Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pholcodine
Pinewood Healthcare
R05DA08
Pholcodine
1mg/1ml
Oral solution
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 03090100; GTIN: 5099186000244 5099186001272
148 148 210 210 PATIENT INFORMATION LEAFLET PHOLCODINE LINCTUS BP Pholcodine BP 5 mg/5 ml Read all of this leaflet carefully because it contains important information for you. This medicine is available from your pharmacy without prescription, however, you still need to take Pholcodine Linctus 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. - You must contact a doctor if your symptoms worsen or do not improve after a few days. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Pholcodine Linctus is and what it is used for 2. Before you take Pholcodine Linctus 3. How to take Pholcodine Linctus 4. Possible side effects 5. How to store Pholcodine Linctus 6. Further 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. 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 mucous. 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 probl Read the complete document
OBJECT 1 PHOLCODINE LINCTUS BP Summary of Product Characteristics Updated 27-Jul-2015 | Pinewood Healthcare 1. Name of the medicinal product Pholcodine Linctus BP 2. Qualitative and quantitative composition Each 5 ml contains Pholcodine BP 5 mg For a full list of excipients, see section 6.1 3. Pharmaceutical form Clear orange viscous syrup 4. Clinical particulars 4.1 Therapeutic indications Adults: Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection Children of 6-12 years of age: Cough suppressant for relief of acute non-productive cough associated with upper respiratory tract infection. 4.2 Posology and method of administration Adults: 10 ml up to six times daily. Dosage should be reduced in elderly or debilitated patients. Children 6-12 years: 5 ml up to four times daily Pholcodine is contraindicated in children under the age of 6 years (see section 4.3) Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment Do not exceed the stated dose Keep out of the reach and sight of children 4.3 Contraindications Pholcodine should not be given to subjects in or at risk of developing respiratory failure as the sedative properties of pholcodine may exacerbate the condition. Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5). Patients with hypersensitivity or idiosyncratic response to pholcodine or to any of the excipients. Patients with liver disease since pholcodine is metabolised in the liver and the drug may accumulate. Not to be used in children under the age of 6 years. 4.4 Special warnings and precautions for use 1. Should be used with caution by patients with liver or renal impairment 2. Ask a doctor before use if you suffer from a chronic or persistent Read the complete document