Package leaflet: Information for the patient

Xanderla LA, 10.8 mg, implant in pre-filled syringe
Goserelinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Xanderla LA is and what it is used for
Important information before using Xanderla LA
How to use Xanderla LA
Possible side effects
How to store Xanderla LA
Contents of the pack and other information

1. What Xanderla LA is and what it is used for

Xanderla LA contains the active substance called goserelin. It belongs to a group of medicines known as
LHRH analogues.
Xanderla LA is used in the treatment of prostate cancer. The medicine works by reducing the amount of testosterone – a hormone produced by the patient's body. Xanderla LA is a long-acting formulation and is administered every 12 weeks.

2. Important information before using Xanderla LA

When not to use Xanderla LA

if the patient is allergic to goserelin or any of the ingredients of this medicine (listed in section 6);
in women.

Xanderla LA must not be used if any of the above situations apply.
If in doubt, discuss this with a doctor or pharmacist before using Xanderla LA.
Warnings and precautions
Before starting treatment with Xanderla LA, tell the doctor, pharmacist or nurse:

if the patient has difficulty passing urine or back pain;
if the patient has diabetes;
if the patient has high blood pressure;
if there are any conditions that may weaken bones, particularly if the patient drinks large amounts of alcohol, smokes cigarettes, or has a family history of osteoporosis (a disease that weakens bones)

or if the patient is taking anticonvulsant medicines (medicines used for epilepsy or seizures) or corticosteroids (steroids);

if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or if the patient is taking medicines for these conditions. Treatment with Xanderla LA may increase the risk of developing heart rhythm disturbances.

Cases of depression, including severe depression, have been reported during treatment with Xanderla LA.
If the patient develops low mood while taking Xanderla LA, inform the doctor.
Medicines of this type may cause reduced calcium levels in bones (bone weakening).
If hospitalization occurs, inform medical staff that the patient is being treated with Xanderla LA.
Inform the doctor about current or planned anti-doping tests, as treatment with Xanderla LA may lead to positive results in anti-doping tests.
Children
Xanderla LA must not be used in children.
Xanderla LA and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Xanderla LA may affect the action of certain medicines used to treat heart rhythm disorders (such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide and ibutilide) or may increase the risk of heart rhythm disturbances when used together with other medicines [e.g. methadone used for pain relief and in detoxification therapy for addiction, moxifloxacin (an antibiotic), and antipsychotic medicines used to treat serious mental illnesses].
Driving and operating machinery
There is a low likelihood that Xanderla LA may affect the ability to drive or operate any devices or machinery.

3. How to use Xanderla LA

Xanderla LA 10.8 mg implant will be administered subcutaneously in the abdomen every 12 weeks.
The injection will be given by a doctor or nurse.

It is important to continue treatment with Xanderla LA even if the patient feels well.
Treatment should be continued until the doctor decides it can be stopped.

Next appointment

Xanderla LA should be administered as an injection every 12 weeks.
Always remind the doctor or nurse to schedule an appointment for the next injection.
If the scheduled appointment falls earlier or later than 12 weeks after the last injection, inform the doctor or nurse.
If more than 12 weeks have passed since the last injection, contact the doctor or nurse to receive the next injection as soon as possible.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Allergic reactions:
These occur rarely. The following symptoms may appear suddenly:

skin rash, itching or hives
swelling of the face, lips or tongue, or other parts of the body
shortness of breath, wheezing or difficulty breathing. If any of these symptoms occur, seek immediate medical advice.

Injury at the injection site of Xanderla LA (including damage to abdominal blood vessels) has been reported. Very rarely, this has led to serious bleeding. Seek immediate medical advice if any of the following symptoms occur:

abdominal pain
abdominal distension
feeling of breathlessness
dizziness
low blood pressure and (or) any disturbance of consciousness.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people):

hot flushes and sweating. Sometimes these adverse reactions may persist for a prolonged period (even several months) after discontinuation of Xanderla LA.
decreased libido and impotence.

Common (may affect up to 1 in 10 people):

lower back pain or difficulty in passing urine. If these symptoms occur, discuss them with your doctor.
bone pain at the beginning of treatment. If these symptoms occur, discuss them with your doctor.
loss of bone mass
increased blood glucose levels
tingling in fingers and toes
skin rashes
weight gain
pain, bruising, bleeding, redness or swelling at the injection site of Xanderla LA
reduced heart function or heart attack
changes in blood pressure
breast swelling and tenderness
mood changes (including depression).

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

joint pain.

Very rare (may affect up to 1 in 10,000 people):

psychiatric disorders known as psychotic disorders, including possible hallucinations (seeing, feeling or hearing things that are not real), disturbances in thinking and personality changes. These symptoms occur very rarely.
development of a pituitary tumour or, in patients who previously had a pituitary tumour, goserelin may cause bleeding from or collapse of the tumour. These events are very rare. Pituitary tumours may cause severe headaches, nausea or vomiting, vision loss and loss of consciousness.

Unknown (frequency cannot be estimated from available data):

hair loss
blood disorders
liver disorders
blood clots in the lungs causing chest pain or breathlessness
lung inflammation; symptoms may resemble those of pneumonia (such as breathlessness and cough)
changes in ECG (prolongation of QT interval).

The above list of possible adverse reactions should not cause undue concern.
It is possible that none of them will occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Xanderla LA

Xanderla LA will be prescribed to the patient by a doctor. The prescription should be filled at a pharmacy,
and the medicine should be brought to the next appointment.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The "expiry date (EXP)" or "EXP" refers to the last day of the stated month. The batch number on the packaging can be found after "Batch number (Lot)" or "Lot".
Do not store above 30°C.
Store in the original packaging to protect from moisture. Do not open the foil packaging.
After first opening: the product should be used immediately after opening the sachet.

6. Contents of the pack and other information

What Xanderla LA contains

The active substance is goserelin. One implant contains 10.8 mg of goserelin (as goserelin acetate).
The other components are: DL-lactide polymer and DL-lactide and glycolide copolymer (75:25).

What Xanderla LA looks like and contents of the pack
White or almost white cylindrical rods (approximate dimensions: diameter 1.5 mm, length 20 mm,
weight 44 mg), embedded in a biodegradable polymer matrix.
The pre-filled syringe containing one implant, placed in a PETP/Aluminium/PE pouch with a desiccant,
packaged in a cardboard box.
The unit pack contains 1, 2 or 3 pre-filled syringes in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater Street 53
00-113 Warsaw
Manufacturer
AMW GmbH Arzneimittelwerk Warngau
Birkerfeld 11
83627 Warngau
Germany
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
For more detailed information about the medicinal product and its names in the Member States of the European Economic Area, please contact the Marketing Authorisation Holder.
Teva Pharmaceuticals Polska Sp. z o.o., Emilii Plater Street 53, 00-113 Warsaw, tel.: (22) 345 93 00.