PRODUCT LEAFLET: USER INFORMATION

 NIBESTAN 25 mg film-coated tablets

Exemestane

 Equivalent drug

 

Read this leaflet carefully before taking this drug.

  • Keep this leaflet. You may need to read it again.
  • If you have any doubt, contact your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may cause them harm even if their symptoms are the same as yours.
  • If any of the side effects worsens or if you experience any side effect that is not listed in this leaflet, contact your doctor or pharmacist.

 

Contents of this leaflet:

  1. What NIBESTAN is and what it is for
  2. Before taking NIBESTAN
  3. How to take NIBESTAN
  4. Possible side effects
  5. How to store NIBESTAN
  6. Other information

 

  1. What NIBESTAN is and what it is for

 

This drug is called NIBESTAN. NIBESTAN belongs to a group of drugs called "aromatase inhibitors". These drugs interfere with a substance called aromatase which is necessary for the production of estrogens, female sex hormones, especially in postmenopausal women. Reducing the level of estrogens in the body is one way of treating hormone-dependent breast cancer.

 

NIBESTAN is used in the treatment of hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of therapy with tamoxifen. NIBESTAN is also used in the treatment of advanced hormone-dependent breast cancer in postmenopausal women when hormone therapy with another medicinal product has proven to be ineffective.

 

  1. Before taking NIBESTAN

 

Do not take NIBESTAN

  • If you are allergic (hypersensitive) to exemestane (active ingredient of NIBESTAN) or to any of the other ingredients of NIBESTAN. See paragraph 6 (“What NIBESTAN contains”) for a complete list of all the ingredients.
  • If you are not yet in menopause, that is if you have a regular menstrual cycle.
  • If you are pregnant, if you may possibly be pregnant or if you are breastfeeding.

 

Be especially careful with NIBESTAN

  • Before beginning treatment with NIBESTAN, your doctor may require blood tests to confirm you are in menopause.  
  • Before taking NIBESTAN, tell your doctor if you have liver or kidney problems.
  • Tell your doctor if you have suffered or suffer from any condition affecting bone resistance. In fact, some drugs belonging to this class may lower the level of female hormones and this can lead to the loss of bone mineral content, causing bones to become less resistant. Your doctor may decide to measure your bone density before and during treatment with NIBESTAN. The doctor may therapies to avoid or treat the loss of bone density.

 

Taking other medicines

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

 

NIBESTAN must not be taken together with hormone replacement therapy (HRT).  The following drugs must be used carefully when taking NIBESTAN. Tell your doctor if you are taking:

  • rifampicin (an antibiotic),
  • carbamazepine or phenytoin (anticonvulsants used in the treatment of epilepsy),
  • St. John's Wort (Hypericum perforatum) or preparations containing it.

 

Pregnancy and breastfeeding

Do not take NIBESTAN if you are pregnant or breastfeeding.

If you are pregnant or if you have any doubt, inform your doctor.

If there is a possibility you may become pregnant, discuss with your doctor the use of an effective method of contraception.

 

Driving and using machines

If you feel sleepy, dizzy or drowsy during treatment with NIBESTAN, you must not drive or operate machines.

 

  1. How to take NIBESTAN

 

Always follow your doctor’s instructions carefully when taking NIBESTAN. If you have doubts, ask your doctor or pharmacist for advice. Your doctor will tell you how to take NIBESTAN and for how long.

 

Adult and elderly patients

The recommended dose is one 25 mg tablet to be taken once a day. NIBESTAN tablets should be swallowed at approximately the same time every day following one of the main meals.

 

Children and teenagers

NIBESTAN is not recommended for use in children and teenagers.

 

If you have taken more NIBESTAN than you should

If you have accidentally taken too many tablets, contact your doctor immediately or go to the nearest emergency room and show them the package of NIBESTAN tablets.

 

If you forget to take NIBESTAN

Do not take a double dose to compensate for a forgotten dose. If you forget to take a tablet, take the next one as soon as you remember. If it almost time for the next dose, take it at the usual time.

 

Interrupting treatment with NIBESTAN

Do not interrupt treatment even if you feel well, unless your doctor tells you otherwise.

 

  1. Possible side effects

 

Like all medicines, NIBESTAN can cause side effects, although not everyone experiences them. NIBESTAN is well-tolerated and the side effects described below, observed in patients treated with NIBESTAN, are mainly mild or moderate. Most side effects are associated with estrogen deficiency (eg, hot flashes).

 

Very common side effects (may affect more than 1 person in 10):

  • Insomnia
  • Headache
  • Hot flashes
  • Nausea
  • Increased perspiration
  • Joint and muscle pain (including: osteoarthritis, back pain, arthritis and joint stiffness)
  • Fatigue

 

Common side effects (may affect more than 1 person in 100 and less than 1 person in 10):

  • Loss of appetite
  • Depression
  • Dizziness, carpal tunnel syndrome (tingling pins-and-needles sensation, numbness and pain of the hand with the exception of the little finger)
  • Stomach pain, vomiting, constipation, indigestion, diarrhea
  • Skin rashes, hair loss
  • Thinning or wasting of the bones that can alter bone resistance (osteoporosis) sometimes leading to bone fractures
  • Pain, swelling of the hands and feet

 

Uncommon side effects (may affect more than 1 person in 1000 but less than 1 person in 100):

  • Drowsiness
  • Muscle weakness

 

Inflammation of the liver (hepatitis) may also occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain to the right of the abdomen and loss of appetite.

Inform your doctor immediately if you experience any of these symptoms.

 

Blood test results may evidence alterations in the liver functions. The alteration of some blood counts (lymphocytes) and of the platelets mainly occurs in patients with pre-existing lymphopenia (reduction in the number of lymphocytes in the blood).

 

If any of the side effects listed in this leaflet worsen or if you experience any side effect that is not listed in this leaflet, contact your doctor or pharmacist as soon as possible.

 

  1. How to store NIBESTAN

 

Keep out of the sight and reach of children.

Do not use NIBESTAN after the expiry date indicated on the package after “Scad”. The expiry date refers to the last day of the month indicated.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that you no longer require. These measures will help protect the environment.

 

  1. Other information

 

What NIBESTAN contains

The active ingredient is exemestane. Each film-coated tablet contains 25 mg of exemestane.

 

The excipients are:

Tablet core:

Mannitol, Copovidone, Crospovidone, Silicified microcrystalline cellulose, Sodium starch glycolate, (Tipo A), Magnesium stearate

 

Coating:

Hypromellose, Macrogol 400, Titanium dioxide.

 

What NIBESTAN looks like and package contents

Round, bioconvex tablets, white to off-white in color, bearing “25” on one side and nothing on the other.

 

NIBESTAN is available in blister packs as follows:

10, 14, 20, 30, 60, 90 and 100 (Blisters of 10 or 14 tablets) film-coated tablets.

Not all package sizes may be marketed.

 

Marketing Authorization Holder

 

Farmagroup S.r.l.

Via Strampelli 18

63074 San Benedetto del Tronto (AP), Italy

 

Manufacturers:

EirGen Pharma Ltd.  

Westside Business Park, Old Kilmeaden Road, Waterford

Ireland

 

Siegfried Generics (Malta) Ltd

HHF070 Hal Far Industrial Estate, Hal Far BBG3000 

Malta

 

Depo-Pack s.n.c. di Del Deo Silvio e C.

Via Morandi 28

21047 Saronno (VA), Italy

 

Authorized distributor:

SOPHOS BIOTECH S.r.l.

Via Latina, 20

00179 Rome,  Italy

 

This medicinal product is authorized for sale in the Member States of the European Union with the following names:

UK:     Exemestane 25mg Film-coated tablets

EL:      AROMESTAN 25mg Επικαλυμένα με λεπτό υμένιο δισκία

ES:      Exemestano Urquima 25mg comprimidos recubiertos con pelicula EFG

IT:       NIBESTAN 25 mg compresse rivestite con film

 

This leaflet was last approved: 04/2016.

 

 

 

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