Luteina Mikro

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Luteina Mikro, 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 another person, even if their symptoms are the same.
If you experience any side effects, contact a doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet. See section 4.

Table of contents of the leaflet

• 1. What is Luteina Mikro, 200 mg and what is it used for
• 2. Important information before taking Luteina Mikro, 200 mg
• 3. How to take Luteina Mikro, 200 mg
• 4. Possible side effects
• 5. How to store Luteina Mikro, 200 mg
• 6. Contents of the packaging and other information

1. What is Luteina Mikro, 200 mg and what is it used for

What is Luteina Mikro, 200 mg

This medicine contains progesterone, which is a natural female sex hormone produced in the body. This medicine maintains hormonal balance in the body. This medicine is used in progestagenic hormone therapy.

What is it used for

This medicine is used in case of disorders caused by a deficiency of progesterone in the body. The doctor will recommend taking this medicine in one of the following situations.
a) In case of progesterone deficiency
The level of progesterone produced by the ovaries (in the luteal phase) is below normal. In such a situation, this medicine may be used to treat irregular periods.
b) Permanent cessation of menstruation (menopause)
Supportive treatment in hormone replacement therapy with estrogen during menopause in women with an intact uterus.

2. Important information before taking Luteina Mikro, 200 mg

When not to take Luteina Mikro, 200 mg:

if the patient is allergic to progesterone or any of the excipients of this medicine (listed in section 6);
in case of vaginal bleeding of unknown cause;
in case of severe liver dysfunction;
in case of liver tumor;
in case of breast cancer or genital organ cancer;
if the patient has a blood clot in a vein (thrombosis), e.g. in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism) or if such blood clots have occurred in the past;
in case of brain bleeding;
in case of a rare blood disease called "porphyria", which is genetically transmitted (inherited);
in case of taking Luteina Mikro, 200 mg during menopause in combination with another hormonal medicine, i.e. so-called estrogen, you should also read the leaflet accompanying the packaging of this medicine (estrogen), to find out when not to take this medicine.

Warnings and precautions

Before taking this medicine, consult a doctor.
This medicine taken as recommended is not a contraceptive.
Before starting hormone replacement therapy during menopause (and then at regular intervals, every year), a medical consultation should be carried out, during which a clinical breast and pelvic examination can be performed.
If therapy with Luteina Mikro, 200 mg is started too early in the month, especially before the 15th day of the cycle, the cycle may be shortened or bleeding may occur.
Inform your doctor:
If the patient has had blood clots in the veins (venous thrombosis) in the past.
In case of uterine bleeding.
Stop taking this medicine if:
Any vision disorders (e.g. impaired vision, double vision, changes in the blood vessels of the retina).
Any blood clots (venous thromboembolic disease or thrombosis).
Severe headaches.
If during treatment, amenorrhea (absence of menstruation) occurs, it should be ensured that the patient is not pregnant.
Excessive growth of the uterine lining (endometrial hyperplasia) may recur or worsen during treatment.
If unexpected bleeding or spotting (minor bleeding) persists during prolonged treatment or at the end of treatment, or after the end of therapy, consult a doctor.

Children

The efficacy and safety of Luteina Mikro, 200 mg in children have not been established.

Luteina Mikro, 200 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. Some medicines may change the effect of Luteina Mikro, 200 mg:
Older-type medicines called barbiturates, used to treat sleep disorders or anxiety states
Medicines for epilepsy (phenytoin, carbamazepine)
Some antibiotics (ampicillin, tetracyclines, rifampicin)
Phenylbutazone (anti-inflammatory medicine)
Spironolactone (diuretic)
Some antifungal medicines (ketoconazole, griseofulvin)
Similarly, Luteina Mikro, 200 mg may affect the way some medicines used to treat diabetes work. Herbal products containing St. John's Wort (Hypericum perforatum) may weaken the effect of Luteina Mikro, 200 mg.

Luteina Mikro, 200 mg with food and drink

This medicine should be taken outside of meal times, preferably in the evening before bedtime.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Pregnancy
If you are pregnant, think you may be pregnant, or plan to have a child, consult a doctor before taking this medicine or any other medicine.
Breastfeeding
Avoid taking this medicine if you are breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Fertility
This medicine may be used in women with fertility problems. There are no known harmful effects on fertility. Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

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

Luteina Mikro, 200 mg contains soybean lecithin

This medicine contains soybean lecithin. This medicine should not be taken in case of allergy to peanuts or soy.

3. How to take Luteina Mikro, 200 mg

This medicine should always be taken as recommended by the doctor. In case of doubts, consult a doctor or pharmacist.

Recommended dose in case of irregular periods:

The medicine should be taken for 10 days in each cycle, usually from the 17th to the 26th day inclusive.
Usually, the recommended dose is 200 to 300 mg of progesterone per day and is taken in 1 or 2 divided doses, i.e. 200 mg in the evening before bedtime and 100 mg in the morning if necessary.

Recommended dose for menopause treatment

Treatment with estrogens alone is not recommended in women during menopause with an intact uterus.
Therefore, for at least 12 to 14 days a month (in the last 2 weeks of each treatment cycle), a single dose of 200 mg of progesterone should be added to the treatment, taken before bedtime.
Then, a break of about one week in replacement therapy can be applied, during which withdrawal bleeding may occur.

How to take the capsules?

The capsules should be swallowed, washed down with a small amount of water.
The capsules should not be taken with food.
It is best to take this medicine in the evening before bedtime. The second dose should be taken in the morning.

Taking a higher dose of Luteina Mikro, 200 mg than recommended

Consult a doctor or pharmacist immediately or go to the hospital.
Overdose symptoms may occur, such as dizziness, fatigue, severe euphoria, or painful menstruation. In such a case, the dose may be reduced. Always consult a doctor first.

Missing a dose of Luteina Mikro, 200 mg

Take the medicine as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Luteina Mikro, 200 mg

The doctor will inform you how long to take this medicine. Do not stop treatment prematurely.
If you have any further questions about taking this medicine, consult a 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 brain bleeding,
Blood clots in the veins of the legs or in the pelvic area,
Sudden severe headache,
Eye disorders,
Yellowing of the skin or whites of the eyes (jaundice).

Common side effects (up to 1 in 10 people):

Headache.
Changes in menstrual bleeding or bleeding at times other than withdrawal bleeding. In such a case, the doctor may change the way the medicine is taken.

Uncommon side effects (up to 1 in 200 people):

Changes in the breasts. Possible breast tenderness.
Feeling of fatigue or dizziness.
Nausea (vomiting), diarrhea, constipation.
Yellowing of the skin or whites of the eyes (jaundice).
Itching, acne.

Rare side effects (up to 1 in 1,000 people):

Allergic reactions.
Feeling of nausea (nausea).

Very rare side effects (up to 1 in 10,000 people):

Depression.
Rash (which may be itchy).
Brown or dark skin discoloration (so-called mask of pregnancy).
Additional side effects have been reported in connection with hormone replacement therapy containing estrogen and progestogen:
Mild or malignant estrogen-dependent tumor, e.g. endometrial cancer.
Blood clots in the veins (venous thromboembolic disease), caused by blood clots (thrombosis) in the deep veins of the legs or in the pelvic area, as well as pulmonary embolism, occur more frequently in women taking hormone replacement therapy than in women not taking it.
Heart attack (myocardial infarction) and stroke.
Disorders of gallbladder function.
Brown pigmentation of the skin (chloasma), various skin diseases with blistering and nodules (erythema multiforme, nodular erythema, purpura).
Probable dementia.

If treatment is started too early in the month (especially before the 15th day of the cycle)

The cycle may be shortened, and bleeding may occur outside of the withdrawal bleeding period.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 Luteina Mikro, 200 mg

Do not store above 30°C. Store in the original packaging to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Do not dispose of medicines in the sewage system or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures will help protect the environment.

6. Contents of the packaging and other information

What does Luteina Mikro, 200 mg contain

The active substance is progesterone. Each capsule contains 200 mg of progesterone.
The excipients are grape seed oil and soybean lecithin.
The capsule shell consists of gelatin, glycerol, and titanium dioxide (E 171).
See section 2, "Luteina Mikro contains soybean lecithin".

What does Luteina Mikro, 200 mg look like and what does the packaging contain

200 mg, soft capsules: oval, soft gelatin capsules, white in color, approximately 16 mm long and 9.6 mm wide, with the marking "PR2".
Each blister pack contains 15 soft capsules. Each package contains 15 or 30 soft capsules
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice
Laboratorios LEÓN FARMA, SA
Calle La Vallina S/N
Poligono Industrial Navatejera
24193 Villaquilambre
Spain

This medicinal product is authorized in the EEA member states under the following names:

Poland
Luteina Mikro

Date of last revision of the leaflet: