Progevera 5 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Progevera 5 mg tablets

Medroxyprogesterone acetate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What Progevera 5 mg tablets are and what they are used for
2. What you need to know before taking Progevera 5 mg tablets
3. How to take Progevera 5 mg tablets
4. Possible adverse effects
5. How to store Progevera 5 mg tablets
6. Contents of the pack and other information

1. What Progevera 5 mg is and what it is used for

Progevera 5 mg contains the active substance dydrogesterone, a synthetic analogue of the naturally occurring female hormone progesterone.

This medicine belongs to the group of progestogens (female hormones). It has no androgenic (masculinizing), oestrogenic (female hormone-like), or anabolic (tissue-building) effects.

Progevera is used for the treatment of conditions associated with progesterone deficiency, such as:

• Irregular menstrual cycles
• Painful menstruation (dysmenorrhoea)
• Premenstrual syndrome (PMS)
• Threatened or recurrent miscarriage due to progester wan deficiency
• Endometriosis
• Prevention of endometrial hyperplasia in women receiving estrogens in hormone replacement therapy (HRT)

The active substance is dydrogesterone.

Progevera 5 mg tablets are supplied in a blister pack containing 24 tablets. It is a hormone (progestagen) that replaces the body's natural hormone deficiency and counteracts certain undesirable effects of other hormones (estrogens, androgens, and gonadotropins) in the specific situations described below:

• As an adjunctive treatment to estrogen therapy in non-hysterectomized postmenopausal women (women without surgical removal of the uterus).
• Secondary amenorrhea (prolonged absence of menstrual bleeding), provided that pregnancy has been previously ruled out.
• Functional metrorrhagia (abundant and irregular bleeding).
• Infertility, as inadequate luteal phase function may be a cause of infertility.
• Premenstrual syndrome (a disorder that typically occurs in the days preceding menstruation).
• Dysmenorrhea (menstrual pain, leg cramps).
• Mild to moderate endometriosis (growth of endometrial tissue patches outside the uterus).

2. What you need to know before starting Progevera 5 mg tablets

Do not take Progevera:

• If you are allergic (hypersensitive) to medroxyprogesterone acetate or to any of the other components of Progevera.
• If you have thrombophlebitis or thromboembolic phenomena, severe arterial hypertension, severe hepatic insufficiency, missed abortion (pregnancy termination without expulsion of the fetus), undiagnosed vaginal or urinary tract bleeding, or undiagnosed breast pathology.
• If you are pregnant or think you might be pregnant.

Age is not a limiting factor for therapy, although treatment with progestogens may mask the onset of menopause.

Take special care with Progevera:

• If you experience vaginal spotting or bleeding, you should consult your doctor to determine the cause. Heavy bleeding may occur in patients being treated for endometriosis.
• If you have a history of epilepsy or migraines, if you are asthmatic, or if you have cardiac or renal disorders, you should inform your doctor, as fluid retention caused by the medication may worsen your condition.
• If you are diabetic or suffer from depression.
• If you have or suspect thromboembolic disorders (conditions that may lead to abnormal blood clot formation), sudden partial or complete loss of vision, double vision, headache, retinal edema, or retinal vascular lesions, you should stop treatment immediately and contact your doctor.
• If you are undergoing laboratory tests, inform the laboratory personnel that you are taking Progevera.

An adequate intake of calcium and vitamin D is recommended.

Bone mineral density assessment may be appropriate in some patients receiving long-term medroxyprogesterone acetate therapy.

Breast cancer

Evidence shows that combined estrogen-progestogen hormone therapy (HT), or estrogen-only therapy, increases the risk of developing breast cancer. This additional risk depends on the duration of HT. The additional risk becomes evident after 3 years of treatment. After stopping HT, this additional risk decreases over time, but may persist for 10 years or more if HT was used for more than 5 years.

Other medicines and Progevera 5 mg

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription. Especially if you are taking hypoglycemic agents, anticoagulants, or aminoglutethimide.

Pregnancy, breastfeeding, and fertility

A possible association has been reported between the administration of progestogens during the first months of pregnancy and congenital malformations in the newborn. In view of this and the risk of virilization in female fetuses, use of this product during pregnancy is not recommended.

Progestogens have been detected in breast milk, and although the effect of these substances on the nursing infant is unknown, as a general rule, you should avoid breastfeeding while taking this medication.

Driving and use of machines

Administration of Progevera does not affect the ability to drive or operate machinery.

Progevera 5 mg contains lactose and sucrose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Progevera 5 mg tablets

Follow these instructions unless your doctor has given you different advice.

Remember to take your medicine. Consult your doctor or pharmacist if you have any doubts.

Method of administration

Menopause: 5 to 10 mg daily (1 to 2 tablets of 5 mg), during the last 10–14 days of estrogen therapy.

Secondary amenorrhea: 2.5 to 10 mg daily (half to 2 tablets of 5 mg), for 5 to 10 days, starting on day 16 or 21 of the cycle. In patients with endometrial atrophy, it is advisable to combine Progevera with estrogen administration; the dose required to induce maximal secretory transformation of the endometrium is 10 mg (2 tablets of 5 mg) of Progevera daily for 10 days. Withdrawal bleeding usually occurs within the first three days after discontinuing Progevera treatment. To restore normal menstrual cycle, treatment should be repeated for three consecutive cycles.

Functional metrorrhagia: 2.5 to 10 mg (half to 2 tablets of 5 mg) daily, for 5 to 10 days, starting on day 16 or 21 of the cycle. Once bleeding is controlled, Progevera treatment should be repeated for two consecutive cycles.

Infertility: 2.5 to 10 mg (half to 2 tablets of 5 mg) daily, starting in the second half of the cycle (day 14).

Premenstrual tension: 2.5 to 10 mg (half to 2 tablets of 5 mg) daily, for 5–7 days before the end of the menstrual cycle.

Dysmenorrhea: 2.5 to 10 mg (half to 2 tablets of 5 mg) daily, from day 5 to day 25 of the menstrual cycle.

Endometriosis: 10 mg (2 tablets of 5 mg) starting on the first day of the menstrual cycle, three times a day, for 90 consecutive days.

If you think that the effect of Progevera is too strong or too weak, tell your doctor or pharmacist.

If you take more Progevera 5 mg than you should

Acute administration of a therapeutic dose of Progevera by oral route is considered safe and non-toxic. If you have taken more Progevera than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Progevera 5 mg

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, Progevera may have adverse effects, although not everyone experiences them.

Uncommon adverse effects, which may affect more than 1 in 1,000 but less than 1 in 100 people, are:

Nervous system disorders: headache, nervousness, drowsiness, dizziness.

Skin and subcutaneous tissue disorders: acne.

Rare adverse effects, which may affect more than 1 in 10,000 but less than 1 in 1,000 people, are:

Psychiatric disorders: difficulty sleeping.

Nervous system disorders: depression.

Vascular disorders: conditions that may lead to abnormal blood clot formation (thromboembolic disorders).

Gastrointestinal disorders: nausea.

Skin and subcutaneous tissue disorders: hair loss, excessive hair growth in women, itching, rash, urticaria.

Immune system disorders: potentially severe allergic reactions, appearance of localized swelling mainly around eyes, lips, hands, feet, and throat.

Investigations: decreased glucose tolerance.

Metabolism and nutrition disorders: weight changes.

Reproductive system and breast disorders: breast tenderness on palpation.

In addition, the following adverse effects have been observed:

Hepatic disorders: yellowing of the skin and whites of the eyes (jaundice).

Reproductive system and breast disorders: abnormal uterine bleeding (irregular, increased, decreased), absence of menstruation, cervical changes (discharges and erosions), breast pain, milk secretion from the breasts outside pregnancy and the postpartum period, prolonged absence of ovulation.

General disorders and administration site conditions: edema/fluid retention, fatigue, fever.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Progevera 5 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required. Store at room temperature.

Expiry

Do not use Progevera after the expiry date stated on the packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Progevera

Progevera 5 mg tablets

• The active substance is medroxyprogesterone acetate. Each tablet contains 5 mg of medroxyprogesterone acetate.
• The other components (excipients) are: lactose, sucrose, maize starch, talc, calcium stearate, liquid paraffin, indigotine (E-132) and aluminium lake blue.

Nature and contents of the container

Progevera 5 mg are blue, film-coated, round, biconvex tablets, scored on one side and engraved with the letter "U" on the other, packed in PVC/aluminum blisters. Each pack contains 24 tablets.

The laboratory also markets another similar product: Progevera 10 mg, available in a blister pack containing 30 tablets.

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa 20-B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid),

Spain

Manufacturer responsible:

Pfizer Italia, S.r.L.

Località Marino del Tronto

63100 Ascoli Piceno (AP)

Italy

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)