LUGESTERON 200 mg SOFT GEL CAPSULES

2. What you need to know before you take Lugesteron

Do not take Lugesteron

• If you are allergic to progesterone or any of the other components of this medicine (listed in section 6).
• If you have unexplained vaginal bleeding.
• If you have severe liver dysfunction.
• If you have a liver tumor.
• If you have or may have a tumor in the breast or genital organs.
• If you have an active blood clot in a vein (thrombosis), such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism), or if you have a history of these types of blood clots.
• If you have a cerebral hemorrhage.
• If you have a rare blood disorder called porphyria that is inherited through the family.
• If you use this medicine during menopause in combination with another hormone treatment, i.e., the so-called "estrogen", you should also consult the package leaflet of that medicine (estrogen) to know when you should not use this medicine.

Warnings and precautions

Consult your doctor before starting to take this medicine.

• The medicine used in the described conditions of use does not have a contraceptive effect.
• Before taking hormone treatment during menopause (and at regular annual intervals thereafter), you should have a medical consultation where a clinical examination of the breasts and pelvis can be performed.
• If you start taking this medicine too early in the month, especially before the 15th day of the cycle, the cycle may be shortened or bleeding may occur.

You should inform your doctor:

• If you have a history of blood clots in the veins (venous thrombosis).
• In case of uterine bleeding.

You should stop taking this medicine if you have:

• Any vision changes (e.g., reduced vision, double vision, lesions of the blood vessels of the retina).
• Any blood clot (thromboembolic or venous thrombotic effects).
• Severe headaches.

If you develop amenorrhea (absence of menstruation) during treatment, you should check that you are not pregnant.

The excessive growth of the uterine lining (endometrial hyperplasia) may return or worsen during treatment.

If unexpected bleeding or spotting persists during long-term treatment or at the end or after treatment, you should consult a doctor.

Children

The efficacy and safety of this medicine have not been established in children.

Other medicines and Lugesteron

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

Some medicines may change the effect of this medicine:

• old medicines called barbiturates used for sleep disorders or to treat anxiety
• medicines for epilepsy (phenytoin, carbamazepine)
• some antibiotics (ampicillin, tetracyclines, rifampicin)
• phenylbutazone (an anti-inflammatory medicine)
• spironolactone (a diuretic)
• some medicines for the treatment of fungal infections (ketoconazole, griseofulvin)

Similarly, this medicine may affect some medicines used for diabetes.

Herbal medicines containing St. John's Wort (Hypericum perforatum) may reduce the effect of this medicine.

Taking Lugesteron with food and drinks

You should take this medicine outside of meals and preferably at night before bedtime.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine or any other medicine.

Breastfeeding

This medicine should not be used during breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Fertility

This medicine may be used in women with problems getting pregnant. Therefore, no harmful effects on fertility are known.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or use machines if you experience drowsiness or dizziness.

Lugesteron contains soybean lecithin

This medicine contains soybean lecithin (soybean oil). Do not use this medicine if you are allergic to peanuts or soy.

3. How to take Lugesteron

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Recommended dose if you have irregular menstrual periods

• You should take this medicine for 10 days per cycle, usually from the 17th to the 26th day, both inclusive.
• The average recommended dose is 200 to 300 mg of progesterone per day, divided into 1 or 2 doses, i.e., 200 mg at night before bedtime plus 100 mg in the morning, if necessary.

Recommended dose for menopause treatment

• Estrogen therapy alone is not recommended for women with an intact uterus.
• A single dose of 200 mg of progesterone should be added at night before bedtime for at least 12 to 14 days per month (in the last 2 weeks of each treatment sequence).
• You can follow approximately one week without treatment replacement, during which withdrawal bleeding may occur.

How to take the capsules

Take the capsules with a little water.

Do not take the capsules with food.

Preferably, take the product at night before bedtime. Take the second dose in the morning.

If you take more Lugesteron than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

You may experience overdose symptoms that include dizziness, fatigue, intense feelings of well-being, or periods of pain. In this case, the dose can be reduced. Always consult your doctor beforehand.

If you forget to take Lugesteron

Take the medicine as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

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

If you stop taking Lugesteron

Your doctor will indicate the duration of treatment with this medicine. Do not stop treatment before it is indicated.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine immediately if you experience any of the following symptoms:

• Stroke, blood clots, or cerebral hemorrhage.
• Blood clots in the veins of the legs or pelvis,
• Sudden and severe headache,
• Eye problems,
• Yellowing of the skin or whites of the eyes (jaundice).

Common (may affect up to 1 in 10 people)

• Headaches.
• Changes in menstrual flow or bleeding at times other than withdrawal bleeding. If this happens, your doctor may change the way you take your medicine.

Uncommon (may affect up to 1 in 100 people)

• Changes in the breasts. They may become sensitive to the touch.
• Feeling tired or dizzy.
• Nausea (vomiting), diarrhea, constipation.
• Yellowing of the skin or whites of the eyes (jaundice).
• Itching of the skin, acne.

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

• Allergic reactions.
• Feeling unwell (nausea).

Very rare (may affect up to 1 in 10,000 people)

• Depression.
• Rash (which can cause itching).
• Bronze or dark discoloration of the skin (so-called "pregnancy mask").

Additional side effects have been reported in relation to hormone replacement therapy that includes an estrogen and a progestogen:

• Benign or malignant estrogen-dependent tumors, such as endometrial carcinoma.
• Blood clots in the veins (venous thromboembolism), due to blood clots (thrombosis) of the deep veins of the legs or pelvis, as well as pulmonary embolism, occur more frequently in those using hormone replacement therapy than in those who do not.
• Heart attack (myocardial infarction) and stroke.
• Gallbladder disorders.
• Pigmentation of the skin (chloasma), various skin disorders with blistering and nodules (erythema multiforme, erythema nodosum, vascular purpura).
• Probable dementia.

If the treatment sequence starts too early in the month (particularly before the 15th day of the cycle)

The cycle may be shortened and bleeding may occur at times other than withdrawal bleeding.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lugesteron

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

Do not use this medicine after the expiration date that appears on the box after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Do not refrigerate.

Keep in the original packaging to protect from moisture.

Do not use this medicine if you notice visible signs of deterioration. Return the medicine to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lugesteron

• The active substance is progesterone. The progesterone is in a micronized form equivalent to 200 mg per soft capsule.
• The other components (excipients) are: soybean lecithin, sunflower oil, titanium dioxide (E171), gelatin, and glycerol.

Appearance and packaging of the product

• Lugesteron 200 mg is available in packs of 15, 30, 45, or 90 soft capsules for oral use and packaged in blisters.
• Lugesteron 200 mg are soft, oval-shaped capsules, slightly yellow, containing a white oily suspension.
• Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Besins Healthcare Ireland Limited

Plaza 4, Level 4 Custom House Plaza

Harbourmaster Place, IFSC

Dublin 1, D01 A9N3

Ireland

Manufacturer:

CYNDEA PHARMA S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31

42110 Ólvega (Soria)

Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Laboratorios Rubió, S.A.

Pol.Ind. Comte de Sert

C/Industria 29

08755 Castellbisbal-Barcelona

Spain

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

Belgium: Progestérone BESINS 200 mg, capsule molles

Luxembourg: Progestérone BESINS 200 mg, capsule molles

Netherlands: Progesteron Besins 200 mg zacht capsules

Poland: Progesterone Besins 200 mg, kapsulki miekkie

Germany: Utrogest 200 mg Weichkapseln

Spain: Lugesteron 200 mg soft capsules EFG

Norway: Utrogestan 200 mg myk kapsel

Iceland: Utrogestan 200 mg, mjúkt hylki

Sweden: Utrogestan 200 mg, mjuk kapsel

Date of last revision of this leaflet: February 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)