1 mg film-coated tablets
anastrozole
1. WHAT ANASTROZOLE ACCORD IS AND WHAT IT IS USED FOR
Anastrozole Accord contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Anastrozole Accord is used to treat breast cancer in menopausal women.
Anastrozole Accord 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 the Anastrozole Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. WHAT YOU NEED TO KNOW BEFORE TAKING ANASTROZOLE ACCORD
Do not take Anastrozole Accord
- 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 Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Accord.
Take special care with Anastrozole Accord
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Anastrozole Accord:
- if you are still menstruating and have not passed menopause.
- have osteoporosis or other diseases that cause osteoporosis.
Anastrozole lowers the level of female sex hormone in the body and this can lead to a reduction in the mineral content of the bone structure, which in turn can make it more fragile. You may need to undergo a bone density test during treatment. Your doctor may prescribe drugs that prevent or treat osteoporosis. - if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see section “Other medicines and Anastrozole Accord”).
- 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 Accord if you are not sure if any of the above apply to you.
Tell your healthcare provider that you are taking Anastrozole Accord if you go to a hospital.
Other medicines and Anastrozole Accord
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 the Anastrozole Accord may affect the way some other medicines work, and some medicines may affect Anastrozole Accord.
Do not take Anastrozole Accord 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 the Anastrozole Accord 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.
Using Anastrozole Accord with food and drink
Using Anastrozole Accord with meals does not affect absorption.
Children and young people
Do not give this medicine to children as there is not enough information about safety.
Pregnancy and breastfeeding
Do not take Anastrozole Accord if you are pregnant or breast-feeding. If you become pregnant, stop taking Anastrozole Accord and talk to a doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Anastrozole Accord is unlikely to affect your ability to drive or use machines. However, some people may sometimes feel weak or drowsy when using Anastrozole Accord. 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.
Anastrozole Accord contains lactose
Anastrozole Accord 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.
3. HOW TO USE ANASTROZOLE ACCORD
Always take Anastrozole Accord 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.
- The tablet should be swallowed whole with a glass of water.
- Try to take the tablet at the same time each day.
- It does not matter if you take the tablet before, with, or after food.
Keep taking your medicine for as long as your doctor or pharmacist tells you to. It is a long-term treatment and you may need to take the medicine for several years. Ask your doctor or pharmacist if you are unsure.
Use for children and adolescents
Anastrozole Accord should not be given to children and adolescents.
If you use more Anastrozole Accord than you should
If you have ingested too much medicine or if a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) immediately for risk assessment and advice. Bring any leftover tablets and/or empty packaging to facilitate identification.
If you forget to take Anastrozole Accord
If you forget to take a dose, just take your next dose as usual. Do not take a double dose (two doses at a time) to make up for a forgotten dose.
If you stop using Anastrozole Accord
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 Anastrozole Accord 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 (may affect more than 1 user in 10)
- Hot flashes
- Feeling weak
- Pain or stiffness in the joints
- Arthritis ( arthritis )
- Rash
- Nausea
- Headache
- Bone tissue loss ( osteoporosis ).
Common (may affect up to 1 in 10 people)
- Vaginal dryness
- Bleeding from the vagina (usually in the first few weeks of treatment – talk to your doctor if bleeding continues)
- Sparser hair growth (hair loss)
- Diarrhea
- Loss of appetite
- Elevated or high levels of a fatty substance called cholesterol in the blood. This can be seen in a blood test.
- Nausea (vomiting)
- Somnolence
- Carpal tunnel syndrome (tingling, pain, cold, weakness in parts of the hand)
- Tickling, tingling or numbness in the skin, loss of taste/taste changes
- Altered blood tests that show how your liver works
- Skeletal pain
- Allergic reactions (hypersensitivity) involving the face, lips, or tongue
- Muscle pain.
Uncommon (may affect up to 1 in 100 people)
- Trigger finger (a condition in which a finger or thumb gets stuck in a bent position)
- Changes in some blood tests that show how your liver works (gamma-GT and bilirubin )
- Inflammation of the liver ( hepatitis )
- Hives
- The increased amount of calcium in the blood. Tell your doctor, pharmacist, or nurse if you feel nauseous, vomit, or get thirsty. You may need to take blood samples.
Rare (may affect up to 1 in 1,000 people)
- A rare skin inflammation that can include red spots or blisters
- 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.
Impact on the skeleton
Anastrozole reduces levels of hormone et estrogen in the blood, which can lead to a reduction in the mineral content of the skeletons. The skeleton becomes more fragile and the risk of bone fractures increases. Your doctor will manage these risks according to the treatment guidelines for the care of bone health in women who have passed menopause. Consult a physician about risks and 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 ACCORD
- Keep out of sight and reach of children. Keep the tablets in a safe place where children can not see or reach them. The tablets may harm them.
- No special storage instructions required.
- Leftover medicines must always be left at the pharmacy. Keep it only at the doctor’s request.
- Use Anastrozole Accord before the expiry date which is stated on the carton and blister after EXP. and the pressure pack at EXP. The expiration date is the last day of the specified month.
- Store the tablets in the original carton.
- The medicine 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.
Other ingredients are:
Tablet core: Lactose monohydrate (95, 250 mg), povidone K-30, sodium starch glycolate (type A), magnesium stearate
Coating film: Titanium dioxide (E171), macrogol 300, hypromellose E-5
What the medicine looks like and the contents of the pack
Anastrozole Accord is white to off-white, round, cupped, film-coated tablets with ‘AHI’ embossed on the top and smooth bottom.
Anastrozole Accord is supplied in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer:
Accord Healthcare Limited
Sage House, 319, Pinner Road,
North Harrow, Middlesex,
HA1 4 HF
UK
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands