FEANOLLA 75 MICROGRAMSFILM-COATED TABLETS - patient leaflet, side effects, dosage

Tell your doctor before you start to use Feanolla if any of these conditions apply to you. Your doctor may advise you to use a non-hormonal method of birth control.

Thrombosis

See your doctor immediately, if you notice possible signs of a thrombosis (see also ‚Regular Check-ups‘).

Consult your doctor immediately if any of these conditions appear for the first time while using Feanolla.

Warnings and precautions

Talk to your doctor before using Feanolla, if

• you have ever had cancer of the breast.
• you have liver cancer, since a possible effect of Feanolla cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines and Feanolla').
• you suffer from tuberculosis (see section ‘Other medicines and Feanolla').
• you have high blood pressure.
• you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the lace); if so, avoid too much exposure to the sun or ultraviolet radiation.

When Feanolla is used in the presence of any of these conditions, you may need to be kept under close observation. Your doctor can explain what to do.

Breast cancer

Regularly check your breasts and contact your doctor as soon as possible if you feel any lump in your breasts.

Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, the risk gradually decreases, so that 10 years after stepping the risk is the same as for women who have never taken the Pill. Breast cancer is rare under 40 years of age but the risk increases as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to take the Pill when she is older. How long she takes the Pill is less important.

Thrombosis is the formation of a blood clot which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called “pulmonary embolism”. As a result, fatal situations may occur. Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills, like Feanolla, is believed to be lower than in users of Pills that also contain oestrogens (combined Pills).

Psychiatric disorders

Some women using hormonal contraceptives including Feanolla have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

Children and adolescents

No clinical data on efficacy and safety are available in adolescents below 18 years.

Other medicines and Feanolla

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines or herbal products. Also tell any other doctor or dentist who prescribes another medicine (or your pharmacist) that you take Feanolla. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long or whether the use of another medicine you need must be changed.

If you are taking medicines or herbal products that might make Feanolla less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Feanolla may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive method for that long. Your doctor can tell you if you need to take additional contraceptive precautions and if so, tor how long.

Feanolla may also interfere with how other medicines work, causing either an increase in effect (e.g. medicines containing ciclosporine) or a decrease in effect (e.g. lamotrigine).

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy and breast-feeding

Pregnancy

Do not use Feanolla if you are pregnant, or think you may be pregnant.

Breast-feeding

Feanolla may be used while you are breast-feeding. Feanolla does not appear to influence the production or the quality of breast milk. However, there have been infrequent reports of a decrease in breast milk production while using Feanolla. A small amount of the active substance of Feanolla passes over into the milk.

The health of children breast-fed for 7 months whose mothers were using desogestrel has been studied up to 2.5 years of age. No effects on the growth and development of the children were observed.

If you are breast-feeding and want to use Feanolla, please contact your doctor.

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Do not take Feanolla

• if you are allergic to desogestrel, soya, peanut or any of the other ingredients of this medicine (listed in section 6).
• if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the

■■■tegs (deep venous thrombosis)or1he­tungs--------------

(pulmonary embolism)).

• if you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver function is still not normal.
• if you have or if you are suspected of having a cancer that grows under the influence of sex-steroids, such as certain types of breast cancer.
• if you have any unexplained vaginal bleeding.

In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be Tess than T extra case of breast cancer found up to 10 years after stopping, in addition to tlte 4 cases normally diagnosed in this age group. Likewise; in 10,000 women who take the Pill tor up to 5 years bqrt stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed. In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.

The risk of breast cancer in users of progestogen-only pills like Feanolla is believed to be I similar to that in women who use' the Pni. 'but the: evidence is less conclusive. i

Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women who do not take the Pill. It is not known whether the difference in breast cancer risk isicaused by the Pill. It may be that the women were examined more often, so that the breast cancer is noticed earlier.

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Some medicines:

• - can have an influence on the blood levels of Feanolla.

• - can make it less effective In preventing pregnancy.

• - can cause unexpected bleeding.

These include medicines used for the treatment of:

• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital);
• tuberculosis (e.g. rifampicin, rifabutin);
• HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (e.g. boceprevir, telaprevir);
• or other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (the herbal remedy St. John's wort);
• certain bacterial infections (e.g. clarithromycin, erythromycin);
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole);
• high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).

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Driving and using machines

There are no indications of any effect of the use of on alertness and concentration.

Feanolla contains lactose and soya oil

Feanolla contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you are allergic to peanut or soya, do not use this medicinal product.

Regular check-ups

When you are using Feanolla, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation.

Contact your doctor as soon as possible if:

• you have severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possibly a sign of a thrombosis).
• you have a sudden, severe stomach ache or look jaundiced (possibly a sign of liver problems);

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• you feel a lump in your breast (possibly a sign of breast cancer);
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of an ectopic pregnancy, this is a pregnancy outside the womb);
• you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you suspect that you are pregnant.

You may stop taking it any day and start taking Feanolla right away. You need not take extra contraceptive precautions.

• When changing from an injection or implant or a progestogen-releasing intrauterine system (IUS) Start using Feanolla when your next injection is due or on the day that your implant or your IUS is removed. You need not take extra contraceptive precautions.
• After having a baby

You can start Feanolla between 21 and 28 days after the birth of your baby. If you start later, make sure that you use an additional barrier method of contraception until you have completed the first 7 days of tablet-taking.

However, if intercourse has already occurred, pregnancy should be excluded before starting Feanolla use. Additional information for breastfeeding women can be found in ‚Pregnancy and Breast-feeding‘ in section 2. Your doctor can also advise you.

• After a miscarriage or a premature termination of pregnancy

Your doctor will advise you.

If you forget to take Feanolla

If you are less than 12 hours late in taking a tablet, the reliability of Feanolla is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual times.

If you are more than 12 hours late in taking any tablet, the reliability of Feanolla may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and take the next tablets at the usual times. Use an additional contraceptive method (barrier method) too for the next 7 days of tablet-taking. If you missed one or more tablets in the very first week of tablet-intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice.

If you suffer from gastro-intestinal disturbances (e.g. vomiting, severe diarrhoea)

Follow the advice for missed tablets in the section above. If you vomit within 3 – 4 hours after taking your Feanolla tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.

If you take more Feanolla than you should

There have been no reports of serious harmful effects from taking too many Feanolla tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight vaginal bleeding. For more information ask your doctor tor advice.

If you stop taking Feanolla

You can stop taking Feanolla whenever you want. From the day you stop you are no longer protected against pregnancy.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Feanolla can cause side effects, although not everybody gets them.

You should see your doctor immediately if you experience symptoms of angioedema, such as (I) swollen face, tongue or pharynx; (II) difficulty to swallow; or (Hi) hives and difficulties to breathe.

The other ingredients are: maize starch, povidone K30, d-a-tocopherol, silica, colloidal anhydrous, silica, colloidal hydrated, stearic acid, hypromellose, polyethylene glycol, titanium dioxide (E 171), lactose monohydrate, soya oil (see also "Feanolla contains lactose and soya oil” in section 2).

Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Marketing Authorisation Holder

Lupin Healthcare (UK) Limited

The Urban Building, 2nd Floor 3–9 Albert Street, Slough, Berkshire, SL1 2BE, United Kingdom

Manufacturer

Laboratorios Leon Farma, S.A.

Pol. Ind. Navatejera.

C/ La Vallina s/n

24008 – Navatejera, Leon.

Spain

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Feanolla 75 microgram film-coated tablets

Austria: Desirett 75 Mikrogramm Filmtabletten

Belgium: Deliges 75 mcg

Gemany: Feanolla 75 Mikrogramm Filmtabletten

Luxembourg: Deliges 75 mcg

This leaflet was last revised in August 2020.

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