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Activella (Generic Estrogen and Progestin Hormone Replacement Therapy)

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The risk of heart attack, stroke, breast cancer, and blood clots in the legs and lungs may all be raised by hormone replacement treatment. Inform your doctor if you smoke, have or have ever had diabetes, high blood pressure, high cholesterol, blood clots, breast lumps, cancer, a heart attack, or any other medical condition. Consult your doctor about quitting oestrogen and progestin at least 4 to 6 weeks before to any surgery or bed rest if you will be undergoing either.

Call your doctor right away if you suffer any of the following side effects: Abrupt, severe symptoms can include a severe headache, severe vomiting, sudden partial or total vision loss, speech difficulties, dizziness or faintness, arm or leg numbness or weakness, crushing chest pain, coughing up blood, sudden shortness of breath, or calf pain.

Discuss the advantages and disadvantages of taking oestrogen and progestin with your doctor.

Why is this medication prescribed?

Certain menopause symptoms are managed using oestrogen and progestin combinations. Two female sex hormones are oestrogen and progestin. The oestrogen hormone that is no longer produced by the body is replaced by hormone replacement therapy. Estrogen lessens hot flashes—periods of sweating and heat—as well as vaginal symptoms including itching, burning, and dryness and difficulty urinating. However, it has little effect on other menopause symptoms like anxiety or sadness. In menopausal women, oestrogen also protects osteoporosis, which is the thinning of the bones. In hormone replacement therapy, progestin is given to oestrogen to lower the risk of uterine cancer in women who still have their uterus.

How should this medicine be used?

Tablets for oral hormone replacement therapy are available. Typically, it is given once day. Take hormone replacement medication at roughly the same time each day to help yourself remember to take it. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on the prescription exactly. Never take it in larger or less amounts or more frequently than directed by your doctor. Without consulting your doctor, do not discontinue using this drug.

Estrogen and progestin are found in the pills Activella, FemHrt, and Prempro. Each day, take one tablet.

The blister card with 30 tablets of Ortho-Prefest is available. Take one pink tablet once daily for three days (it contains only oestrogen), followed by one white tablet once daily for three days (it contains both oestrogen and progestin). Continue doing this until you have consumed every tablet on the card. The day after you finish the previous blister card, start the new one.

The dispenser for Premphase contains 28 tablets. On days 1 through 14, take one maroon tablet (which contains only oestrogen), then on days 15 through 28, take one light-blue tablet (which contains both oestrogen and progestin). The day after you finish the previous dispenser, start the new one.

Request a copy of the manufacturer’s information for the patient from your pharmacist or doctor before beginning hormone replacement treatment, and carefully read it.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking hormone replacement therapy,

  • If you have an allergy to oestrogen, progestin, or any other drugs, let your doctor and pharmacist know right away.
  • Inform your physician and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are taking. Incorporate any of the following: acetaminophen (Tylenol); blood-thinning medications include warfarin (Coumadin); morphine (Kadian, MS Contin, MSIR, others); oral steroids including dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); rifampin (Rifadin, Rimactane); salicylic acid; cyclosporine (Neoral, Sandimmune); drugs for seizures like theophyline (Theobid, Theo-Dur), temazepam (Restoril), and thyroid medications like levothyroxine (Levothroid, Levoxyl, Synthroid). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Tell your doctor if you’ve had a hysterectomy and if you currently have or have ever had asthma in addition to the illnesses listed in the IMPORTANT WARNING section; Toxemia (high blood pressure during pregnancy); depression; epilepsy (seizures); migraine headaches; liver, heart, gallbladder, or renal disorders; vaginal bleeding in between periods; excessive weight gain; and fluid retention (bloating) during the menstrual cycle.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor right away if you get pregnant while taking this medicine. Progestin and oestrogen may be harmful to the foetus.
  • Inform your doctor or dentist that you are taking hormone replacement therapy if you are undergoing surgery, including dental surgery.
  • If you smoke, let your doctor know. If you smoke while taking this medicine, you have a higher chance of experiencing negative side effects like blood clots and stroke. Smoking may potentially reduce this medication’s effectiveness.
  • In case you wear contact lenses, let your doctor and pharmacist know. Consult an eye doctor if you experience changes in your eyesight or ability to wear contact lenses while taking hormone replacement treatment.

What special dietary instructions should I follow?

Ask your doctor about taking calcium supplements if you are taking this medication for prevention of osteoporosis. Follow all dietary and exercise recommendations, as both can help prevent bone disease.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from hormone replacement treatment are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Uneasy stomach
  • Vomiting
  • Constipation or bloating
  • Diarrhea
  • Changes in appetite and weight
  • Alterations in sex desire or capacity
  • Nervousness
  • Skin patches that are brown or black
  • Acne
  • Hand, foot, or lower leg swelling (fluid retention)
  • Spots or bleeding between menstrual cycles
  • Modifications to menstrual flow
  • Tenderness, expansion, or discharge in the breast
  • Using contact lenses is challenging

Some adverse effects can be very harmful. Although the following signs and symptoms are unusual, if you notice any of them or any of the ones in the IMPORTANT WARNING section, call your doctor right away:

  • Dual perception
  • Intense stomach discomfort
  • The skin or eyes turning yellow
  • Severe depression of the mind
  • Uncommon bleeding
  • Reduced appetite
  • Rash
  • Extreme exhaustion, sluggishness, or lack of energy
  • Fever
  • Urine with a deep colour
  • Stool with a light colour

Endometrial cancer and gallbladder disease risk may rise with hormone replacement therapy. The dangers of using this drug should be discussed with your doctor.

Other negative effects of hormone replacement therapy are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it in a cool, dry place away from heat and moisture (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Uneasy stomach
  • Vomiting

What other information should I know?

Keep all of your appointments with your physician and the lab. At least once a year, you should have a thorough medical examination that includes taking your blood pressure, checking your pelvis and breasts, and getting a Pap test. When checking your breasts, according to your doctor’s instructions and report any lumps right away.

Your doctor will check to see if you still need hormone replacement treatment every three to six months if you are taking it to address menopause symptoms. You will need to take this drug for a longer amount of time if you are taking it to prevent osteoporosis, which causes the bones to thin.

Inform the lab staff that you are using hormone replacement therapy prior to any testing, as this drug may affect the results of some tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Bijuva® (as a combination product containing Estradiol, Progesterone)
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