Letrozole 2.5 Mg Film-Coated Tablets
PIL Size 180 x 380 mm
Letrazole 2.5 mg -PIL
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 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.
What is in this leaflet:
1. What Letrozole tablets are and what they are used for
2. What you need to know before you take Letrozole tablets
3. How to take Letrozole tablets
4. Possible side effects
5. How to store Letrozole tablets
6. Contents of the pack and other information
1. WHAT LETROZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Letrozole, the active ingredient in Letrozole tablets, is one of a group of medicines called aromatase inhibitors. These block the production of oestrogens.
Letrozole tablets are used to treat breast cancer in post-menopausal women. They can be used either before surgery to reduce the size of the tumour, or after surgery to help prevent the tumour from returning.
They can also be used in patients with advanced breast cancer to help stop the tumour spreading to other parts of the body.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LETROZOLE TABLETS Do not take Letrozole tablets
- if you think you may be allergic to letrozole or to any of the other ingredients of Letrozole Tablets (These are listed in Section 6.)
- if you have not yet gone through menopause.
- if you are pregnant or if there is a possibility that you might be pregnant.
- if you are breast-feeding.
- if you have a serious liver disease.
Warnings and Precautions
Talk to your doctor or pharmacist before taking letrozole tablets
- if you suffer from any serious kidney disease.
- if you have an inherited intolerance to some sugars such as lactose. The tablets contain a small amount of lactose
- if you have a history of osteoporosis (thinning or wasting of bones) or bone fractures. Your doctor may want to measure your bone density before and during your treatment. Drugs like Letrozole Tablets reduce the levels of female hormones. This can lead to a loss of minerals in bones and cause osteoporosis (decrease in bone density and strength).
Men
Letrozole is not to be used by men.
Children and adolescents (below 18 years)
Letrozole is not to be used by children or adolescents.
Older people (age 65 years and over)
Letrozole tablets can be used by people aged 65 years and over at the same dose as for other adults.
Other medicines and Letrozole tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Letrozole tablets and food and drink
Taking food and drink has no influence on your treatment with Letrozole tablets.
Pregnancy and breast-feeding
Letrozole tablets are not recommended during pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or work with machinery if you feel dizzy, tired or drowsy when you start to take Letrozole Tablets.
Letrozole Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE LETROZOLE TABLETS
Always take Letrozole tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of Letrozole tablets is 1 tablet once a day. You will probably continue to take Letrozole tablets for a number of years.
If you take more Letrozole Tablets than you should
If you accidentally take too many Letrozole tablets than you have been told to take, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.
If you forget to take Letrozole Tablets
Do not take a double dose to make up for a forgotten dose, take it as soon as you remember. Then take your next dose as usual.
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, letrozole tablets can cause side effects, although not everybody gets them.
Most of the side effects are mild or moderate and will generally disappear after a few days to few weeks of treatment.
Some side effects can be serious
Severe allergic reactions, angina, heart attack, thrombosis, pulmonary embolism or stroke have occasionally been reported as side effects. Stop taking the tablets and tell your doctor or go to the emergency department at your nearest hospital IMMEDIATELY if you get any of the following symptoms:
- Heavy or tight chest or pain in the chest, spreading to your arms or shoulders, neck, teeth or jaw, abdomen or back
- Coughing blood
- Unusual pains or swelling of your arms or legs
- Sudden shortness of breath, difficulty in speaking or breathing
- Fainting
- Numbness or weakness in your arm or leg or any part of your body
- Loss of co-ordination
- Vision changes
- Sudden severe headache
- Severe rash or redness, which might include blistering and peeling and be accompanied by fever XXXXX
- Itching, swollen throat, face, eyelids or lips, difficulty breathing.
Cases of Hepatitis (inflamation of the liver) have been reported. If you notice any of the following symptoms please tell your doctor immediately:
- yellow skin and eyes
- nausea
- loss of appetite
- dark urine
The side effects listed below have also been reported:
The most common side effects experienced by more than 10% of people are:
- Hot flushes
- Pains in the joints (arthralgia)
Up to 1 in 10 people have experienced:
- Loss of appetite or increased appetite
- Feeling or being sick, indigestion, constipation, diarrhoea
- Weight gain
- Raised cholesterol levels
- Depression
- Headache
- Dizziness
- Hair loss
- Increased sweating
- Skin rash
- Muscle pain
- Bone problems (pain, bone thining (osteoporosis), fractures)
- Feeling tired
- Swelling in the legs or feet due to fluid retention
Up to 1 in 100 people have experienced:
- Urinary tract infections, urinating more often
- Pain in the breast including in the tumour or in the stomach
- General swelling due to fluid retention
- Decreased white blood cells which can lead to infections (leucopenia)
- Mental problems (anxiety, nervousness, irritability, loss of memory)
- Sleep problems (sleepiness or difficulty in sleeping)
- Changes in sensation, including touch sensation (pins and needles), taste changes
- Eye problems such as cataract (loss of transparency of the lens of the eye), eye irritation, blurred vision, dry eyes
- Heart problems such as palpitations, fast heart beat (tachycardia) irregular heart beat (arrhythmia), angina and heart attack (ischemic cardiovascular disease)
- Inflamed blood vessels
- Hypertension (raised blood pressure)
- Breathlessness
- Dry mouth or mouth ulcers
- Liver problems
- Dry or itchy skin or raised wheals
- Arthritis (inflammation of the joints)
- Vaginal bleeding,vaginal discharge,vaginal dryness
- Fever
- Thirst
- Weight loss
- Cough
- Pain or burning sensation in the hands or wrist (carpal tunnel syndrome).
Up to 1 in 1,000 people have experienced:
- Thrombosis (clotting in the blood vessels e.g. legs)
- Pulmonary embolism (a blood clot in the lungs)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE LETROZOLE TABLETS Store in the original package.
Keep all medicines out of the sight and reach of children.
Do not take Letrozole tablets after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking Letrozole tablets, please take any unused tablets back to your pharmacist to be destroyed. Only keep the tablets if the doctor tells you to.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Letrozole tablets contains
- Each film-coated tablets contains 2.5 mg letrozole
- The other ingredients are lactose monohydrate, sodium starch glycollate, microcrystalline cellulose, hypromellose 6 cP, colloidal anhydrous silica, magnesium stearate.
- The film coat contains hypromellose 15 cP, macrogol 6000, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and tartrazine (E102).
What Letrozole tablet looks like and contents of the pack
Letrozole 2.5 mg film-coated tablets are yellow, circular, biconvex film-coated tablets plain on both sides.
Letrozole 2.5 mg film-coated tablets are available in blister packs of 14 and 28 tablets.
Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, C.P House,
97-107 Uxbridge Road,
Ealing,
London W5 5TL Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, C.P House,
97-107 Uxbridge Road Ealing,
London W5 5TL
This leaflet was last amended 04/2012