SUMMARY CMI

CERVAGEM^®

Consumer Medicine Information (CMI) summary

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

1. Why am I using CERVAGEM?

CERVAGEM contains the active ingredient gemeprost. CERVAGEM is used for the dilation and softening of the cervix prior to surgical procedures during pregnancy or for the induction of miscarriage.

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

2. What should I know before I use CERVAGEM?

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

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

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

3. What if I am taking other medicines?

Some medicines may interfere with CERVAGEM 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 use CERVAGEM?

CERVAGEM is administered by insertion via the vagina by a doctor or nurse.

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

5. What should I know while using CERVAGEM?

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

6. Are there any side effects?

Common side effects: vaginal bleeding or uterine pain, nausea, vomiting, lower abdominal pain, backache, headache, slight fever, flushing, chills, dizziness, lightheadedness, irregular heartbeats, muscle weakness, shortness of breath.

Tell your doctor or nurse immediately if you notice any of the following: asthma, wheezing or shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching, skin rash or fainting. These are symptoms of an allergic reaction. Serious side effects may also include: fainting, chest spasm or pain, prolonged or spasmotic pelvic/lower back pain. You may need urgent medical attention. 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

CERVAGEM^®

Active ingredient(s): gemeprost

Consumer Medicine Information (CMI)

This leaflet provides important information about using CERVAGEM. 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 CERVAGEM.

Where to find information in this leaflet:

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

1. Why am I using CERVAGEM?

CERVAGEM contains the active ingredient gemeprost. Gemeprost is a member of the prostaglandin class of medicines. Prostaglandins are hormone-like substances which stimulate changes to the uterus and cervix.

CERVAGEM is used for the dilation and softening of the cervix prior to surgical procedures during pregnancy or for the induction of miscarriage.

Your doctor may have prescribed Cervagem for another reason.

2. What should I know before I use CERVAGEM?

Warnings

Do not use CERVAGEM if:

• you are allergic to gemeprost, or any of the ingredients listed at the end of this leaflet.
• you are allergic to prostaglandins
• your pregnancy is near full term.
• you have previously experienced a difficult labour. or delivery.
• you are at risk of hemorrhage due to procedures for placenta previa, ectopic pregnancy, etc.
• you have fever due to pelvic infection
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you have:

• given birth more than twice
• uterine scarring
• cervical narrowing
• vaginal bleeding of unknown origin
• had a twin pregnancy
• an infection of the cervix or vagina
• a respiratory condition
• any heart condition
• glaucoma or increased eye pressure
• allergies to any other medicines, any other substances, such as foods, preservatives or dyes.

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

Check with your doctor if you are pregnant or intend to become pregnant.

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

CERVAGEM is not to be used to soften the cervix or to induce labour in the pregnant woman at term.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CERVAGEM.

4. How do I use CERVAGEM?

How to use

• CERVAGEM is administered by insertion via the vagina by a doctor or nurse.

5. What should I know while using CERVAGEM?

Things you should do

Call your doctor straight away if you experience:

• asthma, wheezing or shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, hives, itching, skin
• rash or fainting. These are symptoms of an allergic reaction.
• chest spasm or pain.
• prolonged or spasmodic pelvic/lower back pain
• bleeding

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Remind any doctor, dentist or pharmacist you visit that you are using CERVAGEM.

Driving or using machines

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Store below -10°C (freeze) in the original pack.
• Remove only sufficient pessaries from freezer for immediate use. Any pessaries removed from freezer should NOT be refrozen.

Keep it where young children cannot reach it.

When to discard your medicine

Once the foil sachet has been opened, any pessary not used within 12 hours should be destroyed.

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.

Do not use this medicine after the expiry date.

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.

Less serious 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.

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 CERVAGEM contains

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

What CERVAGEM looks like

CERVAGEM is a white to creamy torpedo shaped pessary. (Aust R 27491).

Who distributes CERVAGEM

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

This leaflet was prepared in August 2022

cervagem-ccdsv1-cmiv2-02aug22

Published by MIMS September 2022

1 Name of Medicine

Gemeprost.

2 Qualitative and Quantitative Composition

Cervagem pessaries each contain 1 mg of gemeprost.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Yellow-white spindle shaped vaginal pessaries.

4 Clinical Particulars

4.1 Therapeutic Indications

For the softening and dilatation of the cervix uteri prior to transcervical, intrauterine operative procedures in the first trimester of pregnancy.
Therapeutic termination of pregnancy in patients in the second trimester of gestation.

4.2 Dose and Method of Administration

See Section 4.4 Special Warnings and Precautions for Use especially for use during second trimester.
Before administration the pessary should be allowed to warm to room temperature for 30 min away from direct heat and sunlight in the unopened foil sachet.
Cervagem pessaries are nonsterile.

Adults.

Cervical dilation (first trimester of pregnancy).

Therapeutic termination (second trimester of pregnancy).

Elderly.

Children.

4.3 Contraindications

Cervagem should not be administered to women with known hypersensitivity to prostaglandins or to any ingredients of this drug. Cervagem is also contra-indicated in women experiencing uterine fragility related to uterine scarring and in placenta praevia.
Cervagem pessaries should not be used for the induction of labour or cervical softening at term.
Cervagem is contraindicated in patients at a risk of hemorrhage due to procedures for placenta previa, ectopic pregnancy, etc. Massive hemorrhage may occur because transvaginal labour cannot occur.
Cervagem is contraindicated in patients with fever due to pelvic infection. Inflammation and infection may be aggravated.

4.4 Special Warnings and Precautions for Use

There have been reports of uterine ruptures and cervical laceration with gemeprost. Therefore, extreme care must be taken and cervical dilatation and uterine contractions monitored when using this drug in the termination of pregnancy (whether therapeutic or for intrauterine foetal death) especially during the second trimester and during the second course of therapy. This is particularly important in women who have one or more of the following conditions: multiparity, uterine scarring, cervical stenosis, vaginal bleeding of unknown origin or twin pregnancy.
Special attention should be paid to the dosage and administration, and precautions for use.
Serious, potentially fatal, cardiovascular accidents (myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported with prostaglandins including gemeprost and cardiac and vascular parameters should be monitored.
There have been reports of uterine rupture following concomitant administration of gemeprost and syntocinon in the second trimester after previous hysterotomy or classical caesarean section.
If surgery is unavoidably delayed much beyond the recommended three hour interval, the patient should be kept under observation as the incidence and severity of vaginal bleeding and uterine pain increases. The possibility that spontaneous abortion may occur should also be considered.
Adequate follow-up for patients having a pregnancy termination is essential to ensure that the process has been completed as the effect of Cervagem on the foetus has not been established.
Clinical trials have suggested that products of conception in the second trimester of termination of pregnancy patients will be retained in many cases. Due to the risk of retention of products of conception which may need to be surgically removed, appropriate facilities should be available.
Cervagem should be used with caution in patients with obstructive airways disease, cardiovascular insufficiency, elevated intraocular pressure, cervicitis or vaginitis.
Patients with the following diseases have not been studied: ulcerative colitis, diabetes mellitus, sickle-cell anaemia, epilepsy, disorders of blood coagulation.

Use in hepatic impairment.

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

See Section 4.4 Special Warnings and Precautions for Use.
Oxytocin and other labour inducers or accelerators can potentiate the action of gemeprost.

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)

Serious or life-threatening reactions.

More common reactions.

Reproductive.

Gastrointestinal.

Musculoskeletal.

General.

Less common reactions.

Cardiovascular.

Musculoskeletal.

Respiratory.

General.

Hypersensitivity-like reactions.

Reporting suspected adverse effects.

4.9 Overdose

The toxic dose of gemeprost in women has not been established. Cumulative dosage of 10 mg in 24 hours has been well tolerated. In animals the acute toxic effects are similar to PGE₁, i.e. relaxation of smooth muscle, leading to hypotension and depression of the CNS.
Clinically valuable signs of impending toxicity are likely to be sedation, tremor, convulsion, dyspnoea, abdominal pain and diarrhoea which may be bloody; palpitations or bradycardia.
Treatment should be symptomatic. A vaginal douche may be of value depending on the elapsed time since insertion of the pessary.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Genito urinary system and sex hormones, Prostaglandins ATC code: G02AD03.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Human pharmacokinetic studies have demonstrated that limited systemic absorption occurs from intravaginal administration of Cervagem.
Based on the urinary elimination of metabolites it is concluded that approximately 12-28% of the administered dose reached the systemic circulation. Results from studies using I.V. administration of the drug have demonstrated it to be rapidly metabolised with about 50% of the dose eliminated as metabolites in the urine during the first 24 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ethanol, hard fat.

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.
Once the foil has been opened, any pessary not used within 12 hours should be destroyed.

6.4 Special Precautions for Storage

Store below -10°C (freeze) in the original pack.
Remove only sufficient pessaries from freezer for immediate use. Any pessaries removed from freezer should not be refrozen.

6.5 Nature and Contents of Container

Container of 5 units dose foil sachets.

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

Gemeprost INN is methyl-(E)- 7-[(1R,2R,3R)- 3-hydroxy- 2-[(1E,3R)- 3-hydroxy-4, 4-dimethyloct- 1-enyl]- 5-oxocyclopentyl]-hept- 2-enoate. It is also known as 16,16-dimethyl-trans-Δ² PGE₁ methyl ester.
It is a colourless to pale yellow viscous liquid having no odour.
Molecular formula: C₂₃H₃₈O₅.
Molecular weight: 394.53.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 Prescription Only Medicine.

Summary Table of Changes