MICRONIZED PROGESTERONE CAPSULE

NAME OF THE MEDICINAL PRODUCT

Micronized ProgesteroneSoft Capsule 100mg,

Micronized ProgesteroneSoft Capsule 200 mg

 

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg micronised progesterone.
Excipients with known effect: Soya lecithin

PHARMACEUTICAL FORM
Capsules, soft, White

CLINICAL PARTICULARS

Therapeutic indications
Micronised progesterone is indicated for adjunctive use with estrogen in post-menopausal women with an intact uterus, as hormone replacement therapy (HRT).


Posology and method of administration

Posology
In women receiving estrogen replacement therapy there is an increased risk of endometrial cancer which can be countered by progesterone administration.
The recommended dose is 200 mg daily at bedtime, for twelve days in the last half of each therapeutic cycle (beginning on Day 15 of the cycle and ending on Day 26). Withdrawal bleeding may occur in the following week.
Alternatively 100 mg can be given at bedtime from Day 1 to Day 25 of each therapeutic cycle, withdrawal bleeding being less with this treatment schedule.

Paediatric population

There is no relevant use of micronised progesterone in the paediatric population.

Older people
As for adults

Method of Administration:
Oral

Micronised progesterone 100mg Capsules should not be taken with food and should be taken at bedtime.
Concomitant food ingestion increases the bioavailability of micronized progesterone.

CONTRAINDICATION
When used in conjunction with oestrogens, the following apply:

  • Known, past or suspected breast cancer
  • Known or suspected estrogen-dependent malignant tumours (e.ggenital tract carcinoma)
  • Undiagnosed genital bleeding
  • Thrombophlebitis
  • Previous or current thromboembolism disorders (e.g. deep venous thrombosis, pulmonary embolism)
  • Known thrombophilic disorders
  • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
  • Known hypersensitivity to the active substances or to any of the excipients listed in section 6.1
  • Porphyria
  • Cerebral haemorrhage

SPECIAL PRECAUTIONS & WARNINGS
Warnings:

• For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

Micronised progesterone 100 mg Capsules are not suitable:

  • in the treatment of premature labour, or
  • as a contraceptive.

Precautions:

Medical examination/follow-up
Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below). Investigations, including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Conditions which need supervision
If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. It should be taken into account that these conditions may recur or be aggravated during treatment with Micronised progesterone 100 mg Capsules, in particular:

  • Leiomyoma (uterine fibroids) or endometriosis
    • Risk factors for thromboembolic disorders
    • Risk factors for estrogen dependent tumours, e.g.1st degree heredity for breast cancer
    • Hypertension
    • Liver disorders (e.g.liver adenoma)
    • Diabetes mellitus with or without vascular involvement
    • Cholelithiasis
    • Migraine or (severe) headache
    • Systemic lupus erythematosus.
    • A history of endometrial hyperplasia
    • Epilepsy
    • Asthma
    • Otosclerosis
    • Fluid retention (e.g. cardiac disease, renal disease)
    • Depression
    • Photosensitivity

Reasons for immediate withdrawal of therapy

Therapy should be discontinued in case a contra-indication is discovered and in the following situations:
• Jaundice or deterioration in liver function
• Significant increase in blood pressure
• New onset of migraine-type headache
• Sudden or gradual, partial or complete loss of vision
• Proptosis or diplopia
• Papilloedema
• Retinal vascular lesions

Endometrial hyperplasia and carcinoma

In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among estrogen-only users varies from 2-to 12-fold greater compared with non-users, depending on the duration of treatment and estrogen dose. After stopping treatment risk may remain elevated for at least 10 years.

The addition of progesterone for at least 12 days per month/28 day cycle or continuous combined estrogen-progestagen therapy in non-hysterectomised women prevents the excess risk associated with estrogen-only HRT.

Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding persists, a lower dose of Micronised progesterone for 25 days per cycle could be considered.

If breakthrough bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.

Breast cancer
The overall evidence suggests an increased risk of breast cancer in women taking combined estrogen-progestagen and possibly also estrogen-only HRT, that is dependent on the duration of taking HRT.

Combined estrogen-progestagen therapy

  • The randomised placebo-controlled trial the (Women’s Health Initiative study (WHI), and epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined estrogen-progestagen for HRT that becomes apparent after about 3 years.

The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.

HRT, especially estrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.

Ovarian cancer
Ovarian cancer is much rarer than breast cancer. Long-term (at least 5-10 years) use of estrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer. Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar, or slightly smaller, risk.

Venous thromboembolism

HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of HRT than later.
Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. HRT is therefore contraindicated in these patients.
Generally recognised risk factors for VTE include, use of estrogens, older age, major surgery, prolonged immobilisation, obesity (BMI > 30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer. There is no consensus about the possible role of varicose veins in VTE.
As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery. If prolonged immobilisation is to follow elective surgery temporarily stopping HRT 4 to 6 weeks earlier is recommended. Treatment should not be restarted until the woman is completely mobilised.
In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g, antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.
Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).

Coronary artery disease (CAD)

There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogen-progestagen or oestrogen-only HRT.

Combined oestrogen-progestagen therapy

  • The relative risk of CAD during use of combined oestrogen+progestagen HRT is slightly increased. As the baseline absolute risk of CAD is strongly dependent on age, the number of extra cases of CAD due to oestrogen+progestagen use is very low in healthy women close to menopause, but will rise with more advanced age.

Ischaemic stroke
Combined estrogen-progestagen and estrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age

Other conditions
HRT use does not improve cognitive function. There is some evidence of increased risk of probable dementia in women who start using continuous combined or estrogen-only HRT after the age of 65.

Interaction with other medicinal products and other forms of interaction

Drugs known to induce the hepatic CYP450-3A4 such as barbiturates, anti-epileptic agents (phenytoin, carbamazepine), rifampicin, phenylbutazone, spironolactone, griseofulvin, some antibiotics (ampicillins, tetracyclines) and also herbal products containing St. John’s wort, (Hypericum perforatum) may increase metabolism and the elimination of progesterone.
On the contrary ketokonazole and other inhibitors of CYP450-3A4 such as ritonavir and nelfinavir may increase bioavailability of progesterone. The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (IC50 <0.1 μM).
Progesterone may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. Progesterone may affect the results of laboratory tests of hepatic and/or endocrine functions.
The clinical relevance of the in vitro findings is unknown.

PREGNANCY & LACTATION
 Pregnancy
Oral Micronized Progesterone 100mg Capsules are not indicated during pregnancy.
If pregnancy occurs during medication, Micronized Progesterone 100mg Capsules should be withdrawn immediately.
Clinically, data on a large number of exposed pregnancies indicate no adverse effects of progesterone on the foetus. The results of most epidemiological studies to date relevant to inadvertent foetal exposure to combinations of estrogens + progesterone indicate no teratogenic or foetotoxic effect.

Prescription of progesterone beyond the first trimester of pregnancy may reveal gravidic cholestasis.

Breast-feeding
Micronized Progesterone 100 mg Capsules is not indicated during breast-feeding.
Detectable amounts of progesterone enter the breast milk.

Fertility
Not relevant

Effects on ability to drive and use machines
Micronized Progesterone 100mg Capsules may cause drowsiness and/or dizziness in a minority of patients; therefore caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.

System organ class Common

≥1/100; <1/10

Uncommon

≥1/1000; ≤1/100

Rare

≥1/10000; ≤1/1000

Very rare

≤1/10000

Reproductive system and breast disorders Altered periods

Amenorrhoea

Intercurrent bleeding

.Mastodynia
Nervous system disorders Headaches Drowsiness

Dizziness

Depression
Gastrointestinal disorders Vomiting

Diarrhoea

Constipation

Nausea
Hepatobiliary disorders Cholestatic jaundice
Immune system disorders Urticaria
Skin and subcutaneous tissue disorders Pruritus

Acne

Chloasma

Undesirable effects
The information given below is based on extensive post marketing experience, primarily from oral administration of progesterone.

Somnolence or transient dizziness may occur 1 to 3 hours after intake of the drug. Bedtime dosing and reduction of the dose may reduce these effects.

When used in conjunction with oestrogen, the following apply.

Breast cancer risk

An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined estrogen-progestagen therapy for more than 5 years.

Any increased risk in users of estrogen-only therapy is substantially lower than that seen in users of estrogen-progestagen combinations.

The level of risk is dependent on the duration of use (see section 4.4).

Results of the largest randomised placebo-controlled trial (WHI-study) and largest epidemiological study (MWS) are presented.

 Million Women study– Estimated additional risk of breast cancer after 5 years’ use

Age range

(years)

Incidence per 1000 women in placebo arm over 5 years Risk ratio & 95%CI Additional cases per 1000 HRT users over 5 years (95%CI)
CEE estrogen-only
50-79 21 0.8 (0.7 – 1.0) -4 (-6 – 0)*3
CEE+MPA estrogen & progestagen‡
50-79 17 1.2 (1.0 – 1.5) +4 (0 – 9)

 US WHI studies – additional risk of breast cancer after 5 years’ use

‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non-users.

2 *Taken from baseline incidence rates in developed countries

3 *WHI study in women with no uterus, which did not show an increase in risk of breast cancer

Endometrial cancer risk

Postmenopausal women with an uterus.

The endometrial cancer risk is about 5 in every 1000 women with an uterus not using HRT.

In women with a uterus, use of estrogen-only HRT is not recommended because it increases the risk of endometrial cancer (see section 4.4).

Depending on the duration of estrogen-only use and estrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases

Age range

(years)

Additional cases per 1000 never-users of HRT over a 5 year period*2 Risk ratio & 95%CI# Additional cases per 1000 HRT users over 5 years (95%CI)
EstrogenEstrogen only HRT
50-65 9-12 1.2 1-2 (0-3)
Combined estrogen-progestagen
50-65 9-12 1.7 6 (5-7)
#Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use

Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.

the TC we finally decided to re-include the figures of table 2 of the Million Women study.

diagnosed in every 1000 women between the ages of 50 and 65.

Adding progesterone to estrogen-only therapy for at least 12 days per cycle can prevent this increased risk. In the Million Women Study (MWS) the use of five years of combined (sequential or continuous) HRT did not increase risk of endometrial cancer (RR of 1.0 (0.8-1.2)).

Ovarian cancer

Age range

(years)

Incidence per 1000 women in placebo arm over 5 years Risk ratio & 95%CI Additional cases per 1000 HRT users
50-59 8 1.3 (1.1 – 1.6) 3 (1 – 5)

Long-term use of estrogen-only and combined estrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer. In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.

Risk of venous thromboembolism
HRT is associated with a 1.3-3-fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism. The occurrence of such an event is more likely in the first year of using HT (see section 4.4). Results of the WHI studies are presented:

Age range

(years)

Incidence per 1000 women in placebo arm over 5 years Risk ratio & 95%CI Additional cases per 1000 HRT users
Oral estrogen-only*4
50-59 7 1.2 (0.6 – 2.4) 1 (-3 – 10)
Oral combined estrogen-progestagen
50-59 4 2.3 (1.2 – 4.3) 5 (1 – 13)

 WHI Studies – Additional risk of VTE over 5 years’ use

4 *Study in women with no uterus

Risk of coronary artery disease

The risk of coronary artery disease is slightly increased in users of combined estrogen-progestagen HRT over the age of 60 (see section 4.4).

Risk of ischaemic stroke

The use of estrogen-only and estrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT.

This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, see section 4.4.

WHI studies combined – Additional risk of ischaemic stroke*5 over 5 years’ use

5*no differentiation was made between ischaemic and haemorrhagic stroke.

Other adverse reactions that have been reported in association with estrogen / progestagen treatment

  • Rashes,
  • Weight changes,
  • Changes in libido,
  • Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura.
  • Pyrexia,
  • Insomnia,
  • Alopecia,
  • Hirsutism;
  • Gall bladder disease.
  • Probable dementia over the age of 65 (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the website www.mhra.gov.uk/yellowcard.

Overdose
Toxic effects Symptoms of overdosage may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and, if necessary, symptomatic and supportive measures should be provided.

Pharmacological particulars:

Pharmacodynamic properties

Pharmacotherapeutic group (ATC code: G03DA): Progestagens

Mechanism of action
Progesterone is a natural progestogen, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretory phase. Micronized Progesterone 100mg Capsules have all the properties of endogenous progesterone with induction of a full secretory endometrium and in particular gestagenic, antiestrogenic, slightly anti-androgenic and antialdosterone effects.

Clinical efficacy and safety
As estrogens promote the growth of the endometrium, unopposed estrogens increase the risk of endometrial hyperplasia and cancer. The addition of progesterone greatly reduces the estrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.

 Pharmacokinetic properties

Absorption
Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that after oral administration of 2 capsules (200mg), plasma progesterone levels increased to reach the Cmax of 13.8ng/ml +/- 2.9ng/ml in 2.2 +/- 1.4 hours. The elimination half-life observed was 16.8+/- 2.3 hours.

Distribution
Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%-54%) and transcortin (43%-48%).


Elimination

Urinary elimination is observed for 95% in the form of glycuroconjugated metabolites, mainly 3 α, 5 β–pregnanediol (pregnandiol).

Biotransformation
Progesterone is metabolised primarily by the liver. The main plasma metabolites are 20 α hydroxy- ∆ 4 α- prenolone and 5 α-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolised in the gut via reduction, dehydroxylation and epimerisation. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum.

Linearity/non-linearity
The pharmacokinetics of micronized progesterone is independent of the dose administered. Although there were some inter-individuals variations, the same individual pharmacokinetic characteristics were maintained over several months permitting appropriate individual adaptation of the posology and indicating predictable responses to the drug.

Older people
As per adults above

 Preclinical safety data

Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

Pharmaceutical particulars

List of excipients
Sunflower oil, refined
Soya lecithin
Gelatin
Glycerol
Titanium dioxide
Purified water

 Incompatibilities

Not applicable.

 Shelf life

3 years.

 Special precautions for storage

No special precautions for storage.

Nature and contents of container

The product is supplied in PVC/Aluminium blisters contained in cartons.

Pack size: 30 capsules

 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER

TAJ PHARMA CIS LTD.
Marksistsky lane 6, office 221, Moscow, 109147, Russia

MANUFACTURER:

Manufactured in India by:
TAJ PHARMACEUTICALS LTD,
220, Mahagujarat Ind. Estate,  Moraiya,

Tal. Sanand , Dist. Ahmedabad,

Gujarat, INDIA.

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet:

1 What is MICRONIZED PROGESTERONE Capsules?

2 What is MICRONIZED PROGESTERONE Capsules used for?

3 Who should not take MICRONIZED PROGESTERONE Capsules?
4
How should I take MICRONIZED PROGESTERONE Capsules?

5   What are the possible side effects of MICRONIZED PROGESTERONE Capsules?

6 What are the ingredients in MICRONIZED PROGESTERONE Capsules? HOW SUPPLIED?

1 What is MICRONIZED PROGESTERONE Capsules?

Micronized Progesterone Capsules contain the female hormone called progesterone.

2 What is MICRONIZED PROGESTERONE Capsules used for?

Treatment of Menstrual Irregularities
Micronized Progesterone Capsules are used for the treatment of secondary amenorrhea (absence of menstrual periods in women who have previously had a menstrual period) due to a decrease in progesterone. When you do not produce enough progesterone, menstrual irregularities can occur. If your healthcare provider has determined your body does not produce enough progesterone on its own, Micronized progesterone  Capsules may be prescribed to provide the progesterone you need.

Protection of the Endometrium (Lining of the Uterus)
Micronized progesterone  Capsules are used in combination with estrogen-containing medications in a postmenopausal woman with a uterus (womb). Taking estrogen-alone increases the chance of developing a condition called endometrial hyperplasia that may lead to cancer of the lining of the uterus (womb). The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).

3 Who should not take MICRONIZED PROGESTERONE Capsules?

 

Do not start taking Micronized progesterone  Capsules if you:
• Are allergic to peanuts
• Have unusual vaginal bleeding
• Currently have or have had certain cancers Estrogen plus progestin treatment may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take Micronized progesterone  Capsules.
• Had a stroke or heart attack
• Currently have or have had blood clots
• Currently have or have had liver problems
• Are allergic to Micronized progesterone  Capsules or any of its ingredients
See the list of ingredients in Micronized progesterone  Capsules at the end of this leaflet.
• Think you may be pregnant
Tell your healthcare provider:
• If you are breastfeeding. The hormone in MICRONIZED PROGESTERONE Capsules can pass into your breast milk.
• About all of your medical problems. Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, or kidneys, or have high calcium levels in your blood.
• About all the medicines you take. This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Micronized progesterone  Capsules work. Micronized progesterone  Capsules may also affect how your other medicines work.

4 How should I take MICRONIZED PROGESTERONE Capsules?

  1. Prevention of Endometrial Hyperplasia: A postmenopausal woman with a uterus who is taking estrogens should take a single daily dose of 200 mg Micronized progesterone Capsules at bedtime for 12 continuous days per 28-day cycle.
    2. Secondary Amenorrhea: Micronized progesterone Capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.
    3. Micronized progesterone  Capsules are to be taken at bedtime as some women become very drowsy and/or dizzy after taking Micronized progesterone  Capsules. In a few cases, symptoms may include blurred vision, difficulty speaking, difficulty with walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider right away.
    4. If you experience difficulty in swallowing Micronized progesterone  Capsules, it is recommended that you take your daily dose at bedtime with a glass of water while in the standing position.

5   What are the possible side effects of MICRONIZED PROGESTERONE Capsules?

Side effects are grouped by how serious they are and how often they happen when you are treated:
Serious, but less common side effects include:Risk to the Fetus: Cases of cleft palate, cleft lip, hypospadias, ventricular septal defect, patent ductus arteriosus, and other congenital heart defects.

Abnormal Blood Clotting: Stroke, heart attack, pulmonary embolus, visual loss or blindness.
Some of the warning signs of serious side effects include:
• Changes in vision or speech
• Sudden new severe headaches
• Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
• Dizziness and faintness
• Vomiting
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.

Less serious, but common side effects include: • Headaches
• Breast pain
• Irregular vaginal bleeding or spotting
• Stomach or abdominal cramps, bloating
• Nausea and vomiting
• Hair loss
• Fluid retention
• Vaginal yeast infection
These are not all the possible side effects of Micronized progesterone  Capsules. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to AbbVie Inc. at 1-800-633-9110 or to FDA at 1-800-FDA-1088.

What can I do to lower my chances of getting a serious side effect with Micronized progesterone  Capsules?
• Talk with your healthcare provider regularly about whether you should continue taking Micronized progesterone  Capsules.
• See your healthcare provider right away if you get unusual vaginal bleeding while taking Micronized progesterone  Capsules.

  • Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
    • If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances for getting heart disease.

General information about safe and effective use of Micronized progesterone  Capsules
• Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not take Micronized progesterone  Capsules for conditions for which it was not prescribed.
• Your healthcare provider has prescribed this drug for you and you alone. Do not give Micronized progesterone  Capsules to other people, even if they have the same symptoms you have. It may harm them.
• Micronized progesterone  Capsules should be taken as a single daily dose at bedtime. Some women may experience extreme dizziness and/or drowsiness during initial therapy. In a few cases, symptoms may include blurred vision, difficulty speaking, difficulty with walking, and feeling abnormal. If you experience these symptoms, discuss them with your healthcare provider right away.
• Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Keep Micronized progesterone  Capsules out of the reach of children.
This leaflet provides a summary of the most important information about Micronized progesterone  Capsules. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Micronized progesterone  Capsules that is written for health professionals. You can get more information by calling the toll free number 1-800-633-9110.

  1. What are the ingredients in MICRONIZED PROGESTERONE Capsules? HOW SUPPLIED?

Active ingredient: 100 mg or 200 mg micronized progesterone The inactive ingredients for Micronized progesterone  Capsules 100 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, FD&C Red No. 40, and D&C Yellow No. 10. The inactive ingredients for Micronized progesterone  Capsules 200 mg include: peanut oil NF, gelatin NF, glycerin USP, lecithin NF, titanium dioxide USP, D&C Yellow No. 10, and FD&C Yellow No. 6.

Micronized progesterone  Capsules 100 mg are round, peach-colored capsules branded with black imprint “SV.” Micronized progesterone  Capsules 200 mg are oval, pale yellow-colored capsules branded with black imprint “SV2.”  

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Protect from excessive moisture.

Manufactured by:
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA

 Marketing Authorization Holder:
Regal sun co., Ltd. Myanmar

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