Exemestane Kern Pharma 25 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Exemestane Kern Pharma 25 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Exemestane Kern Pharma is and what it is used for
- Before you take Exemestane Kern Pharma
- How to take Exemestane Kern Pharma
- Possible side effects
- How to store Exemestane Kern Pharma
- Further information
1. What Exemestano Kern Pharma is and what it is used for
This medicine is called Exemestano Kern Pharma. Exemestane belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is required to produce female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.
Exemestane is used to treat early-stage hormone-dependent breast cancer in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.
Exemestane is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another form of hormonal treatment has not been sufficiently effective.
2. Before taking Exemestano Kern Pharma
Do not take Exemestano Kern Pharma
- if you are or have previously been allergic (hypersensitive) to exemestane or to any of the other components of Exemestano Kern Pharma. See section 6 (“Composition of Exemestano Kern Pharma”) for the full list of excipients.
- if you have not yet reached menopause, that is, if you still have menstrual periods,
- if you are pregnant, think you might be pregnant, or are breastfeeding.
Take special care with Exemestano Kern Pharma
- Before starting treatment with Exemestano, your doctor may perform a blood test to confirm that you have reached menopause.
- Before taking Exemestano, inform your doctor if you have any liver or kidney problems.
- Inform your doctor if you have a history of, or currently suffer from, any condition affecting bone strength. Your doctor may assess your bone density before and during treatment with Exemestano. This is because medicines in this class reduce levels of female hormones, which may lead to a loss of bone mineral content and could reduce bone strength.
Use of other medicines
Inform your doctor if you are currently using or have recently used any other medicines, including those obtained without a prescription.
Exemestano must not be administered at the same time as hormone replacement therapy (HRT).
The following medicines should be used with caution if you are being treated with Exemestano. Inform your doctor if you are taking any of these medicines:
- rifampicin (an antibiotic),
- carbamazepine or phenytoin (antiepileptics used to treat epilepsy),
- the herbal remedy St. John’s wort (Hypericum perforatum), or preparations containing it.
Pregnancy and breastfeeding
Do not take Exemestano if you are pregnant or breastfeeding.
Inform your doctor if you are pregnant or think you might be pregnant.
Talk to your doctor about contraceptive measures if there is any possibility of becoming pregnant.
Driving and using machines
If you experience dizziness, drowsiness, or fatigue while being treated with Exemestano, do not drive or operate machinery.
3. How to take Exemestane Kern Pharma
Adults and elderly
Exemestane tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will advise you on how to take Exemestane and for how long. The recommended dose is one 25 mg tablet daily.
Do not stop taking the tablets even if you feel well, unless your doctor tells you to.
If you need to go to hospital while being treated with Exemestane, inform the medical staff which medication you are taking.
Children
Exemestane is not suitable for use in children.
If you take more Exemestane Kern Pharma than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount taken.
Important information for athletes
Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.
If you forget to take Exemestane Kern Pharma
Do not take a double dose to make up for forgotten doses.
If you forget to take a tablet, take it as soon as you remember. If it is close to the time for your next dose, take the next dose at the usual time.
4. Possible adverse effects
Like all medicines, Exemestane may cause adverse effects, although not everyone experiences them. In general, Exemestane is well tolerated, and the following adverse effects observed in patients treated with Exemestane are mainly of mild or moderate severity. Most of these adverse effects are related to estrogen reduction (for example, hot flashes).
Very common adverse effects (affect more than 1 in 10 people):
- Difficulty sleeping
- Headache
- Hot flashes
- Feeling unwell
- Increased sweating
- Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
- Fatigue
Common adverse effects (affect between 1 and 10 in 100 people):
- Loss of appetite
- Depression
- Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger)
- Stomach pain, vomiting (feeling of nausea), constipation, indigestion, diarrhea
- Skin rash, hair loss
- Decreased bone density, which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
- Pain, swelling of hands and feet
Uncommon adverse effects (affect between 1 and 10 in 1,000 people):
- Numbness
- Muscle weakness
Liver inflammation (hepatitis) may occur. Symptoms include general feeling of being unwell, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you are experiencing any of these symptoms.
If you have had a blood test, you may have noticed changes in liver function. There may be changes in the levels of certain blood cells (lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (low lymphocyte count in the blood).
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist as soon as possible.
5. Storage of Exemestane Kern Pharma
This medicine does not require special storage conditions.
Keep the tablets in their original packaging.
Keep out of the sight and reach of children.
Do not use Exemestane Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Information for the patient
Composition of Exemestano Kern Pharma
- The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
- The other components are: mannitol (E421), microcrystalline cellulose, crospovidone, sodium starch glycolate type A (potato starch), hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate and Opadry White [hypromellose, macrogol and titanium dioxide (E171)].
Appearance of the medicinal product and contents of the pack
Exemestano Kern Pharma is a film-coated, round, biconvex tablet, white to off-white in colour, marked with "E25" on one side.
Exemestano Kern Pharma is supplied in blister packs containing 30 tablets.
Marketing Authorisation Holder and Manufacturer
Kern Pharma, S.L.
Venus, 72 – Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
This leaflet was approved in January 2011