25 mg film-coated tablets 
Exemestane

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

Your medicine is called Exemestan Stada. Exemestan Stada 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 Stadaan is used to treat early hormone-dependent breast cancer in women who have passed menopause, after completing 2-3 years of treatment with tamoxifen.

It is also used to treat advanced breast cancer in women who have passed menopause when another hormone therapy has not worked satisfactorily.

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

2. What you need to know before using Exemestan Stada

Do not use Exemestan Stada

  • if you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6)
  • if you have not already passed menopause, ie you are still menstruating
  • if you are pregnant, planning to become pregnant, or breastfeeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Exemestan Stada again

  • you have liver or kidney problems
  • you have or have had any disease that affects the strength of the bone structure. This is because drugs of this kind lower the female hormones and it can lead to a reduction in the mineral content of the bone structure which in turn can lead to reduced bone strength. You may need to undergo tests to measure your bone density before and during treatment. Your doctor may prescribe medication that can prevent or treat bone loss
  • you suffer from vitamin D deficiency.

Before starting treatment with Exemestan Stada, your doctor may want to take a blood test to make sure you are past menopause.

Other medicines and Exemestan Stada

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

Exemestane Stada should not be given at the same time as hormone replacement therapy ( HRT ). The following medicines should be used with caution when taking Exemestane Stada. Tell your doctor if you are taking

  • rifampicin ( antibiotic ),
  • carbamazepine or phenytoin (anticonvulsant for the treatment of epilepsy ),
  • an herbal medicine containing St. John’s wort ( Hypericum perforatum ).

Pregnancy, breastfeeding, and fertility

Do not take Exemestane Stada if you are pregnant or breast-feeding.

If you are pregnant or think you may be pregnant, talk to your doctor.

Discuss the appropriate contraceptive with your doctor if you may become pregnant.

Driving and using machines

If you feel drowsy, dizzy, or weak while taking Exemestan Stada, 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 Stada contains sodium

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

How to use Exemestan Stada

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

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

Adults and the elderly

The usual dose is one 25 mg tablet daily.

Exemestan Stada tablets should be swallowed after a meal at approximately the same time each day.

Use for children and adolescents

Exemestan Stada is not suitable for use by children and young people.

If you use more Exemestan Stada than 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. Take the pack of Exemestan Stada tablets with you if you are going to the hospital.

If you forget to use Exemestan Stada

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 using Exemestan Stada

Do not stop taking the tablets even if you feel better unless your doctor tells 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 Stada is generally well tolerated and the side effects observed in patients who have been treated with Exemestane Stada 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):

  • 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, carpal tunnel syndrome (a combination of tingling and numbness and pain in the whole hand except the little finger), tingling ( paresthesia )
  • abdominal pain, vomiting, constipation, digestive problems, diarrhea
  • skin rash, hair loss, hives ( urticaria ), itching
  • thinning of the skeleton weakens its 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):

  • hypersensitivity
  • fatigue
  • acute generalized exanthematous pustulosis (skin rash characterized by blisters filled and may be accompanied by fever)
  • muscle weakness.

Inflammation of the liver ( hepatitis ) can occur. Symptoms include a feeling of general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, right-sided abdominal pain, and loss of appetite. Contact a doctor immediately if you think you have any of these symptoms.

If you take a blood test, they may show changes in liver function. Changes in the number of certain types of blood cells ( lymphocytes ) and platelets (which cause clotting of the blood) may occur, especially in patients who already have lymphopenia (decreased number of lymphocytes in the blood).

5. How to store Exemestan Stada

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 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.

Each film-coated tablet contains 25 mg of exemestane.

Other ingredients are:

Tablet core:

Mannitol, copovidone, crospovidone, microcrystalline cellulose with silica, sodium starch cligolate (type A), magnesium stearate.

Film coating:

Hypromellose, macrogol 400, titanium dioxide

What the medicine looks like and the contents of the pack

White to off-white, round, biconvex film-coated tablets with “25” on one side and smooth on the other side.

Exemestane Stada 25 mg film-coated tablets are supplied in blister packs of 10, 30, 60, 90, 100, and 120 (10 blisters)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

EirGen Pharma Ltd.

Westside Business Park

Old Kilmeaden Road

Waterford

Ireland

STADApharm GmbH

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Eurogenerics NV

Heizel Esplanade B22

1020 Brussels

Belgium

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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