Document: label-leaflet SUPERDRUG_PL 03105-0059 change

• label-leaflet MAH GENERIC_PL 00014-5718R
• label-leaflet MAH GENERIC_PL 03105-0059
• label-leaflet MAH GENERIC_PL 03105-0060
• label-leaflet MAH GENERIC_PL 04917-0002
• label-leaflet MANOR DRUG COMPANY_PL 03105-0059
• label-leaflet NUMARK_PL 03105-0059
• label-leaflet NUMARK_PL 04917-0002
• label-leaflet SUPERDRUG_PL 03105-0059
• label-leaflet THORNTON & ROSS_PL 12965-0030
• leaflet MAH GENERIC_PL 04917-0005

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About this Product

Superdrug Pholcodine Linctus BP is taken to relieve unproductive coughs.

Dosage

Liquid for oral use. Read the entire carton before use. Adults and children over 12 years: Take one or two 5ml spoonfuls (5 to 10ml) three to four times per day.

Children from 6-12 years: Take half to one 5ml spoonful (2.5 to 5ml) three to four times per day.

Do not take more than 4 doses In 24 hours. Not to be used for more than 5 days without the advice of a doctor. Medical attention should be sought if the child’s condition deteriorates during treatment.

Do not give to children under 6 years.

Do not take with any other cough and cold medicine.

| Do not exceed the stated dose    |

Warnings

Do not use this medicine If you:

■    Are allergic to any of the ingredients.

•    Have liver disease

•    Have difficulty breathing, chronic lung conditions or a chest infection that produces lots of phlegm in the chest.

•    Have an asthma attack

•    Are taking MAOI’s (monoamine oxidase inhibitors) for depression or within 14 days of stopping.

•    If you are pregnant or breast-feeding unless your doctor has told you to do so. If used when breast-feeding small amounts of the medicine will be present in your milk.

Talk to your doctor before using this medicine If you:

•    Have kidney or liver problems.

■    Have a history of asthma or any other breathing problems including bronchitis

•    Have had a cough for a long time or a cough that produces lots of phlegm.

■    Have a history of drug abuse.

Talk to your doctor or pharmacist before use if you are taking:

•    Medicines used to treat high blood pressure e.g. ACE inhibitors, beta blockers.

•    Diuretics used to remove water from the body e.g. furosemide.

•    Medicines used to treat sleepiness, anxiety and schizophrenia, e.g. citalopram or haloperidol.

•    Medicines used to treat epilepsy e.g. sodium valporate.

•    Medicines to treat sickness e.g. domperidone or metoclopramide.

•    Medicines for cardiac rhythm disorders e.g. mexiletine.

•    Medicines to treat reflux e.g. cisapride.

•    Alcohol or tranquillisers

■    Strong painkillers e.g. morphine

•    Or if you are having surgery, as muscle relaxants e.g. succinylcholine, may interact with this medicine.

Caution: This medicine may cause drowsiness, If affected do not drive or operate machinery.

Further warnings

If you have an intolerance to some sugars, contact your doctor before using this medicinal product. Contains 8g of sucrose per 10ml.

This should be taken into account in patients with diabetes mellitus. This medicinal product contains 6.6 voi% ethanol (alcohol), i.e. up to 526mg per 10ml, equivalent to 13.3ml of beer or 5.5ml of wine per 10ml. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease or epilepsy. Contains E123 and E110 - may cause allergic reactions.

Contains E219 - may cause allergic reactions (possibly delayed). The use of pholcodine with alcohol or other CNS depressants may increase the effects on the CNS and cause toxicity in relatively small doses.

Possible Side Effects

Side effects can include:

•    Allergic reactions that cause swelling of the mouth, lips, skin, and rashes.

•    Feeling excited or confused.

■ Occasional drowsiness or dizziness.

•    Feeling or being sick and constipation

•    Failure to cough up phlegm

•    Difficulty breathing (in overdose).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this carton. 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.

Full Ingredients list

Pholcodine 5mg per 5ml, Sucrose, Ethanol, Glycerol E422, Citric Acid E330, Amaranth E123, Sunset Yellow E110, Sodium Methylhydroxybenzoate E219, Quinoline Yellow E104 and Purified Water.

Storage

Keep out of the sight and reach of children. Do not store above 25"C. Protect from light.

Produced for Superdrug Stores pic Admail 838, Croydon, U.K. CR9 4WZ Manufacturer and Product Licence holder: Bell, Sons & Co. (Druggists) Ltd., Southport PR9 9AL, England PL 03105/0059

Active Ingredients

Pholcodine 5mg per 5ml

Also contains: Sucrose, Ethanol, E123, E219 and E110 (See further warnings section)

About This Product

Superdrug Pholcodine Linctus BP is taken to relieve unproductive coughs.

Dosage

Liquid for oral use. Read the entire carton before use. Adults and children over 12 years: Take one or two 5ml spoonfuls (5 to 10ml) three to four times per day. Children from 6-12 years: Take half to one 5ml spoonful (2.5 to 5ml) three to four times per day.

Do not take more than 4 doses in 24 hours.

Not to be used for more than 5 days without the advice of a doctor. Medical attention should be sought if the child's condition deteriorates during treatment.

Do not give to children under 6 years.

Do not take with any other cough and cold medicine.

| Do not exceed the stated dose.    |

Warnings

Produced for Superdrug Stores pic. Admail 838, Croydon, U.K.

CR9 4WZ

Manufacturer and Product

Licence holder: Bell, Sons & Co (Druggists) Ltd.,

Southport, PR9 9AL, England.

PL03105/0059 C71-0008 Ver B. Revised 11/2015