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Package leaflet: Information for the user PHOLCODINE LINCTUS BP Pholcodine BP 5 mg /5 ml
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicince exactly as described in this in this leaflet or as your doctor or pharmacist or nurse have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 5 days..
What is in this leaflet :
- What Pholcodine Linctus is and what it is used for
- What you need to know before you take Pholcodine Linctus
- How to take Pholcodine Linctus
- Possible side effects
- How to store Pholcodine Linctus
- Contents of the pack and other information 1. What Pholcodine Linctus is and what it is used for
Pholcodine Linctus 5 mg/5 ml is a medicine which helps you to stop coughing, especially if you have a dry non-productive cough. It is related to morphine and codeine, and it acts to stop your automatic cough response.
2. What you need to know before you take Pholcodine Linctus
It's normal for children to get 8 or more colds in a year. 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.
1. 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. 2. For coughs: Coughing serves a purpose, it helps clear phlegm and mucus. Give the child plenty of warm clear fluids to drink. 3.To help with breathing: Plain saline nose drops/sprays can help with blocked noses.
Do not take Pholcodine Linctus if you have:
- an allergy ( hypersensitivity) to pholcodine or any of the other ingredients of Pholcodine Linctus (see Section 6 and end of Section 2.) - liver disease.
- breathing problems, chronic bronchitis, COPD or an obstruction in your lungs. - taken/given any other cough and cold medicine. - ever developed a severe skin rash or skin that peels, blisters and / or sores in the mouth after taking pholcodine. Children under 6 years should not be given this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Pholcodine Linctus
Take special care with Pholcodine Linctus and talk to your doctor or pharmacist if you have/are: asthma. kidney problems. a persistent cough. a cough with excessive secretions. pregnant or breast-feeding. liver problems.
Take care if giving Pholcodine Linctus to the elderly or to children. Supervision of these patients is advisable.
Serious skin reactions, including acute generalized exanthematous pustulosis (AGEP), have been reported with the use of pholcodine. 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.
Consult a doctor before use if you have a history of drug abuse; pholcodine is an opioid and addiction is observed with opioids as a class.
Other medicines and Pholcodine Linctus Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially the following:
- anti-depressants known as monoamine-oxidase inhibitors (MAOIs). Pholcodine should NOT be taken at the same time as or within 14 days of stopping MAOIs
- antihypertensives (for reducing blood pressure)
- water tablets (diuretics)
- medicines for mood disorders such as phenothiazines and tricyclic antidepressants
- CNS depressants e.g. hypnotics (sleeping tablets), tranquillisers, opioid analgesics (drugs for severe pain)
- neuromuscular blocking agents (anaesthetics used during surgery) You must not consume alcohol while taking this medicine as this may increase drowsiness.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine if think you may be pregnant or are planning to have a baby, or if you are breast-feeding. Regular or prolonged use of Pholcodine Linctus during pregnancy or breast-feeding may affect your baby, so follow the advice of your doctor or pharmacist.
Driving and using machines Pholcodine Linctus may cause drowsiness. Do not drive or operate machinery until you know how the medicine will affect you.
Important information about some of the ingredients of Pholcodine Linctus Pholcodine Linctus contains:
- slow or shallow breathing
- difficulty in coughing up mucus or saliva
- excitation, confusion.
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). If you develop these symptoms stop using this medicine and contact or see a doctor immediately.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pholcodine Linctus Keep out of sight and reach of children. Do not use Pholcodine Linctus after the expiry date which is stated on the label. The expiry date refers to the last day of that month. Do not store above 25o^ C. Store in the original container. 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 Pholcodine Linctus contains:
•The active substance is Pholcodine BP 5 mg/5 ml. •The other ingredients are citric acid monohydrate, saccharin sodium, propylene glycol, sodium benzoate (E211) , carboxymethylcellulose, sunset yellow (E110 ), sorbitol (E420) and purified water. See end of Section 2.
What Pholcodine Linctus looks like and contents of the pack Pholcodine Linctus is a clear orange viscous syrup, available in 2000ml or 1000ml plastic (HDPE) bottles, or in 200 ml, 125 ml and 100 ml amber glass bottles.
Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL 04917/
Text Revised May 2020
