Luttagen

Package Leaflet: Information for the Patient

Luttagen, 100 mg, Soft Capsules

Luttagen, 200 mg, Soft Capsules

Progesterone

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Luttagen and what is it used for
• 2. Important information before taking Luttagen
• 3. How to take Luttagen
• 4. Possible side effects
• 5. How to store Luttagen
• 6. Package contents and other information

1. What is Luttagen and what is it used for

This medicine contains the hormone progesterone.
It is indicated for use in disorders related to a deficiency of endogenous progesterone:

• in the case of irregular cycles due to ovulation disorders,
• in the case of pain and other disorders occurring before menstruation,
• in the case of bleeding (bleeding due to fibroids),
• in postmenopausal women (together with estrogen therapy).

2. Important information before taking Luttagen

Do not take Luttagen if:

• you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• you have or have had severe liver disease
• you have vaginal bleeding of unknown cause
• you have or are suspected of having breast or genital cancer
• you have or have had blood clots in the veins (thrombosis), such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• you have or have had active disease caused by the presence of blood clots in the arteries, such as a heart attack, stroke, or angina pectoris
• you have had bleeding into the brain
• you have a rare inherited disease called porphyria.

Special warnings and precautions

Before starting to take Luttagen, talk to your doctor.
Warnings
Stop taking the medicine and contact your doctor if you experience any of the following: heart attack, stroke, sudden severe headache, vision disturbances, blood clots in a vein or artery.
Luttagen can be prescribed together with other medicines containing estrogen used in hormone replacement therapy. The use of such a combination is associated with an increased risk of deep vein thrombosis (DVT) or pulmonary embolism.
There is evidence to suggest that estrogen replacement therapy is associated with a small increased risk of breast cancer. It is not known whether the simultaneous use of progesterone affects the risk of breast cancer in postmenopausal women taking hormone replacement therapy.
This medicine does not treat all causes of spontaneous abortion. It has no effect on abortions resulting from genetic causes (more than half of spontaneous abortions).
The medicine, when used as directed, does not have contraceptive efficacy.
Precautions
Take the medicine between meals, preferably in the evening before bedtime.

• Before starting hormone replacement therapy (and at regular intervals during treatment), each patient should undergo a medical examination, during which the doctor may examine the breasts and uterus.
• Do not take Luttagen during meals; it is recommended to take it before bedtime.
• Luttagen should be used with caution in patients with:
• diseases that may worsen as a result of fluid retention (e.g., hypertension, heart disease, kidney disease, epilepsy, migraine, asthma);
• patients with a history of depression, diabetes, mild to moderate liver function disorders, migraine, or sensitivity to light, as well as breastfeeding women.

Luttagen and other medicines

Tell your doctor about all medicines you are currently taking, have recently taken, or may take.
Some medicines may affect the action of Luttagen. These include:

• medicines used in epilepsy (such as phenobarbital, phenytoin, and carbamazepine)
• medicines used in tuberculosis (such as rifampicin, rifabutin)
• medicines containing St. John's wort
• bromocriptine
• cyclosporine
• ketokonazole. Smoking and drinking alcohol may also affect the action of Luttagen.

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
A large amount of data on pregnant women does not indicate toxicity of progesterone to the fetus or newborn.
Before taking any medicine, consult a doctor or pharmacist.
Breastfeeding
Detectable amounts of progesterone pass into breast milk. The use of progesterone during breastfeeding is contraindicated. However, taking progesterone during breastfeeding does not appear to have a harmful effect on the growth of the child.
Fertility
The product does not have a harmful effect on fertility.

Driving and using machines

People driving vehicles and operating machines should be aware that taking this medicine may cause drowsiness and/or dizziness.

Luttagen contains soy lecithin.

Do not take this medicine if you are allergic to peanuts or soy.

3. How to take Luttagen

Method of administration

The medicine is intended for oral use only.
Luttagen 100 mg or 200 mg should be taken between meals, preferably in the evening before bedtime.
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dose

Usually, in the case of progesterone deficiency, the recommended dose is 200 to 300 mg per day, either as a single dose or in two divided doses: 100 mg in the morning and 100 mg or 200 mg in the evening before bedtime.
In no case should a single dose exceed 200 mg. If you feel that the action of Luttagen is too strong or too weak, consult your doctor or pharmacist.

Frequency of administration

Depending on the case, treatment may be continuous or cyclic, for several days a month, and may be combined with estrogen therapy.
Swallow the capsule with a glass of water, between meals, in one or two doses, depending on the treatment schedule determined by your doctor.

Duration of treatment

The duration of treatment will be determined by your doctor, depending on the individual case.
Depending on the type of indication and the effectiveness of the treatment, the doctor may change the duration of the treatment.

Taking a higher dose of Luttagen than recommended

Contact your doctor or pharmacist immediately.
Overdose symptoms may occur, including: drowsiness, dizziness, euphoria, or menstrual disorders.

Missing a dose of Luttagen

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

4. Possible side effects

Like all medicines, Luttagen can cause side effects, although not everybody gets them.
The following side effects have been observed:

• Common side effects(occurring in no more than 1 in 10 people): changes in menstrual cycle, amenorrhea, intermenstrual bleeding, headache
• Uncommon side effects(occurring in no more than 1 in 100 people): breast pain, drowsiness or dizziness within 1 to 3 hours after taking the medicine, gastrointestinal disorders, rash, acne, fluid retention
• Rare side effects(occurring in no more than 1 in 1000 people): nausea, jaundice, weight changes
• Very rare side effects(occurring in no more than 1 in 10,000 people): disorders of sexual desire, depression, urticaria, hirsutism, fever, hair loss, excessive hair growth.

These disorders are mainly caused by overdose of the medicine.
In such cases, the doctor may recommend:

• reducing the single dose of the medicine
• or changing the time of taking the doses.

In no case should the maximum dose of 200 mg per day be exceeded.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Luttagen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in a temperature not exceeding 30°C. To protect from light, the preparation should be stored in the original carton.
Do not take the medicine if you notice any signs of deterioration. In this case, return the medicine to the pharmacy.
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. Package contents and other information

What Luttagen contains

The active substance of the medicine is progesterone. One capsule of Luttagen 100 mg contains 100 mg of progesterone, and one capsule of Luttagen 200 mg contains 200 mg of progesterone.
The medicine also contains purified peanut oil (type II).
The capsule consists of gelatin, glycerol, and titanium dioxide.
External intermediate products remaining after the manufacturing process (see section 2, "Luttagen contains soy lecithin").

What Luttagen looks like and contents of the pack

Each blister pack contains 15 capsules.
Each pack contains 30 or 90 soft capsules.
Each pack contains 15 or 45 soft capsules.

Marketing authorization holder:

Exeltis Poland Sp. z o.o.
ul. Szamocka 8
01-748 Warsaw

Manufacturer:

EFFIK

Bâtiment «Le Newton»
9-11 rue Jeanne Braconnier
92366 MEUDON LA FORET
France
or
Laboratorios LEON FARMA SA
C/ La Vallina s/n
Polígono Industrial Navatejera
Villaquilambre
24008 LEÓN
Spain
Date of last revision of the leaflet:04/2020