MAGICUL

Main information

  • Trade name:
  • MAGICUL 400 cimetidine 400mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MAGICUL 400 cimetidine 400mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213382
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213382

MAGICUL 400 cimetidine 400mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

4/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. MAGICUL 400 cimetidine 400mg tablet blister pack

Product Type

Single Medicine Product

Effective date

11/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Short-term treatment of proven duodenal & gastric ulcer. Maintenance treatment in those patients with recurrence of duodenal ulceration after short-term

therapy. Maintenance treatment for periods of up to one year to reduce the risks of relapse in patients with documented healing of chronic benign gastric

ulcer. Short-term treatment (no more than 12 weeks) of persistent gastro-oesophageal reflux disease. Short-term treatment of heartburn (up to two

weeks) and other symptoms of gastro-oesophageal reflux disease. Treatment of gastrinoma (Zollinger-Ellison syndrome). Treatment of scleroderma

oesophagus.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White, film coated biconvex tablets embossed CN 400 on one side and

blank on reverse.

Active Ingredients

Cimetidine

400 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 11:15:13 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Magicul

contains the active ingredient cimetidine

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about Magicul.

It does not contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking Magicul against

the benefits they expect it will have

for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Magicul is used

for

Magicul is used to:

treat stomach and duodenal ulcers

(duodenal ulcers occur in the tube

leading out of the stomach)

prevent stomach and duodenal

ulcers from coming back

treat gastro-oesophageal reflux

disease which is the washing back

of food and acid from the

stomach up into the food pipe

(oesophagus)

relieve heartburn and other

symptoms of reflux disease

treat Zollinger-Ellison syndrome,

a rare disorder when the stomach

produces very large amounts of

acid, much more than in ulcers

and reflux disease

treat scleroderma oesophagitis, a

rare condition in which the food

pipe becomes thick and hardened,

allowing acid to reflux.

How Magicul works

Magicul belongs to a group of

medicines called H2-antagonists or

H2-blockers. These medicines work

by reducing the amount of acid made

by the stomach. This helps to:

relieve heartburn, the chest pain

or burning sensation rising up the

food pipe

heal the ulcer and/or reflux

disease.

Your doctor may have prescribed

Magicul for another reason. Ask your

doctor if you have any questions

about why Magicul has been

prescribed for you.

Magicul is available only with a

doctor's prescription.

There is no evidence that Magicul is

addictive.

Before you take

Magicul

When you must not take it

Do not take Magicul if you are

allergic to medicines containing

cimetidine or any of the

ingredients listed at the end of this

leaflet.

Some of the symptoms of an allergic

reaction may include skin rash,

itching or hives, swelling of the face,

lips or tongue, which may cause

difficulty in swallowing or breathing,

wheezing or shortness of breath.

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.

Magicul is not recommended for use

in children unless advised by your

child's doctor, as there have been

limited studies of its effects in

children of this age group.

Before you start to take it

Tell your doctor if you are allergic

to any other medicines, foods, dyes

or preservatives.

Tell your doctor if you are

pregnant or plan to become

pregnant.

Your doctor will discuss the risks and

benefits of taking Magicul during

pregnancy.

Tell your doctor if you are

breastfeeding or wish to

breastfeed.

Magicul passes into breast milk.

Your doctor will discuss the risks and

benefits of taking Magicul when

breastfeeding.

Tell your doctor if you have, any

medical conditions, especially the

following:

liver problems

kidney problems

lung disease

diabetes

lowered immunity.

Your doctor may want to take special

care if you have any of these

conditions.

MAGICUL

If you have not told your doctor

about any of the above, tell them

before you start taking Magicul.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines and Magicul

interfere with each other. These

include:

warfarin, a medicine used to

prevent blood clots

phenytoin, a medicine used to

treat epilepsy

theophylline, a medicine used to

treat asthma

metformin, a medicine used to

treat diabetes

chlormethiazole, a sedating

medicine used in alcohol

withdrawal and some other

conditions

medicines used for high blood

pressure and some heart

conditions

medicines used to treat

depression or anxiety

sleeping tablets

medicines used to relieve arthritis

or other pain

cyclosporin and tacrolimus,

medicines used to prevent

rejection of transplanted organs

atazanavir, a medicine used to

treat HIV infection

some medicines used to treat

fungal infections, such as

ketoconazole, itraconazole or

posaconazole

narcotic analgesics, such as

morphine or codeine

medicines used to treat cancer.

These medicines may be affected by

Magicul or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Some antacids may interfere with

the absorption of Magicul.

To make sure there is no problem

with absorption, you should take

Magicul at least one hour before or

one hour after taking antacids.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take Magicul

How much to take

To treat an ulcer or reflux disease,

the usual dose is 800 mg a day. This

can be taken as 800 mg at bedtime or

as 400 mg in the morning and 400

mg at bedtime.

To prevent an ulcer from coming

back, the usual dose is 400 mg at

bedtime.

For short-term relief of heartburn or

other symptoms of reflux disease, the

usual dose is 200 mg up to four times

a day. The maximum dose is 800 mg

a day. Magicul does not provide

immediate relief of symptoms.

Your doctor may advise you to take a

different dose. This depends on your

condition and whether you are taking

any other medicines.

Follow all directions given to you

by your doctor and pharmacist

carefully.

How to take it

Swallow the tablets whole with a

glass of water.

Do not crush or chew the tablets.

If you crush or chew Magicul tablets,

they will not work as well.

When to take it

Take Magicul at about the same

time each day.

Taking your medicine at the same

time each day will give the best

effect and help you to remember

when to take your medicine.

If your doctor has prescribed

divided doses of Magicul, space

them evenly apart throughout the

day.

Magicul can be taken with or without

food.

If you are undergoing haemodialysis,

Magicul should be taken after

dialysis.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take the missed dose as

soon as you remember, and then go

back to taking your tablets as you

would normally.

Do not take a double dose to make

up for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

How long to take it for

If you are taking Magicul to heal an

ulcer, you will need to take it for 4 to

8 weeks.

If you are taking Magicul to treat

reflux disease, you may need to take

it for up to 12 weeks.

For short-term relief of heartburn and

symptoms of reflux disease, you can

take Magicul for up to 2 weeks. If the

pain or symptoms are not relieved by

Magicul or persist you should see

your doctor.

If you are taking Magicul to stop an

ulcer from coming back or to treat

other conditions, your doctor will tell

you how long you need to take the

tablets.

Keep taking Magicul for as long as

your doctor recommends.

It is very important that you take the

full course of Magicul prescribed by

your doctor so that your condition is

properly treated.

MAGICUL

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26), or go to

Accident and Emergency at the

nearest hospital, if you think you

or anyone else may have taken too

much Magicul. Do this even if

there are no signs of discomfort or

poisoning.

You may need urgent medical

attention.

If you take too much Magicul, you

may feel drowsy or confused.

While you are taking

Magicul

Things you must do

If you are about to be started on

any new medicine, tell your doctor

or pharmacist that you are taking

Magicul.

Tell any other doctors, dentists and

pharmacists who are treating you

that you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all your doctor's

appointments so that your progress

can be checked.

Your doctor may want you to have

tests to make sure that your ulcer or

reflux disease is healing.

Things you must not do

Do not stop taking Magicul, or

change the dose, without checking

with your doctor.

Do not use Magicul to treat any

other complaints unless your

doctor tells you to.

Do not give Magicul to anyone else,

even if they have the same

condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

Magicul affects you.

Magicul may cause drowsiness or

dizziness in some people. If any of

these occur, do not drive, operate

machinery or do anything else that

could be dangerous.

Suggestions that may help

your condition

Some self-help actions suggested

below may help your condition. Talk

to your doctor or pharmacist about

these and ask for more information.

Alcohol - your doctor may advise

you to limit your alcohol intake.

Aspirin and many other

medicines used to treat arthritis,

period pain and headaches - these

medicines may irritate the

stomach and may make your

condition worse. Your doctor or

pharmacist may suggest other

medicines you can take.

Caffeine - your doctor may advise

you to limit the number of drinks

which contain caffeine, such as

coffee, tea, cocoa and cola drinks,

because they contain ingredients

that may irritate your stomach.

Eating habits - eat smaller, more

frequent meals. Eat slowly and

chew your food carefully. Try not

to rush at meal times.

Smoking - your doctor may

advise you to stop smoking or at

least cut down.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Magicul.

Like all other medicines, Magicul

may have unwanted side effects in

some people. Sometimes they are

serious, most of the time they are not.

You may need medical treatment if

you get some of the side effects.

Do not be alarmed by the following

list of side effects.

You may not experience any of them.

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:

headache

tiredness, drowsiness

dizziness

muscle aches and pains

mild skin rash

hair loss

diarrhoea, constipation, wind

nausea (feeling sick), vomiting

in men, enlarged breasts and

impotence (these have been

reported rarely in patients

receiving high doses).

For the most part, these side effects

are mild.

Tell your doctor immediately if

you notice any of the following:

fast, slow or irregular heart beat

yellowing of the eyes or skin

(jaundice)

fever

confusion, hallucinations,

depression

severe upper stomach pain, often

with nausea and vomiting

unusual bruising or bleeding

looking pale, tiredness, being

short of breath when exercising

signs of frequent infections such

as fever, chills, sore throat or

mouth ulcers.

These side effects may be serious.

You may need urgent medical

attention.

If any of the following happen, stop

taking Magicul and tell your

doctor immediately, or go to

Accident and Emergency at the

nearest hospital:

hives or severe skin reactions

MAGICUL

swelling of the face, mouth,

throat or limbs

shortness of breath or difficulty

breathing.

These reactions may be signs of a

severe allergic reaction to Magicul.

Allergic reactions are rare.

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.

Some health problems may arise

from the condition being treated

itself, rather than the treatment. For

this reason, contact your doctor

immediately if you notice any of the

following:

pain or indigestion which occurs

during treatment with Magicul

vomiting

passing black or blood-stained

motions

unexpected weight loss.

After taking Magicul

Storage

Keep Magicul 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.

Keep your tablets in a cool dry

place where the temperature stays

below 30°C for 200 mg and 800 mg

tablets, and below 25°C for 400 mg

tablets

Do not store Magicul or any other

medicine in the bathroom or near a

sink.

Do not leave Magicul in the car or

on window sills.

Heat and dampness can destroy some

medicines.

Disposal

If your doctor tells you to stop

taking Magicul, or your tablets

have passed their expiry date, ask

your pharmacist what to do with

any that are left over.

Product description

What it looks like

Magicul comes in 3 strengths of

tablets:

Magicul 200 - round, pale green,

film-coated tablet marked CE2 on

one side and a Greek Alpha

symbol on the reverse. Each pack

contains 120 tablets.

Magicul 400 mg - White film

coated biconvex tablets embossed

"CN 400" on one side with "G"

on the reverse. Each pack

contains 60 tablets.

Magicul 800 - oval, pale green,

film-coated tablet marked CE8 on

one side and a Greek Alpha

symbol on the reverse. Each pack

contains 30 tablets.

Ingredients

The active ingredient in Magicul is

cimetidine. Each tablet contains 200

mg, 400 mg or 800 mg of cimetidine.

The tablets also contain:

maize starch

povidone

microcrystalline cellulose

sodium starch glycollate (Type

magnesium stearate

Opadry Green OY-8830 (ARTG

no. 1538) for 200 mg and 800 mg

tablets.

Opadry White Y-1-7000 E171

(ARTG no. 2731) for 400 mg

tablets.

The tablets are gluten free.

Manufacturer

Magicul is supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

AUSTRALIA

Phone: (02) 9298 3999

Australian registration numbers:

Magicul 200 - Aust R 70764

Magicul 400 - Aust R 213382

Magicul 800 - Aust R 70766

This leaflet was prepared on

14 November 2013

Magicul_cmi\NOV03/00

MAGICUL