ANTEPSIN 1G

Active substance: SUCRALFATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Antepsin 1g TABLETS
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.

• You have kidney problems
• You find it difficult to swallow
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
Antepsin Tablets.
Other medicines and Antepsin Tablets
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 Tablets can affect the way some
other medicines work. Also some other medicines
can affect the way Antepsin Tablets works.

The name of your medicine is Antepsin 1g Tablets
(called Antepsin Tablets in this leaflet). Antepsin
Tablets contain 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.

In particular, before taking Antepsin Tablets, 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 Tablets.

Antepsin Tablets are 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 Tablets and the
other medicine. For “antacid” medicines, the gap
needs to be at least half an hour.

What is in this leaflet
1. What Antepsin Tablets are and what they are used
for
2. What you need to know before you take Antepsin
Tablets
3. How to take Antepsin Tablets
4. Possible side effects
5. How to store Antepsin Tablets
6. Contents of the pack and other information
1. What Antepsin Tablets are and what they are
used for

2. What you need to know before you take
Antepsin Tablets
Do not take Antepsin Tablets:
• If you are allergic (hypersensitive) to sucralfate
or any of the other ingredients of Antepsin Tablets
(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.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Antepsin Tablets if:
• You are pregnant, trying to become pregnant or
breast-feeding (see ‘Pregnancy and breast-feeding’
below)

Antepsin Tablets with food and drink
If you are being fed by a tube into your stomach,
Antepsin Tablets 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 Tablets 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.

1235751-I02

3. How to take Antepsin Tablets

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 tablets after waking up in the morning and
two tablets at bedtime
or
• One tablet four times a day. Doses should be
taken before meals and at bedtime

Taking this medicine
• Take this medicine by mouth
• Tablets can be swallowed whole, or if preferred,
they can be dispersed in 10 to 15 mL of water
before taking
• 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 tablets
Use in children
Antepsin Tablets are not suitable for children under
14 years old.
If you take more Antepsin Tablets than you should
If you take more Antepsin Tablets 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 Tablets
• 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 Tablets
Do not stop taking Antepsin Tablets 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 Tablets can cause side
effects, although not everybody gets them.
Stop taking Antepsin Tablets 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 Tablets may cause a blockage in the
digestive tract of seriously ill patients in hospital.
This is a rare side effect.

Antepsin Tablets 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 Tablets
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 blister strip. The
expiry date refers to the last day of that month.
Store your medicine below 25 ºC.
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 Tablets contain
• Antepsin Tablets contain 1 g per tablet of the
active substance sucralfate
• The other ingredients contained in the Antepsin
Tablets are macrogol 6000, microcrystalline
cellulose, calcium carmellose and magnesium
stearate
What Antepsin Tablets looks like and contents of
the pack
Antepsin Tablets are oblong and white. The tablets
are packed in blisters of 10 tablets with 5 blister
strips in a carton.
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

1235751-I02

Expand view ⇕

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.

Hide
(web3)