PRODUCT LEAFLET: USER INFORMATION

Adiunastrol 1 mg film-coated tablets (anastrozole)

Equivalent drug

 

 

 

Read this leaflet carefully before taking this drug because it contains important information.

  • Keep this You may need to read it again.
  • If you have any further questions, ask your doctor or
  • This medicine has been prescribed for you Do not pass it on to others. It may cause them harm even if their symptoms are the same as yours.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See paragraph

 

Contents of this leaflet:

  1. What Adiunastrol is and what it is used for
  2. What you need to know before taking Adiunastrol
  3. How to take Adiunastrol
  4. Possibile side effects
  5. How to store Adiunastrol
  6. Package contents and other information

 

  1. WHAT ADIUNASTROL IS AND WHAT IT IS USED FOR

Adiunastrol contains a substance called anastrozole which belongs to a group of drugs called ‘aromatase inhibitors’. Adiunastrol is used to treat breast cancer in women who are in menopause. Adiunastrol works by reducing the amount of hormones called estrogens that the body produces. It does so by blocking a natural substance (an enzyme) of

the body called ‘aromatase’.

 

2.   WHAT YOU NEED TO KNOW BEFORE TAKING ADIUNASTROL

Do not take Adiunastrol

  • if you are allergic (hypersensitive) to anastrozole or to any of the other components of this drug (see section 6).
  • if you are pregnant or are breast feeding (see the section called ‘Pregnancy and breast-feeding’). Do not take Adiunastrol if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking

Warnings and precautions

Consult your doctor or pharmacist before taking Adiunastrol

  • if you still have menstrual cycles and are not yet in menopause
  • if you are taking a medicine that contains tamoxifen or estrogens (see the section called ‘Other Medicines and Adiunastrol’).
  • if you suffer or have suffered a condition that alters bone resistence (osteoporosis).
  • if you have liver or kidney

If you are not sure whether any of the above apply to you, contact your doctor or pharmacist before taking Adiunastrol.

If you go are hospitalized, let the medical staff know you are taking Adiunastrol.

Other Medicines  and  Adiunastrol Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines, including medicines obtained without a prescription and herbal medicine. This is because Adiunastrol can affect the way some medicines work and some medicines can have an effect  on  Adiunastrol.  Do not take Adiunastrol if you are already taking any of the following medicines:

  • some medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifen. This is because these medicines can prevent Adiunastrol from working
  • medicines containing estrogens, for example hormone replacement therapy (HRT).

If any of the above apply to you, ask your doctor or pharmacist for advice.

Inform your doctor or pharmacist if you are taking the following:

  • A medicine known as an ‘LHRH analogue’. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain female health (gynaecological) conditions and

Pregnancy, breastfeeding and fertility

If you are pregnant, if you suspect you are pregnant,if you are planning a pregnancy or if you are breastfeeding, ask your doctor or pharmacist for advice before taking Adiunastrol.

Stop taking Adiunastrol if pregnancy occurs and contact your doctor.

 

Driving and using tools or machines Adiunastrol is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or drowsy while taking Adiunastrol. If this happens to you, ask your doctor or pharmacist for advice.

 

Adiunastrol contains lactose

This product contains lactose, a type of sugar. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking Adiunastrol.

 

3.    HOW TO TAKE ADIUNASTROL

Always follow the instructions of your doctor or pharmacist when taking Adiunastrol. If you have doubts, ask your doctor or pharmacist for advice. - The recommended dose is one tablet once a day. - Try to take the tablet at the same time every day. - Swallow the tablet whole with a glass of water. - It does not matter if you take Adiunastrol before, with or after meals.

Keep taking Adiunastrol for as long as instructed by your doctor. It is a long-term treatment and you may need to take it for several years. If you have any doubts, ask your doctor or pharmacist for advice.

 

Use in children and teenagers

Adiunastrol is not recommended for use in

children or teenagers.

 

If you take more Adiunastrol than you should

If you take more Adiunastrol than you should, contact your doctor immediately.

 

If you forget to take Adiunastrol

  • If you forget to take a dose, take your next dose as
  • Do not take a double dose (two doses at the same time) to compensate for a forgotten

 

If you stop treatment with Adiunastrol Do not stop taking Adiunastrol unless your doctor instructs you to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist for advice.

 

4.    POSSIBILE SIDE EFFECTS

Like all medicines, Adiunastrol may cause some side effects although not everyone experiences them.

Inform your doctor immediately if you experience any of the following very rare symptoms after taking Adiunastrol as you may need to be treated urgently:

  • swelling of the face, lips, tongue or throat, difficulty in swallowing, hives or difficulty in breathing (angioedema)
  • extremely severe allergic reactions with ulcers or blisters on the skin, mouth, eyes and genitals (‘Stevens-Johnson syndrome’).

 

Very common side effects (may affect more

than 1 in 10 people)

  • Headache
  • Hot flashes
  • Sickness (nausea)
  • Skin rashes
  • Pain or stiffness in the joints
  • Inflammation of the joints (arthritis)
  • Weakness
  • Bone loss (osteoporosis)

Common side effects (may affect up to 1 in 10 people)

  • Loss of appetite
  • Increased or high levels of a fatty substance known as cholesterol in your This can be checked through a blood test.
  • Drowsiness
  • Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)
  • Diarrhea
  • General sickness (vomiting)
  • Changes in liver function tests .
  • Hair thinning (hair loss)
  • Allergic reactions (hypersensitivity) including in the face, lips and
  • Bone pain
  • Vaginal dryness
  • Vaginal bleeding (usually during the first few weeks of treatment – if the bleeding persists, contact your doctor).
  • Muscle pain

Uncommon side effects (may affect up to 1

in 100 people)

  • Changes in specific, liver function blood tests that show how well your liver is working (gamma-GT and bilirubin)
  • Liver inflammation (hepatitis)
  • Skin rashes, urticaria or hives
  • Trigger finger (a condition in which your finger or        thumb     catches  in            a              bent        position).
  • Increased amount of calcium in the blood. If nausea, vomiting and thirst occur, contact your doctor, pharmacist or nurse as blood tests may be necessary.

Rare side effects (may affect up to 1 in 1000

people)

  • Rare skin inflammation that may include red spots and
  • Skin rash caused by hypersensitivity (this can be caused by an allergic or anaphylactoid reaction).
  • Inflammation of the small blood vessels that causes the skin to become red or purple. Very rarely this may cause pain in the joints, stomach and kidneys; this is known as "Henoch-Schönlein purpura".

Effects on the bones

Adiunastrol reduces the quantity of a hormone called estrogen that is present in the body. This may lower the mineral content of your bones which may become less strong and more likely to fracture. Your doctor will assess these risks according to treatment guidelines on bone health in women who are in menopause. Talk to your doctor about the risks and treatment options.

 

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

By reporting side effects you can help provide more information on the safety of this product.

 

  1. HOW TO STORE ADIUNASTROLE

Keep this product out of the reach and sight of children.

Do not use Adiunastrole after the expiry date which is reported on the carton and on the blister package. The expiry date refers to the last day of the month indicated.

Store the tablets in the original package. Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of medicines that are no longer required. These measures will help protect the environment.

 

6.     PACKAGE CONTENTS AND OTHER

INFORMATION

What Adiunastrol contains: the active ingredient is Anastrozole. Each film-coated tablet contains 1 mg of Anastrozole.

The other components are lactose monohydrate 93 mg, povidone (K30), sodium starch glycolate, magnesium stearate. The tablets are coated with hypromellose, macrogol 300, titanium dioxide (E171).

What Adiunastrol looks like and package contents: Adiunastrol

tablets are white, round and film-coated.

The tablets are available in blister packs of 28, 30, 98 and 100 tablets.

Not all package types may be available for sale.

 

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB, Torsgatan 11, 111 23 Stockholm, Sweden.

 

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

Member State

Product Name

MA Holder

AT

Anastrozol Bluefish 1 mg Filmtabletten

 

 

 

 

 

 

 

Bluefish Pharmaceuticals AB 11123

Stockholm, Sweden

CZ

Anastrozole Bluefish 1 mg potahované tablety

DE

Anastrozol Bluefish 1 mg Filmtabletten

DK

Anastrozol Bluefish 1 mg filmdragerade tabletter

ES

Anastrozole Bluefish 1 mg comprimidos recubiertos con película

FR

Anastrozole Bluefish 1 mg comprimés peliculés

HU

Anastrozole Bluefish 1 mg filmtabletta

IE

Anastrozole Bluefish 1 mg film-coated tablets

IT

Adiunastrol 1 mg compresse rivestite con film

NL

Anastrozole Bluefish 1 mg filmomhulde tabletten

NO

Anastrozol Bluefish 1 mg filmdragerade tabletter

PL

Anastrozole Bluefish

SE

Anastrozole Bluefish 1 mg filmdragerade tabletter

 

SK

Anastrozole Bluefish 1 mg filmom obalené tablety

 

IS

Anastrozole Bluefish1 mg filmuhúðaðar töflur

 

This product leaftlet was last reviewed on July 2, 2015

 

 

 

 

 

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