Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Docusate sodium
Typharm Ltd
A06AA02
Docusate sodium
10mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060200; GTIN: 5018174010003
_Title:_ _Ref:_ _Date:_ _Size (mm):_ _Modified:_ Docusate Sodium PIL DS/TY/A/50 28/10/15 200x280mm 21/04/16 _Colours_ _(Non printed)_ REFERENCE TRIM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. ALWAYS USE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS YOUR DOCTOR OR PHARMACIST HAVE TOLD YOU. - KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE. - 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. - YOU MUST TALK TO A DOCTOR IF YOU DO NOT FEEL BETTER OR IF YOU FEEL WORSE AFTER A FEW DAYS. What is in this leaflet: 1. What Docusate Sodium Adult 50mg/5ml Oral Solution is and what it is used for 2. What you need to know before you take Docusate Sodium Adult 50mg/5ml Oral Solution 3. How to take Docusate Sodium Adult 50mg/5ml Oral Solution 4. Possible side effects 5. How to store Docusate Sodium Adult 50mg/5ml Oral Solution 6. Contents of the pack and other information 1. WHAT DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION IS AND WHAT IT IS USED FOR Docusate Sodium Adult 50mg/5ml Oral Solution is one of a group of medicines called 'laxatives'. They are usually used to prevent and treat constipation. Docusate Sodium Adult 50mg/5ml Oral Solution may also be used before a stomach X-ray. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION DO NOT TAKE DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION • if you are allergic to docusate sodium or any of the other ingredients of this medicine (listed in section 6). • if you are suffering from stomach pains or an obstruction in the gut. • if you are feeling sick or have been sick in the last 24 hours. TAKE SPECIAL CARE WITH DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION • This medicine is not suitable for children aged 6 months to 12 years but a suitable alte Đọc toàn bộ tài liệu
OBJECT 1 DOCUSATE SODIUM ADULT 50MG/5ML ORAL SOLUTION Summary of Product Characteristics Updated 14-Jun-2017 | Typharm Limited 1. Name of the medicinal product Docusol Adult Solution Docusate Sodium Adult 50mg/5ml Oral Solution 2. Qualitative and quantitative composition 5ml of the solution contains docusate sodium 50mg Excipient(s) with known effect: Aspartame (E951) 15mg per dose of syrup (5 mL) Sorbitol 70% (E420) 1209 mg per dose of syrup (5 mL) Glycerol (E422) 628.5 mg per dose of syrup (5 mL) Methyl p-hydroxybenzoate (E218) 5 mg per dose of syrup (5 mL) Propyl p-hydroxybenzoate (E216) 2.5 mg per dose of syrup (5 mL) Propylene glycol (E1520) 0.003 mL per dose of syrup (5 mL) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral solution Liquid syrupy, clear, nearly colourless and with homogeneous appearance. 4. Clinical particulars 4.1 Therapeutic indications a) To prevent and treat chronic constipation b) As an adjunct in abdominal radiological procedures 4.2 Posology and method of administration _Adults: _10ml to 15ml three times a day. Take as a single dose followed by plenty of water or flavoured drink e.g. milk or orange juice. Maximum daily dose 50ml. Treatment should be commenced with large doses which should be decreased as the condition of the patient improves. _For barium meals: _40ml to be taken with the meal. _Elderly: _There is no evidence to suggest that an adjustment of the dosage is necessary in the elderly. _Children: _For administration to children and infants over 6 months use Docusol Paediatric Solution 0.25% w/v. For barium meals: 40ml to be taken with the meal. 4.3 Contraindications Docusol solution should not be taken • by patients with a known hypersensitivity to docusate sodium or to any of the excipients listed in section 6.1. • in the presence of abdominal pain, intestinal obstruction, nausea or if vomiting occurs. 4.4 Special warnings and precautions for use Docusol should not be given to infants under six months. Prolonged use can precipitate the onset Đọc toàn bộ tài liệu