75 microgram film-coated tablets
desogestrel
What Zarelle is and what it is used for
Zarelle is used to prevent pregnancy.
Zarella contains small amounts of a type of female sex hormone, gestagen et desogestrel. Therefore, Zarella is included in the progestogen pill category.
In contrast to combined oral contraceptives, these contain no estrogen.
Most progestogen contraceptives work primarily by preventing sperm from reaching the uterus, but they do not always prevent eggs from maturing, which is the main effect of combined contraceptives. Zarelle also differs from most other progestogen birth control pills in that it is considered an intermediate -dose progestogen – that is, the progestogen dose is high enough to prevent the egg cells from maturing in the vast majority of cases. Therefore, Zarelle provides good protection against pregnancy.
Unlike combined oral contraceptives, Zarelle can be used by women who cannot tolerate estrogen or by women who are breastfeeding.
A disadvantage is that irregular bleeding can occur when using Zarelle. You may also not have any bleeding at all.
The desogestrel contained in Zarelle may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Zarelle
Like other hormonal contraceptives, Zarelle does not protect against HIV infection (AIDS) or other sexually transmitted diseases. Do not use Zarelle:
- if you are allergic to desogestrel or any of the other ingredients of Zarelle (listed in section 6).
- if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, for example in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism ).
- if you have or have had jaundice (yellowing of the skin) or serious liver disease and your liver function is still not normal.
- if you have or are suspected of having cancer that is sensitive to sex hormones, such as certain types of breast cancer.
- if you have unexplained vaginal bleeding.
- if you are allergic to peanuts or soy.
Talk to your doctor before you start taking Zarelle if any of the above applies to you. He or she can then possibly recommend a contraceptive method that does not contain hormones. Contact your doctor immediately if any of these conditions appear for the first time while you are using Zarelle.
Warnings and precautions
Talk to your doctor before you start taking Zarelle if:
- you have had breast cancer.
- you have liver cancer, as a possible effect of Zarelle on liver cancer cannot be excluded.
- you have had a blood clot in a vessel.
- you have diabetes.
- you have epilepsy (see the section “Other medicines and Zarelle”).
- you have tuberculosis (see the section “Other medicines and Zarelle”).
- you have high blood pressure.
- you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face) – in such cases, you should avoid too much sunlight and ultraviolet rays.
If you use Zarelle and at the same time have any of the above conditions, you may need to go for extra checks. Your doctor can explain this to you.
Mental disorders:
Some women using hormonal contraceptives, including Zarelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.
Breast cancer
Check your breasts regularly and contact your doctor as soon as possible if you notice a lump in one of the breasts. Breast cancer has been detected slightly more often in women who use birth control pills than in women of the same age who do not. If a woman who uses birth control pills stops taking the pills, the risk gradually decreases so that after 10 years it is the same as in women who have never used birth control pills. Breast cancer is rare in women under 40, but the risk increases with age. The extra number of cases of breast cancer that are diagnosed therefore becomes higher the higher in age the woman uses birth control pills. How long the woman has been using birth control pills is less important.
For every 10,000 women who use the pill for up to five years and who stop at age 20, there will be less than 1 extra case of breast cancer up to 10 years after treatment ends, in addition to the 4 cases normally diagnosed in this age group. Similarly, for 10,000 women who have used the pill for up to 5 years and who stop at age 30, 5 extra cases will be detected in addition to the 44 cases that are normally diagnosed. In 10,000 women who have used the pill for up to 5 years and stopped at the age of 40, 20 extra cases will be detected in addition to the 160 that are normally diagnosed.
The risk of breast cancer in women using progestagen oral contraceptives such as Zarelle is thought to be comparable to the risk in women using combined oral contraceptives, but the evidence is not as strong.
The risk of spread appears to be less in breast cancer detected in women taking birth control pills than in breast cancer detected in women not taking birth control pills. It is unknown whether the difference in breast cancer risk is caused by the pill or not. It may be that women who use birth control pills are examined more often so that breast cancer is detected earlier.
Blood clots ( thrombosis )
Contact your doctor immediately if you notice anything that may indicate a blood clot (read more under “Regular check-ups”). Thrombosis means that a blood clot forms, which can block a blood vessel. Thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If such a blood clot detaches from the vein where it has formed, it can be transported to the arteries in the lungs and there cause a so-called pulmonary embolism. Pulmonary embolism can be a life-threatening condition. Deep vein thrombosis is rare and can occur whether or not you are on the pill. It can also occur during pregnancy. The risk is higher for those who use birth control pills than for those who don’t. The risk with progestagen birth control pills, such as Zarelle, is considered to be lower than with birth control pills that also contain estrogen (combined birth control pills ).
Children and young people
No data are available regarding efficacy and safety in adolescents under 18 years of age.
Other medicines and Zarelle
Tell your doctor if you are taking, have recently taken, or might take any other medicines or (traditional) herbal medicines. Also, tell other doctors and dentists who prescribe medicines (or pharmacists) that you are taking Zarelle. They can tell you if you need to use additional contraception (for example condoms) and if so for how long, or if the use of any other medicine you need needs to be changed.
Certain medicines
- can affect the levels of Zarelle in the blood
- may make the medicine less effective in preventing pregnancy
- may cause unexpected bleeding.
This includes medicines used in the treatment of:
- epilepsy (eg primidone, phenytoin , carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital),
- tuberculosis (eg rifampicin, rifabutin),
- HIV – infection (eg ritonavir, nelfinavir, nevirapine, efavirenz),
- Hepatitis C virus infections (eg boceprevir, telaprevir),
- other infectious diseases (e.g. griseofulvin),
- high blood pressure in the blood vessels of the lungs ( bosentan ),
- depression ((traditional) herbal medicines containing St. John’s wort [Hypericum perforatum]),
- certain bacterial infections (eg clarithromycin, erythromycin),
- fungal infections (eg ketoconazole , itraconazole, fluconazole ),
- high blood pressure ( hypertension ), angina (angina), or certain heart rhythm disorders (e.g. diltiazem ).
If you use medicines or (traditional) herbal medicines that can make Zarelle less effective, a barrier method should be used as a supplement. Since the effect of another drug on Zarelle can remain for up to 28 days after the end of treatment with the drug, it is necessary to use a barrier method throughout this time. Your doctor can tell you if you need additional protection and if so for how long.
Zarelle can also affect the effectiveness of other medicines, either by increasing the effect (e.g. medicines containing ciclosporin) or reducing the effect (e.g. lamotrigine). Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy, and breastfeeding
Pregnancy
Do not use Zarelle if you are pregnant or if you suspect that you are pregnant.
Breast-feeding
Zarelle can be used while breastfeeding. Zarelle does not seem to affect the production or quality of breast milk. However, isolated reports have described a decrease in breast milk production while using Zarelle. A small amount of the active substance in Zarelle passes into breast milk.
The health of children who have been breastfed for 7 months and whose mothers have used Zarelle during breastfeeding has been studied until the children are 2.5 years old. No effects on the children’s growth and development were detected.
Talk to your doctor if you are breastfeeding and want to use Zarelle.
Driving ability and use of machinery
There is no indication that Zarelle affects the degree of alertness or the ability to concentrate.
Zarelle contains lactose (milk sugar) and soybean oil.
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
Do not use this medicine if you are allergic to peanuts or soya.
| Regular checks while using Zarelle, you will need to have regular check-ups with your doctor. How often you need to go for a check-up and what the checks include varies from person to person. Contact your doctor as soon as possible if: you get severe pain or swelling in one of the legs, unexplained chest pain, breathing difficulties, and unusual cough, especially if you cough up blood (this may be a sign of a blood clot ( thrombosis )). if you suddenly have severe stomach pain or if you develop yellow skin or yellow whites of the eyes (may indicate jaundice, which is a liver disease).if you notice a lump in the breast (which may be a sign of breast cancer).if you get sudden or severe pain in the lower abdomen, which may be a sign of ectopic pregnancy (pregnancy outside the womb).if you are going to be bedridden for a long period or have an operation (talk to your doctor at least four weeks before the operation).if you have unusual, heavy bleeding from the vagina.if you suspect you are pregnant. |
How to take Zarelle
Mode of administration
Zarelle is to be swallowed.
When and how to take Zarelle
Each card with Zarelle contains 28 tablets. On the tablet map, there are printed days of the week and arrows showing the order in which you should take the tablets. Each tablet corresponds to one day of the week. Each time you start a new map of Zarelle, take a tablet from the top row. Don’t start with any tablet on the map. For example, if you start on a Wednesday, take the tablet in the top row marked “Ons” (Wednesday). Then continue to take one tablet per day until the chart is empty, always following the direction of the arrows. You can always easily see if you have already taken your tablet by looking at the back of the tablet map. Take your tablets at about the same time each day.
The tablets should be swallowed whole with water. You may have bleeding while using Zarelle, but you should continue to take the tablets as usual. When a map is finished, you must continue with a new tablet map with Zarelle the next day – that is, without any tablet break and without waiting for bleeding.
The first tablet map with Zarelle
If you have not used any hormonal contraceptives in the last month
Wait until menstruation begins. On the first day of menstruation, take the first Zarelle tablet. If you do it this way, you don’t need to use any extra contraception.
You can also take the first tablet on days 2-5 of your period, but then you must use extra contraception (eg condoms) for the first seven days.
If you change from a combined birth control pill, birth control ring, or birth control patch
You can take the first Zarelle tablet the day after you take the last tablet of a combination pill map, or on the same day, you take out your contraceptive ring or remove your contraceptive patch (this means that you should not have a tablet-free, ring- or patch-free week). If your previous pill chart contains both active and hormone-free tablets, you can take the first Zarelle tablet the day after you took the last active tablet (if you are not sure which tablet it is, ask your doctor or pharmacist). If you follow these instructions, you do not need to use any additional contraception.
You can also start no later than the first day after the pill-free, ring-free, or patch-free period with your previous contraceptive, but then you must use an additional method of contraception (e.g. a condom) for the first seven days.
If you are switching from another progestogen pill
You can stop progestagen birth control pills and start Zarelle any day. You do not need to use any additional contraception.
If you change from a birth control syringe, birth control stick, or hormonal coil
Start Zarelle on the day you would have had your next contraceptive injection or on the day your contraceptive rod or hormonal coil is removed. You do not need to use any additional contraception.
If you have just given birth
You can start taking Zarelle between 21-28 days after delivery. If you start later, you must use an additional form of contraception (eg a condom) for the first seven days that you take the tablets.
If you have had sexual intercourse, you must make sure you are not pregnant before starting Zarelle. Information about breastfeeding can be found under the heading ‘Pregnancy and breastfeeding’ in section 2. Your doctor can also give you advice.
If you have just had a miscarriage or an abortion
If you have taken too much Zarelle
There are no reports of serious adverse effects from taking multiple Zarelle tablets at one time. If you take several tablets at the same time, you may experience symptoms such as nausea, vomiting, and (in young women) minor vaginal bleeding. Talk to your doctor if you want more information.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zarelle
If you are less than 12 hours late with your tablet, you are still protected against pregnancy. Take the forgotten tablet as soon as you remember and then take the next tablet at the usual time.
If you are more than 12 hours late with your tablet, the protection against pregnancy may be reduced. The more consecutive tablets you forget, the more the protection deteriorates. Take the (last) missed tablet as soon as you remember and then take the following tablets at the usual time. Use an additional form of contraception (e.g. condom) for the next 7 days. If you have forgotten to take one or more tablets during the very first week of treatment and you have had intercourse in the week before you forgot one or more tablets, there is a risk that you have become pregnant. Ask your doctor for advice.
If you get stomach problems (such as vomiting or severe diarrhea)
Follow the advice given on forgotten tablets above. If you vomit or use medicinal charcoal within 3-4 hours of taking a Zarelle tablet or if you have severe diarrhea, the active substance may not be absorbed by the body.
If you stop taking Zarelle
You can stop taking Zarelle at any time. From the day you stop taking the tablets, you are no longer protected against pregnancy.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects that have been associated with the use of Zarelle are described under the headings “Breast cancer” and “Blood clots ( thrombosis )” in section 2: “What you need to know before you take Zarelle”. Read this information and consult a doctor immediately if necessary.
Seek medical attention immediately if you experience allergic reactions ( hypersensitivity reaction ), including swelling of the face, lips, tongue, and/or throat causing breathing or swallowing difficulties ( angioedema and/or anaphylaxis ) (No known frequency).
Irregular vaginal bleeding may occur while using Zarelle. It can be spotting that is so small that you don’t need to use a menstrual pad or heavier bleeding that is more reminiscent of a sparing period and requires a menstrual pad. You may also not have any bleeding at all. The irregular bleeding is not a sign that pregnancy protection of Zarelle has deteriorated. In general, you don’t need to do anything, just keep taking Zarelle. If, however, the bleeding becomes heavy or long-lasting, you should contact your doctor.
The following side effects have been reported:
- Common side effects ( may affect up to 1 in 10 users): mood swings, depression, decreased sex drive ( libido ), headache, nausea, acne, breast pain, irregular or absent menstruation, and weight gain.
- Uncommon side effects ( may affect up to 1 in 100 people): vaginal infection, difficulty wearing contact lenses, vomiting, hair loss, painful periods, fluid-filled cysts (cysts) on the ovaries, and tiredness.
- Rare side effects (may affect up to 1 in 1,000 users): Skin problems, for example rash, hives, painful blue-red bumps on the skin (erythema nodosum).
In addition to these side effects, secretions (fluid) from the chest may occur.
Contact a doctor immediately if you develop symptoms of angioedema, such as (i) swelling of the face, tongue, or throat, (ii) difficulty swallowing, or (iii) hives and difficulty breathing.
How to store Zarelle
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is: desogestrel (75 micrograms)
Other ingredients are lactose monohydrate, corn starch, povidone K30, RRR-alpha-tocopherol, soybean oil, colloidal anhydrous silica, colloidal aqueous silica, stearic acid, hypromellose, macrogol, titanium dioxide (E171) (also read “Zarelle contains lactose (milk sugar) and soybean oil” in section 2).
Appearance and package sizes of the medicine
A blister pack (tablet card) of Zarelle contains 28 white, round, film-coated tablets (approximately 5 mm in diameter). Each box contains 1, 3, or 6 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Stragen Nordic A/S
Helsingørsgade 8C,
DK-3400 Hillerød
Denmark
Tel.: +45 48 10 88 10
Email: info@stragen.dk
Manufacturer
Laboratorios León Farma, SA
Terminal. Ind. Navatejera.
C/ La Vallina s/n
24008 – Villaquilambre, León.
Spain