75 micrograms film-coated tablets 
desogestrel

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor/midwife or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Desogestrel Sandoz is and what it is used for 
2. What you need to know before taking Desogestrel Sandoz 
3. How to take Desogestrel Sandoz 
4. Possible side effects 
5. How to store Desogestrel Sandoz 
6. Contents of the packaging and other information 

1. What Desogestrel Sandoz is and what it is used for

Desogestrel Sandoz is used to preventing pregnancy.

There are two main types of hormonal contraceptives:

  • Combined p- pills containing two types of female sex hormones, estrogen, and progestin.
  • Mini-pills, which do not contain estrogen.

Desogestrel Sandoz is a mini-pill. Desogestrel Sandoz contains a small amount of a female sex hormone, progestogen, and desogestrel.

Most mini-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 pills.

Desogestrel Sandoz differs from most mini-pills by having a high enough dose to in most cases prevent egg cells from maturing. Therefore, Desogestrel Sandoz provides very good protection against pregnancy.

Unlike combined pills, Desogestrel Sandoz can be used by women who do not tolerate estrogen or women who are breastfeeding.

A disadvantage is that the bleeding may become more irregular when using Desogestrel Sandoz. You may also not experience any bleeding at all.

Desogestrel contained in Desogestrel Sandoz may also be approved for the treatment of 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 Desogestrel Sandoz

Generally

Like other hormonal contraceptives do not protect desogestrel Sandoz against HIV – infection ( AIDS ) or other sexually transmitted diseases.

Do not take Desogestrel Sandoz

  • if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
  • if you have thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (eg in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism)).
  • if you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver is still not functioning normally.
  • if you have or are suspected of having cancer that grows under the influence of sex hormones, e.g. certain types of breast cancer
  • if you have unexplained genital bleeding

Tell your doctor/midwife before using Desogestrel Sandoz 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 you use Desogestrel Sandoz.

Warnings and cautions

Tell your doctor/midwife or pharmacist before using Desogestrel Sandoz if:

  • you have ever had breast cancer.
  • you have liver cancer, as a possible effect of Desogestrel Sandoz can not be ruled out
  • you’ve ever had a thrombosis
  • you have diabetes
  • you have epilepsy (see section “Other medicines and Desogestrel Sandoz”)
  • you have tuberculosis (see section “Other medicines and Desogestrel Sandoz”)
  • 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 or ultraviolet rays.

If Desogestrel Sandoz is used in any of the above conditions, you may need to check carefully. Your doctor/midwife can explain this to you.

Breast cancer

  • You must check your breasts regularly and you should contact a doctor/midwife as soon as possible if you feel a lump in a breast.
  • Breast cancer occurs slightly more often in women who take pills than in women of the same age who do not take pills. If women stop taking the pill, this reduces the risk that the 10 years after the women stop using the pill is the same as for women who have never used the pill.

Breast cancer is rare in women under the age of 40, but the risk increases with age. The extra number of cases of breast cancer that are diagnosed will therefore be higher if a woman continues to use pills when she is older. How long the pills are used is less important.

  • Among 10,000 women who take the pill for up to 5 years but stop taking the pill at the age of 20, there will be less than one extra case of breast cancer for up to 10 years after the end of the treatment, except for the 4 cases that normally diagnosed in this age group.
  • Among 10,000 women who take combined pills for up to 5 years but stop at the age of 30, 5 extra cases will be detected in addition to the 44 that are normally diagnosed.
  • Among 10,000 women who take pills for up to 5 years but 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 mini-pills such as Desogestrel Sandoz is considered comparable to the risk in women using pills, but the evidence is not as strong.

Breast cancer detected in women taking pills seems to be less likely to have spread than breast cancer detected in women not taking pills.

It is uncertain whether pills cause the increased risk of breast cancer. It may be that women are examined more often and that breast cancer is thus detected earlier.

Blood clots ( thrombosis )

Seek medical advice immediately if you notice any signs of thrombosis (see also “Regular check-ups”).

Thrombosis is the formation of a blood clot that can clog a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If a blood clot breaks away from the veins where it is formed, it may reach and clog the pulmonary artery and cause what is known as pulmonary embolism. A pulmonary embolism can cause chest pain, shortness of breath, collapse, and even death.

  • Deep vein thrombosis rarely occurs. Thrombosis can develop even if you do not take birth control pills, and it can occur if you become pregnant.

The risk of suffering from thrombosis is higher if you use birth control pills than if you do not. The risk of developing thrombosis when using mini-pills such as Desogestrel Sandoz is considered to be lower than with oral contraceptives that also contain estrogen (combined oral contraceptives ).

Mental disorders

Some women who use hormonal contraceptives, including Desogestrel Sandoz, 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

No data are available regarding safety and efficacy in adolescents under 18 years of age.

Other medicines and Desogestrel Sandoz

Tell your doctor/midwife or pharmacist if you are taking, have recently taken, or might take any other medicines. Also, tell other doctors and dentists who prescribe medicines that you are using Desogestrel Sandoz. 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 affect the levels of Desogestrel Sandoz 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 (such as 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 ),
  • certain bacterial infections (eg clarithromycin, erythromycin),
  • depression ((traditional) herbal medicines containing St. John’s wort [ Hypericum perforatum ]),
  • fungal infections (eg ketoconazole, itraconazole, fluconazole ),
  • high blood pressure ( hypertension ), angina pectoris (angina), or certain heart rhythm disorders (eg diltiazem ).

If you are taking medicines or (traditional) herbal medicines that may make Desogestrel Sandoz less effective, use a barrier method (such as a condom). As the effect of another drug on Desogestrel Sandoz 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.

Desogestrel Sandoz can also affect the effectiveness of other medicines, either by increasing the effect (eg medicines containing cyclosporine) or reducing the effect (eg lamotrigine).

Pregnancy and breastfeeding

Pregnancy

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

Breast-feeding

Desogestrel Sandoz can be used while you are breast-feeding. 

Desogestrel Sandoz does not appear to affect breast milk production or quality. However, occasional reports have described a decrease in breast milk production using desogestrel. A small amount of the active substance in Desogestrel Sandoz passes into breast milk.

The health of children of women who have used Desogestrel Sandoz during breast-feeding for 7 months has been monitored until the child is 2.5 years old. No effects on the child’s growth or development have been observed.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/midwife or pharmacist for advice before taking this medicine.

Driving and using machines

Desogestrel Sandoz has no known effect on the ability to drive or use machines.

Desogestrel Sandoz contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor/midwife before taking this medicine.

Regular checks

When using Desogestrel Sandoz, your doctor/midwife will ask you to have regular check-ups. How often you need to go for a check-up and what the check-up contains depends on your personal situation.

Contact your doctor/midwife as soon as possible if:

  • you notice something that may indicate a blood clot e.g. severe pain or swelling in one of the legs, unexplained chest pain, shortness of breath, unusual cough, especially if you cough up blood (which may be a sign of a thrombosis )
  • you get sudden, severe pain in the stomach or jaundice (you may notice that you have yellow skin, yellow eye whites, or dark urine, which may be a sign of liver problems )
  • you feel a lump in your breast (which may be a sign of breast cancer )
  • you get sudden or severe pain in the lower abdomen (which may be a sign of ectopic pregnancy, ie an ectopic pregnancy)
  • you should be bedridden or have an operation (contact your doctor at least four weeks in advance)
  • you get unusual, heavy genital bleeding
  • you suspect you are pregnant.

How to take Desogestrel Sandoz

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

When and how to take the tablets

Each card contains 28 tablets – 4 weeks of use.

  • Take one tablet every day at about the same time. Swallow the tablet whole with water.
  • On the front of the map, there are arrows printed 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 of Desogestrel Sandoz, take one tablet from the top row. Do not start with any tablet. If you e.g. starting on a Wednesday, take the tablet from the top row marked “ON” (on the back).
  • Continue to take one tablet daily until the map is blank, always following 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.
  • You may experience bleeding while taking Desogestrel Sandoz, but you should continue to take the tablets as usual. See also section 4 Side effects.
  • When a map is finished, you should continue with a new map the next day – that is, without any tablet break and without waiting for a bleed.

The first Desogestrel Sandoz map

  • If you have not used any hormonal contraceptives in the last month wait until menstruation begins. Take the first tablet of Desogestrel Sandoz on the first day of bleeding. You do not need to use any extra protection. You can also start on days 2‑5 of your period, but then you must use extra protection (eg condoms) for the first 7 days.
  • Switch from a combined pill, ring, or patch you do not have a tablet-free, ring-free, or patch-free week:- You can start with the first tablet of Desogestrel Sandoz the day after you take the last tablet of your combined pill, or on the same day that your ring or patch is removed (this means that you should not have any tablet-free, ring-free or patch-free week).- If your pill also contains hormone-free tablets ( placebo ), you can start with Desogestrel Sandoz 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. If you have a tablet-free, ring-free, or patch-free week:- You can also start the last day of the tablet-free, ring-free, or patch-free week, or when you have taken all hormone-free tablets ( placebo ) of your current contraceptive.- If you follow these instructions, you must use extra barrier protection (eg condom) for the first 7 days of taking the tablets.
  • Switching from another mini-pill you can switch from another mini-pill any day. You do not need any extra protection.
  • Change from the syringe, rod, or IUDStart with Desogestrel Sandoz on the day you should have your next syringe or on the day your rod or IUD is removed. You do not need any extra protection.
  • After giving birth you can start with Desogestrel Sandoz 21 to 28 days after delivery. If you start later, you will need to use extra barrier protection for the first 7 days that you take the tablets. If you have had intercourse, you should make sure that you are not pregnant before starting Desogestrel Sandoz. Information on breastfeeding can be found in section 2 under the heading “Pregnancy and breast-feeding”. Your doctor/midwife can also give you advice.
  • After miscarriage or abortion, your doctor/midwife will give you advice.

If you forget to take Desogestrel Sandoz

  • If you are less than 12 hours late:- Take the missed tablet as soon as you remember and then take the next tablet at the usual time, so you are still protected against pregnancy.
  • If you are more than 12 hours late:- If you are more than 12 hours late with your tablet, the protection against pregnancy may be insufficient. The more tablets you have forgotten in succession, the greater the risk that you may become pregnant.- Take the missed tablet as soon as you remember and then take the following tablets at the usual time. Also, use extra protection (eg condom) for the next 7 days. If you missed one or more tablets during the very first week of treatment and you had intercourse the week before you forgot the tablets, there is a risk that you have become pregnant. Ask your doctor/midwife for advice.

If you have stomach problems (vomiting, severe diarrhea)

If you have vomited within 3-4 hours after taking your tablet with Desogestrel Sandoz or have severe diarrhea, the active substance may not have been completely absorbed by your body. Follow the advice in the section on forgotten tablets above.

If you take more Desogestrel Sandoz then you should 

There are no reports of serious side effects if you take more Desogestrel Sandoz tablets at one time. The symptoms that may occur are nausea and vomiting and in young girls slight bleeding.

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

If you stop taking Desogestrel Sandoz

You can stop taking Desogestrel Sandoz 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. Tell your doctor/midwife if you notice any side effects, especially if they are serious or persistent.

Serious side effects are that have been associated with the use of desogestrel Sandoz is described in the paragraphs “Breast cancer” and “Thrombosis” in section 2 “What you need to know before you take Desogestrel Sandoz”. You should read these paragraphs and contact your doctor/midwife for further advice if necessary.

Abdominal bleeding may be irregular when using Desogestrel Sandoz. It can be splash bleeding that does not even require bandaging or bleeding that is similar to sparse menstruation and requires menstrual protection. It can also happen that menstruation is completely absent. Irregular bleeding is not a sign that your pregnancy protection with Desogestrel Sandoz has deteriorated. In general, you do not need to do anything, just continue taking Desogestrel Sandoz. If, on the other hand, the bleeding is heavy and prolonged, you should contact a doctor/midwife.


Other side effects may occur


Common
 (may affect up to 1 in 10 people):

  • Mood swings
  • Depression
  • decreased sex drive ( libido )
  • headache
  • nausea
  • acne
  • chest pains
  • irregular or missed periods
  • weight gain.

Uncommon (may affect up to 1 in 100 people):

  • abdominal infection
  • difficulty wearing contact lenses
  • vomiting
  • hair loss
  • menstrual cramps
  • ovarian cysts
  • fatigue.

Rare (may affect up to 1 in 1,000 people):

Skin problems such as

  • rash
  • hives
  • painful blue-red nodules (tuberous rose or erythema nodosum).

In addition to these side effects, fluid or leakage from the breast may occur.

You should contact your doctor immediately if you experience symptoms of angioedema, such as (i) swelling of the face, swollen tongue or throat, (ii) difficulty swallowing, or (iii) hives and difficulty breathing.

5. How to store Desogestrel Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. day. or EXP. The expiration date is the last day of the specified month.

The medicine does not require any special storage instructions.

Do not use this medicine if you notice any visible signs of change in the medicine.

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.

Environmental risk assessment

The active substance etonogestrel poses an environmental risk to fish.

6. Contents of the packaging and other information

Content declaration

  • The active substance is desogestrel.
  • Other ingredients are lactose monohydrate, maize starch, povidone K 30, stearic acid, alpha-tocopherol, anhydrous colloidal silica, hypromellose, macrogol, titanium dioxide (E171), and polysorbate 80.

What the medicine looks like and the contents of the pack

Desogestrel Sandoz is a white, round, film-coated tablet.

It is available in packs of 1, 3, 6, or 13 blisters packaged separately in an aluminum laminated bag, each containing 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark.

Manufacturer

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

Lek Pharmaceuticals dd, Trimline 2 D 9220 Lendava, Slovenia

or

Lek SA ul. Domaniewska 50 C, 02-672 Warsaw, Poland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Barleben. Germany

or

Sandoz SRL, Str. Livezey no. 7 A, 540472 Targu-Mures, Romania

Muhammad Nadeem

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