25 mg film-coated tablets 
exemestane

1. What Exemestan Actavis is and what it is used for

Exemestane Actavis belongs to a group of medicines called aromatase inhibitors. These drugs affect a substance called aromatase, which is necessary for the production of the female sex hormone estrogen, especially in menopausal women. Reducing estrogen levels in the body is one way to treat hormone-dependent breast cancer.

Exemestane Actavis is used to treat early hormone-dependent breast cancer in postmenopausal women, after completing 2 to 3 years of treatment with tamoxifen.

Exemestane Actavis is also used to treat hormone-dependent advanced breast cancer in women who have passed menopause when another hormone replacement therapy has not worked satisfactorily.

Exemestane contained in Exemestane Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Exemestan Actavis

Do not use Exemestan Actavis

  • if you are allergic to or have previously had an allergic reaction to exemestane (the active substance in Exemestane Actavis) or any of the other ingredients of this medicine (listed in section 6).
  • if you have not passed menopause, ie if you are still menstruating.
  • if you are pregnant, planning to become pregnant, or breastfeeding.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Exemestan Actavis.

  • Before treatment with Exemestane Actavis, your doctor may want to take a blood test to determine that you have reached menopause.
  • Routine monitoring of vitamin D levels will also be done before treatment as the level can be very low in the early stages of breast cancer. You get a supplement of vitamin D if the level is below normal.
  • Before using the Exemestane Actavis, tell your doctor if you have liver or kidney problems.
  • Tell your doctor if you have or have had a condition that affects the strength of the bone structure. Your doctor may want to make bone density measurements before and during treatment with Exemestan Actavis. This is because drugs of this type lower the levels of female hormones and can cause reduced mineral content in the bone structure, which in turn can lead to poorer bone strength.

Other medicines and Exemestan Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Exemestane Actavis should not be given at the same time as hormone replacement therapy. The following medicines must be used with caution with Exemestan Actavis. Tell your doctor if you are taking:

– rifampicin ( antibiotic )

– carbamazepine or phenytoin (an anticonvulsant drug used to treat epilepsy )

– herbal medicine containing St. John’s wort (Hypericum perforatum).

Pregnancy and breastfeeding

Do not use Exemestane Actavis if you are pregnant or breast-feeding.

Tell your doctor if you are or think you may be pregnant.

Discuss the use of appropriate contraception with your doctor if you may become pregnant.

Driving and using machines

If you feel drowsy, dizzy, or weak while taking Exemestan Actavis, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Exemestane Actavis contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Exemestan Actavis

Adults and the elderly

Exemestane Actavis tablets should be taken orally (orally) after a meal at approximately the same time each day. Your doctor will tell you how to take Exemestane Actavis and for how long. The usual dose is one 25 mg tablet daily.

If you have to go to the hospital while taking Exemestan Actavis, tell your healthcare professional what medicines you are taking.

Children

Exemestane Actavis is not suitable for use in children.

If you take more Exemestan Actavis then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the pack of Exemestan Actavis film-coated tablets with you to the hospital.

If you forget to take Exemestan Actavis

Do not take a double dose to make up for a forgotten dose .

If you forget to take your tablet, take it as soon as you remember. If it is soon time to take the next tablet, take it at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Exemestan Actavis

Do not stop taking the tablets even if you feel well, unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Exemestan Actavis can cause side effects, although not everybody gets them.

Hypersensitivity, liver inflammation ( hepatitis ) and inflammation of the bile ducts in the liver leading to yellowing of the skin (cholestatic hepatitis ) can occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching , pain in the right abdomen and loss of appetite. Contact a doctor immediately for advice if you think you have any of these symptoms.

Exemestane Actavis is generally well tolerated and the side effects observed in patients treated with Exemestane Actavis are mainly mild or less severe. Most side effects are related to estrogen deficiency (eg hot flashes).

Very common (may affect more than 1 user in 10):

  • Depression
  • insomnia
  • headache
  • hot flashes
  • dizziness
  • nausea
  • increased sweating
  • muscle and joint pain (including osteoarthritis , back pain and inflammation and stiffness in the joints)
  • fatigue
  • decreased white blood cell count
  • abdominal pain
  • elevated liver enzymes
  • increased degradation of hemoglobin in the blood
  • elevated levels of an enzyme in the blood due to liver damage
  • pain

Common (may affect up to 1 in 10 people):

  • loss of appetite
  • carpal tunnel syndrome (tingling, numbness and pain in the whole hand except the little finger) or tingling in the skin
  • vomiting, constipation, indigestion, diarrhea
  • hair loss
  • skin rash, hives and itching
  • impaired skeletal strength (osteoporosis), which can sometimes lead to fractures(fractures or cracks)
  • swollen hands and feet
  • decreased platelet count
  • muscle weakness

Uncommon (may affect up to 1 in 100 people):

  • hypersensitivity

Rare (may affect up to 1 in 1,000 people)

  • rash of small blisters on a skin area with rash
  • drowsiness
  • hepatitis
  • inflammation of the bile ducts of the liver leading to yellowing of the skin

Has been reported (occurs in an unknown number of users)

  • low levels of certain white blood cells
  • Changes in the number of certain blood cells ( lymphocytes ) and plateletscirculating in the blood, especially in patients with pre-existing lymphopenia (decreased number of lymphocytes in the blood) can also be seen.

5. How to store Exemestan Actavis

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. dat. or EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
  • The other ingredients are: Tablet core: povidone K30, corn starch (bleached), pregelatinized (partial) starch , sodium starch glycolate type A, microcrystalline cellulose type 101, talc, colloidal anhydrous silica, magnesium stearate and polysorbate 80; Film coating : partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171).

What the medicine looks like and contents of the pack

Exemestane Actavis 25 mg film-coated tablets are white, round, cupped and smooth tablets with smooth edges.

Pack sizes

Blister packs: 10, 30, 40, 60, 84, 90 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

SC Sindan-Pharma SRL

11, Ion Mihalache Blvd.

011171 Bucharest

Romania

Muhammad Nadeem

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