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Mercilon (Estrogen and Progestin)

Brand name: Mercilon

Generic Name : Estrogen and Progestin

Manufacturer : Organon

Packing / Presentation : Mercilon 28: Tab 1 x 28's.

Medicine Category : Female Hormones : Oral Contraceptives

Content : Desogestrel 150 mcg, ethinylestradiol 20 mcg, 7 placebo tab (Mercilon 28 only)

FDA Pregnant Category : Not established

What is it used for?

Contraception

How does it work?

This medicine is a combined oral contraceptive often referred to as 'The Pill'. It contains a combination of two synthetic derivatives of naturally occurring sex hormones, oestrogen and progesterone, found in the female body. Ethinylestradiol is a synthetic version of oestrogen and desogestrel is a synthetic form of progesterone.

During a woman's normal menstrual cycle, the levels of these sex hormones change. Oestrogen levels rise causing an egg to ripen (maturation) and be released from the ovaries (ovulation). This causes levels of progesterone in the body to increase, preventing the release of more eggs from the ovary and preparing the lining of the womb for a possible pregnancy.

Combined oral contraceptives work by over-riding the normal menstrual cycle. Ethinylestradiol prevents the ripening and release of an egg from the ovary. Desogestrel works by tricking the body processes into thinking that ovulation has already occurred. In addition, desogestrel affects the natural mucus at the neck of the womb. It increases the thickness of this mucus making it more difficult for sperm to cross from the vagina into the womb. Desogestrel also acts to change the quality of the womb lining (endometrium). This prevents the successful implantation of any fertilised eggs on to the wall of the womb. When the blood levels of these hormones decrease at the end of each 'cycle' in the packet, a menstrual period occurs.

Different brands of combined oral contraceptives may contain a different type of progesterone and/or a different strength of ethinylestradiol - Low Strength (20 micrograms), Standard Strength (30 to 40 micrograms) or High Strength (50 micrograms). There may also be differences in the tablets taken during the monthly cycle. The most widely used preparations are known as 'Monophasic'. In these, all 21 tablets are the same and a seven day pill-free gap is left between packets, during which time a period occurs. Preparations known as 'Bi- or Tri-Phasic' have different coloured tablets which contain different strengths of oestrogen and progesterone. These tablets must be taken in the order specified on the pack for each cycle. 'ED' (Every Day) preparations contain 28 tablets (21 active tablets and 7 inactive tablets). This allows a woman to take a tablet every day of the 28 day cycle rather than having to remember the 7 day break at the end of each pack of 21 tablets. Again, these tablets must be taken in the order specified on the pack.

Warning

- Missed pill: if you forget to take a pill, take it as soon as you remember, and the next one at your normal time. If you are 12 hours or more late, another contraceptive method (e.g. condoms) should be used for the next seven days, whilst continuing with normal pill taking. Read the instructions on your pack carefully regarding missed pills.

- Women using this contraceptive for the first time may experience menstrual irregularities such as spotting, breakthrough bleeding or missed periods. Consult your doctor if any breakthrough bleeding persists. If you don't have a withdrawal bleed for two consecutive months you should do a pregnancy test before starting the next month's contraceptive cycle.

- Women using hormonal contraceptives should have regular medical check-ups.
- It is important to be aware that women using combined hormonal contraceptives appear to have a small increase in the risk of developing a blood clot in a vein or artery (thrombosis), compared with women who do not use these contraceptives. This risk is greater in certain groups of women, particularly smokers. However, this risk must be weighed against the benefits of the contraceptive. Discuss this with your doctor.

- You may need to stop using this medicine four weeks prior to any planned surgery and during periods of immobility. You should not usually start using it again until two weeks after you are mobile and moving around again. Discuss this with your doctor.

- Women who suffer from a condition called chloasma, which causes yellowish-brown patches of colouring on the skin, particularly the face, should avoid prolonged exposure to sunlight or ultraviolet radiation, eg sunbeds or UV lamps, while using this medicine, as they can make this condition worse.

- It is important to be aware that women using hormonal contraceptives appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not use these contraceptives. However, this risk must be weighed against the benefits of using the contraceptive, which can be discussed with your doctor.

- Vomiting and severe diarrhoea may interfere with the absorption of this medicine from the gut and decrease its effectiveness as a contraceptive. If you vomit or have severe diarrhoea within three to four hours of taking a pill, you should take another as soon as possible. If you take the extra pill more than 12 hours later, an additional method of contraception (eg condoms) should be used for the next seven days. Read the instructions in your pack carefully regarding this.

- Stop using this medicine and inform your doctor immediately if any of the following occur while you are using this medicine: migraine or severe headaches, disturbance in vision, stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, sudden breathlessness, sudden severe chest pain, significant rise in blood pressure, itching of the whole body, yellowing of the skin or eyes (jaundice), severe abdominal complaints, severe depression, worsening of epilepsy or if you become pregnant.

Use with caution in

- Anaemia caused by a hereditary blood disorder where abnormal haemoglobin is produced (sickle cell anaemia)
- Blood clotting disorders
- Chronic inflammatory bowel disease
- Current or previous decrease in kidney function
- Current or previous heart failure

- Diabetes mellitus
- Endometriosis
- Epilepsy or history of epilepsy
- Excess of urea in the blood causing damaged red blood cells (haemolytic uraemic syndrome)
- Fibroids of the uterus

- Heart valve disease
- High blood pressure (hypertension)
- History of formation of stones in the gall bladder (cholelithiasis)
- History of liver disease
- History of migraines

- History of or current severe depression
- Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation)
- Obesity
- Smokers, particularly those over 35 years of age
- Women whose menstrual cycle is not yet established

Not to be used in

- An itchy blistering disorder of the skin during pregnancy (pemphigoid gestationis)
- Breast cancer
- Breastfeeding
- Current or previous blood clot in the blood vessels (thromboembolism) causing illness eg stroke or heart attack
- Gall stones (cholelithiasis)

- Hepatitis
- High levels of protein and fat compounds (lipoproteins) in the blood (hyperlipoproteinaemia)
- History of jaundice, severe skin itch or worsening hearing disorder (otosclerosis) during pregnancy or previous use of sex hormones
- Inherited disorder of bile excretion that causes jaundice (Rotor syndrome)
- Jaundice caused by thickened or hardened bile that the body cannot pass from the liver (cholestatic jaundice)

- Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias)
- Liver tumours
- Long-term inflammation of skin and some internal organs (systemic lupus erythematosus)
- Metabolic disorder that runs in families and causes mild jaundice (Dubin-Johnson syndrome)
- Moderate to severe high blood pressure (hypertension)
- Overgrowth of the lining of the womb (endometrial hyperplasia)

- People with risk factors for disease of the arteries, eg high cholesterol levels
- Personal or family history of blood clots in the veins (venous thromboembolism)
- Pregnancy
- Severe diabetes associated with circulatory problems
- Severe liver disease

- Those with risk factors for blood clot formation in the veins (venous thromboembolism)
- Tumours which grow rapidly in the presence of the hormone oestrogen, eg endometrial cancer
- Vaginal bleeding of unknown cause

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby.Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy or breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Depression
- Retention of water in the body tissues (fluid retention), resulting in swelling (oedema)
- Nausea and vomiting
- Weight changes
- Vaginal thrush (candidiasis)
- Headache/migraine
- Menstrual spotting between periods
- Change in menstrual bleeding
- Breast tenderness, swelling or milky white discharge from the nipple(s)
- Rise in blood pressure

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

The contraceptive effect of this medicine may be reduced when it is taken with:
- Rifamycins such as rifabutin and rifampicin
- Antiepileptic medicines such as carbamazepine, phenytoin, phenobarbital and primidone
- Antibiotic medicines such as penicillins
- Antifungal medicines such as fluconazole, itraconazole, ketoconazole and griseofulvin.

Tell your doctor if you are taking any of these medicines before starting the pill.

Barrier contraceptives such as condoms should be used whilst taking a short course of antibiotics or antifungals, and for 7 days after the course has finished. Barrier contraception should be used for 4 weeks after stopping a course of rifampicin.

Some women with diabetes may require small increases or decreases in the dose of their antidiabetic medicine while taking this contraceptive. Blood sugar levels should be monitored.

The herbal remedy St John's Wort should not be taken with this medicine, as it may lead to a loss of contraceptive effect.

Recommended dosage

The 1st tablet of the 1st pack is taken on the 1st day of menstruation. This also applies when changing over from another brand of oral contraceptive.One tab is taken daily at the same time, without interruption for 21 days, followed by a 7-day tablet-free period for Mercilon 21, or 1 tab is taken daily at the same time, without interruption, for 28 days for Mercilon 28. Each subsequent pack is started after the 7-day tablet-free period has elapsed.After delivery, administration can be started on the 1st day of the first spontaneous menstruation. If it is necessary to start earlier, eg immediately after delivery, additional contraceptive precautions are necessary for the first 14 days of tablet intake.After a miscarriage or abortion, administration should start immediately. In this way, no additional contraceptive precautions are required.Note: Additional information on directions for use, changing from another oral contraceptive, missed tablets, delay of menstruation, etc is given in the package leaflet.


Overdosage

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

Storage

Store at room temperature

More Information about Mercilon (Advance Information) NEW


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