Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dicycloverine hydrochloride
Flamingo Pharma (UK) Ltd
A03AA07
Dicycloverine hydrochloride
20mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01020000; GTIN: 5060464501746
OBJECT 1 Dicycloverine 20 mg Tablets 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 Dicycloverine Hydrochloride 20 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 20 mg of Dicycloverine hydrochloride. Excipient(s) with known effect: Each tablet contains 134.00 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White to off white, circular, flat beveled edge uncoated tablet debossed with “S” and “20” separated by break-line on one side and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. Clinical particulars 4.1 Therapeutic indications Smooth muscle antispasmodic primarily indicated for treatment of functional conditions involving smooth muscle spasm of the gastrointestinal tract. 4.2 Posology and method of administration Po Pročitajte cijeli dokument