Prospect: information for the patient

Letrozol Almus Pharma 2.5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because 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 to you alone, and you must not give it to other people 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.

1.What Letrozol Almus Pharma is and for what it is used

2.What you need to know before starting to take Letrozol Almus Pharma

3.How to take Letrozol Almus Pharma

4.Possible adverse effects

5.Storage of Letrozol Almus Pharma

6.Contents of the package and additional information

What is Letrozol Almus Pharma and how it works

Letrozol Almus Pharma contains an active ingredient called letrozol.It belongs to a group of medicines called aromatase inhibitors. It is a hormone (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Letrozol reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore can 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 Almus Pharma used for

Letrozol is used to treat breast cancer in women who have passed 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, if 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 is 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 how this medicine works or the reason why you have been prescribed this medicine, 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 Almus Pharma

• if you are allergic to letrozol or any of the other ingredients in this medicine (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 medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Almus Pharma:

• if you have a serious kidney disease,
• if you have a serious liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control with Letrozol Almus Pharma” 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.

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.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Older adults (65 years and over)

People 65 years and over can use this medicine at the same dose as the rest of adults.

Taking Letrozol Almus Pharma with other medicines

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

Pregnancy, breastfeeding and fertility

• You should only take this medicine if you have passed the menopause stage. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with letrozol.
• You should not take letrozol if you are pregnant or breastfeeding, as it may harm your baby. If you are pregnant, breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

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

Letrozol Almus Pharma contains lactose and sodium. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

Use in athletes:

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

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 usual dose is one tablet of letrozol once a day.If you take letrozol Almus Pharma 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 Almus Pharma

Continue taking this medication 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 this medication, consult your doctor.

Control of treatment with Letrozol Almus Pharma

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

Letrozol may 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 more Letrozol Almus Pharma than you should

If you have taken too many tablets of letrozol, 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 Toxicological Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Almus Pharma

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

If you interrupt treatment with Letrozol Almus Pharma

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

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

Some side effects may be serious:

Rare(may affect up to 1 in 100 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 brain alteration, e.g. stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Swelling and redness in a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

Very rare(may affect up to 1 in 1000 patients):

• 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)
• 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:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellow color in 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 common(may affect more than 1 in 10 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 common(may affect up to 1 in 10 patients):

• Rash on the skin
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the section “Control of Letrozol Almus Pharma treatment in section 3”)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure
• 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 rare(may affect up to 1 in 100 patients):

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity problems, especially in touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Chest 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)

Side effects of unknown frequency(cannot be estimated from available data)

Trigger finger, a situation in which your finger or thumb stays locked in a bent position.

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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: httpss://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 and blister after CAD. The expiration date refers to the last day of the month indicated.

This medication does not require special conditions for conservation.

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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Letrozole Almus Pharma Composition

• The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are:

Core: Lactose monohydrate, microcrystalline cellulose, cornstarch, sodium carboxymethyl starch, anhydrous colloidal silica, magnesium stearate.

Covering (OPADRY II 85F32444 yellow): Polyvinyl alcohol, talc, anhydrous titanium dioxide (E171), macrogol/PEG 3350, yellow quinoline aluminum lake (E104), red iron oxide (E172), black iron oxide (E172).

Product appearance and packaging contents

Letrozole Almus Pharma is presented as film-coated tablets. The tablets are round, with a white core and a dark yellow coating. Dimensions: 6.0 ± 0.2 mm.

Available in perforated unit-dose blisters with 30 x 1 tablets or in blisters containing 30 tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible for manufacturing

Tecnimede - Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dois Portos (Portugal)

This medicine is authorized in the EEA Member States with the following names:

France - Létrozole Almus 2.5 mg, film-coated tablet

Italy - Letrozolo Almus

Last review date of this leaflet: December 2020

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/