GYNASET CR 15 Tablet 5’s

INTRODUCTION

GYNASET CR 15 TABLET contains Norethisterone, which belongs to a group of medicines called Progestogens. It is used to treat and manage heavy menstrual bleeding or abnormal uterine bleeding (that occurs due to hormonal imbalance), painful periods, irregular periods or periods that are more frequent than normal (polymenorrhoea), premenstrual tension, endometriosis (abnormal growth of endometrial tissue of the uterus that causes pain and menstrual irregularities), metriopatheias haemorrhagia (intermenstrual bleeding) and breast cancer. It is also used to delay the menstrual cycle.

GYNASET CR 15 TABLET is not recommended for use in patients with pulmonary embolism (blood clots in the lung), liver disease, heart attack (myocardial infarction) or angina and deep vein thrombosis. GYNASET CR 15 TABLET should be used with caution in patients with asthma, kidney disease, fits, and migraine headaches.

GYNASET CR 15 TABLET is not recommended for use during pregnancy as it may affect the developing baby. Inform your doctor if you have had repeated miscarriages. GYNASET CR 15 TABLET should be used with caution in breastfeeding women as it may pass through the breast milk. If you experience mood changes and depressive symptoms, contact your doctor as soon as possible.

The most common side effects of taking GYNASET CR 15 TABLET are irregular bleeding, heavy menstruation, spotting between menstrual cycles, delayed or not having a menstrual cycle, stomach discomfort, nausea, vomiting, breast tenderness, headache, and dizziness. Contact your physician if the symptoms worsen.

USES OF GYNASET CR 15 TABLET

GYNASET CR 15 TABLET manages and treats:

Heavy periods
Painful periods
Irregular periods
Increased frequency of periods
Premenstrual tension
Endometriosis (a disease where the tissue lining the uterus, grows outside the uterus)
Breast cancer
Metropathia
Haemorrhagia (intermenstrual bleeding)
Abnormal uterine bleeding
Breast cancer
To delay the next periods
HOW GYNASET CR 15 TABLET WORKS

GYNASET CR 15 TABLET inhibits the release of pituitary hormones that are responsible for the release of female hormones (such as oestrogen and progesterone) and thereby suppressing ovulation. This action modifies the lining of the endometrium and thus ceases bleeding in menstrual abnormalities in cancer GYNASET CR 15 TABLET may act by pituitary inhibition or by direct action on tumour deposits.

DIRECTIONS FOR USE

Follow the instructions given by your doctor. Take GYNASET CR 15 TABLET as advised according to your symptoms and disease severity. Swallow the whole tablet with a glass of water.

SIDE EFFECTS OF GYNASET CR 15 TABLET
COMMON
Irregular bleeding, heavy menstruation
Spotting between menstrual cycles
Delayed or not having a menstrual cycle
Stomach discomfort, nausea, vomiting
Breast tenderness
Headache and dizziness
RARE

Stop taking GYNASET CR 15 TABLET and contact your doctor immediately if you experience any of the following side effects:

Yellowing of the skin or white area of the eyes (jaundice)
Migraine headache for the very first time (a headache that usually restricts itself to one side of your head)
High blood pressure
Symptoms of severe allergic reaction such as itchy skin rash, swelling of the face or tongue, hands or feet causing wheezing, difficulty breathing or feeling faint
Symptoms of a blood clot in the lungs include a sudden, severe, sharp pain in the chest, coughing up blood, shortness of breath, rapid heartbeats
Symptoms of a blood clot in the brain (stroke) include unusually severe or long headache, change in sight, difficulty speaking, collapsing, or fainting and weakness or paralysis of any part of your body
Symptoms of a deep-vein thrombosis such as severe pain, tenderness or swelling in your calf, ankle or foot, purplish discolouration of the skin of the leg and red or warmth skin
HOW TO MANAGE SIDE EFFECTS

Nausea, vomiting:

Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if nausea and vomiting get worse.

Headache:

Rest and relax. Apply a pain-relieving balm to your forehead if needed. Do not consume alcohol. Contact your doctor if your headache does not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating machinery if you feel dizzy. Avoid alcohol consumption as it aggravates dizziness. Contact your doctor if the dizziness worsens.

Stomach pain:

Try to rest and relax. Eat small meals but take them frequently. Keep a heating pad on your stomach. Contact your doctor if the stomach pain does not improve.

WARNING & PRECAUTIONS
PREGNANCY

GYNASET CR 15 TABLET is not recommended for use during pregnancy and if you have a history of Idiopathic jaundice during pregnancy or an itchy rash or blisters on the abdomen known as pemphigoid gestationis (rare autoimmune skin disorder in pregnancy) and GYNASET CR 15 TABLET should be used with caution in patients with a history of repeated miscarriages. Contact your doctor before taking GYNASET CR 15 TABLET.

BREASTFEEDING

GYNASET CR 15 TABLET should be used with caution in breastfeeding women as it may pass through the breast milk. Contact your doctor before taking GYNASET CR 15 TABLET.

DRIVING AND USING MACHINES

GYNASET CR 15 TABLET does not affect the ability to drive or operate machinery.

KIDNEY

GYNASET CR 15 TABLET should be used with caution in patients with kidney disease. Contact your doctor before taking GYNASET CR 15 TABLET.

LIVER

GYNASET CR 15 TABLET should be used with caution in patients with liver disease. Contact your doctor before taking GYNASET CR 15 TABLET.

ALLERGY

Do not use GYNASET CR 15 TABLET if you are allergic to norethisterone, similar other hormone medicines or any other ingredients in the medicine.

LUNGS

GYNASET CR 15 TABLET is not recommended for use in patients who have or had a pulmonary embolism (blood clots in the lung) and should be used with caution in patients with asthma. Contact your doctor before taking GYNASET CR 15 TABLET.

HEART DISEASE

GYNASET CR 15 TABLET is not recommended for use in patients with active or recent angina (chest pain) or heart attack. Contact your doctor before taking GYNASET CR 15 TABLET.

OTHERS

GYNASET CR 15 TABLET is not recommended for use if you have:

Blood disorders like porphyria
Clotting disorders like deep vein thrombosis or a family history of the same
Pruritis (a condition with severe generalised itching of the body)
Undiagnosed vaginal bleeding (not a period)

Before taking GYNASET CR 15 TABLET tell your doctor if you have:

Epilepsy
Migraine headache
Are very overweight
Systemic lupus erythematosus.
A blood clot in the veins
Are unable to move for long periods (Ex. after an operation)
Serious injury
Have major surgery or are going to have an operation (particularly abdominal or orthopaedic surgery to the lower limbs)
Blood tests (for liver function, thyroid function, and coagulation).
Vision impairment, bulging eyes, double vision
Depression
INTERACTIONS

A. Drug-Drug Interactions:

Antiepileptic medicines (used to treat fits) (phenytoin, carbamazepine, phenobarbitone)
Antibiotics ex. tetracyclines, co-trimoxazole, ampicillin, oxacillin (medicines used for bacterial infections)
Medicines used for tuberculosis (rifampicin, rifabutin)
Antiviral medicines for treatment of HIV (ritonavir, nelfinavir, efavirenz)
Anticancer medicines
Aminoglutethimide (used in Cushing’s syndrome)
Ciclosporin (immunosuppressants or medicines used to prevent rejection of a transplanted organ)
Nonsteroidal anti-inflammatory drugs NSAID’s (medicines used for pain)
Medicines for treating high blood pressure (amlodipine, captopril, atenolol, telmisartan)
St. john’s wort (medicines used to treat depression)

Overdosage:

If you or anyone else accidentally took more of GYNASET CR 15 TABLET, contact your doctor immediately or visit a nearby hospital immediately if the symptoms worsen. The symptoms may include nausea, vomiting, breast enlargement and vaginal bleeding.

SYNOPSIS
Drug :   Norethisterone
Pharmacological Category :   Progestogens
Therapeutic Indication :   Menstrual disorders and breast cancer
Dosage Forms :   Tablet
MORE INFORMATION
Keep GYNASET CR 15 TABLET below 25°C
Keep GYNASET CR 15 TABLET out of sight and reach from children
FAQs ABOUT GYNASET CR 15 TABLET

Can GYNASET CR 15 TABLET affect the regular menstrual cycle?

GYNASET CR 15 TABLET is a synthetic form of the hormone progesterone. Rather than allowing for the natural fall in progesterone during your period, GYNASET CR 15 TABLET keeps your progesterone levels high. This delays the shedding of your womb lining and the period.

When will my menstrual cycle start after taking GYNASET CR 15 TABLET?

Your doctor will advise you when to take GYNASET CR 15 TABLET and for how long. You’ll usually be prescribed 3 GYNASET CR 15 TABLET tablets a day, starting 3 to 4 days before you expect your period to begin. Your period should arrive 2 to 3 days after you stop taking the GYNASET CR 15 TABLET.

How long will GYNASET CR 15 TABLET take to stop bleeding?

If a period is very heavy or prolonged, your doctor may advise you to take GYNASET CR 15 TABLET. Bleeding will usually stop within 24-48 hours of starting treatment.

What happens if I take GYNASET CR 15 TABLET too late?

It is important to take GYNASET CR 15 TABLET three days before your menstrual cycle. If you take GYNASET CR 15 TABLET too late, it may delay your menstrual cycle.

Can GYNASET CR 15 TABLET cause mood depression?

Yes, GYNASET CR 15 TABLET may cause depressed mood, acne, breast tenderness, fluid retention and loss of libido. Contact your doctor if you get any of the side effects.

REFERENCES

1. K D Tripathi. Hormones and Related Drugs. Essentials of Medical Pharmacology. 7th Edition. Page 309-310.

2. Wockhardt UK Ltd. Electronic Medicines Compendium (EMC). [Revised in February 2020] [Accessed on 19th July 2022] https://www.medicines.org.uk/emc/product/1494/pil

3. Norethisterone. Torrent Pharmaceuticals Ltd. [Revised in May 2020] [Accessed on 19th Jul 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2955.pdf

4. Norethisterone. Torrent Pharmaceuticals Ltd. [Revised in July 2020] [Accessed on 19th Jul 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2950.pdf

5. Norethisterone. Leeford Health Care Ltd. Accessed on 19th Jul 2022] https://www.leeford.in/product/1516/rethrowel-10-cr

USEFUL DIAGNOSTIC TESTS
Complete blood count
Thyroid functions
HCG
Pap smear
Net Qty
1 N
Hsn Code
30043990
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