Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acetylcysteine
Colonis Pharma Ltd
R05CB01
Acetylcysteine
200mg
Powder for oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000; GTIN: 5060380960078
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, pharmacist or nurse. ■ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ■ If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Acetylcysteine 200 mg Powder is and what it is used for 2. What you need to know before you take Acetylcysteine 200 mg Powder 3. How to take Acetylcysteine 200 mg Powder 4. Possible side effects 5. How to store Acetylcysteine 200 mg Powder 6. Contents of the pack and other information 1. What Acetylcysteine 200 mg Powder is and what it is used for This medicine is called Acetylcysteine 200 mg Powder for Oral Solution (referred to as Acetylcysteine 200 mg Powder throughout this leaflet). Each sachet contains the active substance acetylcysteine. Acetylcysteine belongs to a group of medicines called mucolytics which work by thinning the mucus (phlegm) so that it can be coughed up more easily. Acetylcysteine 200 mg Powder is used to treat: ■ breathing difficulties caused by too much mucus in the lungs and airways or the mucus being too thick and sticky to cough up easily. 2. What you need to know before you take Acetylcysteine 200 mg Powder DO NOT TAKE ACETYLCYSTEINE 200 MG POWDER: ■ if you are allergic (hypersensitive) to acetylcysteine, other similar medicines (such as carbocisteine, erdosteine or mecysteine), or any of the other ingredients of this medicine (listed in section 6). ■ if you have a genetic condition called phenylketonuria where you are unable to break down a substance called phenylalanine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Acetylcysteine 200 mg Powder: ■ if you suffer Διαβάστε το πλήρες έγγραφο
OBJECT 1 ACETYLCYSTEINE 200MG POWDER FOR ORAL SOLUTION Summary of Product Characteristics Updated 14-Mar-2017 | Colonis Pharma Ltd 1. Name of the medicinal product Acetylcysteine 200 mg Powder for Oral Solution 2. Qualitative and quantitative composition Each sachet contains Acetylcysteine 200 mg. Excipient(s) with known effect: aspartame (E95l): 26 mg per sachet sorbitol (E420): 723.34 mg per sachet sunset yellow (El 10): 0.66 mg per sachet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Powder for oral solution. White to slightly pink powder. 4. Clinical particulars 4.1 Therapeutic indications Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion. 4.2 Posology and method of administration POSOLOGY Adults and adolescents over the age of 12 years 200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day. The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor treating the patient for adults and adolescents. Abundant fluid intake supports the mucolytic effect of acetylcysteine. METHOD OF ADMINISTRATION Dissolve the contents of one sachet completely in a glass containing a little water just before use, stirring as needed with a teaspoon. 4.3 Contraindications Acetylcysteine 200 mg Powder for Oral Solution must not be used when: • Hypersensitivity to the active substance, other chemically similar substance (for example carbocisteine, erdosteine or mecysteine) or to any of the excipients listed in section 6.1, is present • Phenylketonuria is present, as the product contains aspartame. 4.4 Special warnings and precautions for use Patients with bronchial asthma should be closely monitored during therapy; if' bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately. Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, inc Διαβάστε το πλήρες έγγραφο