Altaria

Package Leaflet: Information for the User

Altaria, 10 mg, coated tablets

Dydrogesterone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Altaria and what is it used for
• 2. Important information before taking Altaria
• 3. How to take Altaria
• 4. Possible side effects
• 5. How to store Altaria
• 6. Contents of the pack and other information

1. What is Altaria and what is it used for

What is Altaria

Altaria contains the active substance dydrogesterone.

• Dydrogesterone is a synthetic hormone.
• It is very similar to the hormone progesterone, which is naturally produced in the body.
• Medicines like Altaria are called progestagens.

What is Altaria used for

Altaria can be used alone or in combination with an estrogen. The simultaneous administration of estrogen depends on the indication for use of this medicine.
Altaria is used to treat:

Disorders caused by insufficient production of progesterone by the body, such as:

• irregular menstrual periods.

Menopausal symptoms as part of a treatment called hormone replacement therapy (HRT).

Altaria may be used in combination with estrogen to treat menopausal symptoms if the patient has a preserved uterus. These symptoms vary from woman to woman.

How Altaria works

Normally, the body produces progesterone and another main female hormone, estrogen, in the right proportions. Altaria is used to treat disorders that may occur if the body does not produce enough progesterone.
The doctor may prescribe simultaneous administration of estrogen with Altaria to restore hormone balance. In some women using HRT, taking only estrogen can cause thickening of the uterine lining. This can also occur in women who have had their uterus removed and have a history of endometriosis. Taking dydrogesterone for part of the menstrual cycle prevents thickening of the uterine lining.

2. Important information before taking Altaria

When not to take Altaria:

• if you are allergic to dydrogesterone or any of the other ingredients of this medicine (listed in section 6)
• if you have or are suspected of having a tumor (cancer) that is dependent on progesterone, such as a brain tumor called a meningioma
• if you have vaginal bleeding of unknown cause
• if Altaria is used in combination with estrogen, you should also read the "When not to take" section in the package leaflet of the estrogen-containing medicine
• in case of severe acute liver disease or disorders of bile pigment excretion (Dubin-Johnson syndrome, Rotor syndrome) or a history of these diseases
• in case of current or past liver tumors
• if you have thrombophlebitis or thromboembolic disease (pathological formation of blood clots in blood vessels).

Warnings and precautions

In case of necessity to take Altaria due to irregular bleeding, the doctor will determine the cause of the bleeding before starting treatment.
Usually, the occurrence of unexpected bleeding or spotting is not a cause for concern. This happens especially during the first few months of taking Altaria.
However, you should contact your doctor immediately if the bleeding or spotting:

• lasts longer than a few months
• appears after some time after starting treatment
• occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia. The doctor will look for the cause of the bleeding or spotting and may order an examination for endometrial cancer.

Note:Altaria is not a contraceptive and does not prevent pregnancy.

You should stop taking Altaria and contact your doctor immediately:

If you notice any of the following symptoms:

• the occurrence of a condition listed in the "When not to take Altaria" section
• jaundice (yellowing of the skin or whites of the eyes). These may be symptoms of liver disease
• swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, which are accompanied by difficulty breathing, which may indicate angioedema
• significant increase in blood pressure (symptoms may include headache, fatigue, dizziness)
• headache resembling migraine or extremely severe headache, occurring for the first time
• sudden vision disturbances
• if you notice symptoms of thrombosis, such as:
• painful swelling and redness of the legs;
• sudden chest pain;
• difficulty breathing;

To learn more, see the "Blood clots in veins (thrombosis)" section.

When to be particularly careful when taking Altaria

You should inform your doctor before starting treatment if you have ever had any of the following health problems, as they may recur or worsen during treatment with Altaria. If this applies to you, you should have more frequent check-ups with your doctor:

• Porphyria (a hereditary metabolic disorder with disturbances in the production of red blood cell pigment)
• Depression
• Abnormal liver function test values due to acute or chronic liver disease
• Jaundice and/or itching.

You should inform your doctor if you have:

• had a stroke (also in the past)
• high blood pressure.

Altaria and HRT

The use of HRT is associated with a risk that should be considered before starting or continuing treatment. When taking Altaria in combination with estrogen as part of HRT, the following information is important. You should also read the patient information leaflet that comes with the estrogen-containing medicine.

Early menopause

Experience with the treatment of women with premature menopause (caused by ovarian failure or surgery) is limited. In patients with premature menopause, the risks associated with HRT may be different. You should discuss this with your doctor.

Medical examinations

Before starting (or re-starting) HRT, the doctor will take a medical history and may decide to perform a physical examination. This may include a breast examination and/or an internal examination if necessary. After starting HRT, the doctor may order check-ups (at least once a year). During these check-ups, the doctor will discuss the benefits and risks of continuing HRT. You should regularly examine your breasts as recommended by your doctor.

Endometrial hyperplasia (thickening of the uterine lining) and endometrial cancer:

Taking HRT with only estrogen increases the risk of endometrial hyperplasia and endometrial cancer. Taking Altaria in combination with estrogen (for at least 12 days in a 28-day cycle) or as continuous combined therapy with estrogen and progestogen may prevent this additional risk.

Breast cancer

Data confirm that taking HRT (estrogen and progestogen or estrogen alone) increases the risk of breast cancer. The additional risk depends on the duration of HRT. This additional risk becomes apparent after about 3 years of HRT. After stopping HRT, the additional risk will decrease over time, but the risk may persist for 10 years or more if HRT lasted more than 5 years.
Comparison
In women aged 50-54 who do not take HRT, breast cancer will be diagnosed in 5 years on average in 13-17 women out of 1000.
In women aged 50 who start taking HRT consisting only of estrogen for 5 years, there will be 16-17 cases per 1000 users (i.e., 0-3 additional cases).
In women aged 50 who start taking HRT consisting of estrogen and progestogen for 5 years, there will be 21 cases per 1000 users (i.e., 4-8 additional cases).
In women aged 50-59 who do not take HRT, breast cancer will be diagnosed in 10 years on average in 27 women out of 1000.
In women aged 50 who start taking HRT consisting only of estrogen for 10 years, there will be 34 cases per 1000 users (i.e., 7 additional cases).
In women aged 50 who start taking HRT consisting of estrogen and progestogen for 10 years, there will be 48 cases per 1000 users (i.e., 21 additional cases).
You should regularly examine your breasts. You should consult your doctor if you notice any changes, such as:

• indentation of the skin;
• changes in the nipple;
• any visible or palpable lumps. Additionally, it is recommended to participate in breast cancer screening programs if they are available. When undergoing mammography, it is important to inform the personnel performing the mammography that you are taking HRT, as this medicine may increase breast density, which can affect the mammography result. With increased breast density, mammography may not detect all lumps.

Ovarian cancer

Ovarian cancer is rare - much rarer than breast cancer. Taking HRT consisting only of estrogen or combined with progestogen is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50-54 who do not take HRT, ovarian cancer will be diagnosed in 5 years in about 2 women out of 2000.
In women who have taken HRT for 5 years, it will occur in about 3 women out of 2000 users (i.e., about 1 additional case).

Effect of HRT on the heart and blood vessels

Blood clots in veins (thrombosis)

The risk of blood clots in veins is about 1.3 to 3 times higher in women taking HRT than in those not taking it, especially in the first year of taking.
Blood clots can be dangerous, and if a clot moves to the lungs, it can cause chest pain, shortness of breath, fainting, or even death.
The likelihood of forming a blood clot in a vein increases with age and if any of the following situations occur. You should inform your doctor if any of the following situations apply to you:

• if you are immobile for a long time due to major surgery, injury, or illness;
• if you are significantly overweight (BMI > 30 kg/m2;
• if you have any blood clotting problems that require long-term treatment with anticoagulant medications;
• if a close relative has ever had a blood clot in the leg, lung, or other organ;
• if you have systemic lupus erythematosus (SLE);
• if you have cancer.

Comparison
In women aged 50 who do not take HRT, it can be expected that on average, 4-7 women out of 1000 will develop a blood clot in a vein in 5 years.
In women aged 50 who take HRT consisting of estrogen and progestogen for more than 5 years, there will be 9-12 cases per 1000 users (i.e., 5 additional cases).

Heart disease (heart attack)

There is no evidence that HRT prevents heart attacks. Women over 60 who take HRT with estrogen and progestogen are slightly more likely to develop heart disease than those not taking HRT.

Stroke

The risk of stroke is about 1.5 times higher in women taking HRT than in those not taking it. The number of additional stroke cases caused by HRT will increase with age.
Comparison
In women over 50 who do not take HRT, it can be expected that on average, 8 women out of 1000 will have a stroke in 5 years.
In women over 50 who take HRT, there will be 11 cases per 1000 users in 5 years (i.e., 3 additional cases).
You should contact your doctor immediately if you notice any of the first symptoms of side effects, become pregnant, or experience irregular bleeding.

Children and adolescents under 18 years of age

There is no indication for the use of Altaria in children before the first menstrual period. Altaria is not recommended for use in adolescents aged 12-18 years due to insufficient data on safety and efficacy.

Altaria and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
Some medicines may affect the action of Altaria. This may lead to a decrease in the effectiveness of Altaria. These include:

• Antiepileptic drugs used to treat epilepsy (e.g., phenobarbital, carbamazepine, phenytoin)
• Medicines used to treat infections (e.g., rifampicin, rifabutin, nevirapine, efavirenz)
• Medicines used to treat HIV infection [AIDS] (e.g., ritonavir, nelfinavir)
• Herbal medicines containing St. John's wort (Hypericum perforatum), sage, or yew.

Progesterone, in turn, may weaken the action of drugs that lower blood sugar levels.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Altaria is not indicated for use during pregnancy. If you become pregnant, you should stop taking Altaria and contact your doctor.
There is a possibility of increased risk of hypospadias (a congenital defect of the penis where the urethral opening is not at the tip) in children whose mothers took certain progestogens. However, this increased risk has not been confirmed. It is estimated that over 10 million women have taken dydrogesterone during pregnancy. So far, there is no evidence that taking Altaria during pregnancy is harmful.

Breastfeeding

You should not take Altaria while breastfeeding. It is not known whether Altaria passes into breast milk or has an effect on the baby. Studies with other progestogens have shown that they pass into breast milk in small amounts.

Fertility

There is no evidence that dydrogesterone reduces fertility when taken as directed by your doctor.

Driving and using machines

After taking Altaria, you may experience slight drowsiness or dizziness. This is more likely to happen during the first few hours after taking the medicine. If you experience these symptoms, do not drive or operate tools or machines. You should wait and see how the medicine affects you before deciding to drive, use tools, or operate machines.

Altaria contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Altaria

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor. The doctor will adjust the dose according to your needs.

How to take this medicine

Swallow the tablet with water.
The tablet can be taken with or without food.
If you take more than one tablet a day, you should divide the tablets evenly throughout the day, e.g., take one tablet in the morning and one in the evening.
Try to take the tablets at the same time every day. This will ensure a constant amount of medicine in your body. It will also help you remember to take the tablets.

How much to take

The number of tablets to take and the days on which the medicine is taken depend on the reason for which you are being treated. The doctor will decide when it is best to take Altaria. If you are still menstruating, the 1st day of the cycle is the day you start bleeding. If you no longer have natural periods, the doctor will decide when the 1st day of the cycle is and when to start taking the tablets.

Use in the treatment of irregular menstrual periods

Take 1 or 2 Altaria tablets per day.
The medicine should be taken in the second half of the cycle, until the first day of the next menstrual period.
The day of starting the medicine and the number of days on which the medicine is taken depend on the length of the cycle.

Use in the treatment of menopausal symptoms (HRT)

In the case of hormone replacement therapy in combination with an estrogen-containing medicine:

• Take 1 Altaria tablet per day for the last 14 days of each 28-day cycle.
• If you are taking HRT in a cyclical regimen (taking an estrogen-containing medicine for 21 days, followed by a 7-day break), take 1 Altaria tablet per day for the last 12-14 days of estrogen use. If necessary, your doctor may increase the dose to 2 tablets per day.

After taking the last Altaria tablet, you will experience menstrual-like bleeding.
Your doctor will prescribe the lowest possible dose, and treatment of symptoms will be as short as possible. You should contact your doctor if you think the dose is too strong or too weak.

Use in children and adolescents under 18 years of age

Altaria is not intended for use in children before the first menstrual period. Altaria is not recommended for use in adolescents aged 12-18 years due to insufficient data on safety and efficacy.

What to do if you take more than you should

It is unlikely that taking too many Altaria tablets will be harmful. If you are unsure, contact your doctor.

What to do if you forget to take Altaria

• If you forget to take a tablet on a given day, and it has been less than 12 hours since you should have taken it, take the tablet as soon as you remember. Take the next tablet at the usual time the next day.
• If you forget to take a tablet on a given day, and it has been more than 12 hours since you should have taken it, skip that tablet. Take the next tablet at the usual time the next day and continue taking the tablets as usual.
• Do not take a double dose to make up for a forgotten dose.
• If you miss a dose, there is a higher likelihood of irregular bleeding or spotting.

What to do if you want to stop taking Altaria

Do not stop taking Altaria without consulting your doctor.

Planned surgery

If you are scheduled for surgery, inform your surgeon that you are taking Altaria. It may be necessary to stop taking Altaria about 4-6 weeks before surgery to reduce the risk of blood clots (see section 2, "Blood clots in veins (thrombosis)"). Your doctor will tell you when you can start taking Altaria again.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Altaria can cause side effects, although not everybody gets them.
The following side effects may occur during treatment.

Side effects that occur when taking Altaria alone

If you experience any of the following side effects, stop taking Altaria and contact your doctor immediately:

• liver disorders - symptoms may include yellowing of the skin or whites of the eyes (jaundice), weakness, general feeling of nausea, or abdominal pain (may occur in less than 1 in 100 patients)
• allergic reactions - symptoms may include difficulty breathing or whole-body symptoms such as nausea, vomiting, diarrhea, or low blood pressure (may occur in less than 1 in 1000 patients)
• skin swelling around the face and throat, which can cause difficulty breathing (may occur in less than 1 in 1000 patients) If you experience any of these side effects, stop taking Altaria and contact your doctor immediately.

Other side effects that occur when taking Altaria alone

Frequent(may occur in less than 1 in 10 patients)
Migraine, headache, nausea, breast tenderness or pain, bleeding disorders: irregular, heavy, or painful menstrual periods, absence of menstruation, or less frequent menstruation.
Uncommon(may occur in less than 1 in 100 patients)
Weight gain, dizziness, depressive mood, vomiting, skin allergic reactions - such as rash, severe itching, or hives.
Rare(may occur in less than 1 in 1000 patients)
Fatigue, breast swelling, hemolytic anemia (anemia caused by increased breakdown of red blood cells), fluid retention, often affecting the legs or ankles, increased size of progestogen-dependent tumors (such as meningioma).
In younger patients, similar side effects are expected to those that occurred in adult women.

Side effects that occur when taking Altaria with estrogen (HRT - estrogen with progestogen)

When taking Altaria with estrogen, you should also read the patient information leaflet that comes with the estrogen-containing medicine. For more information on these side effects, see the "Important information before taking Altaria" section.

If you experience any of the following side effects, stop taking Altaria and contact your doctor immediately

• painful swelling of the legs, sudden chest pain, or difficulty breathing. These may be symptoms of blood clots;
• chest pain radiating to the arm or neck. These may be symptoms of a heart attack;
• severe, unexplained headaches or migraine (which may be accompanied by vision disturbances). These may be symptoms of a stroke. If you experience any of these side effects, stop taking Altaria and contact your doctor immediately.

Contact your doctor immediately if you notice:

• indentations in the skin of the breast, changes in the nipple, visible or palpable lumps. These may be symptoms of breast cancer. Other side effects that occur when taking Altaria with estrogen include endometrial hyperplasia, endometrial cancer, and ovarian cancer.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Altaria

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 packaging after "EXP".
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Altaria contains

• The active substance is dydrogesterone.
• Each coated tablet contains 10 mg of dydrogesterone.
• The other ingredients are: Tablet core: lactose monohydrate, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate. Tablet coating: hypromellose, macrogol, and titanium dioxide (E 171).

What Altaria looks like and contents of the pack

White, round, biconvex coated tablet, with "L1" engraved on one side of the tablet and no engraving on the other side.
The tablets are packaged in blisters in a cardboard box. The pack contains 10, 20, 28, 56, and 84 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: biuro@exeltis.com

Manufacturer

Cyndea Pharma S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida Agreda 31
Ólvega, Soria
42110 Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Dydroxel 10 mg Filmtabletten
France
Dydrogesterone Goibela 10 mg comprimé pelliculé
Germany
Dydroxel
Spain
Dydroxel
Luxembourg
Dydroxel
Poland
Altaria

Date of last revision of the package leaflet: