Patient leaflet - GALENPHOL LINCTUS, CARE PHOLCODINE 5 MG / 5ML ORAL SOLUTION SUGAR FREE
1. Before you use this medicine
□ Do not use the medicine if you have…
- An allergy to any of the ingredients listed in section 3.
- Liver disease Shallow breath or breathing difficulties An asthma attack Taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks Or in children under 12 years old Ever developed a severe skin rash or skin that peels, blisters and/or sores in the mouth after taking this medicine or other pholcodine-containing medicines.
ATalk to your doctor or pharmacist if you have…
- Kidney problems Liver problems A history of asthma or other breathing problems including bronchitis A cough for a long time or a cough which produces lots of phlegm.
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ADriving and using machines…
This medicine may cause drowsiness. If you are affected do not drive or operate machinery.
AImportant ingredient information
- This medicine contains 48mg of alcohol (ethanol) in each 5ml dose. The amount in 5ml of this medicine is equivalent to less than 2ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
- It also contains sodium parahydroxybenzoates and amaranth dye which may cause allergic reactions (possibly delayed).
- This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‚sodium-free‘.
2. possible side effects
Like all medicines, Care Pholcodine Oral Solution Sugar Free can have side effects, although these don’t affect everyone.
Important side effects:
If you think you have any of the following side effects or symptoms, stop using this medicine and contact or see a doctor immediately.
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For syi..ptomJic relief of dry or irritating coughs.
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Active ingredient per 5ml: pholcodine monohydrate 5mg. Also contains amongst other ingredients:
ethanol, sodium parahydroxybenzoates (E215, E217, E219), amaranth dye (E123). Alcohol 1.2 vol%.
Peel where shown for full list of ingredients.
Do not store above 25°C.
or four times a day.
Do not give more than 4 doses in 24 hours. . .
Do not give to children under 12 years old. Keep out of the sight and reach of children
Warning: Do not take more medicine than the label tells you to.
Do not take with other cough and cold medicines.
If symptoms persist consult your doctor.
Manufactured by the licence holder Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK.
PL 00240/0101
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- A history of drug abuse; pholcodine is an opioid and addiction is observed with opioids as a class.
- Serious skin reactions, including acute generalized exanthematous pustulosis (AGEP), have been reported with the use of this medicine. AGEP is a generalized, red, scaly rash with bumps under the skin and vesicles associated with fever. Most common location: mainly located on the folds of the skin, the trunk and the upper limbs. The highest risk of serious skin reactions occurrence is especially during the first week of treatment. If you develop a severe rash or any of these skin symptoms, stop taking this medicine and contact or see a doctor immediately.
ATalk to your doctor or pharmacist if you are taking…
- Medicine for high blood pressure, e.g. ACE inhibitors, beta blockers Diuretics, which help remove fluid from the body, e.g. furosemide, hydrochlorothiazide Medicines used to treat sleeplessness, anxiety and schizophrenia Alcohol or tranquillisers Pain killers, e.g. morphine
- Or are having surgery, as muscle relaxants used may react with this medicine.
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- Allergic reactions which cause difficulty in breathing, fever, swelling of the mouth, lips or skin, severe rashes and itching.
- Not known: frequency cannot be estimated from the available data – Generalized rash, red and scaly with bumps under the skin and vesicles associated with fever at the beginning of treatment (generalized acute exanthematous pustulosis).
Other possible side effects are:
- Feeling sick Constipation Dizziness
- Drowsiness Getting excited Confusion
- Being sick Rash Failure to cough up phlegm. If you notice these or any other side effects, stop use and tell your doctor or pharmacist. They will tell you what to do.
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: or search for ‚MHRA Yellow Card‘ in the Google Play or Apple App Store.
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Concomitant use of this product and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe this product together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
APregnant or breastfeeding…
Ask your doctor or pharmacist for advice before using this medicine if you are pregnant, might be pregnant or are breastfeeding.
Care Pholcodine Oral Solution Sugar Free should not be used in pregnancy unless the doctor has told you to do so. If you use it when breastfeeding, pholcodine monohydrate in this medicine will be present in small amounts in your milk.
By reporting side effects you can help provide more information on the safety of this medicine.
3. Further information
A If you accidentally take too much see a doctor straight away. Take the pack with you to show which medicine you have swallowed.
- Do not use after the expiry date. The expiry date refers to the last day of that month.
- Return any unused medicine to the pharmacy for disposal.
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