Progestan 100 Mg 30 soft capsules ingredient progesteron

Special groups:

Renal insufficiency: The effect of kidney disease on progesterone dysplasia has not been studied

. Progesterone capsules progesterone metabolites

should be used with caution and should be used with caution and patients with renal failure should be followed closely.

Hepatic insufficiency: The effect of liver disease on the progesterone is not studied

. However, because progesterone is metabolized in the liver severe liver

, it is contraindicated for patients with dysfunction or disease. Ifmild or

patients with moderate hepatic dysfunction treated with progesterone,

need to be these patients should be carefully monitored.

Use in children:

Progestan capsules are not used in children.

The use of

patients over 65 years of age to determine the responses that may be different from younger patients

progesterone inis not sufficient. Other reported studies

did not define the difference between older and younger patients. In general, as aliver,

result of decreased kidney or cardiac function, and concurrent discomfort or other medication

treatments, dose selection should be made with caution and should be dose dose

started with the lowest.

4.3. Contraindications

- In patients with progesterone and allergy to the auxiliaries in the formula patients with

- Thrombophlebitis, thromboembolic diseases, cerebral apoplexy, or in thepast

- In severe liver disease or disease

- In known or suspected breast or genital organ carcinomas

- In vaginal bleeding of unknown cause

- Contraindicated in dead embryo abortion

4.4. Special warnings and precautions for use

- The patient up if there is depression in the past, so the patient

should be followed should be monitored and the drug should be discontinued in such a case.

-withwhich may cause fluid retention and hence complaints may be increased

Care should be taken in patients epilepsy, migraine, asthma, diabetes and renal impairment,.

- Loss of vision, diplopia, migraine proptosis, signs and embolic disorders

cases of sudden symptoms of, the drug should be discontinued.

- It should be advised to take the bed at night due to the risk of drowsiness.

- The following tests are very important for patient monitoring;

Physical examination every 6-12 months (especially attention to breast and pelvic organs

), liver function tests, Papanicolaou test.

Progestan contains peanut oil. For this reason, it should patients who have fıstıga allergy

never be used by.

Progestan contains lecithin (soy). Therefore, it should not patients allergic to peanuts or soy

be used by who are.

4.5. Interaction with other medicinal products and other forms of interaction

It is recommended not to be used in combination with Bromocriptine. Because progestins amenorrhea

can cause the effect of bromocriptine by and / or galactorrhea. Ketoconazole cytochrome

is an inhibitor P4503A4, and thus other enzymes such as known inhibitors of progesterone

increase the bioavailability. P4503A4 inducers carbamazepine, phenytoin, rifampin and

aminoglycoside may decrease the effect of progesterone by increasing hepatic metabolism.

Food-herbal drug interaction: Food increases oral bioavailability, St John's wort

can reduce progesterone level.

4.6. Pregnancy and Lactation

General recommendation:

Pregnancy category B

Women with childbearing potential / birth control (contraception):

Studies on reproduction in experimental animals drug has phytotoxic effect

have shown that theno. However, there pregnant women using progesterone

may be an increase in the risk of birth defects in the babies of. Therefore, the drug physicians pregnant women

should be used in control if necessary.

Pregnancy: There Birth defects in infants of pregnant women using progesterone

may be an increase in the risk of. Therefore, the drug can be used in physician control in pregnant women.

During the first 4 months of progesterone use in women who are seen in other

gestation, the cases with risk of being infants are masculinization, and in infants, hypospadias.

Lactation: Progestins are excreted in different amounts by breast milk. Themilk-sucking child

potential adverse effects in theatre not known; therefore,nursing mothers progestin

it is recommended that do not use.

Reproductive ability / Fertility: Reproductive studies in experimental animals drug

have shown that thehas no phytotoxic effect. High doses may affect fertility.

4.7. Effects oncause

ability to drive and use machines In some patients,using the vehicle and the machine as it may dizziness and drowsiness

caution should be exercised when. It is therefore advisable to take it overnight before going to bed.

8.4. Undesirable effects

are often told grouping of adverse reactions:

Very common: 1/10

Common 1/100 to <1/10

Uncommon: 1/1000 to <1/100

Rare 1 / 10,000 to <1/1000

Very rare: <1 /10.000

Unknown: Unable to predict from available data.

Nervous system disorders:

Very common: dizziness (16%), headache (10%)

Common: Irritability (5%)

Uncommon: mouth dryness, confusion, insomnia, speech disorder

Metabolism and malnutrition:

very common : Chest pain (11%), fatigue (10%)

Uncommon: Edema

Gastrointestinal disorders:

Very common: Abdominal pain (10%)

Common: Abdominal tension (6%)

Uncommon: Constipation, dyspepsia, gastroenteritis, hiatus hernia, vomiting

Musculoskeletal system and soft tissue disorders:

Common: skeletal pain (6%)

Uncommon: Arthritis, leg cramps, hypertonia, muscle disorders, myalgia

Respiratory, thoracic and mediastinal disorders:

Common: Upper respiratory tract infections (5%)

Uncommon : Bronchitis, nasal congestion, pharyngitis, pneumonitis, sinusitis

Ear and labyrinth disorders

Uncommon: Ear pain

Psychiatric disorders impaired

Uncommon: Anxiety,concentration, insomnia, change of personality Cardiovascular disorders

Uncommon: Hypertension, palpitations, angina pectoris

Skin and subcutaneous tissue disorders

Uncommon: acne, warts genitourinary system disorders

Uncommon: Urinary tract infection, vaginal dryness, lökor to uterine fibroids, vaginitis and

fungal

General disorders and administration site conditions

Common : Viral infection (7%)

Uncommon: Chest pain, fever

Page 6 of 8

4.9. Dosing and treatment No

information is available about the dose.

Some patients may be over-exposed.

- If an unstable endogenous progesterone secretion occurs or

persistently persists, thief the sensitivity to the product is shown

dose is reduced.

- During the day sleepiness, dizziness can be seen. In this case, 2 capsules night

are taken at(10 days for each cycle).

- If the menstruation period is shortened, the date of the beginning of the treatment is changed;

For example, on the 17th day of menstruation, treatment is started on the 19th day.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Progestogens ATC code: G03DA04

Corpus luteum is the primary source of progesterone, the natural progestin, and the placenta pregnancy

continues to secrete progesterone to maintain. Progestan Soft Capsules

are used orally. The use of micronisation and the use of lubricant solvent has allowed the use of natural progesterone only for the

as vaginally, notoral route, but also for long-term treatment

. In addition to its progestogenic activity, natural progesterone has anti-estrogen, anti-androgen

(weak), anti-aldosterone and estrogen activity.long-term "estrogen" substitution has effectively prevented

Progestan administration (200 mg) once a day in postmenopausal women who have

proliferation and hyperplasia. Estrogen replacement therapy

relieves many symptoms related to estradiol deficiency in menopausal women.lipid

synthetic profile, coagulation factors, glucose tolerance, weight and blood pressure

Unlike Progestins, there are no side effects.

5.2. Pharmacokinetic properties

General characteristics:

Progesterone is a natural progestin. Chemical structure produced in man is the maximest.

Progesterone is a white, whitish crystalline powder. Insoluble in water, easily alcohol

soluble in, hardly soluble in acetone and fatty acids. Shows polymorphism.

The progestan soft capsule is a white opaque oval soft capsule with a viscosity of white homogeneous

fat.

Absorption: Progestan oral absorption is very good. After 3 hours of peak is reached in the plasma

collection, thelevel. Absolute bioavailability is unknown. Serum progesterone

concentration is linear.

Distribution: Progesterone is approximately 96-99% bound to serum proteins, primarily serum

albumin (50 - 54%) and transcortin (43 - 48%).

Biotransformation Progesterone is pregnant and large extent in the liver

metabolized topregnanolons to a. Pregnandiols and pregnanolones are glucuronide liver

converted into and sulfate metabolites in the. The metabolites of progesterone, which are excreted and deconjugated by the bile,

are metabolized in the intestine by reduction, dehydroxylation and epimerization.

Elimination of glucuronide and sulfate conjugates of Pregnanediol and pregnenolone is eliminated by bile and urine

. The metabolites of progesterone excreted in the bile can enter the enterohepatic circulation or canby be removed feces.

Linearity / Non-linearity: Serum progesterone concentrations

were found to postmenopausal women at a dose range of 100 mg / day to 300 mg / day 100 mg of progesterone be proportional and direct to followed by overdose.300 mg / day

Although doses above were not studied in women,a male study

serum concentrations were found to be proportional to the dose between 100 mg / day and 400 mg / day in.

5.3. Preclinical safety data The

carcinogenic and mutagenic effect of progesterone has not been specifically determined.

There was no mutagenic response in micronucleus tests and Ames test. Human studies were

not performed. Studies on medroxyprogesterone and progesterone plus

malignancies resulted in increased malignant breast nodules. Despite the occasional nodule

formation, nodules in progesterone larger, more numerous and malignant

patients are associated with metastases.

6. PHARMACEUTICAL PROPERTIES

6.1. List of auxiliaries

Intermediate oil

Lecithin (soya)

Capsule:

Gelatin

Glycerin

Titanium dioxide

6.2. Incompatibilities

None.

6.3. Shelf life

24 months

6.4. Special precautions