75 micrograms film-coated tablets 
desogestrel

1. What Azalia is and what it is used for

Azalia is used to prevent pregnancy.

Azalia contains a small amount of a female sex hormone, progestin and desogestrel. That is why Azalia is called a mini-pill . Unlike combined pill contains minipills not hormone et estrogen , only progestin . Most mini-pills work mainly by preventing the sperm from reaching the uterus but do not always prevent the egg cell from maturing, which is the main effect of combined birth control pills.

Azalia differs from other mini-pills in that it has a dose that in most cases is high enough to prevent ovulation. Thus, Azalia provides good protection against pregnancy.

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

Desogestrel contained in Azalia 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 taking Azalia

Like other hormonal contraceptives protect Azalia you not against HIV – infection ( AIDS ) and other sexually transmitted diseases.

Do not take Azalia

  • 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 (yellow skin) or severe liver disease and liver function (determined by laboratory examination of the blood) has not been normalized.
  • If you have or are suspected of having cancer that is sensitive to sex hormones e.g. certain types of breast cancer.
  • If you have unexplained vaginal bleeding.

Tell your doctor before using Azalia if any of these conditions apply to you. Your doctor may recommend that you use a contraceptive method that does not contain hormones .

Contact your doctor immediately if any of these conditions occur for the first time when you use Azalia.

Warnings and cautions

Talk to your doctor or pharmacist before taking Azalia.

Tell your doctor before using Azalia if:

  • you have or have had breast cancer
  • you have liver cancer, as a possible effect of Azalia can not be ruled out
  • you have or have had thrombosis
  • you have diabetes
  • you have epilepsy (see “Other medicines and Azalia”)
  • you have tuberculosis (see “Other medicines and Azalia”)
  • you have high blood pressure
  • you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face). If you have it, avoid exposing yourself to sunlight or ultraviolet radiation.
  • you suffer from depression or mood swings.

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

Breast cancer

Check your breasts regularly and contact a doctor as soon as possible if you feel a lump in your breasts.

Breast cancer has been detected somewhat more often in women who take birth control pills than in women of the same age who do not take birth control pills . If women stop taking birth control pills , the risk gradually decreases, so that 10 years after stopping taking birth control pills is the same as that of women who have never taken birth control pills . Breast cancer is rare in women under the age of 40, but the risk increases as the woman gets older. Thereafter, the extra number of breast cancer cases diagnosed is greater if the woman’s age is higher. How long the woman takes birth control pills is less important.

For every 10,000 women who take the pill for up to 5 years but stop at the age of 20, less than 1 extra case of breast cancer will be found up to 10 years after the end of the intake, in addition to the 4 cases normally diagnosed in it. this age group. Similarly, in 10,000 women who take birth control pills for up to 5 years but stop at the age of 30, 5 extra cases will be detected in addition to the 44 cases that are normally diagnosed. In 10,000 women who take birth control pills for up to 5 years but stop taking them at the age of 40, 20 extra cases will be discovered in addition to the 160 cases that are normally diagnosed.

The risk of breast cancer in women who use mini-pills such as Azalia is believed to be similar to that in women who use birth control pills , but the evidence is not as clear.

It seems less likely that breast cancer detected in women taking birth control pills has spread compared to breast cancer in women not taking birth control pills . It is not known if the difference in breast cancer risk is due to the contraceptive pill. It may be that the women were examined more often, so that the breast cancer is detected earlier.

Thrombosis

Contact a doctor 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. A thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis ). If the blood clot breaks away from the veins where it is formed, it may reach and block the artery are in the lungs and lead to what is known as pulmonary embolism . Pulmonary embolism can be a life-threatening condition. Deep vein thrombosis is rare. It can be formed regardless of whether you take birth control pills or not. You can also get a blood clot if you become pregnant.

The risk is higher in women who take birth control pills than in women who do not take birth control pills . The risk with mini-pills , such as Azalia, is believed to be lower than the risk in women who use birth control pills that also contain estrogen(combined birth control pills ).

Mental disorders

Some women who use hormonal contraceptives, including Azalia, 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 clinical data are available on the safety and efficacy in adolescents below 18 years of age.

Other drugs and Azalia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Also tell other doctors and dentists who prescribe other medicines (or pharmacists) that you are taking Azalia. They can tell you if you need to use additional contraceptive protection (eg condoms) and if so, for how long, or if the use of any other medicine you need needs to be changed.

Some medicines:

  • may affect the levels of Azalia in the blood.
  • may make it less effective in preventing pregnancy
  • may cause unexpected bleeding.

This includes medicines used to treat:

  • 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 infection (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 )
  • certain bacterial infections (eg clarithromycin, erythromycin)
  • fungal infections (eg ketoconazole , itraconazole, fluconazole )
  • high blood pressure , angina or certain arrhythmias in the heart (eg diltiazem ).

If you are taking medicines or (traditional) herbal medicines that may make Azalia less effective, a barrier method (eg a condom) should be used. As the effect of another drug on Azalia 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 can tell you if you need additional protection and if so, for how long.

Azalia can also affect the effect 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.

Pregnancy and breastfeeding

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

Pregnancy

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

Breast-feeding

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

The health of children who were breastfed for 7 months and whose mothers used desogestrel has been studied for up to 2.5 years of age. No effects on children’s growth or development were observed.

If you are breast-feeding and want to use Azalia, consult a doctor.

Driving and using machines

There is no evidence that Azalia has an effect on the ability to react or concentrate.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Azalia contains lactose

Patients with lactose intolerance should know that one Azalia tablet contains 52.34 mg of lactose (as lactose monohydrate ).

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

Regular checks

When using Azalia, you may need regular check-ups. How often you need to go for a check-up and what happens at the check-up depends on your personal situation.

Contact a doctor as soon as possible if:you have severe pain or swelling in one of the legs, unexplained pain in the chest, shortness of breath, unusual cough, especially if you cough up blood (possibly indicating a thrombosis )you get sudden, severe stomach pain or if the skin turns yellow (possibly indicating liver problems )you feel a lump in your breasts (possibly indicating breast cancer )you experience sudden or severe pain in the lower abdomen (possibly indicating an ectopic pregnancy , ie an ectopic pregnancy )you become immobile or have to undergo an operation (contact your doctor at least four weeks in advance)you get unusual, heavy bleeding from the vaginayou suspect you are pregnant .

3. How to take Azalia

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Each tablet of Azalia contains 28 tablets. Arrows and days of the week are printed on the front of the tablet map, to help you take the contraceptive pill correctly. Take the tablet every day at about the same time. Swallow the tablet whole with water.

Each time you start a new Azalia tablet map, take one tablet from the top row. Example: If you start on a Wednesday, take a tablet on the top row marked ONS.

You should continue to take one tablet daily until the tablet map is empty. Always follow the direction of the arrows. If you start on a Monday, the tablet chart will be empty at the end of the arrows, but in all other cases, take the tablets left in the upper corner of the tablet chart before starting a new tablet chart. This way, you can easily check if you have taken your daily tablet. You may experience vaginal bleeding when using Azalia (see “Possible side effects”), but you should continue to take the tablets as usual.

When a tablet chart is empty, you must start a new one the next day – without interruption and without waiting for bleeding.

Start with the first tablet map Azalia

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

Wait until you get your period. Take one Azalia tablet on the first day of your period. You do not need to use any extra contraceptive.

You can also start day 2–5 of your menstrual cycle, but in that case you must also use an extra contraceptive (a so-called barrier method such as a condom) during the first 7 days of taking the tablet.

If you are switching from a combined contraceptive pill , vaginal ring or patch

You can start taking Azalia the day after you take the last tablet of your current contraceptive pill , or the day you remove the vaginal ring or patch (this means that you will not have a tablet-, ring- or patch-free break). If your current contraceptive pill also contains inactive tablets, you can start taking Azalia the day after you take the last active tablet (if you are not sure which one it is, ask your doctor or pharmacist). If you follow these instructions, you will not need to use any additional contraceptives.

You can also start the last day after the tablet-, ring- or patch-free break, or taking your inactive pill of your current pill. In the latter case, however, you must use an extra contraceptive (a so-called barrier method such as a condom) during the first 7 days of taking the tablet.

If you switch from another mini-pill

You can stop it any day and start right away with Azalia. You do not need to use any extra contraceptive.

If you switch from injection or implants or a spiral that releases progestogens

Start taking Azalia when you would get your next injection or the day an implant or IUD is removed. You do not need to use any extra contraceptive.

If you have given birth to a child

You can start taking Azalia 21 to 28 days after delivery. If you start later, during the first cycle, use an extra contraceptive (a so-called barrier method such as a condom) during the first 7 days of taking the tablet. However, if you have already had intercourse, pregnancy should be ruled out before you start taking Azalia. Further information for breast-feeding women can be found in section 2 of the section “Pregnancy and breast-feeding”. Your doctor can also give you advice.

If you have had a miscarriage or had an abortion

Your doctor will advise you.

If you forget to take Azalia

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 tablets in a row you have forgotten, the greater the risk that you will become pregnant.

Take the forgotten tablet as soon as you remember and then take the following tablets at the usual time. Also, use an extra contraceptive (such as a condom) for the next 7 days.

If you have forgotten one or more tablets during the first week of taking the tablet and have had intercourse the week before the forgotten tablets, there is a risk that you will become pregnant. Ask your doctor for advice.

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

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

There are no reports of serious adverse effects when taking too many Azalia tablets at the same time. Symptoms that may occur are nausea, vomiting and, in young girls, slight vaginal bleeding. Contact your doctor for more information.

If you stop taking Azalia

You can stop taking Azalia 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 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 Azalia are described in section 2, “What you need to know before taking Azalia”. Read this section carefully and, if necessary, contact a doctor immediately.

Vaginal bleeding may be irregular when using Azalia. You may only get splashing bleeding that does not even require bandaging or bleeding that looks like a frugal period and requires menstrual protection. You may also not experience any bleeding at all. The irregular bleeding is not a sign that the pregnancy protection of Azalia is reduced. In general, you do not need to do anything, just keep taking Azalia. However, if the bleeding becomes more severe or prolonged, consult a doctor.

Desogestrel users have reported the following side effects:

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

  • mood swings,
  • Depression,
  • decreased sexual desire ( libido ),
  • headache,
  • nausea,
  • acne,
  • chest pain,
  • irregular or no menstruation,
  • weight gain

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

  • vaginal infection ,
  • problems using contact lenses,
  • vomiting,
  • hair loss,
  • painful menstruation,
  • ovarian cyst,
  • fatigue

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

  • rash,
  • hives,
  • painful blue-red bumps on the skin (erythema nodosum) (these are skin diseases)

In addition to these side effects , fluid may be secreted or leaked from the breasts.

You should see a doctor immediately if you get symptoms of angioedema , e.g. swelling of the face, tongue or pharynx, difficulty swallowing or hives and difficulty breathing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Azalia

Store in the original package. Sensitive to light. Moisture sensitive.

No special temperature instructions.

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

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. One film-coated tablet contains 75 micrograms desogestrel.

Other ingredients are:

Tablet core:

Lactose monohydrate

Potato starch

Povidone K-30

Colloidal anhydrous silica

Stearic acid

all-rac alpha-tocopherol

Drag:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3000

Talc

What the medicine looks like and the contents of the pack

Azalia are white or almost white, round, biconvex film-coated tablets that are approximately 5.5 mm in diameter, with “D” embossed on one side and “75” on the other.

Azalia film-coated tablets are packaged in a blister of transparent , hard PVC / PVDC aluminum foil. Each blister is in a laminated aluminum sachet. The blisters in sachets are packed in a carton with a package leaflet and a storage case.

Pack sizes: 1×28, 3×28, 6×28, 13×28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Gedeon Richter Plc.

Gyömrői out 19-21

1103 Budapest, Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

This medicinal product is authorized under the European Economic Area under the names:

AZALIA in Denmark

DESOCEANE in Belgium

AZALIA 75 microgram film-coated tablets in Ireland

AZALIA in Italy

DESOCEANE in Luxembourg

AZALIA in Spain

AZALIA in Portugal

Solgest 0.075 mg film-coated tablet in the Netherlands

AZALIA in Finland

AZALIA in Norway

Muhammad Nadeem

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