Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Propiverine hydrochloride
Consilient Health Ltd
G04BD06
Propiverine hydrochloride
15mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040200; GTIN: 5060064170359
(Propiverine hydrochloride) Detrunorm ® 15 mg Coated Tablets Package leaflet: information for the patient 200552/LF/2 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 leaflet provides a summary of the information available on your medicine. - This medicine has been prescribed for you, do not pass it on to others, it may harm them, even if their symptoms 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. IN THIS LEAFLET: 1. What detrunorm 15 mg coated tablets are and what they are used for 2. What you need to know before you take Detrunorm 15 mg Coated Tablets 3. How to take Detrunorm 15 mg Coated Tablets 4. Possible Side Effects 5. How to store Detrunorm 15 mg Coated Tablets 6. Contents of the pack and other information 1. WHAT DETRUNORM 15 MG COATED TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Detrunorm 15 mg Coated Tablets (to be referred to as Detrunorm throughout the leaflet). Detrunorm is used for the treatment of people who have difficulty in controlling their bladders due to bladder overactivity or, in some cases, problems with the spinal cord. Detrunorm contains the active substance propiverine hydrochloride. This substance prevents the bladder from contracting and increases the amount that the bladder can hold. Detrunorm is used to treat the symptoms of overactive bladder. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETRUNORM 15 MG COATED TABLETS DO NOT TAKE DETRUNORM IF: • You are allergic (hypersensitive) to propiverine hydrochloride or any of the other ingredients of Detrunorm listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in Preberite celoten dokument
OBJECT 1 DETRUNORM 15 MG TABLETS Summary of Product Characteristics Updated 03-Dec-2018 | ADVANZ Pharma • 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 Detrunorm ® 15 mg Coated Tablets Propiverine Hydrochloride 15mg Coated Tablets 2. Qualitative and quantitative composition Each coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg propiverine. Excipients with known effect: Lactose monohydrate (63.4 mg/ tablet) Sucrose (49.0 mg/ tablet) Glucose monohydrate (0.6 mg/ tablet) Cochineal red A (E124, lake) (0.2 mg/ tablet) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Coated tablets Rose-coloured, lenticular glazing coated tablets. 4. Clinical particulars 4.1 Therapeutic indications Detrunorm 15 mg Coated Tablets are indicated in adults for the symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor Preberite celoten dokument