PATIENT INFORMATION LEAFLET
LUGESTERON® 100 mg and 200 mg capsule, soft
for oral or vaginal use
Microcrystalline progesterone
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Lugesteron is and what it is used for
2.
Before you take Lugesteron
3.
How to take Lugesteron
4.
Possible side effects
5.
How to store Lugesteron
6.
Further information
1.
WHAT LUGESTERON IS AND WHAT IT IS USED FOR
Lugesteron contains progesterone, which is a natural luteal hormone. Lugesteron is used in certain
situations to replace deficiency of the body's own progesterone excretion.
- perimenopausal hormone replacement therapy in connection with estrogen treatment
- premenstrual syndrome
- functional bleeding disorders
- corpus luteum insufficiency
Vaginal treatment is used alternatively instead of oral treatment especially in connection with
corpus luteum insufficiency.
2.
BEFORE YOU TAKE LUGESTERON
Do not take Lugesteron
if you are allergic (hypersensitive) to progesterone or any of the other ingredients of
Lugesteron, such as peanuts or soya
if you have or have had any of the following conditions: severe liver disease, cholestatic
jaundice, unexplained uterine bleeding, venous or arterial thromboemolic disease.
Take special care with Lugesteron
if you suffer from dizziness.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, natural medicines or natural remedies.
Pregnancy and lactation
Ask your doctor or pharmacist for advice before taking any medicine.
More than half of early miscarriages are due to genetic reasons. Furthermore, infections and
mechanical problems may cause a miscarriage. Supportive treatment with progesterone should
only be used in case the miscarriage is caused by corpus luteum insufficiency.
A complete medical check-up should be carried out before starting the treatment and at regular
intervals during treatment.
Natural progesterone has long been used for treating corpus luteum insufficiency during early
pregnancy. In treatment of infertility, for instance in connection with in vitro fertilization, Lugesteron
is used either vaginally or orally until pregnancy week 9–11. (At a later stage of pregnancy, the
indications of the drug are controversial.) Lugesteron should only be used during the first trimester
of pregnancy and only vaginally. At a later stage of pregnancy, the preparation may cause liver
function disorders.
Progesterone and progestins are considered safe to use during lactation in the above-mentioned
indications as they have not been found to inhibit milk production or to hamper the development of
the child.
Driving and using machines
Lugesteron may sometimes cause tiredness and sense of dizziness 1–3 hours after taking the
medicine.
Important information about some of the ingredients of Lugesteron
Lugesteron contains peanut oil and soya lecithin. If you are allergic to peanut of soya, do not use
this medicine.
3.
HOW TO TAKE LUGESTERON
Always take Lugesteron exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual oral dose of Lugesteron is 200–300 mg per day. The daily dose can be taken either as a
single dose in the evening or divided into two doses, one of which is taken in the morning and the
other, larger dose, in the evening at bedtime. However, a single dose should not exceed 200 mg.
The vaginal dose is usually 300–600 mg per day, and it is divided into two or three doses.
Perimenopausal hormone replacement therapy:
The dose is 200–300 mg per day and it can be taken either as a single dose in the evening at
bedtime or divided into two doses, one of which is taken in the morning and the other, larger dose,
in the evening at bedtime. However, a single dose should not exceed 200 mg. Lugesteron is taken
on days 12–14 of each calendar month in case the treatment is combined with continuous
estrogen replacement therapy, or on the last 12–14 days of each estrogen therapy period in case
estrogen is used periodically.
Functional bleeding disorders:
The dose is 200–300 mg per day and it can be taken either as a single dose in the evening at
bedtime or divided into two doses, one of which is taken in the morning and the other, larger dose,
in the evening at bedtime. However, a single dose should not exceed 200 mg. Lugesteron is taken
for 10–14 days starting on cycle day 15–17. Before starting the treatment, the possibility of
malignant changes should be excluded by taking an endometrial sample by suction, brushing,
rinsing or curettage.
Corpus luteum insufficiency:
The dose is 300 mg per day divided into two doses, one of which is taken in the morning and the
other, larger dose, in the evening at bedtime. However, a single dose should not exceed 200 mg.
Lugesteron is taken starting from the third post-ovulatory day (determined, for instance, with the
help of basal temperature curve, usually cycle day 17) and continuing until pregnancy week 9–11
but no longer, or until bleeding starts.
Premenstrual syndrome:
The dose is 200–300 mg per day and it can be taken either as a single dose in the evening at
bedtime or divided into two doses, one of which is taken in the morning and the other, larger dose,
in the evening at bedtime. However, a single dose should not exceed 200 mg. Lugesteron is taken
for 10 days on cycle days 17–26.
Orally ingested capsules should be swallowed with water, separately from meals, for example in
the evening at bedtime.
Vaginal administration is used in treatment of infertility, for example in connection with in vitro
fertilization, in which case the dose is 300–600 mg/day, divided into three doses starting from the
third post-ovulatory day and continuing until pregnancy week 9–11 but no longer, or until bleeding
starts.
If the medicine is used vaginally, one or more capsules are pushed deep into the vagina by hand.
If you take more Lugesteron than you should
Always contact a doctor, emergency department or the Poison Information Centre (tel. (09) 4711) if
you have or someone else has taken an overdose of Lugesteron.
Tiredness, dizziness and spotting may occur in connection with overdose.
If you forget to take Lugesteron
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Lugesteron can cause side effects, although not everybody gets them.
Temporary tiredness or sense of dizziness may occur within 1–3 hours after taking the medicine.
Spotting withdrawal bleeding may occur. Ask your doctor for advice in case you experience these
adverse effects. Changing the progesterone dose may reduce the spotting. Always follow the
instructions of your doctor carefully. If necessary, an endometrial sample may be taken.
Other possible adverse effects are abdominal pain, fluid retention, breast tension/tenderness,
weakened libido, headache, indigestion, abdominal bloating, thromboembolism and vaginal
irritation/bleeding.
If you experience any other adverse effects than the ones mentioned above during the treatment,
please tell your doctor.
The preparation contains glycerol, which may cause abdominal complaints and diarrhea when
taken orally in high doses.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5.
HOW TO STORE LUGESTERON
Store Lugesteron at room temperature (+15–25 °C).
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the package or in case you notice any changes
in the appearance of the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.
The carton and patient information leaflet can be recycled.
6.
FURTHER INFORMATION
What Lugesteron contains
The active ingredient is microcrystalline progesterone.
The excipients inside the capsule are peanut oil and soy lecithin and on the capsule shell
gelatine, glycerol and titanium dioxide.
What Lugesteron looks like: Round, sightly yellowish, soft gelatine capsule with whitish paste inside.
Marketing authorisation holder
Oy Leiras Finland Ab, PO Box 1406, 00101 Helsinki, tel. 020 746 5000
Manufacturer
Besins Manufacturing Belgium, Drogenbois, Belgium
The patient information leaflet was last revised on 9 October 2007