Velabreeding - Desogestrel uses, dose and side effects

Velavel contains small amounts of a type of female sex hormone, gestagen et desogestrel. Therefore, Velavel is called a progestagen birth control pill. In contrast to combined birth control pills, progestogen birth control pills do not contain the hormone estrogen as a complement to progestin.

Most progestogen birth control pills work primarily by preventing the sperm from reaching the uterus. They do not always prevent eggs from maturing, which is the main effect of combined oral contraceptives. Velavel differs from most progestagen birth control pills by having a high enough dose to prevent egg cells from maturing in the vast majority of cases. Therefore, Velavel provides good protection against pregnancy.

Unlike combined oral contraceptives, Velavel can be used by women who cannot tolerate estrogen or women who are breastfeeding. A disadvantage is that the bleeding can become more irregular when using Velavel. You may also not have any bleeding at all.

The desogestrel contained in Velavel 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 you take Velavel

Do not take Velavel:

if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
if you have an ongoing thrombotic disease. Thrombosis is the formation of a blood clot in a blood vessel (eg in the legs [deep vein thrombosis ] or in the lungs [pulmonary embolism]).
if you have or have had jaundice (yellow skin) or serious liver disease and your liver values have not returned to 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 abdominal bleeding that has not been investigated.
if you are allergic (hypersensitive) to peanuts or soya.

Tell your doctor/midwife before you start using Velavel if any of these apply to you. You may be recommended to use a contraceptive method that does not contain hormones.

Contact your doctor/midwife immediately if any of these conditions occur for the first time while using Velavel.

Like other hormonal contraceptives, Velavel does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases.

Warnings and precautions

Before you start using Velavel, tell your doctor/midwife if:

you have or have had breast cancer
you have liver cancer, as a possible influence of Velavel cannot be excluded
you have or have had a thrombotic disease
you have diabetes
you have epilepsy (see section “Other medicines and Velavel”)
you have tuberculosis (see section “Other medicines and Velavel”)
you have high blood pressure
you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face), in which case you should avoid too much sunlight and ultraviolet rays.

When Velavel is used in the presence of any of the conditions above, you may need to go for extra checks. Your doctor/midwife will inform you.

Breast cancer

Examine your breasts regularly and contact your doctor/midwife as soon as possible if you notice a lump in your 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 the women stop using birth control pills, the risk gradually decreases so that after 10 years it is the same as in women who never used birth control pills. Breast cancer is rare in women under 40, but the risk increases with age. Therefore, the extra cases of diagnosed breast cancer will be more among women who continue to take the pill at an older age. 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 normally detected in this age group. Similarly, among 10,000 women who use the pill for up to five years and who stop at the age of 30, 5 extra cases will be detected in addition to the 44 cases that are normally detected. Among 10,000 women who use the pill for up to five years and who stop at age 40, 20 extra cases will be discovered in addition to the 160 that are normally diagnosed.

The risk of breast cancer in women using progestogen-only oral contraceptives such as Velavel is thought to be comparable to the risk in women using oral contraceptives that also contain estrogen (combined oral contraceptives ), but the evidence is not as strong.

Breast cancer detected in women using oral contraceptives appears to be less likely to have spread than breast cancer detected in women not using oral contraceptives. It is not known whether the difference in breast cancer risk is caused by the pill. It may be that women who use birth control pills are examined more often and that breast cancer is then detected earlier

Thrombosis

See a doctor/midwife immediately if you notice any signs of thrombosis (see also “Regular check-ups”).

Thrombosis is the formation of a blood clot, 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, blocking them and causing a so-called pulmonary embolism. This can lead to life-threatening situations. Deep vein thrombosis is uncommon. It can occur whether you use birth control pills or not. It can also occur during pregnancy. The risk of suffering from thrombosis is higher if you use birth control pills than if you don’t. The risk of suffering from thrombosis is believed to be lower when using progestagen birth control pills such as Velavel, compared to birth control pills that also contain estrogen (combined birth control pills ).

Mental disorders

Some women using hormonal contraceptives, including Velavel, 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.

Children and young people

No data are available regarding efficacy and safety for young people under the age of 18.

Other medicines and Velavel

Tell the doctor/midwife if you are taking, have recently taken, or may be taking other medicines or (traditional) herbal medicines. Also, tell other doctors and dentists who prescribe medicines (or pharmacists) that you are using Velavel. They can tell you if you need to use additional contraceptive protection (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

may have an impact on the levels of Velavel in the blood
may make it less effective in preventing pregnancy
may cause unexpected bleeding.

This applies to 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 (eg, boceprevir, telaprevir)
other infectious diseases (eg griseofulvin)
high blood pressure in the blood vessels of the lungs ( bosentan )
mild moodiness ((traditional) herbal remedies such as St. John’s wort )
certain bacterial infections (eg, clarithromycin, erythromycin)
fungal infections (eg ketoconazole , itraconazole, fluconazole )
high blood pressure ( hypertension ), angina pectoris (angina), or certain heart rhythm disorders (eg diltiazem ).

If you use medicines or (traditional) herbal medicines that can make Velavel less effective, a barrier method (for example a condom) must also be used. Because the effect of another medicine on Velavel can remain for up to 28 days after the end of treatment with the medicine, a barrier method must be used throughout this time. Your doctor/midwife can tell you if you need additional protection and if so for how long.

Velavel can also affect the effectiveness of other medicines, either by increasing the effect (eg medicines containing ciclosporin) or decreasing the effect (eg lamotrigine).

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

Pregnancy and breastfeeding

Pregnancy

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

Breast-feeding

Velavel can be used by lactating women. Velabreeding does not appear to affect the production or quality of breast milk. However, isolated reports have described a decrease in breast milk production while using Velavel. Small amounts of the active substance in Velavel do pass into breast milk.

The health of children of women who have used Velavel while breastfeeding

for 7 months has been followed until the children are 2.5 years old. No negative effects on the children’s growth and development were discovered.

Talk to your doctor/midwife if you are breastfeeding and want to use Velavel.

Driving ability and use of machinery

There is no indication that the ability to react or concentrate is affected by treatment with Velavel.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.

Velavel contains lactose (milk sugar) and soybean oil

If you have an intolerance to certain sugars, you should contact your doctor/midwife before taking this medicine.

Regular checks

When you use Velavel, your doctor/midwife will tell you when to come back for a check-up. How often you need to go for a check-up and what it contains varies from person to person.

Contact your doctor/midwife as soon as possible if:

you get severe pain or swelling in one of the legs, unexplained pain in the chest, shortness of breath, and unusual cough especially if you cough up blood (may indicate thrombosis )
you get sudden, severe pain in your stomach or if your skin turns yellow (may indicate liver problems)
you feel a lump in your breast (may indicate breast cancer)
you have sudden or severe pain in the lower abdomen (may indicate an ectopic pregnancy, i.e. a pregnancy outside the womb)
you are bedridden or about to undergo a major operation (consult your doctor at least four weeks before)
you have unusual, heavy bleeding from the abdomen
you think you are pregnant.

How to take Velavel

Always take this medicine as directed by your doctor/midwife or pharmacist.

Consult a doctor/midwife or pharmacist if you are unsure.

When and how to take the tablets

Each card contains 28 tablets. On the blister cards, the days of the week are printed together with arrows showing the order in which the tablets should be taken. Each tablet corresponds to one day of the week. Each time you start a new map with Velavel, take a tablet from the top row. Don’t start with just any tablet. For example, if you start on a Wednesday, take the tablet from the top row marked “WED” (Wednesday). Continue to take one tablet daily until the chart is empty, always following the direction of the arrows. By checking the tablet chart, you can easily see if you have taken the tablet for a certain day. Take your tablets at about the same time each day.

The tablets should be swallowed whole with water. You may have bleeding while using Velavel but must continue to take the tablets as usual. When a map runs out, you must continue with a new map of Velavel the next day – that is, without any tablet break and without waiting for a bleed.

The first Velavel map

If you have not used any hormonal contraceptives in the last month

Wait until menstruation begins. Take the first tablet of Velavel on the first day of bleeding. You do not need to use any additional protection.

You can also start on days 2-5 of your period, but then you must use extra protection (a barrier method, such as a condom) for the first 7 days.

Changing from a combined birth control pill, birth control ring, or birth control patch

You can start taking Velavel the day after you have taken the last tablet of your combined oral contraceptive pill, or on the same day that your contraceptive ring or contraceptive patch is removed (this means that you should not have a tablet-free, ring-free or patch-free week). If your current pill also contains hormone-free tablets, you can start Velavel the day after you took the last active tablet (if you are not sure which tablet it is, ask your doctor/midwife or pharmacist). If you follow the instructions, you do not need to use any additional protection.

You can also start no later than the day after the pill-free, ring-free, or patch-free week, or the hormone-free period of your current contraceptive. If you follow these instructions, you must use extra protection (eg condoms) for the first 7 days.

Switching from another progestogen pill

You can stop progestagen birth control pills any day and start Velavel straight away. You do not need to use any additional protection.

Change from birth control syringe, birth control stick, or hormonal coil

Start Velavel on the day you would have had your next contraceptive injection or on the day your contraceptive rod or hormonal IUD is removed. You do not need to use any additional protection.

After giving birth

You can start Velavel 21 to 28 days after delivery. If you start later, you must use extra protection (eg a condom) for the first 7 days that you take the tablets.

If you have had sexual intercourse, you should make sure you are not pregnant before starting Velavel. More information about breastfeeding can be found under the heading “Pregnancy and breastfeeding” in section 2. Your doctor/midwife can also give you advice.

After miscarriage or abortion

Your doctor/midwife will advise you.

Use for children and adolescents

There are no clinical data on efficacy and safety for adolescents under the age of 18.

If you have taken too much Velavel

There are no reports of serious harmful effects if too many Velavel tablets are taken at one time. Symptoms that may occur are nausea and vomiting and, in young girls, light bleeding. For further information contact your doctor/midwife.

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 Velavel

If you are less than 12 hours late with your tablet, you are still protected against pregnancy. Take the missed tablet as soon as you remember and then take the following tablets at the usual time.

If you are more than 12 hours late with your tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten in a row, 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. In addition, use additional protection (a barrier method, such as a condom) for the next 7 days. If you have missed one or more tablets during the first week of treatment and you had intercourse the week before you missed the tablets, there is a risk that you have become pregnant. Ask your doctor/midwife for advice.

If you have stomach problems (eg vomiting or severe diarrhea)

Follow the same advice as for the forgotten tablet in the section above. If you vomit within 3-4 hours after taking your Velavel tablet or if you have severe diarrhea, it may be that the active substance has not been fully absorbed by the body.

If you stop taking Velavel

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

If you have any further questions about the use of this medicine, contact your doctor, midwife, or pharmacist.

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 Velavel have described in the paragraphs “Breast cancer” and “Thrombosis” in section 2 “What you need to know before you take Velavel”. You should read this section and contact your doctor for further advice if necessary.

Seek medical attention immediately if you experience allergic reactions ( hypersensitivity reaction er), including swelling of the face, lips, tongue, and/or throat causing breathing or swallowing difficulties ( angioedema and/or anaphylaxis ).

Bleeding may become more irregular when using Velavel. It can be spotting that doesn’t even require a pad or heavier bleeding that resembles a scanty period and requires menstrual protection. You may also not have any bleeding at all. The irregular bleeding is not a sign that pregnancy protection with Velavel has deteriorated. In general, you don’t need to do anything, just keep taking Velavel. If, however, the bleeding is heavy and prolonged, you should contact your doctor/midwife.

Users of Velavel have reported the following side effects:

Common side effects ( may affect up to 1 in 10 women):
- Mood swings
- Depression
- decreased sexual desire ( libido )
- headache
- nausea
- acne
- chest tension
- irregular or absent menstruation
- weight gain.
Uncommon side effects ( may affect up to 1 in 100 women):
- infection in your vagina
- difficulty using contact lenses
- vomiting
- hair loss
- painful menstruation
- fluid-filled blisters on the ovaries (cysts)
- fatigue.
Rare side effects ( may affect up to 1 in 1,000 women):
- rash
- hives
- painful bluish-red rashes (rubella or erythema nodosum). These are skin conditions.
Frequency not known (cannot be estimated from available data):
- allergic reaction.

In addition to these side effects, fluid secretion from the breasts may occur.

How Velavel should be stored

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.

The active substance poses an environmental risk to fish.

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, d-α-tocopherol, soybean oil, colloidal anhydrous silica, colloidal aqueous silica, stearic acid, hypromellose, macrogol, titanium dioxide (E 171) (see also “Velavel contains lactose (milk sugar) and soybean oil” in section 2).

Appearance and package sizes of the medicine

A blister card of Velavel contains 28 white, round, film-coated tablets. Each pack contains 1, 3, 6, or 13 blister cards.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorisation Holder

Exeltis Healthcare SL

Avenida Miralcampo 7

Polígono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, SA

C/ La Vallina s/n, Pol. Ind. Navatejera

24008 – Navatejera, León.