Gestinyl ® 20/75

Land this prospectus carefully before taking this medicine

-Keep this leaflet, may need to read it again.


– If you have any questions, Consult your doctor or pharmacist.

– This medication is prescribed for you, not advise other people as it can be harmful.

– If any of the more serious side effects, or if you notice any side effects not reflected in this leaflet please tell your doctor or pharmacist.

1. WHAT GESTINYL 20/75 AND IT IS USED

• Gestinyl 20/75 is a pill used to prevent pregnancy

• Each tablet contains a small amount of two different types of female hormones, ethinylestradiol and gestodene

• Birth control pills as Gestinyl 20/75 containing two hormones are called combination pills.

2. BEFORE YOU TAKE GESTINYL 20/75

General Notes

Before taking Gestinyl 20/75, your doctor may ask about your medical history or their closest relatives. The doctor will also take the strain and depending on your personal situation you may be carried out other tests.

This leaflet describes several situations where you should stop taking Gestinyl 20/75, or when the reliability of Gestinyl 20/75 may be lower. In these situations must not have sex or take other non-hormonal contraceptive precautions such as using condoms or other barrier method. Do not use rhythm or temperature methods. These methods may not be reliable because Gestinyl 20/75 alter the monthly changes in body temperature as well as the cervical mucus.

Gestinyl 20/75, like other hormonal contraceptive methods do not protect against HIV infection ( PAGE) or against other sexually transmitted diseases.

When not due to take Gestinyl 20/75

• If you have or have had a clot in a blood vessel in the leg (thrombosis), lung ( embolism) or other organs.

• If you have or have had a heart problem or a cerebral hemorrhage some function, obstruction or compression of a cerebral artery (stroke)

• If you have or had any disease that may be an indication of a stroke (eg angina caused severe pain in the chest) or stroke (such a mild stroke and transient with no residual effects)

• If you have a condition that may increase the risk of arterial thrombosis. This applies to the following conditions.

– diabetes with damaged blood vessels

– Very high blood pressure

– a very high level of blood lipids (cholesterol or triglycerides)

– If you have or had an impaired blood clotting (por ejemplo, protein C deficiency)

– if you have migraine

– if you have or have had an inflammation of the pancreas (pancreatitis)

– if you have or have ever had liver disease and liver function is still not normal

– if you have or have had a liver tumor

– if your kidneys are not working well (renal failure)

– if you have , has or is suspected of having breast cancer or a genital organ

– if you have vaginal bleeding of unknown origin

– if you have severe hypertension

– if you are allergic to ethinylestradiol or gestodene, or some other ingredient Gestinyl

20/75. The symptoms are itching, rash or swelling.

When you need special care Gestinyl 20/75.

In some cases it has to take extra care when using Gestinyl 20/75 or other combined oral contraceptive method and may need to see a doctor regularly. If any of these effects is present, should consult with your doctor before you start taking Gestinyl 20/75.También if some of these signs develop or worsen while using Gestinyl 20/75 Call your doctor.

• If you have or had a family history of breast cancer or have been diagnosed.

• If you have liver disease or bladder.

• If you have diabetes.

• If you have depression

• If they have Crohn's disease or ulcerative colitis.

• If you have HUS ,(a blood disease that causes kidney damage)

• If you have sickle cell anemia(an inherited disease of red blood cells)

• If you have epilepsy (take other drugs see section)

• If you have lupus erythematosus (immune system disease)

• If you have a disease that first appears during pregnancy or before the use of sex hormones (such hearing loss, porphyria (a blood disease), herpes gestationis (rash with blisters in pregnancy), Sydenham chorea (nerve disease in sudden movements that occur in the body).

• If you have or have had chloasma (golden brown spots of pregnancy also called patches, especially in the face). In this case you should avoid contact with sunlight and UV rays.

• If you have hereditary angioedema (severe allergic reaction), products containing estrogens may induce or exacerbate symptoms of angioedema. You should see a doctor immediately if you experience symptoms of angioedema such as swollen face or tongue difficulty swallowing or hives together with difficulty breathing.

Venous thrombosis

The use of any combined oral contraceptive, including Gestinyl 20/75 increases the risk of venous thrombosis (formation of a blood clot in blood vessels) compared with their non-use.

The risk of venous thrombosis increases with:

-age

-if you are overweight

-if any of your close relatives have had thrombosis in the legs, lung or other body at an early age.

-if you have any surgery, a period of prolonged immobilization or has had any serious accidents, should consult with your doctor before taking Gestinyl 20/75 and that treatment can be discontinued and your doctor will tell you when to resume treatment once they have recovered.

About two weeks after full recovery.

Arterial thrombosis

The use of oral contraceptives has been associated with an increased risk of blood pressure (blockage of an artery), por ejemplo, in blood vessels of the heart (infarction) or brain (stroke).

The risk of blood pressure in users of combined oral contraceptives increases:

– you smoke. Before you start taking Gestinyl 20/75 will be encouraged to quit smoking especially if you are over 35 años.

– if you have an increase in blood lipids (cholesterol or triglycerides).

– if you have high blood pressure.

– if you have migraine.

– if you have a heart problem (changes in the valves, cardiac rhythm disturbance).

Should stop taking Gestinyl 20/75 and consult your doctor immediately if you notice any possible signs of thrombosis such as :

• severe pain or swelling one one leg.

• sudden severe pain in the chest which may reach the left arm.

• sudden shortness of breath.

• Unexplained sudden cough.

• prolonged headache, severe or unusual may worsen to become migraine.

• Loss of complete or partial vision, double vision.

• Slurred speech.

• Vertigo collapse.

• Sudden weakness or numbness affecting one part of the body.

Gestinyl 20/75 and cancer.

There has been a slight increase in occurrence of breast cancer among women taking combined oral contraceptives, although no one really knows whether this is due to treatment. Por ejemplo, may have found a greater number of tumors in women taking combined contraceptives because they come more often checkups. The appearance of breast tumors is lower after treatment discontinuation. It is important to have regular breast examinations and obtain immediate medical attention if you notice a lump.

In very exceptional cases were found benign liver tumors, and in some cases malignant liver tumors among pill users. You should consult your doctor if you notice any unusual abdominal pain and acute.

Bleeding between periods

During the first few months you are Gestinyl 20/75, may appear unexpected bleeding

(out of the bye week). If bleeding continues after a few months, or if you start again after a few months, your doctor should investigate the cause.

What should you do if there is no bleeding in the bye week?

If you have taken all tablets correctly, has not vomited or had severe diarrhea and have not used other drugs, is unlikely to be pregnant.

If the bleeding does not occur in the expected two successive times you may be pregnant. Contact your doctor immediately. Do not start taking the next tablet blister until you are sure she is not pregnant.

Gestinyl 20/75 and the use of other drugs

Tell your doctor, it is the prescriber Gestinyl 20/75 if you are taking other medicines or herbal preparations. Also kept informed of other doctors or dentists, if you are prescribed other medications (or pharmacist) you are taking Gestinyl 20/75. They can decide whether to take other additional contraceptive measures (eg condom use) and for how long.

• Some medicines can make Gestinyl 20/75 less effective in preventing pregnancy or cause unexpected bleeding.

This includes drugs used to fight epilepsy (como, hidantoina, topiramate, felbamato, lamotrigina, primidona, phenytoin, barbiturates, carbamapezina, oxicarbamapezina, and tuberculosis (eg rifampicin), immunomodulating agents (cyclosporine ), HIV infections (ritonavir) or other infectious diseases (griseofulvina, ampicillin, tetracycline) and the herbal preparation St. John's.

• If you want to use herbal preparations of St. John while taking Gestinyl 20/75 should consult their doctor.

• Gestinyl 20/75 may reduce the effectiveness of other medications such, medicines containing cyclosporin (immunomodulatory drug) or antiepileptic lamotrigine (which can lead to an increase in seizures).

Ask your doctor or pharmacist before taking any medication.

Laboratory Analysis

If you need to take a blood test, tell your doctor or who are to perform the analysis you are taking birth control, as the AOC may modify the results of some tests.

Pregnancy

If you are pregnant use Gestinyl 20/75 is contraindicated. If pregnancy occurs while taking Gestinyl 20/75 stop taking them immediately and consult your doctor.

Consult your doctor before taking other medications.

Breastfeeding

Using Gestinyl 20/75 is contraindicated during breastfeeding. If you are breastfeeding and want to start taking Gestinyl 20/75 ask your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines.

No adverse effects were observed in Gestinyl 20/75 for driving and operating machinery.

Important information about some of the ingredients Gestinyl 20/75. Gestinyl 20/75 contains lactose and sucrose. If you can not tolerate sugar check with your doctor before using Gestinyl 20/75.

3.-TAKING GESTINYL 20/75

Take one tablet of Gestinyl 20/75 every day with a small amount of water if necessary. You can take the tablets with or without food but always at about the same time.

Each blister contains 21 tablets. Beside each tablet is written the day of the week. If for example you start taking the tablet on a Wednesday, Take the tablet which put MI. Follow the direction of the arrow on the tablet blister until it takes all.

There is a rest period 7 days in which the tablets should not be taken and at which to begin bleeding. Also called withdrawal bleeding and usually starts on the second or third day of the week off.

On day 8 after the last shot of Gestinyl 20/75 (after 7 rest days), has to begin taking the next tablet blister bleeding but did not cease. This means you should start the next blister on the same day of the week and the end of menstruation occurring at the same time.

It is used Gestinyl 20/75 thus, be protected against pregnancy during the 7 days that does not take tablets.

When can you start with the first blister

If you have not used hormonal contraceptives in the previous month.

You can start taking Gestinyl 20/75 on the first day of the cycle (the first day of your period).If you begin taking Gestinyl 20/75 the first day of your period is immediately protected against pregnancy. You can also start taking Gestinyl 20/75 the 2 nd -5 th day of the cycle but then it should take additional contraceptive measures (such as using condoms during the first seven days).

If you changed from another combined oral contraceptive, vaginal ring or patch. You can start taking Gestinyl 20/75 the day after the rest period of his previous birth (or after the last placebo tablet). If you change the vaginal ring or patch talk to your doctor.

Changing from a progestogen only preparation containing (progestin pill only, injection, Implante or intrauterine device ( Diu) It releases progestin). You can change any day after taking the pill with progestin. In the case of the implant or IUD removal day. The injection where appropriate the next injection. But in all cases should take additional contraceptive measures (eg condom use) during 7 early days of pill intake.

After abortion

Follow your doctor's instructions

After giving birth

You can start taking Gestinyl 20/75 between days 21 and 28 after giving birth. If you start later than the day 28 must use a barrier method (condom) during 7 first day you start taking the tablet.

If after giving birth, have sex before taking Gestinyl 20/75 must ensure that no pregnancy occurred otherwise must wait until the next period.

Let your doctor tells you you are not sure when to start

If you are breastfeeding and want to start taking Gestinyl 20/75 (again)

Using Gestinyl 20/75 is contraindicated during breastfeeding. (read section "nursing")

Si take more Gestinyl 20/75 than you should.

No adverse effects have been found in the case of taking more tablets than necessary Gestinyl 20/75.

Taking several tablets at once can cause vomiting or nausea. Young girls can have vaginal bleeding.

If you take too many tablets Gestinyl 20/75 or discover that your child has taken them immediately consult your doctor or pharmacist.

If you miss Gestinyl 20/75

• If it has been less than 12 hours since taking the last tablet, the effect of protection against pregnancy decreased. You have to take the next tablet as you remember if I have to take both at the same time.

• If it has been more 12 hours since taking the last tablet, reduces the protection against pregnancy. The greater the number of tablets you forget to take, the greater the risk of pregnancy..

The risk of incomplete protection against pregnancy is higher if you miss a tablet at the beginning or end of the blister. Then you must follow these instructions (see also scheme):

More than one missed tablet in the blister

Consult your doctor

One tablet missed in week 1

Take the missed tablet as soon as remembered, even if it means taking two tablets at once. Take the tablets again at the same time and use additional contraceptive protection (for example condoms) during 7 days. If you have had sex before I forget the pill or if you forgot to start a new blister after the rest period, should be noted that there is a risk of pregnancy. In that case, consult your doctor

One tablet missed in week 2

Take the missed tablet as soon as remembered, even if it means taking two at a time. Take the tablets at the same time. Protection against pregnancy is not reduced and does not need to take extra precautions.

One tablet missed in week 3

You can choose from the following options

1. Take the missed tablet as soon as remembered, even if it means taking two tablets at once. Take the tablet at the same time. Instead of making the rest period must go to the next blister.

It is unlikely that the user have a withdrawal bleed until the end of the second container but may have spotting.

2. You can discontinue taking the tablet from the current blister, and go directly to the rest period. If you want to start a new blister on the day of commencement set can shorten the period of rest.

Following these instructions, be protected against pregnancy.

If you forget any of the tablets in a blister, and has not menstruated in the rest period may be pregnant. You should consult your doctor before taking the next blister.

What to do in case of vomiting or severe diarrhea.

If you vomit within 3-4 hours after taking the tablet or have severe diarrhea, There is a risk that the active substances have not been absorbed into your body. This situation is similar if you forget to take a tablet. After vomiting or diarrhea should take another tablet as soon as possible. If possible in a period within the following 12 hours when normally take the tablet. If this is not possible or have passed 12 hours must follow the instructions in "if you miss Gestinyl 20/75".

Delayed menstruation: You Should Know

Although not recommended it is possible to delay menstruation. You can do it starting next blister directly Gestinyl 20/75, instead of making the rest period, after the first blister. You may experience slight bleeding while using the second blister. After the usual rest period, continue to the next blister

You should consult with your doctor if you decide to delay your period

Change the first day of menstruation: You Should Know.

If you take the tablets as directed, your period will come in the rest period. If you change that day, then the shorter rest period but never longer. Por ejemplo, if your period starts on a Friday break, and wants to change the day to Tuesday (3 days before) should then start a new pack 3 days earlier than usual. If you want to make very short rest period (por ejemplo 3 days or less) then you may not have menses during the rest period. You may experience spotting (spotting) or withdrawal bleeding.

If you are not sure how to proceed ask your doctor.

If you want to stop taking Gestinyl 20/75.

You can stop taking Gestinyl 20/75 whenever. If you do not want to become pregnant consult your doctor about reliable contraceptive methods.

If you have further questions about this medicine ask your doctor or pharmacist.

4.-Possible adverse effects

Like other medicines Gestinyl 20/75 but can cause side effects do not occur in all individuals.

• Common side effects (affecting more than 1 woman among 100 but less than 1 between 10).

Headaches, nervousness, low tolerance to contact lenses, visual disturbances, nausea, acne, migraine, weight gain, fluid retention, light bleeding or bleeding between periods until the body adjusts to Gestinyl 20/75, absence of menstrual periods, depressive state, irritability. If these effects persist, lengthen in time or worsen you should consult your doctor.

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

• Rare side effects (affecting more than 1 woman among 1000 but less than 1 between 100).

Excess blood lipids (cholesterol, triglicéridos), vomiting, high tension (hypertension).

• Rare side effects (affecting more than 1 woman among 10000 but less than 1 between 1000)

Liver disease, disorders of the skin and subcutaneous (lupus erythematosus), hearing disorders, gallbladder, thrombosis, pigmentation disorders. This can happen even if you have taken Gestinyl 20/75 for a few months. Can be reduced by avoiding sun exposure. Changes in vaginal discharge.

• Effects rare ( affecting less than 1 each 10000 women). Movement Disorders, involvement of the pancreas.

5.-HOW TO PRESERVE GESTINYL 20/75.

Do not store above 30 degrees

Keep out of reach and sight of children

In use Gestinyl 20/75 after the expiration date on the blister and carton. The expiry date refers to the last day of that month.

6.-ADDITIONAL INFORMATION

Containing Gestinyl 20/75

Active substances

Gestinyl 20/75: Each tablet contains 20 microgramos de etinilestradiol y 75 micrograms gestodene.

Other Ingredients :

Tablet core: Magnesium stearate, povidone K 25, cornstarch, lactose monohydrate.

Tablet coating: povidone K 90, macrogol 6000, talc, sucrose, carbonate de calcium, montana wax glicolada.

Nature and contents of container

Gestinyl 20/75 are white-coated tablets, round, biconvex and printed without the expensive. Each package contains 1 O 3 blisters with 21 tablets packed in cardboard case. Holder of the marketing authorization

Name and address

Laboratorios Effik

C / San Rafael, 3

28108 Alcobendas (MADRID) Telephone : 91 358 52 73

Fax : 91 358 38 53

E-mail : dtecnico@effik.com

Manufacturer

Haupt Pharma Munster Gm Scheebruugenksamp 15, 48159, Germany

This product is licensed by the member countries of the European Economic Community under the following names.

  • Belgium, Luxembourg : Docgetradiol 20.
  • Hungary: Gestinyl 20.
  • Spain: Gestinyl 20/75.
  • Czech Republic, Slovak Republic : Sunya.
  • Denmark, Finlandia : Gestinyl.
  • Ireland : Estelle 20/75. Italy : Gestodiol.
  • Netherlands: :Etinilestradiol / Gestodeno 0.02 /0,075
  • Polonia : Kontracept.
  • United Kingdom : Sunya 20/75.

This leaflet was approved in:

April/2007

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  1. Beatriz
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