Diane 35 Journal ®

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.

1. WHAT DIANE 35 DAILY AND WHAT IT IS USED

Diane 35 Daily oral hormone preparation is a combination indicated in the treatment of diseases such as acne, especially pronounced forms and those which are accompanied by seborrhea or inflammation or nodules (Acne Papulopustulosa, nodular acne), Androgenic alopecia and mild forms of hirsutism (exaggerated by the presence of).
It is also indicated as an oral contraceptive in patients with the above mentioned manifestations, although Diane 35 Journal should not be used in women solely for contraception.
We recommend stopping treatment 3 ó 4 cycles after the complete resolution of the diseases listed above.
If any of the above processes reappears, Repeated cycles can be administered Diane 35 Daily.

Diane 35 Journal comes in blister (the container where the coated tablets) the 28 coated tablets.

2. BEFORE TAKING DIANE 35 DAILY

No tome Diane 35 Daily:
You should not use Diane 35 In Journal presence of any of the processes listed below. If any of these processes is introduced during use, should be discontinued immediately and consult your doctor.
• If you or a family member (parents and siblings) have or have had related processes clots in the veins of the lower limbs that have fallen affecting other parts of the body, even if it was long ago. The clot can affect the lungs evolved (pulmonary embolism).
• If you have or have had disorders of the arteries of the brain or heart (stroke, myocardial infarction, angina pectoris).
• If you have migraine with focal neurological symptoms (Focal will).
• If you have diabetes combined with heart or circulatory problems.
• The presence of one or more risk factors for severe or multiple arterial or venous thrombosis may also constitute a contraindication (see "Take special care with Diane 35 Journal ").
• If you have uncontrolled high blood pressure.
• If you have thrombogenic valvular (diseases of the heart valves can cause blood clots).
• If you have or have had pancreatitis, if it is associated hypertriglyceridaemia (Elevated triglycerides in the blood) serious.
• If you have or have had a severe liver disease or liver tumors.
• If you have or suspected malignancies of the genital organs or breast.
• If you have vaginal bleeding of unknown cause.
• If you are pregnant or suspect you may be pregnant.
• If you are breast-feeding.
• If you are allergic to the active substances or to any of the excipients.
Diane 35 Journal is not indicated in male patients.

Take special care with Diane 35 Daily:
If some of the processes / risk factors mentioned below are present, your doctor should assess the benefits of using Diane 35 Journal against the possible risks, and discuss them with you before you decide to start using.
Should either of these situations appear for the first time, exacerbated the worse, debe contactar con su médico lo antes posible, since you have to stop using Diane 35 Daily.
– First episode, or worsening, migraine-type headache, headaches or unusually frequent or severe.
– Sudden changes in vision or hearing, or other perceptual disturbances.
– First signs of thrombophlebitis or thromboembolic symptoms (as unusual pain or swelling / s leg / s, pain when breathing or coughing for no apparent reason). Feeling pain or chest tightness.
– Six weeks before any major surgery scheduled (abdominal, orthopedic), any surgery to the legs, Medical treatment of varicose veins or prolonged immobilization, for example,es, after accidents or surgery. Should not be reinstituted until two weeks after complete remobilisation is. In case of emergency surgery, prophylaxis is usually indicated thrombotic, eg subcutaneous heparin.
– Jaundice (yellowing of the whites of the eyes and skin) or liver disorders or generalized itching.
– Epilepsy.
– Significant increase in blood pressure.
– Onset of major depression.
– Severe abdominal pain or hepatomegaly (enlarged liver).
– Clear worsening of diseases that are known to worsen during the use of hormonal contraceptives or during pregnancy.
– Pregnancy is a reason to stop treatment immediately.

Other situations in which you should contact your doctor, who will assess whether treatment should be discontinued, are as follows:
– Certain types of heart rhythm disorders, heart disease.
– High levels of fat (triglicéridos) blood or family history of this.
– Diabetes.
– Depression or history of depression, as this may worsen or come back to use hormonal contraceptives.
– 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).

Potentially serious diseases:

Thrombosis (blood clots)
The use of the pill may increase the chance of thrombosis (blood clots). This risk is greatest during the first year of use of contraceptive pills. Nevertheless, the chances of developing blood clots, are higher during pregnancy than during the contraceptive treatment.
Diane 35 Journal progestogen comprises cyproterone acetate and the estrogen ethinylestradiol, and is administered for 21 days of each monthly cycle. Therefore, has a similar composition to that of a combined oral contraceptive (AOC). The use of any COC, or Diane 35 Daily, is associated with an increased risk of venous thromboembolism (TEV), including deep vein thrombosis and pulmonary embolism, compared with no use.
Blood clots can block the major blood vessels and very rarely may cause permanent disability or death. If the blood clot forms in the deep veins of the legs, may break off and block the pulmonary arteries (pulmonary embolism). Also, Blood clots occur rarely in the heart arteries (myocardial infarction, angina pectoris) or cerebral arteries (cerebral thrombosis).
There is evidence from some studies, which indicates that the frequency is higher venous thrombosis in users of Diane 35 Journal compared with COC users with low estrogen (inferior to 0,05 mg ethinyl).

If you identify the occurrence of any of the possible signs of a blood clot, Tell your doctor. These symptoms are:
– pain and swelling in the leg
– severe chest pain and sometimes in the arm
– cough of acute onset
– severe headache
– vision problems (vision loss, double vision)
– difficulty speaking clearly
– dizziness
– seizures
– weakness or numbness that affects a body part
– difficulty walking or holding things
– severe stomach pain

The following conditions may increase the risk of thrombosis (blood clots), so you must tell the doctor if any of them: – certain thrombophilias (tendency to produce blood clots hereditary or acquired defect) – you are very obese. – Are you a smoker, especially if you have more than 35 años. – just given birth or just had an abortion in the second trimester of pregnancy. – needs to be in bed for several days. In these cases, if possible, treatment should be discontinued. – has undergone or will undergo major surgery. In these cases, whenever possible, treatment should be discontinued six weeks before and two weeks after you undergo such intervention. – elderly

There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism.
To use Diane 35 Journal after delivery or abortion in the second trimester: see "How to take Diane 35 Daily”.
An increase in the frequency or severity of migraine during use of Diane 35 Daily (which can be the beginning of a stroke) may be grounds for immediate suspension of treatment.

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, treatment should be stopped.

Tumors
Several studies have reported that women treated with AOC have a slightly increased risk of having a diagnosis of breast cancer, compared to those who have never taken. The increased risk may be due to a diagnosis of breast cancer earlier in COC users, as they are subjected to a more regular medical surveillance, the biological effects of COCs or a combination of both. 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.

In rare cases have been reported benign liver tumors, and even more rarely malignant, in COC users. In isolated cases, these tumors have led to life-threatening intra-abdominal haemorrhage. This can cause internal bleeding resulting in severe pain in abdomen. If this occurs, should contact your doctor immediately.
Some studies have found an increased risk of cervical cancer (cervix) in COC users long term. 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. Given the biological influence of COCs on these injuries, it is recommended that, should prescribe an AOC, regular cervical smears are made.

Other conditions
In women with hypertriglyceridemia (increased blood triglyceride), or family history of it, may be an increased risk of pancreatitis when using COCs.
During the use of COCs was observed that many users have small increases in blood pressure, although rare cases with clinical relevance. If during treatment with Diane 35 Journal hypertension appears maintained should consult with your doctor.
In women with endometrial hyperplasia physicians should carefully weigh the risk-benefit ratio before prescribing COCs, and closely monitor the patient during the treatment period, regular cervical cytology.
Some conditions may appear or worsen with pregnancy and COC use: jaundice (yellowing of the whites of the eyes and skin) and / or itching (itching) associated with cholestasis (arrest or decreased flow of bile), formation of gallstones, porphyria (familial metabolic disorder), lupus erythematosus (inflammatory dermatitis), Hemolytic uremic syndrome (renal disease with blood disorders), Sydenham chorea (involuntary movements), gravid herpes (injury to the skin and mucous membranes during pregnancy appears) and loss of
otosclerosis-related hearing (a type of ear disease).
Acute or chronic disturbances of liver function require the suspension of the use of Diane 35 Journal until markers of liver function return to normal. Recurrence of cholestatic jaundice which first appeared during pregnancy, or previous use of sex hormones, Diane requires suspension of 35 Daily.
COCs may alter the peripheral insulin resistance and glucose tolerance, but need not alter the therapeutic regimen in women with diabetes who use low-dose COCs (with < 0,05 mg ethinyl). However, diabetic women should be carefully monitored while taking Diane 35 Daily.
Chloasma may occur occasionally (brown spots on skin), especially in women with a history of chloasma gravidarum (pregnancy). If you have a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Diane 35 Daily. If you have hirsutism (exaggerated by the presence of), and recently developed these symptoms or increased, should consult with your doctor, who should clarify the possible causes. If you get severe symptoms of depression should assess discontinuation. Should monitor women with a history of depression.

Exploration and medical consultation

Before starting or restarting treatment with Diane 35 Journal necessary for your doctor to perform a medical history and a complete physical examination, designed to rule out contraindications and precautions observed. These should be repeated periodically throughout treatment.
It should warn women that preparations like Diane 35 Journal not protect against HIV infection (PAGE), or against other sexually transmitted diseases.

Reduced efficacy

The effectiveness of Diane 35 Journal may decrease if you miss one active tablet (see "Conduct to be followed in case of missed taking tablets”), presents gastrointestinal disorders while taking active tablets(see "Tips for gastrointestinal disorders"), or take any other medications simultaneously (see "Taking other medicines”).
You should not take herbal preparations with medicinal St John's Wort (Hypericum perforatum) simultaneous representation with Diane 35 Daily, because it can reduce the therapeutic effect of this and increase the risk of pregnancy and occurrence of breakthrough bleeding (see "Taking other medicines”).

Irregularities in the cycle control

During the use of Diane 35 Journal may appear stained or vaginal bleeding, especially during the first months of use. If bleeding irregularities persist or occur after previously regular cycles, you should see your doctor for it to take appropriate diagnostic measures to exclude non-hormonal causes (malignancies, infections or pregnancy).
In some women may not produce withdrawal bleeding (rule) during the interval of taking placebo tablets. If you have taken Diane 35 Journal following the instructions in "Taking Diane 35 Daily”, is unlikely to be pregnant. Nevertheless, if not taken Diane 35 Journal following instructions before the first missed withdrawal bleed the, or if two withdrawal bleeds, pregnancy should be ruled out before continuing treatment with Diane 35 Daily.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Certain medicines can interact with each other, in these cases may be necessary to change the dose or stop taking any medications. It is especially important to tell your doctor if you use any of the medicines listed below, because it could prevent combined hormonal contraceptives work well and, if this occurs, could become pregnant:

• Drugs that may decrease the concentration of ethinyl estradiol in the body: Reducing the concentration of ethinyl estradiol may increase the incidence of breakthrough bleeding and menstrual irregularities and reducing the effectiveness of Diane 35 Daily:
– Antacids
– Purgatives
– Some antibiotics like erythromycin, tetracyclines and penicillins.
– Anticonvulsants: hidantoínas (phenytoin), barbiturates (phenobarbital), primidona, etosuximida, carbamazepine, oxcarbazepina, topiramate, felbamato
– TB: rifampin, rifabutina
– Some treatments for viral infections and HIV, ritonavir, nelfinavir, nevirapina.
– Others: griseofulvina, lansoprazole, modafinil, Hypericum perforatum (St. John's Wort).
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.
During treatment with any of these drugs should temporarily use a barrier method (condom) Diane plus 35 Daily, or choose another method of contraception. With some drugs, the barrier method should be used for the duration of concomitant drug administration, and during the 28 days of suspension. Women treated with antibiotics (except rifampicin and griseofulvin) should use a barrier method until 7 days after his suspension. If the period during which the method is used beyond the end wall of the container active tablets Diane 35 Daily, should be initiated directly following
container, placebo tablets discarding current packaging. Ask your health care provider any questions you may have in this regard.

• Drugs that may increase the concentration of ethinyl estradiol in the body:
– atorvastatin

• Drugs whose action can be modified by oral contraceptives:
– Oral anticoagulants.
– Oral antidiabetic drugs and insulin.

Ethinylestradiol may interfere with the metabolism of other drugs, therefore their concentration in the body can:
A. Increase
– Cyclosporine: increasing the risk of hepatotoxicity.
– β-blockers.
– Theophylline.
– Corticosteroids: prednisolone.
– Flunarizina: increasing the risk of galactorrhea (mammary secretion).
B. Decrease
– Analgesics: paracetamol and salicylates.
– Clofibrate

You should consult the prescribing information for the medications you are taking together to identify possible interactions.

Laboratory Tests
Using prepared as Diane 35 Journal can affect the results of certain lab tests. If you indicate the performance of any laboratory test, tell your doctor that you are taking AOC.

Pregnancy and lactation
Consult your doctor or pharmacist before taking any medicine.
Diane 35 Journal is contraindicated during pregnancy. If given this circumstance should stop treatment immediately and consult your doctor.
Diane 35 Journal is also contraindicated during lactation. For breast milk can remove small amounts of oral contraceptive. For this, should not be recommended COC use until the end of lactation.

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

Important information about some of the components of Diane 35 Daily
This medication containing glycerol as an excipient can be harmful at high doses. May cause headache, stomach upset and diarrhea.

3. HOW TO TAKE DIANE 35 DAILY

Follow these instructions unless your doctor has given you different.
Remember to take your medicine, since the neglect of coated tablets may decrease the effectiveness of the preparation.
Diane 35 Journal inhibits ovulation and, therefore, prevents pregnancy. Therefore, if you are taking Diane 35 Journal should not use an additional hormonal contraceptive, since they would be exposed to an overdose of hormones.
You should take Diane 35 Journal regularly to achieve the therapeutic efficacy and, further, contraceptive protection required. The administration schedule Diane 35 Journal is similar to the usual pattern of most COCs. Por tanto, should consider the same rules of administration. Taking Diane irregular 35 Journal can cause breakthrough bleeding and may deteriorate the therapeutic efficacy and contraceptive.
In the container, together with the blister reminder (Tablets containing), is a cardboard with 7 adhesive strips. These strips show weekdays. Each strip starts with a different day of the week. It should come off the strip that starts with the day of the week that is going to take the first tablet of Diane 35 Daily (por ejemplo, whether to start taking the tablets a Thursday, should come off the strip that starts at "THU"). You should stick the strip in the rectangle at the top of the blister containing the tablets. Thus, the first day is over the beige tablet which aims the arrow marked with the word
"1st". They should take the tablets in the order indicated on the package, every day, approximately the same time, with some liquid if necessary, until the end of the 28 Blister tablets. In this way, take a tablet beige (active) daily for the first 21 days, then, a white tablet (placebo) daily for the following 7 days. Treatment is continued. This means that when finished the blister, must start anew the next day. During the week of taking placebo tablets, occur, in normal, one menstrual like bleeding. It usually begins in the 2-3 days after start taking placebo tablets, and may not be completed before starting the next pack.

No previous use of hormonal contraceptives (in the previous month)
Taking the tablets have to start the day 1 natural cycle of women (ie, the first day of menstrual bleeding). You can also start on days 2 a,en 5 cycle, but in that case it is recommended to use further in the first cycle a barrier method (condom) during 7 early days of tablet-.

Changing from another combined oral contraceptive (AOC)
You should start taking Diane 35 Preferably Journal the day after taking the last active tablet of the COC was previously taking, the latest, on the day after the end of the usual range of tablet-free (7 days) or placebo tablet- (7 tablets without active components) its AOC prior. This means that, the latest, is due to start treatment with Diane 35 Journal on the same day should start a new pack (blíster) AOC prior.

Changing from a method based only progestogens (minipíldora, injection, implant), or a progestogen-releasing intrauterine system (SIU)
You can change any day of taking the mini pill (case of an implant or IUS, the day of his retirement; if it is an injectable, when the next injection), but in all cases it is recommended to use an additional barrier method during the 7 early days of tablet-.

After an abortion in the first quarter
You can start immediately. When you do so, need not take additional contraceptive measures.

After delivery or abortion in the second trimester
It is advisable to start the day 21 a,en 28 after delivery or abortion in the second trimester. If you do later, is advisable to additionally use a barrier method during the 7 early days of tablet-. However, if you have already had sex, be ruled out that a pregnancy has occurred before the use of Diane 35 Daily, either have to wait to start treatment menstrual period.

Action to take if you miss taking a tablet

White tablets are placebo tablets, therefore, forgetfulness of no consequence, provided between taking the last tablet beige and beige making the first tablet of next pack more have elapsed 7 days. To not alter the intake schedule, if you miss a white tablet, deséchelo. The following tips apply only to forget active tablets (beige tablets).
If you are late less than 12 hours in taking any tablet, contraceptive protection will not be reduced. You should take the tablet as soon as you remember and you should keep taking the tablets again at the usual time.
If delayed more 12 hours in taking any tablet, contraceptive protection may be reduced. The guidance in the event of missed tablets is governed by two basic rules:

1. Never stop taking tablets for more than 7 days.
2. It requires taking the tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian.

Accordingly, in daily practice can advise the following:

• Semana 1
Should take the last missed tablet as soon as you remember, even if this means taking two tablets at once. She then continues to take tablets at her usual time. further, during 7 days must use a barrier method, as a preservative. If you have had sex in 7 days before, one must consider the possibility of pregnancy. The more forgotten tablets, and the nearer phase taking placebo tablets, the greater the risk of pregnancy.
• Semana 2
Should take the last missed tablet as soon as you remember, even if this means taking two tablets at once. Later, continues to take tablets at her usual time. Whenever in the 7 days preceding the first missed tablet you have taken the tablets correctly, no need to use additional contraceptive measures. Nevertheless, if this is not the case, or has forgotten more than one tablet, it is advisable to take extra precautions during 7 days.
• Semana 3
The risk of reduced reliability is imminent because of the proximity of the phase of taking placebo tablets. However, adjusting the tablet-scheme, can still prevent reduction in contraceptive protection. Therefore, if you follow one of the following two options, not need extra contraceptive precautions, provided that the 7 days preceding the first missed tablet has taken all tablets correctly. If this is not the case, it is advisable to follow the first of these two options, and also take additional contraceptive precautions during the 7 days.
1. Should take the last missed tablet as soon as you remember, even if this means taking two tablets at once. Later, continues to take tablets at her usual time, to finish the active tablets. The,es 7 placebo tablets to be disposed. The next pack should be started immediately. You are unlikely to present withdrawal bleeding (rule) until you finish the active tablets of the second pack, but may have spotting or bleeding in the days of making
tablets.
2. You may also stop taking tablets from the current pack. Then you must complete a free interval tablet-up 7 days, including days missed tablets, and then continue with the next pack. If you forget to take tablets and, posteriormente, no withdrawal bleeding (rule) in the acquisition phase of placebo tablets, should consider the possibility of pregnancy.
However, in doubt, Tell your doctor.

Tips for gastrointestinal disorders
In case of serious gastrointestinal absorption may not be complete, and should take additional contraceptive measures.
If you have vomiting in 3-4 hours after taking the tablet, should follow the advice concerning the neglect of taking tablets, as outlined in "Action to take if you miss taking a tablet”. If you do not want to change their normal pattern of taking tablets, take / the tablet / s other necessary additional reserve blister pack.

How advanced or delayed periods

To delay a period, should continue with the next pack of Diane 35 Journal without taking the placebo tablets current packaging. May maintain this extension so as desired until the end of the second container active tablets. During this period you may experience bleeding or spotting. Later, Regular intake of Diane 35 Journal resumed after making phase placebo tablets. In case of doubt, Tell your doctor.

To change the period to another day of the week that is used in accordance with its current cycle, can be advised to shorten the phase of placebo tablets making as many days as you wish. The shorter the interval, the greater the risk of not having a withdrawal bleed (rule), and experiencing breakthrough bleeding and spotting during the taking of the next pack (as when delaying a period).

Duration of administration

The duration of administration depends on the severity of the clinical; and general, Treatment should be carried out for several months.
We recommend taking Diane 35 Journal for at least another 3 a,en 4 cycles after remission of clinical. If a recurrence of clinical, weeks or months after the suspension of the tablets taking, therapy may be resumed with Diane 35 Daily.

Si Vd. Diane takes more 35 Journal than you should

If you take more Diane 35 Journal than you should, immediately consult your doctor or pharmacist or local poison control center (Tel: 91 562 04 20).
No serious adverse reactions have been reported overdose. Symptoms that may occur due to an overdose of active tablets are: nausea, vomiting, teen, ligate hemorragia vaginal. There is no antidote and treatment should be symptomatic.

4. Possible adverse effects

Like all medicines, Diane 35 Journal may have adverse effects.
There is an increased risk of venous thromboembolism in women using all Diane 35 Daily. For more information, see "Take special care with Diane 35 Journal ". On the other hand, oral contraceptive use has been associated with:
– Increased risk of cervical intraepithelial neoplasia and cervical cancer.
– Increased risk of breast cancer diagnosis (see "Take special care with Diane 35 Journal ").
Adverse reactions are listed below, classified according to their frequency in patients treated, according to the following criteria:

Very common: > 10%
FAQ: > 1% and < 10% Uncommon: > 0,1% and <1% Rare: > 0,01 and < 0,1% Very rare: < 0,01%

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

Immune system disorders
– Rare: allergic reactions like hives (itching), angioedema (swollen face, lips, mouth and very rare cases of serious reactions accompanied by difficulty breathing, dizziness and even loss of consciousness).
– Very rare: empeoramiento of systemic lupus erythematosus.

Metabolic and Nutritional Disorders
– Uncommon: changes in appetite (increase or decrease).
– Rare: IGT.
– Very rare: worsening of porphyria.

Psychiatric disorders
– FAQ: mood swings, including depression; changes in libido (sexual desire).

Nervous system disorders
– Very common: headaches, including migraines (migraines).
– FAQ: nervousness, vertigo.
– Very rare: worsening of chorea.

Eye disorders
– Rare: intolerance to contact lenses.
– Very rare: abnormalities in the eye and vision disorders (optic neuritis, retinal vascular thrombosis).

Vascular disorders
– Uncommon: increased blood pressure.
– Rare: venous thrombotic events (blood clots in veins).
– Very rare: worsening of varicose veins.

Gastrointestinal disorders
– FAQ: nausea, vomiting, abdominal pain.
– Uncommon: colic, swelling.
– Very rare: inflammation of the pancreas (pancreatitis), liver adenomas, hepatocellular carcinoma.

Hepatobiliary disorders
– Rare: cholestatic jaundice.
– Very rare: colecistopatía (Gallbladder disorders) including gallstones.

Skin and appendages disorders
– Uncommon: rash (urticaria), chloasma which may persist.
– Rare: erythema nodosum (a type of skin inflammation with nodules on the legs).
– Very rare: erythema multiforme (a type of skin inflammation).

Renal and urinary disorders
– Very rare: Hemolytic uremic syndrome.

Reproductive system and breast
– Very common: bleeding, stained.
– FAQ: breast pain, breast tenderness, breast augmentation, mammary secretion, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge and cervical ectropion (altering the cervical mucus), amenorrhea (absent menstruation).

General disorders
– FAQ: fluid retention, edema (swelling), weight changes (gain or loss).

Laboratory Tests
– Uncommon: changes in serum lipid levels, including hypertriglyceridemia.
– Rare: decreased serum folate levels.

Do not be alarmed by these reactions, since it is quite possible that none of them displayed. If any of these side effects tell your doctor, who will advise you to stop if it might affect their welfare.
If you notice any other effects not listed in this leaflet, check with your doctor or pharmacist.

5. DIANE STORE 35 DAILY

Keep Diane 35 Journal out of reach and sight of children.
Store in original container.
No use Diane 35 Journal after the expiry date shown on the packaging.

6. ADDITIONAL INFORMATION

Diane Composition 35 Daily

Each package contains 21 active tablets, beige, with 2,0 mg cyproterone acetate and 0,035 mg ethinylestradiol each, followed by 7 placebo tablets (tablets without active components), white.

The active ingredients of the tablets are: lactose monohydrate; cornstarch; povidone 25.000; magnesium stearate; sucrose; povidone 700.000; macrogol 6000; carbonate de calcium; talc; glycerol 85%; titanium dioxide; yellow iron oxide pigment and montan wax glycol.
The excipients are placebo tablets: lactose monohydrate; cornstarch; povidone 25.000; magnesium stearate; sucrose; povidone 700.000; macrogol 6000; carbonate de calcium; montana talc and glycol wax.

Holder of the marketing authorization
BAYER HISPANIA, SL.
By. Baix Llobregat, 3-5 -08970-
Sant Joan Despi (Barcelona)

Responsible for manufacturing
SCHERING GMBH AND CO. PRODUCTION
KG Döbereiner road 20 (Weimar)
– D-99427 – Germany

 

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