Melodene 15 ®

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. MELODENE-15 WHAT IS AND WHAT IT IS USED

Melodene-15 comes in kits 1 ó 3 blíster (the container where the coated tablets) each blister containing 28 coated tablets (24 yellow 4 white).

Melodene-15 is an oral hormonal contraceptive minimum dosage. Inhibits ovulation. It is used to prevent pregnancy.

  • Each yellow coated tablet of Melodene-15 contains 0,060 mg gestodene and the active ingredient 0,015 mg of ethinyl estradiol active. The other ingredients are lactose monohydrate, microcrystalline cellulose, estearato magnésico, polacrilina potásica, OPADRY yellow YS-1-6386-G [hipromelosa, titanium dioxide (E 171), Yellow iron oxide (E 172), iron oxide red (E 172)], macrogol 1450, And wax (montana wax glicolada).
  • Each white film-coated tablet contains lactose monohydrate, microcrystalline cellulose, estearato magnésico, polacrilina potásica, Opadry white Y-5-18024-A [hipromelosa, hidroxipropilcelulosa, titanium dioxide (E 171), macrogol 400], macrogol 1450, And wax (montana wax glicolada) and contains no active ingredient.

2. BEFORE YOU TAKE MELODENE-15

Do not take Melodene-15 if found in any of the following circumstances or have any of the following diseases:

– Known hypersensitivity to any component of Melodene-15.

– Are you pregnant or might be pregnant.

– Severely impaired liver function or liver tumors.

– Venous thrombosis: blood clots in the veins of the lower limbs that have fallen affecting other parts of the body, even if it was long ago. The clot can affect the lungs evolved (pulmonary embolism).

– Lumps in the breasts, Cervical, uterus vagina.

– Diabetes combined with heart problems circulatory problems.

– Disorders of the arteries of the brain or heart (arterial thromboembolism).

– If you have an inherited or acquired predisposition for venous or arterial thrombosis.

– Certain diseases of the heart valves (valvulopatías trombogénicas).

– Heart rhythm disorders with possible blood clots (thrombogenic arrhythmias).

– High Blood Pressure.

– Vaginal bleeding of unknown cause.

Take special care with Melodene-15:

Before using Melodene-15 will have to go to your doctor to perform a physical examination. It is important to tell if you have or have had in the past any of the diseases listed below. If so, your doctor may have to watch her more often. It should also go to your doctor if any of these conditions worse or occurs while using Melodene-15:

– Heart Disease (chest pain, certain types of heart rhythm disorders, heart disease).

– High levels of fat (triglicéridos) blood or family history of this.

– High Voltage, particularly if it worsens or does not improve when taking antihypertensive medications.

– Migraines (migraines) intensive and repetitive.

– Diabetes.

– Depression or history of depression, as this may worsen or come back to use hormonal contraceptives.

– Epilepsy.

– Disturbance in liver function.

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

– Vascular disease, Varicose veins (varicose veins) or kidney disorders. Also contact your doctor if you think you might be pregnant.

Potentially serious diseases:

Thrombosis (blood clots)

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

Blood clots can block major blood vessels and may rarely 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).

If you identify the occurrence of any of the possible signs of a blood clot, Tell your doctor. These symptoms are:

– Pain and swelling in the leg.

– Severe pain in the chest and sometimes in the arm.

– Cough flare.

– Severe headache.

– Vision problems (vision loss, double vision).

– Difficulty speaking clearly.

– Dizziness.

– Seizures.

– Weakness or numbness affecting one part of the body.

– Difficulty walking or holding things.

– Severe stomach pain.

The following conditions may increase the risk of blood clots, so you must tell the doctor if any of them:

– Certain thrombophilias (tendency to produce blood clots hereditary or acquired defect).

– You are very obese.

– Are you a smoker, especially if you have more than 35 años.

– Just given birth or just have an abortion in the second trimester of pregnancy.

– You need to be in bed for days. In these cases, if possible, treatment should be discontinued.

– It has undergone or will undergo major surgery. In these cases, whenever possible, treatment should be discontinued four weeks before and two weeks after you undergo such intervention

– Migraines (severe pain migraine headache). If you increase the frequency or severity of such treatment should be discontinued with the contraceptive.

– Elderly

To use Melodene-15 after delivery or abortion in the 2 nd quarter: see section "Taking Melodene-15".

Blood Pressure

If you have hypertension (High Blood Pressure) or disease related to hypertension ( including kidney diseases), is preferable to use other contraceptive methods. If you choose to use oral contraceptives, blood pressure should be monitored, but if this increases, and can not be controlled with medication, treatment should be stopped.

Tumors

There have been cases of breast tumors with slightly more often in women who use birth control pills, but whether this is due to treatment. Por ejemplo, could be that more tumors were detected in women who use birth control pills because they attend more often medical consultation. This increased frequency decreases gradually after stopping treatment. After ten years, the chances of having breast cancer would be the same for women who have never used birth control pills.

Also, cervical tumors (cervix) occur more frequently in women using the contraceptive pill. Nevertheless, the occurrence of this tumor is associated with an increase in sexual activity and sexual transmitted diseases, so it is unclear whether the pill plays a direct role in this risk. On the other hand, oral contraception reduces the risk of ovarian cancer and endometrial.

Rarely been reported liver tumors in women using the pill. This can cause internal bleeding that results in severe pain in abdomen. If this occurs, should contact your doctor immediately.

You should ensure close monitoring if you or a relative have or have had breast or benign uterine pathology (endometrial hyperplasia, fibroids), hiperprolactinemia (excess of a hormone called prolactin, blood), otosclerosis (a type of ear disease), suspended, herpes during pregnancy, gallstones, chorea or HUS.

Genital bleeding

You might not have the "period" in the days planned. If the pill is taken correctly, is unlikely to be pregnant. Nevertheless, if you have two faults, should consult your doctor as you should rule out pregnancy. If you have not taken the pill according to the instructions in "How to take Melodene-15" and has a lack, should discontinue treatment and use a non-hormonal method of contraception until pregnancy has been ruled.

Melodene-15 can cause bleeding or spotting between periods. If this occurs you, continue treatment with Melodene-15, and if bleeding continues to occur past the first three cycles, consult your doctor immediately. Errors in the use of the pill can also cause spotting and light bleeding.

Some women may experience amenorrhea (lack of menstrual flow) u oligomenorrhea (decreased menstrual flow) post-therapeutic, especially when there is a history of it. These situations usually resolve spontaneously, but if it were not so you should consult your doctor.

The contraceptive pill does not protect against HIV infection (PAGE) or any other sexually transmitted disease (p. not., Chlamydia, genital herpes, condyloma acuminata, gonorrhea, hepatitis B and syphilis). You must use condoms to protect against these diseases.

Diarrhea and vomiting may reduce the absorption of the contraceptive (see “How to take Melodene-15 ").

Others:

Although not conclusively shown the association with combined oral contraceptives, reported that both during pregnancy or during the taking of these can cause or worsen a picture of cholestasis (arrest or decreased flow of bile into the bile ducts, due to obstruction of hepatic or extrahepatic origin).

Be especially careful if Melodene-15 has high levels of fat (triglicéridos) blood or family history of the same. Estrogen preparations may be associated with increases in triglycerides, rare but important, that can cause pancreatitis.

Tell your doctor if any of the symptoms or risk factors described above.

Pregnancy

Melodene-15 Do not use if pregnant or think you may be pregnant.

If you become pregnant, must immediately discontinue taking Melodene-15 and consult with your doctor.

Breastfeeding

Do not use Melodene-15 until you have fully completed lactation.

Driving and using machines

You can drive or use tools while taking Melodene-15.

Important information about some of the components of Melodene-15

For polacrilin contain potassium as excipient is detrimental to patients with potassium diet. Excess potassium may cause, after oral administration, stomach upset and diarrhea.

Tell your doctor if you take Melodene-15, it may alter the results of certain lab tests or.

If you have questions about any of the above, consult your doctor before taking Melodene-15.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. However, see the prospectus of the medications given simultaneously to identify possible interactions with Melodene-15.

Note that these instructions may also apply to medicines you have taken can be taken before or after.

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

– Some treatments for viral infections and HIV (ritonavir).

– Some antibiotics (e.g., ampicillin, rifampin, rifabutina, tetracyclines, griseofulvina).

– Some antiepileptic (topiramate, barbiturates, phenytoin, carbamacepina, primidona, felbamato).

– Antacids.

– Others (fluranizina).

– Some substances to lift the spirits (modafinil).

The herb St. John's wort (Hipericum perforatum) also reduces the effect of oral contraceptives and pregnancy have been reported in women taking both the pill and some preparation St John's wort. The decrease of contraceptive effect lasts up to two weeks after he stopped taking the preparation with that St. John's wort.

You should use reliable contraceptive method if you are taking any of the drugs mentioned above. The effect of any of these medications can last up 28 days after stopping treatment.

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

3. TAKING MELODENE-15

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.

This medicine is for oral administration.

Before starting treatment with Melodene-15, The doctor should perform a thorough medical history and a thorough overall and gynecological (including breast), and must rule out pregnancy.

The tablets are swallowed with a little liquid. Should take a daily coated tablet, same time (about) every day. Start with a yellow coated tablet active during the first 24 days, after, inactive for the white one 4 last days to complete the 28 coated tablets. Continue with another blister the next day, without a rest interval. The withdrawal bleeding (rule) usually begins 2-3 days after socket last active tablet (yellow), and may not be completed before starting the next pack. It is important not to forget making any coated tablet (if this occurs, read later as take appropriate measures).

Along with the blister reminder (coated tablets containing) find a card with seven adhesive strips (see figure 1). These strips show weekdays. Each strip starts with a different day of the week. Peel the strip that starts with the day of the week that will take the first tablet coated Melodene – 15 (por ejemplo, if you start taking the tablets coated on a Thursday, off the strip that starts from "THU").

HOME

Peel the strip that starts with the day of the week that will take the first tablet (eg., si Apart. begins on a Thursday off the strip that starts THU).

LUN

MARMIETHULIFESABJUDGEMENT
MARMIETHULIFESatJUDGEMENTLUM
MIETHULIFESABJUDGEMENTLUNMAR
THULIFESABJUDGEMENTLUNMARMIE
LIFESABJUDGEMENTLUNMARMIETHU
SatJUDGEMENTLUNMARMIETHULIFE
JUDGEMENTLUNMARMIETHULIFESat

Figure 1

Glue the strip into the rectangle on the top of the blister pack containing tablets coated. Thus, the first day is on the yellow-coated tablet, at which point the arrow marked with the word "start" (see figure 2).

Blister y uso de Melodene 15

Figure 2

Take a coated tablet each day following the direction of the arrows, until the end of the 28 reminder blister coated tablets. In this way, take a yellow coated tablet daily for the first 24 days, then, a white-coated tablet daily for the following 4 days.

First stage, start Melodene-15

If you have not used contraception in the previous month, take the first tablet coated on the first day of menstrual bleeding.

Subsequent cycles

By not requiring rest periods between blisters, to prevent irregularities and olvido en la take, You must also have the second blister before the end of the first. Should begin the day after taking the last white-coated tablet blister that just ended.

If you switch from another birth control:

Oral contraceptives

You must start making Melodene-15 the day after taking the last active coated tablet its previous oral contraceptive.

Injection or implant

You must start making Melodene-15 the day of implant removal or, if using an injection, the day it should be for the next injection.

Whether changes to Melodene-15 from another oral contraceptive as from an implant or injection, it is advisable to use another method of birth control during the 7 early days of making the coated tablet.

After the first trimester abortion:

You can start making Melodene-15 immediately. No additional contraceptive measures are necessary.

After delivery or abortion in the second quarter:

You should not start taking Melodene-15 before the day 21 the 28 after delivery or abortion in the second trimester. It is advisable to use another method of birth control during the 7 early days of making the coated tablet. If you had sex before you start making Melodene-15, Call your doctor to rule out pregnancy before you start taking the preparation.

Your doctor will tell you how long your treatment with Melodene-15. Do not stop treatment before, Doing so may cause the desired effect.

If you take more tablets coated Melodene-15 than you should:

If you take more tablets coated Melodene-15 than you should, immediately consult your doctor or pharmacist or local poison control center. Telephone: 91 562 04 20.

No serious adverse effects have been reported after massive ingestion of high doses of combined oral contraceptives. Based on general experience with combined oral contraceptives, symptoms may occur if an excess assets are taking tablets: nausea, vomiting, teen, vaginal bleeding.

If you miss taking a tablet coated Melodene-15:

The neglect of one or more coated tablets may create a risk of pregnancy.

If you miss a yellow coated tablet and realizes within 12 hours at the usual time, Take the missed tablet immediately and follow the treatment normally taking the next tablets at the usual time. Need not take any additional measures.

If you miss a yellow coated tablet and realizes after 12 hours at the usual time, risk of pregnancy. In this case,es: Immediately take the missed tablet, even if it means taking two tablets on the same day, Continue treatment until the end of the container and simultaneously use another birth control method (condom, spermicide) during 7 days. If 7 days that is required to use an additional contraceptive method extend beyond the last active tablet taken from the current pack, the next pack should be started the day after taking the last active tablet of the current container, dispose all inactive tablets. It is unlikely that you submit a withdrawal bleed (rule) until the time of making the second container inactive tablets, may have spotted (spotting) or breakthrough bleeding. If you do not have a withdrawal bleed at the end of the second pack must discard a possible pregnancy before proceeding with taking tablets.

Do not use natural methods such as rhythm or temperature, because they can not adequately protect. Once you start the new packaging is already protected again facing the possibility of pregnancy.

The neglect of taking some white-coated tablet is not important, long as the time between taking the last yellow coated tablet and coated tablet takes the first yellow of the next package do not exceed four days.

Gastrointestinal Disorders

The occurrence of vomiting or severe diarrhea in 4 hours after taking the tablet coated can cause transient ineffective contraceptive, because it reduces the absorption of the. In this case, proceed in the same way as in the case where one has forgotten coated tablet for less than 12 hours. The tablet should be taken of additional reserve container. If gastrointestinal problems are repeated over several days, then you must use a non-hormonal contraceptive additional (condom, spermicide, etc.) until the beginning of the next blister pack.

4. Possible adverse effects

Like all medicines, Melodene-15 can have adverse effects.

Some of the most frequently reported adverse events (over 10% Incidence) during the studies are Melodene-15: headache, including migraines, and breakthrough bleeding / stained (spotting).

It has been reported other adverse reactions when using Melodene-15.

These are listed below, classified according to their frequency in patients treated, according to the following criteria:

Very common: ≥ 10% FAQ: > 1% and < 10%

Uncommon: > 0,1% and < 1% Rare: > 0,01% and < 0,1%

Very rare: < 0,01%

Common Infections:

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

Amongs,enlathes immune system:

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

Very rare: Exacerbation of systemic lupus erythematosus (inflammatory dermatitis).

Metabolic and Nutritional Disorders:

Uncommon: Changes in appetite (increase or decrease). Rare: Glucose intolerance.

Very rare: Exacerbation of porphyria (familial metabolic disorder).

TrustOrnos psychiatric:

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

Amongs,enlathes nervous system:

Very common: Headache, including migraines (migraines). FAQ: Nervousness, vertigo.

Very rare: Exacerbation of chorea (involuntary movements).

TrustOrnos ocular:

Rare: Intolerance to contact lenses.

Very rare: Eye abnormalities and visual disturbances such as optic neuritis (optic nerve inflammation) and retinal vascular thrombosis (occlusion of retinal vessels).

Vascular disorders

Uncommon: Increases in blood pressure.

Rare: Venous thrombotic (blood clots in veins).

Very rare: Worsening varices.

Gastrointestinal disorders:

FAQ: Nausea, vomiting, abdominal pain.

Uncommon: Colic, swelling.

Very rare: Pancreatitis (inflammation of the pancreas), liver adenomas, hepatocellular carcinoma.

Hepato-biliary disorders:

Rare: Cholestatic jaundice (yellowing of the whites of the eyes and skin).

Very rare: Gallstones and cholestasis (OCs may worsen cholestasis gallstones or existing).

Skin and appendages:

FAQ: Acne.

Uncommon: Rash (urticaria), skin spots, 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).

TrustOrno renal and urinary:

Very rare: HUS (renal disease with blood disorders).

TrustOrnos Reproductive system and breast:

Very common: Stained vaginal bleeding the unexpected.

FAQ: Pain or tightness in chest, breast swelling, mammary secretion, dysmenorrhoea (painful menstruation), menstrual flow changes, changes in vaginal secretion and cervical ectopia (altering the cervical mucus), amenorrhea (absent menstruation).

TrustOrnos General:

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

Laboratory Tests

Uncommon: Change in lipid levels in the blood, including hipertriglice- ridemia (High levels of fatty acids in blood).

Do not be alarmed by these reactions, since it is quite possible that none of them displayed.

If any of these side effects tell your doctor, who will advise you to stop if it might affect their welfare.

If you notice any other effects not listed in this leaflet, check with your doctor or pharmacist.

5. STORE MELODENE-15

Melodene-15 Keep out of reach and sight of children. No special storage conditions required.

Melodene-15 Do not use after the expiration date on the package. Melodene-15 is a registered trademark.

The holder of the marketing authorization is Melodene-15:

SA Schering Spain.

Alvaro Mendez, 55

28045 MADRID

Responsible for the manufacture of Melodene-15:

Schering AG

D-13342 Berlin

Germany

This leaflet was approved in December 2003

Price: 11,71- 13 EUR

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