Loette ® and Loette Journal ®

Please read this leaflet carefully before taking this medicine.

– Keep this leaflet, You may need 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, even if their symptoms, as yours.

If you notice any side effects not listed in this leaflet or if you have one of the side effects become serious, tell your doctor or pharmacist.

1.WHAT Loette 100/20 MicroGrid TABLETS AND WHAT IT IS USED

Loette is a monophasic combined oral contraceptive, and that all the tablets combine the same container in the same dose hormones. Each tablet contains two female hormones: progestin and estrogen Ethinylestradiol Levonorgestrel. Due to the small amounts of hormones, Loette is considered a low-dose oral contraceptive.

Loette as COC or "pill for birth control" or "the pill", inhibit ovulation and induce changes in the endometrium and thus is used to prevent pregnancy.

2. BEFORE TAKING Loette 100/20 MicroGrid TABLETS

This product (Like other oral contraceptives) is intended to prevent pregnancy. Does not protect against HIV infection (PAGE) or against other sexually transmitted diseases.

Do not use any oral contraceptive if you have or have had any of the following diseases. Tell your doctor if you have any of them. Your doctor may recommend another method of birth control.

Do not take if Loette:

• If you are allergic (hypersensitive) any of the active substances or any of the other components Loette

• If you are pregnant or suspect you may be pregnant.

• Attack heart stroke (stroke).

• Thrombosis (blood clots), such as blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism) or eyes, or (as valvular and rhythm disturbances that produce an embolus).

• Blood clots in the deep veins of the legs.

• Diagnosis or suspected breast cancer or cancer of the uterine wall, cervix or vagina.

• Tumor hepático (cancer in the cancerous), or acute liver disease or chronic, as liver function has not returned to normal.

• Chest pain (angina pectoris).

• unexpected vaginal bleeding (until the doctor establish the diagnosis).

• High blood pressure (p. not. 160/100 mm Hg or higher) Uncontrolled

• Diabetes mellitus combined with heart problems circulatory problems

• Migraine with focal neurological symptoms, as migraine with aura

Take special care with Loette:

Your doctor should know your medical and family history before prescribing oral contraceptives. When using the pill, Your doctor will tell you to return for regular checkups. Should be re-examined at least once a year. Be sure to tell your doctor if you have a family history of any of the diseases listed in this leaflet.

• Lumps in the breast, fibrocystic breast disease, or abnormal X-rays

or breast mammography.

• Diabetes (due to alterations in glucose tolerance, may vary the required dose of insulin or other antidiabetic agents).

• high cholesterol or triglycerides.

• High blood pressure.

• Migraine or other headaches or epilepsy.

• Mental depression.

• gallbladder disease, heart or kidney.

Women with any of these conditions should see your doctor often to pass a review if you choose to use oral contraceptives. further, make sure you tell your doctor if you smoke or take any other medication.

RISKS OF TAKING ORAL CONTRACEPTIVES

Any woman who is considering the use of oral contraceptives (the pill for birth control pill or) should understand the benefits and risks of using this form of birth control.

Women with risk factors for thrombotic or thromboembolic disorders or cardiovascular disease, Caution should be used with oral contraceptives.

1. Risk of developing blood clots

Thrombosis is the formation of a blood clot which may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (DVT). If this blood clot can be seen from the vein into which has been formed, can reach and block the arteries of the lungs, causing a pulmonary embolism.

The use of any combined oral contraceptive (AOC) carries an increased risk of venous thromboembolism (TEV), in relation to the non-use of the. The increased risk is greatest during the first year a woman ever uses a combined oral contraceptive. The increased risk is less than the risk of VTE associated with pregnancy, which is estimated as 60 cases 100.000 women-years. VTE is fatal in 1 – 2% cases.

In some cases, thrombosis may cause serious permanent disabilities or may even be mortal.El risk of venous thrombosis complications increases with age, a family history, prolonged immobilization or obesity.

If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently had a baby, may be at risk of developing blood clots. You should consult with your doctor to stop taking oral contraceptives. You should also consult your doctor about when to begin taking oral contraceptives after having a baby or after an interruption of pregnancy in midterm. (See WARNINGS: During lactation)

Tell your doctor if you think you have venous or arterial thrombosis, Symptoms may include:

• Pain and / or swelling and unusual unilateral leg

• severe chest pain that can spread to the left arm or not

• fatiga ropes thaw

• sudden onset of cough

• any unusual headache, intense prolonged

• Sudden loss of vision, partially or completely

• Diplopia (double vision)

• Aphasia (difficulty speaking)

• vertigo

• loss of consciousness with or without focal seizure

• intense weakness or numbness suddenly affecting one side or one part of the body

• motor disorders

• severe stomach pain

2. Heart attacks and stroke

Oral contraceptives may increase the tendency to develop stroke (blockage or rupture of blood vessels in the brain) and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. The use of oral contraceptives has also been associated with transient ischemic attacks (temporary state of reduced blood flow to a part of the brain).

The risk of stroke and heart attack increases with age, smoke, dislipoproteinemia, high blood pressure, vascular heart disease, fibrillation atrialy obesity.

Contraceptive users with migraine (especially migraine with aura) may have an increased risk of cerebral vascular accident.

Smoking increases the risk of serious adverse events in the heart and blood vessels due to oral contraceptive use. This risk increases with age and the amount of snuff and is quite marked in women over 35 age. Women who use oral contraceptives should not smoke. If smoke should consider the use of other oral contraceptives.

3. High blood pressure

Has reported an increase in blood pressure in women taking oral contraceptives and this increase is more likely in oral contraceptive users older and with continued use.

4. Gallbladder disease

Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogen.

5. Liver tumors / Liver disease

Rarely, Oral contraceptives can cause liver tumors, non-carcinogenic but dangerous, that may rupture, causing internal bleeding that threatens life. further, found a possible association, although not confirmed, between the pill and liver cancers. The risk of developing liver cancer from pill use is therefore unlikely.

Women with a history of cholestasis (removing or stopping the flow of bile) related to the use of contraceptives or women with cholestasis during pregnancy, must be controlled during use of contraceptive. Use should be discontinued if the condition persists.

6. Cancer of the reproductive organs

Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use. This very small increase in the number of breast cancer diagnoses gradually disappears during the 10 years after stopping the pill. It is not known whether the difference in the diagnosis of breast cancer in pill users compared to nonusers to be on the pill. It may be that women taking the pill are examined more often, so that there would be more likely to breast cancer is detected before.

Some studies have found an increased risk of cervical cancer in women who use oral contraceptives. Nevertheless, This finding may be related to factors other than oral contraceptives.

7. Metabolism lipídico y pancreatitis:

Some oral contraceptive users has been an increase in blood levels of cholesterol and triglycerides. An increase in plasma triglycerides may lead to pancreatitis (pancreatic inflammation) in some cases.

8. Irregularities en la hemorrhage

Loette can cause unexpected vaginal bleeding or spotting during the time it takes the oral contraceptive, especially in the first three months. Normally this does not happen after the first cycle. Continue Loette treatment and if the bleeding continues after the first three months, Consult your doctor or pharmacist immediately.

No menstrual periods (faults) and use of oral contraceptives before or during early pregnancy: There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If taken regularly and pills occurs lack of menstrual periods, continue taking the pills for the next cycle, but make sure you tell your doctor. If you have taken the pills daily as has been taught and there is the absence of a menstrual period, or lack of two consecutive menstrual periods, you may be pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another contraceptive method.

9. Other irregularities

Diarrhea and / or vomiting may reduce hormone absorption, resulting in a lower concentration of the same serum.

Some diseases appear to deteriorate with the use of combined oral contraceptives, although there is no clear evidence of an association. These diseases are jaundice, porphyria, lupus erythematosus, HUS, Sydenham chorea, herpes gestationis, related hearing loss of otosclerosis, and depression.

Laboratory Tests: If you have any laboratory tests performed, tell your doctor you are taking birth control pills. Some blood tests may be affected by birth control pills.

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.

Some drugs may interact with birth control pills making them less effective in preventing pregnancy or causing an increase in breakthrough bleeding, to reduce the concentration of ethinyl estradiol.

Among the substances that decrease ethinyl estradiol concentrations are: ritonavir, any substance that reduces gastrointestinal transit time, substances that induce hepatic microsomal enzymes (carbamezepina, oxicarbamazepina, rifampin, rifabutina, barbiturates, primidona, phenylbutazone, phenytoin, griseofulvina, topiramate, and modafinil); Hypericum perforatum; and certain antibiotics (ampicillin and other penicillins, tetracycline). You may need to use an additional non-hormonal contraceptive method (as the spermicidal condoms) during any cycle in which taking drugs that can make oral contraceptives less effective.

There are other substances that may increase the concentrations of ethinyl estradiol and atorvastatin, competitive inhibitors (as vitamin C and paracetamol).

Troleandomycin may increase the risk of intrahepatic cholestasis.

By interfering with ethinylestradiol, you can see changed the concentrations of other drugs, well increase as in the case of cyclosporin and theophylline; or decreases in the case of lamotrigine.

In patients treated with flunarizine, oral contraceptive use increase the risk of galactorrhea.

Pregnancy and Lactation

Consult your doctor or pharmacist before taking any medicine.

Before starting treatment with the pregnancy must be ruled Loette. If pregnancy occurs while using Loette, treatment should be stopped immediately.

No conclusive evidence that oral contraceptive use is associated with increased birth defects, when taken inadvertently during early pregnancy. However, Oral contraceptives should not be used or any other drug during pregnancy, unless clearly necessary and prescribed by a doctor. You should check with your doctor the risks to the unborn child of any medication taken during pregnancy.

If you are breast-feeding, consult your doctor before taking oral contraceptives.

Some of the drugs passed to baby through breast. It has been reported some adverse effects in children, including yellowing of the skin (jaundice) and breast augmentation. further, Oral contraceptives can reduce the quantity and quality of milk. If possible, do not use oral contraceptives while breastfeeding. You should use another method, and that breastfeeding provides only partial protection against pregnancy and this partial protection decreases significantly as you breast-feed for longer periods of time. You should consider starting oral contraceptives only after you have completely stopped breastfeeding her baby.

Driving and using machines

No effects were observed on the ability to drive.

Important information about some of the components Loette

Polacrilin to contain potassium as an excipient is harmful for patients with potassium diet. Excess potassium may cause, after oral administration, stomach upset and diarrhea.

If a doctor says you have an intolerance to some sugars, Consult your doctor before taking this medication.

3. TAKING Loette 100/20 MicroGrid TABLETS

Loette always use exactly as described in this leaflet, otherwise may increase the risk of getting pregnant.

Always follow management instructions from your doctor Loette. Consult your doctor or pharmacist if.

When and how to take the tablets?

The pack contains Loette 21 tablets. It is important to take regular daily during 21 consecutive days to maintain contraceptive efficacy. Take the tablet at about the same time each day, with a little water if necessary. Follow the direction of the arrows until you have taken the 21 tablets. The,es 7 days do not take tablets: is the rest period. The period (menstruation) should begin during these 7 days. Usually start the day 2-3 after the last tablet Loette. Start taking your next pack on day 8, but continue bleeding. This means that you start a new pack the same day of the week and also have your period about the same day, each month.

Beginning of the first container Loette

When not used any hormonal contraceptive in the previous month.

Loette start taking the first day of your cycle, ie, the first day of your period. Por ejemplo, if your period starts on Friday, begins to take a tablet marked with "Vi". Then follow the days in the order of the arrows. Loette protects against pregnancy from day, whenever you start taking the tablets on the first day of menstruation. You can also begin in days 2-7 cycle, but in this case make sure you also use a backup method (such as condoms and spermicides) during the first 7 days of the taking of tablets in the first cycle.

When you take another pill and change it to Loette

You can start taking Loette the day after taking the last active tablet of your current pack of pills (this means no tablet break). If current packaging also contains inactive tablets pills, Loette should start taking the day after taking the last tablet active (If you are unsure of what, ask your doctor or pharmacist).

When changing a pill that contains only progestin.

You can stop taking the progestogen pill any day and start taking the next day Loette, at the same time. Nevertheless, make sure you also use a backup method (as, Condoms and spermicides) during the first 7 day taking tablets when sexual intercourse.

When changing from an injection or implant.

Start using appropriate Loette when you next injection or the day that your implant removed. Nevertheless, also make sure to use a backup method (as, condoms or spermicides) during 7 early days of tablet-taking when sexual intercourse.

After having a baby.

Your doctor may advise you to wait until you have completed your first normal period before you start taking Loette. It is sometimes possible to start sooner. Your doctor will advise. If you are breastfeeding and want to take Loette, should treat it first with your doctor.

After a miscarriage or abortion.

Your doctor will advise.

If you take more than you should Loette:

If you have taken over what to Loette, immediately consult your doctor or pharmacist, or local poison control center. Telephone: 91 562 04 20.

Not serious adverse effects reported following ingestion of large doses of oral contraceptives by children. Overdose in adults and children can cause nausea, vomiting, drowsiness / fatigue, vaginal bleeding in young women. No antidote exists, and treatment is symptomatic.

If you miss Loette:

WHAT IF…?

…pass it or forget tablets

• 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 efficacy may be reduced. There is more risk of becoming pregnant if you forget to take your tablets during the first week, or third week of the current packaging.

• 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 at the 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

second container, contact your doctor, you should verify that you are not pregnant before starting the next pack.

• If you miss tablets in the first week of the pack, and had sex in the previous week to forget the tablets, there is a possibility of getting pregnant. Tell your doctor immediately. further, begins to use a backup method.

…vomit or have severe diarrhea

If you vomit or have severe diarrhea in 3 a,en 4 hours after taking the tablet Loette, active ingredients may not have been fully absorbed. This is just like a pill to forget. Por tanto, follow the advice in the event of delay in making a tablet for less than 12 hours. If this situation is repeated over several days, contraception should be used no hormonal support (condoms, spermicide) until the beginning of the next blister pack.

…want to delay your period

Ask your doctor.

Effects that occur when you stop taking Loette:

PREGNANCY AFTER STOP TAKING THE PILL:

It may take some time to get get pregnant after stopping oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. Once you have stopped taking the pill and want to get pregnant, may be advisable to postpone conception until you return to your normal menstrual cycle.

There seems to be no increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.

4. Possible adverse effects

Like all medicines, Loette can have side effects, although not everybody gets them.

Talk to your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is a change in your health that you think may be due to oral contraceptive.

Serious side effects associated with oral contraceptive use are described in section “RISKS OF TAKING ORAL CONTRACEPTIVES”. Please, See this section for more information.

The most commonly reported effects are vaginitis (including candidiasis); mood swings (including depression); changes in libido; nervousness; dizziness; nausea; vomiting; abdominal pain; acne; pain, sensitivity, enlargement and secretion in breast; painful periods; change in menstrual flow; change in ectropion (cervical mucus) and cervical secretion; missed periods, fluid retention / edema, weight changes (increase or decrease).

Infrequent adverse effects are: changes in appetite (increase or decrease), abdominal cramps, abdominal swelling, eruption, discoloration and spots on the skin (cloasma /melasma), increasing the amount of old (hirsutism), Hair loss, increased blood pressure, and changes in blood fat levels (including high triglyceride levels).

Rare side effects include: anaphylactic / anaphylactoid (including rare cases of urticaria), angioedema and severe reactions with respiratory and circulatory symptoms, IGT, intolerance to contact lenses, cholestatic jaundice (yellowing of the whites of the eyes and skin), erythema nodosum (nodules in the legs), and decreased blood folate levels.

Very rare side effects include: enhancement of systemic lupus erythematosus (systemic disease of unknown origin), empowerment of porphyria (a type of metabolic disorder), strengthening of korea (uncontrolled movements of certain body parts), optic neuritis (which can lead to partial or total loss of vision), worsening of varicose veins, Retinal vascular thrombosis, pancreatitis, liver adenomas, carninomas hepatocelulares, gallstones and cholestasis (suppressing or stopping the flow of bile), erythema multiforme (skin lesions), and hemolytic uremic syndrome.

WARNING SIGNS

If any of the following side effects occur while taking the pill, call your doctor immediately:

• Severe pain in the chest, bloody cough or sudden shortness of breath (indicating a possible clot in the lung).

• Pain in the calf (indicating a possible clot in the leg).

• Chest pain or pressure oppressive chest (indicating a possible heart attack)

• Sudden severe headache or vomiting, dizziness or fainting, changes in vision or speech, weakness or numbness of an arm or leg (indicating a possible stroke).

• Sudden partial or complete vision (indicating a possible clot in the eye).

• breast lumps (indicating a possible breast cancer or fibrocystic breast disease; ask your doctor to teach you to examine your chest)

• Severe pain or discomfort in the stomach area (indicating a possible ruptured liver tumor).

• Difficulty sleeping, weakness, lack of energy, fatigue or mood swings (possibly indicating severe depression).

• Jaundice or a yellowing of the skin or eyeballs, often accompanied by fever, fatigue, loss of appetite, dark urine or pale stools (indicating possible liver problems).

If you notice side effects not mentioned in this leaflet, or if you have one of the side effects become serious, Consult your doctor or pharmacist.

5. Loette STORE 100/20 MicroGrid TABLETS

Keep your tablets out of reach and sight of children

No conservar a temperatura superior a 25ºC. Store in a dry place protected from light.

Loette not use after expiration date on the package.

Do not use the product if, por ejemplo, color change in the tablet, disintegration of the tablet or any visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. FURTHER INFORMATION Loette

The active ingredients are levonorgestrel and Etinielestradiol Loette.

Each tablet contains Loette 100 micrograms of levonorgestrel and 20 micrograms ethinyl estradiol.

Other COMPONENTS (excipients) are lactose monohydrate, microcrystalline cellulose, polacrilina potásica, magnesium stearate, polietilenglicol 1450, hipromelosa, titanium dioxide (E171), iron oxide red (E172), and wax montanglicol.

Looks like and contents of container

The tablets are round, biconvex pink, marked with a “In” on one side and “912” on the other side, and are extracted by pressure.

Loette is available in blister packaging 21 tablets.

Loette is presented in the following pack sizes: 21 the tablets 3 x 21 tablets.

Holder of the marketing authorization, responsible manfacture representante local and

Authorisation Holder:

Wyeth Farma S.A. Ctra. Burgos, km 23

28700 San Sebastian de los

Reyes (Madrid) Spain

Responsible for manufacturing:

Wyeth Medica Ireland Little Connell, Newbridge Co. Kildare

Ireland

Local Representative:

Pfizer, SA.

Ave. the Europe, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Logo Pfizer

This leaflet was revised in August 2010

Price Range (may vary throughout the year)

Loette 21 tablets 12-14 EUR

Daily Loette 100/20 (Like Loette 21 but week of placebo) 28 tablets 12-14 EUR

Loette 3×21 Daily 3 or Loette×21 37-39 EUR

3 Comments

  1. laura perez

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