Cerazet ® 75 mg tablets

Please read this leaflet carefully before taking this medicine.

- Keep this leaflet. You may have 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.

Yours, even if their symptoms are the same as yours.

In this leaflet:

1. What is Cerazette 75 mg film-coated tablets and what is used

2. Before taking Cerazet 75 mg film-coated tablets

3. Taking Cerazette 75 mg film-coated tablets

4. Possible side effects

5. Conservation Cerazet 75 mg film-coated tablets film-coated Desogestrel

- The active substance is desogestrel. Each tablet contains 75 microgram desogestrel

- The other ingredients (excipients) are colloidal silicon dioxide, anhydrous; a-tocoferol, lactose monohydrate, cornstarch; povidone; stearic acid. The tablets are coated with a thin layer containing hydroxypropylmethylcellulose; polietilenglicol 400; talc and titanium dioxide (E 171).

Headline:

Spanish Organon, SA.

Cornella de Llobregat (Barcelona)

Responsible for manufacturing:

NV. Organon Oss (Netherlands)

1. WHAT IS Cerazette 75 mg FILM-COATED TABLETS AND WHAT IT IS USED

Cerazette tablets are round and are marked with the code on one side and KV2

Organon in the other.

Cerazette is presented in boxes with 1×28 and 3×28 tablets.

Cerazette contains a female sex hormone, the progestin desogestrel, which presents contraceptive activity. Unlike the combined pill, type does not contain hormones estrogen plus progestin.

Cerazette is used to prevent pregnancy.

2. BEFORE YOU TAKE Cerazette 75 mg film-coated tablets

Do not take Cerazette:

You should not take Cerazette if any of the conditions described below. In this case,es, tell your doctor before you start using Cerazette. Your doctor can suggest a method of non-hormonal birth control.

• If you have a thrombosis. Thrombosis is the formation of a clot in a blood vessel [eg leg (DVT) or lung (pulmonary embolism)].

• If you have jaundice (yellowing of the skin) or severe liver disease.

• If you have a progestin-dependent cancer.

• If there is any unexplained vaginal bleeding.

• If you are pregnant or think you may be pregnant.

• If you are allergic to any ingredient of Cerazette.

If any of these conditions appear for the first time while using Cerazette, Call your doctor immediately.

Take special care with Cerazette:

Before starting treatment with Cerazette

If you use Cerazette and any of the conditions described below, must remain under medical supervision. Your doctor can explain what to do. Por tanto, If any of the following, tell your doctor before you start using Cerazette:

• if you have or have had breast cancer;

• if you have liver cancer;

• if you have ever had a thrombosis;

• if you have diabetes;

• si sufre epilepsy;

• if you have tuberculosis;

• 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.

Once the treatment with Cerazette

Consideration must be given the following warnings:

Circumstances potentially serious

Decreased bone mass

Estrogens are important for maintaining bone strength. While taking Cerazette, blood levels of natural estrogen estradiol is comparable to the situation in the first half of a woman's natural cycle, but in the second half of the cycle, the amount of estradiol is lower. It is unknown whether an effect on the bone.

Breast cancer

All women have a risk of breast cancer, either pill users or not, although there has been appearing more frequently in women taking the pill. When you stop taking, gradually decreases the risk 10 años, to equalize the situation of a woman who had never taken the pill.

The risk of breast cancer increases with age, while the treatment time with the pill has less influence. The data in the table below give an idea of ​​what this risk.

Treatment Time

the pill

Age to stop taking

pill

Cases diagnosed in

general population

Additional cases

found in pill users

Up 5 años20 años4 where 10000

women

None
Up 5 años30 años44 where 10000 women5 cases
Up 5 años40 años160 where 10000 women20 cases

Thrombosis

Thrombosis is the formation of a blood clot can obstruct a blood vessel, which can lead to fatal situations. Thrombosis occurs rarely, but the risk of thrombosis is higher in Pill users than in nonusers, although not as high as the risk that exists during pregnancy. It is believed that the risk in users of progestogen-only pills such as Cerazette is less than in users of pills containing estrogen also (Combined pills). If you notice possible signs of thrombosis, Call your doctor immediately. (See chart)

Contact your doctor as soon as possible in the following cases:

• If you notice possible signs of thrombosis (eg severe pain or swelling in one leg, unexplained pain in the chest, difficulty breathing, unusual cough, especially accompanied by spitting up blood);

• if you have stomach pain and sudden pain or jaundice (which may indicate possible liver problems);

• if it is a lump in the breast;

• if there is a sudden or severe pain in the lower abdomen or stomach area

(possibly may indicate an ectopic pregnancy, ie, a pregnancy outside the uterus);

• whether to remain immobilized or be subjected to surgery (Consult your doctor at least four weeks before);

• if you have unusual vaginal bleeding and intense;

• If you suspect that you are pregnant.

Regular checks

During treatment with Cerazette your doctor will be required to undergo periodic inspections. Overall, the frequency and characteristics of these controls will depend on your personal situation.

EmbaraofO

Cerazette should not be taken by pregnant or who suspect they may be pregnant.

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Cerazette does not affect production or quality of breast milk, While small amounts of active ingredient the same pass Cerazette. However, tell your doctor that you are breast-feeding before taking Cerazette.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines:

There is no evidence that the use of Cerazette produce an effect on alertness and attention span.

Taking other medicines:

Tell your doctor or pharmacist if you take, or have recently taken any other medicines, obtained without a prescription.

Note that these instructions may also apply to drugs that have to be taken before or after.

Some medications can cause a lack of effectiveness of the pill, as some medicines used to treat epilepsy (eg primidone, hidantoínas, barbiturates, carbamazepine, oxcarbazepina, felbamato), TB (eg rifampicin, rifabutina) and HIV infections (eg ritonavir); activated carbon used to induce vomiting and products bearing the herb St. John's Wort (used primarily for the treatment of depressed mood).

3. HOW Cerazette 75 mg FILM COATED TABLETS

Method of administration

Each blister contains Cerazette 28 tablets. There are arrows printed on the front of the blister, between compressed. If you flip to blister and looks back on her face, see the days of the week printed on the sheet. Each day corresponds to a tablet. Every time you start a new blister Cerazette take one tablet in the top row, but not any compressed. Por ejemplo, If you start on a Wednesday should take the tablet on the top row that is marked (behind) “MIE”. Continue taking one tablet a day until the blister is empty, always following the direction of the arrows.

Remember to take your medicine.

Looking back face of the blister can easily control if you have taken your tablet on a given day. Take your tablet at about the same time each day, swallowed whole with water. May have some bleeding while using Cerazette but should continue taking the tablets usually. When you finish a blister should start a new one the next day, therefore leaving no rest day and without waiting for the emergence of a bleeding.

You can stop taking Cerazette when you want. From the day you stop taking it and not be protected from pregnancy.

The first blister of Cerazette

If you have not used hormonal contraception in the previous month

Wait to start the period and the first day of the period, take the first tablet

Cerazet. This form does not need extra contraceptive precautions.

You can also start day 2 a,en 5 of its cycle, but in this case also make sure to use an additional contraceptive method (barrier method) whilst you are 7 first tablets of the first cycle.

Changing from a combined pill

You can start taking Cerazette the next day after taking the last tablet of the current packaging. This means you do not have to leave a rest period. If the preparation was taking contains inactive tablets, can start taking Cerazette the next day after taking the last active tablet (If you are unsure, Consult your doctor or pharmacist). Following these instructions, need not take additional contraceptive precautions.

If I took another progestogen-only pill

You can leave your current prepared at any time and start immediately afterwards Cerazette. No need to take additional contraceptive precautions.

If using an implant, progestin injection or IUD

Start using Cerazette at the time you should get the next shot or the day we removed the implant or IUD. It is not necessary to take additional contraceptive precautions.

After delivery

Consult your doctor.

In paragraph 2. BEFORE YOU TAKE Cerazette, under "Breastfeeding" may find more information about breastfeeding.

If vomiting or use of activated carbon

If you vomit or use activated carbon in the range of 3-4 hours after taking Cerazette tablet, may not be completely absorbed the active. Follow signs for the case of tablets miss.

Si Vd. Cerazette takes longer than you should:

Symptoms that may occur in overdose are nausea, vomiting and women or girls, slight vaginal bleeding. For more information, consult your doctor or local poison control center. Telephone 91 562 04 20.

If you forget to take Cerazette:

Do not take a double dose to make up for missed doses.

If it has been less than 12 hours from the usual time of taking, maintaining efficacy of Cerazette. Take the missed tablet as soon as you remember and the next tablet at the usual time.

If it has been more 12 hours from the usual time of taking, effectiveness may be reduced. The more consecutive tablets have forgotten, the risk that the effectiveness

has decreased contraceptive is higher. Take the last missed tablet as soon as you remember and continue to the next tablets at the usual time, also using a condom during 7 days.

If you miss one or more tablets in the first week of treatment and had sex during the previous week, there is a possibility of becoming pregnant.

4. Possible adverse effects

Like all medicines, Cerazette may have adverse effects.

In paragraph 2. BEFORE YOU TAKE explains Cerazette serious adverse events that may be associated with the use of Cerazette. Read this section to find detailed information and contact your doctor right away if necessary.

Adverse reactions may occur during treatment are as follows:

Vaginal bleeding may occur at irregular intervals while using Cerazette, which may be a slight spotting or heavier bleeding, which is rather like a scanty menstruation. It also may have no bleeding. Irregular bleeding are not a sign that the fall protection Cerazette. Overall, need not do anything, just keep taking Cerazette. Nevertheless, If bleeding is severe or prolonged contact your doctor.

Other common side effects are: acne, breast pain, headache, mood swings, nausea, decreased libido and weight gain. Effects are less common or rare: discomfort with contact lens wear, vesicle formation fluid in the ovaries (cysts), Hair loss, vaginal infection, painful menstruation, fatigue, Various skin reactions, vomiting.

If you notice any other effects not listed in this leaflet, check with your doctor or pharmacist.

5. CONSERVATION CERAZET 75 mg FILM COATED TABLETS

Cerazette Keep out of reach and sight of children. Store in original container.

Expiry

Cerazette not use after the expiration date on the box. This leaflet was approved in September 2004.

RA 0390 ES P2 (ref 3.0)

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  41. Nathalia molina,,pt,Hi, I'm Nathalia and I'm,,es,months taking cerazet and the first month well,,es,but this month not what is happening,,es,first I had,,es,days of delay so I worry a lot and read in the proapecto that one of the contraindications is absence of rule,,es,but then I get down and hard,,es,days what is not normal in my,,es,and after,,es,A brown flow has gone down and today is the third day of being mabchando but nowa is pink blood with brown flow,,es,I am very worried that I may become pregnant,,es

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