Dimetriose 2.5mg Capsules
gestrinone
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Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
- 1. What Dimetriose is and what it is used for
- 2. Before you take Dimetriose
- 3. How to take Dimetriose
- 4. Possible side effects
- 5. How to store Dimetriose
- 6. Further Information
What Dimetriose is and what it is used for
Dimetriose contains a medicine called gestrinone. It works by changing the way some hormones act in your body.
It is used to treat endometriosis – an illness where some of the tissues that line the womb are found elsewhere in the body.
Before you take Dimetriose
Do not use this medicine and tell your doctor if:
- You are allergic (hypersensitive) to gestrinone or any of the other ingredients of Dimetriose (listed in Section 6 Further Information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue - You are pregnant, might become pregnant, or think you may be pregnant. You are breast-feeding (see Pregnancy and breast-feeding below)
- You have severe kidney, liver or heart disease
You have ever had problems caused by other hormone medicines such as estrogens or progestogens (including oral contraceptives, implants or injections)
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Dimetriose.
Take special care with Dimetriose
Check with your doctor or pharmacist before taking your medicine if:
- You have any heart or kidney problems.
- You have diabetes. Your blood sugar levels must be checked regularly
- You have blood fat problems (called ‘lipid disorders’).
Your blood fat levels must be checked regularly - You do not have menstrual periods or they are not regular. The possibility of pregnancy must be ruled out before taking this medicine
- You are already using a hormonal contraceptive (such as the ‘the Pill’ or ‘mini Pill’), the method of contraception you use should be reviewed by your doctor. This is because oral contraceptives such as the ‘the Pill’ can affect the way Dimetriose works and other reliable barrier methods of contraception must be used. Dimetriose must not be used as a contraceptive measure
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dimetriose.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal medicines. This is because Dimetriose can affect the way some other medicines work. Also some medicines can affect the way Dimetriose works.
In particular, tell your doctor if you are taking any of the following:
- Estrogen, progesterone (including ‘the Pill’ or hormone replacement therapy - known as HRT)
The following medicines may lower the effect of Dimetriose:
- Medicines for epilepsy, fits or convulsions (anticonvulsants)
- Rifampicin used for serious infections such as tuberculosis
Pregnancy and breast-feeding
Do not take Dimetriose if you are pregnant, might become pregnant or think you may be pregnant. If you think you may have become pregnant while taking Dimetriose, stop taking it straight away and talk to your doctor.
Do not breast-feed if you are taking Dimetriose. This is because small amounts may pass into mothers’ milk. If you are planning to breast-feed, talk to your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Important information about some of the ingredients of Dimetriose
This medicine contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
How to take Dimetriose
Always take Dimetriose exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
- This medicine is for adult females only. Do not use in children or the elderly
- Take this medicine by mouth
- Swallow the capsules whole with a drink of water
- If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
- It is important that you do not become pregnant while taking Dimetriose. Use reliable contraception (such as an Intra Uterine Device or barrier method in conjunction with contraceptive foam or jelly). The contraceptive pill should not be used until your treatment with Dimetriose has finished
- This medicine is usually taken for 6 months
How much to take
- One capsule twice a week. Start taking the capsules on the first day of your period
- The second dose should be taken three days later
- Afterwards the capsules should be taken on the same two days of the week and, if possible, at the same time of day
If you take more Dimetriose than you should
If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away.
Take the medicine pack with you. This is so the doctor knows what you have taken.
If you forget to take Dimetriose
- If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose
- If you miss two or more doses stop taking the capsules and inform your doctor. Your doctor should carry out a pregnancy test and ask you to wait until your next period before starting your treatment as before
If you stop taking Dimetriose
Keep taking Dimetriose until your doctor tells you to stop taking it. Do not stop taking Dimetriose just because you feel better. If you stop your illness may get worse.
Blood tests
Your doctor may carry out regular blood tests to check your liver is working properly and your blood levels are normal. If you are diabetic, the doctor will also keep a close eye on your blood sugar levels.
If you are going to have a blood test, it is important to tell your doctor you are taking Dimetriose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Dimetriose Side Effects
Like all medicines, Dimetriose can cause side effects, although not everybody gets them.
Stop taking Dimetriose and see a doctor or go to a hospital straight away if:
- You have an allergic reaction. The signs may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tell your doctor as soon as possible if you have any of the following side effects:
- More hair than usual on the body or face
- Hair loss (similar to male baldness)
- Headache, which is usually worse in the morning, on coughing or straining, and feeling sick. Also, fits, fainting, eyesight problems or confusion can occur. These could be signs of a condition called ‘benign intracranial hypertension’
- Sore throat, hoarse voice or your voice sounds higher or lower than usual
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
- Changes to your menstrual period
- Spots, acne, greasy skin
- Water retention or bloating
- Putting on weight, or a change in appetite
- Stomach pains, feeling or being sick, diarrhoea or constipation
- Changes to your sex drive (libido) or if your breasts get smaller
- Flushing
- Feeling depressed, or more nervous than usual
- Pain in your joints
- Muscle cramps
Blood Tests
- A blood test may show changes in the way your liver is working
Tell your doctor or pharmacist if any of the side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
How to store Dimetriose
Keep this medicine in a safe place where children cannot see or reach it.
Store below 25ºC protected from light.
Do not use Dimetriose after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Dimetriose contains
- Each capsule contains 2.5mg of the active substance, gestrinone
- The other ingredients are colloidal silicon dioxide, maize starch, microcrystalline cellulose, lactose, magnesium stearate, talc, titanium dioxide and gelatine
What Dimetriose looks like and contents of the pack
Dimetriose 2.5mg capsules are hard, white, opaque capsules printed with “roussel” and a logo, containing a white to slightly yellow powder. The capsules are supplied in blister packs of 8 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
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 06/2007
© Sanofi-aventis, 1999 - 2007
DTE 90060
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