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Read all of this leaflet carefully before you are given this medicine

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask you doctor or nurse.

-    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 nurse.

In this leaflet:

1.    What Cervagem Pessary is and what it is used for.

2.    What you need to know before you take Cervagem Pessary.

3.    How you are given Cervagem Pessary

4.    Possible side effects

5.    How Cervagem Pessary is stored

6.    Contents of the pack and other information.

1. What Cervagem Pessary is and what it is used for

H Cervagem Pessary contains a medicine called gemeprost.

This belongs to a group of medicines called

prostaglandins. It works by making the womb contract.Cervagem is normally given to women in the following situations:

• To make the operation to terminate a pregnancy in the first three months easier.

• To terminate a pregnancy between the fourth and sixth month.

• To terminate a pregnancy between the fourth and sixth month, if the unborn baby (foetus) has already died.

2. What you need to know before you use Cervagem Pessary

Do not use Cervagem Pessary if:

x You are allergic (hypersensitive) to gemeprost or any of the other ingredients of this medicine (See section 6: Further information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

x You are allergic or sensitive to prostaglandin medicines such as alprostadil, bimatoprost, latanoprost, travoprost or misoprostol.

x You have or have had placenta previa (light or heavy vaginal bleeding which may be sudden, painless and recurring). Your doctor should check on this and may perform an ultrasound scan.

x You have kidney problems. x You have had an operation on your womb, like a caesarean section.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given the first pessary.

Take special care with Cervagem Pessary

Talk to your doctor or nurse before you are given this medicine if:

▲    You have breathing problems.

▲    You have glaucoma (raised pressure in the eye which affects your sight).

▲    You have any heart problems.

▲    You have dizziness, lightheadedness or fainting. This may be due to low blood pressure

▲    You have a rare genetic disease known as sickle cell anaemia

▲    You have epilepsy

▲    You have unusual vaginal discharge, pain when passing water or increased need to pass water.

These may be signs of cervicitis

▲    You have vaginal pain, itching or discharge. These may be signs of vaginitis

▲    You have an illness where the level of glucose in your blood is not controlled properly (diabetes mellitus)

▲    You have a problem with your blood clotting

Taking or using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without prescription. This includes medicines you can buy without prescription, including herbal medicines. This is because Cervagem can affect the way some other medicines work. Also some medicines can affect the

way Cervagem works.

In particular, tell your doctor you are taking any of the following.

Medicines used to speed up labour such as oxytocin. This can increase the effect of Cervagem.

3. How you will be given Cervagem Pessary

•    Cervagem pessaries will be given to you by a doctor or nurse.

•    The pessaries are inserted into your vagina.

•    The number of pessaries given to you will depend on the reason for its use.

The doctor or nurse will keep an eye on you while you are being treated with Cervagem pessaries.

Cervagem 1mg Pessary

gemeprost

PRESENTATION

White to yellowish-white spindle shaped vaginal pessaries each containing 1mg GEMEPROST.

INDICATIONS

Softening and dilatation of the cervix uteri prior to trans-cervical intrauterine operative procedures in pregnant patients in the first trimester of gestation.

Therapeutic termination of pregnancy in patients in the second trimester of gestation, in licensed institutions.

Induction of abortion of second trimester pregnancies complicated by intrauterine foetal death.

ADMINISTRATION AND DOSAGE

Before administration, the pessary should be allowed to warm to room temperature for 30 minutes, away from direct heat and sunlight, in the unopened foil sachet.

1.    Softening and dilatation of the cervix in the first trimester of gestation.

Adults: One pessary to be inserted into the posterior vaginal fornix 3 hours before surgery.

2.    Therapeutic termination of pregnancy in the second trimester of gestation.

Adults: One pessary to be inserted into the posterior vaginal fornix at 3-hourly intervals to a maximum of 5 administrations. If abortion is not established after 5 pessaries, a second course of treatment may be instituted starting 24 hours after the initial commencement of treatment.

If abortion is not well established after 10 pessaries, a further course of CERVAGEM treatment is not recommended and alternative means should be employed to effect uterine emptying

3. Intrauterine foetal death in the second trimester of gestation.

One pessary to be inserted into the posterior vaginal fornix at 3-hourly intervals up to a maximum of 5 administrations.

Elderly: Not applicable.

Children: Not applicable.

CONTRAINDICATIONS

CERVAGEM should not be administered to women with known hypersensitivity to prostaglandins or to women with renal function disturbances. CERVAGEM is also contraindicated in women experiencing uterine fragility related to uterine scarring, and in placenta previa.

CERVAGEM pessaries should not be used for the induction of labour or cervical softening at term as foetal effects have not been ascertained.

PRECAUTIONS

CERVAGEM should be used with caution in patients with obstructive airways disease, those with cardiovascular insufficiency, elevated intraocular pressure, cervicitis or vaginitis.

Serious, potentially fatal, cardiovascular accidents (myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported with protaglandins including CERVAGEM.

Cardiac and vascular parameters should be monitored by taking regular measurements of the patients pulse and blood pressure. Coagulopathy may occur following intrauterine foetal death and should be monitored and managed actively according to current standard clinical practice.

Cervagem pessaries can be given in one of the following ways in these situations:

Termination of pregnancy in the first three months to make the operation easier

•    One pessary inserted three hours before the operation.

•    If the operation is delayed for more than three hours, you will be kept under observation. This is because termination may occur anyway.

•    If you start to bleed, tell the doctor or nurse.

Termination of pregnancy between the fourth and sixth month

•    One pessary inserted every three hours.

•    Up to 5 pessaries are normally given.

•    Sometimes you may need up to five more pessaries.

•    If the termination has not happened by this time, your doctor or nurse will use another method to finish the termination.

Termination of a pregnancy between the fourth and sixth month, if the unborn baby (foetus) has already died

•    One pessary will be inserted every three hours.

•    Up to 5 pessaries are normally given to you.

After the treatment, the doctor or nurse will check to make sure the termination has been completed properly.

It is important to keep your appointment if you are due a follow-up examination after this treatment.

4. Possible side effects

0Like all medicines, Cervagem Pessary can cause side effects, although not everybody gets them.

Very rare allergic reactions that can occur with prostaglandins such as Cervagem

You could notice the following signs of an allergic reaction:

• Flushing, fainting, fever and chills • Itching and redness all over your body • Tight chest and difficulty in breathing • Back pain

If you think that Cervagem is causing an allergic reaction, tell your doctor straight away.

Very rare side effects

• Splitting or tearing of the womb. This usually happens in women who have had several children or a previous operation on the womb (such as a caesarian section).

• Heart and circulation problems.

Other side effects If you have any of the following side effects, do not worry. However if they are troublesome, talk to your doctor or nurse. These side effects usually last for a short time.

• Bleeding from your vagina and mild pain in your womb (like period pain)

• Feeling sick (nausea) and being sick (vomiting)

• Diarrhoea

• Headache and flushing • Muscle weakness and backache

•    Feeling dizzy, light headed and faint

•    High temperature and chills (shivering)

•    Difficulty in breathing

•    Very fast and uneven heartbeat (palpitations)

•    Fall in blood pressure

•    Chest pain or in some cases with tightness, crushing or squeezing pressure on the chest and may radiate to the neck, shoulder or arms (coronary spasm)

•    Heart attack Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cervagem Pessary

•    Keep this medicine in a safe place where children cannot see or reach them

•    Store below minus 10°C in a freezer

•    Do not use Cervagem Pessary after the expiry date stated on the box and the foil pouches. The expiry date refers to the last day of that month.

•    Before use, each pessary should be allowed to warm up to room temperature

Medicines should not be disposed of via wastewater or household waste. Ask your doctor or nurse how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Cervagem Pessary contains

•    The active substance is gemeprost.

•    The other ingredients are Witepsol S 52 and dehydrated ethanol.

What Cervagem Pessary looks like and contents of the pack

The pessary is a bullet-shaped waxy solid, 2-3 centimetres long and it comes in boxes of 5 pessaries.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Sanofi

One Onslow Street Guildford

Surrey, GU1 4YS, UK Tel: 0845 372 7101

email:uk-medicalinformation@sanofi.com

Manufacturer

Sanofi S.P.A.

Loc. Valcanello 03012 Anagni (FR)

ITALY

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in

May 2016

©Sanofi, 2000 - 2016    89029190

>4

Patients with the following diseases have not been studied: ulcerative colitis, diabetes mellitus, sickle-cell anaemia, epilepsy, disorders of blood coagulation, cardiovascular or pulmonary disease.

If it is necessary to postpone surgery for much beyond the recommended 3 hour interval, patients should be kept under observation as there is a possibility that spontaneous abortion may occur.

Adequate follow-up of the procedure is essential to ensure that the termination process has been completed as the embryopathic effects of CERVAGEM have not been determined. CERVAGEM pessaries should not be used for the induction of labour or cervical softening at term as foetal effects have not been ascertained.

INTERACTIONS

Oxytocin and other labour inducers or accelerators can potentiate the action of CERVAGEM.

SIDE-EFFECTS

Vaginal bleeding and mild uterine pain, similar to menstrual pain, may occur in the interval between the administration of the pessary and surgery, especially if this interval is prolonged beyond the recommended 3 hours. Nausea, vomiting, loose stools or diarrhoea may occur but are rarely severe enough to require treatment. However, standard anti-emetic or anti-diarrhoeal agents may be administered if required. Other reported side-effects include headache, muscle weakness, dizziness, flushing, chills, backache, dyspnoea, chest pain, palpitations and mild pyrexia.

Uterine rupture has been reported on rare occasions, most commonly in multiparous women with a history of uterine surgery. Anaphylactic reactions have not occurred with CERVAGEM but such reactions have very rarely been noted with other prostaglandins.

In very rare cases, severe hypotension and coronary spasms with subsequent myocardial infarctions have been reported.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

OVERDOSAGE

The toxic dose of CERVAGEM in women has not been established. Cumulative dosage of 10mg in 24 hours has been well tolerated. In animals the acute toxic effects are similar to those of prostaglandin E1 and include depression of the CNS and relaxation of the smooth muscle, leading to hypotension. 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.

PHARMACEUTICAL PRECAUTIONS

Store below minus 10°C (-10°C) in the original pack. Temperature cycling should be avoided. Once the foil sachet has been opened, any pessary not used within 12 hours should be destroyed.

Aventis Pharma Ltd, One Onslow Street,

Guildford, Surrey, GU1 4YS, UK

Manufactured by: SANOFI S.PA.,

Loc. Valcanello, 03012 Anagni (FR), ITALY

Text issued: May 2016

89029190

I MIN. FONT SIZE: CODE:    VERSION: OLD CODE :    DIMENSIONS mm: COLOURS N°: COLOUR 1:    COLOUR 2:

8 /9.5 pt. 89029190    7 a 89027065    125 x 420    1 REFLEX BLUE