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Dufaston 10 mg. 30 tablets

Product Code: Dufaston 10 mg. 30 tablets
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What Dufaston is and what it is used for

Duofoston contains a medicine called dydrogesterone. Dydrogesterone is a human hormone progesterone. Medicines such as Duffon are called progestagens.

Dufaston can be used alone or concurrently with estrogen.

Dufaston is given:

if you have problems that you may have if your body does not produce enough progesterone:
to relieve painful menstruation;
to alleviate the symptoms of endometriosis (a problem caused by the growth of the uterine lining outside the uterus);
to cause menstruation that has stopped before menopause (secondary amenorrhea) occurs;
to control irregular menstruations (those that occur at an unusual time or do not occur at all);
to stop or prevent unusually severe or prolonged menstrual bleeding (often due to the onset of menopause);
to relieve the symptoms of premenstrual syndrome (PMS);
to reduce the risk of abortion;
to treat infertility due to low levels of progesterone;
To treat the signs of menopause - this treatment is called hormone replacement therapy or HRT. Duofoston is taken together with estrogen to treat the signs of menopause. These signs can be different for each woman.
How does Dufaston work?

Dufaston is used to treat problems that may occur when the body does not produce enough of the hormone progesterone. Progesterone is synthesized in the ovaries from the beginning of puberty to the onset of menopause. Progesterone (dydrogesterone) in Duffon replaces the missing hormone. In the body, progesterone is usually balanced by the main female hormone estrogen.
Your doctor may prescribe an estrogen-containing medicine to have the right balance of hormones.
In postmenopausal women who are on HRT, taking estrogen only may cause an excessive increase in the thickness of the lining of the uterus. Taking dydrogesterone over a period of time during estrogen treatment may reduce the negative effects of estrogens on the lining of the uterus.

2. What you need to know before taking Dufaston

Do not take Dufaston

if you are allergic (hypersensitive) to dydrogesterone or any of the other ingredients of Duffonton listed in section 6;
if you have or are likely to have a tumor that can be aggravated by progesterone - like a brain tumor called meningioma;
if you have bleeding from the vagina for no reason;
if you have contraindications for estrogen therapy when used in combination with dydrogesterone.
Warnings and precautions
Talk to your doctor before taking Dufaston

If you have to take Dufaston due to vaginal bleeding, your doctor will determine the cause of the bleeding before you start treatment.

If you get unexpected bleeding or dirt from the vagina »this should not be a cause for concern. This is likely to happen during the first months of treatment with DuPonton. However, talk to your doctor straight away if vaginal bleeding or spotting:

has lasted more than several months;
started some time after the start of treatment;
even after stopping treatment.
This may be a sign that the lining of your uterus has become thicker. Your doctor will identify the cause of vaginal bleeding or spotting and can do research to rule out malignancy of the uterine lining.

Tell your doctor if you have:

depression
liver problems
a rare blood disease that is transmitted to the family by heritage and is called porphyria.
If any of these conditions apply to you (even if you are not sure), tell your doctor before taking DuPonton. It is extremely important to tell whether these conditions have worsened during pregnancy or previous hormonal therapy. Your doctor may wish to monitor you more often during treatment. If the complaints worsen or worsen while taking Duffon, your doctor may stop treatment.

Dufaston and HRT

As it helps, HRT has some risks that you and your doctor should discuss when deciding whether to take these medicines. If you are taking Duaston with estrogen as part of HRT, the information below is important. Please also read the package leaflet of the estrogen you are going to take!

Early menopause
There is limited evidence of the risk of HRT when used to treat early menopause. In younger women the level of risk is low. This means that the benefit / risk balance of younger women taking HRT for early menopause may be better than older women.

Medical examinations
Before you start HRT, your doctor will ask you about your disease history as well as your family and may decide to examine your chest and organs in the small pelvis.
After starting
Administration of Dufaston and estrogen (for at least 12 days a month on a 28-day cycle) or as a permanent combination estrogen-progesterone therapy in women without removing an operative uterus may prevent this risk.

Breast cancer
Women taking estrogen-progesterone HRT and possibly estrogen alone, such as HRT, have a higher risk of breast cancer. The risk of breast cancer depends on how long you take HRT. The additional risk increases with the duration of the treatment and becomes apparent after about 3 years. However, the risk returns to normal within 5 years after discontinuation of treatment.

If you notice any of the following changes in your breasts, tell your doctor immediately:

wrinkle skin;
grain changes;
lumps that you can get or feel.
Ovarian cancer
Ovarian cancer is rarely seen - much less often than breast cancer. The use of HRT only with estrogen or combined estrogen-progestagen HRT is associated with a slightly increased risk of ovarian cancer.

The risk of ovarian cancer varies with age. For example, in women aged 50-54 who do not take HRT, about 2 per 2,000 women will be diagnosed with ovarian cancer for a period of 5 years. In women who take HRT for 5 years, there would be about 3 cases per 2000 treated (ie about 1 extra case).

Blood thrombi
HRT increases the risk of thrombi in the veins (deep vein thrombosis or pulmonary thromboembolism). The risk is up to three times higher than in people who do not take HRT, especially during the first year of HRT.

Thrombi is more likely to form:

if you are older;
if you have cancer;
if you are overweight;
if you are taking estrogen;
if you are pregnant or have recently given birth;
if you have (or your close) thrombi, incl. in the legs or lungs;
if you have been immobilized for a long time due to a major surgery, injury or illness;
if you have a disease called "systemic lupus erythematosus" (SLE) - a problem that can cause joint pain, skin rash and fever.
If any of the listed conditions apply to you (or you are not sure), talk to your doctor to find out if you should take HRT.

If you get a painful swelling of the leg, sudden chest pain or difficulty in breathing:

contact your doctor immediately.
do not take more HRT until the doctor says it is allowed.
This may be a sign of formation of a thrombus.

Tell your doctor if you are taking medicines to prevent the formation of thrombi (anticoagulants) such as warfarin. Your doctor will pay special attention to the benefits and risks of HRT.

Surgical Procedures
If you have a planned operation, tell your doctor in advance that you are taking HRT. You may need to stop HRT 4 to 6 weeks before surgery to reduce the risk of thrombus formation. Your doctor will tell you when you can start HRT again.

Heart disease
HRT will not help prevent heart disease. Women taking estrogen-progesterone HRT have a slightly increased risk of developing heart disease compared to those who do not take HRT. The risk of heart disease increases with age. The number of additional cases of heart disease due to the use of estrogen-progesterone HRT is very low in healthy women near menopause. The number of additional cases increases with age.

If you get heart pain spreading to your neck and arm:

go to a doctor immediately;
stop taking HRT until the doctor tells you that it is allowed.
This pain may be a sign of heart disease.

Brain stroke
Taking estrogen-progesterone HRT or estrogen alone increases the risk of
stroke (ischemic stroke). This risk is up to one and a half times higher than in women who do not take HRT. The risk of stroke increases with age.

If you get a severe unexplained headache or migraine (which may be accompanied by vision problems):

go to a doctor immediately;
stop taking HRT until the doctor tells you that it is allowed.
This may be an early warning sign of a stroke.
Other Drugs and DuPonton
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines. These medicines can change the effectiveness of DuPonton:

herbal products containing St. John's wort, sage or gingko biloba;
anti-convulsive medications (epilepsy) such as phenobarbital, carbamazepine, phenytoin;
anti-infections medicines - such as rifampicin, rifabutin, nevirapine, efavirenz;
anti-AIDS medicines - such as ritonavir, nelfinavir.
Duffonton with food and beverages
Duffon can be taken with or without food.

Children and adolescents
Duffon should not be used in children before their first menstrual bleeding. It is not known how effective and safe Dufaston is in children aged 12 to 18 years
To induce menstruation that has stopped before menopause (amenorrhea):

1 or 2 tablets a day;
take the tablets for 14 days during the second half of the menstrual cycle.
To control irregular menstrual:

1 or 2 tablets a day.
take the tablets from the second half of the menstrual cycle until the first day of your next cycle.
the day you start treatment and the number of treatment days depend on the duration of your cycle.
To stop or prevent unusually severe or prolonged menstrual bleeding:

To stop bleeding:
2 or 3 tablets a day;
take the tablets for 10 days.
For continuous treatment:
1 or 2 tablets a day;
take the tablets during the second half of the cycle.
the day you start treatment and the number of treatment days depend on your cycle.
To relieve the symptoms of premenstrual syndrome (PMS)

2 tablets daily;
take the tablets from the second half of the menstrual cycle until the first day of the next cycle;
the day you start treatment and the number of treatment days depend on the length of your cycle.
To reduce the risk of abortion

if you have not had a previous miscarriage:
initial dose up to 4 tablets daily;
then take 2 or 3 tablets a day until the symptoms disappear.
if you have had a previous miscarriage:
2 tablets daily;
take the tablets until 12 weeks of pregnancy.
To treat infertility due to low levels of progesterone

1 or 2 tablets a day;
take the tablets from the second half of the menstrual cycle until the first day of the next cycle;
the day you start treatment and the number of treatment days depend on the duration of your cycle;
treatment should continue for at least three consecutive cycles.
For treatment of symptoms of menopause - HRT

if you are on "sequential" HRT (you are taking estrogen for the entire period of the cycle):
1 tablet daily;
take the tablets during the second 14 days of the 28 day cycle.
If you are on "cyclic" HRT (you are taking estrogen for 21 days, followed by a 7-day interval without treatment):
1 tablet daily;
take the tablets for the last 12 to 14 days of estrogen therapy.
if necessary, your doctor will increase the dose to 2 tablets a day.
If you take more DuPontone than you should
If you have taken more than the prescribed dose of Duffon you have been prescribed (a situation known as an overdose), contact your doctor immediately or go to the nearest hospital immediately by taking the medicine pack with you.

If you forget to take DuPonton
You should take DuPonton as prescribed. However, if you miss a dose, take it as soon as you remember, except when the time for the next dose is near. Then take the next dose straight;
Do not take a double dose to make up for the missed dose;
You may notice a slight bleeding or spotting if you miss a dose.

If you stop taking Dufaston
Do not stop taking Dufaston without telling your doctor.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

As with all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects of DuPonton, taken alone
Stop taking Duffon and talk to your doctor straight away or go to the nearest hospital if you notice any of the following side effects:

liver problems - signs may include yellowing of the skin and whites of the eyes (jaundice), feeling weak, general malaise with abdominal pain (affects less than 1 in 100 people);
allergic reactions - signs may include difficulty in breathing or malaise, diarrhea or low blood pressure (affects less than 1 in 1,000 people);
swelling of the skin of the face and throat, which may cause difficulty in breathing (affects less than 1 in 1,000 people).
Other side effects of Duffonton, taken alone:

Common side effects (may affect between 1 and 10 patients in every 100 treated):

migraine, headache;
nausea;
sensitive / painful breasts;
irregular menstruation;
painful menstruation;
increased menstrual bleeding;
decreased menstrual bleeding;
lack of menstruation.
Uncommon side effects (may affect between 1 and 10 patients in every 1,000 treated):

weight gain;
feeling dizzy;
feeling of depression;
vomiting;
skin allergic reactions - rash, pruritus, or urticaria.
Rare side effects (may affect between 1 and 10 patients in every 10,000 treated):

drowsiness;
swelling of the chest;
anemia due to destruction of red blood cells;
swelling of the feet and / or ankles;
increase in tumor size affected by progestagen (such as meningooma).
Adverse effects in adolescents are expected to be similar to those seen in
How to Store Dufaston

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Dufaston  contains

the active substance is dydrogesterone. Each film-coated tablet contains 10 mg dydrogesterone.
the other ingredients are: lactose monohydrate, hypromellose, corn starch, colloidal anhydrous silica, magnesium stearate, titanium dioxide (E171), macrogol 400.
What Doufoston looks like and contents of the pack

the tablets are round, biconvex, scored, white in color;
on one side the tablets are marked "155" on both sides of the dividing line;
tablets are packaged in blisters of aluminum and PVC foil;
each pack contains 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.

 

 

 

 

 

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