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.
Table of Contents
1. WHAT gratia TABLETS AND WHAT IT IS USED
Gracial belongs to a group of drugs called combined oral contraceptive biphasic ("Pills" combined). The active ingredients are combined at different doses in blue and white tablets.
Gracial is indicated to prevent pregnancy.
2. BEFORE TAKING PILLS GRACIAL
You should not take the combined pill if any of the conditions described below. In this case,es, tell your doctor before you start using Gracial. Your doctor can suggest another method of birth control other than.
• If you have or have ever had a condition that affects circulation, particularly thrombosis (clot formation), in a blood vessel in the legs, lungs (pulmonary embolism) or other organs.
• If you have or have ever had a heart attack or stroke.
• If you have or have ever had a condition that can be an early sign of heart attack (as angina pectoris or chest pain) the embolism (as transient ischemic attack or small reversible stroke).
• If you have any blood clotting disorder (por ejemplo, protein C deficiency).
• If you have or have had migraine with visual symptoms, mobility disorders or weakness or numbness in any body part.
• If you are diabetic (diabetes mellitus) and are affected blood vessels.
• If you have high blood pressure (hypertension) and not controlled.
• If you have a serious risk factor or multiple risk factors for developing thrombosis.
• If you have or have had an inflammation of the pancreas (pancreatitis), together with high levels of fats in their blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have ever had a cancer that grows influenced by sex hormones (for example breast or genital organs).
• If you have or have ever had a liver tumor.
• If there is any unexplained vaginal bleeding.
• If you experience abnormal growth of tissue inside the matrix.
• If you are pregnant or think you may be pregnant.
• If you are allergic (hypersensitive) to the active substances or any of the other components Gracial.
If any of these conditions appear for the first time while using the pill, take no more and contact your doctor immediately. Meanwhile, use non-hormonal contraceptive measures.
Take special care with Gracial
Before starting treatment with Gracial
If you use the combined pill and either of the situations described below, must remain under medical supervision. Your doctor will explain in detail. Por tanto, If any of the following, tell your doctor before you start taking Gracial:
• If you are a smoker;
• If you are diabetic;
• If you are overweight;
• If you have high blood pressure;
• If you have heart rhythm disorders or certain heart disorders;
• If there is inflammation in the veins (superficial phlebitis);
• If you have varicose veins;
• If a family has had thrombosis, heart attack cerebral embolism;
• If you have migraine;
• You sufre epilepsia;
• If you or a family member has or had cholesterol or triglycerides (fat) high blood;
• If a family member has had breast cancer;
• If you have liver or gall;
• If you have Crohn's disease or ulcerative colitis (chronic intestinal inflammation);
• If you have a disease called systemic lupus erythematosus (THE, a disease that causes many skin problems in all areas of the body)
• If you have a condition called hemolytic uremic syndrome (SHU, presence of a lesion in the kidney blood vessels);
• If you have sickle cell disease (a rare disease in blood);
• If you have an illness that appeared or worsened during pregnancy or previous use of sex hormones (p. not. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a disease called Sydenham's chorea);
• If you have or have had chloasma (spots yellowish-brown skin, particularly in the face); in this case should avoid intense exposure to sunlight or ultraviolet radiation.
In the event that any of the above appears for the first time, have relapsed or worse treatment with the pill should consult your doctor, who can recommend to stop taking the pill.
Gracial, like all birth control pills, not protect against AIDS or other sexually transmitted disease.
Once the treatment Gracial
While taking the pill, Your doctor will be required to undergo periodic inspections, and general, once a year.
Contact your doctor as soon as possible in the following cases:
• If you notice any changes in your health, especially any of the items mentioned in this leaflet (see also "Do not take Gracial" and "Before starting treatment with Gracial"); And do not forget the points related to their immediate families;
• if it is a lump in the breast;
• if you are taking other medicines (see also "Taking other medicines");
• whether to remain immobilized or will operate, since in these cases increases the risk of thrombosis temporarily; consult your doctor at least four weeks before;
• if you have unusual vaginal bleeding and intense;
• if you miss tablets in the first week of the pack and had intercourse in the seven days before;
• if you have severe diarrhea;
• if you have two fouls in a row or suspect you are pregnant, do not start the next pack until your doctor tells.
Thrombosis (blood clots)
The use of the contraceptive pill, Included Gracial, can increase the chances of developing venous thrombosis (clot formation in veins) compared to women not using any contraceptive pill.
The possibility of developing venous thrombosis is greater if you use Gracial compared with other pills containing the progestin levonorgestrel. The risk of venous thrombosis in users of the pill increases:
– family history of clots (thrombi) in legs, lung or other body at an early age.
– whether to undergo an operation, detention for a period of time or a serious accident. It is important to tell your doctor you are using Gracial and that treatment should be suspended. Your doctor will tell you when to re-take Gracial. Normally be within two weeks of starting to walk.
The combined pill use is associated with an increased risk of arterial thrombosis (blockage of an artery), por ejemplo, in the arteries of the heart (myocardial infarction) or brain (cerebral thrombosis). The risk of coronary artery thrombosis in users of the pill increases:
-if smoking. If you take Gracial, should quit especially if over 35 años.
-if you have an increase in blood fatty acids (cholesterol or triglycerides)
-if you suffer from migraines
-if you have heart problems (valve problems, decompensated heart rhythm)
Stop taking tablets and see your doctor immediately if you detect any signs of thrombosis:
• unusual cough, for example blood;
• Severe chest pain that may spread to the left arm;
• sudden difficulty in breathing;
• any unusual headache intense or prolonged, or migraine attack;
• partial or complete loss of vision or double vision;
• difficulty speaking;
• Sudden changes in the ear, sense of smell or taste;
• dizziness or fainting;
• weakness or numbness in any part of your body;
• severe abdominal pain;
• severe pain or swelling in the legs.
If you have hypertension (High Blood Pressure) or 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, need to discontinue treatment.
There have been reports of breast cancer diagnosed slightly more often in women using birth control pills than women of the same age who do not use. This slight increase in diagnosed breast tumors gradually decreased during the ten years after stopping treatment. It is not known whether this difference is due to treatment with the pill. It could be that women who use birth control pills medical consultation attend more often.
Rarely been reported benign liver tumors and even more rarely malignant tumors in women using the contraceptive pill. This can cause internal bleeding resulting in severe pain in abdomen. If this occurs, should contact your doctor immediately.
The situation that most affects the risk of cervical tumors (cervix) infection is continued by the human papilloma virus. In women using the pill for many years, the chance of developing cervical cancer is somewhat higher. Nevertheless, it is unclear whether the contraceptive pill plays a direct role in this risk, or do sexual habits and other factors (as a further medical).
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 instructions in paragraph "3. TAKING TABLETS gratia "and has a lack, should discontinue treatment and use a nonhormonal contraceptive method until pregnancy is ruled out.
Gracial can cause bleeding or spotting between periods. If this occurs you, Gracial continued treatment and the bleeding is still occurring past the first three cycles, consult your doctor immediately. Errors in the use of the pill can also cause vaginal spotting and light.
When you stop using Gracial, 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.
Taking other medicines
Some medicines may interact with the pill. Not recommended to take the pill along with the following medications:
• drugs for the treatment of epilepsy (eg phenytoin, barbiturates
(phenobarbital), primidona, carbamazepine, oxcarbazepina, topiramate, felbamato)
• drugs for treating tuberculosis (eg rifampicin, rifabutina)
• medications for treating HIV infections (eg ritonavir)
• antibiotics or antifungal agents used for treatment of other infectious diseases
(as ampicillin, tetracyclines, griseofulvina).
• Hierba de San Juan (herb medicine used to treat mood disorders).
You should use non-hormonal contraceptive method reliable if you take any medications mentioned above. The effect of any of these medications can last up 28 days after stopping treatment.
Oral contraceptives may interfere with the activity of other drugs (such as cyclosporine and lamotrigine).
Always tell your doctor to prescribe the pill on drugs that already are taking and also tell any other doctor or dentist who prescribes another medicine (or pharmacist) you are taking Gracial. They can tell you whether you need any additional contraceptive measure and for how long, if necessary.
Tell your doctor or pharmacist if you are taking or have recently taken other drugs, even those not prescribed.
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 you are taking Gracial.
Pregnancy and lactation
Gracial should never be used by pregnant or who suspect they may be pregnant.
Generally not recommended Gracial in case you are breast-feeding. If you want to take the Pill while breast-feeding consult your doctor.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
There has been no effect.
Important information about some of the components Gracial
This product contains lactose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.
3. HOW TO TAKE TABLETS gratia
Always follow dosing instructions provided by your doctor Gracial. Consult your doctor or pharmacist if.
The blister has Gracial 22 tablets: 7 blue (numbered 1 the 7) and 15 white (numbered 8-22). Take your tablet at about the same time each day, with liquid if necessary. Each time you start a new blister Gracial, take the blue tablet number 1, which is in the upper left corner of the blister and mark the day of the week drilling the aluminum from the corresponding day on the left side of the blister. In this way you can easily control if you have taken your tablet each day. Follow the direction of arrows to finish the 22 tablets. Thus, will first take all the tablets blue and white tablets after all. In 6 days should not take Gracial, during which a rule appears (withdrawal bleeding) usually begins two or three days after the last tablet Gracial. Continue with the next blister on the seventh day, even if it is still the rule. Thus, packages always begin the same day of the week and will have withdrawal bleeding about the same days each month.
The first blister Gracial
If you have not used hormonal contraception in the previous month.
Start taking Gracial the first day of the cycle, ie, the first day of menstruation. Gracial begin to act immediately. No need to take additional contraceptive measures. You can also start on days 2 a,en 5 of its cycle, but in this case also make sure to use an additional contraceptive method (such a barrier method) while taking the first 7 tablets of the first cycle. Do not use methods based on the menstrual cycle and temperature because these methods are not reliable while taking the pill.
Changing from another combined hormonal (Píldoras combined contraceptive, vaginal ring or transdermal patch).
Gracial can start taking the next day after taking the last tablet of the current packaging. This means you do not have to leave a rest period. If your current preparation has Gracial inactive tablets can start the day after the last tablet active (If you are unsure please consult your doctor or pharmacist). You can also start later, but not beyond the period of rest of your preparation today, (or after the last inactive tablet of your preparation today). If you are using a vaginal ring or transdermal patch, should start taking Gracial preferably on the day of the vaginal ring extraction, or on the day you should remove the patch. You can also start, but no later than the day that correspond the following application of the patch or vaginal ring.
If you follow these instructions, is not necessary to use an additional contraceptive method.
Changing from a progestogen-only pill.
You can stop taking the pill any day now and start taking Gracial the next day at the same time, but be sure to use an additional contraceptive method (such a barrier method) while taking the first 7 tablets if you have sex.
Changing from an injectable, an implant or releasing intrauterine systems (SLI) progestogen-only.
Gracial start using at the time you should get the next shot or the day you removed the implant or SLI, but be sure to use an additional contraceptive method (barrier method) while taking the first 7 tablets, if you have sex.
If you have just one child, your doctor may advise you to wait for your first normal before starting Gracial. It is sometimes possible to start earlier, but your doctor will advise how. If you are breastfeeding and want to use Gracial should discuss with your doctor first.
Consult your doctor.
You can leave at any time Gracial. If you leave because you want to become pregnant Gracial, is generally recommended to wait until you've had your first period before trying to conceive naturally, which will help you calculate your due date.
If you take more than you should Gracial
In case of overdose accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information, phone: 91 562 04 20 (indicating the drug and the amount ingested).
No serious effects have been cited for taking too much Gracial tablets at once. If you have taken several tablets at once may have nausea, vomiting or vaginal bleeding.
What to do if . . .
. . . forget to take tablets
If it has been less than 12 hours from the usual time, maintaining the reliability of the pill. Take the tablet as soon as you remember and continue taking these tablets at the usual time.
If it has been more 12 hours from the usual time, the reliability of the pill may be reduced. The more tablets in a row he has forgotten, the higher the risk that lower the contraceptive efficacy. The risk of being pregnant is a particularly high if you miss the tablets at the beginning or end of container. Por tanto, should follow the recommendations set out below (see also the diagram).
If you miss more than one tablet in a container
Consult your doctor.
If you forget 1 compressed in the first week
Take the missed tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablets at the usual time. Take additional contraceptive precautions (barrier method) during 7 days.
If you have had sex in the previous week there is a possibility of becoming pregnant. Por tanto, Tell your doctor immediately.
If you forget 1 compressed in the second week
Take the missed tablet as soon as you remember (even if it means taking two tablets at once) and take the next tablets at the usual time. The reliability of the pill is maintained and requires no additional contraceptive precautions.
If you forget 1 compressed in the third week (8 days)
You can choose any of the following, without the need for additional contraceptive precautions.
1- Take the missed tablet as soon as you remember (even if it means taking two tablets at once) and take these tablets at the usual time. Start the next pack the day after finishing the current pack without leaving a rest period between packages. You may not be the rule until the end of the second container, although it may have spotting or a short period while taking the tablets from the second container.
2- Stop taking tablets from the current pack, leave a maximum rest period 6 days
(count also the day that the tablet has been forgotten) and continue with the next pack. Using this method you can always start your next pack the day of the week you normally. If you forgot tablets in a container and is not expected to rule the first normal period of rest may be pregnant.
Consult your doctor before starting the next pack.
. . . if you vomit or have severe diarrhea
• discard the current package
• Allow a rest period (maximum 6 days including the day I forgot the tablet)
• continue with the next pack
If you vomit or have severe diarrhea in 3 ó 4 hours after taking the tablet Gracial may be that the active principles are not completely absorbed, equivalent to one tablet forget. Por tanto, follow the recommendations for a forgotten tablet.
In the case of severe diarrhea, ask your doctor.
. . . To change the day your period starts
If you take the tablets as he has indicated, will get your period about every day
4 semanas. If you want change, needs to be shortened (never extend) The following rest period. Por ejemplo, if your period usually starts on Friday and want to start on Tuesday in the future, ie three days before, should start the next pack three days before the day began.
If the rest period is too short, the 1 a,en 3 days, may not have bleeding during the break and have some spotting during the next pack.
. . . if you have unexpected bleeding
As with all pills, irregular vaginal bleeding may occur between the rules during the first months (is called breakthrough bleeding or spotting). In this case,es, typically continue taking the tablets. This irregular vaginal bleeding usually stops once your body has adapted to the pill, usually after three cycles.
If you continue, becomes more severe or reappears, ask your doctor.
. . . if it is not the rule
If you have taken all the tablets at the same time and has not vomited, had severe diarrhea, or taken other drugs, is unlikely to be pregnant. Continue to take as usual Gracial.
If you have 2 fouls in a row may be pregnant, so you should see your doctor immediately. Do not start the next pack of Gracial until your doctor has confirmed she is not pregnant.
4. Possible adverse effects
Like all medicines, Gracial can have adverse effects, although not everybody gets them.
Serious adverse reactions such as thrombosis and tumors have been described throughout this prospectus. See section 2. Take special care with Gracial.
The adverse reactions listed below are ranked by frequency according to the following criteria:
FAQ: that affects 1 and 10 each 100 patients
Uncommon: that affects 1 and 10 each 1000 patients
Rare: that affects 1 and 10 each 10.000 patients
Common adverse reactions:
– depressed mood, mood swings
– nausea, abdominal pain
– Breast pain, breast discomfort
– weight gain
Uncommon adverse reactions:
– fluid retention
– decreased sexual appetite
– vomiting, diarrhea
– Rashes, urticaria
– increase in breast size
Rare adverse reactions:
– allergic reactions
– increased sexual appetite
– intolerance to contact lenses
– erythema nodosum, erythema multiforme (which are diseases of the skin)
– altered menstrual flow, mammary secretion
– weight loss
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. TABLETS gratia STORE
Keep out of reach and sight of children. No conservar a temperatura superior a 30 º C. Store in original container.
Gracial not use after the expiration date on the carton. The expiry date is the last day of that month.
Do not use if you notice such Gracial, color change, broken tablets or any other visible sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Thus, help protect the environment.
6. FURTHER INFORMATION Gracial
The active principles are:
Blue tablets: 25 micrograms of desogestrel and 40 micrograms ethinylestradiol. White tablets: 125 micrograms of desogestrel and 30 micrograms ethinylestradiol.
Other components (excipients) its:
Blue tablets: colloidal anhydrous silica, all-rac-alpha-tocopherol, indigotina (E-132), lactose monohydrate, potato starch, povidone and stearic acid.
White tablets: colloidal anhydrous silica, all-rac-alpha-tocopherol, lactose monohydrate, potato starch, povidone and stearic acid.
Looks like and contents of container
The tablets are round and flat. Measure 6 mm. Organon are coded and marked with an asterisk on one side and TR8 (white tablets) he TR9 (blue tablets) on the opposite side. Gracial presented in blisters 22 tablets (7 blue 15 white), packaged in boxes with 1×22 and 3×22 tablets.
Holder of the authorizing responsible for placing and manfacture
Holder of the marketing authorization:
Spanish Organon, SA. Ctra. Hospital, 147-149
CityParc - Building Amsterdam
08940 Cornella de Llobregat (Barcelona)
Responsible for manufacturing:
NV. Organon, Us (Netherlands)
PO Box 20
5340 BH Oss
Organon (Ireland) Ltd., PO Box 2857
Drynam Road Swords, What. Dublin Ireland
This leaflet was approved in September 2009