Luteina mikro

Package leaflet: Information for the patient

Luteina Mikro, 100 mg, soft capsules
Progesteronum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If any adverse reactions occur, contact your doctor or pharmacist. This includes any possible adverse reactions not listed in this leaflet. See section 4.
Table of contents

1. What Luteina Mikro, 100 mg is and what it is used for
2. Important information before taking Luteina Mikro, 100 mg
3. How to take Luteina Mikro, 100 mg
4. Possible side effects
5. How to store Luteina Mikro, 100 mg
6. Contents of the pack and other information

1. What Luteina Mikro, 100 mg is and what it is used for

What Luteina Mikro, 100 mg is
This medicine contains progesterone, which is a natural female sex hormone produced in the body. This medicine helps maintain hormonal balance. It is used in progestagen hormone therapy.
What it is used for
This medicine is used in cases of disorders caused by a deficiency of progesterone in the body. Your doctor may recommend 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 cases, this medicine may be used to treat irregular menstruation.
b) Permanent cessation of menstruation (menopause)
Adjunctive treatment in estrogen-progestogen hormone replacement therapy during menopause in women with an intact uterus.

2. Important information before using Luteina Mikro, 100 mg

When not to use Luteina Mikro, 100 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 dysfunction;
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 blood disorder called "porphyria";
when using Luteina Mikro, 100 mg during menopause in combination with another hormonal medicine, i.e. so-called oestrogen, the patient should also read the leaflet included in the oestrogen medicine package to learn when this medicine should not be used.

Warnings and precautions
Before using this medicine, consult a doctor.
This medicine, when used as directed, is not a contraceptive.
Before starting hormone therapy during menopause (and subsequently at regular annual intervals), a medical consultation should be carried out, during which clinical examination of the breasts and pelvic organs may be performed.
If therapy with Luteina Mikro, 100 mg is started too early in the menstrual 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.
The use of this medicine should be discontinued in the following cases:
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 menstruation does not occur 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 therapy has ended, consult a doctor.

Children
The efficacy and safety of Luteina Mikro, 100 mg in children have not been established.

Luteina Mikro, 100 mg and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used. Some medicines may alter the effect of Luteina Mikro, 100 mg:
barbiturates (older type medicines used to treat sleep disorders or anxiety)
antiepileptic drugs (phenytoin, carbamazepine)
some antibiotics (ampicillin, tetracyclines, rifampicin)
phenylbutazone (anti-inflammatory medicine)
spironolactone (diuretic)
some antifungal medicines (ketoconazole, griseofulvin)
Likewise, Luteina Mikro, 100 mg may affect the action of certain medicines used to treat diabetes. Herbal products containing St John's wort (Hypericum perforatum) may reduce the effectiveness of Luteina Mikro, 100 mg.

Luteina Mikro, 100 mg with food and drink
This medicine should be taken outside mealtimes, preferably in the evening before bedtime.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 child, 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 in 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, 100 mg

This medicine should always be taken exactly as directed by the doctor. In case of any doubts, consult
your doctor 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 100 mg in the morning if needed.
Recommended dose for menopausal treatment:
Estrogen-only therapy is not recommended for menopausal women who still 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 introduced, during which withdrawal bleeding may occur.
How to take the capsules?
The capsules should be swallowed whole 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, 100 mg
Seek immediate medical advice from your doctor or pharmacist, or go to the hospital.
Symptoms of overdose may include dizziness, fatigue, strong feelings of euphoria, or painful menstruation. In such cases, the dose may be reduced. Always consult your doctor first.
If you miss a dose of Luteina Mikro, 100 mg
Take the missed dose 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 a missed dose.
Stopping treatment with Luteina Mikro, 100 mg
Your doctor will advise you on how long you should continue taking this medicine. Do not stop treatment prematurely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 effects (in up to 1 in 10 people):
Headache.
Changes in menstrual bleeding or bleeding between periods, or bleeding other than withdrawal bleeding. In such cases, the doctor may change the way the medicine is taken.
Uncommon adverse effects (in up to 1 in 100 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 effects (in up to 1 in 1,000 people):
Allergic reactions.
Feeling sick (nausea).
Very rare adverse effects (in up to 1 in 10,000 people):
Depression.
Rash (which may be itchy).
Brown or dark skin discolouration (so-called melasma).
Additional adverse effects 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 the veins), caused by blood clots (thrombosis) in the deep veins of the legs or pelvic area, 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 (chloasma), various skin diseases with blister and nodule formation (erythema multiforme, nodular erythema, vasculitic purpura).
Possible 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 effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Luteina Mikro, 100 mg

Do not store above 30°C. Store in the original packaging to protect from light.
Keep the medicine out of the 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 month indicated.
Medicines should not be disposed of via wastewater or household waste bins. Ask your pharmacist
how to dispose of medicines that are no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Luteina Mikro, 100 mg contains
The active substance is progesterone. Each capsule contains 100 mg of progesterone.
The excipients are grape seed oil and soy lecithin.
The capsule shell consists of gelatin, glycerol and titanium dioxide (E 171).
See section 2, "Luteina Mikro contains soy lecithin".

What Luteina Mikro, 100 mg looks like and contents of the pack
100 mg, soft capsules: oval, soft gelatin capsules, whitish in colour, approximately 12 mm in length and approximately 8 mm in width.
Each blister contains 15 soft capsules. Each package 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