Prospect: information for the patient

Letrozol Combix 2.5 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

What is Letrozol Combix and how it works

Letrozol Combixcontains an active ingredient called letrozol. It belongs to a group of medications called aromatase inhibitors. It isa hormonal (or “endocrine”) treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Letrozol Combixreduces the amount of estrogen by blocking an enzyme (“aromatase”) involved in estrogen production and therefore may block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What is Letrozol Combix used for

Letrozol Combixis used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, in cases where immediate surgery is not suitable, or it can be used as the first treatment after breast cancer surgery,or after five years of treatment with tamoxifen.Letrozol Combixis also used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about howLetrozol Combixworks or the reason why you have been prescribed this medication, consult your doctor.

Follow carefully all the instructions given by your doctor. They may be different from the general information contained in this leaflet.

Do not take Letrozol Combix

• if you are allergic to letrozol or any of the other components of this medication (listed in section 6),
• if you still have menstrual cycles, that is, you have not reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these cases apply to you,do not take this medication and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Combix

• if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control with Letrozol Combix” in section 3).

If any of these cases apply to you,inform your doctor. Your doctor will take this into account during your treatment with Letrozol Combix.

Children and adolescents (under 18 years)

Children and adolescents should not use this medication.

Older adults (65 years and older)

People 65 years and older can use this medication at the same dose as adults.

Taking Letrozol Combix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

• You should only takeLetrozol Combixif you have passed the menopause stage.However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment withLetrozol Combix.

-You should not take Letrozol Combix if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machinery

If you feel dizzy, tired, sleepy, or unwell, do not drive or operate tools or machinery until you feel better again.

Letrozol Combixcontains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Use in athletes

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

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of tendon pain or inflammation, rest the affected area and contact your doctor.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one Letrozol Combix tablet once a day. If you take Letrozol Combix at the same time every day, it will help you remember when to take the tablet.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozol CombixLetrozol Combix

Continue taking Letrozol Combix every day for the time your doctor tells you. You may need to take it for months or even years. If you have any doubt about how long you should take Letrozol Combix, consult your doctor.

Control of treatment with Letrozol Combix

You should only take this medication under strict medical supervision. Your doctor will periodically check your situation to ensure that the treatment has the desired effect.

Letrozol Combixmay cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements(a way to control osteoporosis) before, during, and after treatment.

If you take moreLetrozol Combixthan you should

If you have taken too many Letrozol Combix tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the packaging of the tablets. You may need medical treatment. You can also call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount taken.

If you forget to takeLetrozol Combix

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take the missed dose and take the next dose at the time it is due.
• Otherwise, take the missed dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment withLetrozol Combix

Do not stop taking Letrozol Combix unless your doctor tells you to. See also the section “How long to take Letrozol Combix”.

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

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

The majority of side effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to a lack of estrogen.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:

Rare or infrequent side effects(that is, they may affect1 in100 of every 10,000 patients):

• Weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain alteration, e.g., stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Difficulty breathing, chest pain, fainting, rapid heart rate, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed).
• Swelling and redness in a very soft and possibly painful vein.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe and continuous blurred vision.
• Tendon rupture (connective tissue that connects muscles to bones).

If you experience any of the above, inform your doctor immediately.

You must also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Combix:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellow discoloration of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Some side effects are very frequent.These side effectsmay affect more than 10 in every 100 patients.

• Hot flashes.
• Elevated cholesterol levels (hypercholesterolemia).
• Fatigue
• Increased sweating.
• Bone and joint pain (arthralgia).

If any of these affect you severely, consult your doctor.

Some side effects are frequent. These side effects mayaffect1 to10 in every 100 patients.

• Skin rash.
• Headache.
• Dizziness.
• General discomfort.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Weight loss or bone loss (osteoporosis), which may cause bone fractures in some cases (see also the section “Treatment control with Letrozol Combix in section3”).
• Swelling of arms, hands, feet, ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• High blood pressure (hypertension).
• Abdominal pain.
• Skin dryness.
• Vaginal bleeding.
• Palpitations, rapid heart rate.
• Joint stiffness (arthritis).
• Chest pain.

If any of these affect you severely, inform your doctor.

Some side effects are infrequent.These side effectsmay affect1 to10 in every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Sensitivity problems, especially in touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal discharge or dryness.
• Breast pain.
• Fever.
• Thirst, taste disorder, dry mouth.
• Membrane mucosa dryness.
• Weight loss.
• Urinary tract infection, increased frequency to urinate.
• Cough.
• Elevated enzyme levels.
• Yellow discoloration of the skin and eyes.
• Elevated bilirubin levels (a product of red blood cell breakdown).
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

If any of these affect you severely, inform your doctor.

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 for Pharmacovigilance of Medicines for Human Use: 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.

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.

Do not store at a temperature above30°C. Store in the original packaging to protect it from moisture.

Do not use any packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Depositthe packaging and medications that you no longer need at the SIGREcollection pointat the pharmacy.Incase of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Letrozol Combix

• The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components (excipients) are: lactose monohydrate (lactose), microcrystalline cellulose (E460i), sodium carboxymethylstarch from potato (potato starch), cornstarch, anhydrous colloidal silica (E551), magnesium stearate (E470b). The coating consists of hypromellose (E464), titanium dioxide (E171), and macrogol (E1521).

Appearance of Letrozol Combix and content of the container

• Letrozol Combix is presented as film-coated tablets. The tablets are white, round, biconvex, marked with “ZF5” on one side and smooth on the other.
• Each container with blisters contains 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Last review date of this leaflet: August 2019

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