GALDAR 2.5 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

GALDAR 2.5 mg film-coated tablets EFG

Letrozole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Galdar and what is it used for.
2. What you need to know before you take Galdar.
3. How to take Galdar.
4. Possible side effects.
5. Storing Galdar.

Contents of the pack and further information.

1. What is Galdar and what is it used for

What is Galdar and how does it work

Galdar contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Galdar reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, and thus 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 Galdar used for

Galdar is used to treat breast cancer in women who have gone through the menopause, i.e., the cessation of menstrual periods.

It is used to prevent breast cancer from coming back. It can be used as the first treatment before breast cancer surgery, if surgery is not immediately possible, or it can be used as the first treatment after breast cancer surgery, or after 5 years of treatment with tamoxifen. Galdar is also used to prevent the breast tumor from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Galdar works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Galdar

Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.

Do not take Galdar

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking Galdar

• 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 of treatment with Galdar" in section 3).

If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Galdar.

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

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People aged 65 and over can use this medicine at the same dose as for adults.

Other medicines and Galdar

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You should only take Galdar if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you may still be able to become pregnant during treatment with Galdar.
• Do not take Galdar if you are pregnant or breast-feeding, as it may harm your baby.

Driving and using machines

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

Use in athletes

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

3. How to take Galdar

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is one Galdar tablet once a day. If you take Galdar 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.

How long to take Galdar

Keep taking Galdar every day for as long as your doctor tells you to. You may need to take it for months or even years. If you are unsure how long to take Galdar, ask your doctor.

Monitoring of treatment with Galdar

You should only take this medicine under strict medical supervision. Your doctor will regularly check your condition to ensure that the treatment has the desired effect.

Galdar may cause a decrease in bone density 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 check for osteoporosis) before, during, and after treatment.

If you take more Galdar than you should

If you have taken too many Galdar tablets, or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. You can also call the Toxicology Information Service, phone: 915620420, stating the medicine and the amount taken.

If you forget to take Galdar

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

If you stop taking Galdar

Do not stop taking Galdar unless your doctor tells you to. See also the section "How long to take Galdar".

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 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 the lack of estrogen.

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

Some side effects can be serious:

Uncommon(may affect up to 1 in 100 people):

• Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain (sign of heart disorder).
• Swelling and redness along a vein that is extremely soft and possibly painful to the touch.
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Tendinitis or tendon inflammation (tissue that connects muscles to bones).

Rare(may affect up to 1 in 1,000 people)

• Difficulty breathing, chest pain, fainting, rapid heartbeat, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• Tendon rupture (tissue that connects muscles to bones).

If you experience any of these, tell your doctor immediately.

You should also tell your doctor immediately if you experience any of the following during treatment with Galdar:

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

Some side effects are very common(may affect more than 1 in 10 people)

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

If any of these affect you severely, talk to your doctor.

Some side effects are common.(may affect up to 1 in 10 people)

• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain
• Skin rash.
• Headache.
• Dizziness.
• General malaise.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Weight loss or bone loss (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Galdar" in section 3)
• Swelling of arms, hands, feet, ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• High blood pressure (hypertension).
• Abdominal pain.
• Dry skin.
• Vaginal bleeding

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

Some side effects are uncommon(may affect up to 1 in 100 people)

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia.
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity disorders, especially touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal discharge or dryness.
• Breast pain.
• Fever.
• Thirst, taste disorder, dry mouth.
• Dryness of mucous membranes.
• Weight loss.
• Urinary tract infection, increased frequency of urination.
• Cough.
• Increased enzyme levels
• Yellowing of the skin and eyes
• High blood levels of bilirubin (a product of red blood cell breakdown)

Side effects with frequency not known(cannot be estimated from the available data)

Trigger finger, a condition in which your finger or thumb gets stuck in a bent position.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Galdar

• 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 after EXP. The expiry date refers to the last day of the month stated.
• No special storage conditions are required.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

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 protect the environment.

6. Contents of the pack and further information

Composition of Galdar

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are lactose monohydrate (lactose), microcrystalline cellulose, corn starch, colloidal anhydrous silica, sodium starch glycolate (potato starch), magnesium stearate. The coating consists of polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol/PEG 3350, yellow quinoline aluminum lacquer, iron oxide red (E 172), iron oxide black (E 172).

Appearance and packaging

• Galdar is presented as film-coated tablets. The tablets are dark yellow in color with a white core and are round.
• Each blister pack contains 30 tablets. Not all pack sizes may be available.

Marketing authorization holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets-Els Fogars, sector 2

Carretera Comarcal C-244, km 22

08777 Sant Quintí de Mediona (Barcelona)

Spain

Manufacturer

Tecnimede – Sociedade Técnico Medicinal, S.A.

Quinta da Cerca, Caixaria, 2565-187 Dosis Portos

Portugal

Date of last revision of this leaflet:June 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/