Harmoni ®

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 personally and not pass it on to others.

Yours, even if their symptoms are the same as yours.

1. WHAT HARMONET COATED TABLETS AND WHAT IT IS USED

HARMONET is a drug administered orally. Calendar is available in packs containing 1 ó 3 blisteres, with 21 tablets in blister.

Doctors prescribe this medication in the following indications: oral hormonal contraception, menstrual cycle disorders.

Each tablet contains white 0,075 mg gestodene and the active ingredient 0,020 mg of ethinyl estradiol active.

Other components (excipients) its: Sucrose (19,660 mg), lactose (37,505 mg), cornstarch, polivinilpirrolidona 25.000, estearato magnésico, polivinilpirrolidona K-90, polietilenglicol 6.000, calcium carbonate, montana talc and glycol wax.

2. BEFORE YOU TAKE HARMONET COATED TABLETS

Do not take HARMONET if you are in any of the following circumstances or have any of the following diseases:

– Known hypersensitivity to any component of HARMONET.

– Are you pregnant or might be pregnant.

– Severely impaired liver function.

– 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 loose clot can affect the lungs (pulmonary embolism), eyes, brain, heart.

– Lumps in the breasts, liver, Cervical, uterus vagina.

– Diabetes combined with heart problems circulatory problems.

– Disorders of the arteries of the brain or heart.

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

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

– Inherited or acquired disorders that predispose to the formation of clots (trombofilias)

– Migraines (migraines) associated with symptoms such as loss of strength or sensation of a body part, or impaired vision (will)

– High Blood Pressure.

– Vaginal bleeding of unknown cause.

Take special care with HARMONET

Before using HARMONET will go to their 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 it were, your doctor may need to watch her more often. It should also see your doctor if any of these conditions worse or appears while using HARMONET:

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

• 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 come back to use hormonal contraceptives.

• Epilepsia.

• 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.

Potentially serious diseases:

Thrombosis (blood clots)

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 birth control during 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). Likewise, Blood clots occur rarely in the heart arteries (myocardial infarction, angina pectoris) or cerebral arteries (transient cerebral thrombosis (TIA) or permanent (stroke); the cerebral hemorrhage). The risk of blood clots occurring in the liver, intestines, kidney or eyes is extremely rare. Blood clots in the eyes may cause loss of vision or double vision.

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 chest pain and sometimes in the arm

-cough of acute onset

-severe headache

-vision problems (vision loss, double vision)

-difficulty speaking clearly

-dizziness

-seizures

-weakness or numbness that affects a body part

-difficulty walking or holding things

-severe stomach pain

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

-you are very obese.

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

-has had a severe injury to the leg or hip.

-just given birth or just had an abortion in the second trimester of pregnancy.

-needs to be in bed for several days. In these cases, if possible, treatment should be discontinued.

-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 this operation.

-elderly

Since immediately after birth increases the likelihood of emergence of a venous thromboembolism, not begin treatment with oral contraceptives until the expiration 28 days after delivery or abortion in the second quarter.

Blood Pressure

If you have hypertension (high blood pressure) or disease related to hypertension (renal diseases including), is preferable to use other contraceptive methods. If you choose to use oral contraceptives, blood pressure should be monitored, but if it increases, and can not be controlled with medication, need to discontinue treatment.

Tumors

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.

Likewise, 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.

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

Migrañas

The onset or worsening of a migraine (migraine), or the onset of a migraine characteristics different from the usual, recurrent, Persistent severe, required discontinuation of contraception and the assessment of accrued.

Women with migraines (particularly associated with symptoms such as loss of strength or sensation of a body part, or impaired vision (will)) oral contraceptives may experience an increased risk of stroke.

Genital bleeding

You might not have the "period" during the bye week. 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 contraceptive pill

according to the instructions in "TAKING HARMONET 3" and has a lack, should discontinue treatment and use a nonhormonal contraceptive method until pregnancy is ruled out.

HARMONET can cause vaginal bleeding or spotting between periods. If this occurs you, HARMONET continue treatment 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.

When you stop using HARMONET, is possible that this irregular bleeding, little or no staining, especially in the early 3 months, especially if their periods were irregular and before you start taking hormones.

Effects on carbohydrate and lipid

In oral contraceptive users have been cases of glucose intolerance. Women with impaired glucose tolerance or diabetes mellitus should be monitored carefully.

A small proportion of women taking contraceptives may have changes in their lipid profile. Should be considered non-hormonal contraceptives in women with uncontrolled lipid abnormalities. In a small proportion of women who take oral contraceptives can cause hypertriglyceridemia (increased blood triglyceride) persistent. A significant increase in plasma triglycerides may lead to other complications pancreatitis and.

Women who have been treated for hyperlipidemias should be subjected to follow-up if they decide to take oral contraceptives.

Eye Injuries

With the use of oral contraceptives have been reported cases of retinal vascular thrombosis that can lead to vision loss or complete. If signs or symptoms such as visual changes, proptosis principle (protruding eyes) or diplopia (double perception of objects), papilledema or retinal vascular lesions, should discontinue treatment with oral contraceptives and the case must be evaluated immediately.

Depression

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.

Others

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

Pregnancy and lactation

Consult your doctor or pharmacist before taking any medicine

HARMONET not use if pregnant or think you may be pregnant (for information on using HARMONET after pregnancy, see "3. TAKING HARMONET ").

If you become pregnant, must immediately discontinue taking HARMONET and consult with your doctor.

HARMONET not be used until the end of lactation.

Driving and using machines

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

Important information about some components HARMONET

This medicine contains lactose and sucrose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.

This medicine does not contain gluten.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, obtained without a prescription.

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

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

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

• Some antibiotics (penicillins and derivatives (ampicillin), rifampin, rifabutina, griseofulvina, erythromycin, troleandomycin y tetraciclinas).

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

• Some anti-inflammatory (phenylbutazone, dexamethasone)

• Antacids

• purgatives

• Some substances to improve mood (modafinilo).

• Drugs that reduce triglycerides and / or cholesterol (atorvastatin)

• Antifúngicos (fluconazole)

• Vitamin C

• Analgesics (paracetamol)

The herb St. John's wort (Hypericum perforatum), also reduces the effect of oral contraceptives and pregnancy have been reported in women taking both the pill and a preparation of the herb St. John. The decrease of 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.

HARMONET may decrease the effect of oral anticoagulants (acenocumarol), analgesics (as paracetamol and salicylates), oral agents and insulin and lamotrigine, while it may 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.

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.

3. TAKING HARMONET COATED TABLETS

Follow these instructions, unless your doctor gave you different advice.

This medicine is for oral administration.

Remember to take your medicine, oblivion as coated tablets may decrease the effectiveness of the preparation.

Before starting treatment with HARMONET the doctor should perform a thorough medical history and a thorough overall and gynecological (including breast), and ruled out the existence of pregnancy. See section 2 "Before taking HARMONET".

Instructions for proper drug administration.

Should take the tablets by mouth, in the order listed on the blister pack, approximately the same time, daily, with a little liquid if necessary. You should take one tablet daily for 21 consecutive days. Each package will start back after an interval of 7 day tablet, which usually occur during a withdrawal bleed. This hemorrhage, similar to the rule, usually begins between days 2 a,en 3 after taking the last tablet, and may not be completed before the start of the next pack.

Your doctor will indicate the duration of treatment with Harmoni.

If you feel that HARMONET action is too strong or weak, Tell your doctor or pharmacist.

Beginning of the first container HARMONET

When not used any hormonal contraceptive in the previous month.

The treatment begins the first day of menstrual cycle (ie, the first day of bleeding).

So, por ejemplo, if bleeding occurs on a Monday should start making the day HARMONET, coated tablet marked with "Lu", and follow the arrow indicator for the following shots.

It is also possible to begin in days 2-7, although during the first cycle is further recommended birth control to support non-hormonal birth control (such as condoms and spermicides during the first 7 days of taking tablets).

When you are taking another contraceptive and replace it Harmonet

You can start taking HARMONET the day after taking the last active tablet of your current pack of pills (this means no tablet break). If your current pill pack also contains inactive tablets, HARMONET should start taking the day after taking the last tablet active. Never be postponed later than the day following the end of the usual tablet-free interval or placebo tablet interval of her previous COC.

When changing a method that contains only a progestogen (minipildora, injection or implant).

You can stop taking the progestogen pill (minipildora) any day and start taking the next day HARMONET, at the same time.

Start using appropriate HARMONET when you next injection or the day that your implant removed.

In all these situations, Also be sure to use a backup method (such as, condoms or spermicides) during 7 early days of tablet-taking when sexual intercourse.

After an abortion in the first quarter

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

After delivery or abortion in the second quarter

If you are breast-feeding, see "Pregnancy and lactation".

The use of compressed begins 28 days after delivery or abortion in the second quarter. If you start later, must use an additional barrier method during the 7 early days of tablet-. However, if you have had sex, be ruled out that a pregnancy has occurred before the actual use of contraception or have to wait for her next menstrual period.

Subsequent cycles

After 7 rest days, continues with a new package of HARMONET, starting the day of the week began the first container.

What to do if bleeding occurs during the 21 days of tablet-taking

The occurrence of bleeding during 3 weeks of making the coated tablets is no reason to stop treatment. A slight haemorrhage usually resolves itself. If the bleeding reached an intensity similar to normal menstruation, and they lasted for more than 3 cycles, will need to seek medical advice.

No bleeding

If the rest period does not appear vaginal bleeding, should consult a doctor immediately, to exclude the possibility of pregnancy if the coated tablets were not taken regularly or have been vomiting or diarrhea during cycle.

Action to take if you miss taking a tablet

Contraceptive protection may be reduced if you forget to take tablets. In particular, if in the first week of the pack and had intercourse in the week before the oblivion of the tablets, should consider the possibility of getting pregnant.

• If delayed less than 12 hours in taking any tablet, maintaining the effectiveness of the pill. Take it as soon as you remember and take these tablets at the usual times.

• If delayed more 12 hours in taking any tablet, contraceptive effectiveness may be reduced.

  • Always take the last missed tablet as soon as you remember, even if this means taking two tablets in one day. Keep taking the tablets following your normal time, but use a backup method (as, Condoms and spermicides) during 7 days.
  • If during the 7 day that require the use of a birth control method you run the package, start another container while rest period between them. You will not have your period until the end of the second pack, but can be stained or have breakthrough bleeding on the days when taking the tablets.
  • If you do not have periods at the end of the second container, contact your doctor, you should verify that you are not pregnant before starting the next pack.

Advice if inOmintOs,en

If vomiting occurs within 4 hours after taking the tablet, should follow the advice concerning the neglect of taking tablets. If you do not want to change their normal pattern of taking tablets, should take the necessary additional tablets of another pack.

How to delay a period

To delay a period, should start a new pack immediately after finishing the current pack, without pause. Periods may be delayed as much as you want it, but not beyond the end of the second container. During this time you may experience bleeding or spotting. Later, Regular intake of HARMONET resumes after the usual interval 7 tablet-free days.

If you take more than you should HARMONET:

You may experience nausea, vomiting and vaginal bleeding; Treatment consists of discontinuation of HARMONET. Contact your doctor or pharmacist as soon as possible.

In case of overdose accidental ingestion, consult your local poison control center. Telephone

915 620 420.

4. Possible adverse effects

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

– Increased risk of venous and arterial thrombotic, and thromboembolic, including stroke, TIA, Myocardial infarction, venous thrombosis and pulmonary embolism (see "Take special care with HARMONET")

– Increased risk of cervical intraepithelial neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (Cervical cancer).

– Increased risk of breast cancer diagnosis (see "Special care HARMONET")

The adverse reactions listed below are ranked by frequency 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).

Neoplasias benignas / or malignas inespecíficas

Very rare: Hepatic adenomas (benign liver tumors). Carcinomas hepatocelulares (malignant liver tumors)

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: Worsening of systemic lupus erythematosus (inflammatory dermatitis)

Metabolic and Nutritional Disorders

Uncommon: Changes in appetite (increase or decrease).

Rare: Glucose intolerance.

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

Psychiatric disorders

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

Nervous system disorders

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

Very rare: Worsening of disease Korea (involuntary movements).

Eye disorders

Rare: Intolerance to contact lenses.

Very rare: Eye abnormalities and visual disturbances

Vascular disorders

Uncommon: Increased blood pressure.

Rare: Venous thrombotic events (blood clots in veins).

Very rare: Worsening varices.

Gastrointestinal disorders

FAQ: Nausea, vomiting, abdominal pain.

Uncommon: Colic, bloating.

Very rare: Pancreatitis (inflammation of the pancreas)

Hepatobiliary disorders

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

Very rare: Colecistopatía (Gallbladder disorders) including gallstones.

Skin and appendages disorders

FAQ: Acne

Uncommon: Rash (urticaria), cloasma (skin spots), hirsutism (hair growth), alopecia (hair loss).

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

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

Renal and urinary disorders

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

Reproductive system and breast

Very common: Stained vaginal bleeding the unexpected.

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

General disorders

FAQ: Fluid retention, edema (swelling)

Others

FAQ: Change in weight (increase or decrease)

Uncommon: Increased blood pressure; changes in serum lipid levels, including hypertriglyceridemia (High levels of fatty acids in blood).

Rare: Decreased blood levels of folate.

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 side effects not mentioned in this leaflet, Consult your doctor or pharmacist.

5. STORE HARMONET COATED TABLETS

This medicine does not require special storage conditions. HARMONET Keep out of reach and sight of children.

Expiry

HARMONET not use after the expiration date on the package.

This leaflet was approved in July 2007

Marketing Authorisation Holder

WYETH FARMA, SA.

Ctra. Burgos, Km 23. Diversion Algete, Km 1. San Sebastian de los Reyes - Madrid SPAIN

Responsible Manufacturing

WYETH MEDICA IRELAND

Little Connell Newbridge, What. Kildare

IRELAND

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