Verlamga

Package Leaflet: Information for the User

VERLAMGA 500 mg film-coated tablets

abiraterone acetate
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What VERLAMGA is and what it is used for
2. What you need to know before taking VERLAMGA
3. How to take VERLAMGA
4. Possible side effects
5. How to store VERLAMGA
6. Contents of the pack and other information

1. What VERLAMGA is and what it is used for

VERLAMGA contains an active substance called abiraterone acetate. It is used to treat prostate cancer in adult men when the cancer has spread to other parts of the body. VERLAMGA stops the body from producing testosterone, which may slow down the growth of prostate cancer.

When VERLAMGA is prescribed in the early stage of the disease that still responds to hormone therapy, it is used together with a treatment that lowers testosterone levels (androgen deprivation therapy).

When taking this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the likelihood of developing high blood pressure, too much fluid in the body (fluid retention), or low levels in the blood of a chemical known as potassium.

2. What you need to know before taking VERLAMGA

DO NOT take VERLAMGA

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6);
• if you are a woman, especially if pregnant. VERLAMGA is intended for use only in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above conditions apply to you. If you have any doubts, consult your
doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been told you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have an irregular or rapid heartbeat
• if you are short of breath
• if you have gained weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• regarding the need to take this medicine with prednisone or prednisolone
• regarding possible effects on bones
• if you have high blood sugar levels. Inform your doctor if you have been diagnosed with any heart or blood vessel disorder, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting,
as these may be signs or symptoms of liver problems. Rarely, a liver function problem (called acute liver failure) may occur, which can lead to death.
Possible effects include reduction in red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.
VERLAMGA must not be given in combination with Ra-223 due to a possible increased risk of fractures or death.
If you are considering taking Ra-223 after treatment with VERLAMGA and prednisone/prednisolone, you must wait 5
days before starting Ra-223 treatment.
If you have any doubts whether any of the points listed above may apply to you, consult your doctor or
pharmacist before taking this medicine.
Blood monitoring
VERLAMGA may affect the liver, and you may not experience any symptoms. While taking this
medicine, your doctor will periodically perform blood tests to check for any effects on the
liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If VERLAMGA is accidentally
ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to
show the emergency doctor.
Other medicines and VERLAMGA
Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is important because VERLAMGA may increase the effects of certain medicines, including
heart medications, tranquilizers, certain diabetes medicines, herbal remedies (e.g., St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines. Additionally, some
medicines may increase or decrease the effects of VERLAMGA. This could lead to unwanted side effects,
or VERLAMGA may not work as effectively as it should.
Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking medicines:
used to treat heart rhythm problems (e.g., quinidine, procainamide, amiodarone, and sotalol);

• known to increase the risk of heart rhythm problems [e.g., methadone (used to relieve pain and in drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.
VERLAMGA with food

• This medicine must not be taken with food (see section 3 “How to take this medicine”).
• Taking VERLAMGA with food may cause adverse effects.

Pregnancy and breastfeeding
VERLAMGA is NOT indicated for use in women.

• This medicine may harm the unborn baby if taken during pregnancy.
• Pregnant women or women who may be pregnant must wear gloves if they need to touch or handle VERLAMGA.
• If you have sexual intercourse with a woman of childbearing age, you must use a condom and another effective contraceptive method.
• If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn baby.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use tools or machines.
VERLAMGA contains lactose and sodium
VERLAMGA contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain
sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

3. How to take VERLAMGA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is 1,000 mg (two tablets) once daily.

Administration of this medicine

• Take this medicine by mouth.
• Do not take VERLAMGA with food. Taking VERLAMGA with food may lead to higher than intended absorption of the medicine into the body, which could cause unwanted side effects.
• Take VERLAMGA tablets as a single daily dose on an empty stomach. VERLAMGA should be taken at least two hours after a meal, and no food should be consumed for at least one hour after taking VERLAMGA (see section 2, “VERLAMGA with food”).
• Swallow the tablets whole with some water.
• Do not break the tablets.
• VERLAMGA is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day during the time you are taking VERLAMGA.
• The dose of prednisone or prednisolone may need to be adjusted in case of a medical emergency. Your doctor will inform you if any dose adjustment is necessary. Do not stop taking prednisone or prednisolone unless your doctor tells you to do so. Your doctor may also prescribe other medicines while you are taking VERLAMGA and prednisone or prednisolone.

If you take more VERLAMGA than you should
If you take more VERLAMGA than prescribed, contact your doctor or go to a hospital immediately.

If you forget to take VERLAMGA
If you forget to take VERLAMGA, or prednisone or prednisolone, take the usual dose the next day.
If you forget to take VERLAMGA, or prednisone or prednisolone for more than one day, speak to your doctor as soon as possible.

If you stop taking VERLAMGA
Do not stop taking VERLAMGA or prednisone or prednisolone unless your doctor tells you to do so.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking VERLAMGA and contact a doctor immediately if you notice any of the following side effects:

• Muscle weakness, muscle cramps, or a sensation of pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common (may affect more than 1 in 10 people):
Fluid retention in the legs or feet, low potassium levels in the blood, increased liver function test values, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people):
Elevated levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, rapid heartbeat, severe infection called sepsis, bone fractures, indigestion, blood in the urine, skin rash.
Uncommon (may affect up to 1 in 100 people):
Problems with the adrenal glands (related to salt and water balance), abnormal heartbeat (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1,000 people):
Lung irritation (also known as allergic alveolitis).
Liver function problems (also known as acute liver failure).
Not known (frequency cannot be estimated from available data):
Heart attack, changes in ECG (electrocardiogram) – QT interval prolongation – and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or an itchy skin rash.
Bone loss may occur in men treated for prostate cancer. VERLAMGA in combination with prednisone or prednisolone may increase the loss of bone tissue.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store VERLAMGA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What VERLAMGA contains
The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate, equivalent to 446.3 mg of abiraterone.
The other ingredients are monohydrate lactose, sodium lauryl sulfate, croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate and anhydrous colloidal silica. The coating film contains polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b) and yellow iron oxide (E172).
Description of the appearance of VERLAMGA and package contents
VERLAMGA tablets are film-coated, oblong-shaped, yellow tablets, marked with "A436" on one side.
VERLAMGA is available in blister packs containing 56 film-coated tablets.
Marketing Authorization Holder
Day Zero ehf.
Reykjavíkurvegi 62
Hafnarfjördur - 220
Iceland
Manufacturer
Balkanpharma Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Teva Operations Poland Sp. z o.o.
ul. Emilii Plater 53
31-546 Kraków
Poland
This medicinal product is authorized in the European Economic Area countries under the following
names:
Denmark: Verlamga
Italy: Verlamga