Package leaflet: Information for the user

Altaria, 10 mg, film-coated tablets
Dydrogesterone
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this 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 personally. 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Altaria is and what it is used for
What you need to know before taking Altaria
How to take Altaria
Possible side effects
How to store Altaria
Contents of the pack and other information

1. What Altaria is and what it is used for

What Altaria is
Altaria contains an active substance called dydrogesterone.

Dydrogesterone is a synthetic hormone.
It is very similar to the hormone progesterone, which is naturally produced in the body.
Medicines such as Altaria are called progestogens.

What Altaria is used for
Altaria may be used alone or in combination with oestrogen. Whether oestrogen is taken at the same time depends on the medical condition being treated.
Altaria is used in the treatment of:
Disorders caused by insufficient production of progesterone in the body, such as:

Irregular menstrual periods.

Symptoms of menopause as part of a treatment known as hormone replacement therapy (HRT).
Altaria may be used in combination with oestrogen to treat menopausal symptoms in women who still have their uterus. These symptoms vary between women.

How Altaria works
Normally, the body produces progesterone and another main female hormone, oestrogen, in appropriate proportions. Altaria is used to treat disorders that may occur if the body does not produce enough progesterone.
Your doctor may prescribe oestrogen to be taken together with Altaria to restore hormonal balance. In some women receiving HRT, taking oestrogen alone may cause overgrowth of the lining of the uterus (endometrial hyperplasia). This may also occur in women who have had a hysterectomy if they previously had endometriosis. Taking dydrogesterone for part of the menstrual cycle helps prevent overgrowth of the endometrium in these patients.

2. Important information before taking Altaria

When not to take Altaria:

if the patient is allergic to dydrogesterone or any of the other ingredients of this medicine (listed in section 6)
if the patient has or there is suspicion of a tumour (growth) dependent on progesterone, such as a brain tumour called "meningioma"
if the patient has vaginal bleeding of unknown cause
if Altaria is used in combination with oestrogen, please also read the section "When not to take" in the patient information leaflet included with the oestrogen-containing medicine
in case of severe acute liver disease or disorders of bile pigment excretion (Dubin-Johnson syndrome, Rotor syndrome) or if these diseases occurred in the past
in case of previous or current liver tumours
if the patient has thrombophlebitis or thromboembolic disease (abnormal formation of blood clots in blood vessels).

Warnings and precautions
If Altaria must be taken due to abnormal bleeding, the doctor will determine the cause of the bleeding before starting treatment with this medicine.
Usually, unexpected vaginal bleeding or spotting is not a reason for concern. It may occur especially during the first few months of taking Altaria.
However, you should contact your doctor immediately if bleeding or spotting:

lasts longer than a few months
appears after some time from the start of treatment
occurs even after stopping treatment. These may be symptoms of endometrial hyperplasia (thickening of the uterine lining). Your doctor will investigate the cause of bleeding or spotting and may recommend testing for endometrial cancer.

Note: Altaria is not a contraceptive medicine and does not prevent pregnancy.
You must stop taking Altaria and contact your doctor immediately if you notice any of the following symptoms:

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

For more information, see section "Blood clots in veins (thrombosis)".
When to exercise particular caution when using 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 any of these apply to you, you should visit your doctor more frequently for check-ups:

Porphyria (an inherited metabolic disorder with disturbances in the formation of red blood pigment)
Depression
Abnormal liver function test results due to acute or chronic liver disease
Jaundice and (or) itching.

Inform your doctor if you have:

stroke (even in the past)
high blood pressure.

Altaria and HRT
HRT use is associated with risks that should be considered before starting or continuing treatment. When taking Altaria together with oestrogen as part of HRT, the following information is important. You should also read the patient leaflet included with the oestrogen-containing medicine.
Early menopause
Experience in treating women with premature menopause (caused by ovarian failure or surgical intervention) is limited. In women with premature menopause, risks associated with HRT use may differ. Please discuss this with your doctor.
Medical examinations
Before starting (or restarting) HRT, your doctor will take a medical history of you and your family. The doctor may decide to perform a physical examination, which may include breast examination and (or) pelvic examination if necessary. After starting HRT, your doctor may recommend regular check-ups (at least once a year). During these check-ups, your doctor will discuss the benefits and risks of continuing HRT. You should have regular breast examinations as recommended by your doctor.
Excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer):
Taking oestrogen-only HRT increases the risk of excessive thickening of the uterine lining (endometrial hyperplasia) and cancer of the uterine lining (endometrial cancer). Taking Altaria together with oestrogen (for at least 12 days per month in a 28-day cycle) or as continuous combined oestrogen-progestogen therapy may prevent this additional risk.
Breast cancer
Data confirm that taking hormone replacement therapy (HRT) containing oestrogen and progestogen or oestrogen alone increases the risk of breast cancer. The additional risk depends on the duration of HRT use. This additional risk becomes apparent after about 3 years of HRT use. After stopping HRT, the additional risk will gradually decrease, but the risk may persist for 10 years or longer if HRT lasted more than 5 years.
Comparison
In women aged 50 to 54 years who do not use HRT, breast cancer will be diagnosed over a 5-year period in an average of 13 to 17 women per 1000.
In women aged 50 who start oestrogen-only HRT for 5 years, there will be 16-17 cases per 1000 users (i.e. 0 to 3 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 5 years, there will be 21 cases per 1000 users (i.e. 4 to 8 additional cases).
In women aged 50 to 59 years who do not use HRT, breast cancer will be diagnosed over a 10-year period in an average of 27 women per 1000.
In women aged 50 who start oestrogen-only HRT for 10 years, there will be 34 cases per 1000 users (i.e. 7 additional cases).
In women aged 50 who start combined oestrogen-progestogen HRT for 10 years, there will be 48 cases per 1000 users (i.e. 21 additional cases).
You should have regular breast examinations. Consult your doctor if you notice any changes such as:

skin indentation;
changes in the nipple;
any visible or palpable lumps. In addition, participation in breast cancer screening mammography programs is recommended if available. For mammograms, it is important to inform the staff performing the mammogram that you are using HRT, as this medicine may increase breast density, which may affect mammogram results. With increased breast density, mammography may not detect all lumps.

Ovarian cancer
Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only HRT or combined oestrogen-progestogen HRT is associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer depends on age. For example, in women aged 50 to 54 years who do not use HRT, ovarian cancer will be diagnosed over a 5-year period in about 2 out of 2000 women.
In women who used HRT for 5 years, it will occur in about 3 out of 2000 users (i.e. about one additional case).
Effect of HRT on the heart and circulation
Blood clots in veins (thrombosis)
The risk of blood clots in veins is about 1.3 to 3 times higher in women using HRT than in those who do not, especially during the first year of use.
Blood clots can be dangerous, and if a clot travels to the lungs, it may cause chest pain, shortness of breath, fainting, or even death.
The likelihood of developing a blood clot in veins increases with age and if any of the following conditions apply. Inform your doctor if any of the following 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 disorders requiring long-term anticoagulant treatment;
a close relative has ever had a blood clot in the leg, lungs or another organ;
if you have systemic lupus erythematosus (SLE);
if you have cancer.

Comparison
In women aged 50 who do not use HRT, it can be expected that on average 4 to 7 out of 1000 women will develop a blood clot in a vein over a 5-year period.
In women aged 50 who use combined oestrogen-progestogen HRT for more than 5 years, there will be 9 to 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 years of age who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than women not using any HRT.
Stroke
The risk of stroke is about 1.5 times higher in women using HRT than in those who do not. The number of additional stroke cases caused by HRT use will increase with age.
Comparison
In women over 50 years of age who do not use HRT, it can be expected that on average 8 out of 1000 women will have a stroke over a 5-year period.
In women over 50 years of age who use HRT, there will be 11 cases per 1000 users over a 5-year period (i.e. 3 additional cases).
You should inform your doctor immediately if you notice the first symptoms of adverse effects, become pregnant or experience abnormal bleeding.
Children and adolescents under 18 years of age
There is no indication for using Altaria in children before the onset of the first menstrual bleeding. Altaria is not recommended for use in adolescents aged 12-18 years, as there is insufficient data on safety and efficacy.
Altaria and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some medicines may affect the action of Altaria. This may lead to reduced effectiveness of Altaria. These include:

Antiepileptic medicines 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 chasteberry.

Progesterone, in turn, may weaken the effect of medicines that lower blood sugar levels.
Pregnancy, breastfeeding and effect on fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, you should consult your doctor or pharmacist before using 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 may be an increased risk of hypospadias (a congenital malformation of the penis where the urethral opening is in an abnormal location) in children whose mothers took certain progestogens. However, this increased risk has not been confirmed so far. It is estimated that more than 10 million pregnant women have taken dydrogesterone. To date, there is no evidence that using Altaria during pregnancy is harmful.
Breastfeeding
You must not take Altaria while breastfeeding. It is not known whether Altaria passes into human milk and whether it affects the child. Studies with other progestogens have shown that they pass into human milk in small amounts.
Fertility
There is no evidence that dydrogesterone reduces fertility when taken as recommended by a doctor.
Driving and operating machinery
After taking Altaria, slight drowsiness or dizziness may occur. This is more likely during the first few hours after taking the medicine. If these symptoms occur, do not drive or operate tools or machinery. You should wait and observe how the medicine affects you before deciding to drive, use tools or operate machinery.
Altaria contains lactose
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to take Altaria

This medicine should always be taken as directed by your doctor. If you have any doubts,
you should consult your doctor. Your doctor will adjust the dose according to your needs.
Taking this medicine
Swallow the tablet with water.
The tablet may be taken with or without food.
If you are taking more than one tablet per day, the doses should be divided evenly throughout the day; for example, one tablet in the morning and one in the evening.
Try to take the tablets at the same time each day. This will help maintain a constant level of the medicine in your body and will also help you remember to take your tablets.
How much medicine to take
The number of tablets taken and the days on which the medicine is taken depend on the reason for treatment. Your doctor will decide when it is best to take Altaria. If you are still menstruating, day 1 of your cycle is the first day of bleeding. If you no longer have natural periods, your doctor will decide when day 1 of the cycle falls and when to start taking the tablets.
Use in the treatment of irregular menstruation
Take 1 or 2 tablets of Altaria per day.
The medicine should be used during the second half of the cycle, up to the first day of the next menstruation.
The day to start taking the medicine and the number of days on which it is taken depend on the length of your cycle.
Use for the treatment of menopausal symptoms (HRT)
In hormone replacement therapy combined with an oestrogen-containing medicine:
If you are using HRT in a "continuous sequential" regimen (taking an oestrogen tablet or applying an oestrogen patch or gel throughout a 28-day cycle):

Take 1 tablet of Altaria once daily for the last 14 days of each 28-day cycle.
If you are using HRT in a "cyclical" regimen (taking an oestrogen tablet or applying an oestrogen patch or gel usually for 21 days, followed by a 7-day treatment-free interval):
Take 1 tablet of Altaria daily for the last 12 to 14 days of oestrogen use. If necessary, your doctor may increase the dose to 2 coated tablets per day.

After taking the last coated tablet of Altaria, a withdrawal bleed resembling a menstrual period will occur.
Your doctor will prescribe the lowest possible dose, and treatment for symptoms should be as short as possible. If you feel the dose is too strong or too weak, you should contact your doctor.
Use in children and adolescents under 18 years of age
Altaria is not intended for use in children before the onset of first menstrual bleeding. Altaria is not recommended for adolescents aged 12 to 18 years due to insufficient data on safety and efficacy.
Taking more than the recommended dose of Altaria
It is unlikely that taking too many Altaria tablets (by you or another person, including a child) would be harmful. If in doubt, consult your doctor.
Missing a dose of Altaria

If you forget to take a tablet on a given day and less than 12 hours have passed since it should have been taken, take the tablet as soon as you remember. Take the next tablet the following day at your usual time.
If you forget to take a tablet and more than 12 hours have passed since it should have been taken, skip that dose. Take the next tablet the following day at your usual time and continue as normal.
Do not take a double dose to make up for a missed dose.
If you miss a dose, there is an increased chance of irregular bleeding or spotting.

Stopping Altaria
Do not stop taking Altaria without consulting your doctor.
Planned surgical procedure
If you are scheduled for surgery, inform the surgeon that you are taking Altaria. It may be necessary to stop taking Altaria approximately 4 to 6 weeks before surgery to reduce the risk of blood clots (see section 2, "Blood clots in the veins (thrombosis)"). Your doctor will advise you when you can restart taking Altaria.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment with this medicine.
Adverse effects occurring during treatment with Altaria alone
If any of the adverse effects listed below occur, treatment with Altaria must be discontinued immediately and a doctor should be contacted:

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 fewer than 1 in 100 patients)
Hypersensitivity reactions – symptoms may include difficulty breathing or systemic symptoms such as nausea, vomiting, diarrhoea or low blood pressure (may occur in fewer than 1 in 1000 patients)
Swelling of the skin around the face and throat, which may cause difficulty breathing (may occur in fewer than 1 in 1000 patients). If any of the above adverse effects occur, treatment with Altaria must be discontinued immediately and a doctor should be contacted.

Other adverse effects occurring during treatment with Altaria alone
Common (may occur in fewer than 1 in 10 patients)
Migraine, headache, nausea, breast tenderness or pain, menstrual bleeding disorders: irregular, heavy or painful menstrual bleeding, absence of menstruation or less frequent menstruation.
Uncommon (may occur in fewer than 1 in 100 patients)
Weight gain, dizziness, depressed mood, vomiting, skin hypersensitivity reactions such as rash, severe itching or urticaria.
Rare (may occur in fewer than 1 in 1000 patients)
Fatigue, breast swelling, anaemia due to increased breakdown of red blood cells (haemolytic anaemia), fluid retention causing oedema, frequently affecting the lower legs or ankles, increase in size of progestogen-dependent tumours (such as meningioma).
In younger patients, adverse effects are expected to be similar to those observed in adult women.

Adverse effects occurring during treatment with Altaria combined with oestrogen
(HTZ – oestrogen-progestogen combination)
When taking Altaria with oestrogen, the patient information leaflet included with the oestrogen-containing medicine should also be consulted. For further information regarding the adverse effects listed, see section "Important information before taking Altaria".
If any of the adverse effects listed below occur, treatment with Altaria must be discontinued immediately and a doctor should be contacted:

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 myocardial infarction;
Severe, unexplained headache or migraine (possibly accompanied by visual disturbances) – these may be symptoms of stroke. If any of the above adverse effects occur, treatment with Altaria must be discontinued immediately and a doctor should be contacted.

A doctor should be contacted immediately if the patient notices:

Dimpling of the skin on the breast(s), changes in the nipple, or visible or palpable lumps – these may be symptoms of breast cancer. Other adverse effects occurring during treatment with Altaria combined with oestrogen include endometrial hyperplasia, endometrial cancer and ovarian cancer.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store the medicine Altaria

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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: monohydrate lactose, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate.
Tablet coating: hypromelose, macrogol, titanium dioxide (E 171).

What Altaria looks like and contents of the pack
White, round, biconvex coated tablet, marked with "L1" on one side and unmarked on the other side.
The tablets are packed in blisters in a cardboard box. The pack contains 10, 20, 28, 56 or 84 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw
e-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Dydroxel 10 mg Filmtabletten
France Dydrogestérone Goibela 10 mg comprimé pelliculé
Germany Dydroxel
Spain Dydroxel
Luxembourg Dydroxel
Poland Altaria