Skip to main content

ANTEPSIN 1G/5ML ORAL SUSPENSION / SUCRALFATE 1G/5ML ORAL SUSPENSION

Active substances: SUCRALFATE

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antepsin® 1g/5ml Oral Suspension
(sucralfate)
This product is available as the above name but will be
referred to as Antepsin Suspension throughout this leaflet.
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
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.

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.

Antepsin Suspension is used to treat:
• Stomach ulcers
• Ulcers in your bowel
• Inflammation of your stomach lining

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 can also be used to prevent bleeding
ulcers in seriously ill patients in hospital.

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 .

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 Suspension.
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 breastfeeding (see 'Pregnancy and breast-feeding' below)
• You have kidney problems

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
and sodium methyl hydroxybenzoate. These may cause
allergic reactions and sometimes this allergic reaction
may not happen straight away.

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.
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
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.
Do not store above 25°C.
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 throwaway
any medicines you no longer use. These measures will help
to protect the environment.
If your medicine becomes discoloured or shows any other
signs of deterioration consult your pharmacist who will tell
you what to do.
6. Contents of the pack and other information
What Antepsin Suspension contains
• Antepsin Suspension contains the active substance
sucralfate. Each 5ml dose contains 1g sucralfate.
• The other ingredients contained in the Antepsin
Suspension are sodium methyl hydroxybenzoate, sodium
propyl hydroxybenzoate, sodium dihydrogen phosphate
dihydrate, xanthan gum, aniseed flavour, caramel flavour,
sodium saccharin dihydrate, glycerol 85% and deionized
water.
What Antepsin Suspension looks like and contents of
the pack
Antepsin Suspension is a white to off-white suspension with
an odour of aniseed/caramel. It comes in 200 ml amber
glass bottle with a tamper evident screw cap and 5 ml
measuring spoon.
PL: 15814/1328

POM

Manufactured by Laboratori Baldacci S.p.A., Via S. Michele
degli Scalzi, 73 – Pisa, Italy.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision date (Ref.): 29.08.2017.
Antepsin is a registered trademark of Chugai
Pharmaceutical Co., Ltd., Japan.

To request a copy of this leaflet in
Braille, large print or audio please
call 01923 332 796.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sucralfate 1g/5ml Oral Suspension
This product is available as the above name but will be
referred to as Sucralfate Suspension throughout this leaflet.
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 Sucralfate Suspension is and what' it is used for
2. What you need to know before you take Sucralfate
Suspension
3. How to take Sucralfate Suspension
4. Possible side effects
5. How to store Sucralfate Suspension
6. Contents of the pack and other information
1. What Sucralfate Suspension is and what it is used
for
Sucralfate 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.
Sucralfate Suspension is used to treat:
• Stomach ulcers
• Ulcers in your bowel
• Inflammation of your stomach lining
Sucralfate Suspension can also be used to prevent bleeding
ulcers in seriously ill patients in hospital.
2. What you need to know before you take Sucralfate
Suspension
Do not take Sucralfate Suspension:
• If you are allergic (hypersensitive) to sucralfate or any of
the other ingredients of Sucralfate 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 Sucralfate Suspension.
You must not be given this medicine by injection into a vein.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sucralfate
Suspension if:
• You are pregnant, trying to become pregnant or breastfeeding (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 Sucralfate
Suspension.
Other medicines and Sucralfate 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 Sucralfate
Suspension can affect the way some other medicines work.
Also some other medicines can affect the way Sucralfate
Suspension works.
In particular, before taking Sucralfate 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 Sucralfate
Suspension.
If you are taking any other medicine, leave a two hour gap
between taking Sucralfate Suspension and the other
medicine. For "antacid" medicines, the gap needs to be at
least half an hour.
Sucralfate Suspension with food and drink
If you are being fed by a tube into your stomach, Sucralfate
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
Sucralfate 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.
Sucralfate Suspension contains Hydroxybenzoates
• This medicine contains sodium propyl hydroxybenzoate
and sodium methyl hydroxybenzoate. These may cause
allergic reactions and sometimes this allergic reaction
may not happen straight away.

3. How to take Sucralfate 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
Sucralfate Suspension is not suitable for children under 14
years old.
If you take more Sucralfate Suspension than you should
If you take more Sucralfate 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 Sucralfate 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 Sucralfate Suspension
Do not stop taking Sucralfate 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, Sucralfate Suspension can cause side
effects, although not everybody gets them.
Stop taking Sucralfate 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

Sucralfate Suspension may cause a blockage in the
digestive tract of seriously ill patients in hospital.
This is a rare side effect.
Sucralfate 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.
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
5. How to store Sucralfate 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.
Do not store above 25°C.
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 throwaway
any medicines you no longer use. These measures will help
to protect the environment.
If your medicine becomes discoloured or shows any other
signs of deterioration consult your pharmacist who will tell
you what to do.
6. Contents of the pack and other information
What Sucralfate Suspension contains
• Sucralfate Suspension contains the active substance
sucralfate. Each 5ml dose contains 1g sucralfate.
• The other ingredients contained in the Sucralfate
Suspension are sodium methyl hydroxybenzoate, sodium
propyl hydroxybenzoate, sodium dihydrogen phosphate
dihydrate, xanthan gum, aniseed flavour, caramel flavour,
sodium saccharin dihydrate, glycerol 85% and deionized
water.
What Sucralfate Suspension looks like and contents of
the pack
Sucralfate Suspension is a white to off-white suspension
with an odour of aniseed/caramel. It comes in 200 ml amber
glass bottle with a tamper evident screw cap and 5 ml
measuring spoon.
PL: 15814/1328

POM

Manufactured by Laboratori Baldacci S.p.A., Via S. Michele
degli Scalzi, 73 – Pisa, Italy.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision date (Ref.): 29.08.2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01923 332 796.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.