Nibestan

Patient Information Leaflet: Information for the user

NIBESTAN 25 mg film-coated tablets

Exemestane
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What NIBESTAN is and what it is used for
  2. What you need to know before taking NIBESTAN
  3. How to take NIBESTAN
  4. Possible side effects
  5. How to store NIBESTAN
  6. Contents of the pack and other information

1. What NIBESTAN is and what it is used for

This medicinal product is called NIBESTAN. NIBESTAN belongs to a class of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is required for the production of the female sex hormone, estrogen, particularly in postmenopausal women. Reducing the body's estrogen levels is a treatment for hormone-dependent breast cancer.
NIBESTAN is indicated for the treatment of postmenopausal women with hormone-dependent breast cancer, following initial therapy with tamoxifen for 2–3 years.
It is also indicated for the treatment of advanced hormone-dependent breast cancer in postmenopausal women in whom prior therapy with another anti-estrogenic agent has been ineffective.

2. What you need to know before taking NIBESTAN

Do not take NIBESTAN
if you are or have previously been allergic (hypersensitive) to exemestane (the active
substance in NIBESTAN) or to any of the excipients of NIBESTAN (see section 6).
if menopause has not yet occurred, i.e. if you still have menstrual cycles
if you are pregnant, may be pregnant, or are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking NIBESTAN.

• Before treatment with NIBESTAN, your doctor may take blood samples to confirm that menopause has occurred. Before taking NIBESTAN, inform your doctor if you have any liver or kidney problems.

If you have had or currently have any condition affecting bone strength.
Medicines of this class reduce levels of female hormones and may lead to a loss of bone mineral content, thereby reducing bone strength. You may undergo tests to measure bone density before and during treatment. Your doctor may prescribe medications to prevent or treat bone density loss.

Other medicines and NIBESTAN
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
NIBESTAN must not be taken concurrently with hormone replacement therapy (HRT). The following medicines should be used with caution while taking NIBESTAN. Inform your doctor if you are taking medicines such as:
rifampicin (an antibiotic),
carbamazepine or phenytoin (anticonvulsants used in the treatment of epilepsy),
the herbal remedy St. John's wort (Hypericum perforatum) or preparations containing it.

Pregnancy, breastfeeding and fertility
You must not take NIBESTAN if you are pregnant or breastfeeding.
If you are pregnant or suspect you might be, inform your doctor.
Discuss contraceptive methods with your doctor if there is any possibility of pregnancy.

Driving and use of machinery
If you experience drowsiness, dizziness or weakness while taking NIBESTAN, you should not attempt to drive vehicles or operate machinery.

3. How to take NIBESTAN

Always take NIBESTAN exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Your doctor will tell you how to take NIBESTAN and for how long.

Adult and elderly patients
The usual dose is one 25 mg film-coated tablet daily.
Swallow the NIBESTAN film-coated tablets after a meal, at approximately the same time each day.

Use in children and adolescents
The use of NIBESTAN in children and adolescents is not recommended.

If you take more NIBESTAN than you should
If you have accidentally taken many tablets, contact your doctor immediately or go directly to the nearest hospital emergency department. Show them the packaging of the NIBESTAN film-coated tablets.

If you forget to take NIBESTAN
Do not take a double dose to make up for the forgotten dose.
If you forget to take the film-coated tablet, take it as soon as you remember.
If it is almost time for your next dose, take the tablet at the scheduled time.

If you stop taking NIBESTAN
Do not stop taking the film-coated tablets even if you feel well, unless your doctor decides otherwise. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NIBESTAN can cause side effects, although not everyone experiences them. NIBESTAN has generally been well tolerated, and the following side effects observed in patients treated with NIBESTAN have been mild to moderate in severity. Most adverse reactions can be attributed to estrogen deprivation (e.g., hot flushes).

Very common side effects (may affect more than 1 in 10 people):
Sleep disturbances
Headache
Hot flushes
Nausea
Increased sweating
Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
Fatigue

Common side effects (may affect up to 1 in 10 people):
Loss of appetite
Depression
Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain in the entire hand except the little finger)
Stomach pain, vomiting, constipation, indigestion, diarrhoea
Skin rash, alopecia
Bone thinning which may reduce bone strength (osteoporosis), possibly leading to bone fracture (break or crack) in some cases
Pain, swelling of hands and feet

Uncommon side effects (may affect up to 1 in 100 people):
Drowsiness
Muscle weakness
Liver inflammation (hepatitis) may also occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Inform your doctor promptly if you experience any of these symptoms.
Blood test results may show changes in liver function. Levels of certain blood cells (lymphocytes) and platelets (cells involved in blood clotting) may be altered, particularly in patients with pre-existing lymphopenia (reduced lymphocyte count).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIBESTAN

Keep this medicine out of the sight and reach of children.
Do not use NIBESTAN after the expiry date stated on the carton after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIBESTAN contains
The active substance is exemestane. Each film-coated tablet contains 25 mg of
exemestane.
The other components are:
Tablet core:
Mannitol, Copovidone, Crospovidone, Microcrystalline Cellulose, Sodium Starch
Glycolate (Type A), Magnesium Stearate
Coating:
Hypromellose, Macrogol 400, Titanium Dioxide.
Description of the appearance of NIBESTAN and contents of the pack
Round, biconvex film-coated tablets, white to off-white in colour, imprinted with "25" on one side and blank on the other.
NIBESTAN is available in blister packs containing:
10, 14, 20, 30, 60, 90 and 100 tablets (blister packs of 10 or 14) film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
WAVE PHARMA S.r.l.
Via Talamone, 5
00179 Rome
Italy
Manufacturers
EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford
Ireland
Depo-Pack S.N.C. di Del Deo Silvio e C.
Via Morandi 28,
21047 Saronno (VA)
Italy
This medicinal product is authorised in the European Economic Area Member States
under the following names:
UK: Exemestane 25mg Film-coated tablets
EL: AROMESTAN 25mg Επικαλυμένα με λεπτό υμένιο δισκία
IT: NIBESTAN 25mg compresse rivestite con film
This leaflet was last approved in 05/2020.