Gestone PIL V4 (Manufac's).qxp 16/6/10    16:01 Page 1

5. HOW TO STORE YOUR MEDICINE

Keep out of the reach and sight of children.

Store your medicine in the original package to protect it from light. Store at room temperature (15~25°C). During storage, solid matter may form in the ampoule. This should be re-dissolved by warming the ampoule before use.

On the label you will find the letters “EXP” followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use this medicine after this date.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines which you no longer require. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Gestone 50mg/ml & 100mg/2ml ampoules contain

Each ampoule of Gestone 50mg/ml contains 50mg of Progesterone in 1ml of liquid. Each ampoule of Gestone 100mg/2ml contains lOOmg of Progesterone in 2ml of liquid.

The ampoules also contain benzyl alcohol and ethyl oleate.

What Gestone 50mg/ml & 100mg/2ml ampoules look like and contents of the pack

Gestone 50mg/ml & 100mg/2m1 is a sterile, pale yellow oily liquid. It is supplied in clear glass ampoules in packs containing 10 ampoules.

Marketing Authorisation Holder

Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park,Theale, Reading, RG7 4SA, United Kingdom

Manufacturers

Recipharm Limited,

Vale of Bardsley, Ashton-under-Lyne,

0L7 9RR, United Kingdom and

SCM Pharma Limited,

Unit 6, Regents Drive,

Low Prudhoe Industrial Estate,

Prudhoe, Northumberland, NE42 6PX, United Kingdom

This leaflet was prepared in June 2010

This leaflet has been prepared, for patients by:

Nordic Pharma Ltd., Abbey House, 1650 Arlington Business Park,Theale,Reading RG7 4SA United Kingdom GESTONE 50mg/ml PL 05827/0012 100mg/2ml PL 05827/0013 GESTONE is a registered trade mark.

5—	APPROVED i
	By Adeyanju Patrick at 4:34 pm, Sep 13, 2010 K_y

J GeSTONE® 50mg/ml and 10^^^/2ml

Package leaflet:

INFORMATION FOR THE USER

Read all of this leaflet carefully before you start using this medicine.

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

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR

2.    BEFORE YOU USE YOUR MEDICINE

3.    HOW TO USE YOUR MEDICINE

4.    POSSIBLE SIDE EFFECTS

5.    HOW TO STORE YOUR MEDICINE

6.    FURTHER INFORMATION

NORDICS

1.    WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR

The name of your medicine is Gestone 50mg/mi & 100mg/2mi.The active ingredient of Gestone 50mg/ml & 100mg/2mi is Progesterone (a hormone which acts on the lining of the uterus and is produced naturally by the body). Each ampoule of Gestone 50mg/ml contains 50mg of Progesterone in 1ml of liquid. Each ampoule of Gestone 100mg/2m1 contains lOOmg of Progesterone in 2ml of liquid.

It may be prescribed in women for the following conditions:-

•    To help early pregnancy to continue in cases where the body is not producing enough progesterone and where there have been 3 or more unexplained miscarriages

•    In selected cases, to assist infertility treatment techniques such as in-vitro fertilisation (IVF) or gamete intra-fallopian transfer (GIFT)

•    Bleeding disorders of the uterus

2.    BEFORE YOU USE YOUR MEDICINE

Do not use Gestone 50mg/ml & 100mg/2ml if

•    you are allergic to progestins, or any of the ingredients of this medicine

•    you are suffering from vaginal bleeding other than during periods

•    you have ever had a missed or incomplete abortion

•    you have, or have ever had, breast cancer or cancer of the reproductive tract

•    you have redness, swelling or pain of the veins or any other related problem

•    you have ever had a stroke, or bleeding in the brain

•    you have liver disease

Tell your doctor if any of the above conditions apply to you, before you use Gestone 50mg/ml & 100mg/2ml.

Take Special Care (check with your doctor) with Gestone 50mg/ml & 100mg/2ml if

•    you have high blood pressure, heart disease or kidney disease

•    you have epilepsy

•    you suffer, or have ever suffered, from mental depression

•    you are diabetic

•    you suffer from porphyria

•    you are breast feeding a child

•    you have a sensitivity to light

•    you suffer from migraine attacks

•    you are having regular blood tests to check your liver or hormones (Gestone 50mg/ml or 100mg/2ml may interfere with these tests)

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those which your doctor has not prescribed for you, but which you may have bought yourself without a prescription.

Before using Gestone 50mg/ml & 100mg/2ml please check with your doctor if you are taking any of the following :-

•    bromocryptine

•    ciclosporin

Driving and using machines

It is not known whether Gestone 50mg/ml & 100mg/2ml affects your ability to drive or operate machinery. Do not drive or operate machinery if you feel sleepy after using Gestone 50mg/ml & 100mg/2mi.

3. HOW TO USE YOUR MEDICINE

Gestone 50mg/ml & 100mg/2ml will be given to you by a doctor or nurse. The number of injections given to you per day or per week is called the ‘dose’. Depending on which condition you are being treated for, the doctor will give the appropriate dose by injection into a muscle (this should be deep into the buttock).

The most common dose for bleeding of the uterus is 5-10mg daily for 5-10 days until 2 days before the anticipated start of a menstrual period.

The most common dose for maintaining pregnancy is twice weekly (or more frequent) injections of 25-100mg starting from about day 15, or day of transfer of embryo or gametes, usually until 6-8 weeks of pregnancy when secretion of progesterone from the placenta should be established. The maximum frequency of injections should be once a day.

Daily dosage can be increased to 200mg at the discretion of your doctor. The correct dose will have been decided by your doctor. If you are not sure ask your doctor.

The use of Gestone 50mg/ml & 100mg/2ml is only for women of child bearing age. There are no appropriate dosage recommendations for children or the elderly.

If you think that you have missed a dose or have been given too much Gestone 50mg/ml & 100mg/2ml, please tell a nurse or doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gestone 50mg/ml & 100mg/2m1 can cause side effects, although not everybody gets them.

If any of the follo wing side effects occur suddenly, or gradually, without explanation, contact the doctor or your nearest hospital casualty department at once:-

•    problems with vision (such as blurred vision, partial vision, sudden shortsightedness or complete loss of vision)

•    any swelling of the eye

•    migraine type headache

If you experience one or more of the following side effects, or any other undesirable effects, please tell a nurse or doctor:-

•    breakthrough bleeding, changes in period flow, missed periods, changes in vaginal secretions

•    breast changes

•    fluid retention with swelling

•    weight gain

•    weight loss

•    jaundice

(yellowing of the skin or eyes)

•    allergic reactions (skin rash, or sudden pain, swelling, shortness of breath or fever)

•    acne

•    dark colouration of the skin on the face

•    mental depression

•    fever

•    sleep disturbance (difficulty with sleeping at night, or falling asleep during the day)

•    nausea

•    hair loss from the scalp

•    excessive hair growth on the face or body

•    local irritation (reactions) at the site of injection.

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 pharmacist