1 mg film-coated tablets
anastrozole
What Anastrozole Bluefish is and what it is used for
Anastrozole Bluefish contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Anastrozole Bluefish is used to treat breast cancer in postmenopausal women.
Anastrozole Bluefish 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 Bluefish may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Anastrozole Bluefish
Do not take Anastrozole Bluefish
- 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 Bluefish if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Bluefish.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Anastrozole Bluefish
- 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 Bluefish”).
- 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 Bluefish if you are not sure if any of the above applies to you.
Tell your healthcare provider that you are taking Anastrozole Bluefish if you go to the hospital.
Other medicines and Anastrozole Bluefish
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. This is because Anastrozole Bluefish can affect the way some other medicines work, and some medicines can affect Anastrozole Bluefish.
Do not take Anastrozole Bluefish 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 Anastrozole Bluefish 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, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant, stop taking Anastrozole Bluefish and talk to your doctor.
Driving and using machines
Anastrozole Bluefish is unlikely to affect your ability to drive or use tools or machines. However, some people may sometimes feel weak or sleepy when taking Anastrozole Bluefish. 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 Bluefish contains lactose
Anastrozole Bluefish 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.
Anastrozole Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 1 mg tablet, ie essentially ‘sodium-free’.
How to take Anastrozole Bluefish
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The usual 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 Bluefish before, with, or after food.
Keep taking Anastrozole Bluefish for as long as your doctor tells 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
Anastrozole Bluefish should not be given to children and adolescents.
If you forget to take Anastrozole Bluefish
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 Bluefish
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.
Tell your doctor immediately:
If you experience any of the following very rare symptoms after taking this medicine, these symptoms may be severe:
- Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema ).
- Severe allergic reactions with blisters on skin, mouth, eyes, and genitals ( Stevens-Johnson syndrome ).
Very common side effects (may affect more than 1 in 10 people)
- 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)
- 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).
- The increased amount of calcium in the blood. If you experience nausea, vomiting, or thirst, tell your doctor, pharmacist, or nurse as you may need blood tests.
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 Bluefish 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.
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 Bluefish
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” and EXP, respectively. The expiration date is the last day of the specified month.
No special storage instructions.
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 tablet contains 1 mg of anastrozole.
- The other ingredients are lactose monohydrate 93 mg, povidone (K30), sodium starch glycolate, and magnesium stearate. Ingredients in the tablet coating are hypromellose, macrogol 300, and titanium dioxide (E171)
What the medicine looks like and the contents of the pack
Anastrozole Bluefish 1 mg is a white, film-coated, round, biconvex tablet with a diameter of 6.0 – 6.2 mm. Anastrozole Bluefish is supplied in blister packs of 28, 30, 98, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm,
Genepharm SA, 18th Marathonos Avenue, 153 51 Pallini Attikis, Greece
This medicinal product is authorized under the European Economic Area under the names:
| Austria | Anastrozole Bluefish 1 mg film tablets |
| Spain | Anastrozole Bluefish 1 mg compresses recovered with EFG film |
| France | Anastrozole Bluefish 1 mg compresses compressed |
| Iceland | Anastrozole Bluefish 1 mg film-coated tablets |
| Ireland | Anastrozole Bluefish 1 mg film-coated tablets |
| Italy | Adiunastrol 1 mg compresses rivestite with film |
| Poland | Anastrozole Bluefish |