Desogestrel 75 Microgram Film-Coated Tablets
PATIENT INFORMATION SHEET: INFORMATION FOR THE USER
Desogestrel 75 microgram film-coated tablets Desogestrel
Read this entire leaflet carefully before you start taking the medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally. It is not suitable for all women, so you should not give it to anyone else as it may harm them.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist._
In this leaflet:
1. What Desogestrel is and what it is used for
2. Before you take Desogestrel
3. How to take Desogestrel
4. Possible side effects
5. How to store Desogestrel
6. Further information
1. WHAT Desogestrel IS AND WHAT IT IS USED FOR
Desogestrel is used to prevent pregnancy. Desogestrel contains a small amount of one type of female sex hormone, the progestogen de sogestrel. For t his reason Desogestrel is called a progestogen-only-pill (POP), or a mini-pill.
Contrary to the combined pill, the POP or mini-pill do es no t c ontain a n oe strogen hormone next to the progestogen.
Most P OPs or m inipills w ork p rimarily b y preventing the sp erm cells from entering the w omb but do no t a lways pr event t he egg cell from ripening, which is the primary action of c ombined pi lls. Desogestrel is distinct from o ther m ini-pills in h aving a dose that in m ost c ases i s hi gh e nough to prevent t he eg g ce ll f rom r ipening. As a result, Desogestrel provides hi gh contraceptive ef ficacy. In co ntrast to t he combined pill, Desogestrel can be used by women who do not tolerate oestrogens and by women who are breastfeeding.
A d isadvantage i s that vaginal b leeding may occur at irregular intervals during the use of Desogestrel. You also may not have any bleeding at all.
2. BEFORE YOU TAKE Desogestrel
Desogestrel, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not take Desogestrel
• If you a re a llergic to any of t he ingredients of Desogestrel.
• If you ha ve a t hrombosis. T hrombosis is the f ormation of a b lood c lot i n a blood v essel ( e.g. of the legs (deep venous t hrombosis) o r t he l ungs (pulmonary embolism)).
• If y ou ha ve or ha ve h ad jaundice (yellowing of the sk in) or sev ere liver disease and your l iver f unction i s st ill not normal.
• If you have or are suspected to have a cancer that is sensitive to progestogens, such as certain types of breast cancer.
• If you ha ve a ny une xplained v aginal bleeding.
• If you are allergic to peanut or soya.
Tell y ou doc tor b efore y ou s tart to us e Desogestrel if any of these conditions apply to you. Y our doctor may advise you to use a non-hormonal method of birth control.
Consult your doctor immediately if any of these conditions a ppear for t he f irst time while using Desogestrel.
Take special care with Desogestrel
Tell your doctor before you start to use Desogestrel, if
• you have ever had cancer of the breast.
• you h ave l iver can cer, s ince a p ossible effect o f Desogestrel cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you su ffer f rom ep ilepsy (see se ction ‘Taking other medicines’).
• you suffer from tuberculosis ( see section ‘Taking other medicines’).
• you have high blood pressure.
• you ha ve or ha ve ha d c hloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposure to the sun or ultraviolet radiation.
When Desogestrel is used in the presence of any of these conditions, you may need to be kept unde r c lose obs ervation. Y our doctor can explain what to do.
Desogestrel and breast cancer
Regularly ch eck y our b reasts an d co ntact your doctor as soon as possible if you feel any lump in your breasts. Breast cancer has been found s lightly m ore often i n women who t ake t he P ill t han i n w omen of t he same a ge w ho do not take th e P ill. If women s top t aking t he P ill, the r isk gradually decreases, so that 10 years after stopping the risk is the same as for women who ha ve ne ver taken the P ill. B reast cancer is rare under 40 years of age but the risk increases as t he w oman g ets o lder. Therefore, t he e xtra nu mber of br east cancers diagnosed is higher if the age until which the woman continues to take the Pill is higher. How long she takes the Pill is less important.
In every 10 000 w omen who take the Pill for up to 5 y ears but stop taking it by the age of 20, there would be less than 1 e xtra case o f breast cancer found up to 1 0 ye ars after s topping, i n a ddition t o t he 4 cases normally di agnosed i n t his age gr oup. Likewise, in 10 000 w omen w ho t ake t he Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in a ddition t o t he 44 c ases n ormally diagnosed. In 10 000 w omen 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 t o the 160 c ases no rmally diagnosed.
The r isk o f b reast cancer i n u sers progestogen-only pills lik e Desogestrel is believed to be similar to that in women who use t he P ill, but t he e vidence i s less conclusive.
Breast c ancers found i n w omen who take the Pill, seem less likely to have spread than breast cancers found in women who do not take t he P ill. It is n ot known whether t he difference in breast cancer risk is caused by the P ill. It may be that the w omen were examined m ore of ten, s o t hat t he br east cancer is noticed earlier.
Desogestrel and thrombosis
See your doctor immediately, if you notice possible s igns of at hrombosis ( see also 'Regular C heck-ups') T hrombosis is t he formation of a blood clot which may block a bl ood v essel. A t hrombosis s ometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks away from the v eins where it is f ormed, it m ay reach a nd b lock t he arteries o f the l ungs, 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. T he r isk is higher i n Pill-users than i n non -users. T he r isk w ith progestogen-only pills, like Desogestrel, is believed to be lower than in users of Pills that a lso c ontain oestrogens ( combined Pills).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines or h erbal products, including medicines obt ained w ithout a prescription. Some medicines may stop Desogestrel from working properly.
These i nclude m edicines u sed f or the treatment of e pilepsy ( e.g. pr imidone, phenytoin, c arbamazepine, oxc arbazepine, felbamate an d P henobarbital) o r tuberculosis (e.g. r ifampicin), H IV
Regular check-ups
While y ou a re us ing Desogestrel you
should see y our d octor r egularly at least
twice a year.
Contact your doctor as soon as possible if:
• you h ave se vere p ain or sw elling i n either of your legs, unexplained pains in the ch est, b reathlessness, an u nusual cough, especially w hen you cough up blood ( possibly i ndicating a thrombosis).
• you h ave a su dden, sev ere s tomach ache or l ook j aundiced (possibly indicating liver problems);
• you feel a lump in your breast (possibly indicating breast cancer);
• you have a sudden or severe pain in the lower abdomen or s tomach a rea (possibly i ndicating an e ctopic pregnancy, this is a pregnancy outside the womb);
• you are to be immobilised or are to have s urgery ( consult yo ur d octor a t least four weeks in advance);
• you ha ve unus ual, he avy v aginal bleeding;
• you suspect that you are pregnant.
infections (e.g. ritonavir) or other infectious diseases (e.g. g riseofulvin), s tomach ups et (medical ch arcoal), d epressive moods (the herbal remedy St John's wort).
Your doctor can tell you if you need to take additional c ontraceptive precautions and i f so, for how long.
Desogestrel may al so interfere w ith h ow certain m edicines w ork, c ausing e ither an increase in effect (e.g. medicines containing cyclosporine) or a decrease in effect.
Pregnancy and breast-feeding
Pregnancy
Do not use Desogestrel if you are pregnant, or think you may be pregnant.
Breast-feeding
Desogestrel may be us ed w hile y ou a re breast-feeding. Desogestrel does no t influence the production or the quality of breast m ilk. H owever, a s mall a mount of the active su bstance o f Desogestrel passes over into the milk.
The he alth of c hildren br east-fed fo r 7 months w hose m others w ere u sing Desogestrel has b een studied up to 2.5 years of age. No effects on the growth and development of the children were observed.
If you are b reast-feeding a nd w ant to us e Desogestrel, please contact your doctor.
Driving and using machines
There are no indications of any effect of the use o f Desogestrel on al ertness a nd concentration.
Important information about some of the ingredients of Desogestrel
Desogestrel contains lactose (milk sugar) and soy bean oil.
If you ha ve be en t old by y our doc tor t hat you have an intolerance to some sugars, contact y our doc tor be fore t aking t his medicinal product.
If you are allergic to peanut or soya, do not use this medicinal product.
Use in adolescents
No clinical data on effectiveness and safety are available in adolescents below 18 years.
3. HOW TO TAKE Desogestrel
When and how you should take Desogestrel
The Desogestrel pack co ntains 2 8 t ablets. The days of t he w eek a re pr inted i n the blister a nd a lso ar rows ar e p rinted indicating the order to take the pills. Each day correspond with one tablet. Every time you start a new pack of Desogestrel, take a tablet from the t op r ow. D on’t s tart with just any tablet. For example if you start on a Wednesday, you must take the tablet from the t op r ow marked with ‘ WED’ (Wednesday). Continue to take one tablet a day u ntil t he p ack i s em pty, al ways following t he di rection i ndicated by t he arrows. By looking at the pill pack you can easily ch eck if y ou h ave already t aken a tablet on a particular day. T ake your tablet each day at about the same time.
Swallow the tablet whole, with water. Y ou may have some bleeding during the use of Desogestrel, but you must continue to take your tablets as n ormal. Wh en a p ack is empty, y ou must s tart w ith a new p ack of Desogestrel on the next day - thus without interruption a nd w ithout w aiting f or a bleed.
When to start with the first strip Desogestrel
When no hormonal contraceptive has been used in the past month
Wait for your period to begin. On the first day of your period take the first Desogestrel tablet. Y ou ne ed n ot t ake e xtra contraceptive precautions.
You m ay also st art on d ays 2-5 of y our cycle, but in that case make sure you also use a n additional c ontraceptive m ethod (barrier method) fo r t he fi rst 7 days of tablet-taking.
When you change from a combined pill, vaginal ring, or transdermal patch
You can start taking Desogestrel on the day after y ou t ake t he l ast tablet f rom t he present P ill pa ck, or on t he l ast da y of removal of your vaginal ring or patch (this means no tablet-, ring- or patch-free break). If your pr esent P ill pa ck a lso contains inactive tablets you can start Desogestrel on the day after taking the last active tablet (if you a re no t sure w hich this is, a sk y our doctor or pharmacist). If you follow these instructions, y ou ne ed not t ake e xtra contraceptive precautions.
You can al so s tart a t th e la test th e d ay following t he t ablet-, r ing-, pa tch-free break, o r p lacebo t ablet interval, o f y our present c ontraceptive. I f you f ollow these instructions, m ake s ure y ou us e a n additional c ontraceptive m ethod (barrier method) for the first 7 days of tablet-taking.
When changing from another progestogen-only (mini-pill)
You may stop taking it any day and start taking Desogestrel right a way. Y ou need not take extra contraceptive precautions.
When changing from an injectable or implant or a progestogen-releasing intrauterine device (IUD)
Start u sing Desogestrel when y our ne xt injection is due or on t he da y t hat y our implant or your IUD is removed. Y ou need not take extra contraceptive precautions.
After having a baby
You can start Desogestrel between 21 a nd 28 days after the birth of your baby. If you start l ater, m ake s ure y ou us e dur ing t he first cy cle an ad ditional contraceptive method (barrier method) for the first 7 days of tablet-taking.
However, i f i ntercourse h as al ready occurred, p regnancy s hould be e xcluded before starting Desogestrel use. Additional information fo r breast-feeding w omen 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 Desogestrel
If you are less than 12 hours late in taking a ta blet, th e r eliability o f Desogestrel is maintained. Take the missed tablet as soon as you remember and take the next tablets at the usual times.
If y ou a re more than 12 hours late i n taking a ny ta blet, th e r eliability o f Desogestrel may b e r educed. The m ore consecutive tablets you have missed, the higher t he r isk t hat t he co ntraceptive efficacy is decreased. T ake the last missed tablet as soon as you remember and take the next tablets at t he usual times. U se an additional c ontraceptive m ethod ( barrier method) too for the ne xt 7 d ays of tablettaking. If you missed one or more tablets in the first w eek o f tablet-intake a nd ha d intercourse in the week before missing the tablets, there is a p ossibility of b ecoming 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 or use medical charcoal within 3 - 4 hours after taking your Desogestrel tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.
If you take more Desogestrel than you should
There a re no m entions of s eriously damaging r esults of t aking t oo many Desogestrel pills simultaneously. Should you ha ve t aken a nu mber of pi lls simultaneously, y ou m ay s uffer from nausea, v omiting or v aginal b lood loss. I f you find out that a child has taken multiple pills, contact your doctor for advice.
If you stop taking Desogestrel
You can stop taking Desogestrel whenever you want. From the day you stop you are no longer protected against pregnancy.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Desogestrel can cause side e ffects, a lthough not e verybody gets them. Serious undesirable affects associated with the us e of Desogestrel are described the p aragraphs " Breast C ancer" an d "Thrombosis" in section 2 “Before you take Desogestrel” P lease r ead this se ction for additional information and consult y our doctor at once where appropriate.
Vaginal b leeding m ay o ccur a t i rregular intervals during the use of Desogestrel. This may be j ust slight staining which may not even r equire a p ad, or heavier bleeding,
which looks rather like a scanty period and requires sanitary protection. You may also not have any bleeding at all. The irregular bleedings are n ot a sign t hat t he contraceptive pr otection o f Desogestrel is decreased. I n general, y ou ne ed not t ake any a ction; just c ontinue to t ake Desogestrel. If, however, bleeding is heavy or prolonged consult your doctor.
• Common side effects (affects 1 to 10 users in 1 00) are: mood a ltered, decreased s exual d rive ( libido), headache, nausea, acn e, b reast pain, irregular or no m enstruation, i ncreased body weight.
• Uncommon side effects (affects 1 to 10 users in 1,000) are: infection of t he vagina, d ifficulties in w earing co ntact lenses, v omiting, ha ir l oss, pa inful menstruation, ovarian cyst, tiredness.
• Rare side effects (affects 1 to 10 users in 10,000) are: rash, hives, painful blue-red skin lumps (erythema nodosum). These are skin conditions.
Apart from t hese s ide ef fects, b reast secretion may occur.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, pl ease t ell y our doc tor or pharmacist.
5. HOW TO STORE Desogestrel
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Desogestrel after the expiry date which is stated on the carton after ”Do not use after:” or “ EXP:”. T he E xpiry da te refers to the last day of that month.
Medicines s hould no t be di sposed of v ia wastewater o r household waste. Ask your pharmacist how to dispose of medicines no longer r equired. These m easures w ill h elp to protect the environment.
6. FURTHER INFORMATION
What Desogestrel contains
The active substance is: desogestrel (75 microgram)
The o ther i ngredients ar e: lactose monohydrate, maize starch, povidone K30, d-a-tocopherol, soybean oil, silica, colloidal anhydrous, silica, colloidal hydrated, stearic acid, hypromellose, pol yethylene g lycol, titanium di oxide (E 1 71) (see a lso "Important information about s ome of the ingredients of Desogestrel" in section 2).
What Desogestrel looks like and content of the pack
One blister pack of Desogestrel contains 28 white round f ilm-coated t ablets. E ach carton contains 1, 3 or 6 blisters.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Leon Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n 24008 - Navatejera, Leon.
Spain
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 S tates of t he EEA unde r the following names:
This leaflet was last approved on 08/2013
6
Desogestrel 75 mcg
UK/H/3416-8, 4784/001/DC