Letrozole 2.5 Mg Film-Coated Tablets
fond type: Arial Narrow fond size: 8pt
title fond type: Arial Narrow Bold title fond size: 8pt
150x280mm
PACKAGE LEAFLET: INFORMATION FOR THE USER Letrozole 2.5 mg film-coated tablets
Letrozole
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Letrozole is and what it is used for
2. Before you take Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Further information
1. WHAT LETROZOLE IS AND WHAT IT IS USED FOR
Letrozole contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors.
It is an hormonal treatment (or “endocrinal" treatment) of breast cancer.
What is Letrozole used for
Letrozole is used to prevent breast cancer relapses. It can be used as first-line treatment after mammary surgery or after 5 years of treatment with tamoxifen. Letrozole is also used to prevent the tumour from spreading to other parts of the body in patients with advanced breast cancer.
Letrozole must only be used :
- in oestrogen receptor positive breast cancer
- only in postmenopausal women, i.e. who have no more menstrual periods
How does Letrozole work
The proliferation of breast cancer is often stimulated by oestrogens, which are female sex hormones. Letrozole reduces the oestrogen level by inhibiting an enzyme (“aromatase") involved in the oestrogen production. As a consequence, the proliferation and/or the extension of tumoral cells to other parts of the body is slowed or stopped.
Monitoring of the treatment with Letrozole
Letrozole should be used only under strict medical monitoring. Your doctor will regularly monitor your health state to determine whether the treatment has the expected effect. Letrozole can lead to bone thinning or bone brittleness (osteoporosis), due to the decrease of oestrogens in the body. This means that your doctor may decide to assess your bone density (test for osteoporosis control) before, during and following the treatment.
If you have questions on the way Letrozole works or about why this medicinal product has been prescribed for you, ask your doctor.
2. BEFORE YOU TAKE LETROZOLE
List of information necessary before taking the medicinal product
Follow carefully the complete instructions of your doctor. They can be different from the general information given in this leaflet.
Do not take Letrozole:
- if you are allergic (hypersensitive) to letrozole or any of the other ingredients of Letrozole . See section 6 for the full list of ingredients,
- if you still have menstrual periods, i.e if you have not passed menopause,
- if you are pregnant,
- if you are breast feeding.
If you have one of these conditions, don’t take this medicinal product and inform your doctor.
Take special care with Letrozole:
- 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 section 1 “Monitoring of the treatment with Letrozole")
Ifyou have one of these conditions, inform your doctor. You doctor will take it into account during your treatment with Letrozole
Children and adolescents (under 18 years of age)
This medicinal product should not be used in children or adolescents.
Elderly (65 years and over)
This medicinal product can be used in patients aged 65 years and over, at the same dose as other adults.
Taking other medicines
Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
- Letrozole is contraindicated in case of pregnancy or breast-feeding, as this may harm your child.
-As Letrozole is recommanded only in postmenopausal women, it is very likely that you will not be concerned by restrictions on pregnancy and breast-feeding
- However, ifyou have recently passed menopause or ifyou are in perimenopause, your doctor may discuss with you of the necessity of taking a pregnancy test before initiating the treatment with Letrozole and of a contraception if you can become pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ifyou feel dizzy, tired, sleepy, or ifyou feel a general malaise, don’t drive or use machines until you feel well again.
Important information about some of the ingredients of Letrozole:
Letrozole contains lactose. Ifyou have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE LETROZOLE
Always take the dose prescribed by your doctor. You should check with your doctor or pharmacist if you are not sure.
What dose of Letrozole should you take ?
The usual dose is one tablet of Letrozole daily. Taking Letrozole at the same time each day will help you remember when to take your tablet.
How to take Letrozole
Tablets should be swallowed whole with a glass of water or another liquid.
How long should you take Letrozole ?
You should continue to take Letrozole each day as long as prescribed by your doctor. You may need to take it during several months or even several years. Ifyou have questions on the duration of your treatment with Letrozole ,ask your doctor.
Ifyou take more Letrozole than you should
Ifyou have taken too much of Letrozole or if another person has taken your tablets by accident, contact immediately your doctor or hospital for advice. Show them the pack of tablets.
A medical treatment may be necessary.
If you forget to take Letrozole
• If you realize you have forgotten to take your tablet when it’s nearly time for the next dose (for instance 2 or 3 hours before the next dose), don’t take the missed dose and take the next dose at the usual time.
• Otherwise, take the dose as soon as you remember and then take the next tablet at the usual time.
• Do not take a double dose to make up for a forgotten dose.
Ifyou stop taking Letrozole
You should not stop taking Letrozole unless if your doctor asks you to. See also the section above “How long should you take Letrozole ?’’.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Letrozole can cause side effects, although not everybody gets them.
Most of the side effects are mild or moderate in nature and usually disappear within a few days or weeks of treatment. Some of them, such as hot flushes, loss of hair or vaginal bleeding, may be due to a shortage 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 may be serious.
Rare or uncommon These side effects are rare or uncommon (i.e. they can affect one to 10 patients in 10 000 or one to 10 patients in 1 000).
• Ifyou experience weakness, a paralysis or a loss of sensitivity in an arm or leg, or in any other body part, a loss of coordination, nausea or difficulty in speaking or breathing (signs of cerebral disorders, e.g. of a stroke).
• Ifyou have a sudden oppressive chest pain (sign of cardiac disorders),
• Ifyou experience difficulty in breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration or sudden arm or leg (foot) pain (signs that a blood clot may have formed),
• Ifyou experience swelling and a redness along a vein which is very extremely tender and possibly painful when touched,
• Ifyou get severe fever chills, or mouth ulcers due to infections (lack of white blood cells)
• Ifyou get severe persistent blurred vision.
Some patients experienced other side effects during treatment with Letrozole:
- Swelling mainly of the face and throat (signs of allergic reaction)
- Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis)
- Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder)
If any of the above occur, tell your doctor straight away
Some side effects are very common. These side effects may affect more than 1 patient in 10.
• hot flushes,
• feeling tired,
• increased sweating,
• bone and joint pain (arthralgia).
If any of the side effects gets serious, please tell your doctor.
Some side effects are common. These side effects may affect 1 to 10 patients in 100.
• skin rash,
• headache,
• dizziness,
• malaise (general feeling of being unwell),
• digestive disorders, such as nausea, vomiting, indigestion, constipation, diarrhoea,
• increased appetite or loss of appetite,
• muscle pain,
• bone thinning or bone brittleness (osteoporosis) which may lead in some cases to bone fractures (see also section 1 “Monitoring of the treatment with Letrozole"),
• swelling of arms, hands, feet or ankles (oedema),
• sad mood (depression),
• weight gain,
• hair loss.
If any of the side effects gets serious, please tell your doctor.
Other side effects are uncommon. These side effects may affect 1 to 10 patients in 1000.
• Nervous disorders, such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia,
• sense alteration, in particular touch sensation,
• eye disorders, such as blurred vision, eye irritation,
• palpitations, faster heart beat, increased blood pressure (hypertension),
• skin disorders, such as itching (hives), dryness of the skin,
• vaginal disorders, such as bleeding, vaginal discharge or vaginal dryness,
• belly ache,
• joint stiffness (arthritis),
• breast pain,
• fever,
• thirst, taste disturbance, dry mouth,
• dryness of mucous membranes,
• weight loss,
• urinary tract infections, urinating more often,
• cough.
If any of the side effects gets serious, please tell your doctor. You may also have some blood disorders during the treatment with Letrozole, i.e. an increased cholesterol level (hypercholesteremia) or increased liver enzymes.
If any of the side effects gets severe, or ifyou notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE LETROZOLE
Keep out of the reach and sight of children.
Do not use Letrozole after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Letrozole contains
- The active substance is letrozole. Each film-coated tablet contains 2,5 mg letrozole.
- The other ingredients are :
Core tablet: Lactose monohydrate, microcrystalline cellulose, maize starch, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate.
Film-coating : Opadry yellow 02B38014 [titanium dioxide (E171), iron oxide yellow (E172), macrogol 4000, iron oxide red (E172), talc, hypromellose].
What Letrozole looks like and contents of the pack Letrozole tablets are yellow, round, biconvex, film-coated tablets.
Letrozole tablets are packed in blisters of: 10,14, 28, 30 or
100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MEDIPHA SANTE
Les Fjords - Immeuble Oslo 19 avenue de Norvege 91953 Courtaboeuf Cedex FRANCE
Manufacturer
GENEPHARM SA
18th Km, Marathonos avenue 15351 Pallini Attikis GREECE
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Letrozol Medicopharm, 2,5 mg Filmtabletten Denmark: Letrozol Medipha Sante 2,5 mg filmovertrukne tabletter
France: Letrozole Medipha Sante 2,5 mg comprime pellicule Ireland: Letrozole Medipha Sante 2,5 mg film-coated tablets Italy: Letrozolo Medipha Sante 2,5 mg compresse rivestite con film
Slovenia: Alvozol 2,5 mg filmsko oblozene tablet Sweden: Letrozol Medipha Sante 2,5 mg filmdragerad tablett United Kingdom: Letrozole 2,5 mg film-coated tablets
This leaflet was last approved in 09/2011.
<[To be completed nationally]>