Docusate 12.5mg/5ml oral solution sugar free

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Docusate sodium

Dostępny od:

Typharm Ltd

Kod ATC:

A06AA02

INN (International Nazwa):

Docusate sodium

Dawkowanie:

2.5mg/1ml

Forma farmaceutyczna:

Oral solution

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 01060200; GTIN: 5018174010058

Ulotka dla pacjenta

DOCUSATE SODIUM PAEDIATRIC
12.5MG/5ML ORAL SOLUTION
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THE PATIENT STARTS 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
THE
PATIENT’S DOCTOR OR PHARMACIST HAVE TOLD YOU.
-
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
-
ASK THE PATIENT'S PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE.
-
IF YOU GET ANY SIDE EFFECTS, TALK TO THE PATIENT’S DOCTOR OR
PHARMACIST.
THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
SEE SECTION 4.
-
YOU MUST TALK TO A DOCTOR IF THE PATIENT DOES NOT FEEL BETTER OR IF
THE
PATIENT FEELS WORSE AFTER A FEW DAYS.
What is in this leaflet:
1. What Docusate Sodium Paediatric 12.5mg/5ml Oral Solution is and
what
it is used for
2.
What you need to know before the patient takes Docusate Sodium
Paediatric 12.5mg/5ml Oral Solution
3.
How to take Docusate Sodium Paediatric 12.5mg/5ml Oral Solution
4.
Possible side effects
5.
How to store Docusate Sodium Paediatric 12.5mg/5ml Oral Solution
6.
Contents of the pack and other information
1.
WHAT DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML
ORAL SOLUTION IS AND WHAT IT IS USED FOR
Docusate Sodium Paediatric 12.5mg/5ml Oral Solution is one of a group
of
medicines called 'laxatives'. They are usually used to prevent and
treat
constipation. Docusate Sodium Paediatric 12.5mg/5ml Oral Solution may
also be used before a stomach X-ray.
2.
WHAT YOU NEED TO KNOW BEFORE THE PATIENT TAKES
DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL
SOLUTION
DO NOT GIVE DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL SOLUTION
•
if the patient is allergic to Docusate Sodium or any of the other
ingredients of this medicine (listed in section 6).
•
if the patient is suffering from stomach pains or an obstruction in
the gut.
•
if the patient is feeling sick or has been sick in the last 24 hours.
TAKE SPECIAL CARE WITH DOCUSATE SODIUM PAEDIATRIC 12

Charakterystyka produktu

OBJECT 1
DOCUSATE SODIUM PAEDIATRIC 12.5MG/5ML ORAL
SOLUTION
Summary of Product Characteristics Updated 14-Jun-2017 | Typharm
Limited
1. Name of the medicinal product
Docusol Paediatric Solution
Docusate Sodium Paediatric 12.5mg/5ml Oral Solution
2. Qualitative and quantitative composition
5ml of the solution contains docusate sodium 12.5mg
Excipient(s) with known effect:
Aspartame (E951) 15 mg per dose of syrup (5 mL)
Sorbitol 70% (E420) 903 mg per dose of syrup (5 mL)
Glycerol (E422) 628.5 mg per dose of syrup (5 mL)
Methyl p-hydroxybenzoate (E218) 50 mg per dose of syrup (5 mL)
Propyl p-hydroxybenzoate (E216) 25 mg per dose of syrup (5 mL)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
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
For oral administration
Children: one to two 5ml spoonfuls three times daily. Dilute the
medicine in a glass of flavoured drink eg
fruit juice or milk. Drink the diluted medicine within 30 minutes of
preparation.
Infants (Over six months): one 5ml spoonful three times daily. Dilute
the medicine in a glass of flavoured
drink eg fruit juice or milk. Drink the diluted medicine within 30
minutes of preparation.
Adults: not appropriate for adults or elderly. For administration to
adults use
Docusol Adult Solution.
For barium meals: 30ml to be taken with 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 of an
atonic non-functioning colon and hypokalaemia.
Patients with rare hereditary problems of fructose intolerance should
not take this medicine.