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Anastrozole 1mg Film Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Anastrozole 1mg Film-coated Tablets

Anastrozole


Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet as 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 as it may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Anastrozole Tablets are and what they are used for

2.    Before you take Anastrozole Tablets

3.    How to take Anastrozole Tablets

4.    Possible side effects

5.    How to store Anastrozole Tablets

6.    Further information

1. What Anastrozole Tablets are and what they are used for

Anastrozole tablets are one of a group of medicines called aromatase inhibitors and are used to treat breast cancer in post menopausal women (women who no longer get their periods). The tablets decrease the amount of oestrogen the body makes. This can slow or stop the growth of many types of breast cancer cells that need oestrogen to grow.

2. Before you take Anastrozole Tablets

Do not take Anastrozole tablets

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

•    if you are pregnant, or breast-feeding.

•    if you have not gone through the menopause.

•    if you are taking oestrogen-containing medicines, for example hormone replacement therapy.

•    if you are taking tamoxifen.

Take special care with Anastrozole tablets

•    if you are taking LHRH analogues (medicines used to treat breast cancer, certain gynaecological conditions and infertility).

•    if you are suffering from any disorder or disease which affects your liver or kidneys.

•    if you are an adolescent with growth hormone deficiency undergoing growth hormone treatment.

Anastrozole lowers the levels of female hormones in the body which may lead to thinning of the bones. This can reduce bone strength therefore you may be required to have bone density tests before and during your treatment.

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.

Certain drugs may decrease the effectiveness of anastrozole, including tamoxifen and oestrogen-containing drugs.

Taking Anastrozole Tablets with food and drink

Anastrozole tablets may be taken before or after food.

Pregnancy and breast-feeding

Do not take anastrozole tablets if you are pregnant or breast-feeding your baby.

Driving and using machines It is unlikely that anastrozole tablets will affect your ability to drive a car or to operate machinery. However, some patient may occasionally feel weak or sleepy. If this happens to you, ask your doctor for advice.

Important information about some of the ingredients of Anastrozole tablets

Patients who are intolerant to lactose should note that each anastrozole tablet contains a small amount of lactose.

3. How to take Anastrozole Tablets

Always take anastrozle tablets exactly as your doctor has told you. You should check with your dotor or pharmacist if you are not sure. The usual dose is one tablet daily. The tablets should be swallowed whole with a drink of water. Try to take your tablets at the same time each day.

If you take more Anastrozole than you should

Tell your doctor or contact the nearest hospital, taking the medicine or this leaflet with you.

If you forget to take Anastrozole Tablets

If you miss a dose, just carry on next one as usual.Do not take a double dose to make up for a forgotten tablet.

If you stop taking Anastrozole Tablets

If you stop taking anastrozole, tell your doctor as soon as possible. Only stop taking your tablets if your doctor tells you even if you are feeling well.

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

4. Possible side effects

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

Below is a list of the side effects that some patients have experienced whilst taking anastrozole tablets:

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

•    hot flushes

•    headache

•    skin rash

•    joint pain or stiffness

•    inflammation of the joints (arthritis)

•    feeling weak

•    feeling sick (nausea)

Common side effects (could affect more than 1 in 100 peopled

•    loss of appetite (anorexia)

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

•    sleepiness

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

•    diarrhoea

•    being sick

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

•    thinning of the hair

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

•    bone pain

•    diarrhea

•    vaginal dryness

•    vaginal bleeding (usually in the first few weeks of treatment if the bleeding continues, talk to your doctor).

Uncommon side effects (could affect less than 1 in 100 peopled

•    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 10.0001

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

•    skin rash 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 (could effect less than 1 in 10.000 peoplel

•    severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing. You should contact your doctor immediately if you have these symptoms.

•    extremely severe skin reactions (Stevens-Johnson syndrome) with lesions, ulcers or blisters. You should contact your doctor immediately if you have these symptoms.

Anastrozole tablets lower the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength and in some cases might result in fractures.

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

5. How to store Anastrozole Tablets

Keep out of the reach and sight of children. Do not use anastrozole tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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 no longer required. These measures will help to protect the environment.

6. Further information

What anastrozole tablets contains

The active substance is anastrozole. Each film coated tablet contains 1 mg anastrozole. The other ingredients arejactose monohydrate, povidone K-30, sodium starch glycolate and magnesium stearate. The tablets are coated with hypromellose, titanium dioxide (E171), macrogol 6000 and talc.

What Anastrozole tablets look like and contents of the pack

Anastrozole tablets are supplied to you as round white coloured tablets. The tablets are provided in blister packs containing 7,10,14,20,28,30,40,50,56,60 and 100 tablets. Not all pack sizes may be marketed

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturer

Doppel Farmaceutici S.r.l

Via Martiri delle Foibe, 1-29016, Cortemaggiore

Genepharm

18th Km, Marathon Av, 15351 Pallini, Greece

This leaflet was last revised in April 2013