Salofalk 2g/59ml enema

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Mesalazine

Prieinama:

Dr. Falk Pharma UK Ltd

ATC kodas:

A07EC02

INN (Tarptautinis Pavadinimas):

Mesalazine

Dozė:

33.9mg/1ml

Vaisto forma:

Enema

Vartojimo būdas:

Rectal

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01050100; GTIN: 5060096430018

Pakuotės lapelis

Package leaflet: information for the user
SALOFALK ENEMA 2G
Mesalazine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

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
What is in this leaflet:
1.
What Salofalk enemas are and what they are used for
2.
What you need to know before you use Salofalk enemas
3.
How to use Salofalk enemas
4.
Possible side effects
5.
How to store Salofalk enemas
6.
Contents of the pack and other information
1.
WHAT SALOFALK ENEMAS 2G ARE AND WHAT THEY ARE USED FOR
Salofalk enemas contain the active substance mesalazine, an
anti-inflammatory agent used to treat
inflammatory bowel disease.
Salofalk enemas are used for:

the treatment of mild episodes of an inflammatory disease in parts of
the colon and the rectum
(back passage) known by doctors as ulcerative colitis or ulcerative
proctitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALOFALK ENEMA 2G
DO NOT USE SALOFALK ENEMAS

If you are allergic to mesalazine, salicylic acid, salicylates such as
aspirin or any of the other
ingredients of this medicine (listed in section 6).

If you have a serious liver or kidney disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Salofalk enemas:

If you have a history of problems with your lungs, particularly if you
suffer from
BRONCHIAL
ASTHMA
.

If you have a history of allergy to sulphasalazine,
a substance related to mesalazine.

If you suffer with problems of your
LIVER
.

If you suffer with problems of your
KIDNEY
.
FURTHER PRECAUTIONS
During treatment your doctor may want to keep you under close medical
su

Prekės savybės

OBJECT 1
SALOFALK ENEMA 2G
Summary of Product Characteristics Updated 08-Dec-2017 | Dr. Falk
Pharma UK Ltd
1. Name of the medicinal product
Salofalk Enema 2g
2. Qualitative and quantitative composition
Each enema contains 2g mesalazine in 59 ml of suspension.
Excipient with known effect: sodium benzoate (E211).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Enema
4. Clinical particulars
4.1 Therapeutic indications
Therapy and prophylaxis of acute attacks of mild ulcerative colitis,
especially in the rectum and sigmoid
colon and also in the descending colon.
4.2 Posology and method of administration
Posology
_Adults and the Elderly_: 1 enema once a day at bedtime. The action of
Salofalk is enhanced if the patient
lies on the left side when introducing the enema. The dosage should be
adjusted to suit the progress of the
condition. Do not discontinue treatment suddenly.
Paediatric population
There is little experience and only limited documentation for an
effect in children.
Method of administration:
Rectal
The best results are achieved if the bowels are emptied before
administration of the enema.
The patient should be advised to:
- Shake the bottle for 30 seconds.
- Remove the protective cap.
- Hold the bottle at the top and bottom and keep it upright to avoid
spillage.
- Lie down comfortably on the left side with the left leg stretched
out and the right leg bent. If more
convenient, lie on the right side with the right leg stretched out and
with the left leg bent. In this case, turn
to the left side after application of the enema.
- Insert the applicator deep into the rectum keeping the bottle tipped
downwards slightly.
- Slowly squeeze the bottle until empty.
- Slowly withdraw the applicator from the rectum.
- Lie on the left side for at least 30 minutes to allow the contents
of the enema to spread.
- If possible, retain the enema all night.
4.3 Contraindications
Salofalk is contraindicated in cases of:
• Severe impairment of renal or hepatic function.
• Hypersensitivity to the activ