PROGYNOVA-IS IT SAFE? USES,SIDE EFFECTS,DOSAGE

What is Progynova?

Progynova tablets are an estrogen-only continuous form of Hormone replacement therapy. They are also used to relieve symptoms of menopause and for treatment of many hormone-mediated diseases.

It is available in the form of tablets for oral administration.

It is manufactured by Zydus Cadila.

PROGYNOVA-IS IT SAFE? USES,SIDE EFFECTS,DOSAGE

What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
Who should not use Progynova?
How effective is this medicine?
Is it addictive?
What is the dosage?
How to use Progynova?
What if I miss a dose?
What to do in case of overdosage?
What to do if there is an allergic reaction?
Can I drive after taking it?
Can it be taken with food?
Can it be consumed on an empty stomach?
Can it be taken with alcohol?
What are the side effects?
Does this medicine has any drug interactions?
Precautions
Is it safe to use if I am pregnant?
Is it safe to use if I am breastfeeding?
Can this medicine be given to children and infants?
Is this medicine available as over the counter product?
Frequently asked questions
Reference

What is the Generic name(s)?

The generic name of Progynova is Estradiol[1].

What is its composition?

The active ingredient is Estradiol valerate. It may be present in strengths 1 mg or 2 mg.

The inactive ingredients of the tablets are:

• Lactose[2]
• Glycerol[3]
• Maize starch[4]
• Purified talc
• Sucrose[5]
• Titanium dioxide[6]
• Magnesium stearate[7]
• Glycol[8]montanate
• Povidone[9]
• Macrogol 6000
• Calcium carbonate[10]
• 1 mg tablet additionally contains Iron oxide whereas 2 mg tablet contains indigo carmine.

How does it work?

Estradiol valerate is a natural form of estrogen[11]. This medicine helps in regulation of the menstrual cycle[12] with the development of secondary sex characters. When ovaries[13] are damaged due to any condition and are unable to produce the desired level of estradiol in the body, this medicine helps in maintaining its levels in the blood. Then the required actions of the hormone are carried out.

What are its uses?

This tablet is used to treat:

• Post-menopausal symptoms like hot flushes with a disturbance in sleep, urogenital atrophy[14], excess sweating, urinary incontinence and dyspareunia (pain during or after intercourse).
• Hormone replacement therapy for symptoms of estrogen deficiency.
• Hypoestrogenism- characterized by low levels of estrogen and other side effects. This condition may be due to failure in ovaries, hypogonadism and castration.
• Prevention of osteoporosis[15] in post menstrual women who are at a significant risk of fractures in future.
• Prostate cancer- Management of symptoms.
• Vaginal or vulvar atrophy-characterized by shrinking and thinning of the tissues in vagina or urethra and lack of lubrication due to deficiency of estrogen.
• Primary ovarian failure resulting in infertility and low levels of estrogen.
• During Oophorectomy (removal of one or both the ovaries)
• Signs of mucosal and cutaneous involution in the genital area particularly which occurs with increasing age.

Who should not use Progynova?

This medicine is contraindicated in women with:

• Hypersensitivity to Estrodial, inactive ingredients or other similar drugs.
• Undiagnosed vaginal bleeding
• Liver disease (acute) or history of liver damage like hepatitis or liver cancer.
• The past, present or suspected case of cancer of the breast.
• High quantity of triglycerides (fat) in the blood.
• Known or suspected malignant tumours which are estrogen-dependent like endometrial cancer.
• Recent or active heart and arterial thromboembolic disorder e.g recent heart attack (in the past 6 months), blood clotting disorders, Angina, myocardial infarction, etc.
• Hearing loss caused due to abnormal growth of a bone in ears (otosclerosis).
• Untreated excessive growth of the lining of the womb (endometrial hyperplasia).
• Rare genetic disorders like galactose intolerance, glucose-galactose malabsorption and Lapp lactase deficiency.
• Diagnosed thrombophilic disorders like deficiency of antithrombin, protein S or protein C or antiphospholipid syndrome.
• Recent stroke.
• Very severe diabetes.
• Previously idiopathic or current venous thromboembolism like a blood clot in veins of the leg (Deep Vein Thrombosis) or in the lung/s (pulmonary embolism).
• Porphyria (Hereditary disease where the body is unable to convert natural compounds into haem which contains iron).

How effective is this medicine?

The onset of action of this tablet is around 14-30 days when taken by oral administration. The effect may last for about 7-12 days. If used under strict guidelines of the doctor and for the required duration, the medicine will be effective in reducing symptoms and treating the condition.

Is it addictive?

No. This medicine does not have any habit-forming tendencies.

What is the dosage?

One tablet of Progynova taken orally once a day. The dose would be 1 mg or 2 mg (will be prescribed by the doctor).

How to use Progynova?

• When being taken daily, it is advised to be taken at the same time every day. The strength and the duration will be determined by the doctor as per the condition to be treated.
• The lowest effective dose required for relieving symptoms is to be used.
• It should be swallowed with water.
• It should not be chewed, crushed, split or bitten in the mouth.
• Each pack covers 28 days. Treatment is continuous, hence, the next pack should be followed immediately without any breaks.
• The treatment is to be discontinued if irregular vaginal bleeding is observed. In such cases, thorough consultation with the doctor is strongly recommended.

Before starting the treatment course, inform your doctor if you have the following conditions:

• High blood pressure (hypertension)
• Thyroid disease
• Asthma
• A migraine
• Diabetes
• Hereditary angioedema(episodes of continuous swelling repeatedly)
• Epilepsy
• Hepatic hemangiomas (abnormal building of arteries and veins in the liver)
• Benign breast disease (painful and lumpy breasts)
• A tumour/s in uterus or pituitary gland.
• Low levels of calcium in blood and plasma.
• Cholasma (brownish yellow patches on the skin)
• Systemic lupus erythematous (a chronic inflammatory disease)
• Chorea minor (an involuntary movement disorder)

What if I miss a dose?

If a missed dose is noticed by the woman within 12 hours, the dose can be taken. If the missed dose is remembered after 12 hours, the forgotten tablet should not be taken. The remaining tablets are to be continued as usual. One should consult with the doctor in this situation.

A missed dose can cause breakthrough spotting or bleeding.

Do not take a double dose to make up for the missed dose.

What to do in case of overdosage?

Acute toxicity studies depict that in case of multiple intakes of the therapeutic dose, no toxicity is to be expected. The symptoms of an overdose like nausea, vaginal bleeding or vomiting might be observed in some women. Managing the acute overdose case should be supportive and symptomatic. One should get in touch with the doctor immediately in the even of overdosage.

What to do if there is an allergic reaction?

Allergy to the product, or its active ingredient, Estradiol or other ingredients mentioned in the packaging can lead to the following symptoms:

• Rashes
• Itching
• Swelling of lips, face, throat and tongue
• Wheezing and difficulty in breathing
• Shortness in breath
• Hives on the skin

Call for emergency help or an ambulance immediately.

Can I drive after taking it?

This medicine does not usually affect the ability to drive. But sometimes consuming Progynova can cause sleepiness and dizziness. In this case, it is advised to not drive.

Can it be taken with food?

• The tablet can be taken with food. It does not affect the medicine’s bioavailability in the systemic circulation.
• It is practised by many patients to be taken with food to prevent nausea.
• Swallowing it with milk or water is advised too.
• However, it can have some interactions with grape juice. Consult your doctor for this.

Can be it taken on an empty stomach?

Yes. It can be taken on an empty stomach. A snack or meal is though recommended if the individual experiences nausea.

Can it be taken with alcohol?

The interactions of alcohol and the drug are unknown. But alcohol intake during consumption of tablet or during the course of hormone replacement therapy can cause a rise in circulating levels of estradiol. So, it is better to discuss with the doctor regarding the consumption of alcohol.

What are the side effects?

Side effects are not observed in every individual consuming this tablet, but some have been reported. They are:

• Back, neck or muscle pain
• A headache
• Tenderness in breasts
• Unwanted hair growth
• Flu-like symptoms
• Menstrual bleeding or spotting
• A cough
• Swelling, redness or itching of the vagina
• Pain in breasts
• Weight gain or loss
• Fluid discharge from vagina with no odour
• A runny nose and congestion
• Constipation
• Acidity, bloating, flatulence
• Heartburn
• Painful menstrual periods
• Hair loss
• Depressive Mood
• Changes in sexual drive
• Changes in mood
• Leg cramps
• Fatigue
• Anxiety
• A rise in blood pressure

Severe side effects seen include:

• Discharge from one or both nipples
• Inverted nipples (rarely)
• Change in texture in breast skin and the nipples
• Unexplained vaginal bleeding
• Vaginal thrush
• Disturbance in liver function or jaundice
• Increase in the shape of the uterine fibroids(if present)
• Inflammation of the pancreas i.e. pancreatitis
• Clots of blood in arteries and veins
• Gallbladder disease

Report to your doctor immediately if any of these severe side effects are observed.

Does this medicine has any drug interactions?

Progynova has interactions with various drugs. They can reduce its levels in blood and decrease its effectiveness. The symptoms can come back or there can be irregular menstrual bleeding due to these interactions. The drugs are:

• Anti-infectants like Rifabutin, Rifampicin, Efavirenz, Nevirapine, etc.
• Anti-convulsants like Carbamazepine, Primidone, Barbiturates, Phenytoin, Rufinamide, etc.
• Modafinil
• Aprepitant
• Telaprevir
• Crizotinib
• Fosaprepitant
• Oxcarbazepine
• Bosentan
• Cobicistat
• Ritonavir and other HIV/AIDS drugs
• Dabrafenib
• Fosphenytoin
• Vemurafenib
• Eslicarbazepine
• Topiramate
• Herbel remedy, St John’s wort (Hypericum perforatum)
• Medicines used to treat fever and pain like Paracetamol
• Phenobarbital, Lamotrigine and other antiepileptics.
• Warfarin
• Dexamethasone
• Prednisolone
• Insulin and anti-diabetic medications

Precautions

• Do not use this tablet if you are under 18 years of age.
• In women whose uterus is still intact, to prevent endometrial hyperplasia during the treatment, Progestogen is added with Prognova for 12-15 days in the 28-day cycle. This is contraindicated if there is any previous history of endometriosis.
• As a general rule, the treatment should be stopped for every 6 months to check the status of all the complaints during the course of the treatment.
• This medicine is not a contraceptive.
• This medicine should be stopped 4 weeks prior to any surgery as it poses a risk and various complications while performing a surgery.
• It can get difficult to wear contact lenses during the course of the treatment due to steepening of corneal curvature of eyes.
• Do not consume the medicine if the packaging is torn or looks tampered with.
• Do not stop using this medicine just because the symptoms have vanished. Stop only after the doctor tells you to do so.
• Exercise caution if you are overweight or obese.
• Monitor blood pressure closely to notice any abnormal rise or fall.

Is it safe to use if I am pregnant?

In animal studies, administration of high dose of synthetic estrogen leads to urogenital abnormalities in the offspring. In epidemiological studies of estrogen effects on humans, there was no indication of any teratogenic or foetotoxic effects on the infant. Yet, the safety of this medicine in pregnant women is not established and is therefore not indicated.

If you get pregnant during the course of the treatment, stop taking the medicine immediately and consult your doctor.

Is it safe to use if I am breastfeeding?

Using this tablet is not indicated in breastfeeding women as some of the drugs can enter the breast milk and may affect the infant.

Can this medicine be given to children and infants?

Use of this medicine in children and infants is not well established. The risks and efficacy are not studied and therefore it is not advisable to be administered to children, infants as well as adolescents.

Is this medicine available as over the counter product?

No. This tablet is a Prescription only medicine (POM).

Frequently asked questions

Q: How to store these tablets?

• Progynova 1 mg has 2 blister strips with 28 yellow coloured tablets. These are to be stored below a temperature of 30 degrees (in Celsius).
• Progynova 2 mg has 2 blister strips of 28 blue coloured tablets. These are to be stored below 25 degrees (in Celsius).
• It should be stored in a dry place with no moisture.
• Do not keep it in the washroom or car.
• Keep it out of reach from children.

Q: Can Progynova tablet delay periods?

Yes, Progynova can cause some imbalance in hormones leading to delay in periods (amenorrhea). If the delay is more than a month, consult your doctor.

Q: Can Progynova medicine cause cancer?

Post-menopausal women on a long-term treatment using this medication are at risk of developing endometrial cancer. The duration and strength of the tablet used will decide it. If there are some unexplained vaginal bleeding observed during this long-term use, report this to your doctor without any delay.

Q: Does this tablet cause acne?

No, incidences of acne formation are reported following consumption of this medicine. Rather acne which is caused due to low estrogen levels might be corrected by Progynova.

Q: Can this drug cause breast enlargement?

Yes. In higher doses, breast enlargement is reported in many women. This is due to the effects of Estradiol causing the development of secondary sexual characteristics including this.

Q: Can I take the medicines, Provera and Progynova together?

Yes, these tablets can be taken together, after due consultation with the doctor, as no harmful drug interactions are established as of now. If any discomfort or other changes are felt after consuming both these tablets, do not hesitate to inform your doctor or gynaecologist.

Q: Can this tablet cause joint pain?

For reasons unknown, yes. This tablet is known to cause joint pain (arthralgia) in many individuals. If the pain is not tolerable after taking this medicine, consume a painkiller or apply balm. If pain does not subside after this, consult your doctor.

Q: Is this medicine safe for elderly?

Safety of this medicine in the elderly is not very well established. Elder patients (age is more than 65 years) are more susceptible to side effects like the formation of blood clots and dementia (memory loss). Consult a doctor first and then only give it to elderly patients.

Reference

Wikipedia page on Menstrual cycle

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