Letrozole 2.5 Mg Film-Coated Tablets
PHARMA CODE
MANX
Healthcare
PACKAGE LEAFLET: INFORMATION FOR THE USER
Letrozole 2.5mg film-coated tablets
Letrozole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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 signs of illness are the same as yours
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Letrozole is and what it is used for
2. What you need to know before you take Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Contents of the pack and other information
1. What Letrozole is and what it is used for
What Letrozole is and how it works
Letrozole contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") breast cancer treatment. Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. Letrozole reduces the amount of oestrogen by blocking an enzyme ("aromatase") involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body.
What Letrozole is used for
Letrozole is used to treat breast cancer in women who
have gone through menopause i.e cessation of periods.
It is used to prevent cancer from happening again. It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years treatment with tamixofen. Letrozole is also used to prevent breast tumor spreading to other parts of the body in patients with advanced breast cancer.
If you have any questions about how Letrozole works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take Letrozole
Follow all the doctor's instructions carefully. They may differ from the general information in this leaflet.
Do not take Letrozole
■ if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6)
■ if you still have periods, i.e. if you have not yet gone through the menopause
■ if you are pregnant
■ if you are breast-feeding.
If any of these conditions apply to you, do not take this medicine and talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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 "Follow-up during Letrozole treatment" in section 3).
If any of these conditions apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole.
Children and adolescents (below 18 years)
Children and adolescent should not use this medicine. Older people (age 65 years and over)
People aged 65 years and over can use this medicine at the same dose as for other adults.
Other medicines and Letrozole Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy, breast-feeding and fertility
■ You should only take Letrozole when you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you may still have the potential to become pregnant during treatment with Letrozole.
■ You must not take Letrozole if you are pregnant or breast feeding as it may harm your baby.
Driving and using machines If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate any tools or machines until you feel normal again.
Letrozole contains lactose
Letrozole contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Letrozole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Letrozole to be taken once a day. Taking Letrozole at the same time each day will help you remember when to take your tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.
How long to take Letrozole
Continue taking Letrozole every day for as long as your doctor tells you. You may need to take it for months or even years. If you have any questions about how long to keep taking Letrozole, talk to your doctor.
Follow-up during Letrozole treatment
You should only take this medicine under strict medical supervision. Your doctor will regularly monitor your condition to check whether the treatment is having the right effect.
Letrozole may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body. Your doctor may decide to measure your bone density (a way of monitoring for osteoporosis) before, during and after treatment.
If you take more Letrozole than you should If you have taken too much Letrozole, or if someone else accidentally takes your tablets, contact a doctor or hospital for advice immediately. Show them the pack of tablets. Medical treatment may be necessary.
If you forget to take Letrozole
■ If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to
■ Otherwise, take the dose as soon as you remember, and then take the next tablet as you would normally
■ Do not take a double dose to make up for the one that you missed.
If you stop taking Letrozole
Do not stop taking Letrozole unless your doctor tells you to. See also the section above "How long to take Letrozole".
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogens in your body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Some side effects could be serious:
Rare or uncommon side effects (i.e. they may affect between 1 to 100 in every 10,000 patients):
■ Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty in speaking or breathing (sign of a brain disorder, e.g. stroke)
■ Sudden oppressive chest pain (sign of a heart disorder)
■ Difficulty breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm, leg or foot pain (signs that a blood clot may have formed)
■ Swelling and redness along a vein which is extremely tender and possibly painful when touched
■ Severe fever, chills or mouth ulcers due to infections (lack of white blood cells)
■ Severe persistent blurred vision.
If any of the above occurs, tell your doctor straight away.
You should also inform the doctor straight away if you experience any of the following symptoms 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).
Some side effects are very common. These side effects may affect more than 10 in every 100 patients.
■ Hot flushes
■ Increased level of cholesterol (hypercholesterolaemia)
■ Fatigue
■ Increased sweating
■ Pain in bones and joints (arthralgia).
If any of these affects you severely, tell your doctor.
Some side effects are common. These side effects may affect between 1 to 10 in every 100 patients.
■ Skin rash
■ Headache
■ Dizziness
■ Malaise (generally feeling unwell)
■ Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
■ Increase in or loss of appetite
■ Pain in muscles
■ Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also "Follow-up during Letrozole treatment" in section 3)
■ Swelling of arms, hands, feet, ankles (oedema)
■ Depression
■ Weight increase
■ Hair loss
■ Raised blood pressure (hypertension)
■ Abdominal pain
■ Dry skin
■ Vaginal bleeding
If any of these affects you severely, tell your doctor.
Other side effects are uncommon. These side effects may affect between 1 to 10 in every 1,000 patients.
■ Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
■ Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
■ Impairment of sensation, especially that of touch
■ Eye disorders such as blurred vision, eye irritation
■ Palpitations, rapid heart rate
■ Skin disorders such as itching (urticaria)
■ Vaginal discharge or dryness
■ Joint stiffness (arthritis)
■ Breast pain
■ Fever
■ Thirst, taste disorder, dry mouth
■ Dryness of mucous membranes
■ Weight decrease
■ Urinary tract infection, increased frequency of urination
■ Cough
■ Increased level of enzymes
Side effects with frequency not known
■ Trigger finger, a condition in which your finger or thumb catches in a bent position.
If any of these affects you severely, tell your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10am to 2pm Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Letrozole
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. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Letrozole contains
■ The active substance is letrozole. Each film-coated tablet contains 2.5mg letrozole
■ The other ingredients are lactose monohydrate, croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, yellow iron oxide, titanium dioxide, macrogols and talc.
What Letrozole looks like and contents of the pack
■ Letrozole is supplied as film-coated tablets. The film-coated tablets are dark-yellow and round. They are marked with '5' on one side and 'H' on the other side
■ Each blister pack contains 10, 14, 28, 30, 90, 98 or 100 tablets. Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Hetero Europe S.L.
Viladecans Business Park - Edificio Brasil
Catalunya 83-85
08840 Viladecans (Barcelona)
Spain
Manufacturer
Pharmadox HeaIthcare Ltd
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Distributor
Manx Healthcare Ltd
Taylor Group House, Wedgnock Lane, Warwick CV34 5YA, UK
This medicinal product is authorised in the Member States of the eEa under the following names:
Germany Letrozol Hetero 2,5 mg Filmtabletten
Denmark Letrozol Hetero
Norway Letrozol Hetero
The Netherlands Letrozol Hetero 2.5 mg, filmomhulde
tabletten
Sweden Letrozol Hetero
Poland Letraxon
This leaflet was last revised in October 2015
WIP URN: 261015-GLE10-PIL-03