Letrozole Almus

PACKAGE LEAFLET

Package leaflet: Information for the user

Letrozole Almus 2.5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What Letrozole Almus is and what it is used for

What Letrozole Almus is and how it works
Letrozole Almus contains an active substance called letrozole. It belongs to a group of medicines
called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer.
The growth of breast cancer is often stimulated by oestrogens, which are female sex hormones.
Letrozole reduces the amount of oestrogens by blocking an enzyme ("aromatase") involved in oestrogen production, and therefore can block the growth of breast tumours that require oestrogens to grow.
As a result, the growth of cancer cells is slowed down or stopped, and/or their spread to other parts of the body is prevented.

What Letrozole Almus is used for
Letrozole Almus is used for the treatment of breast cancer in postmenopausal women, i.e. women who no longer have menstrual periods.
It is used to prevent the recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not possible, or as initial treatment after breast surgery, or after five years of treatment with tamoxifen.
Letrozole is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced-stage breast cancer.
If you have any questions about how Letrozole Almus works or why this medicine has been prescribed for you, please consult your doctor.

2. What you should know before taking Letrozole Almus

Follow your doctor's instructions carefully. They may differ from the general information provided in this leaflet.
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Do not take Letrozole Almus

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
• if you still have your menstrual periods, i.e. if you are not yet in menopause,
• if you are pregnant,
• if you are breastfeeding. If any of these conditions apply to you, do not take this medicine and inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole Almus

• 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 Letrozole Almus” in section 3). If any of these conditions apply to you, inform your doctor. This will be taken into consideration by your doctor during treatment with Letrozole Almus.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.

Elderly (65 years of age and over)
Women aged 65 years and over can use this medicine at the same dose as adult women.

Other medicines and Letrozole Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Pregnancy, breastfeeding and fertility

• You must take Letrozole Almus only after you have entered menopause. However, your doctor will discuss with you the need to use an effective method of contraception, as you could potentially become pregnant during treatment with Letrozole Almus.
• You must not take Letrozole Almus if you are pregnant or breastfeeding, as it may harm the baby. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
If you feel dizzy, tired, drowsy, or generally unwell, do not drive or operate machinery until you feel normal again.

Letrozole Almus contains lactose
Letrozole Almus contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Letrozole Almus

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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The usual dose is one tablet of Letrozole Almus taken once daily. Take Letrozole Almus at the same time each day; this will help you remember when to take the tablet.
The tablet may be taken with or without food and must be swallowed whole with a glass of water or another drink.

How long to take Letrozole Almus
Continue taking Letrozole Almus every day for as long as your doctor has told you. You may need to take it for months or even years. If you have any questions about how long you should take Letrozole Almus, speak with your doctor.

Monitoring during treatment with Letrozole Almus
You must take this medicine under close medical supervision. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
Letrozole Almus may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to measure bone density (a way of monitoring osteoporosis) before, during, and after treatment.

If you take more Letrozole Almus than you should
If you have taken too much Letrozole Almus, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show them the tablet packaging. Medical treatment may be necessary.

If you forget to take Letrozole Almus

• If it is nearly time for your next dose (for example, within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, then take your next tablet at the usual time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Letrozole Almus
Do not stop taking Letrozole Almus unless your doctor tells you to. See also the section above, “How long to take Letrozole Almus”.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be caused by the lack of oestrogen in the body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:
Uncommon (may affect up to 1 in 100 patients):
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• 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 (symptoms of a brain disorder, e.g. stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness along a vein which is extremely tender and painful to touch.
• High fever, chills or mouth ulcers due to infections (lack of white blood cells).
• Severe and persistent blurred vision.

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discolouration of the skin, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).

If any of these effects occur, inform your doctor immediately.
You must contact your doctor immediately if any of the following symptoms occur during treatment with Letrozole Almus:

• Swelling, mainly of the face and throat (signs of allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis).
• Skin rash, red skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of skin disorders).

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

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)
  If any of these effects become severe, inform your doctor.

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

• Skin rash
• Headache
• Dizziness
• Malaise (usually a feeling of discomfort)
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Fragility or loss of bone mass (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring during treatment with Letrozole Almus” in section 3)
• Swelling of the arms, hands, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, tachycardia
• Joint stiffness (arthritis)
• Chest pain
  If any of these effects become severe, inform your doctor.

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Other side effects are uncommon (may affect up to 1 in 100 patients):

• Disorders of the nervous system such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Impaired sensation, especially to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal dryness or discharge
• Breast pain
• Fever
• Thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased levels of enzymes
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a breakdown product of red blood cells)

Side effects with unknown frequency
Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position.
If any of these effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp. The expiry
date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Letrozolo Almus contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, corn starch, sodium starch glycolate (from potato), anhydrous colloidal silica, magnesium stearate.
  Tablet coating: OPADRY II 85F32444 yellow (polyvinyl alcohol, talc, titanium dioxide (E171), macrogol/PEG 3350, quinoline yellow aluminium lake (E104), red iron oxide (E172), black iron oxide (E172)).

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Description of the appearance of Letrozolo Almus and contents of the pack
Letrozolo Almus is supplied as film-coated tablets. The film-coated tablets are dark yellow in colour and round convex in shape. Size: 6.0 ± 0.2 mm.
Each blister contains 30 tablets.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa, Italy
Manufacturer
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria, 2565-187 Dois Portos
Portugal
This medicinal product is authorised in the European Economic Area countries under the following names:
Country Name of the medicinal product
Spain Letrozol Almus Pharma 2.5 mg tablets, film-coated EFG
France Létrozole Almus 2.5 mg, comprimé pelliculé
Italy Letrozolo Almus 2.5 mg film-coated tablets

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