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ANTEPSIN 1G/5ML ORAL SUSPENSION

Active substance: SUCRALFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Antepsin 1 g / 5 mL ORAL SUSPENSION
sucralfate

Read all of this leaflet carefully before you start
taking 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 effect
not listed in this leaflet. See section 4.

What is in this leaflet
1. What Antepsin Suspension is and what it is used for
2. What you need to know before you take Antepsin
Suspension
3. How to take Antepsin Suspension
4. Possible side effects
5. How to store Antepsin Suspension
6. Contents of the pack and other information
1. What Antepsin Suspension is and what it is
used for
The name of your medicine is Antepsin 1 g/ 5 mL
Oral Suspension (called Antepsin Suspension in this
leaflet). Antepsin Suspension contains a medicine
called sucralfate. This belongs to a group of medicines
called “Ulcer-healing” medicines. It works by forming
a protective barrier over a stomach ulcer and helps
stop further irritation caused by stomach acid.
Antepsin Suspension is used to treat:
• Stomach ulcers
• Ulcers in your bowel
• Inflammation of your stomach lining
Antepsin can also be used to prevent bleeding
ulcers in seriously ill patients in hospital.
2. What you need to know before you take
Antepsin Suspension

Do not take Antepsin Suspension:
• If you are allergic (hypersensitive) to sucralfate
or any of the other ingredients of Antepsin
Suspension (listed in Section 6). Signs of an
allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face,
throat or tongue
• If you are on dialysis for kidney problems
Do not take this medicine if any of the above apply
to you. If you are not sure talk to your doctor or
pharmacist before taking Antepsin.
You must not be given this medicine by injection into
a vein.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Antepsin Suspension if:
• You are pregnant, trying to become pregnant or
breast-feeding (see ‘Pregnancy and breast-feeding’
below)

• You have kidney problems
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
Antepsin Suspension.
Other medicines and Antepsin Suspension
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This includes medicines obtained without a
prescription, including herbal medicines. This is
because Antepsin Suspension can affect the way
some other medicines work. Also some other medicines
can affect the way Antepsin Suspension works.
In particular, before taking Antepsin Suspension, tell
your doctor or pharmacist if you are taking any of
the following medicines:
• Medicines containing citrates
• Medicines containing aluminium
• Medicines for stomach ulcers such as cimetidine
or ranitidine
• Medicines for infection (antibiotics) such as
tetracycline, ciprofloxacin or norfloxacin
• Sulpiride -used for mental health problems
(psychotic episodes)
• Digoxin-used for heart problems
• Phenytoin-used for fits (epilepsy)
• Warfarin-used for blood clots
• Theophylline-used for asthma or other breathing
problems
• Levothyroxine-used for thyroid problems
• Quinidine-used for heart problems
• Ketaconazole-used for fungal infections
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before taking
Antepsin Suspension.
If you are taking any other medicine, leave a two
hour gap between taking Antepsin Suspension and
the other medicine. For “antacid” medicines, the gap
needs to be at least half an hour.
Antepsin Suspension with food and drink
If you are being fed by a tube into your stomach,
Antepsin Suspension should be given at least one
hour before or after a feed.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before taking this
medicine if:
• You are pregnant, might become pregnant or
think you might be pregnant
• You are breast-feeding or planning to breast-feed
Ask your doctor or pharmacist for advice before
taking any medicine if you might be pregnant.
Driving and using machines
Antepsin Suspension may make you feel dizzy or
drowsy. If you feel dizzy or drowsy, do not drive or
use tools or machines while taking this medicine.

Antepsin Suspension contains Hydroxybenzoates
• This medicine contains sodium propyl
hydroxybenzoate (E217) and sodium methyl
hydroxylbenzoate (E219). These may cause
allergic reactions and sometimes this allergic
reaction may not happen straight away.
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3. How to take Antepsin Suspension

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is either:
• Two 5 mL spoonfuls after waking up in the
morning and two 5 mL spoonfuls at bedtime
or
• One 5 mL spoonful four times a day. Doses
should be taken before meals and at bedtime
In seriously ill patients in hospital, the dose may be
increased to 5 mL six times a day.
Taking this medicine
• Take this medicine by mouth
• This medicine is usually taken for 4 to 6 weeks,
but may be taken for up to 12 weeks if necessary
• The maximum dose in a day is eight 5 mL spoonfuls
Use in children
Antepsin Suspension is not suitable for children
under 14 years old.
If you take more Antepsin Suspension than you
should
If you take more Antepsin Suspension than you
should, talk to a doctor or go to hospital straight
away. Take the medicine pack with you. This is so
the doctor knows what you have taken.
If you forget to take Antepsin Suspension
• If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose
• Do not take a double dose to make up for a
forgotten dose
If you stop taking Antepsin Suspension
Do not stop taking Antepsin Suspension without
talking 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, Antepsin Suspension can cause
side effects, although not everybody gets them.
Stop taking Antepsin Suspension and tell your
doctor straight away if:
• You have an allergic reaction. The signs include a
rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
Tell a doctor or pharmacist if any of the following
side effects gets serious or lasts longer than a
few days:
• Constipation or diarrhoea
• Indigestion, stomach ache or wind
• Being sick (vomiting) or feeling sick (nausea)
• Feeling dizzy, drowsy or being unsteady on your feet
• Back pain
• Dry mouth
• Headache
• Itching
Antepsin Suspension may cause a blockage in the
digestive tract of seriously ill patients in hospital.
This is a rare side effect.

Antepsin Suspension may cause aluminium to build
up in your body. This can cause changes in your
bones such as thinning or softening, impairment of
your brain or problems with your blood.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
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 (see
details below). By reporting side effects you can
help provide more information on the safety of this
medicine.
UK - Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland - Pharmacovigilance Section, Irish Medicines
Board, Kevin O’Malley House, Earlsfort Centre,
Earlsfort Terrace, IRL - Dublin 2.
Tel: +353 1 6764971. Fax: +353 1 6762517.
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
5. How to store Antepsin Suspension
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton and on the bottle label. The
expiry date refers to the last day of that month.
Store your medicine below 25 ºC.
Once opened the medicine should be used within
28 days.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away any medicines you no longer use. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Antepsin Suspension contains
• Antepsin Suspension contains 1 g per 5 mL of
the active substance sucralfate
• The other ingredients contained in the Antepsin
Suspension are sodium saccharin, sodium
dihydrogen phosphate, purified water, glycerol,
sodium methyl hydroxybenzoate (E219), sodium
propyl hydroxybenzoate (E217), xanthan gum,
aniseed flavour and caramel flavour
What Antepsin Suspension looks like and
contents of the pack
Antepsin Suspension is a white or off-white sticky
liquid and comes in a 250 mL brown glass bottle.
Marketing Authorisation Holder
Chugai Pharma UK Ltd., Mulliner House, Flanders
Road, Turnham Green, London W4 1NN, U.K.
Manufacturer
Merck, S.L., Poligono Merck, E-08100 Mollet del
Valles, Barcelona, Spain.
This leaflet was last revised in:
September 2013
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ARTWORK DETAILS

SPECIFICATION DETAILS

Client:

Chugai Pharmaceutical Co., Ltd.

Origination

17 October 2013 — (as Issue 01)

Product Name:

Antepsin1g/5ml Oral - PIL

Dimensions

150 x 210 mm

Market(s):

United Kingdom (UK)

Border

10 mm

Language(s):

English

Pharmacode No.

Laetus: 235

QRD Doc Ref.

UK and IE m1-3-1-leaflet-trackedcombined-update.docx

Font details

Client Comp Code:

1235752-G

PD Ref.:

PD-UK-PIL1235752-G-v03 —
(** to follow final proof)

Main title:
Helvetica Neue - Bold - 8.5 pt
Sub-titles:
Helvetica Neue - Bold - 7.5 pt
Body copy:
Helvetica Neue - Regular - 7.5 pt

Customer Ref.:

N/A

Colours

Black - K
Pantone - 300 CVU (Logo)

Issue

03

Date

28 October 2013

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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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