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Document: leaflet MAH BRAND_PL 20075-0516 change

• leaflet MAH BRAND_PL 16431-0055
• leaflet MAH BRAND_PL 20075-0516

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PACKAGE LEAFLET: INFORMATION FOR THE USER SOLUBLE CUPANOL-CO LEMON FLAVOUR

Codeine Phosphate and Paracetamol

Important things you should know about Soluble Cupanol-Co Lemon Flavour

•    This medicine is can only be used for the short term treatment of acute moderate pain when other painkillers have not worked

•    You should only take this product for a maximum of 3 days at a time. If you need to take it for longer than three days, you should see your doctor or pharmacist for advice

•    This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

•    If you take this medicine for headaches for more than 3 days, it can make them worse.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    If you get any side effects, talk to your doctor or pharmacist (See section 4). This includes any possible side effects not listed in this leaflet.

•    You must talk to a doctor if you do not feel better, or if you feel worse after 3 days.

The name of your medicine is Soluble Cupanol-Co Lemon Flavour. Soluble Cupanol-Co Lemon Flavour contains codeine phosphate and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other painkillers such as paracetamol. Soluble Cupanol-Co Lemon Flavour is for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine. Soluble Cupanol-Co Lemon Flavour can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

This medicine contains codeine which can cause addiction if you take it continuously for more than 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it

If you take a painkiller for headaches for more than 3 days it can make them worse

Do not take Soluble Cupanol-Co Lemon Flavour and tell your doctor if:

•    If you are allergic (hypersensitive) to the active substances or any of the ingredients of Soluble Cupanol-Co Lemon Flavour (listed in Section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue.

•    The person going to take the tablets is under 12 years of age. Soluble Cupanol-Co Lemon Flavour must not be given to children under 12 years of age.

•    You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome.

•    You know that you metabolise very rapidly codeine into morphine.

•    You are breastfeeding or planning to breastfeed

Do not take Soluble Cupanol-Co Lemon Flavour if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Soluble Cupanol-Co Lemon Flavour.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before Soluble Cupanol-Co Lemon Flavour if:

•    You have severe kidney or liver problems

•    You have a liver problem caused by alcohol

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery

Soluble Cupanol-Co Lemon Flavour should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

Soluble Cupanol-Co Lemon Flavour is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Other medicines and Soluble Cupanol-Co Lemon Flavour

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Soluble Cupanol-Co Lemon Flavour can affect the way some other medicines work.

Whilst taking Soluble Cupanol-Co Lemon Flavour you should not take any other medicines which contain paracetamol. This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Do not take this medicine and tell your doctor or pharmacist if you are taking the

following:

•    Medicines used to thin the blood such as warfarin

•    Metoclopramide or domperidone - used to stop you feeling sick {nausea) or being sick

(vomiting)

•    Colestyramine - for lowering blood cholesterol levels

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Soluble Cupanol-Co Lemon Flavour.

Pregnancy and breast-feeding

Talk to your doctor before taking these tablets if:

•    You are pregnant, think you may be pregnant or plan to get pregnant

•    You are planning to breastfeed

•    Do not take Soluble Cupanol-Co Lemon Flavour whilst you are breastfeeding. Codeine

and morphine passes into breast milk.

Driving and using machines

Soluble Cupanol-Co Lemon Flavour can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive whilst taking this medicine until you know how it affects you

•    It is an offence to drive if this medicine affects your ability to drive.

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this medicine.

Soluble Cupanol-Co Lemon Flavour contains sodium

There is 430.1 mg of sodium per effervescent tablet. The maximum recommended daily dose of this medicinal product contains 3440.8mg sodium (found in table salt). This is equivalent to 172.04% of the adult recommended maximum daily dietary intake for sodium.

Talk to your pharmacist or doctor if you need Soluble Cupanol-Co Lemon Flavour on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

Soluble Cupanol-Co Lemon Flavour with food and drink

This medicine may be taken with or without food.

Always take Soluble Cupanol-Co Lemon Flavour exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not take more than the recommended dose.

Adults

•    Do not take for more than 3 days. If the pain does not improve after 3 days, you must speak to your doctor or pharmacist

•    The usual dose of Soluble Cupanol-Co Lemon Flavour is one or two effervescent tablets, taken together

•    Dissolve the effervescent tablets in a full glass of water before taking

•    Adults should wait at least 4 hours before taking another dose

•    Do not take more than 8 tablets in any 24-hour period

Use in children

Children aged less than 12 years

•    This product is not suitable for children aged less than 12 years.

Children aged 12 years and over to 18 years

•    One tablet to be taken every four to six hours if necessary.

•    Do not exceed 4 tablets in 24 hours.

Soluble Cupanol-Co Lemon Flavour should not be given to children under 18 years of age due to the risk of severe breathing problems.

If you take more Soluble Cupanol-Co Lemon Flavour than you should

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause pallor, nausea, vomiting, anorexia (loss of appetite) and abdominal pain and delayed, serious liver damage. Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.

If you forget to take Soluble Cupanol-Co Lemon Flavour

If you forget to take a dose at the right time, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.

If you stop taking Soluble Cupanol-Co Lemon Flavour

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Important side-effects you should know about Soluble Cupanol-Co Lemon Flavour

•    Taking a painkiller for headaches too often or for too long can make them worse.

•    Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

Stop taking Soluble Cupanol-Co Lemon Flavour and see a doctor or go to a hospital straight away if:

•    You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash

(hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to Soluble Cupanol-Co Lemon Flavour

•    Serious skin reactions. Very rare cases have been reported.

•    Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas {pancreatitis}. This is a very rare side effect

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts

longer than a few days:

•    Constipation

•    Feeling sick {nausea), being sick {vomiting)

•    Dizziness, light-headedness, drowsiness, confusion

•    Difficulty in passing water

•    You get infections or bruise more easily than usual. This could be because of a blood problem {such as agranulocytosis, neutropenia or thrombocytopenia)

•    Becoming addicted to codeine

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 do I know if I am addicted?

If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:

•    You need to take the medicine for longer periods of time

•    You need to take more than the recommended dose

•    When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after expiry date which is stated on the label, blister and carton after EXP. The expiry date refers to last day of that month.

•    Store your medicine in the original packaging in order to protect from moisture.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Soluble Cupanol-Co Lemon Flavour contains:

•    The active substances are codeine phosphate and paracetamol. Each effervescent tablet contains 8mg of codeine phosphate and 500mg of paracetamol.

•    The other ingredients are Sodium Bicarbonate, Sodium Carbonate (Anhydrous) Sodium Cyclamate 1968 Sodium Saccharin, Citric Acid Anhydrous Polyethylene Glycol Powder 6000 Povidone, Lemon F-O-L 610406E.

What Soluble Cupanol-Co Lemon Flavour looks like and content of the pack:

Soluble Cupanol-Co Lemon Flavour are white to off white round, flat, beveled edged plain on both sides.

Soluble Cupanol-Co Lemon Flavour come in Cartoned strip packs containing 10, 12, 16, 24, 30, 50, 56, 60,100 or 112 tablets

‘Not all pack sizes may be marketed’.

Marketing Authorisation Holder:

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, U K.

Manufacturer

Cupal Ltd King Street, Blackburn, Lancashire, BB2 2DX The leaflet was last revised in 11/2016.

GSL