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Nastrosa 1mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nastrosa lmg 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 Nastrosa 1mg Film-Coated Tablets are and what they are used for

2.    Before you take Nastrosa 1mg Film-Coated Tablets

3.    How to take Nastrosa 1mg Film-Coated Tablets

4. Possible side effects

5. How to store Nastrosa 1mg Film-Coated Tablets

6. Further information

1.    WHAT NASTROSA 1mg FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Nastrosa 1 mg Film-Coated Tablets contain a substance called Anastrozole. This belongs to a group of medicines called 'aromatase inhibitors'. Nastrosa 1 mg Film-coated Tablets are used to treat breast cancer in women who have gone through the menopause.

Nastrosa 1 mg Film-coated Tablets work 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 NASTROSA 1mg FILM-COATED TABLETS

Do not take Nastrosa 1mg Film-Coated Tablets

   if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Nastrosa 1mg Film-Coated Tablets (see section 6: Further information)

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

Do not take Nastrosa 1mg Film-Coated Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Nastrosa 1 mg Film-Coated Tablets.

Take special care with Nastrosa 1mg Film-Coated Tablets

Before treatment with Nastrosa 1mg Film-Coated Tablets 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 Nastrosa 1 mg Film-Coated Tablets.

If you go into the hospital, let the medical staff know you are taking Nastrosa 1mg Film-Coated Tablets.

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 Nastrosa 1mg Film-Coated Tablets can affect the way some medicines work and some medicines can have an effect on Nastrosa 1mg Film-Coated Tablets.

Do not take Nastrosa 1 mg Film-Coated Tablets 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 Nastrosa 1mg Film-Coated Tablets 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 Nastrosa 1 mg Film-Coated Tablets if you are pregnant or breast feeding. Stop Nastrosa 1mg Film-Coated Tablets if you become pregnant and talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Nastrosa 1mg Film-Coated Tablets 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 Nastrosa 1 mg Film-Coated Tablets. If this happens to you, ask your doctor or pharmacist for advice.

Important information about some of the ingredients of Nastrosa Nastrosa 1mg Film-Coated Tablets contain lactose. 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 NASTROSA 1mg FILM-COATED TABLETS

Always take Nastrosa 1mg Film-Coated Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

   The usual dose is one tablet once a day.

   Try to take your tablet at the same time each day

   Swallow the tablet whole with a drink of water.

   It does not matter if you take Nastrosa 1mg Film-Coated Tablets before, with or after food.

Keep taking Nastrosa 1mg Film-Coated Tablets 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

Nastrosa 1mg Film-Coated Tablets should not be given to children and adolescents.

If you take more Nastrosa 1mg Film-Coated Tablets than you should

If you take more Nastrosa 1mg Film-Coated Tablets than you should, talk to a doctor straight away.

If you forget to take Nastrosa 1mg Film-Coated Tablets

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 Nastrosa lmg Film-Coated Tablets

Do not stop taking your tablets even if you are feeling well, 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, Nastrosa 1mg Film-Coated Tablets 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 (affect 1 to 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 in the first few weeks of treatment - if the bleeding continues, talk to your doctor).

Uncommon side effects (affect 1 to 10 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 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 (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 Nastrosa 1 mg Film-Coated Tablets 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE NASTROSA 1mg FILM-COATED TABLETS

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.

This medicinal product does not require any special storage conditions.

Do not use Nastrosa 1mg Film-Coated Tablets after the expiry date which is stated on the outer packaging / blister after 'EXP'. The expiry date refers to the last day of that month.

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 Nastrosa 1mg Film-Coated Tablets contain

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

   The other ingredient(s) are:

   Tablet core: lactose monohydrate, sodium starch glycolate (type A), magnesium stearate

   Film-coating:Opadry II white 85F18422 consisting of poly (vinyl alcohol) - partially hydrolysed, titanium dioxide, macrogol 3350, talc.

What Nastrosa 1mg Film-Coated Tablets look like and contents of the pack

   Nastrosa 1mg Film-Coated Tablets tablets are white, round, film-coated tablets, with the number '1' on one side and plain on the reverse.

   Nastrosa 1mg Film-Coated Tablets are available in pack sizes of 20, 28, 30, 84, 98, 100 and 300 tablets contained in a carton. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Niche Generics Limited,

1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW, United Kingdom.

Manufacturers

Niche Generics Limited,

1 The Cam Centre, Wilbury Way, Hitchin, Herts SG4 0TW, United Kingdom.

Eirgen Pharma Limited,

64-65 Westside Business Park,

Old Kilmeaden Road, Waterford, Ireland.

Distributed by

Discovery Pharmaceuticals,

The Old Vicarage, Market Place,

Castle Donington, Derbyshire DE74 2JB, UK

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

UK: Nastrosa 1mg Film-Coated Tablets IE: Anastrozole Niche 1 mg Film-Coated Tablets

This leaflet was last approved in: June 2012


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