Zolitrat

Anastrozole

1 mg Film-coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER Zolitrat 1 mg Film-coated tablets

Anastrozole

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Zolitrat is and what it is used for

2.    Before you take Zolitrat

3.    How to take Zolitrat

4.    Possible side effects

5.    How to store Zolitrat

6.    Further information

1.    WHAT ZOLITRAT IS AND WHAT IT IS USED FOR

Zolitrat contains a substance called anastrozole. This belongs to a group of medicines called aromatase inhibitors'. Zolitrat is used to treat breast cancer in women who have gone through the menopause.

Zolitrat works by cutting down the amount of the hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called aromatase'.

2.    BEFORE YOU TAKE ZOLITRAT Do not take Zolitrat:

-    if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Zolitrat (see Section 6: Further information).

-    if you are pregnant or breast-feeding. (See the section called ‘Pregnancy and breast-    feeding'.

Do not take Zolitrat if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zolitrat.

Take special care with Zolitrat

Before treatment with Zolitrat check with your doctor or pharmacist

-    If you still have menstrual periods and have not yet gone through the menopause.

-    If you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ‘Taking other medicines').

-    If you have ever had a condition that affects the strength of your bones (osteoporosis).

-    If you have problems with your liver or kidneys.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zolitrat If you go into hospital, let the medical staff know you are taking Zolitrat Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes medicines that you buy without a prescription and herbal medicines.

This is because Zolitrat can affect the way some medicines work and some medicines can have an effect on Zolitrat

Do not take Zolitrat if you are already taking any of the following medicines:

-    Certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines that contain tamoxifen. This is because these medicines may stop Zolitrat from working properly.

-    Medicines that contain estrogen, such as hormone replacement therapy (HRT).

If this applies to you, ask your doctor or pharmacist for advice.

Tell 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 infertility.

Pregnancy and breast-feeding

Do not take Zolitrat if you are pregnant or breast-feeding. Stop Zolitrat if you become pregnant and talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines

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

Important information about some of the ingredients of Zolitrat

Zolitrat contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE ZOLITRAT

Always take Zolitrat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

-    The usual adult dose is one tablet once a day.

-    Try to take your tablet at the same time each day

-    Swallow the tablet with a drink of water.

-    It does not matter if you take Zolitrat before, with or after food.

Keep taking Zolitrat for as long as your doctor tells you to. It is a long-term treatment and you may need to take it for several years.

Use in children

Zolitrat should not be given to children and adolescents.

If you take more Zolitrat than you should

If you take more Zolitrat than you should, talk to a doctor straight away.

If you forget to take Zolitrat

-    If you forget to take a dose, just take your next dose as normal.

-    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Zolitrat

Do not stop taking your tablets unless your doctor tells you to.

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

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Zolitrat can cause side effects, although not everybody gets them.

Very common side effects (affect more than 1 in 10 people)

•    Headache.

•    Hot flushes.

•    Feeling sick (nausea).

•    Skin rash

•    Pain or stiffness in your joints.

•    Inflammation of the joints (arthritis).

•    Feeling weak.

•    Bone loss (osteoporosis).

Common side effects (affectlto 10 people in 100)

•    Loss of appetite.

•    Raised or high levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test.

•    Feeling sleepy.

•    Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand).

•    Diarrhoea.

•    Being sick (vomiting).

•    Changes in blood tests that show how well your liver is working.

•    Thinning of your hair (hair loss).

•    Allergic (hypersensitivity) reactions including face, lips, or tongue.

•    Bone pain

•    Vaginal dryness

•    Bleeding from the vagina (usually the first few weeks of treatment-if the bleeding continues, talk to your doctor).

Uncommon side effects (affect 1 to10 people in 1,000)

•    Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin).

•    Inflammation of the liver (hepatitis).

•    Hives or nettle rash.

•    Trigger finger (a condition in which your finger or thumb catches in a bent position).

Rare side effects (affect 1 to 10 people in 10,000)

•    Rare inflammation of your skin that may include red patches or blisters.

•    Skin rashes caused by hypersensitivity (this can be from allergic or anaphylactoid reaction).

•    Inflammation of the small blood vessels causing red or purple colouring of the skin. Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schonlein purpura'.

Very rare side effects (affect less than 1 person in 10,000 people)

•    An extremely severe skin reaction with ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome'.

•    Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing. This is known as ‘angioedema'.

If any of these happen to you, call an ambulance or see a doctor straight away- you may need urgent medical treatment.

Effects on your bones

Zolitrat lowers the amount of the hormone called estrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risks and treatment options.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE ZOLITRAT

Keep out of the reach and sight of children. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

Do not use Zolitrat after the expiry date which is stated on the carton and blister.

The expiry date refers to the last day of that month.

Keep your tablets in the container they came in.

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

6.    FURTHER INFORMATION What Zolitrat contains

-    The active substance is anastrozole.Each film-coated tablet contains 1 mg anastrozole

-    The other ingredients are:

Tablet core:

Lactose monohydrate, Maize starch, Povidone K-30, Cellulose microcrystalline pH102, Sodium starch

glycolate Type A, Colloidal silica anhydrous, Magnesium stearate (E572), Talc

Film-coating:

Hypromellose 5cp (E464), Macrogol 400, Titanium dioxide (E171), Talc What Zolitrat looks like and contents of the pack

Zolitrat tablets are white, round, film-coated tablets with a diameter of 6.6 mm approximately.

The tablets are provided in blisters of 10 and 14.

Pack sizes:

10, 14, 28, 30, 56, 60, 84, 90 tablets contained in a carton Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novisis Pharma Ltd

66 Acropolis street

CY-2012 Strovolos, Nicosia

Cyprus

Manufacturer

Remedica Ltd.

Limassol Industrial Estate P.O Box 51706 CY-3508 Limassol Cyprus

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany    Zolitrat 1mg Filmtabletten

Greece    Zolitrat 1 mg EniKoAuMMevo pe Aemo upevio SioKfo

Italy    Zolitrat    1    mg    compresse rivestite con film

Norway    Zolitrat    1    mg,    filmdrasjerte tabletter

Poland    Zolitrat

Spain    Zolitrol 1mg comprimidos recubiertos con pelicula EFG

United Kingdom    Zolitrat    1    mg    film-coated tablets

This leaflet was last revised in 03/2013.