Anastrozole 1mg Film Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Anastrozole
Anastrozole 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:
- What Anastrozole is and what it is used for
- Before you take Anastrozole
- How to take Anastrozole
- Possible side effects
- How to store Anastrozole
- Further information
1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR
Anastrozole belongs to a group of medicines called aromatase inhibitors. This means that it interferes with some of the actions of aromatase, an enzyme within the body which affects the level of certain female sex hormones such as oestrogens.
Anastrozole is used to treat breast cancer in post-menopausal women.
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 gone through menopause yet.
- if you are pregnant or breast feeding.
- if you suffer from certain disorders or diseases which affect your liver or kidneys.
- if you are taking tamoxifen or oestrogen-containing medicines, for example hormone replacement therapy (see section 2, ‘Taking other medicines’).
Anastrozole should not be given to children.
Take special care with Anastrozole
- if you are unsure whether or not you have gone through menopause yet. Your doctor should check your hormone levels.
- if you are sufferring from any disorder or disease which affects your liver or kidneys.
- if you have any history of or are suffering from any condition which affects the strength of your bones. 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. You may have to have bone density tests during treatment. Your doctor can give you medicine to prevent or treat the bone loss.
- if you are taking any LHRH analogues (medicines used to treat breast cancer, certain gynaecological conditions and infertility). No studies have been done on the combination of LHRH analogues and anastrozole. Therefore anastrozole and LHRH analogues should not be used in combination.
If you go into hospital let the medical staff know that you are taking anastrozole.
Taking other medicines
You should not take Anastrozole if you are taking any of the following (see also ‘Do NOT take Anastrozole’, above):
• Medicines that contain oestrogen e.g HRT
• Tamoxifen, another breast cancer treatment.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Anastrozole with food and drink
Anastrozole can be taken before, during or after a meal, but also you can take them without food. The tablet should be swallowed with water .
Pregnancy and breast-feeding
Do not take Anastrozole if you are pregnant or if you are breast-feeding your baby.
Please contact your doctor immediately if you think you may be pregnant.
Driving and using machines
Anastrozole is unlikely to adversely affect your ability to drive a car or to operate machinery. However, you 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
Anastrozole contains lactose. If you have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption you should ask your doctor before taking this medicine.
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.
Adults including the elderly:
Take one tablet daily. Swallow with a glass of water. You should try to take your tablet at the same time each day. Children:
Anastrozole is not recommended for children.
If you take more Anastrozole than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Anastrozole a
Do not take a double dose to make up for a forgotten tablet. Just resume your usual schedule.
Remedica
If you stop taking Anastrozole
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
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.
The following side effects are possible for anastrozole:
Very common (ocurring in more than 1 in 10 people)
• Hot flushes
Common side effects (occuring in more than 1 in 100 but less than 1 in 10 people):
• Feeling weak
• Joint pain or joint stiffness
• Vaginal dryness
• Hair thinning
• Rash
• Nausea
• Diarrhoea
• Headache
• Abnormal liver tests
Uncommon side effects (occurring in more than 1 in 1000 but less than 1 in 100 people):
• 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 side effects (occuring in less than 1 in 10,000 people):
Contact a doctor immediately if the following happens to you, as you may need further examinations or treatment:
• 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Other possible side effects:
Anastrozole lowers oestrogen levels. This may cause reduction in bone mineral content that can decrease bone strength and in some cases may result in fractures.
5. HOW TO STORE ANASTROZOLE
This medicinal product does not require any special storage conditions 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. Each film-coated tablet contains 1 mg anastrozole
- The other ingredients are:
Tablet core:
Lactose monohydrate, Maize starch, Povidone, Microcrystalline cellulose, Sodium starch glycolate Type A, Colloidal
anhydrous silica, Magnesium stearate, Talc
Film-coating:
Hypromellose, Macrogol 400, Titanium dioxide (E171), Talc What Anastrozole looks like and contents of the pack
Anastrozole tablets are white, round, film-coated tablets.
The tablets are provided in blisters of 14.
28 film-coated tablets Marketing Authorisation Holder
Waymade PLC
Trading as Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex
SS143FR
Manufacturer
Remedica LTD
Limassol Industrial Estate, Aharnon Street,
P.O.Box 51706, 3508
Limassol
Cyprus
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Anastrozole 1mg Film-coated tablets IT Anastrozolo Fidia 1mg compresse rivestite con film
This leaflet was last approved in 06/11/2008.
69/0890/8 Ld