Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Piracetam
UCB Pharma Ltd
N06BX03
Piracetam
1.2gram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090300; GTIN: 5024091120978
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NOOTROPIL ® 1200 MG FILM-COATED TABLETS PIRACETAM 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. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nootropil Tablets are and what they are used for 2. What you need to know before you take Nootropil Tablets 3. How to take Nootropil Tablets 4. Possible side effects 5. How to store Nootropil Tablets 6. Contents of the pack and other information. 1. WHAT NOOTROPIL TABLETS ARE AND WHAT THEY ARE USED FOR Nootropil Tablets belongs to a group of medicines known as GABA analogues. Nootropil Tablets contains the active ingredient Piracetam. It acts on the brain and nervous system and is thought to protect it against a shortness of oxygen. Nootropil Tablets are used in combination with other medicines to treat myoclonus. This is a condition in which the nervous system causes muscles, particularly in the arms and legs, to start to jerk or twitch uncontrollably. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOOTROPIL TABLETS DO NOT TAKE NOOTROPIL TABLETS • if you are allergic to piracetam or any of the other ingredients of this medicine (listed in section 6). • if you have ever had serious kidney problems • if you have ever experienced a brain haemorrhage • if you suffer from Huntington‘s Disease (also known as Huntington‘s Chorea) IF ANY OF THE ABOVE APPLIES TO YOU, DO NOT TAKE NOOTROPIL TABLETS AND TALK TO YOUR DOCTOR OR PHARMACIST. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Nootropil Tablets • if you think your Preberite celoten dokument
OBJECT 1 NOOTROPIL TABLETS 1200 MG Summary of Product Characteristics Updated 30-May-2022 | UCB Pharma Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Nootropil 1200 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 1200mg of piracetam For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets for oral administration. 4. Clinical particulars 4.1 Therapeutic indications Nootropil is indicated in adult patients suffering from myoclonus of cortical origin, irrespective of aetiology, and should be used in combination with other anti-myoclonic therapies. 4.2 Posology and method of administration Posology The daily dosage should begin at 7.2 g increasing by 4.8 g every three to four days up to a maximum of 24 g, divided in two or three doses. Treatment with other anti-myoclonic medicinal products should be maintained at the same dosage. Depending on the clinical benefit obtained, the do Preberite celoten dokument