Letrozole Almus Pharma 2.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Letrozol Almus Pharma 2.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Letrozol Almus Pharma is and what it is used for
2. What you need to know before taking Letrozol Almus Pharma
3. How to take Letrozol Almus Pharma
4. Possible side effects
5. How to store Letrozol Almus Pharma
6. Contents of the pack and other information

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

What Letrozol Almus Pharma is and how it works

Letrozol Almus Pharma contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can inhibit the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly, or their growth and spread to other parts of the body are stopped.

What Letrozol Almus Pharma is used for

Letrozole is used to treat breast cancer in women who have undergone menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as the initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozole is also used to prevent the spread of breast tumors to other parts of the body in patients with advanced breast cancer.

If you have any questions about how this medicine works or why it has been prescribed for you, please consult your doctor.

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

Carefully follow all instructions provided by your doctor. They may differ from the general information contained in this leaflet.

Do not take Letrozol Almus Pharma

• if you are allergic to letrozol or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e. you have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding.

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

Warnings and precautions

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

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

If any of these situations 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 immediately.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over can take this medicine at the same dose as other adults.

Taking Letrozol Almus Pharma with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

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

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

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

Use in athletes:

This medicine contains letrozol, which may result in a positive doping test.

3. How to take Letrozol Almus Pharma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The usual dose is one letrozole tablet once daily. Taking Letrozol Almus Pharma at the same time each day will help you remember when to take the tablet.

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

For how long to take Letrozol Almus Pharma

Continue taking this medicine every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take this medicine, consult your doctor.

Monitoring of treatment with Letrozol Almus Pharma

You should only take this medicine under strict medical supervision. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect.

Letrozole may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring osteoporosis) before, during, and after treatment.

If you take more Letrozol Almus Pharma than you should

If you have taken too many letrozole tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to hospital immediately. Show them the medicine packaging. You may require medical treatment. You may also call the Toxicology Information Service at: 915620420, indicating the medicine and the amount taken.

If you forget to take Letrozol Almus Pharma

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

If you stop taking Letrozol Almus Pharma

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

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

4. Possible adverse effects

Some adverse effects can be serious:

Uncommon (may affect up to 1 in 100 patients)

• Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, pressing chest pain (sign of heart disorder).
• Swelling and redness in a vein that is extremely soft and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (caused by lack of white blood cells).
• Severe, persistent blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue linking muscles to bones).

Rare (may affect up to 1 in 1,000 patients):

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Rupture of a tendon (connective tissue linking muscles to bones).

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

You should also inform your doctor immediately if you develop any of the following symptoms during treatment with letrozole:

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

Some adverse effects are very common (may affect more than 1 in 10 patients):

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

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

Some adverse effects are common (may affect up to 1 in 10 patients):

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bones (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Almus Pharma treatment” in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

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

Some adverse effects are uncommon (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)
• Sensory disturbances, 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 disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowish discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

Adverse effects with frequency not known (cannot be estimated from available data)

Trigger finger, a condition in which your finger or thumb becomes locked in a bent position.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole Almus Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Almus Pharma

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

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

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

Appearance of the product and contents of the pack

Letrozol 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 single-dose perforated blisters containing 30 x 1 tablet or in blisters containing 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer

Tecnimede - Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos (Portugal)

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

France – Létrozole Almus 2.5 mg, comprimé pelliculé
Italy – Letrozolo Almus

Date of the most recent revision of this leaflet: December 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/