Docusate 50mg/5ml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Docusate sodium

Available from:

Typharm Ltd

ATC code:

A06AA02

INN (International Name):

Docusate sodium

Dosage:

10mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060200; GTIN: 5018174010003

Patient Information leaflet

_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

Summary of Product characteristics

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