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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Bone Effects

Advise patients that AROMASIN lowers the level of estrogen in the body. This may lead to reduction in bone mineral density (BMD) over fourth dimension. The lower the BMD, the greater the risk of osteoporosis and fracture [encounter Warnings and Precautions (5.1)].

Other Estrogen-Containing Agents

Advise patients that they should non take estrogen-containing agents while they are taking AROMASIN every bit these could interfere with its pharmacologic action [see Warnings and Precautions (5.three)].

Use in Premenopausal Women

Propose patients that AROMASIN is not for apply for the treatment of breast cancer in premenopausal women [meet Warnings and Precautions (5.5)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential that exposure during pregnancy or inside 1 month prior to formulation can result in fetal harm. Suggest females to inform their healthcare provider of a known or suspected pregnancy [come across Warnings and Precautions (five.six) and Utilize in Specific Populations (eight.ane)].

Advise females of reproductive potential to use constructive contraception while taking AROMASIN and for 1 month after the terminal dose [run into Apply in Specific Populations (8.iii)].

Lactation

Advise women not to breastfeed during treatment with AROMASIN and for ane month subsequently the last dose [see Use in Specific Populations (8.2)].


Patient Information
AROMASIN® (ah ROME ah sin)
(exemestane) tablets
This Patient Information has been approved by the U.S. Nutrient and Drug Administration Revised: eleven/2021

What is AROMASIN?

AROMASIN is used in women who are past menopause for the treatment of:

  • Early chest cancer (cancer that has not spread outside the breast) in women who:
    • accept cancer that needs the female person hormone estrogen to grow, and
    • take had other treatments for breast cancer, and
    • have taken tamoxifen for 2 to 3 years, and
    • are switching to AROMASIN to consummate 5 years in a row of hormonal therapy.
  • Advanced breast cancer (cancer that has spread) subsequently treatment with tamoxifen, and it did non work or is no longer working.

Information technology is not known if AROMASIN is rubber and effective in children.

Do not take AROMASIN if yous are allergic to AROMASIN or any of the ingredients in AROMASIN. See the cease of this leaflet for a consummate listing of ingredients in AROMASIN.

Earlier you accept AROMASIN, tell your doctor most all your medical conditions, including if you lot:

  • are still having menstrual periods (are not past menopause). AROMASIN is only for women who are past menopause.
  • have weak or breakable bones (osteoporosis)
  • are pregnant or program to become pregnant. Taking AROMASIN during pregnancy or inside ane month of becoming significant tin harm your unborn infant.
    • Females who are able to become pregnant should take a pregnancy test within 7 days earlier starting treatment with AROMASIN.
    • Females who are able to go pregnant should employ constructive nascence command (contraceptive) during handling with AROMASIN and for 1 calendar month later your last dose of AROMASIN. Tell your medico right away if you become pregnant or think you may be pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if AROMASIN passes into your breast milk. Practice not breast-feed during treatment with AROMASIN and for 1 calendar month after your concluding dose of AROMASIN.
  • Have liver or kidney problems.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Particularly tell your doctor if y'all accept medicines that contain estrogen, including other hormone replacement therapy or birth command pills or patches. AROMASIN should non exist taken with medicines that contain estrogen as they could impact how well AROMASIN works.

How should I take AROMASIN?

  • Take AROMASIN exactly as your medico tells yous.
  • Take AROMASIN 1 fourth dimension each day after a meal.
  • If you accept too much AROMASIN, phone call your doctor right away or become to nearest hospital emergency room.

What are the possible side furnishings of AROMASIN?

AROMASIN may cause serious side effects, including:

  • Bone loss. AROMASIN decreases the amount of estrogen in your body which may reduce your bone mineral density (BMD) over time. This may increment your adventure for bone fractures or weak and brittle bones (osteoporosis). Your doctor may check your bones during treatment with AROMASIN if y'all have osteoporosis or at adventure for osteoporosis.

The most common side effects of AROMASIN in women with early chest cancer include:

  • hot flashes
  • headache
  • feeling tired
  • trouble sleeping
  • joint pain
  • increased sweating

The virtually common side furnishings of AROMASIN in women with avant-garde breast cancer include:

  • hot flashes
  • increased sweating
  • nausea
  • increased appetite
  • feeling tired

Your doctor will do blood tests to check your vitamin D level before starting handling with AROMASIN.

AROMASIN may crusade decreased fertility in males and females. Talk to your doctor if you take concerns most fertility.

These are not all the possible side effects of AROMASIN. Telephone call your physician for medical advice about side effects. You may report side furnishings to FDA at one-800-FDA-1088.

How should I store AROMASIN?

  • Store AROMASIN at room temperature 68°F to 77°F (xx°C to 25°C).
  • Continue AROMASIN and all medicines out of the reach of children.

General information about the safe and effective utilise of AROMASIN.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Exercise not use AROMASIN for a condition for which it was non prescribed. Do non requite AROMASIN to other people, even if they have the same symptoms you have. Information technology may impairment them. You tin enquire your pharmacist or doctor for information nigh AROMASIN that is written for health professionals.

What is in AROMASIN?

Agile ingredient: exemestane

Inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl booze.

Logo

LAB-0399-ix.0

For more information, become to world wide web.AROMASIN.com or call i-888-AROMASIN (1-888-276-6274).

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