Phospho-soda 24.4g/10.8g oral solution

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Sodium dihydrogen phosphate dihydrate; Disodium hydrogen phosphate dodecahydrate

Prieinama:

Recordati Pharmaceuticals Ltd

INN (Tarptautinis Pavadinimas):

Sodium dihydrogen phosphate dihydrate; Disodium hydrogen phosphate dodecahydrate

Dozė:

542mg/1ml ; 240mg/1ml

Vaisto forma:

Oral solution

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01060500; GTIN: 5011111805120

Pakuotės lapelis

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER PHOSPHO-SODA 24.4 G / 10.8 G ORAL SOLUTION
Sodium Dihydrogen Phosphate Dihydrate / Disodium Phosphate
Dodecahydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Phospho-soda carefully to
get the best results from it.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Phospho-soda is and what it is used for
2.
What you need to know before you take Phospho-soda
3.
How to take Phospho-soda
4.
Possible side effects
5.
How to store Phospho-soda
6.
Contents of the pack and other information
1.
WHAT PHOSPHO-SODA IS AND WHAT IT IS USED FOR
Phospho-soda is a bowel cleanser that acts by increasing the water
content of your stools. It is a solution
which you take by mouth and it comes in packs containing two 45 ml
bottles. Each bottle contains one dose
which must be diluted with water before use (see Section 3).
You need to take Phospho-soda in order to clean your bowel (also
called large intestine or colon) before
your endoscopy, bowel surgery or X-ray examination. It is important
that your bowel is completely empty so
that the doctors can see it clearly.
Phospho-soda is not a treatment for constipation.
Phospho-soda is indicated in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHOSPHO-SODA
DO NOT TAKE PHOSPHO-SODA IF YOU:

are allergic to disodium phosphate dodecahydrate, sodium dihydrogen
phosphate dihydrate or any of
the other ingredients of this medicine (listed in section 6);

are under the age of 18 years;

feel sick or are v

Prekės savybės

OBJECT 1
PHOSPHO-SODA 24.4G / 10.8G ORAL
SOLUTION
Summary of Product Characteristics Updated 19-Feb-2020 | Casen
Recordati S.L.
•
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
Phospho-soda 24.4g / 10.8g oral solution
2. Qualitative and quantitative composition
per 45ml dose
per 1ml
Sodium dihydrogen phosphate dihydrate
24.4 g
0.542 g
Disodium phosphate dodecahydrate
10.8 g
0.24 g
Excipient(s) with known effect: Ethanol, Sodium, Sodium benzoate (E
211).
Phospho-soda contains less than 100 mg of ethanol per dose.
Each 45ml bottle contains 5.0 g sodium and 15 mg of sodium benzoate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral solution. Clear colourless solution with a ginger-lemon odour,
free from precipitation and turbidity.
4. Clinical particulars
4.1 Therapeutic indications
As a bowel cleanser in preparing the patient for colon surgery, or for
preparing the colon for x-ray or for
endoscopic examination.
Bowel cleansing agents are not to be