Lovima Contraceptive 75 Microgram Film-coated (Desogestrel) Lovima Contraceptive 75 Microgram Film-coated (Desogestrel)

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

Lovima like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Do not take Lovima:

• If you are pregnant or thing you may be pregnant. If you are unsure talk to your pharmacist.
• If you have thrombosis. 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'. Signs of a thrombosis include: severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially if you cough up blood.
• If you have of have had jaundice (yellowing of the skin) or severe liver disease and you have been told that your liver is still not working properly.
• If you have or are suspected of having cancer that grows under the influence of sex-steroids, such as certain types of breast, uterine, or ovarian cancer.
• If you have any unexplained vaginal bleeding.
• If you are allergic to desogestrel, peanut, soya, or any of the other ingredients of this medicine.

If any of these conditions apply to you, you should consult your doctor before using Lovima.

Warnings and precautions

Talk to your pharmacist, doctor, or family planning nurse before using Lovima:

• If you have ever had breast cancer
• If you have liver cancer or other liver problems
• If you have ever had a thrombosis
• If you have diabetes
• If you suffer from epilepsy
• If you suffer from tuberculosis
• If you have high blood pressure
• If you have or have had a chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposure to the sun or ultraviolet radiation

These are important conditions that your doctor may need to monitor carefully.

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

Tell your doctor or pharmacist if you notice any unwanted effect, especially if severe or persistent.

Serious side effects associated with the use of Lovima are described in section 2 'What you need to know before you take Lovima.' Please read this section for additional information on Thrombosis and Ectopic Pregnancy and consult your doctor immediately where appropriate.

You should seek medical advice immediately if you experience symptoms of angioedema (rapid swelling of area under skin or mucous membranes usually caused by an allergic reaction). Symptoms of angioedema include swollen face, tongue, or throat, difficulty in swallowing, or hives and difficulty in breathing.

Vaginal bleeding may occur at irregular intervals while using this medicine. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period. You may need to use tampons or sanitary towels. You may also not have any bleeding at all. After a few months of treatment bleeding tends to become less frequent or stop altogether.

Irregular bleeding is not a sign that Lovima is not working. In general, you do not need to take an action; just continue taking Lovima. If bleeding is frequent, heavy, or prolonged, or if you are worried by any changed in bleeding, you should talk to your doctor.

How often are other possible side effects seen?

Common (may affect up to 1 in 10 women): mood changes, depressed mood, decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no periods, weight increase.

Uncommon(may affect up to 1 in 100 women):infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful periods, ovarian cyst, tiredness.

Rare (may affect up to 1 in 1,000 women): skin conditions such as rash, hives, erythema nodosum (painful rounded blue-red skin lumps usually on the shin and ankles, or sometimes thighs or forearms). Breast secretion or leakage may occur.

Each blister strip of Lovima contains 28 tablets - 4 weeks supply. One tablet should be taken each day at the same time without a break between packs.

The days of the week and arrows are printed on the blister strip indicating the order in which to take the pills. Each day corresponds to one tablet.

Every time you start a new pack of Lovima, take a tablet from the top row. Don't start with just any tablet. For example if you start on a Wednesday, you must take the tablet from the top row marked with 'WED'.

How you first start taking Lovima will depend on whether you have previously used other contraception or if you have recently been pregnant. You may also need to use additional contraception for the first 7 days.

Read the contained information leaflet carefully to see which applies to you.

If you are not sure what to do, talk to your pharmacist.

If you are starting or resuming Lovima following emergency contraception:

Ask your pharmacist for advice on how to start taking or resume taking Lovima following emergency contraception. If you have taken emergency contraception, it is advisable to wait until day 1 of your next menstrual cycle before taking Lovima.

• Emergency contraception containing levonorgestrel can be used with Lovima. If you want to start taking or continue taking Lovima after using emergency contraception containing levonorgestrel, you can start or continue taking Lovima the same day. You need to use additional barrier contraception (condom) for the next 7 days.
• Using Lovima and emergency contraception containing ulipristal acetate together can alter the effect of both medicines, resulting in reduced contraceptive effect and increased risk of pregnancy. If you have used emergency contraception containing ulipristal acetate during your cycle, you must wait 5 days after taking ulipristal acetate before taking Lovima. You need to use additional barrier contraception (condom) for 5 days after taking ulipristal acetate while you wait to start or resume taking Lovima and then for the first days after starting Lovima (for a total of 12 days).

If you are not using hormonal contraception at present or have not used it in the past month:

• Wait for your period to begin and start taking Lovima on the first day of your period. You do not need additional contraception.
• You can also start on day 2-5 of your period. You need to use additional barrier contraception (condom) for 7 days.

If you are changing from a combined pill (COC):

• Start taking Lovima on the day after the last active tablet from your present pill pack. Some COC pack have inactive pills so if you are not sure what is the last active tablet, check with the pharmacist. You do not need additional contraception.
• If there is a break between when you took your last COC pill and when you start taking Lovima (i.e. you do not start taking Lovima the day immediately after taking the last active tablet), you need to use additional barrier contraception (condom) for 7 days.

If you are changing from a vaginal ring or transdermal patch:

• Start taking Lovima on the day your vaginal ring or patch is removed. You do not need additional contraception.
• If there is a break between removal of your ring or patch before you start taking Lovima (i.e. if you do not take it on the same day), you need to use additional barrier contraception (condom) for 7 days.

If you are changing from another progestogen-only pill (mini-pill) including another desogestrel mini-pill which your doctor may have prescribed for you:

• Start taking Lovima without a break. You do not need additional contraception.

If you are changing from an injection or implant or hormonal IUS:

• Start taking Lovima when your next injection is due or on the day your implant or IUS is removed. You do not need additional contraception.

If you have recently given birth and your period has not started again:

• You can start Lovima before your period starts.
• If you start taking Lovima more than 21 days after giving birth, you need to use additional contraception (condom) for 7 days. If you have had sex check that you are not pregnant before taking Lovima.
• If your period has started again, refer to section 'If you are not using hormonal contraception at present or have not used in the past month'.

If you have recently had a miscarriage or abortion:

• Start taking Lovima immediately or within 5 days after a miscarriage or abortion. You do not need additional contraception.

The active substance is desogestrel (75 microgram).

The other ingredients are: lactose monohydrate, maize starch, povidone K30 (E1201), d-a-tocopherol (E307), soybean oil, silica, colloidal hydrated (E551), silica, colloidal anhydrous (E551), stearic acid (E570), Hypromellose 2910 (E464), polyethylene glycol, titanium dioxide (E171).