Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Milpharm Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 08901175040704
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 Loperamide is and what it is used for 2. What you need to know before you take Loperamide 3. How to take Loperamide 4. Possible side effects 5. How to store Loperamide 6. Contents of the pack and other information 1. WHAT LOPERAMIDE IS AND WHAT IT IS USED FOR This medicine contains Loperamide which helps to stop diarrhoea by making the stools more solid and less frequent. This medicine is used for the treatment of sudden short-lived (acute) attacks of diarrhoea in adults and children over 12 years of age. PLEASE NOTE THAT THIS MEDICINE ONLY RELIEVES THE SYMPTOMS OF DIARRHOEA AND IT IS IMPORTANT TO DRINK SUFFICIENT FLUID TO REPLACE THE WATER LOST IN THE LOOSE STOOLS. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE DO NOT TAKE LOPERAMIDE - You are allergic to loperamide or to any of the other ingredients in this medicine (listed in section 6). - You suffer from colitis (inflammation of the colon) or any other inflammatory bowel disease, such as ulcerative colitis. - You have severe diarrhoea after taking antibiotics. - You have a swollen stomach or tummy, and/or constipation. - You are suffering from acute dysentery the symptoms of which may include blood in your stools and a high temperature. - if it is for a child aged below 12 If any of these apply to you, get advice from a doctor or pharmacist. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Loperamide - If you have AIDS and your stomach becomes swollen. Stop taking t Прочитайте повний документ
OBJECT 1 LOPERAMIDE 2MG CAPSULES Summary of Product Characteristics Updated 03-Oct-2022 | Aurobindo Pharma - Milpharm 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 Loperamide 2 mg Hard Capsules 2. Qualitative and quantitative composition Each hard capsule contains 2 mg of loperamide hydrochloride. Excipient with known effect: Each hard capsule contains 144.6 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule, White opaque cap/White opaque body, size '4' hard gelatin capsule shells, imprinted with '2'on cap and 'L' on body with black ink filled with white to off-white powder. 4. Clinical particulars 4.1 Therapeutic indications For symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over. 4.2 Posology and method of administration _Posology_ _Adults and children over 12 years of age:_ Two capsules to be taken initially, followed by one capsule after each loose motion, up to a Прочитайте повний документ