Dimetrum 2 mg Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

1. What Dimetrum 2 mg tablets is and what it is used for
2. What you need to know before you take Dimetrum 2 mg tablets
3. How to take Dimetrum 2 mg tablets
4. Possible side effects
5. How to store Dimetrum 2 mg tablets
6. Contents of the pack and other information

• are suffering from a blood clot (thromboembolic disorder) in your veins. This may occur, for example, in the blood vessels of the legs (deep vein thrombosis) or the lungs (pulmonary embolism). See also “Dimetrum 2 mg tablets and venous blood clots” below
• have or have ever had a severe arterial disease, including cardiovascular disease, such as a heart attack, stroke or heart disease which causes a reduced blood supply (angina pectoris). See also " Dimetrum 2 mg tablets and arterial blood clots" below
• have diabetes with blood vessel damage
• have or have ever had severe liver disease (and your liver function values have not returned to normal). Symptoms of liver disease may be yellowing of the skin and/or itching of the whole body,
• have or have ever had a benign or malignant liver tumour
• suffer or have ever suffered, or if it is suspected that you suffer from a malignant sex-hormone dependent tumour such as cancer of the breast or the genital organs
• have any unexplained vaginal bleeding
• are allergic (hypersensitive) to dienogest or any of the other ingredients of this medicine (see Section 6, and end of Section 2).

If any of these conditions appear for the first time while using Dimetrum 2 mg tablets, stop taking it at once and consult your doctor.

You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Dimetrum 2 mg tablets.

Dimetrum 2 mg tablets is NOT a contraceptive. If you want to prevent pregnancy, you should use condoms or other non-hormonal contraceptive precautions.

In some situations you need to take special care while using Dimetrum 2 mg tablets, and your doctor may need to examine you regularly. Tell your doctor if any of the following conditions applies to you:

If you:

• have ever had a blood clot (venous thromboembolism) or anyone in your immediate family has had a blood clot at a relatively early age
• have a close relative who has had breast cancer
• have ever suffered from depression
• have high blood pressure or develop high blood pressure while taking Dimetrum 2 mg tablets
• develop a liver disease while taking Dimetrum 2 mg tablets. Symptoms may include yellowing of the skin or eyes or itching all over your body. Inform your doctor also if such symptoms occurred during a previous pregnancy
• have diabetes or had diabetes temporarily during previous pregnancy
• have ever had chloasma (golden-brown patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation
• suffer from pain in your lower abdomen while taking Dimetrum 2 mg tablets.

While taking Dimetrum 2 mg tablets your chance of becoming pregnant is reduced because Dimetrum 2 mg tablets may affect ovulation.

If you become pregnant while taking Dimetrum 2 mg tablets you are at a slightly increased risk of having an extrauterine pregnancy (the embryo develops outside the womb). Tell your doctor before you start taking Dimetrum 2 mg tablets, if you had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.

Uterine bleeding, for example in women with a condition where the mucous membrane of your uterus (endometrium) grows into the muscle layer of your uterus, called adenomyosis uteri or benign tumours of the womb sometimes called uterine fibroids (uterine leiomyomata), may become worse with the use of Dimetrum 2 mg tablets. If bleeding is heavy and continuous over time, this may lead to low red blood cell levels (anemia), which may be severe in some cases. In the event of anemia, you should discuss with your doctor if you should stop taking Dimetrum 2 mg tablets.

Most women treated with Dimetrum 2 mg tablets experience changes in their menstrual bleeding pattern (see section 4, possible side effects).

Some studies indicate that there may be a slight, but not statistically significant, increased risk of a blood clot in the legs (venous thromboembolism) associated with the use of preparations with progestagens like Dimetrum 2 mg tablets. Very rarely, blood clots may cause serious permanent disabilities or may even be fatal.

The risk of a venous blood clot increases:

• with increasing age
• if you are overweight
• if you or one of your close relatives had a blood clot in the leg (thrombosis), lung (pulmonary embolism), or other organ at a young age
• if you must have surgery, if you have had a serious accident or if you are immobilized for a long time. It is important to tell your doctor in advance that you are using Dimetrum 2 mg tablets as the treatment may have to be stopped. Your doctor will tell you when to start Dimetrum 2 mg tablets again. This is usually about two weeks after you are back on your feet.

There is little evidence for an association between preparations with progestagens like Dimetrum 2 mg tablets and an increased risk of a blood clot in, for example, the bloodvessels of the heart (heart attack) or the brain (stroke). In women with hypertension the risk of stroke may be slightly enhanced by these preparations.

The risk of an arterial blood clot increases:

• if you smoke. You are strongly advised to stop smoking when you use Dimetrum 2 mg tablets, especially if you are older than 35 years.
• if you are overweight
• if one of your close relatives had a heart attack or stroke at a young age
• if you have high blood pressure

Talk to your doctor before taking Dimetrum 2 mg tablets

Stop taking Dimetrum 2 mg tablets and contact your doctor immediately if you notice possible signs of a blood clot, such as:

• severe pain and/or swelling in one of your legs
• sudden severe pain in the chest which may reach the left arm
• sudden breathlessness
• sudden cough without an obvious cause
• any unusual, severe or long-lasting headache or worsening of migraine
• partial or complete blindness or double vision
• difficulty in speaking or inability to speak
• giddiness or fainting
• weakness, strange feeling, or numbness in any part of the body.

It is not clear from the data currently available whether or not Dimetrum 2 mg tablets increases the risk of breast cancer. Breast cancer has been observed slightly more often in women taking hormones compared to those not taking hormones, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected and detected earlier in women taking hormones because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the hormone treatment. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in women taking hormones. Contact your doctor if you have unusually severe stomach pain.

Changes in bone mineral density (BMD)

The use of Dimetrum 2 mg tablets may affect the strength of the bone of adolescents (12 to under 18 years). If you are under 18 your doctor will, therefore, carefully weigh the benefits and risks of using Dimetrum 2 mg tablets for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

If you use Dimetrum 2 mg tablets, it will help your bones if you have an adequate intake of calcium and vitamin D either via your food or via supplements.

If you have an increased risk of getting osteoporosis (weakening of bones due to loss of bone minerals), your doctor will carefully weigh the risks and benefits of treatment with Dimetrum 2 mg tablets because Dimetrum 2 mg tablets has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by your body.

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you are taking Dimetrum 2 mg tablets.

Some medicines can have an influence on the blood levels of Dimetrum 2 mg tablets and can make it less effective, or can cause undesirable effects.

These include:

• medicines used for the treatment of:
  • epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • tuberculosis (e.g. rifampicin)
  • HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (griseofulvin, ketoconazole)
• the herbal remedy St. John’s wort.

Ask your doctor or pharmacist for advice before taking any medicine.

During Dimetrum 2 mg tablets treatment, you should avoid drinking grapefruit juice, because this may increase the levels of Dimetrum 2 mg tablets in your blood. This may increase the risk of getting side effects.

Dimetrum 2mg tablets can be taken with or without food.

If you need a blood test, tell your doctor or the laboratory staff that you are taking Dimetrum 2 mg tablets, because Dimetrum 2 mg tablets can affect the results of some tests.

Do not take Dimetrum 2 mg tablets if you are pregnant or breast-feeding.

No effects on the ability to drive and use machines have been observed in users of Dimetrum 2 mg tablets.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Dimetrum 2 mg tablets.

Dimetrum 2 mg tablets is not for use in girls before menarche (first menstrual bleeding).

The use of Dimetrum 2 mg tablets may affect the strength of the bone of adolescents (12 to under 18 years). If you are under 18 your doctor will, therefore, carefully weigh the benefits and risks of using Dimetrum 2 mg tablets for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).

There have been no reports of serious harmful effects from taking too many Dimetrum 2 mg tablets tablets at one time. However, if you are concerned, contact your doctor.

Dimetrum 2 mg tablets will be less effective if you miss a tablet. If you miss one or more tablets, take one tablet only as soon as you remember, and then continue next day taking the tablet at your usual time.

If you vomit within 3-4 hours of taking Dimetrum 2 mg tablets or you have severe diarrhoea, there is a risk that the active substance in the tablet will not be taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea within 3-4 hours of taking Dimetrum 2 mg tablets, you should take another tablet as soon as possible.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Dimetrum 2 mg tablets, your original endometriosis symptoms may return.

If you get any side effects, talk to your doctor or pharmacist. 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.

• The active substance is dienogest. Each tablet contains 2 mg dienogest.
• The other ingredients are lactose monohydrate, povidone, pregelatinized maize starch, microcrystalline cellulose, crospovidone, silica, colloidal anhydrous, magnesium stearate.

Dimetrum 2 mg tablets are white to slightly yellowish round tablets marked with “D2” on one side and without marking on the other side, with a diameter of approximately 7 mm.

They are supplied in a blister pack containing 28 film-coated tablets.

Boxes contain blister packs with 28, 84 or 168 tablets.

Not all pack sizes may be marketed