Carafate

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Sucralfate 1 g equivalent to to 190 mg aluminium;  
Available from:
Mylan New Zealand Ltd
INN (International Name):
Sucralfate 1 g (Equiv. to 190 mg aluminium)
Dosage:
1 g
Pharmaceutical form:
Tablet
Composition:
Active: Sucralfate 1 g equivalent to to 190 mg aluminium   Excipient: Carmellose sodium Macrogol 1500 Magnesium stearate Microcrystalline cellulose Water
Units in package:
Bottle, plastic, HDPE, 1x120, 120 tablets
Class:
General sale
Prescription type:
General sale
Manufactured by:
Fuji Chemical Industries Co. Ltd.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, HDPE, 1x120 - 120 tablets - 24 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-3480
Authorization date:
1983-04-28

Page 1 of 3

NEW ZEALAND CONSUMER MEDICINE INFORMATION

CARAFATE

Sucralfate, tablet 1g

What is in this leaflet

Please read this leaflet carefully

before you start taking CARAFATE.

This leaflet answers some common

questions about CARAFATE.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor or pharmacist

has weighed the risks of you taking

CARAFATE. against the benefits

they expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What CARAFATE is

used for

CARAFATE is used to treat and

prevent duodenal and gastric

ulcers.

CARAFATE contains the active

ingredient sucralfate. It belongs to a

group of medicines used to treat

ulcers and gastro-oesophageal

reflux disease.

It works in the stomach by

producing a substance that sticks to

the ulcer site that protects it from

the damaging action of enzymes

and stomach acid which can cause

ulcers

CARAFATE is not an antacid.

Your doctor or pharmacist may

have recommended this medicine

for another reason.

Ask your doctor or pharmacists if

you have any questions about

why this medicine has been

recommended for you.

This medicine is available from your

pharmacy without a prescription.

This medicine is not addictive.

Before you take

CARAFATE

When you must not take

it

Do not take CARAFATE if you

have an allergy to:

any medicine containing

sucralfate

any of the ingredients listed

at the end of this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath; wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of

the body; rash, itching or hives on

the skin.

Do not give this medicine to a

child under the age of 18 years.

Safety and effectiveness in children

younger than 18 years have not

been established.

Do not take this medicine if you

are on dialysis

have a bleeding peptic ulcer

have a cancerous stomach

ulcer

have impaired kidney

function.

CARAFATE contains high levels of

aluminium (190 mg per tablet)

which can lead to toxicity in people

who have kidney problems.

Do not take this medicine after

the expiry date printed on the

pack or if the packaging is torn or

shows signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor or pharmacist.

Before you start to take

it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

bleeding ulcer

phosphate deficiency

kidney problems

Tell your doctor or pharmacist if

you are pregnant or plan to

become pregnant or are breast-

feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell them

before you start taking

CARAFATE.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

If you are taking any other

medicines, they should be taken

at least 2 hours before or after

taking CARAFATE.

You should also tell any health

professional who is prescribing a

new medication for you that you are

taking CARAFATE

Page 2 of 3

Some medicines may interfere with

CARAFATE. These include:

Antacids – these should not be

taken within two hours of taking

CARAFATE

This medicine may be affected by

CARAFATE or may affect how well

it works. You may need different

amounts of your medicines, or you

may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

this medicine.

How to take

CARAFATE

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the bottle, ask

your doctor or pharmacist for

help.

How much to take

The usual daily dose of CARAFATE

to treat an ulcer is either:

One tablet three times a day, taken

one hour before meals and one

tablet at bedtime

Two tablets taken one hour before

breakfast and two tablets at

bedtime.

The usual daily dose of CARAFATE

to prevent an ulcer recurring is one

tablet one hour before breakfast

and one tablet at bedtime.

How to take it

Swallow the tablets whole with a

full glass of water.

The tablet has a score or break line

on it. This is to allow the tablet to be

broken so that it is easier to swallow

and does not necessarily divide the

tablet into equal halves.

When to take it

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

Take your medicine on an empty

stomach, 1 hour before food or 2

hours after food.

Food can interfere with the action of

this medicine.

If you need to take an antacid or

any other medicine take it at least

two hours before or after your dose

of CARAFATE.

How long to take it

Continue taking your medicine

for as long as your doctor tells

you. This can be for up to 8

weeks for the treatment of an

ulcer and for 12 months for the

prevention of the recurrence of

an ulcer.

This medicine helps to control your

condition but does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

Take the missed dose as soon as

you remember, and then go back

to taking your medicine as you

would normally.

Do not take a double dose to

make up for the dose that you

missed.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

While you are taking

CARAFATE

Things you must do

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking CARAFATE.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking] this

medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are taking this medicine.

It may affect other medicines used

during surgery.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any

blood tests, tell your doctor that

you are taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor’s

appointments so that your

progress can be checked.

Things you must not do

Do not take CARAFATE to treat

any other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

CARAFATE affects you. There

have been side effects reported with

this medicine that may affect your

ability to drive or operate

machinery. Individual responses to

CARAFATE may vary.

In case of overdose

If you take too much

(overdose)

Immediately telephone your

doctor or the National Poisons

Centre (telephone 0800 POISON

or 0800 764 766), or go to

accident and emergency at your

nearest hospital, if you think that

you or anyone else may have

taken too much CARAFATE. Do

this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Page 3 of 3

Symptoms of an overdose may

include constipation and nausea.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

CATAFATE

This medicine helps most people

with ulcers, but it may have

unwanted side effects in a few

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

treatment if you get some of the

side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

Constipation

Headache

Itchy skin

Nausea

Stomach discomfort

Dry mouth

Thirst

Skin rash

Back pain

Dizziness

Drowsiness

Diarrhoea

Indigestion

Thirst

Hives

Vertigo

Sleepiness

Tell your doctor as soon as

possible if you notice any of the

following:

Tiredness, headaches, being

short of breath, dizziness,

looking pale and yellowing of

the skin and/or eyes (anaemia)

Seizures

Tremors or muscle twitching

Hallucinations/confusion

Speech problems

Bone pain

Muscle weakness

Difficulty walking

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people. Tell

your doctor if you notice any other

effects.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After taking

CARAFATE

Storage

Keep your tablets in the bottle

until it is time to take them.

If you take the tablets out of the

bottle they may not keep well.

Keep your tablets in a cool dry

place where the temperature

stays below 30°C.

Do not store CARAFATE or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy

some medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

CARAFATE tablets are white

capsule-shaped scored tablets.

Ingredients

Active ingredient(s):

CARAFATE contains 1g of

sucralfate as the active ingredient.

Inactive ingredient(s):

CARAFATE also contains:

Carmellose sodium

Macrogol 1500

Magnesium stearate

Microcrystalline cellulose

This medicine does not contain

lactose, sucrose, gluten, tartrazine

or any other azo dyes

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

CARAFATE is supplied in New

Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland

NEW ZEALAND

Telephone: 0800 168 169

Date of Preparation

30 Jan 2020.

(Based on datasheet dated 30 Jan

2020)

Page 1 of 5

NEW ZEALAND DATA SHEET

CARAFATE

1. Product Name

Carafate, 1 g, tablet.

2. Qualitative and Quantitative Composition

Each tablet contains 1 g sucralfate

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Carafate is a large white capsule shaped tablet with a score line

Dimensions: 20 mm x 9 mm x 7mm

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1

Therapeutic indications

Treatment of acute, non-malignant gastric ulcer and duodenal ulcer.

Maintenance therapy to prevent the recurrence of duodenal ulcers.

4.2

Dose and method of administration

Acute ulcerous conditions

The recommended adult dose of Carafate for duodenal ulcer and gastric ulcer is 1 g tablet three

times a day, one hour before meals and one 1 g tablet at bedtime or two 1 g tablets twice daily taken

before breakfast and at bedtime (for up to 8 weeks).

For relief of pain, antacids may be added to the treatment. However, they should not be taken within

two hours before or after sucralfate intake.

In duodenal ulcer, while healing with sucralfate often occurs within two to four weeks, treatment

should be continued for up to 8 weeks unless healing has been demonstrated by x-ray and/or

endoscopic examination. In the case of gastric ulcers an alternative treatment should be considered

if no objective improvement is observed following 6 weeks of sucralfate therapy. Large gastric ulcers

that show a progressive healing tendency may require the full 8 weeks of therapy.

Maintenance treatment

To reduce the risk of recurrence of duodenal ulcers, the recommended dose is one 1 g tablet before

breakfast and one at bedtime (for up to 12 months). When necessary for relief of pain, antacids may

be added to the treatment. However, they should not be taken within two hours before or after taking

sucralfate.

Page 2 of 5

4.3

Contraindications

Carafate is contraindicated in patients on dialysis as long term administration may cause symptoms

such as aluminium encephalopathy, aluminium osteomalacia and anaemia.

If considering the use of the drug in pregnant patients or women of child bearing potential - see

section 4.6. The drug is not recommended for use in children (see section 4.4), patients with actively

bleeding peptic ulcer or those with severely impaired renal function.

4.4

Special warnings and precautions for use

Proper diagnosis is important since symptomatic response to Carafate therapy does not preclude

the presence of a gastric malignancy. There is no clinical experience in the use of sucralfate in

patients with actively haemorrhaging ulcers.

Recurrence may be observed in patients with gastric or duodenal ulcers. While the treatment with

sucralfate can result in complete healing of the ulcer, a successful course of treatment should not

be expected to alter the underlying cause of ulcer disease.

The risk of recurrence of duodenal ulcers may be reduced by maintaining the patient on a reduced

dose for up to 12 months after ulcer healing is complete (see section 4.2). Carafate should be

administered with care in patients with phosphate deficiencies as aluminium binds to phosphate in

the gastrointestinal tract it inhibits its absorption.

Other medicines should not be taken within 2 hours (before or after) taking Carafate.

Use in children

The paediatric dose has not been determined, as clinical experience in children is limited. Therefore,

sucralfate therapy cannot be recommended for children under 18 years of age unless, in the

judgement of the physician, anticipated benefits outweigh the potential risk.

Renal impairment

Care should be taken in patients with impaired renal function as each g of sucralfate contains 190 mg

of aluminium.

4.5

Interaction with other medicines and other forms of interaction

Antacids should not be taken within two hours before or after sucralfate intake because of the

possibility of decreased binding of sucralfate with the gastro-duodenal mucosa as a consequence of

a change of intragastric pH. The interaction of food with sucralfate is also related to the effect of food

on gastric pH.

Other medicines should not be taken within 2 hours (before or after) taking Carafate.

4.6

Fertility, pregnancy and lactation

Pregnancy

There have been no reports to date on the use of sucralfate in pregnant women. Therefore,

sucralfate should be used in pregnant women or women of child bearing potential only if, in the

judgement of the physician, the anticipated benefits outweigh the potential risk.

Breast-feeding

No data available.

Fertility

No data available.

Page 3 of 5

4.7

Effects on ability to drive and use machines

Patients should be warned about potential for dizziness, sleepiness and vertigo and advised not to

drive or operate machinery if these symptoms occur or until their individual susceptibility is known.

4.8

Undesirable effects

Constipation has been encountered in about 2 to 3% of patients in various trials. Other adverse

effects reported include headache (2.4%), urticaria (1%), nausea, diarrhoea, gastric discomfort,

indigestion, dry mouth, thirst, skin rash, pruritus, back pain, dizziness, sleepiness and vertigo.

No additional side effects have been associated with maintenance use of sucralfate for up to

12 months at the recommended dose.

Carafate should be administered with care as long term use may cause symptoms such as

aluminium encephalopathy, aluminium osteomalasia, and anemia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9

Overdose

In acute oral toxicity studies in animals, using doses up to 12 g/kg body weight, a lethal dose could

not be found. Risks associated with overdosage should, therefore, be minimal but constipation and

nausea might be expected.

For further advice on management of overdose please contact the National Poisons Information

Centre (0800 POISON or 0800 764 766).

5. Pharmacological Properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease,

ATC code: A02BX02

Four grams (4 g) daily of sucralfate is effective in increasing the rate of healing of duodenal ulcer

and gastric ulcer over a period of 4 to 8 weeks. Two grams (2 g) daily is effective for prophylactic

use.

Sucralfate is minimally absorbed after oral administration and is believed to act primarily at the ulcer

site.

Sucralfate produces an adherent and cytoprotective barrier at the ulcer site. This barrier protects the

ulcer site from the potential ulcerogenic properties of acid, pepsin and bile. Furthermore, sucralfate

complexes directly with pepsin and bile and also blocks acid diffusion across the sucralfate-protein

barrier at the ulcer site.

The enzyme pepsin is now known to be the primary agent that damages the gastric mucosa directly

and the role played by acid is merely supportive in that it maintains an optimal pH condition for the

damaging action of enzymes on the mucosa.

Experiments have shown that sucralfate is not an antacid.

Inhibition of pepsin by sucralfate is bimodal: formation of pepsin resistant complexes with substrate

proteins and direct absorption of the proteolytic enzyme.

Page 4 of 5

5.2

Pharmacokinetic properties

The action of sucralfate is nonsystemic as the drug is only minimally absorbed (3.5%) from the

gastrointestinal tract. The minimal amounts of the sulphated disaccharide, which are absorbed, are

primarily excreted in the urine.

5.3

Preclinical safety data

No data available.

6. Pharmaceutical Particulars

6.1

List of excipients

Carafate tablets also contain

Carmellose sodium

Macrogol 1500

Magnesium stearate

Microcrystalline cellulose

Water

Carafate tablets contain 190 mg aluminium per tablet.

Carafate tablets are gluten, lactose, and sugar free.

6.2

Incompatibilities

No data available

6.3

Shelf life

2 years

6.4

Special precautions for storage

Store at or below 30°C.

6.5

Nature and contents of container

HDPE bottle containing 120 tablets.

6.6

Special precautions for disposal

No data available

7. Medicines Schedule

General Sale Medicine

8. Sponsor Details

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

AUCKLAND

Freephone: 0800 168 169

Page 5 of 5

9. Date of First Approval

26 May 2005

10. Date of Revision of the Text

30 Jan 2020

Summary table of changes

Section

Summary of new information

Revised statement - ‘For relief of pain, antacids may be added to the

treatment. However, they should not be taken within two hours before

or after sucralfate intake’. Amended from half an hour to two hours.

Additional statement - ‘Do not take other medicines within 2 hours

(before or after) taking Carafate’.

Revised statement - ‘Antacids should not be taken two hours before or

after sucralfate intake’

Additional statement - ‘Other medicines should not be taken within 2

hours (before or after) taking Carafate’.

Additional statement – ‘Patients should be warned about potential for

dizziness, sleepiness and vertigo and advised not to drive or operate

machinery if these symptoms occur or until their individual susceptibility

is known’.

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