Picolax oral powder 16.1g sachets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Magnesium oxide; Citric acid anhydrous; Sodium picosulfate

Disponibil de la:

Ferring Pharmaceuticals Ltd

Codul ATC:

n/a

INN (nume internaţional):

Magnesium oxide; Citric acid anhydrous; Sodium picosulfate

Dozare:

3.5gram ; 12gram ; 10mg

Forma farmaceutică:

Powder for oral solution

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Never Valid To Prescribe As A VMP

Rezumat produs:

BNF: 01060500; GTIN: 5015919705590 5015919577418

Prospect

Package leaflet: Information for the patient
PICOLAX
®
Powder for oral solution
Sodium Picosulfate / Magnesium Oxide / Citric Acid
• if you are younger than 18 years,
elderly or physically weak. You should
make sure to drink a sufficient amount
of fluid and electrolytes during the
course of the treatment
• if you are taking Picolax
®
prior to
surgery involving the bowel
If you have an early time of the day
procedure, you might need to take the
second dose during night and possible
sleep disturbance may occur.
OTHER MEDICINES AND PICOLAX
®
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
It is especially important to tell your
doctor if you are taking:
• bulk forming laxatives e.g. bran
• prescribed oral medication, especially
if it is regularly prescribed as
their effects may be modified e.g.
contraceptives, antibiotics, anti-
diabetics, iron, penicillamine or anti-
epileptics. These medicines should be
taken at least 2 hours before and not
less than 6 hours after administration
of Picolax
®
• prescribed medication that may affect
water and/or electrolyte balance e.g.
water tablets, steroids, lithium, digoxin,
antidepressants, carbamazepine or
anti-psychotics
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding,
think you may be pregnant or are trying
to have a baby, ask your doctor or
pharmacist for advice before taking this
medicine.
DRIVING AND USING MACHINES
Picolax
®
has no effect on the ability to
drive and use machines. However, you
should make sure that you have access
to a toilet at all times following each
dose, until the effect wears off.
PICOLAX
® CONTAINS POTASSIUM AND
LACTOSE
Each sachet contains 5 mmol (or 195 mg)
potassium. You should discuss this with
your doctor if you have kidney problems
or you have been put on a controlled
potassium diet.
This medicine also contains lactose. If
you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
med

Caracteristicilor produsului

OBJECT 1
PICOLAX
Summary of Product Characteristics Updated 28-Jul-2016 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
PICOLAX powder for oral solution
2. Qualitative and quantitative composition
Each sachet contains the following active ingredients:
Sodium picosulfate
10.0mg
Magnesium oxide, light
3.5g
Citric acid, anhydrous
12.0g
-
Each sachet also contains:
Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg)
potassium]
Lactose (as a component of the flavour)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution.
White crystalline powder.
4. Clinical particulars
4.1 Therapeutic indications
PICOLAX is indicated in adults, adolescents and children from the age
of 1 year:
- To clean the bowel prior to X-ray examination or endoscopy.
- To clean the bowel prior to surgery when judged clinically necessary
(see section 4.4 regarding open
colorectal surgery).
4.2 Posology and method of administration
Posology
_Adults (including the elderly):_
The two PICOLAX sachets are taken dependent on the planned time of the
procedure:
• The first reconstituted sachet is taken 10 to 18 hours before the
procedure, followed by at least five 250
ml drinks of clear liquids, spread over several hours
• The second reconstituted sachet is taken 4 to 6 hours before the
procedure, followed by at least three
250 ml drinks of clear liquids, spread over several hours
• Clear liquids may be consumed until 2 hours before the time of the
procedure
_Special populations_
Limited data is available for treatment of patients with low body
weight (BMI less than 18). The
rehydration regimen above has not been tested in such individuals and
therefore monitoring of their
hydration status is required and the regimen may need to be altered
appropriately (see section 4.4).
_Paediatric population:_
A measuring spoon is provided with the product. It is recommended that
a narrow flat edge, for example
the back of a knife blade, is drawn across the top of a heaped
measuring spoon to o