Letroheal 2.5 mg LETROZOLE 30 Tablets
|Product Code:||LETRO 001|
Letrozole 2.5 mg film-coated tablets
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 2.5 mg is and what it is used for
2. What you need to know before you take Letrozole 2.5 mg
3. How to take Letrozole 2.5 mg
4. Possible side effects
5. How to store Letrozole 2.5 mg
6. Contents of the pack and other information
Letrozole 2.5mg 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.
Letrozole 2.5mg is used to treat breast cancer in women who have gone through the 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 cases where immediate surgery is not suitable;
- as first treatment after breast cancer surgery;
- following five years treatment with tamoxifen.
Letrozole 2.5mg 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 Letrozole 2.5mg works or why this medicine has been prescribed for you, ask your doctor.
Follow all the doctor’s instructions carefully. They may differ from the general information in this leaflet
Do not take Letrozole 2.5 mg
- 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 2.5mg
- 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 2.5mg 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 2.5mg.
Children and adolescents (below 18 years)
Children and adolescents should not use this medicine.
Older people (aged 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 2.5mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Letrozole 2.5 mg with food, drink and alcohol
Food and drink do not affect letrozole.
Pregnancy,breast-feeding and fertility
- You must not take Letrozole 2.5mg if you are pregnant or breast-feeding as it may harm your baby.
- You should only take Letrozole 2.5mg when you have gone through the menopause. However, your doctor should discuss with you about using effective contraception, as you may still have the potential to become pregnant during treatment with Letrozole 2.5mg.
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 2.5 mg contains lactose
Letrozole 2.5mg tablets 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.
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 2.5mg to be taken once a day. Taking Letrozole 2.5mg 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 2.5mg
Continue taking Letrozole 2.5mg 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 2.5mg, talk to your doctor.
Follow-up during Letrozole 2.5mg 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 2.5mg 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 2.5 mg than you should
If you have taken too much Letrozole 2.5mg, 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 2.5 mg
- 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 2.5 mg
Do not stop taking letrozole even if you are feeling well, unless your doctor tells you to. See also the section above “How long to take Letrozole 2.5mg”
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 alarmed by this list of possible side effects. You may not experience any of them.
Some side effects could be serious.
Uncommon or rare (may affect up to 1 in 100 or 1,000 people)
- 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 in 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.
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).
You should inform the doctor straight away if you experience any above of listed side effects.
Other side effects can be:
Very common (may affect more than 1 in 10 people):
- hot flushes,
- increased sweating,
- pain in bones and joints (arthralgia),
- increased level of cholesterol
Common (may affect up to 1 in 10 people):
- increase in or loss of appetite,
- sad mood (depression),
- headache, dizziness,
- raised blood pressure,
- nausea, vomiting, indigestion, constipation, diarrhoea, stomach-ache,
- hair loss and skin rash, dry skin,
- muscle pain, bone pain, thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also section 2),
- vaginal bleeding,
- weight increase,
- swelling of arms, hands, feet, ankles (peripheral oedema).
Uncommon (may affect up to 1 in 100 people)
- urinary tract infection,
- tumour pain,
- anxiety, nervousness, irritability,
- somnolence, insomnia, memory problems, impairment of sensation (especially that of touch), taste disorder,
- lens opacity (cataract), eye irritation,
- abnormal strong heart beats (palpitations), rapid heart rate, heart problems (ischemic cardiac events),
- shortness of breath, cough,
- inflammation of the mucous lining of the mouth, dry mouth,
- increased liver enzymes,
- itching, hives,
- joint stiffness (arthritis),
- increased frequency of urination,
- vaginal discharge or dryness, breast pain,
- swelling of body parts (general oedema), dryness of mucous membranes, thirst, fever,
- weight decrease.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use letrozole after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. 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.
What Letrozole 2.5 mg contains
- The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.
- The other ingredients are lactose monohydrate, cellulose microcrystalline (E460), maize starch pregelatinised, sodium starch glycolate, magnesium stearate (E572), colloidal silicon dioxide (E551).
The ingredients in the tablet coating are macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172).