Tevalet ®

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

1. TEVALET WHAT IS AND WHAT IT IS USED

Tevalet is a combined oral hormonal contraceptive. Inhibits ovulation and causes changes in cervical secretion. It is used to prevent pregnancy and to get ovarian sleep states.
This medicine comes in blister packs (the container where the coated tablets) the 21 coated tablets.

2. BEFORE TAKING TEVALET

Do not take Tevalet: You should not use combined oral contraceptives (AOC) in the presence of any of the situations shown below. If any of these conditions appear for the first time during COC use, 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 (diseases of the heart valves can cause blood clots).
– 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 suspect the existence of malignancies of the genital organs or the breasts.
– If you have vaginal bleeding of unknown cause.
– If you are pregnant or suspect you might be.
-If allergic (hypersensitive) to the active ethinylestradiol / gestodene or any of the other components.

Take special care with Tevalet:
If any of the risk situations mentioned below are present, your doctor should discuss the benefits of using this medicine against the 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, who will decide whether to stop using Tevalet:
– Heart Diseases (which produces certain types of heart rhythm disorders).
– High levels of fat (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 history of depression, as this may worsen or come back to use 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.
– Itching, 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 (not. solarium).
Also contact your doctor if you think you might be pregnant. – Embolism and other vascular disorders.

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. No clutch, 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 a blood clot forms in the deep veins of the leg, 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 (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 loss of vision, partially or completely; diplopia (double vision); language
unintelligible or aphasia (difficulty speaking); vertigo; seizures; weakness or very marked numbness suddenly affecting one side or a body part; 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 (more irrigation increases with heavy smoking and age, 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).
If you use this medicine after delivery or abortion in the 2nd quarter: see "Taking Tevalet”.

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 COC use (which may indicate the onset of stroke) Tell your doctor, as it can be grounds for immediate suspension of the AOC.
Your doctor must provide special attention to those biochemical factors that may be indicative of hereditary or acquired predisposition for venous or arterial thrombosis.

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.
Some studies have reported an increased risk of cervical cancer in users who have been taking COCs 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 COC 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 influence of COCs on these injuries, recommended
that, prescribe if AOC become regular cervical smears.

Other conditions
In women with hypertriglyceridemia (increased triglycerides), or family history of it, may be an increased risk of developing pancreatitis (inflammation of the pancreas) during COC use.
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 COCs was observed that many users have small increases in blood pressure, although rare cases with clinical relevance. If during COC use sustained arterial hypertension appears should consult with your doctor.
In women with endometrial hyperplasia (thickening of the lining of the uterus) the physician should carefully weigh the risk-benefit ratio before prescribing COCs, and closely monitor the patient during the treatment period, regular cervical cytology.
The following conditions may occur, or worsen with pregnancy and COC 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), lupus erythematosus (inflammatory dermatitis), Hemolytic uremic syndrome (renal disease with blood disorders), Sydenham chorea
(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 disturbances of liver function require discontinuation of COC 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 AOC.
The AOC may alter peripheral insulin resistance and glucose intolerance. No evidence of a need to alter the therapeutic regimen in diabetics using low-dose COCs (with < 0,05 mg ethinyl). However, diabetic women should be carefully observed while taking COCs.
It has been associated with COC use Crohn's 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 the sun or lightning while taking COCs ulatravioletas.
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 is necessary for your doctor to perform a history and physical examination, complete, 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.

Reduced efficacy
The efficacy of COCs may be reduced if you forget to take a tablet (see "Conduct to follow if you miss taking any 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 in the cycle control
During the use of any COC may appear stained or vaginal bleeding between two rules, especially during the first months of use. If bleeding irregularities persist or occur after previously regular cycles, should be considered non-hormonal causes, and therefore, Go to your doctor so that it can take appropriate diagnostic measures to exclude malignancy, infections or pregnancy.
In some women may not produce withdrawal bleeding (rule) during the bye week. If you have taken the AOC following the instructions in "Taking Tevalet”, is unlikely to be pregnant. Nevertheless, if you have not taken the AOC following instructions before the first missed, or if
produces a second offense, pregnancy must be ruled out before COC use is continued.
If in doubt about any of the above, consult your doctor before taking Tevalet.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other drugs, even those not prescribed. Certain medicines may interact. In these cases it may be necessary to change the dose or stop taking any medicines. 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 for viral infections and HIV (ritonavir, nelfinavir, nevirapina).
  • Some antibiotics (penicillins and derivatives, rifampin, rifabutina, griseofulvina, erythromycin, tetracyclines).
  • Some antiepileptic (topiramate, barbiturates (phenobarbital), phenytoin, carbamacepina, pirimidona, felbamato, etosuximida).
  • Antacids and lansoprazole.
  • Some substances to lift the mood (modafinil).

You should not take herbal preparations with medicinal St John's Wort (Hypericum perforatum) simultaneously with Tevalet, because their effectiveness may be reduced risk of unexpected pregnancy and breakthrough bleeding. 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.
Tevalet may decrease the effect of oral anticoagulants, analgesics (as paracetamol and salicylates), fibratos (medication to reduce triglyceride levels 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.
Tevalet not indicated during pregnancy. If this was so, should stop taking it immediately and consult with your doctor.
During COC use can remove small amounts of milk oral contraceptives, but there is no evidence that this adversely affects the child's health. However, generally should not be used until the end AOC lactating.

Driving and using machines
No effects were observed on the ability to drive or to operate machinery.

Important information about some of the components of Tevalet
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.

3. TAKING TEVALET

Follow directions exactly Tevalet management provided by your doctor. Consult your doctor or pharmacist if. 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 that corresponds (not. "LU" 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 should you start taking Tevalet

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, we recommend further in the first cycle a barrier method during the 7 early days of tablet-.

To replace another combined hormonal contraceptive (AOC):
You should begin taking Tevalet 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 AOC prior (contraception if 28 days).

To replace a method based solely on progestin (minipíldora, injection, implant) or a progestogen-releasing intrauterine system (SIU):
You can replace the mini pill for Tevalet any day (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 for the first 7 days of taking the tablet.

After an abortion in the first quarter:
You can start taking immediately Tevalet. When you do so, need not take additional contraceptive measures.

After delivery or abortion in the second quarter:
It is recommended that you start taking Tevalet 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 AOC, or should expect to have their first menstrual period.

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

Consequently, following the above, in daily practice may be advised following:

  • Week 1: Should take the last missed tablet as soon as you remember, but it forces you to take two tablets at once. From there, continues to take tablets at her 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. Many more forgotten tablets, and the closer the range usual tablet-free, the greater the risk of pregnancy.
  • Week 2: Should take the last missed tablet as soon as you remember, but it forces you to take two tablets at once. From there, continues to take tablets at her 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.
  • Week 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 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, continues to take tablets at her 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 container, but may experience spotting or bleeding by interruption in the days of taking the tablets. 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 concerning the neglect of taking tablets, as described in "Action to take 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 to delay a withdrawal bleed
To delay a period, should continue with the next pack without leaving the usual bye. You can keep this extension as long as desired until the end of the second container. During this period, may experience bleeding or spotting. Then leave the usual tablet-free period of 7 days and resumed regular decision Tevalet.

To change the period to another day of the week 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 experience a disruption bleeding or spotting during the taking of the next pack (as happens when you delay a period).

If you take more than you should Tevalet

In case of overdose accidental ingestion, immediately consult your doctor or pharmacist or call the poison control center, tel.: 915 620 420, indicating the drug and the amount ingested.
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.

If you stop taking Tevalet
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tevalet can cause side effects, although not everybody gets them.
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 Tevalet”).
– Increased risk of cervical intraepithelial neoplasia and cancer.
– Increased risk of breast cancer diagnosis (see "Take special care with Tevalet”).

The frequency of adverse events classified in:
– Very common (At least 1 each 10 patients).
– FAQ (At least 1 each 100 patients).
– Uncommon (At least 1 each 1.000 patients).
– Rare (At least 1 each 10.000 patients).
– Very Rare (Under 1 per 10.000 patients).

Infections and infestations
– FAQ: Vaginitis (inflammation of the vagina), including candidiasis (fungal infection of the vagina).

Immune System Disorders
– 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 unconsciousness).
– Very rare: Worsening of systemic lupus erythematosus.

Metabolism and nutrition
– Uncommon: Changes in appetite (increase or decrease).
– Rare: Glucose intolerance.
– Very rare: Worsening of porphyria.

Psychiatric disorders
– Frequent: Mood, including depression; changes in libido (sexual desire).

Nervous system disorders
– Very common: Headaches, including migraines.
– FAQ: Nervousness, vertigo.
– Very rare: Worsening of Korea.

Eye disorders
– Rare: Intolerance to contact lenses.
– Very rare: Optical Neuritis, trombosis vascular retinal (abnormalities in the eye and vision disorders).

Vascular disorders
– Uncommon: Increased blood pressure.
– Rare: Venous thrombotic events (blood clots in veins).
– Very rare: Aggravation of varicose veins.

Gastrointestinal disorders
– FAQ: Nausea, vomiting, abdominal pain.
– Uncommon: Colic, swelling.
– Very rare: Pancreatitis, liver adenomas, hepatocellular carcinoma.

Hepatobiliary disorders
– Rare: Cholestatic jaundice.
– Very rare: Colecistopatía (Gallbladder disorders), including gallstones.

Skin and subcutaneous tissue
– FAQ: Acne.
– Uncommon: Rash, photosensitivity reactions, cloasma (skin spots) may persist, 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.

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).

General disorders and administration site in
– FAQ: Fluid retention, edema (swelling), weight changes (gain or loss).

Investigations
– Uncommon: Changes in blood lipid levels, including hypertriglyceridemia.
– Rare: Decreased serum folate.

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

5. TEVALET STORE

Keep out of reach and sight of children.
Store in original container.
In keep the temperature above 30 ° C.
Tevalet not use after the expiration date on the carton.
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. ADDITIONAL INFORMATION

Composition Tevalet
– The active principles are: ethinylestradiol, 0,03 and gestodene mg, 0,075 mg.
– The other ingredients are: lactose, cornstarch, povidone, calcium and sodium edetate, magnesium stearate, sucrose, povidone, polyglycol, carbonate de calcium, montana talc and glycol wax.

Looks like and contents of container
Tevalet comes in aluminum blisters 21 tablets and 3×21 tablets.
The tablets are white, round, biconvex and bright.

Holder of the marketing authorization

Teva Pharma, S.L.U.
C / Anabel Segura, 11, Albatros Building B, 1Floor, Alcobendas
28108 Madrid

Responsible for manufacturing:
Haupt Pharma Münster GmbH.
Schlee Brüggenkamp 15
48159 Muenster
Germany

This leaflet was approved in October 2007

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