البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pramipexole dihydrochloride monohydrate
Consilient Health Ltd
N04BC05
Pramipexole dihydrochloride monohydrate
180microgram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 5391512451219 5391512451271
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OPRYMEA 0.088 MG TABLETS OPRYMEA 0.18 MG TABLETS OPRYMEA 0.35 MG TABLETS OPRYMEA 0.7 MG TABLETS OPRYMEA 1.1 MG TABLETS Pramipexole 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 Oprymea is and what it is used for 2. What you need to know before you take Oprymea 3. How to take Oprymea 4. Possible side effects 5. How to store Oprymea 6. Contents of the pack and other information 1. WHAT OPRYMEA IS AND WHAT IT IS USED FOR Oprymea contains the active substance pramipexole and belongs to a group of medicines known as dopamine agonists which stimulate dopamine receptors in the brain. Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements. Oprymea is used to treat the symptoms of primary Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine for Parkinson’s disease). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OPRYMEA DO NOT TAKE OPRYMEA: - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Oprymea. Tell your doctor if you have or have had or develop any medical conditions or symptoms, especially any of the following: - Kidney disease. - Hallucinations (seeing, hearing or feeling things that are not there). Most hallucinations are visual. - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs). If you have advanced Parkinson’s disea اقرأ الوثيقة كاملة
OBJECT 1 OPRYMEA 0.18MG TABLETS Summary of Product Characteristics Updated 20-May-2016 | Consilient Health Ltd • 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 Oprymea 0.18 mg tablets 2. Qualitative and quantitative composition Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate). _Please note:_ Pramipexole doses as published in the literature refer to the salt form. Therefore, doses will be expressed in terms of both pramipexole base and pramipexole salt (in brackets). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. White, oval, with bevelled edges, both sides scored, with imprint "P7" on both halves of one side of the tablet. The tablet can be divided into equal halves. 4. Clinical particulars 4.1 Therapeutic indications Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of t اقرأ الوثيقة كاملة