Meliane ® y Meliane Diario ®

Please read this leaflet carefully before taking this medicine.

– Keep this leaflet. You may have to read it again.

– If you have any questions, Consult your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. Yours, even if their symptoms are the same as yours.

1. Meliane WHAT IS AND WHAT IT IS USED

Meliane is a combined oral hormonal contraception. Inhibits ovulation and causes changes in the cervical secretion. It is used to prevent pregnancy. Also used in menstrual cycle disorders.

Meliane comes in blister (the container where the coated tablets) the 21 coated tablets.

The active principles are: gestodene and ethinyl estradiol.

Each coated tablet contains Meliane 0,075 mg gestodene 0,02 mg ethinyl. The other ingredients are: lactose monohydrate; cornstarch; povidone 25 000; magnesium stearate; sucrose; povidone 700 000; macrogol 6000; carbonate de calcium; montana talc and glycol wax.

2. Before taking Meliana take Meliana:

You should not use COCs (ACO) in the presence of any of the conditions listed below. If any of these situations is introduced for the use of ACO, should be discontinued immediately and consult your doctor.

If you have or have had a venous thrombosis: DVT (blood clots in the veins), pulmonary embolism (blood clots in the vessels of the lungs).

  • If you have or have had an arterial thrombosis (blood clots in the arteries, for example,es, stroke, myocardial infarction) or situations that may indicate the onset of thrombosis (TIA, angina pectoris).
  • If you have or have had a stroke of thromboembolic origin (por ejemplo, due to bleeding).
  • If you have migraine with focal neurological symptoms (Focal will).
  • If you have diabetes mellitus combined with heart or circulatory problems.
  • If you have hypertension, and not controlled.
  • If you have thrombogenic valvular (disease of the heart valves that may cause thrombi).
  • If you have heart rhythm disorders with the possibility of blood clots (thrombogenic arrhythmias).
  • If you have or have had a serious liver disease, whenever the values ​​of liver function tests were not standardized.
  • If you have or have had liver tumors (benign or malignant).
  • If you have or suspected malignancies of the genital organs or the breasts.
  • If you have unexplained vaginal bleeding.
  • If you are pregnant or suspect you might be.
  • If you are allergic to any of the active ingredients or excipients Meliane.

Take special care with Meliane:

If some of the risk situations mentioned below are present, Your doctor should assess the benefits of using Meliane against the possible risks, and discuss them with you before you decide to start using. Tell your doctor if you have or have had any of the situations described below. Similarly, If any of these situations is introduced, worsens or worsens, debe contactar con su médico lo antes posible, quien decidirá si debe interrumpir el uso de Meliane.

• Enfermedades del corazón (those that produce certain types of heart rhythm disorders).

• Niveles altos de grasa (triglicéridos) blood or family history of this.

• High blood pressure, particularly if it worsens or does not improve when taking antihypertensive medications.

• Migraines (migraines) intensive and repetitive.

• Diabetes.

• Depression or a history of depression, as this may worsen or reappear when using hormonal contraceptives.

• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).

• Certain types of jaundice (yellow whites of the eyes and skin) or disturbances in liver function.

• Picores, especially if they occurred during a previous pregnancy.

• permanent brown spots on the skin of the face, especially if you've had during a previous pregnancy. If any, Avoid sunlight and ultraviolet radiation (p.ej. solarium).

Also contact your doctor if you think you might be pregnant.

• Thromboembolism and other vascular disorders

The use of the pill may increase the chance of thrombosis (blood clots). This risk is greatest during the first year of use of contraceptive pills. Nevertheless, the chances of developing blood clots, are higher during pregnancy than during the contraceptive treatment.

Blood clots can block the major blood vessels and very rarely may cause permanent disability or death. If the blood clot forms in the deep veins of the legs, may break off and block the pulmonary arteries (pulmonary embolism). Also, Blood clots occur rarely in the heart arteries (myocardial infarction, angina pectoris) or cerebral arteries (cerebral thrombosis).

Symptoms of venous or arterial thrombosis may be: pain and / or swelling in one leg; sudden severe pain in the chest, that may radiate to left arm or not; dyspnoea (difficulty breathing) sudden; sudden onset of coughing; unusual headache, intense and prolonged; sudden vision loss, partially or completely; diplopia (double vision); slurred speech or aphasia (difficulty speaking); vertigo; seizures; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disorders (difficulty walking or grasping objects); abdominal pain.

The risk of thromboembolic complications occurring (blood clots) in oral contraceptive users increases with:

– The age.

– The existence of a family history of venous or arterial thromboembolism ever in a sibling or parent / s in relatively early age.

– Obesity.

– Smoking (the risk increases more with age and heavy smoking, especially in women over 35 años).

– Prolonged immobilization, major surgery, any surgery to the legs or a severe trauma. In these situations it is advisable to stop taking the pill (in case of elective surgery, at least four weeks before), and not resume until two weeks after fully recovering mobility.

– The dyslipoproteinemia.

– Hypertension.

– Atrial fibrillation (Heart rhythm disturbance).

To use Meliane after delivery or abortion in the 2 nd quarter: see "Taking Meliane".

Other conditions that have been associated with adverse circulatory events include: diabetes mellitus, lupus erythematosus, Hemolytic uremic syndrome, Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis) and sickle cell disease.

If you experience an increase in the frequency or intensity of migraine (migraines) during use of oral (which may indicate the onset of stroke) Tell your doctor, it may be grounds for immediate suspension of the ACO.

Your doctor will pay particular attention to those biochemical factors that may be indicative of hereditary or acquired predisposition to arterial or venous thrombosis.

• Tumores

There have been reports of breast tumors with a frequency slightly higher in women using contraceptive pills, but whether this is due to treatment. Por ejemplo, could be more tumors are detected in women using contraceptive pills because medical consultation attend more often. This increase in frequency gradually decreases after stopping treatment. After ten years, the chances of breast cancer are the same as for women who have never used birth control pills.

Some studies have reported an increased risk of cervical cancer in users who have been taking OCs for long periods of time, but there is still controversy about the extent to which this finding can be attributed to the effect of other factors, such as sexual behavior and sexually transmitted diseases.

In rare cases have been reported benign liver tumors, and even more rarely malignant, in OC users. This can cause internal bleeding resulting in severe pain in abdomen. If this occurs, should contact your doctor immediately.

There has been a slight increase in relative risk of cervical cancer and cervical intraepithelial neoplasia. Given the biological effect of OCs on these lesions, it is recommended that, if prescribing OCs become regular cervical smear tests.

• Other conditions

In women with hypertriglyceridemia (increased blood triglyceride), or family history of it, may be an increased risk of pancreatitis (inflammation of the pancreas) for the use of ACO.

Women who have been treated for hyperlipidemia (increased blood fats such as triglycerides and / or cholesterol) should be monitored if they decide to take oral contraceptives.

During the use of OCP has been observed that many users have small increases in blood pressure, although rare cases with clinical relevance. If during OC use appears sustained hypertension should consult with your doctor.

In women with endometrial hyperplasia (thickening of the lining of the uterus) the physician must weigh carefully the risk-benefit ratio before prescribing OC, and closely monitor the patient during the treatment period, regular cervical cytology.

The following conditions may occur or worsen with pregnancy and OC use: jaundice (yellowing of the whites of the eyes and skin) and / or itching (itching) associated with cholestasis (arrest or decreased flow of bile), formation of gallstones, porphyria (familial metabolic disorder), Systemic Lupus Erythematosus (dermatitis inflamatoria), HUS (kidney disease with blood disorders), Core Sydenham (involuntary movements), gravid herpes (injury to the skin and mucous membranes during pregnancy appears) and hearing loss in otosclerosis (a type of ear condition).

Acute or chronic disorders of liver function requiring withdrawal of OC use until markers of liver function return to normal. The emergence of new cholestatic jaundice, already appeared for the first time during pregnancy, or previous use of sex hormones, requires the suspension of the ACO.

OCs may alter peripheral insulin resistance and glucose tolerance. No evidence of a need to alter the therapeutic regimen in diabetics using low-dose OCs (with < 0,05 mg ethinyl). However, diabetic women should be monitored closely while taking ACO.

It has been associated with OC use Crohn disease and ulcerative colitis (Inflammatory bowel disease).

Chloasma may occur occasionally (brown spots on skin), especially in women with a history of chloasma gravidarum. If you have a tendency to chloasma should avoid exposure to sunlight or UV rays while taking ACO.

If you get severe symptoms of depression should discontinue the medication and use an alternative contraceptive method. Should monitor women with a history of depression.

It should warn women that oral contraceptives do not protect against HIV infection (PAGE), or against other sexually transmitted diseases.

Exploration and medical consultation

Before starting or restarting treatment with Meliane is necessary that your doctor perform a medical history and complete physical examination, designed to rule out contraindications and precautions to observe, and these must be repeated at least once a year for the use of combined oral contraceptives.

Reduction dand efficiency

The efficacy of OCs may decrease if you miss any tablet (see "Conduct follow if you miss taking a tablet"), if you have gastrointestinal disturbances such as vomiting or severe diarrhea (see "Tips for gastrointestinal disorders"), or take any other medications simultaneously (see "Taking other medicines").

Irregularities en el cycle control

During the use of any ACO staining or vaginal bleeding between two rules, especially during the first months of use. If these bleeding irregularities persist or occur after previously regular cycles, should be considered non-hormonal causes and, therefore, you should see your physician for appropriate diagnostic measures taken to exclude malignancy, infections or pregnancy.

In some women may not produce withdrawal bleeding (rule) during the bye week. If you have taken the ACO, as described in "How to take Meliane", is unlikely to be pregnant. Nevertheless, if you have not taken the ACO following these instructions before the first missed, or if a second offense, should rule out pregnancy before you take the ACO.

If you have questions about any of the above, consult your doctor before taking

Meliane.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Certain medicines may interact, in these cases may be necessary to change the dose or stop taking any medications. It is especially important to tell your doctor if you use any of the following medications:

The medications listed below may prevent combined hormonal contraceptives work well and, if this occurs, could become pregnant:

• Some treatments against viral infections and HIV (ritonavir, nelfinavir, nevirapina).

• Some antibiotics (penicillins and derivatives, rifampin, rifabutina, griseofulvina, erythromycin, tetracyclines).

• Some antiepileptic (topiramate, barbiturates (phenobarbital), phenytoin, carbamacepina, primidona, oxcarbazepina, felbamato, etosuximida).

• Antacids and lansoprazole

• Some substances to lift mood (modafinil).

You should not take herbal preparations with medicinal St John's Wort (Hypericum perforatum) simultaneously Meliane, because their effectiveness may be reduced risk of unexpected pregnancy and breakthrough bleeding. Decreased contraceptive effect lasts up to two weeks after he stopped taking the preparation with St. John's wort.

You should use another reliable method of contraception if you take any medications mentioned above. The effect of any of these medications can last up 28 days after stopping treatment.

Meliane may decrease the effect of oral anticoagulants, analgesics (as paracetamol and salicylates), fibratos (drugs for reducing triglycerides and / or cholesterol), oral agents and insulin, and increase the effect of other drugs such as β-blockers (metoprolol), theophylline (for the treatment of asthma), corticosteroids (as prednisolone), cyclosporine (increasing the risk of liver toxicity), flunarizina (increasing the risk of milk secretion).

You should never take another drug on its own initiative without your doctor's advice, since some combinations should be avoided.

You should consult the prescribing information for the medications you are taking together to identify possible interactions.

Laboratory Tests

The use of oral contraceptives may affect the results of certain lab tests. If you indicate the performance of any laboratory test, tell your doctor that you are using oral contraceptives.

Pregnancy and lactation

Consult your doctor or pharmacist before taking any medicine.

Meliane not indicated during pregnancy. If given this circumstance, must immediately discontinue making Meliane, and consult with your doctor.

During the use of ACO can be eliminated by small amounts of milk oral contraceptives, but there is evidence that this adversely affects a child's health. However, generally not be used until the end ACO breastfeeding.

Driving and using machines

No effects were observed on the ability to drive or to operate machinery.

3. TAKING Meliane

Follow these instructions unless your doctor has given you different.

Remember to take your medicine, since the neglect of coated tablets may decrease the effectiveness of the preparation.

The first tablet is taken from one of the boxes marked with the day of the week corresponding (p. not., "LUN" for Monday). The tablets should be taken every day at about the same time, with a little liquid if necessary and in the order shown on the blister pack. It will take one tablet daily for 21 consecutive days. Will start a new pack after an interval of 7 day tablet, which usually occur during a withdrawal bleed. Withdrawal bleeding, similar to the rule, appear two or three days after taking the last tablet, and you may not be finished before starting the next pack.

How is should start taking Meliane

• If you have not previously taken any hormonal contraceptive (in the previous month)

The tablets will begin to take on the day 1 natural cycle of women (ie, the first day of menstrual bleeding). You can also start on days 2 a,en 5 cycle, but then, is recommended additionally in the first cycle a barrier method during the 7 early days of tablet-.

• Changing from another combined oral contraceptive (ACO)

Meliane should start taking the day following the end of the week off (in case of contraceptive to be taking 21 days) or the following day after taking the placebo tablets (no active component) its previous ACO (contraception if 28 days).

• To replace a method based solely on gestagens (minipíldora, injection, implant), or a progestogen-releasing intrauterine system (SIU)

You can replace the mini pill for any day Meliane (case of an implant or IUS, the day of his retirement; if it is an injectable, the corresponding day the next injection), but in all cases it is recommended to use an additional barrier method during the 7 early days of tablet-.

• After an abortion in the first trimester

You can start taking immediately Meliane. When you do so, need not take additional contraceptive measures.

• Following delivery or abortion in the second trimester

It is recommended that you start taking Meliane after 21-28 days after delivery or abortion in the second quarter. If you do later, must use an additional barrier method during the

7 early days. However, if intercourse has already occurred, be ruled out that a pregnancy has occurred before taking the ACO, or expect to have their first menstrual period.

Conduct to follow if you miss taking a tablet

The contraceptive protection is not reduced if you take one tablet is delayed less than 12 hours. In this case, should take the tablet as soon as you remember it and keep taking

next tablets at the usual time (even if it means taking two tablets in one day). In this case there is no need to take additional contraceptive measures.

If you are late in making more 12 hours, contraceptive protection may be reduced. The pattern to follow in case of neglect is governed by two basic rules:

1. Never stop taking tablets of 7 days.

2. You need to take the tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian.

Accordingly, and following the directions above, in daily practice may be advised following:

• Semana 1

Should take the last missed tablet as soon as you remember, but it forces you to take two tablets at once. From there continue to take the tablets at the usual time. further, during 7 days must use a barrier method, as a preservative. If you have had sex in 7 days before, should consider the possibility of getting pregnant. The more forgotten tablets, and the closer the range usual tablet-free, the greater the risk of pregnancy.

• Semana 2

Should take the last missed tablet as soon as you remember, but it forces you to take two tablets at once. From there continue to take the tablets at the usual time. If the 7 days prior to the missed tablet has taken the tablets correctly, not need extra contraceptive precautions. Nevertheless, if you have forgotten to take over 1 compressed, it is advisable to take extra precautions during 7 days.

• Semana 3

The risk of reduced efficacy is imminent due to the proximity of the bye week. However, adjusting the program is still taking tablets can prevent decrease contraceptive protection. Por tanto, if you follow one of the following two options, not need extra contraceptive precautions, provided that the 7 days preceding the first oblivion has taken all tablets correctly. If not, should follow the first of the two options listed below and must take extra contraceptive precautions in 7 days.

1. Should take the last missed tablet as soon as you remember, but it forces you to take two tablets at once. From there continue to take the tablets at the usual time. You must start the next blister pack as you run the current, while, therefore, separation between them. Is unlikely to have a withdrawal bleed (rule) until the end of the second pack, but may experience spotting or breakthrough bleeding on tablet-taking days.

2. You can stop taking the tablets from the blister pack today. Then you must complete a range of up 7 day tablet, including those days when you forget to take tablets, and then start again with the next blister pack.

When, in case you forget taking tablets, This is not withdrawal bleeding (rule) in the first tablet-free interval, should consider the possibility of becoming pregnant.

However, in doubt, Tell your doctor.

Tips for gastrointestinal disorders

In case of serious gastrointestinal absorption may not be complete, and should take additional contraceptive measures.

If you have vomiting in 3-4 hours after taking the tablet, should follow the advice regarding the neglect of taking tablets, as outlined in the "Conduct to be followed if you miss taking a tablet". If you do not want to change their normal pattern of taking tablets, should take / the tablet / s extra needed another container.

How delay a bleeding afterr deprivation

To delay a period, should continue with the next pack of Meliane without leaving the usual bye. You can keep this extension as long as desired until the end of the second container. During that period, may experience bleeding or spotting. Then leave the usual tablet-free period of 7 days and resumed making regular Meliane.

To change the period to the next weekday that is used in accordance with its current cycle, can be advised to shorten the week off as many days as you wish. The shorter the interval, greater the risk that a withdrawal bleed appears (rule) and to experience breakthrough bleeding or spotting while taking the next pack (as happens when you delay a period).

Si Vd. Meliane takes longer than you should:

If you take more than you should Meliane, immediately consult your doctor or pharmacist or local poison control center (Tel: 91 562 04 20).

No serious adverse reactions have been reported overdose. Symptoms that may appear in this case are: nausea, vomiting, teen, slight vaginal bleeding. There is no antidote and treatment should be symptomatic.

4. Possible adverse effects

Like all medicines, Meliane can have side effects. The use of oral contraceptives has been associated with:

– Increased risk of venous and arterial thrombotic events, and thromboembolic, including myocardial infarction, thrombosis venosa pulmonar y embolismo (see "Take special care with Meliane").

– Increased risk of cervical intraepithelial neoplasia and cancer.

– Increased risk of breast cancer diagnosis (see "Take special care with

Meliane”).

Adverse reactions are listed below, classified according to their frequency according to the following criteria:

Very common: ≥ 10% Common: ≥ 1% <10%

Uncommon: ≥ 0.1% <1% Rare: ≥ 0.01% <0,1%

Very rare: <0,01%

1. Common Infections

FAQ: vaginitis (inflammation of the vagina), including candidiasis (fungal infection of the vagina).

2. Immune system disorders

Rare: allergic reactions like hives (itching), angioedema (swollen face, lips, mouth and very rare cases of severe reactions accompanied by difficulty breathing, dizziness and even loss of consciousness).

Very rare: empeoramiento of systemic lupus erythematosus.

3. Metabolic and Nutritional Disorders

Uncommon: changes in appetite (increase or decrease). Rare: IGT.

Very rare: worsening of porphyria.

4. Psychiatric disorders

FAQ: mood swings, including depression; changes in libido (sexual desire)..

5. Nervous system disorders

Very common: headaches, including migraines. FAQ: nervousness, vertigo.

Very rare: worsening of chorea.

6. Eye disorders

Rare: intolerance to contact lenses.

Very rare: optic neuritis, trombosis vascular retinal (abnormalities in the eye and vision disorders).

7. Vascular disorders

Uncommon: increased blood pressure.

Rare: venous thrombotic events (blood clots in veins). Very rare: worsening of varicose veins.

8. Gastrointestinal disorders

FAQ: nausea, vomiting, abdominal pain. Uncommon: colic, swelling.

Very rare: pancreatitis, liver adenomas, hepatocellular carcinoma.

9. Hepatobiliary disorders

Rare: cholestatic jaundice.

Very rare: colecistopatía (Gallbladder disorders), including gallstones.

10.Skin and appendages disorders

FAQ: acne.

Uncommon: rash (urticaria), photosensitivity reactions, cloasma (skin spots) may persist, hirsutism (hair growth), alopecia (hair loss).

Rare: erythema nodosum (a type of skin inflammation with nodules on the legs).

Very rare: erythema multiforme (a type of skin inflammation).

11.Renal and urinary disorders

Very rare: Hemolytic uremic syndrome.

12.Reproductive system and breast

Very common: bleeding, stained.

FAQ: breast pain, breast tenderness, breast augmentation, mammary secretion, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical ectropion (altering the cervical mucus), amenorrhea (absent menstruation).

13.General disorders

FAQ: fluid retention, edema (swelling), weight changes (gain or loss).

14.Laboratory Tests

Uncommon: changes in blood lipid levels, including hypertriglyceridemia. Rare: decreased serum folate levels.

If you notice any side effects not listed in this leaflet, ask your doctor or pharmacist.

5. Meliane STORE

Meliane Keep out of reach and sight of children. Store in original container.

Meliane not use after the expiration date on the package. Meliane is a registered trademark.

This leaflet was approved in July 2003.

The holder of the marketing authorization is Meliane:

SA Schering Spain.

Alvaro Mendez, 55

28045 Madrid - Spain

Responsible for the manufacture of Meliane is:

Schering AG Müller cup, 170-178

13342 Berlin – Germany

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