Letrogratis 2.5 mg. 28 tablets

What Letrogratis is and what it is used for
What Letrogratis is and how it works
Letrogratis contains an active substance called letrozole. It belongs to a group of drugs called aromatase inhibitors. It is used for hormonal (or endocrine) treatment of breast cancer. Tumor growth in breast cancer is often stimulated by estrogens, which are the female sex hormones. Letrogratis reduces the amount of estrogens by blocking an enzyme (aromatase) involved in their formation, and thus can block the growth of breast cancer that needs estrogens for its growth. As a result, tumor cells slow or stop their growth and/or spread to other parts of the body.

What Letrogratis is used for
Letrogratis is used to treat breast cancer in women who have gone through the menopause, i.e. the cessation of menstruation.

It is used to prevent cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case immediate surgical treatment is inappropriate. It can be used as the first treatment after breast cancer surgery or after five years of tamoxifen treatment. Letrogratis is also used to prevent the tumor from spreading to other parts of the body in advanced breast cancer.
If you have any questions about how Letrogratis works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrogratis
Follow your doctor's instructions carefully. These may differ from the general information in this leaflet.

Do not take Letrogratis:
if you are allergic to letrozole or any of the other ingredients of Letrogratis (listed in section 6);
if you are still menstruating, i.e. if you are not yet in a menstrual break;
if you are pregnant;
if you are breastfeeding.
If any of these conditions apply to you, do not take this medicine and consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Letrogratis:

if you have severe kidney disease;
if you have severe liver disease;
if you have a history of osteoporosis or bone fractures (see also “Monitoring during treatment with Letrogratis” in section 3).
If any of the conditions listed apply to you, inform your doctor. Your doctor will keep this in mind during your treatment with Letrogratis.

Children and adolescents (under 18 years)
Children and adolescents should not take this medicine.

Elderly patients (aged 65 years or older)
Patients age 65 and older can use this drug in the same doses as other adults.

Other medicines and Letrogratis
You should 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, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

You should only take Letrogratis if you are past menopause. Nevertheless, your doctor should discuss with you the need to use effective contraception, as it is still possible to become pregnant during treatment with Letrogratis.
You should not take Letrogratis if you are pregnant or breast-feeding as it may harm your baby.
Driving and using machines
If you feel dizzy, tired, sleepy or generally unwell, do not drive or operate tools or machines until you feel normal again.

Letrogratis contains lactose
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

3. How to take Letrogratis
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one Letrogratis tablet once a day. Take the Letrogratis tablet at the same time each day so that you remember when you should take it.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrogratis
Continue to take Letrogratis every day for as long as your doctor tells you to. This may need to continue for months or even years. If you have any questions about how long you should take Letrogratis, talk to your doctor.

Follow-up during treatment with Letrogratis
You should take this medicine only under strict medical supervision. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

Letrogratis may cause thinning or weakening of the bones (osteoporosis) as a result of the reduction of estrogens in the body. Your doctor may decide to measure your bone density
If you have stopped taking Letrogratis
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

Do not stop taking Letrogratis unless your doctor tells you to "See also the point "How long to take Letrogratis" above.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and generally resolve within a few days to a few weeks of treatment.

Some of the side effects, such as hot flashes, hair loss or vaginal bleeding, may be due to the lack of estrogens in your body.

The following side effects can be serious.
Uncommon side effects (may affect up to 1 in 100 patients):

weakness, paralysis or loss of sensation in any part of the body (especially an arm or leg), loss of coordination, nausea or difficulty speaking or breathing (sign of brain damage, eg stroke);
sudden tight chest pain (a sign of heart disease);
swelling or redness along the course of a vein that is particularly sensitive and painful to the touch;
severe fever, chills or mouth sores due to infection (lack of white blood cells);
severe permanent blurring of vision;
inflammation of a tendon (tendinitis).
Rare (may affect up to 1 in 1,000 patients);

difficulty breathing, chest pain, fainting, fast heart rate, blue skin, or sudden pain in the arm, leg, or foot (signs of possible blood clots);
tendon rupture.
If any of the symptoms listed above occur, inform your doctor immediately.
You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrogratis:

swelling of the face and throat (a sign of an allergic reaction);
yellowing of the skin and eyes, nausea, loss of appetite, darkening of the urine (signs of hepatitis);
rash, reddening of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (signs of a skin disease).
Some side effects are very common (may affect more than 1 in 10 patients):

hot flashes;
increased cholesterol levels (hypercholesterolemia);
tiredness; profuse sweating;
bone and joint pain (arthralgia).
If any of these side effects affect you severely, tell your doctor.

Some side effects are common (may affect up to 1 in 1 people

skin rashes;
headache;
dizziness;
malaise (general malaise); gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea;
increase or loss of appetite; muscle pain;
thinning or weakening of the bones (osteoporosis), leading to bone fractures in some cases (see also “Monitoring during your treatment with Letrogratis” in section 3);
swelling of hands, palms, feet, ankles (edema);
sad mood (depression);
weight gain;
hair loss;
increased blood pressure (hypertension);
stomach ache;
dry skin;
vaginal bleeding;
palpitations, fast pulse;
joint stiffness (arthritis); chest pain.
If any of these side effects affect you severely, tell your doctor.

Other side effects are uncommon (may affect up to 1 in 100 patients):

nervous disorders such as anxiety, nervousness, irritability, sleepiness, memory problems, absent-mindedness, insomnia;
pain or burning sensation in the hands or wrists (carpal tunnel syndrome);
sensory disturbances, especially when touched;
eye disturbances, such as blurred vision, eye irritation;
skin disorders such as itching (urticaria);
vaginal discharge or dryness;
chest pains;
fever (high temperature);
thirst, taste disturbances, dry mouth; drying of the mucous membranes;
weight loss;
urinary tract infection, frequent urination;
cough;
elevated enzyme levels;
yellowing of the skin and eyes;
high levels of bilirubin in the blood (a product of the breakdown of red blood cells);
Adverse reactions with an unknown frequency (frequency cannot be determined from the available data):

"Snapping finger" - a condition where your finger or thumb becomes curled up.

If any of these side effects affect you severely, tell your doctor.
5. How to store Letrogratis
Keep out of the reach of children.

Do not use Letrogratis after the expiry date which is stated on the packaging. The expiration date corresponds to the last day of the specified month.

This medicine does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Letrogratis contains
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other ingredients are:
tablet core: lactose monohydrate, microcrystalline cellulose, corn starch, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate;
tablet shell (o pad rai yellow 02B38014): titanium dioxide (E171), yellow iron oxide (E 172), macrogol 4000, red iron oxide (E 172), talc, hypromellose 5sr.
What Letrogratis looks like and contents of the pack
Letrogratis tablets are yellow, round, biconvex, film-coated tablets.

The package contains 28 or 30 tablets.
7 tablets are packed in a PVC/PE/PVDC/Alu blister. 4 blisters are placed in a cardboard box, with a leaflet for the user.
14 tablets are packed in a PVC/PE/PVDC/Alu blister. 2 blisters are placed in a cardboard box, with a leaflet for the user.
10 tablets are packed in a PVC/PE/PVDC/Alu blister. 3 blisters are placed in a cardboard box, with a leaflet for the user.

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