Prospect: Patient Information

Letrozol Kern Pharma 2.5 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they 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 prospect. See section 4.

1.What is Letrozol Kern Pharma and what it is used for

2.What you need to know before starting to take Letrozol Kern Pharma

3.How to take Letrozol Kern Pharma

4.Possible adverse effects

5.Storage of Letrozol Kern Pharma

6.Contents of the pack and additional information

What is Letrozol Kern Pharma and how it works

Letrozol Kern Pharma contains an active ingredient called letrozol.It belongs to a group of medicines called aromatase inhibitors. It is a hormone (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones.Letrozol Kern Pharma 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 Kern Pharma used forKern Pharma

Letrozol Kern Pharma 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 Kern Pharma 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 Kern Pharma works or the reason 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 Kern Pharma

• if you are allergic to letrozol or any of the other components of this medication (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 medication and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Kern Pharma

• 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 Kern Pharma” 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 Kern Pharma

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 medication.

Older adults (65 years and over)

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

Taking Letrozol Kern Pharma with other medications

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

Pregnancy, breastfeeding, and fertility

• You should only take Letrozol Kern Pharma if you have passed the menopause stage. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Kern Pharma.
• You should not take Letrozol Kern Pharma 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.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in athletes:

This medication 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 tablet of Letrozol Kern Pharma once a day. If you take Letrozol Kern Pharma 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

Continue taking Letrozol Kern Pharma 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 Kern Pharma, consult your doctor.

Control of treatment with Letrozol Kern Pharma Kern Pharma

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

Letrozol 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 Kern Pharma than you should

If you have taken too many tablets of Letrozol Kern Pharma, 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 Toxicological Information Service, Tf: 915620420 , indicating the medication and the amount taken.

If you forget to take Letrozol Kern Pharma Kern Pharma

• If it is almost time for your next tablet (e.g. 2 or 3 hours), do not take the dose you missed and take the next dose at the time it is due.
• Otherwise, take the 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 doses you missed.

If you interrupt treatment with Letrozol Kern Pharma

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

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

Most 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 affect1 to100of every 10,000patients):

• 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, bluish 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 withLetrozol Kern Pharma:

Some side effects are very frequent.These side effects can 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 can affect1 to10 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 section “Treatment control withLetrozol Kern Pharma in section3”)
• 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 can affect1 to10 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
• Elevated blood 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.

Reporting side effects

If you experience any type ofside effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 Kern Pharma after the expiration date that appears on the packaging after CAD. The expiration date refers to the last day of the month indicated.

-No special storage conditions are required.

-Store in the original packaging to protect it from moisture.

-Do not use any damaged packaging or packaging showing signs of manipulation.

Medications should not be disposed of through drains or trash. Deposit empty packaging and unused medications at the SIGRE point of 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 Kern Pharma Composition

• The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components are: lactose monohydrate (lactose), sodium carboxymethyl starch from potato (potato starch), anhydrous colloidal silica, microcrystalline cellulose, crospovidone, pregelatinized cornstarch (cornstarch) and magnesium stearate (E-470b).The components of the tablet coating are: hypromellose (E-464), polyethylene glycol 400, titanium dioxide (E-171) and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging

Letrozol Kern Pharma is presented as film-coated tablets. The tablets are yellow and round. Each blister pack contains 30 tablets.

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

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/