Luttagen

Package Leaflet: Information for the Patient

Luttagen, 100 mg, Soft Capsules

Luttagen, 200 mg, Soft Capsules

Progesterone

Read the 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 specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

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. Contents of the pack and other information

1. What is Luttagen and what is it used for

This medicine is a progesterone hormone therapy.
It is indicated for use in disorders related to progesterone deficiency:

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

2. Important information before taking Luttagen

Do not take Luttagen if:

• you are allergic (hypersensitive) 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 suspect breast or genital cancer
• you have or have had blood clots in the veins (thrombosis), e.g. in the limbs (deep vein thrombosis) or lungs (pulmonary embolism)
• you have or have had active disease caused by blood clots in the arteries, e.g. heart attack, stroke or angina pectoris
• you have bleeding into the brain
• you have a rare inherited disease called porphyria.

Warnings and precautions

Before starting to take Luttagen, consult a doctor.
Warnings
Stop taking the medicine and contact a doctor if you experience any of the following: heart attack, stroke, sudden severe headache, vision disturbances, blood clot 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 concurrent 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 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 then at regular intervals), each patient should consult a doctor. During the visit, a clinical breast examination and gynecological examination can be performed.
• Do not take Luttagen capsules during meals; they should be taken before bedtime.
• Luttagen should be used with caution in patients with:
• diseases that may worsen due to 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 hypersensitivity to light, and breastfeeding women.

Luttagen and other medicines

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

• medicines used to treat epilepsy (such as phenobarbital, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (such as rifampicin, rifabutin)
• medicines containing St. John's Wort (Hypericum perforatum)
• 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 the use of this medicine in pregnant women does not indicate the existence of toxicity causing developmental abnormalities or harmful effects of progesterone on the fetus or newborn.
Before taking any medicine, consult a doctor or pharmacist.
Breastfeeding
Measurable amounts of progesterone pass into the breast milk of nursing mothers. 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 medicine does not have a harmful effect on fertility.

Driving and using machines

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

Luttagen contains soy lecithin

Do not use if you are known to be hypersensitive to peanuts or soy.

3. How to take Luttagen

Method of administration

This medicine is intended for oral use only.
Luttagen 100 mg or 200 mg should be taken between meals, preferably in the evening before bedtime. This medicine should always be taken strictly according to the doctor's instructions. In case of doubts, consult a 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 a doctor or pharmacist.

Frequency of administration

Depending on the case, treatment may be continuous or cyclic, for several days a month, and may be associated with estrogen therapy.
The capsule should be swallowed with a glass of water, taken between meals, once or twice, depending on the treatment schedule determined by the doctor.

Duration of treatment

The duration of treatment will be determined by the 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

Consult a 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 bleeding, amenorrhea, intermenstrual bleeding, headache
• Uncommon side effects(occurring in no more than 1 in 100 people): breast tenderness, 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): changes in libido, depression, urticaria, hirsutism, fever, excessive hair loss, excessive hair growth. These disorders are mainly caused by overdose. In such cases, the doctor may recommend: reducing the single dose of the medicine or changing the time of administration.
• reducing the single dose of the medicine
• or changing the time of administration.

In no case should the maximum dose of 200 mg per day be exceeded.
If overdose symptoms occur, consult a doctor who will adjust the treatment.
If you experience any side effects, including any side effects 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, 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.
Reporting side effects will help to gather more information on the safety of the 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.
Do not store above 30°C.
Store in the outer packaging to protect from light.
Do not take the medicine if you notice 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. Contents of the pack and other information

What Luttagen contains

• The active substance of the medicine is progesterone. Each Luttagen 100 mg capsule contains 100 mg of progesterone, and each Luttagen 200 mg capsule contains 200 mg of progesterone.
• The other ingredients are: purified peanut oil (type II), gelatin, glycerol, titanium dioxide (E 171), saturated fatty acid triglycerides of medium chain length, soy lecithin (see section 2. "Luttagen contains soy lecithin").

What Luttagen looks like and contents of the pack

Each blister pack contains 15 capsules.
Each pack of Luttagen 100 mg contains 30 or 90 soft capsules.
Each pack of Luttagen 200 mg contains 15 or 45 soft capsules.
Dimensions of the capsules (100 mg): length: 12.5 mm (10-15 mm), width: 7.5 mm (5-10 mm)
Dimensions of the capsules (200 mg): length: 15.5 mm (12-19 mm), width: 9 mm (6-12 mm)

Marketing authorization holder:

Exeltis Poland Sp. z o.o.
Ul. Gen. Józefa Zajączka 9
01-518 Warsaw
Poland

Manufacturer:

Laboratorios Leon Farma S.A.
Calle Vallina S/N, Pradiello, Villaquilambre
24193 Leon
Spain
Effik France
Bâtiment Le Newton, 9-11 Rue Jeanne Braconnier
Meudon La Foret Cedex 92366
France

Date of last revision of the leaflet: