Patient leaflet - Dimetrum 2 mg tablets
1. WHAT DIMETRUM® IS AND WHAT IT IS USED FOR
Dimetrum® is a preparation for the treatment of endometriosis (painful symptoms due to displaced tissue of the lining of the womb). Dimetrum® contains a hormone, the progestogen dienogest.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIMETRUM®
Do not take Dimetrum® if you:
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® 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® 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®, stop taking it at once and consult your doctor.
Warnings and precautions
You must not use hormonal contraceptives of any form (tablet, patch, intrauterine system) while taking Dimetrum®.
Dimetrum® 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®, 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®
develop a liver disease while taking Dimetrum®. 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®. While taking Dimetrum® your chance of becoming pregnant is reduced because Dimetrum® may affect ovulation.
If you become pregnant while taking Dimetrum® 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®, if you had an extrauterine pregnancy in the past or have an impaired function of the Fallopian tubes.
Dimetrum® and serious uterine bleeding
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®. 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®.
Dimetrum® and changes in bleeding pattern
Most women treated with Dimetrum® 2 mg tablets experience changes in their menstrual bleeding pattern (see section 4, possible side effects).
Dimetrum® and venous blood clots
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®. 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® as the treatment may have to be stopped. Your doctor will tell you when to start Dimetrum® again. This is usually about two weeks after you are back on your feet.
Dimetrum® and arterial blood clots
There is little evidence for an association between preparations with progestagens like Dimetrum® 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®, 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®
Stop taking Dimetrum® 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.
Dimetrum® and cancer
It is not clear from the data currently available whether or not Dimetrum® 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.
Dimetrum® and osteoporosis
Changes in bone mineral density (BMD)
The use of Dimetrum® 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® for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).
If you use Dimetrum®, 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® because Dimetrum® has a moderate suppressing effect on the production of oestrogen (another type of female hormone) by your body.
Other medicines and Dimetrum®
Some medicines can have an influence on the blood levels of Dimetrum® 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.
Dimetrum® with food and drink
During Dimetrum® treatment, you should avoid drinking grapefruit juice, because this may increase the levels of Dimetrum® in your blood. This may increase the risk of getting side effects.
Dimetrum® can be taken with or without food.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking Dimetrum®, because Dimetrum® can affect the results of some tests.
Pregnancy, breast-feeding and fertility
Do not take Dimetrum® if you are pregnant or breast-feeding.
Driving and using machines
No effects on the ability to drive and use machines have been observed in users of Dimetrum®.
Dimetrum® contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Dimetrum®.
Children and adolescents
Dimetrum® is not for use in girls before menarche (first menstrual bleeding).
The use of Dimetrum® 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® for you as an individual patient, taking into account possible risk factors for bone loss (osteoporosis).
3. HOW TO TAKE DIMETRUM®
Always take Dimetrum® exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. For adults, the usual dose is 1 tablet per day.
The following statements apply to Dimetrum® unless otherwise prescribed by your doctor. Please follow these instructions, otherwise you will not fully benefit from Dimetrum®.
You can start treatment with Dimetrum® on any day of your natural cycle. Adults: take one tablet every day, preferably at the same time with some liquid as needed. When a pack is finished the next one should be started without interruption. Continue to take the tablets also on days of menstrual bleeding.
Your tablets have days of the week printed on the blister. The following is a translation of the days of the week which appear on the blister:
If you take more Dimetrum® than you should
There have been no reports of serious harmful effects from taking too many Dimetrum® tablets at one time. However, if you are concerned, contact your doctor.
If you forget to take Dimetrum® or suffer from vomiting or diarrhoea
Dimetrum® 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® 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®, 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®
If you stop taking Dimetrum®, your original endometriosis symptoms may return.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are more common during the first months after start of intake of Dimetrum® and usually disappear with continued use. You may also experience changes in your bleeding pattern, such as spotting, irregular bleeding or your periods may stop completely.
Common (affecting between 1 and 10 in every 100 users)
- weight gain
depressed mood, problems sleeping, nervousness, loss of interest in
sex, or changed mood
- headache or migraine
- nausea, abdominal pain, wind, swollen tummy or vomiting
- acne or hair loss
- back pain
- breast discomfort, ovarian cyst or hot flushes
- uterine/vaginal bleeding including spotting
- weakness or irritability.
Uncommon (affecting between 1 and 10 in every 1,000 users)
- anemia
- weight loss or increase in appetite
- anxiety, depression or mood swings
imbalance in the autonomic nervous system (controls unconscious
bodily functions, e.g. perspiration) or disturbed attention
- dry eye
- tinnitus
- unspecific circulatory problems or uncommon palpitations
- low blood pressure
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®.
- shortness of breath
- diarrhoea, constipation, abdominal discomfort, inflammation of the stomach and intestines, (gastrointestinal inflammation), inflammation of the gums (gingivitis)
- dry skin, excessive sweating, severe itching of the whole body, male pattern hair growth (hirsutism), brittle nails, dandruff, dermatitis, abnormal hair growth, hypersensitive response to light or problems with skin pigmentation
- pains in your bones, muscle spasms, pains and/or a sensation of heaviness in your arms and hands or legs and feet
- urinary tract infection
- vaginal thrush, dryness of the genital area, vaginal discharge, pelvic pain, atrophic inflammation of the genitals with discharge (atrophic vulvovaginitis), or a lump or lumps in the breast
- swelling due to fluid retention.
Additional side effects in adolescents (12 to under 18 years): loss of bone density.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE DIMETRUM®
- Keep out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
- Store in the original package in order to protect from light.
- If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dimetrum® contains
- The active substance is dienogest. Each tablet contains 2 mg dienogest.
- The other ingredients are lactose monohydrate, povidone K30, pregelatinized maize starch, microcrystalline cellulose, crospovidone, silica colloidal anhydrous and magnesium stearate.
What Dimetrum® looks like and contents of the pack
Dimetrum® 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 or 84 tablets.
Manufactured by Cyndea Pharma SL, Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda 31, Olvega 42110, Soria, Spain.
Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., Unit 2-3, Townsend Industrial Estate, Waxlow Road, London, NW10 7NU, UK.
Revision date: 19.10.2023
PLGB 16378/1198 POM
Dimetrum® is a registered trademark of Besins Healthcare Luxembourg S.A.R.L.
Blind or partially sighted? Is this leaflet hard to see or read? Phone Beachcourse, Tel: 020 8896 9054 for help. Ref. number: 1198