Letrozol Hetero 2,5 mg, filmomhulde tabletten

Letrozol Hetero 2,5 mg, filmomhulde tabletten


Farmacologische groep Hormoonantagonisten en aanverwante agentia


Alles om te weten



Waarvoor wordt dit middel gebruikt?

What Letrozol Hetero is and how it works

Letrozol Hetero 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. Letrozol Hetero 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 Letrozol Hetero is used for

Letrozol Hetero is used to treat breast cancer in women who have gone through menopause i.e cessation of periods.

It is used to prevent breast cancer 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. Letrozol Hetero 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 Letrozol Hetero works or why this medicine has been prescribed for you, ask your doctor.


Wanneer mag u dit middel niet gebruiken of moet u er extra voorzichtig mee zijn?

Follow the doctor’s instructions carefully. They may differ from the general information in this leaflet.

Do not take Letrozol Hetero

  • 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 Letrozol Hetero

  • 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 “Follow-up during Letrozol Hetero 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 Letrozol Hetero.

Children and adolescents (below 18 years)

Children or 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 Letrozol Hetero

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 Letrozol Hetero when you have gone through the menopause. However, your doctor should discuss with you about using effective contraceptive, as you may still have the potential to become pregnant during treatment with Letrozol Hetero.
  • You must not take Letrozol Hetero if you are pregnant or beast 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.

Letrozol Heterocontains lactose.

Letrozol Hetero contains lactose (milk sugar).If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before thaking this medicine.

Hoe gebruikt u dit middel?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet of Letrozol Hetero to be taken once a day. Taking Letrozol Hetero 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 Letrozol Hetero

Continue taking Letrozol Hetero 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 Letrozol Hetero, talk to your doctor.

Follow-up during Letrozol Hetero 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.

Letrozol Hetero 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 Letrozol Hetero than you should

If you have taken too much Letrozol Hetero, 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 Letrozol Hetero

  • 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.
  • Othewise, take the dose as soon as you remember, and then take the next tablet as you would normally.
  • Do not take double dose to make up for the one that you missed.

If you stop taking Letrozol Hetero

Do not stop taking Letrozol Hetero unless your doctor tells you to. See also the section above “How long to take Letrozol Hetero”.

Mogelijke bijwerkingen?

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 effets. You may not experience any of them.

Some side effects could be serious:

Rare or uncommon (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 occur, tell your doctor straight away.

You should also inform the doctor straight away if you experience any of the following symptoms during treatment with Letrozol Hetero:

  • 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 cholestero (hypercholesterolaemia)
  • Fatigue
  • Increased sweating
  • Pain in bones and joints (arthralgia)

If any of these affects you severly, tell your doctor.

Some side effects are common. These side effects may affect between 1 to 10 in every 100 patinets.

  • 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 Letrozol Hetero treatment” in section 3)
  • Swelling of arms, hands, feet, amkles (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 patinets.

  • 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
  • Urinary tract infection, increased frequency of urination
  • Cough
  • Increased level of enzymes

If any of these affects you severely, tell your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Hoe bewaart u dit middel?

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.

Anvullende Informatie

What Letrozol Hetero contains

  • The active substance is letrozole. Each film-coated tablet contains 2.5 mg 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 Letrozol Heterolooks like and contents of the pack

  • Letrozol Hetero 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 and Manufacturer

Marketing Authorisation Holder

Hetero Europe S.L.

Viladecans Business Park – Edificio Brasil

Catalunya 83-85

08840 Viladecans (Barcelona)



Pharmadox Healthcare Ltd.

KW 20A Corradino lndustrial Estate

Paola PLA 3000


In het Register ingeschreven onder:

RVG 111266

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
United Kingdom Letrozole 2.5 mg Film-coated tablets

This leaflet was last revised in maart 2013.

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