ORGAMETRIL 5 MG TABLETS ORGANON - Modern Medicine

1 08-15. ORGAMETRIL 5 mg TABLETS ORGANON . Lynestrenol Therefore it is important to tell your doctor if you 1. WHAT ORGAMETRIL IS AND WHAT IT IS have or have had any of the following conditions: USED FOR blood clotting disorder ( thrombosis). ORGAMETRIL contains lynestrenol, a progestagen simi- heart or blood vessel disease lar to the natural hormone progesterone. severely depressed mood Progestagens, as in ORGAMETRIL , are often prescribed liver disease, such as jaundice, or a tumor in the for disturbances of the menstrual cycle. ORGAMETRIL liver can also be prescribed: abnormal vaginal bleeding f or premenstrual syndrome (the regular occurrence high cholesterol or other lipids in the blood of one or more complaints in the period before the chloasma (brown, blotchy spots on the skin often menstruation); appearing during pregnancy). f or endometriosis (abnormal growth of the lining of acne, seborrheic skin and increased body or facial the uterus); hair f or treatment of endometrial cancer; Using other medicines f or the treatment of certain disorders of the breast; Other medicines may influence the effects of t o suppress the release of an egg cell (ovulation) ORGAMETRIL , or ORGAMETRIL may affect other medi- or menstruation; cines.

2 Ask your doctor or pharmacist for advice a s an adjunct to estrogen therapy during or after before taking any Medicine . Tell your doctor if you the menopause. are using, or are about to use, one of the following 2. BEFORE YOU TAKE ORGAMETRIL medicines: Do not take ORGAMETRIL if you rifamycins or troleandomycin (medicines for bacte- a re pregnant or think you may be pregnant; rial infections). h ave a severe liver disease such as jaundice, hydantoins, barbiturates and carbamazepine (med- inflammation of the liver (hepatitis), tumors of the icines for epilepsy). liver, the rare liver diseases Rotor syndrome or aminoglutethimide ( Medicine for treatment of Dubin-Johnson syndrome, or when the liver has not Cushing syndrome). completely recovered from such a severe condition; cyclosporine ( Medicine used after transplantation). h ave abnormal vaginal bleeding, which has not theophyllines ( Medicine for asthma, bronchitis and been evaluated by your doctor; emphysema). h ave conditions that deteriorated during pregnancy beta-adrenergic blockers (medicines for high blood or during previous use of hormones like: jaundice, pressure or heart conditions).

3 Severe itching, skin rash (herpes gestationes), a insulin ( Medicine for diabetes). metabolic disease of the liver (porphyria), or a heri- Pregnancy and breast-feeding table form of hearing loss (otosclerosis); If you are pregnant or you think you may be preg- nant, do not take ORGAMETRIL . a re hypersensitive to ORGAMETRIL or one of its ingre- dients. If you are breastfeeding, do not take ORGAMETRIL Take special care with ORGAMETRIL without asking your doctor first. Regular examination by your doctor can be neces- Ask your doctor or pharmacist for advice before tak- sary in some cases. ing any Medicine . ORGANON - ORGAMETRIL - ORGANON - ORGAMETRIL - Driving and using machines ORGAMETRIL for a number of days per month. A few ORGAMETRIL may cause dizziness. If affected do not days (often within three days) after completing the drive or use machines. ORGAMETRIL course, the inner lining of the uterus will Important information about some of the ingredi- be shed. ents of ORGAMETRIL This is accompanied by a vaginal bleeding (like a ORGAMETRIL TABLETS contain lactose.)

4 If you have been normal menstruation). told by your doctor that you are intolerant to some 4. POSSIBLE SIDE EFFECTS. sugars, contact your doctor before taking this medic- ORGAMETRIL may cause side effects, depending on inal product. the dosage and sensitivity of the patient. The follow- 3. HOW YOU TAKE ORGAMETRIL ing side effects have been reported: Always take ORGAMETRIL exactly as your doctor has Hypersensitiviy, fluid accumulation in the tissues told you. You should check with your doctor or phar- (fluid retention), slightly increased blood sugar after macist if you are not sure. a meal (reduced glucose tolerance), changes in lipid For disturbances of the menstrual cycle and some and cholesterol levels in the blood, nervousness, other disorders the usual dosage is: 1 tablet daily on depressed mood, increase or decrease of sexual days 14-25 of the cycle. The first day of the cycle is desire (libido), headache, migraine, dizziness, nau- the first day of the menstruation.

5 For the treatment sea, vomiting, abdominal pain, diarrhea, constipa- of excessive or prolonged menstrual bleeding the tion, jaundice (icterus), increased sweating, chloas- usual dosage is 2 TABLETS daily for 10 days. ma (pregnancy spots, patchy discoloration of the For some other disorders ORGAMETRIL has to be taken skin), itching, oily skin (seborrhea), acne, skin reac- each day for prolonged periods of time. In that case tions, increased body or facial hair, vaginal bleeding there is no monthly tablet-free period. Take the tab- (in between the normal periods) mainly during the lets at about the same time each day with a suffi- first two months, sensitive breasts, absence of men- cient amount of fluid ( with a glass of water). If struation, change in vaginal secretion. you have the impression that the effect of ORGAMETRIL If you notice any of these side effects contact your is too strong or too weak, talk to your doctor or phar- doctor, especially when you experience vaginal macist.

6 Bleeding that has not been evaluated by your doctor. If you take more ORGAMETRIL than you should: If you notice a side effect not mentioned in this leaf- If you have taken more ORGAMETRIL than you should, let or you experience a serious side effect, inform talk to your doctor or pharmacist immediately. Taking your doctor or pharmacist. too much ORGAMETRIL may cause nausea and vomiting. 5. STORING ORGAMETRIL . If you forgot to take ORGAMETRIL : Keep ORGAMETRIL out of reach and sight of children. Take the missed tablet as soon as you remember, Store at 2 - 30 C. Store in original package to pro- unless you are more than 24 hours late. In that tect from light and moisture. case, skip the missed dose. Do not use ORGAMETRIL after the date stated on the Never take a double dose to make up for a forgotten package following do not use after or exp . dose. Effects when treatment with ORGAMETRIL is 6. FURTHER INFORMATION. stopped: What ORGAMETRIL contains Lynestrenol has a strong influence on the inner lin- The active substance of ORGAMETRIL is lynestrenol.

7 Ing of the uterus and therefore can be used for the The other ingredients are potato starch, alpha- treatment of disturbances of the menstrual cycle. In tocopherol, glycerol, magnesium stearate, talc and many cases the cycle can be normalized by taking lactose monohydrate. ORGANON - ORGAMETRIL - What ORGAMETRIL looks like and contents of the pack White, round scored TABLETS marked ORGANON on one side; the other side is marked with the code TT above and the code 4 below the score line. 1 push-through strip with 30 scored TABLETS of 5 mg.