•    If you are pregnant ! Talk to your doctor:

•    If you have a long-term cough or asthma (do not take this medicine if you are wheezing or if you are having an asthma attack)

! Talk to your pharmacist or doctor:

•    If you have other kidney problems (see "Do not take”)

•    If you also have a fever, rash or constant headache

•    If you are breastfeeding

Other important information

This medicine may interfere with the results of some urine tests. If you are having any urine tests, tell the doctor or hospital staff that you are taking this medicine.

Information about some of the ingredients in this medicine: The colour carmoisine (E122) in this medicine may cause allergic reactions.

If you take other medicines

Before you take this medicine make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Medicines to treat high blood pressure

•    Medicines for heart problems (e.g. digoxin)

•    Medicines which may cause a dry mouth (e.g. tricyclic antidepressants), medicines to reduce your appetite or stimulant medicines

•    Ergot alkaloids (for migraine)

•    Oxytocin (to induce labour and stop excessive bleeding after the birth)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

S How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Age

How much to take

How often to take

Adults and children of 12 years and over

Two 5 ml spoonfuls

4 times a day

Children of 6 to 11 years

One 5 ml spoonful

3 times a day

This medicine should be swallowed.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

Do not give this medicine to a child for more than 5 days, unless their doctor tells you to.

If you are treating a child and their symptoms worsen at any time, talk to a pharmacist or doctor.

If a cough lasts for more than 5 days, or comes back, stop taking this medicine and talk to a pharmacist or doctor.

If symptoms do not go away, talk to your doctor.

! If you take too much: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

! If you get any of these serious side effects, stop taking the medicine. See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

! If you get any of the following side effects see your pharmacist or doctor:

•    Hallucinations

•    Restlessness

•    Sleep disturbances

These other effects are less serious. If they bother you talk to a pharmacist:

•    Other allergic reactions such as skin rash

•    Feeling sick, being sick, stomach discomfort

•    Anxiety, feelings of paranoia, irritability, feeling excited or confused, difficulty sleeping

•    Tremors, headache, dizziness

•    Fast, slow or irregular heart beat, palpitations

•    High blood pressure

•    Difficulty in passing urine

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

How to store this medicine

Do not store above 30°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the bottle label or on the end flap of the carton. After this date return any unused product to your nearest pharmacy for safe disposal.

What is in this medicine

Each 5 ml of oral solution contains Guaifenesin 100 mg, Pseudoephedrine Hydrochloride 30 mg, which are the active ingredients.

As well as the active ingredients, the solution also contains purified water, liquid sugar (sucrose), glycerol (E422), citric acid, sodium citrate, hyetellose, potassium sorbate (E202), acesulfame potassium, carmoisine (E122), patent V (E131), flavours (strawberry, blackcurrant, menthol, cream).

The pack contains 120 ml of purple, strawberry flavoured syrup.

Who makes this medicine

MA Holder: BCM, Nottingham, NG2 3AA Manufacturer: BCM Ltd, Nottingham, NG2 3AA Leaflet prepared May 2015

Almus® is a registered trademark

Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1.    If your child is hot or has a fever: Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.

2.    For coughs: Although it may be distressing to hear your child cough, the coughing itself serves an important purpose. It helps to clear phlegm on the chest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may help loosen the phlegm and relax the airways.

3.    To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.

Bar code Item code Component code

PACK MOCK UP BOX

Product Name: Almus Chesty Cough Linctus with Decongestant

Product Licence No: 00014/0555

Reason for change: Addition of the Yellow Card warning

Status: Almus Internally Approved

Date: 20 May 2015

Pack Details: Leaflet

Wording Reference: A4 text as not currently marketed.