Zequipra 2.5 mg. 30 tablets

What Zequipra is and what it is used for

What Zequipra is and how it works

Zequipra contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is used for hormonal (or "endocrine") treatment of breast cancer. Tumor growth in breast cancer is often stimulated by estrogen, which is the female sex hormone. Zequipra reduces the amount of estrogen by blocking an enzyme (aromatase) involved in their formation, and thus can block the growth of breast cancer, which needs estrogen for its growth. As a result, tumor cells slow or stop their growth and / or spread to other parts of the body.

What is Zequipra used for?

Zequipra is used to treat breast cancer in postmenopausal women, ie. cessation of menstruation.

It is used to prevent the recurrence of cancer. It can be used as a first treatment before breast cancer surgery, in case immediate surgical treatment is inappropriate. It can be used as a first treatment after breast cancer surgery or after five years of tamoxifen treatment. Zequipra is also used to prevent the spread of the tumor to other parts of the body in advanced breast cancer.

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

2. What you need to know before you take Zequipra

Follow your doctor's instructions carefully. They may differ from the general information in this leaflet.

Do not take Zekvnpra:

if you are allergic to letrozole or any of the other ingredients of Zequipra (listed in section 6)

if you are still menstruating, ie if you are not yet menopausal

if you are pregnant

if you are breast-feeding.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zequipra

if you have severe kidney disease

if you have severe liver disease

if you have a history of osteoporosis or bone fractures (see also “Follow-up during treatment with Zequipra” in section 3).

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

Children and adolescents (under 18)

Children and adolescents should not take this medicine.

Elderly patients (65 years of age or older)

Patients aged 65 years and older can use this medicine in the same doses as other adults.

Other medicines and Zequipra

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

You should only take Zequipra if you are menopausal.

However, your doctor should discuss with you the need for effective contraception, as it is still possible to become pregnant during treatment with Zekvipra.

You should not take Zequipra 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 use any tools or machines until you feel normal again.

Zequipra contains lactose

Zequipra tablets contain 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 medicinal product.

3. How to take Zequipra

Always take Zequipra exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The usual dose is one tablet of Zequipra once a day. Take Zequipra at the same time each day to remember when to 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 Zequipra

Continue to take Zequipra every day until your doctor tells you to. This may take months or even years. If you have any questions about how long to take Zequipra, talk to your doctor.

Follow-up during treatment with Zequipra

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

Zequipra can cause thinning or weakening of the bones (osteoporosis) as a result of a decrease in estrogen in the body. Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during and after treatment.

If you take more Zequipra than you should

If you have taken too much

4. Possible side effects

Like all medicines, Zequipra 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 a lack of estrogen in your body.

Some side effects can be serious.

Rare or uncommon side effects (ie may affect between t to 100 in every 10,000 patients):

Weakness, paralysis or loss of sensitivity in any part of the body (especially the arm or leg), loss of coordination, nausea or difficulty speaking or breathing (a sign of brain damage, eg stroke).

Sudden tightening pain in the chest (a sign of heart disease).

Difficulty breathing, chest pain, fainting, rapid heartbeat, bruising of the skin or sudden pain in the arm, leg or foot (signs of possible clot formation).

Swelling or redness along a vein that is particularly sensitive and painful to the touch.

Severe fever, chills or cold sores due to infection (lack of white blood cells).

Severe permanent blurred vision.

If any of the above symptoms occur, tell your doctor immediately.

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

Swelling of the face and throat (a sign of an allergic reaction).

Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis).

Rash, reddening of the skin, swelling of the lips, eyes or mouth, peeling of the skin, fever (signs of skin disease).

Some side effects are very common. They can affect more than 10 in 100 patients

Hot flashes

Elevated cholesterol

Fatigue

Heavy sweating

Bone and joint pain (arthralgia)

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

Some side effects are common. They can affect between 1 and 10 in every 100 patients.

Skin rashes

Headache

Dizziness

General malaise

Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea

Increased or lost appetite

Muscle pain

Thinning or wear of the bones (osteoporosis), which leads to bone fractures in some cases (see also “Follow-up during your treatment with Zequipra” in section 3)

Swelling of the hands, palms, feet, ankles (swelling)

Sad mood (depression)

Weight gain

Hair loss

High blood pressure (hypertension)

Stomach ache

Dry skin

Vaginal bleeding

Heartbeat, rapid heartbeat (fast heart rate)

Joint stiffness (arthritis)

Chest pain

If any of these side effects gets serious, tell your doctor.

Other side effects are uncommon. They can affect between 1 and 10 per 1000 patients.

Nervous disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, drowsiness, insomnia.

Sensory disturbances, especially touch

Eye disorders, such as blurred vision, eye irritation

Skin disorders such as pruritus (urticaria)

Vaginal discharge or dryness

Chest pain

Fever

Thirst, taste disturbances, dry mouth

Drying of the mucous membranes

Weight loss

Urinary tract infection, frequent urination

Cough

Elevated levels of enzymes

Yellowing of the skin and eyes

High levels of bilirubin in the blood (waste product of red blood cells)

5. How to store Zequipra

Keep out of reach of children.

Do not use Zekvipra after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not store above 30 ° C.

Store in the original package in order to protect from moisture.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Package contents no additional information

What Zequipra contains

The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.

The other ingredients are (core): lactose monohydrate, microcrystalline cellulose, maize starch, silica, colloidal anhydrous, sodium starch glycol (type A), magnesium stearate, and (shell): polyvinyl alcohol, talc, titanium dioxide 3350, quinoline yellow aluminum lacquer (E 107), red iron oxide (E 172) and black iron oxide (E172).

What Zekvnpra looks like and contents of the pack

Zequipra is in the form of film-coated tablets. The tablets are round with a white core and a yellow coating. The pack contains 10, 30 or 60 tablets.

Not all pack sizes may be marketed.