75 micrograms of film-coated tablets
desogestrel

1. What Gestrina is and what it is used for

Gestrina is used to prevent pregnancy.

It contains small amounts of a kind of female sex hormone, progestin, and desogestrel. That’s why Gestrina is called a progestogen pill. Unlike combined contraceptive pills, these do not contain any estrogen as a supplement to progestogen.

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

Unlike combined contraceptive pills, Gestrina can be used by women who do not tolerate estrogen or women who are breastfeeding. A disadvantage is that the bleeding can become more irregular when using Gestrina. You may also not experience any bleeding at all.

Desogestrel contained in Gestrina may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Gestrina

Do not use Gestrina

Like other hormonal contraceptives protects Gestrina not against HIV – infection ( AIDS ) or other sexually transmitted diseases.

Ao not Gestrina

  • if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
  • if you have 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 and ( pulmonary embolism ).
  • if you have or have had jaundice (yellow skin) or a 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 genital bleeding that has not been investigated .

Tell your doctor/midwife before using Gestrina if any of these apply to you. You may be advised 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 when using Gestrina.

Warnings and cautions

Talk to your doctor, midwife, or pharmacist before using Gestrina

  • if you have or have had breast cancer
  • if you have liver cancer , then a possible effect of Gestrina can not be ruled out
  • if you have or have had thrombotic disease
  • if you have diabetes
  • if you suffer from epilepsy (see section “Other medicines and Gestrina”)
  • if you suffer from tuberculosis (see section “Other medicines and Gestrina”)
  • if you have high blood pressure or your blood pressure increases significantly
  • if you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face); in that case you should avoid too much sunlight and ultraviolet rays.

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

Regular checks

When you use Gestrina, your doctor/midwife will tell you when to come back for a check-up. How close the controls should be and what they contain varies from person to person.

Contact a doctor as soon as possible

  • if you have severe pain or swelling in any of the legs, unexplained chest pain, shortness of breath, unusual cough, especially if you have bloody cough (which may be a sign of thrombosis or embolism)
  • if you experience sudden, severe pain in the abdomen or if the skin turns yellow (which may be a sign of liver problems)
  • if you feel a lump in your breast (which may be a sign of breast cancer)
  • if you experience sudden, severe pain in the lower abdomen (this may be a sign of an ectopic pregnancy, ie an ectopic pregnancy)
  • if you are in bed or undergoing major surgery (consult your doctor at least four weeks before)
  • if you experience unusual, heavy bleeding from the abdomen
  • if you suspect you are pregnant.

Breast cancer

Check 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 somewhat more often in women who use birth control pills than in women of the same age who do not. If women stop taking birth control 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 the age of 40, but the risk increases with increasing age. Therefore, the extra cases of diagnosed breast cancer will be more at an older age. How long the woman has used the contraceptive pill is less important.

For every 10,000 women who use the contraceptive pill for up to five years and who stop at the age of 20, less than one extra case of breast cancer will be found up to 10 years after the end of treatment, except for the 4 that normally occur in this age group. In the same way, for 10,000 women who have used the contraceptive pill up to the age of five and who stop at the age of 30, 5 extra cases will be detected in addition to the 44 cases that normally occur. In 10,000 women who have used the contraceptive pill for up to five years and stop 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 progestogen-based contraceptives such as Gestrina is considered 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 that is detected in women who use birth control pills seems to be less likely to have spread than breast cancer that is detected in women who do not use birth control pills. It is not known whether the difference in breast cancer risk is caused by the contraceptive pill. It may be that women who use birth control pills are examined more often and that breast cancer is detected earlier.

Thrombosis

See your 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 this blood clot breaks away from the veins where it is formed, it can come to the artery are in the lungs, causing a so-called pulmonary embolism. Pulmonary embolism can be a life-threatening condition. Deep vein thrombosis is uncommon. It can occur whether you use birth control pills or not. It can also occur during a pregnancy.

The risk is greater if you use birth control pills than if you do not.

The risk of developing thrombosis is believed to be lower when using gestagent contraceptives such as Gestrina, compared to oral contraceptives that also contain estrogen (combined oral contraceptives ).

Mental disorders:

Some women who use hormonal contraceptives, including Gestrina, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Children and young people

The safety and efficacy of desogestrel in adolescents below 18 years have not been established.

Other medicines and Gestrina

Tell your doctor, midwife, or pharmacist if you are taking or have recently taken or might be taking other medicines or (traditional) herbal medicines. Also, tell other doctors and dentists who prescribe medicines (or pharmacists) that you are using Gestrina. They can tell you if you need to use additional contraceptive protection (such as a condom) and if so, for how long or if the use of any other medicine you need needs to be changed.

Some drugs

  • may have an effect on the levels of Gestrina 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 (for example, ritonavir, nelfinavir, nevirapine, efavirenz),
  • Hepatitis C virus infections (eg boceprevir, telaprevir),
  • other infectious diseases (eg 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 pectoris (angina) or certain heart rhythm disorders (eg diltiazem ).

If you are using medicines or (traditional) herbal medicines that may make Gestrina less effective, use a barrier method (such as a condom). As the effect of another drug on Gestrina may persist for up to 28 days after stopping treatment with the drug, it is necessary to use a barrier method throughout this time. Your doctor/midwife can tell you if you need additional protection and if so, for how long. Gestrina may also affect the effectiveness of other medicines, either by increasing the effect (eg medicines containing cyclosporine) or reducing the effect (eg lamotrigine).

Ask your doctor or pharmacist for advice before taking any medicine

Gestrina with food and drink

You can take Gestrina with or without food and drink.

Pregnancy and breastfeeding

Pregnancy

Do not use Gestrina if you are pregnant or suspect you may be pregnant.

Breast-feeding

Gestrina can be used while breastfeeding. Gestrina does not appear to affect breast milk production or quality. However, occasional reports have described a decrease in breast milk production using Gestrina. A small amount of the active substance in Gestrina passes into breast milk.

The health of children of women who have used Gestrina during breastfeeding for 7 months has been monitored until the child is 2.5 years old. No adverse effects on the child’s growth and development were detected.

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

Driving and using machines

Desogestrel does not affect your ability to drive or use machines.

Gestrina contains lactose

Gestrina 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 Gestrina.

3. How to use Gestrina

Always use this medicine exactly as your doctor/midwife or pharmacist has told you. If you are not sure, talk to your doctor, midwife, or pharmacist.

How to take Gestrina

  • each Gestrina card contains 28 tablets
  • take one tablet every day
  • swallow the tablet whole with a little water

Arrows are printed on the front of the map, between the tablets. The foil is printed on the back of the map on weekdays. Each table corresponds to one day a week. Each time you start a new map Gestrina, take a tablet from the top row. Do not start with any tablet. For example, if you start on a Wednesday, take the tablet from the top row marked “ONS”. Continue to take one tablet daily until the map is empty. Always follow the direction of the arrows. By checking on the back of the map, you can always easily see if you have already taken today’s tablet.

Take your tablets at about the same time each day so that there are always about 24 hours between two tablets. You may experience bleeding while using Gestrina, but you should continue to take the tablets as usual. When a map is finished, you should continue with a new Gestrina map the next day – that is, without any tablet break and without waiting for a bleed.

The first Gestrina map

  • If you have not used any hormonal contraceptives in the last monthWait until menstruation begins. Take the first Gestrina tablet on the first day of bleeding. You do not need to use any extra protection. You can also start on day 2-5 of your period, but then you must use extra protection ( barrier method , eg condom) for the first seven days.
  • If you change from a combined contraceptive pill , contraceptive ring or contraceptive patchYou can start with the first Gestrina tablet the day after you take the last tablet of your combined contraceptive pill , or on the same day as you take out your contraceptive ring or remove your contraceptive patch (this means that you do not should have a tablet-free, ring-free or patch-free week). About your current birth control pillalso contains hormone-free tablets, you can start taking Gestrina the day after you take the last active tablet (if you are not sure which tablet it is, ask your doctor / midwife or pharmacist). If you follow these instructions, you do not need to use any extra protection. You can also start no later than the day after the last day of the tablet-free, ring-free or patch-free week, or after taking the inactive tablets of your current contraceptive pill , but then you must use extra protection ( barrier method , eg condom) the first seven days.
  • If you are switching from another gesture agent pill to GestrinaYou can stop taking progestogen pills any day and then start taking Gestrina immediately. You do not need any extra protection.
  • If you change from a contraceptive syringe , contraceptive rod or IUD to GestrinaStart with Gestrina on the day you should have received your next contraceptive injection or on the day your contraceptive rod or IUD is removed. You do not need any extra protection.
  • If you have just given birthYou can start Gestrina 21 to 28 days after giving birth. If you start later, you will need to use extra protection for the first seven days of taking the tablets. If you have had intercourse, you should make sure that you are not pregnant before starting Gestrina. Information on breastfeeding can be found under the heading “Pregnancy and breastfeeding”. Your doctor / midwife can also give you advice.
  • If you have just had a miscarriage or had an abortionYour doctor will advise you.

If you forget to take Gestrina

  • If you are less than 12 hours late with your tablet, the protection against pregnancy with Gestrina will not be affected. Take the missed 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 with Gestrina may have decreased. The more tablets you have forgotten in succession, the greater the risk of reduced protection. Take the missed tablet as soon as you remember and then take the following tablets at regular times. Also use extra protection ( barrier method , eg condom) for the following 7 days. If you missed one or more tablets during the first week of treatment and you had intercourse the week before you forgot the tablets, there is a risk that you may have become pregnant. Ask your doctor / midwife for advice.

If you have stomach upset (vomiting, severe diarrhea)

Follow the same advice as for a forgotten tablet. If you have vomited within 3-4 hours after taking your tablet with Gestrina or have severe diarrhea, the active substance may not have been absorbed by your body.

If you use more Gestrina than you should

There are no reports of serious side effects if you take more Gestrina tablets at one time. Symptoms that may occur are nausea and vomiting and in young girls slight genital bleeding. Contact your doctor for further information.

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you stop taking Gestrina

You can stop taking Gestrina 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, midwife, or pharmacist.

4. Possible side effects

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

Serious side effects associated with the use of Gestrina are described in the sections “Breast cancer” and “Thrombosis” in section 2 “What you need to know before using Gestrina”. You should read that information and contact your doctor if necessary.

Genital bleeding often becomes irregular when using Gestrina. It can be a splash bleeding that does not even require bandages or bleeding that resembles a frugal period and requires menstrual protection. It can also happen that menstruation is completely absent. The irregular bleeding is not a sign that the pregnancy protection with Gestrina has decreased. In general, you do not need to do anything, just keep taking Gestrina. If, on the other hand, the bleeding is heavy and prolonged, you should contact your doctor/midwife.

Desogestrel users have reported the following side effects:

Common (may affect up to 1 in 10 users) Uncommon (may affect up to 1 in 100 people) Rare (may affect up to 1 in 1000 people)
mood swings, depression, decreased sexual desire ( libido ), infection is in the abdomen, rash, hives, painful bluish-red rash (tuberculosis or erythema nodosum (these are skin diseases))
headache, difficulty using contact lenses,  
nausea, vomiting,  
acne, hair loss,  
chest tightness, irregular or missed periods, menstrual cramps, fluid-filled blisters on the ovaries (cysts),  
weight gain fatigue  

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

Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, or throat, difficulty swallowing or rash, and difficulty breathing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gestrina

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”.

The expiration date is the last day of the specified month.

Medicines stored in bag packaging:

Gestrina has no special storage instructions.

Medicines that are not stored in bagged packaging:

When Gestrina is not in the bag packaging, it should be stored at a maximum of 30 ° C.

The active substance poses an environmental risk to fish.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is: desogestrel. Each film-coated tablet contains 75 micrograms of desogestrel.
  • The other ingredients are: lactose monohydrate (see also “Gestrina contains lactose” in section 2), corn starch, povidone, stearic acid, all-rac-α-ocopherol, colloidal anhydrous silica, hypromellose, macrogol 400, talc, titanium dioxide.

What the medicine looks like and contents of the pack

The Gestrina tablets are white to off-white, round, biconvex film-coated tablets, 5.4-5.8 mm in diameter. The tablets do not have any labels.

A blister card Gestrina contains 28 film-coated tablets. Each carton contains 1, 3, or 6 blister cards.

A blister case can be delivered together with the blister cards.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Manufacturer

Cenexi

17 Rue de Pontoise

95520 Osny

France

Muhammad Nadeem

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