Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Loperamide hydrochloride
Flamingo Pharma (UK) Ltd
A07DA03
Loperamide hydrochloride
2mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01040200; GTIN: 5060464500459 5060464500800
LOPERAMIDE 2 MG CAPSULES (POM) LEAFLET SIZE : 150 X 285 MM MPLLLOP0002CPCOMFPLXXX071V05 FONTS SIZE : Generic Name font size : 11 pt. Composition fonts size : 9 pt. FONTS : Arial 285 mm 285 mm 150 mm 150 mm WHAT IS IN THIS LEAFLET: 1. What Loperamide Capsule is and what it is used for 2. What you need to know before you take Loperamide Capsules 3. How to take Loperamide Capsules 4. Possible side effects 5. How to store Loperamide Capsules 6. Contents of the pack and other information 1. WHAT LOPERAMIDE CAPSULE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOPERAMIDE CAPSULES 3. HOW TO TAKE LOPERAMIDE CAPSULES 4. POSSIBLE SIDE EFFECTS PACKAGE LEAFLET: INFORMATION FOR THE USER LOPERAMIDE 2 MG CAPSULES, HARD (loperamide hydrochloride) LOPERAMIDE CAPSULE IS USED • To treat sudden short-lived (acute) attacks of diarrhoea in adults and in children over 9 years of age. • To treat long lasting (chronic) diarrhoea in adults REPLACING FLUID AND SALTS Loperamide capsules only treats the symptoms of diarrhoea. Your body can lose large amounts of fluids and salts when you have diarrhoea. You need to replace the fluid by drinking more liquid than usual. This is especially important for children. Your doctor may also give you a special powder containing sugar and salts (known as oral rehydration therapy) to help your body replace the fluid and salts lost during diarrhoea. The prevention of fluid depletion (dehydration) is particularly important in infants, children, and frail and elderly people with acute diarrhoea. PREGNANCY AND BREAST-FEEDING If you are pregnant, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine if you are breast-feeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment. DRIVING AND USING MACHINES Do not drive if you feel dizzy, tired or sleepy. You may feel less alert, feel faint or pass out. If you're affected do not drive or use machines. LOP Belgenin tamamını okuyun
OBJECT 1 Loperamide 2 mg Capsules Summary of Product Characteristics Updated 16-Jun-2021 | Flamingo Pharma (UK) 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 Capsules, hard 2. Qualitative and quantitative composition Each capsule contains 2mg loperamide hydrochloride. Excipient(s) with known effect: Each capsule contains 109.00 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard (Capsule) Size '4' (about 14 mm in length) Hard gelatin capsule with Green cap imprinted with 'L' in black ink & grey body imprinted with '2mg' in black ink, containing white to off-white powder. 4. Clinical particulars 4.1 Therapeutic indications For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for periods of up to 5 days in adults and children over 9 years. For the symptomatic treatment of chronic diarrhoea in adults. 4.2 Posology and method of admin Belgenin tamamını okuyun