Triclofem Side Effects

Like all medicines, this medicine can cause side effects although not everybody gets them.
Seek medical help immediately if any of the following side effects are noticed: Hypersensitivity (allergic) reaction (It is not known how frequently this occurs). Symptoms include sudden skin rash, swelling of the face, lips, tongue or throat, wheezing or difficulty in breathing.
A blood clot in the lungs (this occurs rarely - may affect up to 1 in 1000 people). Symptoms include: Shortness of breath; Breath-related chest pains; Coughing up blood.
A blood clot in the leg (this occurs rarely - may affect up to 1 in 1000 people). Deep vein thrombosis (DVT) is a condition in which blood clot forms in one of the deep veins, usually in the leg. These are symptoms of a deep-vein thrombosis (DVT): The patient has pain, tenderness or swelling in the calf, ankle or foot; The patient has painful or inflamed veins in the leg; The patient finds it difficult to put full weight on the affected leg; The patient has purple discolouration of the skin of the leg or the skin becomes red and warm to touch.
Jaundice (yellowing of the skin or the whites of the eyes).
Other side-effects include: Very common: may affect more than 1 in 10 people: nervousness; headache; stomach pain or discomfort; weight increase or decrease.
Common: may affect up to 1 in 10 people: depression; libido decreased (reduced sex drive); dizziness; feeling sick; feeling bloated; hair loss; acne; back pain; vaginal discharge; breast tenderness; difficult or painful period; urinary tract infection; oedema/fluid retention; weakness.
Uncommon: may affect up to 1 in 100 people: appetite increased or decreased; difficulty sleeping; convulsions (fits); drowsiness; tingling; hot flush; liver disorder; facial hair growth; nettle rash or hives; itchy skin; temporary brown patches; difficult or painful period; unexpected or unusual vaginal bleeding or spotting; milky discharge from the breast when not pregnant or breast-feeding; pelvic pain; painful intercourse; prevention of lactation.
Rare: may affect up to 1 in 1,000 people: breast cancer; reduction in red blood cell; blood disorder; difficulty reaching orgasm; behavior change; mood change; irritability; anxiety; migraine; paralysis; fainting; feeling of dizziness or spinning; heart beats more rapidly; high blood pressure; varicose veins; rectal bleeding; digestive disorder; liver enzyme disorder; accumulation of fat (at injection site); inflammation of the skin; scar tissue formation; stretch marks; pain in a joint; muscular cramps; bone density decreased (osteoporosis); vaginal pain or inflammation; stopping or extended break of periods; inflammation of the vagina; breast pain; uterine bleeding or excessive bleeding; periods with abnormally heavy or prolonged bleeding; vaginal dryness; change in breast size; ovarian or vaginal cyst; premenstrual syndrome; excessive thickening of the lining of the womb; breast lump; nipple bleeding; delayed egg release with longer menstrual cycles (periods); feel pregnant; fever; tiredness; injection site pain or tenderness; injection site lump or dimple; feeling thirsty; hoarseness; facial nerve paralysis; decreased sugar tolerance; abnormal smear.
Possible effect on periods: After the first injection of Triclofem it is likely that the patient will have irregular, possibly lengthy bleeding or spotting. This is quite normal and nothing to worry about.
One third of women will not have any bleeding at all after the first injection. After 4 injections, most women find that their periods have stopped completely. Not having periods is nothing to worry about.
If the patient experiences very heavy or prolonged bleeding, she should talk to the health care provider. This happens rarely but can be treated.
When the patient stops taking Triclofem, periods will return to normal in a few months.
Possible effects on the bones: Triclofem works by lowering levels of oestrogen and other hormones. However, lower oestrogen levels can cause bones to become thinner (by reducing bone mineral density). Women who use Triclofem tend to have lower bone mineral density than women of the same age who have never used it.
The effects of Triclofem are greatest in the first 2-3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery of bone density when Triclofem is stopped. It is not yet possible to say whether Triclofem increases the risk of osteoporosis (weak bones) and fractures in later life (after the menopause).
The following are risk factors in the development of osteoporosis in later life. The patient should discuss with the health care provider before starting treatment if she has any of the following as an alternative contraceptive may be more suitable to her needs: Chronic alcohol or tobacco use; Chronic use of drugs that can reduce bone mass, e.g. epilepsy medication or steroids; Low body mass index or eating disorder, e.g. anorexia nervosa or bulimia; Previous low trauma fracture that was not caused by a fall; Strong family history of osteoporosis.
Teenagers (up to 18 years): Normally, the bones of teenagers are rapidly growing and increasing in strength. The stronger the bones are when adulthood is reached, the greater the protection against osteoporosis in later life. Since Triclofem may cause teenage bones to become thinner at a time when they should be growing, its effect may be particularly important in this age group. Bones start to recover when Triclofem is stopped, but it is not yet known whether the bone mineral density reaches the same levels as it would have if Triclofem had never been used.
The patient should therefore discuss whether another form of contraception might be more suitable for her with the person who provides the contraception before starting Triclofem.
If the patient uses Triclofem, it may help her bones if she takes regular weight-bearing exercise and has a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish).
Possible risk of cancer: Studies of women who have used different forms of contraception found that women who used Triclofem, for contraception had no increase in overall risk of developing cancer of the ovary, womb, cervix or liver.
Possible risk of breast cancer: Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives. Older women have a higher baseline risk of breast cancer and therefore the increase in the number of cases due to Triclofem is greater in older women than in younger women.
Possible risk of forming an abscess at the injection site: As with any intramuscular injection, there is a risk of an abscess forming at the site of injection. This may require medical or surgical attention.
Possible risk of weight gain: Some women gained weight while using Triclofem. Studies show that over the first 1-2 years of use, the average weight gain was 5-8 lbs. Women completing 4-6 years of therapy gained an average of 14-16.5 lbs.
Reporting of side effects: If the patient gets any side effects, the patient should talk to the health care provider. This includes unwanted effects not listed. If available, the patient can also report side effects directly through the national reporting system. By reporting side effects the patient can help provide more information on the safety of this medicine.