Luteina mikro

Package leaflet: Information for the patient

Luteina Mikro, 200 mg, soft capsules
Progesterone
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are identical.
If you experience any adverse reactions, contact your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet. See section 4.
Table of contents of the leaflet

1. What is Luteina Mikro, 200 mg and for what purpose is it used
2. Important information before using Luteina Mikro, 200 mg
3. How to use Luteina Mikro, 200 mg
4. Possible adverse reactions
5. How to store Luteina Mikro, 200 mg
6. Contents of the pack and other information

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

What is Luteina Mikro, 200 mg
This medicine contains progesterone, which is a natural female sex hormone produced in the body. This medicine helps maintain hormonal balance in the body. It is used in progestogen hormone therapy.
For what purpose is it used
This medicine is used in cases of disorders caused by a deficiency of progesterone in the body. Your doctor may recommend using this medicine in one of the following situations:
a) In case of progesterone deficiency
The concentration of progesterone produced by the ovaries (in the luteal phase) is below normal. In such a case, this medicine may be used to treat irregular menstruation.
b) Permanent cessation of menstruation (menopause)
Adjunctive treatment in hormone replacement therapy with estrogen during menopause in women with an intact uterus.

2. Important information before using Luteina Mikro 200 mg

When not to use Luteina Mikro 200 mg:
if the patient is allergic to progesterone or to any of the excipients
of this medicine (listed in section 6);
in case of vaginal bleeding of unknown cause;
in case of severe liver function disorders;
in case of liver tumour;
in case of existing or suspected breast or genital organ cancer;
if the patient has a blood clot in a vein (venous thrombosis), e.g. in the legs (deep vein thrombosis)
or in the lungs (pulmonary embolism), or if she has previously experienced such blood clots;
in case of cerebral haemorrhage;
in case of a rare inherited genetic blood disorder called "porphyria";
when using Luteina Mikro 200 mg during menopause in combination with another hormonal medicine, i.e. an oestrogen, the package leaflet of the oestrogen product should also be consulted to determine when this medicine should not be used.

Warnings and precautions
Consult a doctor before using this medicine.
This medicine, when used as directed, is not a contraceptive.
Before starting hormone therapy during menopause (and subsequently at regular intervals, annually), a medical consultation should be carried out, during which clinical examination of the breasts and pelvic organs may be performed.
If treatment with Luteina Mikro 200 mg is started too early in the cycle,
particularly before day 15, the cycle may be shortened or bleeding may occur.
Inform the doctor:
if the patient has previously experienced venous blood clots (venous thrombosis).
in case of uterine bleeding.
This medicine should be discontinued in the event of:
any visual disturbances (e.g. blurred vision, double vision, changes in retinal blood vessels).
any blood clots (venous thromboembolic disease or thrombosis).
severe headaches.
If absence of menstruation occurs during treatment, pregnancy should be ruled out.
Excessive growth of the uterine lining (endometrial hyperplasia) may recur or worsen during treatment.
If unexpected bleeding or spotting (light bleeding) persists during long-term treatment, at the end of treatment, or after treatment has ended, 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 the patient is currently taking or has recently taken, as well as any medicines she plans to take. Some medicines may alter the effect of Luteina Mikro 200 mg:
barbiturates (older type medicines used to treat sleep disorders or anxiety)
antiepileptic drugs (phenytoin, carbamazepine)
some antibiotics (ampicillin, tetracyclines, rifampicin)
phenylbutazone (an anti-inflammatory medicine)
spironolactone (a diuretic)
some antifungal medicines (ketoconazole, griseofulvin)
Similarly, Luteina Mikro 200 mg may affect the way some diabetes medicines work. Herbal products containing St John's wort (Hypericum perforatum) may reduce the effectiveness of Luteina Mikro 200 mg.

Luteina Mikro with food and drink
This medicine should be taken apart from meal times, preferably in the evening before going to sleep.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this or any other medicine.

Breastfeeding
This medicine should be avoided if the patient is breastfeeding.
Before starting any medicine, consult a doctor or pharmacist.

Fertility
This medicine may be used in women experiencing difficulties becoming pregnant. Therefore, there are no known harmful effects on fertility. Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Do not drive or operate machinery if drowsiness or dizziness occurs.

Luteina Mikro contains soya lecithin
This medicine contains soya lecithin. This medicine should not be used if the patient is allergic to peanuts or soya.

3. How to use Luteina Mikro, 200 mg

This medicine should always be taken as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Recommended dose for irregular menstruation:
The medicine should be taken for 10 days in each cycle, usually from day 17 to day 26 inclusive.
The usual dose is 200 to 300 mg of progesterone per day, administered in 1 or 2 divided doses, i.e. 200 mg in the evening before bedtime and, if necessary, 100 mg in the morning.
Recommended dose for menopausal hormone therapy:
Estrogen-only therapy is not recommended for menopausal women who have an intact uterus.
Therefore, for at least 12 to 14 days per month (during the last 2 weeks of each treatment cycle), a single daily dose of 200 mg of progesterone should be added, taken before bedtime.
Afterwards, a break of approximately one week in hormone replacement therapy may be taken, during which withdrawal bleeding may occur.
How to take the capsules:
Swallow the capsules with a small amount of water.
Do not take the capsules with food.
It is best to take this medicine in the evening before bedtime. The second dose should be taken in the morning.
Taking more than the recommended dose of Luteina Mikro, 200 mg
Seek immediate medical advice from a physician or pharmacist, or go to hospital.
Symptoms of overdose may include dizziness, fatigue, intense euphoria, or painful menstruation. In such cases, the dose may be reduced. Always consult a physician beforehand.
Missed dose of Luteina Mikro, 200 mg
Take the missed dose as soon as the patient remembers. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Luteina Mikro, 200 mg
The physician will inform the patient how long this medicine should be taken. Do not discontinue treatment prematurely.
If there are any further questions regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking this medicine immediately if you experience any of the following symptoms:
Stroke, blood clots or bleeding in the brain,
Blood clots in the veins of the legs or pelvic area,
Sudden severe headache,
Eye disturbances,
Yellowing of the skin or whites of the eyes (jaundice).
Common adverse reactions (in up to 1 in 10 people):
Headache.
Changes in menstrual bleeding or bleeding at times other than withdrawal bleeding. In such cases, the doctor may change the way the medicine is taken.
Uncommon adverse reactions (in up to 1 in 200 people):
Breast changes. Breast tenderness may occur.
Feeling tired or dizzy.
Nausea (vomiting), diarrhoea, constipation.
Yellowing of the skin or whites of the eyes (jaundice).
Itching, acne.
Rare adverse reactions (in up to 1 in 1,000 people):
Allergic reactions.
Feeling sick (nausea).
Very rare adverse reactions (in up to 1 in 10,000 people):
Depression.
Rash (which may be itchy).
Brown or dark skin discolouration (so-called chloasma).
Additional adverse reactions reported with hormone replacement therapy containing estrogen and progestagen:
Benign or malignant estrogen-dependent tumours, e.g. endometrial cancer.
Venous thromboembolic disease (blood clots in veins), caused by blood clots (thrombosis) in deep leg veins or pelvic veins, as well as pulmonary embolism, occur more frequently in women using hormone replacement therapy than in women not using it.
Heart attack (myocardial infarction) and stroke.
Gallbladder function disorders.
Brownish skin pigmentation (melasma), various skin diseases with blister and nodule formation (erythema multiforme, nodular erythema, vasculitic purpura).
Probable dementia.
If treatment is started too early in the cycle (especially before day 15 of the cycle)
The cycle may be shortened, and bleeding may occur outside the withdrawal bleeding period.
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package.
The expiry date refers to the last day of the stated month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the pack and other information

What Luteina Mikro, 200 mg contains
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 Luteina Mikro, 200 mg looks like and contents of the pack
200 mg, soft capsules: white, oval-shaped soft gelatin capsules approximately 16 mm long and 9.6 mm wide, marked with "PU2".
Each blister contains 15 soft capsules. Each pack contains 15 or 30 soft capsules.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the EEA countries under the following names:
Poland Luteina Mikro