25 mg film-coated tablets 
exemestane

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

Exemestane 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, estrogens , especially in women who have passed menopause. Reducing estrogen levels in the body is one way to treat hormone-dependent breast cancer.

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

Exemestane Accord is also used to treat advanced breast cancer in women who have passed menopause, when other hormone replacement therapy has not worked satisfactorily.

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

2. What you need to know before using Exemestane Accord

Do not use Exemestane Accord

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

Talk to your doctor, pharmacist or nurse before using Exemestane Accord

Warnings and cautions

  • Your doctor may want to take a blood test to make sure you are past menopause before you are treated with Exemestane Accord.
  • 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 Accord, tell your doctor if you have liver or kidney problems.
  • Tell your doctor if you are in or have previously been in a condition that affects the strength of the bone structure. Your doctor may want to measure your bone density before and during treatment with Exemestane Accord. 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.

Other medicines and Exemestane Accord

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

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

The following medicines must be used with caution in conjunction with Exemestane Accord.

Tell your doctor if you are taking:

  • rifampicin ( antibiotic )
  • carbamazepine or phenytoin ( anticonvulsant drug used to treat epilepsy )
  • the herbal medicine St. John’s wort (Hypericum perforatum) or agents containing it.

Exemestane Accord with food, drink and alcohol

Exemestane Accord should be taken after a meal at approximately the same time each day

Pregnancy, breastfeeding and fertility

You should not use Exemestane Accord 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 it is possible that you may become pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using 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.

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

3. How to use Exemestane Accord

Adults and the elderly

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

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

Your doctor will tell you how to take Exemestane Accord and for how long.

The recommended dose is one 25 mg tablet daily.

If you need hospitalization while taking Exemestane Accord, tell your healthcare provider what medicines you are taking.

Use for children and adolescents

Exemestane Accord should not be given to children.

If you take more Exemestane Accord than you should

If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital or the Poison Information Center for risk assessment and advice.

If you forget to take Exemestane Accord

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 stop taking Exemestane Accord

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

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

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.

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

  • Depression
  • Difficulty sleeping
  • Headache
  • Hemorrhoids
  • Dizziness
  • Nausea
  • Increased sweating
  • Muscle and joint pain (including osteoarthritis , back pain, arthritis and joint stiffness)
  • Fatigue
  • Decreased white blood cell count
  • Abdominal pain
  • Elevated liver enzymes
  • Increased breakdown 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 and numbness in the whole hand except the little finger) or tingling in the skin
  • Stomach pain, vomiting, constipation, digestive problems, diarrhea
  • Hair loss
  • Skin rash, hives and itching
  • Impaired skeletal strength (osteoporosis), which can sometimes lead to fractures(fractures and cracks)
  • Pain, swollen hands and feet
  • Reduced platelet count
  • Muscle weakness

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

  • Hypersensitivity

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

  • Outbreak of small blisters on a skin area with rash
  • Drowsiness
  • Liver inflammation
  • Inflammation of the bile ducts of the liver leading to yellow 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 platelets circulating 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 Exemestane Accord

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 and the 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.

Other ingredients are:

Core : Mannitol, microcrystalline cellulose, crospovidone, sodium starch glycolate (type A), hypromellose E5, polysorbate 80, colloidal anhydrous silica, magnesium stearate

Film coating : Hypromellose 6 cp (E464), titanium dioxide (E171), macrogol 400

What the medicine looks like and contents of the pack

Exemestane Accord is a white to off-white, round, cupped film-coated tablet marked with E25 on one side and unmarked on the other.

Exemestane Accord is available in white opaque blister packs (PVC / PVdC-aluminum) on 15, 20, 28, 30, 90, 98, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer:

Accord Healthcare Limited

Sage House, 319, Pinner Road,

North Harrow,

Middlesex, HA1 4HF,

UK

Laboratori Fundació DAU

C / C, 12-14 Pol. Ind. Zone, France, Barcelona 08040 (Barcelona) Spain

Spain

European Pharma Hub Kft.,

7000/9 hrsz, Gorcsev Iván u. 5., warehouse 15., 16., H-2360 Gyál

Hungary

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Muhammad Nadeem

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