SUMMARY CMI

CYTOTEC^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.

1. Why am I taking CYTOTEC?

CYTOTEC contains the active ingredient misoprostol. CYTOTEC can help make your stomach produce less acid, and it helps your stomach protect itself against damage from acid and certain other substances, such as NSAIDs. CYTOTEC can be used also to treat acute ulcers in the stomach and small intestine. CYTOTEC can also be used to prevent bleeding in the stomach or upper intestine in hospital patients after surgery.

For more information, see Section 1. Why am I taking CYTOTEC? in the full CMI.

2. What should I know before I take CYTOTEC?

Do not take if you have ever had an allergic reaction to misoprostol or any of the ingredients listed at the end of the CMI.

Do not take CYTOTEC if pregnant, planning to be pregnant or if there is any chance you may be pregnant, or are breastfeeding.

Talk to your doctor if you have any other medical conditions, or take any other medicines.

For more information, see Section 2. What should I know before I take CYTOTEC? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CYTOTEC and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take CYTOTEC?

• Follow doctor's instructions for how to take CYTOTEC.
• CYTOTEC is best taken with food.

More instructions can be found in Section 4. How do I take CYTOTEC? in the full CMI.

5. What should I know while taking CYTOTEC?

For more information, see Section 5. What should I know while using CYTOTEC? in the full CMI.

6. Are there any side effects?

Common side effects include stomach pains, diarrhoea, nausea, vomiting, wind or heartburn. Anaphylaxis is is a serious side effect.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CYTOTEC^®

Active ingredient(s): misoprostol

Consumer Medicine Information (CMI)

This leaflet provides important information about using CYTOTEC. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CYTOTEC.

Where to find information in this leaflet:

1. Why am I taking CYTOTEC?
2. What should I know before I take CYTOTEC?
3. What if I am taking other medicines?
4. How do I take CYTOTEC?
5. What should I know while taking CYTOTEC?
6. Are there any side effects?
7. Product details

1. Why am I taking CYTOTEC?

CYTOTEC contains the active ingredient misoprostol.

Misoprostol is very similar to a group of substances called prostaglandins, which occur naturally in the stomach and other parts of the body.

When the amount of these natural prostaglandins is lower than normal, there is a risk that ulcers may occur in the stomach or duodenum (the first part of the small intestine).

This reduction in prostaglandins is often a side effect of medicines known as non-Steroidal anti-inflammatory Medicines (NSAIDs).

CYTOTEC makes your stomach produce less acid. CYTOTEC can also help prevent ulcers by strengthening the stomach lining

CYTOTEC is used:

• To treat acute ulcers in the stomach (gastric ulcers), or in the first part of the small intestine (duodenal ulcers).
• To prevent development of stomach ulcers in patients at high risk of developing ulcers, which may be caused by anti-inflammatory medicines knows as NSAIDs.
• To prevent stress-induced bleeding in the stomach or upper intestine in hospital patients after surgery.

Your doctor, however, may prescribe CYTOTEC for another purpose.

Ask your doctor if you have any questions about why CYTOTEC has been prescribed for you.

There is no evidence that CYTOTEC is addictive.

2. What should I know before I take CYTOTEC?

Warnings

Do not take CYTOTEC:

1. If you are allergic to misoprostol (or another prostaglandin medicine), or any of the ingredients listed at the end of this leaflet. If you have an allergic reaction you may get a skin rash, difficulty in breathing, hayfever or faintness. Always check the ingredients to make sure you can use this medicine.
2. If you are pregnant, or there is a possibility you may be pregnant, or if you intend to become pregnant.

Tell your doctor if you become pregnant while you are taking CYTOTEC - see Pregnancy and Breastfeeding below.

3. After the expiry date (EXP) printed on the pack.

It may have no effect at all, or worse, an entirely unexpected effect if you use it after the expiry date.

4. If the packaging shows signs of tampering.
5. To treat any other complaints unless your doctor says to.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Check with your doctor if you:

• have any other medical conditions especially:
  - epilepsy
  - asthma
  - diseases of the heart or blood vessels.
  - bowel disease
• take any medicines for any other condition including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop
• You are allergic to any other medicines or any foods, dyes or preservatives

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take CYTOTEC if your are pregnant or intend to become pregnant.

The effects of CYTOTEC may be harmful to a developing baby (fetus).

CYTOTEC must not be used by pregnant women as it may cause miscarriage, and this could lead to potentially dangerous bleeding, hospitalisation, surgery, infertility or death. You should not become pregnant while taking CYTOTEC.

If it is possible for you to become pregnant, you should use adequate contraception while you are taking CYTOTEC. Examples of adequate contraception include oral contraceptives ("the pill") or intra-uterine devices (IUDs).

Talk to your doctor if you are breastfeeding or intend to breastfeed.

CYTOTEC passes into breast milk, therefore it is not recommended that you take CYTOTEC if you are breast feeding.

Use in children

The effects of CYTOTEC have only been studied in adults, and there is no specific information comparing its use in children with use in adults.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, or if you are not sure about any medicines, including any vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

If an antacid is needed, please see Section 5. What should I know while taking CYTOTEC? for more information.

4. How do I take CYTOTEC?

How much to take / use

• The usual dosage of CYTOTEC is one tablet two, three or four times a day.
• CYTOTEC is best taken with food. Do not take CYTOTEC on an empty stomach.
• Follow your doctor's instructions exactly on how much CYTOTEC to take, and for how long to take it.
• If you are taking an NSAID, CYTOTEC may be prescribed for as long as you are taking the NSAID, whether or not you have stomach pain or other symptoms of ulcers. Some ulcers are painless, particularly those caused by NSAIDs.

If you forget to take CYTOTEC

CYTOTEC should be used regularly at the same time each day.

If you miss a dose of CYTOTEC, take it as soon as possible. However, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much CYTOTEC

If you think that you have used too much CYTOTEC, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre Australia (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Signs that may indicate an overdose of CYTOTEC include: sedation (feeling sleepy), shaking, fits, shortness of breath, stomach pains, diarrhoea, contraction of the uterus (womb), heart palpitations, low blood pressure or slow heart beat.

5. What should I know while taking CYTOTEC?

Things you should do

Take CYTOTEC exactly as your doctor has prescribed.

Tell all doctors, dentist and pharmacists who are treating you that you are taking CYTOTEC.

If an antacid is needed for stomach pain, use one which does not contain magnesium. Aluminium-containing antacids may be used when needed for relief of pain. Ask your doctor or pharmacist for advice if necessary.

Things you should not do

Stop taking CYTOTEC if you become pregnant or you think you may be pregnant.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CYTOTEC affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place (where the temperature stays below 25°C) away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat or moisture may cause CYTOTEC tablets to deteriorate.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

Keep your tablets in their blister until it is time to take them. If you take the tablets out of the blister they may not keep well.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Check with your doctor as soon as possible if you have any problems while taking CYTOTEC even if you think they are not connected with the medicine or are not listed in this leaflet.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CYTOTEC contains

Do not take this medicine if you are allergic to any of these ingredients.

What CYTOTEC looks like

CYTOTEC tablets are scored, white, hexagonal tablets, marked on one side with SEARLE/1461 (AUST R 63983).

Packs contain 120 tablets.

Who distributes CYTOTEC

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

This leaflet was prepared in March 2023.

^®Registered trademark

Published by MIMS June 2023

1 Name of Medicine

Misoprostol.

2 Qualitative and Quantitative Composition

Cytotec tablets contain 200 micrograms of misoprostol.

3 Pharmaceutical Form

Tablets 200 micrograms.

4 Clinical Particulars

4.1 Therapeutic Indications

Cytotec is indicated in the treatment of acute duodenal and gastric ulcers.
Cytotec is indicated in the prevention of stress-induced upper gastrointestinal mucosal bleeding and lesions in postsurgical patients in intensive care units.
Cytotec is indicated for the prevention of gastric ulceration in patients in whom NSAID therapy is essential and who have been assessed at high risk of gastric ulceration or the complications of gastric ulceration.

4.2 Dose and Method of Administration

Dosage.

Treatment of duodenal ulcers.

Treatment of gastric ulcers.

Prevention of stress induced mucosal bleeding and lesions in postsurgical ICU patients.

Prevention of NSAID induced gastric ulceration.

Dosage adjustment.

Elderly.

Use in renal impairment.

4.3 Contraindications

Cytotec should not be administered to anyone with a known hypersensitivity to misoprostol or any other ingredient of the product, or to other prostaglandins.
Cytotec is contraindicated in pregnancy, or in patients in whom pregnancy has not been excluded (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy; Section 4.8 Adverse Effects (Undesirable Effects), Post-marketing experience).

4.4 Special Warnings and Precautions for Use

Gastrointestinal bleeding, ulceration and perforation have occurred in NSAID treated patients receiving misoprostol. Physicians and patients should remain alert for ulceration, even in the absence of gastrointestinal symptoms.
Symptomatic responses to misoprostol do not preclude the presence of gastric malignancy.
Patients with conditions that predispose to diarrhoea, such as inflammatory bowel disease, or those in whom dehydration would be dangerous, should be monitored carefully.

Nosocomial pulmonary infections.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The serum protein binding of misoprostol acid was not affected by indomethacin, ranitidine, digoxin, phenylbutazone, warfarin, diazepam, methyldopa, propranolol, triamterene, cimetidine, paracetamol, ibuprofen, chlorpropamide, and hydrochlorothiazide.
With salicylic acid (300 micrograms/mL) the protein binding of misoprostol was lowered from 84% to 52% which is not considered clinically significant since the binding of misoprostol acid is not extensive and its elimination half-life is very short.
In laboratory studies, misoprostol has no significant effect on the cytochrome P450-linked hepatic mixed function oxidase system, and therefore should not affect the metabolism of theophylline, warfarin, benzodiazepines or other drugs normally metabolised by this system. No drug interactions have been attributed to misoprostol in extensive clinical trials. As such, other drugs would be unlikely to interfere with misoprostol's metabolism in either normal or hepatically impaired patients. There are no data on clinical safety beyond 12 months for the use of concurrent misoprostol and NSAIDs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

In clinical trials, the most frequent adverse events were diarrhoea, abdominal pain, and loose stools. These events occurred in approximately one-tenth of patients receiving Cytotec 800 micrograms daily in two or four divided doses. The events were usually transient and mild to moderate in severity. Diarrhoea, when it occurred, usually developed early in the course of treatment, was dose related, self-limiting and required discontinuation of Cytotec in less than 2% of the patients, though it has occasionally been reported to lead to severe dehydration. The incidence of diarrhoea can be minimised by administering Cytotec immediately after meals and at bedtime, and by avoiding the use of magnesium containing antacids. Dose adjustment may also be helpful. Abdominal pain has been associated with Cytotec therapy, and in controlled trials with concomitant NSAIDs the incidence was not significantly different from placebo.
Women who received Cytotec during clinical trials reported the following gynaecological disorders: uterine cramping, menorrhagia, menstrual disorder, spotting, dysmenorrhoea, intermenstrual bleeding and vaginal haemorrhage (including postmenopausal bleeding). The incidence of each of these adverse reactions in women was < 1%.
In clinical trials, the following adverse reactions were reported by more than 1% but less than 3% of the subjects receiving Cytotec and may be causally related to the drug: nausea, headache, flatulence, dyspepsia, vomiting, constipation and dizziness.

Elderly.

Post-marketing experience.

Immune system disorder.

Pregnancy, puerperium, and perinatal conditions.

Reproductive system and breast disorders.

Congenital, familial and genetic disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Hypertension and tachycardia have also been reported following overdoses. Overdose in pregnancy has resulted in uterine contractions with foetal death.
The toxic dose of Cytotec in human beings has not been determined. Cumulative total daily doses of 1600 micrograms have been tolerated with only symptoms of gastrointestinal discomfort being reported.
There is no specific antidote. Treatment should be symptomatic and supportive. Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal is most effective when administered within 1-hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. Because misoprostol is metabolised like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Acid secretion.

Mucosal cytoprotective activity.

Clinical trials.

5.2 Pharmacokinetic Properties

Cytotec is rapidly absorbed following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occurring in about 30 minutes, as measured either by radioactive or cold (radioimmunoassay) methods. Misoprostol acid undergoes further metabolism by fatty acid oxidizing systems (beta and omega oxidation) which are present in numerous tissues in the body. The plasma elimination half-life of misoprostol acid is 20 - 40 minutes. The plasma elimination half-life of additional misoprostol metabolites is 1.5 hours.
Seventy-three percent of the radioactivity of an oral dose of radiolabelled misoprostol is excreted in the urine, with an additional 15% excreted in the faeces. About 56% of total radioactivity was eliminated in urine within 8 hours.
The serum protein binding of misoprostol acid, the primary metabolite, was in the range of 80 - 90% and was concentration independent in the therapeutic range. There was no accumulation of misoprostol in red blood cells.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Microcrystalline cellulose, hypromellose, sodium starch glycollate, hydrogenated castor oil.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C and protect from moisture.

6.5 Nature and Contents of Container

The following presentations are registered: cold formed blister packs of 20 and 120* tablets and bottles of 12, 28, 60 and 120 tablets.
* Currently marketed pack size.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Misoprostol is a water soluble, viscous liquid.
Misoprostol is a synthetic prostaglandin E₁ analogue. Misoprostol has a molecular formula of C₂₂H₃₈O₅ and a molecular weight of 382.5.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes