25 mg film-coated tablets 
exemestane

1. What Exemestane Sandoz is and what it is used for

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

Exemestane Sandoz is used to treating early hormone-dependent breast cancer in women who have passed menopause, after undergoing 2 to 3 years of treatment with tamoxifen.

Exemestane Sandoz 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 Sandoz 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 taking Exemestane Sandoz

Do not take Exemestane Sandoz

  • if you are or have previously been shown to be allergic to exemestane 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 or planning to become pregnant or breast-feeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Exemestan Sandoz.

  • Before starting treatment with Exemestane Sandoz, your doctor may want to take a blood sample to make sure you are past menopause.
  • Before you start using Exemestane Sandoz, tell your doctor if you have liver or kidney problems.
  • Tell your doctor if you are in, or have been in before, conditions that affect the strength of the bone structure. Your doctor may want to measure your bone density before and during treatment with Exemestane Sandoz. This is because drugs of this type lower the levels of female hormones that can cause a decrease in the mineral content of the bone structure, which in turn can lead to poorer bone strength.
  • Your doctor may consider giving you vitamin D supplements as it is common for women with early breast cancer to have severe vitamin D deficiency.

Other medicines and Exemestane Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Exemestane Sandoz should not be given at the same time as hormone replacement therapy ( HRT ).

Tell your doctor if you are taking any of the following medicines:

  • rifampicin ( antibiotic )
  • carbamazepine or phenytoin (an anticonvulsant drug used to treat epilepsy )
  • herbal medicine used for mild depression and mild anxiety (containing St. John’s wort, Hypericum perforatum )

Exemestane Sandoz with food and drink

The Exemestan Sandoz tablet should be taken after a meal at about the same time each day.

Pregnancy and breastfeeding

Do not take Exemestane Sandoz if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Discuss contraception with your doctor if there is a risk that you may become pregnant.

Driving and using machines

If you feel drowsy, dizzy, or weak while taking Exemestan Sandoz, 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 sharpened attention. 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 Sandoz contains sodium

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

How to take Exemestane Sandoz

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Exemestane Sandoz tablets should be taken after a meal at about the same time each day.

The recommended dose is one 25 mg tablet daily.

If you need to visit a hospital while taking Exemestan Sandoz, tell your healthcare provider what medicines you are taking.

Use for children

Exemestane Sandoz is not suitable for children.

If you take more Exemestan Sandoz then you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Show them the package with Exemestan Sandoz.

If you forget to take Exemestane Sandoz

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

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

If you stop taking Exemestane Sandoz

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Exemestane Sandoz is generally well tolerated and the following side effects observed in patients treated with Exemestane tablets are usually mild or moderate in nature. Most of the side effects are associated with estrogen deficiency (eg hot flashes).

Contact a doctor immediately if you think you have been affected by the following:

  • severe allergic reactions. Symptoms include rash, itching, hives, difficulty breathing or swallowing, and dizziness.
  • inflammation of the liver ( hepatitis ). Symptoms include general malaise, nausea, jaundice (yellowing skin or eyes), itching, right-sided abdominal pain, and decreased appetite.

The following other side effects have been reported in people taking exemestane tablets.

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

  • difficulty sleeping
  • headache
  • hot flashes
  • nausea
  • increased sweating
  • muscle and joint pain (including osteoarthritis, back pain and inflammation, and stiffness in the joints)
  • fatigue.

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

  • loss of appetite
  • Depression
  • dizziness
  • tingling or numbness in the hands or feet
  • carpal tunnel syndrome (pain and numbness in the whole hand except the little finger)
  • abdominal pain, vomiting, constipation, digestive problems, diarrhea
  • skin rash, itching  hair loss
  • impaired skeletal strength (osteoporosis) which can sometimes lead to fractures(fractures or cracks)
  • pain, swollen hands, and feet.

Uncommon (may affect up to 1 in 100 people)

  • decreased number of white blood cells, which increases the risk of infection. Symptoms can include fever, sore throat, or mouth ulcers due to infection s
  • an acute widespread rash with varicose veins ( acute generalized exanthematous pustulosis )
  • drowsiness
  • weakness in the muscles.

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

  • decreased platelet count (with an increased risk of bleeding and bruising).

5. How to store Exemestan Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton/blister after “EXP”.

The expiration date is the last day of the specified month.

No special storage instructions.

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. One film-coated tablet contains 25 mg of exemestane.
  • The other ingredients are mannitol, microcrystalline cellulose, crospovidone, sodium starch glycolate (Type A), hypromellose E5, polysorbate 80, colloidal anhydrous silica, magnesium stearate, hypromellose 6cp (E 464), titanium dioxide (E 171), and macrogol 400.

What the medicine looks like and the contents of the pack

White to off-white, round, biconvex film-coated tablets marked with “E25” on one side and unlabeled on the other side.

The film-coated tablets are packaged in white, opaque PVC / PVdC-Al pressure packs in a carton.

Pack sizes:

15, 20, 28, 30, 90, 98, 100, 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

SC Sandoz SRL, Str. Livezeni no. 7A, 540472 Targu-Mures, Romania

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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