Letrozol Dr. Reddy's 2,5mg, filmomhulde tabletten

What [Invented Name] is

[Invented Name] 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.

What [Invented Name] is used for

[Invented Name] is used to prevent breast cancer happening again. It can be used as a first treatment after breast surgery or following five years of treatment with tamoxifen. [Invented Name] is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.

[Invented Name] should only be used for:

• oestrogen receptor-positive breast cancer and
• only in women after menopause i.e. cessation of periods.

How [Invented Name] works

Growth of breast cancer is frequently stimulated by oestrogens, which are female sex hormones. [Invented Name] reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens. As a consequence tumour cells slow or stop the growing and/or spreading to other parts of the body.

Monitoring your [Invented Name] treatment

You should only take this medicine under strict medical supervision. Your doctor will regularly monitor your condition to check if the treatment is having the right effect.

[Invented Name] may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body. This means that doctor may decide to measure your bone density (a way of monitoring for osteoporosis) before, during and after treatment.

If you have any questions about how [Invented Name] 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 [Invented Name]

• if you are allergic (hypersensitive) to letrozole or to any of the other ingredients of [Invented Name] listed in section 6 of this leaflet,
• 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.

Take special care with [Invented Name]

• 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 “Monitoring your [Invented

Name] treatment).

If any of these conditions apply to you, tell your doctor. Your doctor will take this into account during your treatment with [Invented Name].

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Children and adolescents (below 18 years)

Children or adoscelents 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.

Pregnancy and breast-feeding mothers

• You must not take [Invented Name] if you are pregnant or breast feeding as it may harm your baby.
• Since [Invented Name] is only recommended for postmenopausal women, pregnancy and breast- feeding restrictions most likely will not apply to you.
• However, if you recently became postmenopausal or if you are perimenopausal, your doctor should discuss with you about the necessity of a pregnancy test before taking [Invented Name] and of a contraception as you might have the potential to become pregnant.

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.

Important information about some of the ingredients of [Invented Name]

[Invented Name] 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 [Invented Name] exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much [Invented Name] to take

The usual dose is one tablet of [Invented Name] to be taken once a day. Taking [Invented Name] at the same time each day will help you remember when to take your tablet.

How to take [Invented Name]

The tablet should be swallowed whole with a glass of water or another liquid.

How long to take [Invented Name]

Continue taking [Invented Name] 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 [Invented Name], talk to your doctor.

If you take more [Invented Name] than you should

If you have taken too much [Invented Name], or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately. Show them the pack of tablets. Medical treatment may be necessary.

If you forget to take [Invented Name]

• 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 your 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 [Invented Name]

Do not stop taking [Invented Name] unless your doctor tells you. See also the section above “How long to take [Invented Name]”.

Like all medicines, [Invented Name] 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 (i.e. they may affect between 1 to 100 in every 10,000 patients):

• If you experience weakness, paralysis or loss of feeling in an arm or leg or any other part of the body, loss of coordination, nausea, or difficulty in speaking or breathing (sign of a brain disorder, e.g. stroke)
• If you have sudden oppressive chest pain (sign of a heart disorder)
• If you experience difficulty in breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm or leg (foot) pain (signs that a blood clot may have formed)
• If you experience swelling and redness along a vein which is extremely tender and possibly painful when touched
• If you get severe fever, chills or mouth ulcers due to infections (lack of white blood cells)
• If you get severe persistent blurred vision

Some patients experienced other side effects during treatment with [Invented Name]:

• 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)

If any of the above occur, tell your doctor straight away.

Some side effects are very common. These side effects may affect more than 10 in every 100 patients.

• Hot flushes
• 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 section 1 “Monitoring your [Invented Name] treatment”)
• Swelling of arms, hands, feet, ankles (oedema)
• Sad mood (depression)
• Weight increase
• Hair loss

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
• Impairment of sensation, especially that of touch
• Eye disorders such as blurred vision, eye irritation
• Palpitations, rapid heart rate, raised blood pressure (hypertension)
• Skin disorders such as itching (urticaria), dry skin
• Vaginal disorders such as bleeding, discharge or dryness
• Abdominal pain
• 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

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

You may also have some blood tests disorders while taking [Invented Name], i.e. high level of cholesterol (hypercholesterolemia) or high level of liver enzymes.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use [Invented Name] 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.

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 to protect the environment.

What [Invented Name] contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.
• The other ingredients are lactose monohydrate, croscarmellose sodium, povidone K 30, Silica colloidal anhydrous and magnesium stearate The ingredients in the tablet coating are macrogol 3350, talc (E553b), hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172).

What [Invented Name] looks like and contents of the pack

Letrozole is a dark yellow colored, round, biconvex , film-coated tablet with ‘LET’ debossed on one side and ‘2.5’ on the other side

Letrozole is available in blisters of 10, 14, 28, 30, 100 or 120 tablets per box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Dr. Reddy´s Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD United Kingdom

Manufacturers:

<[To be completed nationally]>

Marketing authorisation number

RVG 109649

This medicinal product is authorised in the Member States of the EEA under the following names:>

<{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>

<[To be completed nationally]>

This leaflet was last approved in januari 2012.