Suavuret ®

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. SUAVURET TABLETS WHAT IS AND WHAT IT IS USED

Suavuret belongs to the group of medicines called monophasic oral contraceptives ("Pills" combined). All tablets of the container containing the same active ingredient combination.
Suavuret is indicated to prevent pregnancy.

2. BEFORE TAKING PILLS SUAVURET

Do not take Suavuret if any of the conditions described below. In this case,es, tell your doctor before you start using Suavuret. 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 disorder 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 a 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 have diabetes (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 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 cancer that grows influenced by sex hormones (for example breast or genital organs).
• if you have or have ever had a tumor in the liver.
• if there is any unexplained vaginal bleeding.
• if you have 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 of Suavuret.

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 Suavuret if any of the situations described below. In such a case should remain under medical supervision. Your doctor will explain in detail. Por tanto, If any of the following, tell your doctor before you start taking Suavuret:
• if a smoker;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have heart rhythm disorders or certain heart disorders;
• if you have swelling in the veins (superficial phlebitis);
• if you have varicose veins;
• whether any immediate family has had thrombosis, heart attack cerebral embolism;
• if you have migraine;
• si sufre epilepsy;
• 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.

Suavuret, like all birth control pills, not protect against AIDS or other sexually transmitted disease.

Once the treatment Suavuret:

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 Suavuret" and "Before starting treatment with Suavuret"); And do not forget the points related to their immediate families;
• if it is a lump in the breast;
• If you experience symptoms of angioedema, as swelling of the face, lengua y / o Garganta, and / or difficulty swallowing, or hives together with difficulty breathing;
• if you are taking other medicines (see also "Taking other medicines");
• si debe remain immobilized if the va operating, 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 forget to take tablets in the first week of the pack and had intercourse in the seven days prior;
• if you have severe diarrhea;
• if you have two failures 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 Suavuret, may increase the chance of having thrombosis (venous (clot formation in veins) compared to women not using any contraceptive pill.
The possibility of developing venous thrombosis is higher if you take Suavuret compared to other pills containing the progestin levonorgestrel. The risk of venous thrombosis in users of the pill increases:
– elderly
– sobrepeso
– 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 Suavuret and that treatment should be suspended. Your physician will tell you when to re-take Suavuret. 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. Si toma Suavuret, should quit especially if over 35 años.
-if you have an increase in blood fatty acids (cholesterol or triglycerides)
-if hypertensive
-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.

Blood pressure
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.

Tumors
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).

Vaginal 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. HOW TO TAKE PILLS SUAVURET"And has a lack, should discontinue treatment and use a nonhormonal contraceptive method until pregnancy is ruled out. Suavuret can cause vaginal bleeding or spotting between periods. If this occurs you, Suavuret continue treatment and the bleeding is still occurring after the first three cycles, consult your doctor immediately. Errors in the use of the pill can also cause vaginal spotting and light.

After you finish using Suavuret, 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 píldora.No the pill is recommended along with the following medications:
• medications for the treatment of epilepsy (eg phenytoin, barbiturates (phenobarbital), primidona, carbamazepine, oxcarbazepina, topiramate, felbamato)
• drugs for treatment of tuberculosis (eg rifampicin, rifabutina)
• medications for treating HIV infections (eg ritonavir)
• antibiotics or antifungal agents are 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) that is taking Suavuret. 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.

Laboratory Tests
The use of oral contraceptives may affect the results of certain lab tests. If you indicate the performance of any laboratory test, advierta su doctor who is taking Suavuret.

Pregnancy and lactation
Suavuret should never be used by pregnant or who suspect they may be pregnant. Generally not recommended Suavuret 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 of Suavuret
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 PILLS SUAVURET

Carefully follow the dosing instructions provided by your doctor Suavuret. Consult your doctor or pharmacist if.
El blister the Suavuret tiene 21 tablets marked with days of the week. Take your tablet at about the same time each day, with liquid if necessary. Each time you start a new blister Suavuret, take the tablet from the top row that corresponds to the day of the week that you take.
Follow the direction of arrows to finish the 21 tablets.
In 7 days should not take Suavuret, during which a rule appears (withdrawal bleeding) usually begins two or three days after the last tablet of Suavuret. Continue with the next blister on the eighth 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 Suavuret

If you have not used hormonal contraception in the previous month:

Start taking Suavuret the first day of the cycle, ie, the first day of menstruation. Suavuret 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, ring
vaginal or transdermal parche):
You can start taking Suavuret the next day after taking the last tablet of current. This means you do not have to leave a rest period. In case your current prepared inactive tablets have Suavuret can start the day after the last active tablet (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 Suavuret preferably the same day of collection of the vaginal ring, 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 have taken the pill, or using the vaginal ring or patch continuously and correct and safe
she is not pregnant, also can stop taking the pill, or remove the vaginal ring or patch any day of the current cycle and start immediately Suavuret.
If you follow these instructions, is not necessary to use an additional contraceptive method.

Changing from a progestogen-only pill:
You can stop taking your pill today any day and start taking Suavuret 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) with progestagen only:
Start using Suavuret at the time you should get the next shot or the day he extracted 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.

After delivery:
If you have just one child, your doctor may advise you to wait until you see your first normal period before you start Suavuret. It is sometimes possible to start earlier, but your doctor will advise how. If you are breastfeeding and want to use Suavuret should discuss with your doctor first.

After abortion:
Consult your doctor.
You can leave anytime Suavuret. If you leave because you want to get pregnant Suavuret, 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 Suavuret
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 by taking an excess of tablets at once Suavuret. If you have taken several tablets at once may have nausea, vomiting or vaginal bleeding.

What to do if you 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:

  • 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: 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 containers. 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.
    Or,
    2- Stop taking tablets from the current pack, leave a maximum rest period 7 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.

What to do if you vomit or have severe diarrhea
If you vomit or have severe diarrhea in 3 ó 4 hours after taking your tablet might Suavuret active ingredients are not fully absorbed, equivalent to one tablet forget. Por tanto, follow the recommendations for a forgotten tablet. In the case of severe diarrhea, ask your doctor.

What to do if you want to change the day your period begins
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.

What 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.

What to do if there is no menses
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. Keep taking as usual Suavuret.
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 Suavuret until your doctor has confirmed she is not pregnant.

4. Possible adverse effects

Like all medicines, Suavuret can cause side 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 Suavuret“.

The adverse reactions listed below are ranked by frequency according to the following criteria:
-FAQ: may affect up to one in 10 patients.
-Uncommon: may affect up to one in 100 patients.
-Rare: may affect up to one in 1000 patients.

Common adverse reactions:
– depressed mood, mood swings
– headache
– nausea, abdominal pain
– Breast pain, breast discomfort
– weight gain
Uncommon adverse reactions:
– fluid retention
– decreased sexual appetite
– migraines
– 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 SUAVURET STORE

Keep out of reach and sight of children.
No conservar a temperatura superior a 30 º C.
Store in the original package.
Suavuret 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 Suavuret, color change, broken tablets or any other visible sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required at the point of their usual pharmacy SIGRE. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. ADDITIONAL INFORMATION

Composition Suavuret
The active principles are: 150 micrograms of desogestrel and 20 micrograms ethinylestradiol.
The other ingredients are: Silica Coloidal anhidra, all-rac-alpha-tocopherol, lactose monohydrate, potato starch, povidone and stearic acid.
Looks like and contents of container
The tablets are biconvex, round and 6 mm. Each tablet is marked code, TR on 4 on one side and an asterisk Organon and on the opposite side.

Suavuret see one presentation blisters the 21 tablets, packaged in boxes with 1×21 and 3×21 tablets.

Holder of the marketing authorization:

Merck Sharp and Dohme OF SPAIN, SA.
Josefa Valcarcel, 38
(Madrid) – 28027 – Spain

Responsible for manufacturing:
Organon (Ireland) Ltd.,
PO Box 2857
Drynam Road
Swords, What. Dublin
Ireland

This leaflet was last approved in April/2011.

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