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SALOFALK ENEMA 2G

Active substance(s): MESALAZINE / MESALAZINE / MESALAZINE

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Salofalk 2g60ml Klysmen Gebrauchsinformation (GI) für Großbritannien
Format: 300 x 185 mm
Druckfarben: (2/2) Schwarz + Pantone 644
Mat.-Nr.: Mock-up (Vifor AG)
Falk-Datumscode: GB/02.17
Font: 9pt / ZAB: 10,5pt

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 antiinflammatory 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.

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 supervision and you may need to have regular
blood and urine tests.

Other medicines and Salofalk Enema 2g

Tell your doctor if you take or use any of the medicines
mentioned below as the effects of these medicines may
change (interactions):
− Certain agents that inhibit blood clotting (medicines for
thrombosis or to thin your blood, e.g., warfarin)
– Azathioprine, 6-mercaptopurine or thioguanine (medicines
used to treat immune disorders).
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. It may still be alright for you
to use Salofalk enemas and your doctor will be able to decide
what is suitable for you.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
You should only use Salofalk enemas during pregnancy if your
doctor tells you to.

The other ingredients in Salofalk enemas are not likely to cause
side effects (see section 6).

3. How to use Salofalk Enema 2g
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Method of administration:

This medicine may only be used rectally, so it has to be inserted
through the anus. Do NOT take by mouth.
Dosage:
Adults and elderly
The recommended dose is one enema once a day, at bedtime.
For the best results empty your bowels before using the enema.
– Shake the bottle well for at least 30 seconds before use to
ensure thorough mixing.
– Remove the protective cap. Hold the container upright to
avoid spillage.
– Lie on your left side with your left leg stretched out and your
right knee bent for balance. If this is not convenient, then lie
on your right side with your right leg stretched out and your
left leg bent for balance to apply the enema but turn to your
left side after application.
– Insert the lubricated applicator deep into your rectum. Keep
the bottle pointed towards your navel.
– Tip the bottle slightly downwards and then squeeze it slowly
and evenly.
– Once the bottle is empty, slowly remove the applicator.
– Lie on your left side for at least 30 minutes to enable the
medicine to spread evenly through the bowel. Try to retain
the enema all night.

2. What you need to know before you use
Salofalk Enema 2g

You should also only use Salofalk enemas during breast-feeding
if your doctor tells you to, as this medicine may pass into breast
milk.

Use in children
There is little experience and only limited documentation for an
effect in children.

Do not use Salofalk enemas

Driving and using machines

Duration of treatment
Your doctor will decide how long you need to continue the
treatment with this medicine. This will depend on your
condition.

– 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.

Mockup_SAE_GI_GB.indd 1

There are no effects on the ability to drive and use machines.
Salofalk Enema 2g contains sodium benzoate, which may be
mildly irritant to the skin, eyes and mucous membranes.

01.02.17 09:46

To obtain the maximum benefit from this medicine, you should
use Salofalk enemas regularly and consistently, as directed.
If you think your Salofalk enemas are too strong or too weak,
talk to your doctor.

If you use more Salofalk enemas than you should

Contact a doctor if you are in doubt, so he or she can decide
what to do.
If you use too many enemas on one occasion, just use your
next dose as prescribed. Do not use a smaller amount.

If you forget to use Salofalk enemas

Do not use a larger than normal dose of Salofalk enema next
time, but continue treatment at the prescribed dosage.

If you stop using Salofalk enemas

Do not stop using this product until you have talked to your doctor.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Salofalk enemas can cause side effects,
although not everybody gets them.
All medicines can cause allergic reactions although serious
allergic reactions are very rare. If you get any of the
following symptoms after using this medicine, you should
contact your doctor immediately:
– Allergic skin rash
– Fever
– Breathing difficulties
If you experience a marked reduction of your general health,
especially if accompanied by fever, and/or a sore throat and
mouth, stop using the enemas and contact your doctor
immediately. These symptoms can, very rarely, be due to a fall
in the number of white cells in your blood (a condition called
agranulocytosis) which may make you more prone to developing
a serious infection. A blood test can confirm whether your
symptoms are due to an effect of this medicine on your blood.
The following side effects have also been reported by patients
using mesalazine:

Mockup_SAE_GI_GB.indd 2

Rare side effects (that affect less than 1 in 1,000 patients):
− Abdominal pain, diarrhoea, wind (flatulence), nausea and
vomiting, constipation
– Headache, dizziness
– Chest pain, breathlessness or swollen limbs because
of an effect on your heart
Very rare side effects (that affect less than 1 in 10,000 patients):
− Changes in kidney function, sometimes with swollen limbs or
flank pain
– Severe abdominal pain because of acute inflammation
of the pancreas
– Fever, sore throat or malaise because of blood count changes
– Shortness of breath, cough, wheezing, lung shadow on x-ray
due to allergic and/or inflammatory lung conditions
– Severe diarrhoea and abdominal pain because of an allergic
reaction to this medicine within the bowel
– Skin rash or inflammation
– Muscle and joint pain
– Jaundice or abdominal pain because of liver and bile flow
disorders
– Hair loss and the development of baldness
– Numbness and tingling in the hands and feet (peripheral
neuropathy)
– Reversible decrease in semen production
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the national
reporting system:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Do not store above 30°C.
Store in the original container in order to protect contents from
light.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Salofalk enemas contain

The active substance is mesalazine and one enema contains
2g mesalazine.
The other ingredients are
Carbomer, disodium edetate, potassium acetate (E261),
potassium metabisulphite (E224), purified water, sodium
benzoate (E211), xanthan gum (E415).

What Salofalk enemas look like and contents
of the pack

Salofalk enemas are in a low-density, concertina shaped,
polythene bottle with a low-density polythene application nozzle.
Salofalk enemas are available in packs of 7
Marketing Authorisation Holder
Dr. Falk Pharma UK Ltd
Bourne End Business Park, Cores End Road
Bourne End, SL8 5AS
Manufacturer

By reporting side effects you can help provide more information
on the safety of this medicine.

Leinenweberstr. 5
79108 Freiburg
Germany

5. How to store Salofalk Enema 2g
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the bottle and on the carton. The expiry date refers to the
last day of that month.

This leaflet was last revised in
02/2017

Mock-up

GB/02.17

01.02.17 09:46

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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