PATIENT INFORMATION LEAFLET

Anastrozol Accord 1 mg Film-Coated Tablets

Anastrozol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Anastrozol Accord contains a substance called anastrozol. This belongs to a group of medicines called aromatase inhibitors.It is used to treat breast cancer in women who have gone through menopause.

Anastrozol Accord works by reducing the amount of certain hormones called estrogens that are produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase.

Do not take Anastrozol Accord:

• If you are allergic to anastrozol or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding (see the section called “Pregnancy and breastfeeding”).

Do not take Anastrozol Accord if you are in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking Anastrozol Accord.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Anastrozol Accord:

• If you still have menstrual periods and have not experienced menopause.You have osteoporosis or have suffered from any condition that affects the strength of your bones. Anastrozol reduces female hormone levels, which can lead to a loss of bone mineral density, thus reducing the strength of your bones. Your doctor may prescribe medications to prevent or treat bone density loss.
• If you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section called “Other medications and Anastrozol Accord”).
• If you have ever had any condition that affects the strength of your bones (osteoporosis).
• If you have liver or kidney problems.

If you are unsure whether this affects you, consult your doctor or pharmacist before taking Anastrozol Accord.

Inform hospital staff that you are taking Anastrozol Accord.

Children and adolescents

Do not administer this medication to children as it may not be safe.

Other medications and Anastrozol Accord

Inform your doctor or pharmacist if you are taking, have taken recently any other medication. This includes medications you acquire without a prescription and herbal remedies. This is because Anastrozol may affect the activity of other medications, and some medications may have an effect on Anastrozol.

Do not take Anastrozol if you are already being treated with any of the following medications:

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), for example, medications that contain tamoxifeno. This is because these medications may make Anastrozol ineffective.
• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you are in any of these situations, seek advice from your doctor or pharmacist.

Consult your doctor or pharmacist if you are taking the following:

• A medication known as an “LHRH analog”. This includes gonadorelina, buserelina, goserelina, leuprorelina, and triptorelina. These medications are used to treat breast cancer, certain female health conditions (gynecological conditions and infertility).

Use of Anastrozol Accord with food and beverages:

There are no effects on the absorption of Anastrozol Accord when taken with food.

Pregnancy, breastfeeding:

Do not take Anastrozol Accord if you are pregnant or breastfeeding. Discontinue treatment with Anastrozol if you become pregnant and consult your doctor.

Consult your doctor or pharmacist before taking this medication.

Driving and operating machinery:

It is unlikely that Anastrozol Accord will affect your ability to drive or use any tools or machinery. However, occasionally some people may feel weakness or drowsiness while taking Anastrozol Accord. If this occurs, seek advice from your doctor or pharmacist.

Anastrozol Accord contains lactose

This medication contains lactose, a type of sugar. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Anastrozol Accord contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for Anastrozol Accord indicated by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

• The recommended dose for adults is one tablet once a day.
• Tablets should be swallowed whole, with water.
• Try to take one tablet at the same time every day.

You can take Anastrozol Accord before, during, or after meals.

Continue taking Anastrozol Accord for the time indicated by your doctor or pharmacist. This is a long-term treatment and you may need to take it for several years. If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Anastrozol Accord should not be administered to children and adolescents.

If you take more Anastrozol Accord than you should

If you have taken more Anastrozol Accord than necessary, contact a doctor immediately.

If you forget to take Anastrozol Accord

If you forget to take a dose, simply take the next dose normally. Do not take a double dose (two doses at the same time) to make up for the missed doses. Simply resume the usual dose.

If you interrupt treatment withAnastrozol Accord

Do not interrupt treatment with this medication, unless your doctor tells you to.

If you have any doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Anastrozol Accord and seek urgent medical treatment if you experience any of the following severe but very rare side effects:

• A severe skin reaction with blisters or ulcers on the skin, known as "Stevens-Johnson syndrome".
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing, known as "angioedema".

Very common (can affect more than 1 in 10 people)

• Hot flashes
• Weakness
• Pain or stiffness in the joints
• Joint inflammation (arthritis)
• Skin rash
• Sensation of dizziness (nausea)
• Headache
• Bone loss (osteoporosis)
• Depression

Common (can affect up to 1 in 10 people)

• Vaginal dryness
• Vaginal bleeding (usually in the first weeks of treatment - if bleeding continues, speak with your doctor)
• Hair thinning (hair loss)
• Diarrhea
• Loss of appetite
• Increased or elevated levels of a lipid compound in the blood known as cholesterol, which would be observed in a blood test
• Vomiting
• Drowsiness
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in hand areas)
• Itching, tingling, or numbness of the skin, loss/absence of taste
• Changes in blood tests showing how your liver is functioning
• Bone pain
• Allergic reactions (hypersensitivity) including face, lips, or tongue
• Muscle pain

Rare (can affect up to 1 in 100 people)

• Trigger finger (alteration in which one of the fingers of the hand remains bent)
• Changes in special blood tests showing how your liver is functioning (gamma-GT and bilirubin)
• Liver inflammation (hepatitis)
• Hives or welts

Increased calcium levels in the blood. If you experience nausea, vomiting, and thirst, report to your doctor, pharmacist, or nurse as you may need a blood test.

Rare (can affect up to 1 in 1,000 people)

• Rare skin inflammation that may include red patches or blisters.
• Inflammation of small blood vessels causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach, and kidney pain may occur; this is known as "Henoch-Schönlein purpura".

Effects on your bones

Anastrozol reduces the levels of hormones called estrogens present in your body and this can reduce the mineral content of your bones, making them weaker and more prone to fractures. Your doctor will monitor these risks according to the bone treatment guidelines for postmenopausal women. You should speak with your doctor about the risks and treatment options.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, report to your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medicines Vigilance System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children. Store the tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
• No special storage conditions are required.
• Always return any leftover tablets of the medication to your pharmacist. Store them only when your doctor instructs you to do so.
• Do not use Anastrozol Accord after the expiration date shown on the packaging, after (CAD). The expiration date is the last day of the month indicated.
• Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Anastrozol Accord

The active ingredient is Anastrozol. Each film-coated tablet contains 1 mg of anastrozol.

The other components are:

Core tablet: lactose monohydrate (92,250 mg), povidone K-30, sodium glycolate starch (Type A) and magnesium stearate.

Coating: titanium dioxide (E171), macrogol 300 and hypromellose E-5.

Presentation of Anastrozol Accord and contents of the package:

Anastrozol Accord are white to off-white, round, biconvex film-coated tablets marked with ‘AHI’ on one face and smooth on the other face.

Anastrozol Accord is packaged in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona s/n, Edifici Est, 6th floor, 08039 Barcelona

Responsible for manufacturing:

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland

Or

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Netherlands

Or

Accord Healthcare Single Member S.A., 64th Km National Road Athens, Lamia, 32009, Greece

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 09/2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es