PRODUCT INFORMATION FOR THE USER

Anastrozol Combix 1 mg Film-Coated Tablets

Anastrozol

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

Anastrozol Combix contains a substance called anastrozol and belongs to a group of medicines called aromatase inhibitors. Anastrozol is used to treat breast cancer in women who are in menopause.

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

Do not take Anastrozol Combix

• if you are allergic to anastrozol or any other component of this medication (see section 6: Contents of the package and Additional Information).
• if you are pregnant or breastfeeding (see the section called “Pregnancy and breastfeeding”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Anastrozol Combix.

Be extra careful with Anastrozol Combix

Before taking Anastrozol Combix, check with your doctor or pharmacist

• if you still have menstrual periods and have not reached menopause.
• if you are taking a medication that contains tamoxifeno or medications that contain estrogen (see the section called “Use of other medications”).
• if you have ever had any alteration that affects the strength of your bones (osteoporosis).
• if you have any liver or kidney problems.

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

Inform hospital staff that you are taking anastrozol if you are admitted to the hospital.

Use of Anastrozol Combix with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased 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), such as 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 gynecological health conditions, and infertility.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Anastrozol Combix contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in athletes

This medication contains anastrozol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• The usual dose is one daily tablet.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with the help of water.
• You can take anastrozol before, during, or after meals.

Continue taking anastrozol for the time your doctor tells you to. This is a long-term treatment and you may need to take it for several years.

Use in children

Anastrozol should not be administered to children and adolescents.

If you take more Anastrazol Combix than you should

If you take more anastrozol than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrazol Combix

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 compensate for a missed dose.

If you interrupt treatment with Anastrazol Combix

Do not stop taking your tablets unless your doctor tells you to.

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

Like all medicines, Anastrozol Combix can cause side effects, although not everyone will experience them.

Very common side effects (affect more than 1 in 10 people)

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

Common side effects (affect between 1 and 10 people in every 100)

• Loss of appetite.
• Increased or high levels of a fatty compound in the blood known as cholesterol, which would be observed in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of the hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips, or tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first weeks of treatment - if bleeding continues, talk to your doctor).

Rare side effects (affect between 1 and 10 people in every 1,000)

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

Very rare side effects (affect between 1 and 10 people in every 10,000)

• Rare skin inflammation that may include red patches or blisters.
• Skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• 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".

Extremely rare side effects (affect less than 1 person in every 10,000)

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

If you experience any of these, call an ambulance or see a doctor immediately.

You may need urgent medical treatment.

Effects on your bones

Anastrozol reduces the levels of hormones called estrogens present in your body. This can reduce the mineral content of your bones. These may be less strong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone health in postmenopausal women. You should talk to your doctor about the risks and treatment options.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es.

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.

Store in the outer packaging

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Anastrozol Combix

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

The other components (excipients) are:

• Tablet core: lactose monohydrate (lactose), povidone, sodium carboxymethyl starch (potato starch), magnesium stearate (E470b).
• Tablet coating: hypromellose (E464), macrogol, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Film-coated tablets, white in color, biconvex, round, with the mark “A7” on one face and smooth on the other.

PVC/PVDC/Aluminum blisters.

Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix Laboratories, S.L.U.

C/ Badajoz 2. Building 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 Rue de la Chapelle

63450 Saint Amant Tallende

France

This leaflet was approved in April 2021

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