Package Insert: Information for the Patient

Letrozol Tarbis 2.5 mg Film-Coated Tablets

Letrozol

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

What is Letrozol Tarbis and how it works

Letrozol Tarbis contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone treatment (or "endocrine") for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. Letrozol Tarbis reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore can block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What is Letrozol Tarbis used for

Letrozol Tarbis is used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, if immediate surgery is not suitable, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Tarbis is also used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Tarbis works or why you have been prescribed this medicine, consult your doctor.

Follow carefully all the instructions given by your doctor. They may be different from the general information contained in this leaflet.

Do not take Letrozol Tarbis

• if you are allergic to letrozol or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, that is, you have not reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these cases apply to you,do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Tarbis

• 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 “Treatment control with Letrozol Tarbis” in section 3).

If any of these cases apply to you,inform your doctor. Your doctor will take this into account during your treatment with Letrozol Tarbis.

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of tendon pain or inflammation, rest the affected area and contact your doctor.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Older patients (65 years and over)

People 65 years and over may use this medicine at the same dose as for adults.

Taking Letrozol Tarbis with other medicines

Inform your doctor or pharmacist that you are taking, have taken recently or may have to take any other medicine, including over-the-counter medicines.

Pregnancy, breastfeeding and fertility

• You should only take Letrozol Tarbis after menopause. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Tarbis.
• You should not take Letrozol Tarbis if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machines

If you feel dizzy, tired, sleepy or unwell, do not drive or operate tools or machines until you feel better again.

Letrozol Tarbis contains lactose(milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes:

This medicine contains letrozol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one Letrozol Tarbis tablet once a day. If you take Letrozol Tarbis at the same time every day, it will help you remember when to take the tablet.

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

For how long to take Letrozol Tarbis

Continue taking Letrozol Tarbis every day for the time your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol Tarbis, consult your doctor.

Control of Letrozol Tarbis treatment

You should only take this medication under strict medical supervision. Your doctor will check your situation periodically to ensure that the treatment has the desired effect.

Letrozol Tarbis may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements (a way to control osteoporosis) before, during, and after treatment.

If you take more Letrozol Tarbis than you should

If you have taken too many Letrozol Tarbis tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the packaging of the tablets. You may need medical treatment. You can also call the Toxicology Information Service, Tf: 915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Tarbis

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take the missed dose and take the next dose at the time it is due.
• Otherwise, take the missed dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If you interrupt Letrozol Tarbis treatment

Do not stop taking Letrozol Tarbis unless your doctor tells you to. See also the section “For how long to take Letrozol Tarbis”.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The majority of side effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to a lack of estrogen.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:

Rare or infrequent side effects(i.e., may affect 1 to 100 of every 10,000 patients):

• Weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain alteration, e.g., stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Difficulty breathing, chest pain, fainting, rapid heart rate, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot formation).
• Swelling and redness along a very soft and possibly painful vein.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe and continuous blurred vision.
• Rare - tendon rupture (connective tissue that connects muscles to bones)

If you experience any of the above, inform your doctor immediately.

You must also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Tarbis:

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellow discoloration of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Some side effects are very frequent.These side effects may affect more than 10 of every 100 patients.

• Hot flashes
• Elevated cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these affect you severely, consult your doctor.

Some side effects are frequent.These side effects may affect 1 to 10 of every 100 patients.

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the "Control of Letrozol Tarbis treatment in section 3")
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

If any of these affect you severely, inform your doctor.

Some side effects are infrequent.These side effects may affect 1 to 10 of every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Sensitivity problems, especially in touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Chest pain
• Fever
• Thirst, taste disorder, dry mouth
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Increased enzyme levels
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels in the blood (a product of red blood cell breakdown)
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)

If any of these affect you severely, inform your doctor.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use Letrozol Tarbis after the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use any packaging that is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Letrozol Tarbis Composition

• The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components (excipients) are Lactose monohydrate (lactose), cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato (potato starch), talc, magnesium stearate. The coating is composed of Aquopolish^® yellow formed by: Hydroxypropyl methylcellulose, hydroxypropyl cellulose, talc, cottonseed oil, iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171).

Appearance of the product and content of the container

• Letrozol Tarbis is presented as film-coated tablets. The tablets are round, biconvex, and yellow in color.
• The container with blisters contains 30 tablets or 100 tablets (clinical pack).

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028– Barcelona

(Spain)

Responsible for Manufacturing

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

Or

TECNIMEDE-SOCIEDADE TECNICO MEDICINAL, S.A.,

Quinta Da Cerca, Caixaria, Dois Portos

PORTUGAL

Last review date of this leaflet: October 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/