Anastrozole 1mg Film Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Anastrozole 1mg film-coated tablets
Read all of this leaflet carefully before you start using 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 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 is and what it is used for
2. Before you take Anastrozole
3. How to take Anastrozole
4. Possible side effects
5. How to store Anastrozole
6. Further information
1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR
Anastrozole belongs to a group of medicines called aromatase inhibitors. Anastrozole works by interfering with the action of an enzyme called aromatase, which affects the level of certain female sex hormones such as oestrogens. Anastrozole is used in the treatment of advanced breast cancer in post-menopausal women.
2. BEFORE YOU TAKE ANASTROZOLE Do not take Anastrozole
- If you are allergic (hypersensitive) to Anastrozole or any of the other ingredients of Anastrozole.
- If you have not yet had the menopause
- If you are pregnant or breast feeding
- If you have severe kidney problems
- If you have moderate or severe liver disease
- If you are taking tamoxifen or oestrogen-containing medicines, for example hormone replacement therapy (see also ‘Taking other medicines' below)
Take special care with Anastrozole
Before taking this medicine, tell your doctor if:
- you have a history of or are suffering from any condition which affects the strength of your bones
- you are taking any LHRH analogues (medicines used to treat breast cancer, certain gynaecological conditions and infertility)
- you are taking tamoxifen. It may lessen the effect of Anastrozole
- If you are unsure whether or not you have gone through menopause yet. Your doctor should check your hormone levels Using 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 medicines can interact with Anastrozole; in these cases it may be necessary to change your dose or interrupt your treatment with some of these medicines. It is especially important that you tell your doctor if you are taking some of the following medicines: tamoxifen or oestrogens (female hormones).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. See section “Do not take Anastrozole”.
Driving and using machines
Anastrozole may make you feel tired or sleepy. If you experience these symptoms you should not drive or operate machinery. Important information about some of the ingredients of Anastrozole
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product as Anastrozole contains lactose.
3. HOW TO TAKE ANASTROZOLE
Always take Anastrozole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Remember to take your medicine.
Your doctor will tell you how long to take the tablets for. Only stop taking your tablets if your doctor tells you.
Usual dose:
- In adults (including the elderly), the usual dose is one tablet (1mg of Anastrozole) taken daily
- In patients with mild or moderate kidney disorder or mild liver disorder, the usual dose is also one tablet (1mg of Anastrozole) taken daily.
Swallow the tablet whole with a drink of water.
Try to take your tablet at the same time each day.
If you take more Anastrozole than you should
If you take more than your normal dose contact your doctor or nearest hospital.
If you forget to take Anastrozole
You should take Anastrozole as prescribed. However, if you miss a dose do not take a double dose to make-up for a forgotten dose. Just resume your usual schedule.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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If you stop taking Anastrozole
Do not stop treatment with Anastrozole before consulting your doctor because treatment with Anastrozole is a long-term treatment. Contact your doctor if you have any problems with the use of Anastrozole. 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 can cause side effects, although not everybody gets them.
If you experience the following, stop taking Anastrozole and tell your doctor immediately or go to the casualty department of the nearest hospital:
• A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).
This is a serious but very rare side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice these effects or experience any other problem with your treatment:
Very common (affecting more than 1 per 10 patients):
• hot flushes.
Common (affecting less than 1 per 10 but more than 1 per 100 patients):
• feeling weak,
• joint pain or joint stiffness,
• vaginal dryness,
• thinning of the hair,
• skin rash,
• nausea,
• diarrhoea,
• headache.
• abnormal liver tests.
Uncommon (affecting less than 1 per 100 but more than 1 per 1,000 patients):
• vaginal bleeding (usually in the first few weeks of treatment),
• anorexia (loss of appetite),
• raised or high levels of fatty substances called lipids in the blood,
• vomiting,
• sleepiness.
• abnormal liver tests and hepatitis.
Very rare (affecting fewer than 1 per 10,000 patients):
• extremely severe skin reactions (Stevens-Johnson syndrome) with lesions,
• ulcers or blisters,
• allergic reaction with swelling of the face, lips, tongue and/or throat (angioedema), which may cause difficulty in swallowing and/or breathing,
• allergic reactions such as hives or nettle rash.
Other possible side effects:
Anastrozole lowers 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.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ANASTROZOLE Keep out of the reach and sight of children.
Do not use Anastrozole after the expiry date which is stated on the carton 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 Anastrozole contains
- The active substance is Anastrozole.
- The other ingredients are lactose monohydrate,
- Sodiumcarboxymethylstarch, povidone, magnesium stearate, Hydroxypropylmethylcellulose, macrogol, Cotton Seed Oil, modified starch and titanium dioxide (E171).
What Anastrozole looks like and contents of the pack
Anastrozole comes in white, round biconvex film-coated tablets.
Each pack contains 14, 28 and 30 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was last revised in 02/2015.
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MAT 51730388 ■ Code 1484