Letrozole 2.5 Mg Film-Coated Tablets
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• Urinary tract infection, increased frequency of urination
• Cough
• Increased level of enzymes
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
Not known (frequency cannot be estimated from the available data)
• Trigger finger, a condition in which your finger or thumb catches in a bent position.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• 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
iron oxide (E172), macrogol 4000, red iron oxide (E172), talc, hypromellose 5cP
What this medicine looks like and contents of the pack
• These tablets are yellow, round, biconvex film coated tablets.
• This medicine is available in packs of 10, 14, 28, 30 or100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted,Hertfordshire, HP4 1EG,
United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
This medicinal product is authorised in the Member States of the EEA under the following names:
DE- Letrozole axcount 2.5 mg Filmtabletten ES- Letrozole Brill Pharma 2.5 mg
comprimidos recubiertos con pelicula EFG
Letrozole 2.5 mg film-coated tablets;
PL 17907/0496
This leaflet was last revised in July 2016
To request a copy of this leaflet in Braille, large font or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
Package leaflet: Information for the patient
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 only. 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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
What this medicine contains
• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are lactose spray dried, microcrystalline cellulose, maize starch sodium starch glycolate (Type A), silica colloidal anhydrous, magnesium stearate in tablet core. The tablet coat consists of titanium dioxide (E171), yellow
V4 19-07-16 DO
This medicine 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. It 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.
This medicine 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 tamoxifen. This medicine is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.
If you have any questions about how this medicine works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take this medicine
Follow all the doctor's instructions carefully. They may differ from the general information in this leaflet.
Do not take this medicine
• if you are allergic to letrozole or to 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 this medicine:
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• 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 treatment with this medicine” 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 this medicine.
Children and adolescents (below 18 years)
Children and adolescents 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Fertility, pregnancy and breast-feeding
• You should only take this medicine 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 this medicine.
• You must not take this medicine 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.
This medicine contains lactose
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 this medicine
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 usual dose is one tablet, to be taken once a day. Taking this medicine at the same time
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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 this medicine
Continue taking this medicine 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 this medicine, talk to your doctor.
Follow-up during treatment with this medicine
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.
This medicine 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 of this medicine than you should
If you have taken too much of this medicine, 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 this medicine
• 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 forgotten dose.
If you stop taking this medicine
Do not stop taking this medicine unless your doctor tells you to. See also the section above “How long to take this medicine”.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 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 this medicine:
• 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).
Other side effects
Very common (may affect more than 1 in 10 people)
• Hot flushes
• Increased level of cholesterol (hyper-cholesterolaemia)
• Fatigue
• Increased sweating
• Pain in bones and joints (arthralgia) Common (may affect up to 1 in 10 people)
• 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 treatment with this medicine” 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
Uncommon (may affect up to 1 in 100 people)
• Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
• 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
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