1 mg film-coated tablets
anastrozole
1. What Anastrozole Sandoz is and what it is used for
Anastrozole Sandoz contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Anastrozole Sandoz is used to treating breast cancer in menopausal women.
Anastrozole Sandoz 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”.
Anastrozole contained in Anastrozole Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Anastrozole Sandoz
Do not take Anastrozole Sandoz
- 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 Anastrozole Sandoz if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before taking Anastrozole Sandoz
- if you are still menstruating and have not passed menopause.
- if you are taking a medicine containing tamoxifen or medicines containing estrogen (see section “Other medicines and Anastrozole Sandoz”).
- 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 Anastrozole Sandoz if you are not sure if any of the above applies to you.
Tell your healthcare provider that you are taking Anastrozole Sandoz if you go to a hospital.
Other medicines and Anastrozole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Anastrozole Sandoz may affect the way some other medicines work, and some medicines may affect Anastrozole Sandoz.
Do not take Anastrozole Sandoz 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 may prevent Anastrozole Sandoz 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 Anastrozole Sandoz if you are pregnant or breast-feeding. If you become pregnant, stop taking Anastrozole Sandoz and talk to your doctor.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Anastrozole Sandoz is unlikely to affect your ability to drive or use tools or machines. However, some people may sometimes feel weak or drowsy when taking Anastrozole Sandoz. 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 sharpened 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.
Anastrozole Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
Anastrozole Sandoz contains lactose, which is a type 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 Anastrozole Sandoz
Always take this medicine 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 Anastrozole Sandoz before, with, or after food.
Continue to take Anastrozole Sandoz for as long as your doctor tells you. It is a long-term treatment and you may need to take it for several years.
Use for children and adolescents
Anastrozole Sandoz should not be given to children and adolescents.
If you forget to take Anastrozole Sandoz
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 Anastrozole Sandoz
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 or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Anastrozole Sandoz 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 (may affect 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 (may affect up to 1 in 10 people )
- 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 (may affect up to 1 in 100 people )
- 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 (may affect up to 1 in 1,000 people )
- 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
Anastrozole Sandoz reduces the levels 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.
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 Anastrozole Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister pack/jar and carton after EXP. or EXP. The expiration date is the last day of the specified month.
ALU / PVC blister:
No special storage instructions.
HDPE jar:
Do not store above 30 ° C.
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.
1 film-coated tablet contains 1 mg of anastrozole.
The other ingredients are:
Tablet core:
lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, colloidal anhydrous silica, hydroxypropyl cellulose
Tablet coating:
Opadry II white: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).
What the medicine looks like and the contents of the pack
White, round, and biconvex film-coated tablet marked with “A1” on one side.
The film-coated tablets are packed in blister cards of ALU / PVC inserted in a carton or in HDPE jars with PP screw caps.
Blisters: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets
Can: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany