Minulet ®

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. Minulet WHAT IS AND WHAT IT IS USED

Minulet is an oral contraceptive drug.
Minulet is prescribed in the following indications: oral hormonal contraception, menstrual cycle disorders and ovarian rest.
Additionally the use of oral contraceptives may have beneficial effects in conditions such as dysmenorrhea (menstrual pain) and to reduce the incidence of certain disorders of the breast and reproductive organs.

2. BEFORE TAKING Minulet

Minulet not take if you are in any of the following circumstances or have any of the following diseases:
– If you are allergic (hypersensitive) to Gestodeno, to ethinylestradiol or any of the other ingredients of Minulet.
– If you are pregnant or might be pregnant.
– If you have severe disorders of liver function.
– If you have had blood clots in the veins of the lower limbs that have fallen affecting other parts of the body, even if it was long ago.
– If you have had breast tumors, liver, Cervical, uterus vagina.
– If you suffer from diabetes associated with heart problems circulatory problems.
– If you suffer from disorders of the arteries of the brain or heart.
– If you have a disease of the heart valves (valvular).
– If you have heart rhythm disorders (arrhythmias) with possibility of clots.
– If you have inherited or acquired disorders that predispose to clot formation (trombofilias).
– If you suffer from migraines (migraines) associated with symptoms such as loss of strength or sensation of a body part, or impaired vision (will). – If you have high blood pressure.
– If you have vaginal bleeding of unknown cause.
– If you have inflammation of the pancreas (pancreatitis) due to a severe increase in triglycerides.

Take special care with Minulet:

Before taking Minulet will have to see 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 see your doctor if any of these conditions worse or appears while using this medicine:
• Heart disease (chest pain, certain types of heart rhythm disorders, heart disease).
• Personal or family history of high levels of fat (triglicéridos) blood.
• High Blood Pressure, particularly if it worsens or does not improve when taking antihypertensive medications.
• Headaches (migraines) intense and repetitive or associated with impaired vision (will).
• Diabetes.
• Depression or history of depression, as this may worsen or come back to use hormonal contraceptives. • Epilepsy.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• Ictericia (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).
• Angioedema (swelling similar to hives, but it is beneath the skin rather than on the surface) particularly in women with hereditary angioedema (immune system problem that is passed from parents to children).
Also contact your doctor if you think you might be pregnant.

Potentially serious diseases:

Thrombosis (blood clots)
The use of birth control pills may increase the chance of having thrombosis (blood clots). This risk is greatest during the first year of use of contraceptive pills.
Blood clots can block blood vessels and can cause major: pulmonary embolism, myocardial infarction, angina pectoris, cerebral thrombosis, etc..
If you notice the appearance of any of the following signs, tell your doctor because you might be forming clots:
– 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 in the blood, so you must tell the doctor if any of them:
– Obesity.
– If you are a smoker and has over 35 años.
– If you have had a severe injury to his legs or hips.
– If you have just given birth or just had an abortion in the second trimester of pregnancy.
– If you need to stay in bed for days. In these cases, if possible, treatment should be discontinued.
– If you have had or will undergo major surgery. In these cases, whenever possible, treatment should be discontinued for four weeks before and two weeks after the procedure.
– Elderly.

Do not start treatment with oral contraceptives until the expiration 28 days postpartum if not breast-feeding or abortion in the second trimester because the odds of you getting a venous thromboembolism, increase immediately after birth.

Blood Pressure
If you have hypertension (High Blood Pressure) or suffer from some 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 it increases and can not be controlled with medication, treatment should be stopped.

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.
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. Rarely been reported liver tumors in women using the contraceptive pill.
In these cases it can cause internal bleeding leading to severe pain in the abdomen. If this occurs, should contact your doctor immediately.
Women who have had cholestasis (obstruction of the bile) during treatment with oral contraceptives in the past or during pregnancy, are more likely to develop it again if they use oral contraceptives. It should keep track of these women and if it appears cholestasis, should discontinue treatment with oral contraceptives. There have been reports of severe liver injury with the use of oral contraceptives. If your doctor determines that while taking oral contraceptives developed severe liver injury, will suspend treatment with oral contraceptives and will recommend the use of non-hormonal contraceptives.

Migraines
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.

Immune System
The use of oral contraceptives can aggravate symptoms of angioedema (swelling similar to hives, but it is beneath the skin rather than on the surface) particularly in women with hereditary angioedema (immune system problem that is passed from parents to children).

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 pill according to the instructions in "3. TAKING Minulet"And has a lack, should discontinue treatment and use a nonhormonal contraceptive method until pregnancy is ruled out.
This medicine may cause vaginal bleeding or spotting between periods. If this occurs you, continue treatment and if the bleeding is still occurring after 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 this medicine, 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 (content analysis of blood fats). 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 (increased cholesterol and / or triglycerides) shall be subject 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), papiledema (ocular inflammation) or retinal vascular injury, 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.
It 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, herpes genital, condyloma acuminata, gonorrhea, hepatitis B and syphilis). You must use condoms to protect against these diseases.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken other drugs, even those not prescribed.
You should never take another drug on its own initiative without your doctor's advice, since some combinations should be avoided.
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 (Penicillin 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 some preparation St John's wort. Decreased contraceptive effect lasts up to two weeks after he stopped taking the preparation with St. John's wort.
You should use another reliable method of contraception if you take any medications mentioned above. The effect of any of these medications can last up 28 days after stopping treatment.

Minulet may decrease the effect of other drugs, such as:
– Oral anticoagulants (acenocumarol).
– Analgesics (as paracetamol and salicylates).
– Oral antidiabetic drugs and insulin.
– Lamotrigine (to treat epilepsy and certain psychiatric disorders).

Also, Minulet may increase the effect of other drugs as:
– β-blockers such as metoprolol (to treat high blood pressure).
– Theophylline (for the treatment of asthma).
– Corticosteroids (as prednisolone).
– Cyclosporine (immunosuppressive), increasing the risk of liver toxicity.
– Flunarizina (to treat migraine), increasing the risk of milk secretion.

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.
Do not use this medication if you are pregnant or think you may be pregnant (For information on the use of Minulet after pregnancy, see section "3. TAKING Minulet”).
If you become pregnant, must immediately discontinue taking the drug and consult with your doctor.
Do not use this medication until the end of lactation.

Use in children
It has established the efficacy and safety of oral contraceptives in women of childbearing age. It is not indicated for use before the first menarche (menstruation).

Elderly
It is indicated in postmenopausal women.

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

Important information about some components Minulet
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.

3. TAKING Minulet coated tablets

Follow directions exactly Minulet management provided by your doctor. Consult your doctor or pharmacist if.
This medicine is for oral administration.
Remember to take your medicine, since Minulet forgetting may decrease the effectiveness of the preparation.
Before starting treatment with Minulet the doctor should perform a thorough medical history and a thorough medical examination, including blood pressure, and must be excluded pregnancy. You should also perform a breast examination, liver, extremities and pelvic organs (urinary bladder, vagina, uterus and part of the large intestine). Your doctor may need to perform a cervical cytology (slight scraping painless cervical taking zone cells for analysis). Your doctor will repeat this revision to 3 months after starting treatment, and subsequently, every year.
See paragraph "2. Before taking Minulet”.

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 and then be over 7 day tablet. Each package will start back after the interval 7 day tablet, which usually occur during hemorrhage. 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 tell you how long your treatment with this medicine.
If you feel that the effect of this medicine is too strong or weak, Tell your doctor or pharmacist.

Starting your first pack of Minulet

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 the first take of this medicine on the same day, coated tablet marked with "Lu", and follow the arrow indicator for the following shots.
It is also possible to begin in days 2-7 of the menstrual cycle, in this case it is recommended to use a method of support for non-hormonal birth control (p. not. condoms or spermicide) during the first 7 days of taking tablets.

When you are taking another contraceptive and change it Minulet:
You can start taking Minulet the day after taking the last active tablet of her current pack of pills (this means no tablet break). If your current pill pack also contains inactive tablets, Minulet can start taking the day after taking the last active tablet. Never be postponed later than the day following the end of the usual tablet-free interval or placebo tablet interval of her previous contraceptive.

When changing a method that contains only a progestogen (minipíldora, implant,
intrauterine device (Diu) or injection):
You can stop taking the progestogen pill (minipíldora) any day and start taking the next day Minulet, at the same time. Start using this medicine for the next injection will or the day you remove your implant or intrauterine device (Diu).
In all these situations, Also be sure to use an additional barrier method when you have sex (p. not., condoms or spermicides) during 7 early days of tablet-taking.

After an abortion in the first quarter:
You can start taking the tablets immediately. Doing so, need not take additional contraceptive.

Postpartum:
If you are breast-feeding should not take this medicine, see "Pregnancy and lactation".
The use of compressed begins 28 days after delivery in women who are not breast-feeding or abortion in the second trimester. 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 taking the pill or have to wait for her next menstrual period.

Subsequent cycles
After 7 rest days, continues with a new package of Minulet, 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 bleeding reach an intensity similar to that of normal menstrual were prolonged 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.

If you forget to take Minulet
Contraceptive protection may be reduced if you forget to take tablets. In particular, if oblivion is in the first week of treatment and had sex in the previous week, might be possible to get 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 the next tablets at your normal time. If delayed more 12 hours in taking any tablet, contraceptive effectiveness may be reduced. In this case,es, follow the following guidelines according to the week in which cycle is:
• 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 an additional barrier method (as, condoms or spermicides) during 7 days.
• If you take the last tablet before the end of the 7 days that require the use of an additional contraceptive method, immediately start another container while rest period between them. You will not have your period until the end of the new packaging, although it may have bleeding or spotting days in taking tablets.
• If you do not have periods at the end of the new packaging, contact your doctor, you should verify that you are not pregnant before starting the next pack.

If vomiting and / or diarrhea
If vomiting or diarrhea in the 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 can be delayed as much as you want, but not beyond the end of the second container. During this time you may experience bleeding or spotting. Later, Regular intake of this medication is resumed after the usual interval 7 tablet-free days.

If you take more than you should Minulet
You may experience nausea, vomiting, sleepiness, breast pain, dizziness and vaginal bleeding; Treatment consists of discontinuation of this medication. 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Minulet 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, and thromboembolic, including stroke, TIA, myocardial infarction, thrombosis venosa pulmonar y embolismo (see "Take special care with MINULET”).
– Cervical Intraepithelial Neoplasia (abnormal cells on the surface of the cervix) and cervical cancer (Cervical cancer).
– Diagnosis of breast cancer (see "Take special care with Minulet").
– Benign liver tumors (not. Focal nodular hyperplasia, liver adenomas).

The side effects listed below are ranked by frequency according to the following
criterion:

Very common: >1/10 (more 1 each 10 patients).
FAQ: >1/100, <1/10 (more 1 each 100 and less than 1 each 10 patients).
Uncommon: >1/1.000, <1/100 (more 1 each 1.000 and less than 1 each 100 patients (more 1
each 1.000 and less than 1 each 100 patients).
Rare: >1/10.000, <1/1.000 (more 1 each 10.000 and less than 1 each 1.000 patients).
Very rare: <1/10.000 (less than 1 each 10.000 patients).

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

Neoplasias benignas / or malignas inespecíficas
– Very rare: Carcinomas hepatocelulares (malignant liver tumors).

Immune system disorders
– Rare: Allergic reactions like hives (itching), angioedema (swollen face, lips, mouth and very rarely accompanied by difficulty breathing, dizziness and even loss of consciousness).
– Very rare: Worsening of systemic lupus erythematosus (autoimmune disease).

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); colitis isquémica (certain types of inflammation of the colon).
– Not known: Inflammatory bowel disease (Crohn's Disease, ulcerative colitis) (certain types of inflammatory bowel).

Hepatobiliary disorders (liver and gallbladder)
– Rare: Cholestatic jaundice (yellowing of the whites of the eyes and skin of the bile stagnation).
– Very rare: Colecistopatía (Gallbladder disorders) including gallstones.
– Not known: Hepatocellular injury (not. hepatitis, abnormal liver function).

Skin and appendages disorders
– FAQ: Acne.
– Uncommon: Rash (eruption), 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 (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 secretion 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 the levels of blood lipids, including hypertriglyceridemia (High levels of fatty acids in blood).
– Rare: Decreased blood levels of folate.

Do not be alarmed by these adverse, as it is very possible that none of them appears. 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. COATED TABLETS Minulet STORE

This medicine does not require special storage conditions.
Keep out of reach and sight of children.
Minulet not use after the expiration date on the carton. The expiry date is the last day of that month.
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 of coated tablets Minulet
The active ingredients are coated tablets Minulet: 75 mcg of Gestodene and 30 mcg of ethinyl.
Other components (excipients) its: lactose, cornstarch, povidona K-25, magnesium stearate, calcium and sodium edetate, sucrose, macrogol 6000, carbonate de calcium, talc, polivinilpirrolidona 700.000 and emulsifying wax.

Looks like and contents of container
Calendar is available in packs containing 1 ó 3 blisters with 21 blister coated tablets.

Holder of the marketing authorization
WYETH FARMA, SA.
Ctra. Burgos, Km 23. Diversion Algete, Km 1.
San Sebastian de los Reyes - Madrid
SPAIN

Responsible Manufacturing
Pfizer Irelands Pharmaceuticals
Little Connell Newbridge, What. Kildare
IRELAND

Local Representative
Pfizer, SA.
Ave. the Europe, 20-B
Parque Empresarial La Moraleja
28108 Alcobendas (Madrid)
(Logo Pfizer)

This leaflet was prepared in March 2011

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