Jadelle ® 75mg

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 JADELLE 2 x 75 mg IMPLANTS AND WHAT IT IS USED

Jadelle composite implants. The implants are flexible cylinders in white or whitish, sealed, about 43 mm in length and 2,5 mm. Each package contains 2 implants for subcutaneous administration.

Jadelle belongs to a group of drugs called systemic hormonal contraceptives. Its active ingredient is levonorgestrel. Each implant contains 75 mg de levonorgestrel

The excipients are colloidal anhydrous silica and silicone elastomer.

Jadelle is indicated as a contraceptive in women between 18 and 40 años.

2. BEFORE USING JADELLE not use Jadelle:

• If you are allergic to levonorgestrel or any other component of the product.

• If you have abnormal vaginal bleeding or undiagnosed.

• If you suspect or confirm that you have a sex hormone dependent tumor.

• If you suffer from severe liver disease .

• If you have a liver tumor benign or malignant.

• If you have thromboembolic disease (formation of clots in blood vessels).

Take special care with Jadelle:

• The effectiveness of implants Jadelle decreases from the fourth year of use. Por tanto, should consider Jadelle implants removed and replaced by new ones to 4 años, especially in women weighing more than 60 kg.

• Jadelle Using certain alterations have been observed in some fat and blood proteins. Jadelle can influence coagulation factors. If you have a history of thromboembolic disease your doctor will assess the risk / benefit.

• If you have a history or a migraine develops, or that migraine worsens while using

Jadelle, your doctor should carefully weigh the situation.

• If contact lens wearer and tolerate longer or has vision changes, should be seen by an ophthalmologist. It may be appropriate to stop using these lenses, well for a while or permanently.

• If you are diabetic should be careful monitoring of blood glucose levels.

• If you submit a cholestatic hepatitis (difficulty bile flow through the liver) or jaundice (yellowing of skin and mucous) , should remove implants. There is also a slightly increased risk of gallstones (formation of gallstones la).

• If you have severe depression should consider the advisability of removing the implants Jadelle, because their depression may be related to hormone levels.

• The contraceptive steroids (similar to sex hormones) can cause some fluid retention, with subsequent weight gain. If you have processes that can be exacerbated by such tax, Jadelle use should be valued and their status should be carefully monitored during use.

• Rarely, There have been cases of benign intracranial hypertension headaches If there are persistent and / or visual disturbances should be taken into account this possibility, particularly in obese or have gained weight recently. If diagnosed with idiopathic intracranial hypertension (of unknown cause), your doctor will remove the implants.

• modify Jadelle implants menstrual pattern most users. Breakthrough bleeding have been reported (between two rules) Irregular and prolonged, Spotting and amenorrhea (absence of menstruation). Overall, these disorders resolve with continued use of implants..

• A prolonged amenorrhea for six or more weeks after a normal menstrual period may suggest a pregnancy. If confirmed, shall proceed to remove the implants.

• Ectopic pregnancy (outside its usual location) is rare with levonorgestrel implants. Their presence should be discarded in case of pain in the lower abdomen or positive pregnancy test.

• Using Jadelle allows the development of follicles, but they can reach a larger than normal. In most women these large follicles disappear spontaneously. However, in rare cases can cause abdominal pain. In these cases, conservative treatment is indicated, but should be ruled out ectopic pregnancy.

• In some rare cases have been described autoimmune diseases (abnormal response against the subject's own tissue), as scleroderma, LED (lupus erythematosus) or rheumatoid arthritis.

Precautions:

• Before starting the treatment with implants Jadelle must perform a medical history and a complete physical examination.

• The area where we have introduced the implants should examinársela at all visits. In case of occurrence of vaginal bleeding of unknown cause should see their doctor to take appropriate measures

• If you have a family history of breast cancer or benign breast lumps or mastopathy (a disease of the breast), monitoring should be a special form.

Procedures for major and minor surgery:

• Jadelle implants do not contain estrogen so their use, is contraindicated in surgery, pero, if there is a risk of thrombosis, your doctor will weigh whether to remove implants.

Pregnancy and lactation:

Consult your doctor or pharmacist before taking any medicine.

If you become pregnant during treatment with Jadelle, should remove implants. Levonorgestrel passes into breast milk, but in an amount not seem to affect child. However, should warn nursing mothers not to use Jadelle begin until the expiration of six weeks after delivery.

Driving and using machines:

Using Jadelle implants will not affect your ability to drive or operate machinery.

Taking other medicines:

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

– The drugs listed below should not be taken if you are using Jadelle implants:

• difenilhidantoína, carbamazepine, rifampin, St. John's Wort (Hypericum perforatum) . because they may decrease the effectiveness of implants Jadelle. This effect may persist at least two weeks after stopping treatment with St John's Wort. Por tanto, may be necessary to use a different contraceptive method for the duration of these treatments and even some time after.

– Jadelle implants can have an effect on the results of some laboratory tests.

3.USING JADELLE

Follow these instructions unless your doctor has given you different.

Jadelle is a subcutaneous contraceptive method for long-term (to 5 años). Jadelle implants may be removed at any time if desired.

After cleaning and anesthetizing the insertion site, your doctor will place the implants under the skin Jadelle.

It should help dry the area of insertion for 3 days (also after quitdayslos). The bandage can be removed as soon as the incision has healed, normally within 3-5 days.

To continue using this method, You can insert a new set of Jadelle implants after removal of previous implants, through the same incision.

When the implants have been removed, pregnancy can occur at any time.

For more detailed information on the procedure of inserting and withdrawing see paragraph 6 "Information of interest to the physician performing the insertion".

4. Possible adverse effects

Like all medicines, Jadelle can have side effects.

In clinical trials in Jadelle have been reported following adverse reactions:

SystemCommon undesirable effects: more 1/100

but less than 1/10 Users

Undesirable effects

rare: more

1/1.000 but less than

1/100 Users

Rare undesirable effects: more 1/10.000

but less than 1/1.000 Users

PsychiatricMood changes, depression, libido changes
NervousMigraine
CardiacPalpitations, chest pain
VascularHypertension, Varicose veins
RespiratoryDyspnoea (respiratory distress)
GastrointestinalAbdominal discomfort
HepatobiliarIncreased serum total bilirubin la
SkinAcne, Contact dermatitis, alopecia (lost by), hipertricosis (higher growth

hair or hair appearance

in areas previously devoid), exanthema (rash), itching, pigmentation changes

Renal and urinaryUrinary symptoms
Reproductive system and breastVaginitis, ovarian cysts, Benign breast lumps, secretion

mammary

General disorders and administration siteItching at the insertion site, pain

widespread, fatigue, back pain, weight loss

Pain at the insertion site, infection

the implant

Expulsion of implant, arm pain,

numbness, tingling and healing, difficulty

extraction

implant, ulnar nerve injury associated with implant removal, hyperpigmentation at the site of implantation

The expulsion of the implant is rare but can occur before the incision heals. The implant removed must be replaced by a new sterile implant.

Have been reported rare cases of cholestatic hepatitis, jaundice, bilirrubinemia (increased level of bilirubin).

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

5. JADELLE STORE

Jadelle Keep out of reach and sight of children. No special storage conditions required

Jadelle not use after the expiration date on the package.

This leaflet was approved in July 2003

Headline

Schering Spain, SA. Alvaro Mendez, 55

28045 Madrid - Spain

Manufacturer Schering Oy Pansiontie 47

20210 Turku – Finlandia

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