1 mg film-coated tablets
anastrozole
1. What Arimidex is and what it is used for
Arimidex contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Arimidex is used to treat breast cancer in women who have passed menopause.
Arimidex works by reducing the amount of a hormone called estrogen, which is produced in the body. It does this by blocking a natural substance (an enzyme ) in the body called “aromatase”.
2. What you need to know before using Arimidex
Do not take Arimidex
- if you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant or breast-feeding (see section “Pregnancy and breast-feeding”).
Do not take Arimidex if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Arimidex.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Arimidex
- if you are still menstruating and have not passed menopause.
- if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see section “Other medicines and Arimidex”).
- if you have ever had a condition that affects the strength of your skeleton ( osteoporosis, ie osteoporosis).
- if you have liver or kidney problems.
Talk to your doctor or pharmacist before taking Arimidex if you are not sure if any of the above applies to you.
Tell your healthcare provider that you are taking Arimidex if you go to the hospital.
Other medicines and Arimidex
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to over-the-counter medicines and herbal medicines. This is because Arimidex can affect the way some other medicines work, and some medicines can affect Arimidex.
Do not take Arimidex if you are already taking any of the following medicines:
- Certain drugs used to treat breast cancer (selective estrogen receptor modulators), e.g. medicines containing tamoxifen. This is because these medicines can prevent Arimidex from working properly.
- Drugs that contain estrogen, such as hormone replacement therapy ( HRT ).
Ask your doctor or pharmacist for advice if this applies to you.
Tell your doctor or pharmacist if you are taking any of the following:
- A drug called an “LHRH analog”. These include gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These drugs are used to treat breast cancer, certain gynecological diseases (gynecological conditions), and infertility.
Pregnancy and breastfeeding
Do not take Arimidex if you are pregnant or breast-feeding. If you become pregnant, stop taking Arimidex and talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Arimidex is unlikely to affect your ability to drive or use any tools or machines. However, some people may sometimes feel weak or sleepy when taking Arimidex. Ask your doctor or pharmacist for advice if this happens to you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Arimidex contains lactose
Arimidex contains lactose, which is a kind 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.
How to take Arimidex
Always take Arimidex exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose is one tablet once a day.
- Try to take the tablet at the same time each day.
- Swallow the tablet whole with water.
- It does not matter if you take Arimidex before, with, or after food.
Continue to take Arimidex for as long as your doctor or pharmacist has told you. It is a long-term treatment and you may need to take it for several years. Ask your doctor or pharmacist if you are unsure
Use for children and adolescents
Arimidex should not be given to children and adolescents.
If you forget to take Arimidex
If you forget to take a dose, just take your next dose as usual.
Do not take a double dose (two doses at the same time) to compensate for a missed dose.
If you stop taking Arimidex
Do not stop taking the tablets unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Arimidex and seek emergency care if you experience any of the following serious but very rare side effects:
- A very severe skin reaction with sores or blisters on the skin. This is called “Stevens-Johnson syndrome”.
- Allergic (hypersensitivity) reactions with swelling in the throat that may cause difficulty swallowing or breathing. This is called “angioedema”.
Very common side effects (affects more than 1 user in 10)
- Headache
- Hot flashes
- Nausea
- Rash
- Pain or stiffness in the joints
- Arthritis ( arthritis )
- Feeling weak
- Bone tissue loss ( osteoporosis ).
Common side effects (affects 1 to 10 users in 100)
- Loss of appetite
- Elevated or high levels of a fatty substance called cholesterol in the blood. This can be seen in a blood test.
- Somnolence
- Carpal tunnel syndrome (tingling, pain, cold, weakness in parts of the hand)
- Tickling / stinging sensation or numbness in the skin, lost/weakened sense of taste.
- Diarrhea
- Nausea (vomiting)
- Altered blood tests that show how your liver works
- Sparser hair growth (hair loss)
- Allergic reactions (hypersensitivity) involving the face, lips or tongue
- Skeletal pain
- Vaginal dryness
- Bleeding from the vagina (usually in the first few weeks of treatment – talk to your doctor if bleeding continues)
- Muscle pain.
Uncommon side effects (affects 1 to 10 users in 1,000)
- Changes in some blood tests that show how your liver works (gamma-GT and bilirubin )
- Inflammation of the liver ( hepatitis )
- Hives
- Trigger finger (a condition in which a finger or thumb gets stuck in a bent position)
- Increased levels of calcium in the blood. If you experience nausea, vomiting, and thirst, you should talk to a doctor, pharmacist, or nurse, as your blood may need to be tested.
Rare side effects (affects 1 to 10 users in 10,000)
- A rare skin inflammation that can include red spots or blisters
- Skin rash caused by hypersensitivity (which may be due to an allergic or anaphylactoid reaction)
- Inflammation of the small blood vessels, which causes red or purple discoloration of the skin. Very rare symptoms of joint, stomach, and kidney pain may occur; this is called “Enoch-Schönlein’s purple”.
Effects on the skeleton
Arimidex reduces the level of a hormone called estrogen in your body. This can reduce the mineral content of your skeleton. Your skeleton may become weaker and more easily affected by fractures. Your doctor will manage these risks according to treatment guidelines for the care of bone health in women who have passed menopause. Talk to your doctor about these risks and different 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.
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Arimidex
Do not store above 30 ° C.
Keep this medicine out of the sight and reach of children. Keep your tablets in a safe place out of the reach and sight of children. Your tablets can be harmful to them.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.
Store the tablets in the original package.
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. Contents of the packaging and other information
Content declaration
- The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
- The other ingredients are lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.
What the medicine looks like and the contents of the pack
White, round, biconvex, film-coated tablets of approximately 6.1 mm marked with ‘A’ on one side and ‘Adx1’ on the other side.
Pack sizes: day-marked blister packs of 28 and 98 tablets.
Marketing Authorisation Holder
AstraZeneca AB, 151 85 Södertälje
Manufacturer
AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK
Locations for release of batches
AstraZeneca UK Ltd
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
UK
AstraZeneca GmbH
Tinsdaler Weg 183
D-22880 Wedel
Germany
This medicinal product is authorized under the European Economic Area under the names:
Arimidex