ANASTROZOLE 1

Read all of this leaflet carefully before you are given ANASTROZOLE 1

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, nurse or other health care provider.
  • ANASTROZOLE 1 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS:

S4

NAME OF THE MEDICINAL PRODUCT:

ANASTROZOLE 1 (FILM-COATED TABLETS)

WHAT ANASTROZOLE 1 CONTAINS:

Each tablet contains:
Anastrozole 1 mg.
Contains Lactose.
The other ingredients are maize starch, povidone, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, purified talc, hypromellose, titanium dioxide.

WHAT ANASTROZOLE 1 IS USED FOR:

ANASTROZOLE 1 is used to treat early or advanced breast cancer in post-menopausal women.

BEFORE YOU TAKE ANASTROZOLE 1:

Do not take ANASTROZOLE 1:

It is important that you tell your doctor or healthcare professional if you suffer from any of the conditions mentioned, if you are taking ANASTROZOLE 1 or have been prescribed ANASTROZOLE 1.

  • Hypersensitivity to anastrozole and other chemically related medications or to any of the ingredients of ANASTROZOLE 1.
  • If you are pregnant or breastfeeding.
  • Pre-menopausal women.
  • If you suffer from severe renal (kidney) problems.
  • If you suffer from moderate or severe hepatic (liver) problems.

Take special care with ANASTROZOLE 1

Caution should be observed with the use of  ANASTROZOLE 1 tablets in the following patients:

  • If you have weak bones or are arthritic, as ANASTROZOLE 1 may cause a reduction in bone mineral density, which may cause increased risk of fractures. If you have or are at risk of getting arthritis, you should get your bone density test done at the start of therapy with ANASTROZOLE 1 and at regular intervals thereafter.
  • ANASTROZOLE 1 is not recommended for use in children.
  • If you suffer from liver or kidney problems tell your doctor before using ANASTROZOLE 1.

PREGNANCY AND BREASTFEEDING:

Do not take ANASTROZOLE 1 if you are pregnant or breastfeeding your baby. [see ‘Do not take ANASTROZOLE 1’]. Please consult your doctor, pharmacist or other healthcare professional for advice.

Important information about some ingredients of ANASTROZOLE 1

  • ANASTROZOLE 1 contains lactose. If you suffer from lactose intolerance then do not take this medicine or consult with your doctor or pharmacist first.

Effects on ability to drive and use machines:

  • Asthenia (weakness) and somnolence (sleepiness) have been reported with the use of ANASTROZOLE 1. Should these symptoms persist / prevail, caution should be observed when driving or operating machinery.

Taking other medicines with ANASTROZOLE 1:

If you are taking other medicines on a regular basis including complementary or traditional medicines, using ANASTROZOLE 1 with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

When you are taking ANASTROZOLE 1, it is especially important to tell your doctor or healthcare professional if you are taking any of the following:

  • Tamoxifen (medicine also used for breast cancer) and / or oestrogen-containing therapies (such as oral contraceptives or hormone replacement medicines) should not be taken together with ANASTROZOLE 1 as they would diminish its activity.

HOW TO TAKE ANASTROZOLE 1

Adults:
Take one tablet (1 mg) daily.

The doctor will prescribe different doses for different patients and therefore follow the orders given by your doctor or pharmacist, do not change it.

Take ANASTROZOLE 1 exactly as your doctor has prescribed it.

If you have the impression that the effect of ANASTROZOLE 1 is too strong or too weak talk to your doctor or pharmacist.

If you take more ANASTROZOLE 1 than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

If you forget to take ANASTROZOLE 1:

If you have missed a dose of ANASTROZOLE 1 tablets, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular scheduling. Never double your dose.

POSSIBLE SIDE-EFFECTS

ANASTROZOLE 1 can have side-effects.

Check with your doctor immediately if any of the following side effects occur:

  • Erythema multiforme – a skin lesion with fever, joint aches and itching of skin.
  • Stevens-Johnson Syndrome – a severe skin disorder that causes the top layer of the skin to separate and peel off.
  • Allergic reactions
  • Erythema – a swelling or welts beneath the skin
  • Urticarial – red itchy skin
  • Drowsiness or an inability to sleep
  • Bone fractures
  • Hepatitis – a condition that causes swelling of the liver and causes, tiredness, loss of appetite, dark urine, weight loss.

Consult your doctor as soon as possible should the below side effects occur while taking ANASTROZOLE 1:

  • Hot flushes
  • Nausea
  • Diarrhoea
  • Headache
  • Carpel Tunnel Syndrome – symptoms include numbness of the thumb, long finger and ring finger
  • Hair thinning
  • Rash
  • Vaginal dryness
  • Joint Pain / Stiffness
  • Asthenia – weakness or lack of energy or strength.
  • Vaginal bleeding
  • Anorexia
  • Poor appetite with excessive weight loss.
  • High cholesterol levels
  • Vomiting

Not all side effects reported for ANASTROZOLE 1 are included in this leaflet. Should your general health worsen while taking  ANASTROZOLE 1, please consult your doctor, pharmacist or other healthcare professional for advice

STORAGE & DISPOSAL INORMATION FOR ANASTROZOLE 1:

Store this medicine away from heat and moisture at or below 25 ̊ C.

Keep blister in carton until required for use.

Do not refrigerate or freeze this medicine.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.

Store all medicines out of reach and sight of children.

PRESENTATION:

10 tablets are placed in a PVC Blister with aluminium backing. 3 blister strips are placed in a carton of 30 tablets or 14 tablets are placed in a PVC Blister with aluminium backing. 2 blister strips are placed in a carton of 28 tablets.

IDENTIFICATION:

ANASTROZOLE 1

White, round, film coated tablets with a diameter of approximately 6.6 mm.

REGISTRATION NUMBER:

43/21.12/0010

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

DATE OF PUBLICATION THE PATIENT INFORMATION LEAFLET:

14/09/2012