GEPRETIX 200 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Gepretix 200mg Soft Capsules EFG

Progesterone

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

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

Contents of the Package Leaflet

1. What is Gepretix 200 mg and what is it used for
2. What you need to know before you take Gepretix 200 mg
3. How to take Gepretix 200 mg
4. Possible side effects
5. Storage of Gepretix 200 mg
6. Contents of the pack and further information

1. What is Gepretix 200 mg and what is it used for

What isGepretix

This medicine contains progesterone, which is a natural female sex hormone produced in the body. The action of this medicine is to adjust the hormonal balance in the body. This medicine is a hormonal treatment with progestogens.

What it is used for

This medicine is used if you experience disorders due to a lack of progesterone in the body. Your doctor will ask you to take this medicine if you are in one of the following situations.

1. You have a progesterone deficiency

The levels of progesterone produced by the ovaries (during the luteal phase) are below the normal value. In this situation, this medicine could be used to treat irregular menstrual periods.

1. Your menstrual period stops permanently (menopause)

Complementary use in hormone replacement therapy with an estrogen in postmenopausal women with an intact uterus.

2. What you need to know before you take Gepretix 200 mg

Do not takeGepretix200mg if:

• You are allergic to progesterone or any of the other ingredients 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 breast or genital tumor
• 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

Warnings and precautions

If you use this medicine during menopause in combination with another hormonal treatment, i.e., an estrogen, you should also check the package leaflet of that medicine (estrogen) to know the cases in which you should not use this medicine.

Consult your doctor before starting to take this medicine.

• The medicine, when used in the recommended conditions, is not a contraceptive.
• Before taking hormone replacement therapy during menopause (and at periodic annual intervals thereafter), you should have a medical consultation where a clinical examination of the breasts and pelvis can be performed.

You must inform your doctor:

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

You must stop taking this medicine if you have:

• Any vision changes (e.g., reduced vision, double vision, blood vessel lesions in 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.

Excessive growth of the uterine lining (endometrial hyperplasia) may recur or worsen during treatment.

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

Children

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

Other medicines andGepretix200mg

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-type 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 antifungal medicines (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.

TakingGepretixwith food and drinks

You should take this product away from meals and preferably at night when going to bed.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

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

Breastfeeding

You should avoid using this medicine if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

This medicine may be used in women with problems conceiving. Therefore, it has no known harmful effects on fertility.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Gepretixcontains soybean lecithin.

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

3. How to take Gepretix 200 mg

Follow exactly the administration instructions of this medicine 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 day 17 to 26, both included.
• The average dose is 200 to 300 mg of progesterone per day, taken as 1 or 2 divided doses, i.e., 200 mg at night when going to bed plus 100 mg in the morning, if necessary.

Recommended dose for menopause treatment

• Hormone replacement therapy with estrogen alone is not recommended for postmenopausal women with an intact uterus.
• A single dose of 200 mg of progesterone should be added at night when going to bed for at least 12 to 14 days per month (in the last 2 weeks of each treatment sequence).
• This may be followed by approximately one week without treatment, during which withdrawal bleeding may occur.

How to take the capsules?

Swallow the capsules with a little water.

Do not take the capsules with food.

Preferably, take the product at night when going to bed. Take the second dose in the morning.

If you take moreGepretix200mg than you should

Contact your doctor or pharmacist immediately or go to a hospital.

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

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

If you forget to takeGepretix200mg

Take it 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 forgotten doses.

If you stop takingGepretix200mg

Your doctor will indicate how long you should use this medicine. Do not stop treatment prematurely.

If you have any further questions on 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:

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

The following side effects are common (up to 1 in 10people):

• Headaches.
• Changes in menstrual flow or bleeding at times other than withdrawal bleeding. In these cases, your doctor may modify the way you take your medicine.

The following side effects are uncommon (up to 1 in 100people):

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

The following side effects are rare (up to 1 in 1,000people):

• Allergic reactions.
• Nausea.

The following side effects are very rare (up to 1 in 10,000people):

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

Other additional side effects have been reported in relation to hormone replacement therapy containing an estrogen and a progestogen:

• Benign or malignant estrogen-dependent tumors, e.g., 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 users of hormone replacement therapy than in non-users.
• Heart attack (myocardial infarction) and stroke.
• Gallbladder disorders.
• Brownish discoloration of the skin (chloasma), some skin disorders with blistering and nodules (erythema multiforme, erythema nodosum, vascular purpura).
• Probable dementia.

If the treatment sequence starts too early in the month (especially before day15 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, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gepretix 200 mg

Do not store above 30°C. Keep in the original package to protect from light.

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 and blister, after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Gepretix 200mg

The active substance is progesterone. Each capsule contains 200 mg of progesterone.

The other ingredients are grape seed oil and soybean lecithin.

The capsule is composed of gelatin, glycerol, and titanium dioxide (E171).

See section 2. Gepretix contains soybean lecithin.

Appearance of the product and contents of the pack

Soft capsules of 200 mg: soft gelatin capsules, white, approximately 16 mm in length and approximately 9.6 mm in width.

Each blister pack contains 15 soft capsules.

Each carton contains 15, 30, 45, 60, or 90 soft capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Exeltis Healthcare, S.L.

Avda. de Miralcampo, 7.

Pol. Ind. Miralcampo.

19200 Azuqueca de Henares. Guadalajara.

Spain.

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial Navatejera

24193 Villaquilambre, León

Spain

Date of last revision of this package leaflet:March 2022

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