CAMCEVI 42 mg Prolonged-Release Injectable Suspension In Pre-Filled Syringe

Зміст інструкції

1. CAMCEVI 42 mg prolonged-release injectable suspension
   1. What is CAMCEVI and what is it used for
   2. What you need to know before using CAMCEVI
   3. How to use CAMCEVI
   4. Possible side effects
   5. How to store CAMCEVI
   6. Contents of the pack and other information

CAMCEVI 42 mg prolonged-release injectable suspension

leuprorelin

Read this leaflet carefully before using 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, pharmacist or nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4. Contents of this leaflet
• 1. What CAMCEVI is and what it is used for
• 2. What you need to know before using CAMCEVI
• 3. How to use CAMCEVI
• 4. Possible side effects
• 5. How to store CAMCEVI
• 6. Contents of the pack and other information

1. What is CAMCEVI and what is it used for

The active ingredient of CAMCEVI is leuprorelin, a GnRH agonist (a synthetic version of a natural hormone called gonadotropin-releasing hormone), which acts in the same way as the natural hormone, lowering the level of the sex hormone testosterone in the body.
Prostate cancer is sensitive to hormones such as testosterone and reducing the levels of this hormone helps to control tumor growth.
CAMCEVI is used for the treatment of adult men with:

• hormone-dependent metastatic prostate cancer and
• hormone-dependent high-risk non-metastatic prostate cancer in association with radiotherapy.

2. What you need to know before using CAMCEVI

DO NOT use CAMCEVI:

• if you are a woman or a person under the age of 18 years;
• if you are allergicto leuprorelinor to medicinessimilar that affect sex hormones(GnRH agonists); your doctor will help you identify them if necessary;
• if you are allergic to any of the other ingredientsof this medicine (listed in section 6);
• following surgical removal of the testicles. This medicine cannot further reduce testosterone levels if you no longer have testicles;
• as a single treatment if you experience symptoms related to pressure on the spinal cord or if you have a tumor of the spine. In this case, CAMCEVI can only be used in combination with other medicines for prostate cancer. Warnings and precautionsContact your doctor immediatelyif you experience:
• sudden headache;
• vomiting;
• loss of vision or double vision;
• loss of the ability to move the muscles inside or near the eyes;
• altered mental state;
• early symptoms of heart failure including: o fatigue; o swelling of the ankles; o increased need to urinate at night; o more serious symptoms such as shortness of breath, chest pain and fainting. These may be signs of a condition called pituitary apoplexy, which involves bleeding inside the pituitary gland or impaired blood supply to this gland, located at the base of the brain. Pituitary apoplexy can occur due to a pituitary tumor and can rarely occur after starting treatment. Most cases occur within 2 weeks of the first dose; some cases occur within the first hour. Skin rashes, including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported in association with leuprorelin treatment. Stop leuprorelin treatment and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4. Contact your doctor, pharmacist or nurse before using CAMCEVI if
• you experience signs and symptoms of cardiovascular disease including fast and irregular heartbeats, which can cause fainting or seizures (convulsions);
• you have heart or blood vessel disease, including heart rhythm disorders (arrhythmia), or are taking medicines for these conditions. The risk of developing these heart rhythm disorders may increase if you take CAMCEVI. Your doctor may monitor your heart using an electrocardiogram (ECG);
• you have prostate cancer that has spread to the brain or spinal cord. Your doctor will monitor you more closely during the first few weeks of treatment;
• you have diabetes mellitus (high blood sugar). CAMCEVI may worsen existing diabetes, so blood glucose levels should be tested more frequently in diabetic patients;
• you have hepatic steatosis (a condition in which excess fat accumulates in the liver). Contact your doctor, pharmacist or nurse during treatment with CAMCEVI if
• you have a heart attack. Symptoms include chest pain, shortness of breath, dizziness and sweating;
• you have a stroke. Symptoms include drooping of the face on one side, inability to raise arms and slurred speech;
• you suffer a bone fracture. Treatment with CAMCEVI may increase the risk of fractures due to osteoporosis (decreased bone density);
• you have seizures (convulsions);
• you notice an increase in blood sugar. Your doctor will monitor your blood sugar levels during treatment;
• you have difficulty urinating. There may be an obstruction of the urinary tract. Your doctor will monitor you closely during the first few weeks of treatment;
• you develop symptoms of spinal cord compression including pain, numbness or weakness in the arms, hands, legs or feet. Your doctor will monitor you closely during the first few weeks of treatment. Side effects you may experience during the first few weeks of treatmentDuring the first few weeks of treatment, there is generally a brief increase in the male sex hormone, testosterone, in the blood. This may cause a temporary worsening of symptoms related to the disease and also the appearance of new symptoms that you have not experienced before, including, in particular:
• bone pain;
• problems with urination, pain, numbness or weakness in the arms, hands, legs or feet, or loss of bladder or bowel control due to spinal cord compression;
• blood in the urine. These symptoms usually subside as treatment continues. If not, contact your doctor. You may need to take another medicine before starting treatment with CAMCEVI to reduce the initial increase in testosterone in the blood. You may need to continue taking this other medicine for a few weeks after starting treatment with CAMCEVI. If CAMCEVI is not workingSome patients have tumors that are not sensitive to lower levels of testosterone. Contact your doctor if you think the effect of CAMCEVI is too weak. Other medicines and CAMCEVITell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. CAMCEVI may interfere with some medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol, dofetilide and ibutilide) or may increase the risk of developing heart rhythm disorders if used with other medicines, such as methadone (used to relieve pain and as a substitute for heroin for the treatment of drug addicts), moxifloxacin (an antibiotic) and antipsychotic drugs used for serious mental illnesses. Pregnancy and breastfeedingThis medicine is not intended for use in women. Driving and using machinesSubjects treated with CAMCEVI may experience fatigue, dizziness and visual disturbances. If you experience any of these side effects, do not drive, or use tools or machinery.

3. How to use CAMCEVI

CAMCEVI is administered by the doctor or nurse by means of a single injection under the skin
(subcutaneous) every 6 months.
This medicine must be administered only by the doctor or a nurse, who will
ensure that it is injected correctly under the skin and not into a vein.
After the injection, the medicine solidifies and slowly releases leuprorelin into
the body over a period of 6 months.

In association with radiotherapy
This medicine can be used before or together with radiotherapy for high-risk and locally advanced
prostate cancer. “High-risk localized” means that it is
likely that the cancer will spread beyond the prostate gland to reach nearby tissues and to
become locally advanced. “Locally advanced” means that the cancer has spread beyond the
pelvic area to reach nearby tissues, such as the lymph nodes.

Monitoring of treatment
The doctor will monitor the response to treatment through blood tests, including the prostate
specific antigen (PSA).

If you use more CAMCEVI than you should
The injection is performed by the doctor or by adequately trained personnel, therefore it is
unlikely that an overdose will occur. If you are inadvertently given an excessive dose of
medicine, the doctor will monitor you and administer further treatments, if necessary.

If you forget to use CAMCEVI
Contact your doctor if you believe you have forgotten to receive the semi-annual dose of
CAMCEVI.

If you stop using CAMCEVI
Generally, the treatment of prostate cancer with CAMCEVI requires long-term therapy,
therefore do not stop treatment too early, even if the symptoms improve or if they disappear
completely. If you stop treatment too early, the symptoms may reappear. Do not
stop treatment prematurely without first consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

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

Seek medical attention immediatelyif you experience:

• sudden headache;
• vomiting;
• loss of vision or double vision;
• loss of ability to move the muscles inside or near the eyes;
• altered mental state;
• early signs of heart failure including: o fatigue; o swelling of the ankles; o increased need to urinate at night; o more serious symptoms such as shortness of breath, chest pain and fainting. These may be signs of a condition called pituitary apoplexy, which involves bleeding inside the pituitary gland, or a compromise of the blood supply to this gland, located at the base of the brain. Pituitary apoplexy can occur due to a pituitary tumor and can rarely emerge after the start of treatment. Most cases manifest within 2 weeks of the first dose; some cases manifest within the first hour. Not known (frequency cannot be estimated based on available data):
• if you develop flat, reddish spots in a circular shape or with a bullseye appearance on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin rashes may be preceded by fever or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).
• skin redness and itchy rash. (Toxic skin rash).
• a skin reaction that causes small spots or red patches on the skin, which may look like a bullseye with a dark red center surrounded by lighter red rings (Erythema multiforme). Early side effectsDuring the first week of treatment, there is generally a brief increase in the sex hormone, testosterone, in the blood. This may cause a temporary worsening of symptoms related to the disease and also the appearance of new symptoms that you may not have experienced before, including, in particular:
• bone pain;
• problems with urination, pain, numbness or weakness in the arms, hands, legs or feet, or loss of bladder or bowel control due to spinal cord compression;
• blood in the urine. Your doctor may prescribe another medicine at the beginning of treatment to reduce some of these

early side effects (See also section 2 Disorders that you may experience during the
first weeks of treatment).

Side effects at the injection site
After the injection, you may experience the following side effects near the injection site:

• mild burning and numbness immediately after the injection (very common: may affect more than 1 in 10 people)
• pain, bruising and tingling after the injection (common: may affect up to 1 in 10 people)
• itching and skin hardening near the injection site (uncommon: may affect up to 1 in 100 people)
• skin injury or soreness at the injection site (rare: may affect up to 1 in 1,000); dead tissue at the injection site (very rare, may affect up to 1 in 10,000). These side effects are mild and do not last long. They only occur at the time of injection. If you experience any of these side effects, contact your doctor. Very common side effects(may affect more than 1 in 10 people)
• hot flashes
• bruising and/or skin redness
• fatigue Common side effects(may affect up to 1 in 10 people)
• common cold symptoms (nasopharyngitis)
• feeling unwell (nausea), discomfort, diarrhea, stomach inflammation (gastroenteritis/colitis)
• itching
• night sweats
• joint pain, pain in the arms and legs, muscle soreness and pain
• need to urinate more often than usual, including at night, difficulty urinating, pain during urination, incomplete emptying of the bladder or needing to urinate less frequently
• breast tenderness and/or swelling, shrinkage of the testicles, testicular pain, infertility, erectile dysfunction, decreased penis size
• episodes of violent tremors with high fever (febrile chills), weakness, general feeling of discomfort
• changes in laboratory blood test results (prolonged bleeding time, changes in blood parameters, decreased red blood cells/low red blood cell count). Uncommon side effects(may affect up to 1 in 100 people)
• urinary tract infection (UTI), localized skin infection
• worsening of diabetes mellitus
• abnormal dreams, depression, decreased libido (sexual desire)
• dizziness, headache, partial or total loss of sensation in a part of the body, insomnia, altered sense of taste and/or smell
• lightheadedness and loss of balance (vertigo)
• changes in electrocardiogram (ECG) (prolongation of the QT interval)
• heart attack. Symptoms include chest pain, shortness of breath, dizziness and sweating
• high or low blood pressure
• runny nose, shortness of breath
• constipation, dry mouth, digestive disorders with symptoms such as feeling of fullness, stomach pains, belching, nausea, vomiting, heartburn (dyspepsia), vomiting
• feeling sticky and sweaty
• back pain, muscle cramps
• bladder spasms, blood in the urine, overactive bladder (needing to urinate before the

bladder is full), inability to urinate

• enlargement of the breasts, impotence, testicular disorders (e.g. swollen, red or warm scrotum, pain or discomfort in the pelvic area)
• drowsiness (lethargy), pain, fever
• changes in blood tests, weight gain Rare side effects(may affect up to 1 in 1,000 people)
• uncontrolled and involuntary body movements
• fainting, collapse
• flatulence and belching
• hair loss, pustules on the skin
• breast pain

Not known(frequency cannot be estimated based on available data)

• inflammation of the lungs (interstitial lung disease)
• idiopathic intracranial hypertension (increased pressure inside the skull around the brain, characterized by headache, double vision and other visual disturbances and ringing or buzzing in one or both ears). The following serious allergic reactions have been reported with medicines belonging to the samegroup of medicines as CAMCEVI
• difficulty breathing or dizziness (rarely). The following side effects have been reported with other medicines containing leuprorelin
• swelling of the hands and feet (edema)
• symptoms of pulmonary embolism (a blood clot in the vessels leading to the lungs), including chest pain, shortness of breath, difficulty breathing and coughing up blood
• significantly rapid, strong or irregular heartbeat
• muscle weakness
• chills
• skin rash
• memory impairment
• visual disturbances
• muscle atrophy/loss of muscle tissue after prolonged use
• medical condition in which bones become brittle and fragile, called osteoporosis, and consequently increased risk of bone fractures. The following side effect has been reported with medicines belonging to the same groupof medicines as CAMCEVI
• seizures. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CAMCEVI

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 pack after Scad./EXP. The
expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Store in the original package to protect the medicine from light.
Before using CAMCEVI, allow the medicine to reach room temperature (from 15 °C to
25 °C). This will take approximately 15-20 minutes.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CAMCEVI contains

• The active substance is leuprorelin. A pre-filled syringe with a prolonged-release injectable suspension contains leuprorelin mesylate equivalent to 42 mg of leuprorelin.
• The other ingredients are Poly(D,L-lactide) and N-methylpyrrolidone. Description of the appearance of CAMCEVI and contents of the packCAMCEVI is a prolonged-release injectable suspension. The pre-filled syringe contains a viscous and opalescent suspension ranging in colour from whitish to light yellow. CAMCEVI is available in a pack containing: 1 pre-filled syringe and 1 sterile safety needle. Marketing Authorisation HolderAccord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039, Barcelona, Spain ManufacturerAccord Healthcare Polska Sp. z.o.o. Ul. Lutomierska 50 95-200, Pabianice Poland Accord Healthcare Single Member S.A. 64 Km National Road Athens, Lamia, Schimatari, 32009, Greece For further information on this medicinal product, contact the local representative of the marketing authorisation holder: AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES Accord Healthcare S.L.U. Tel: +34 93 301 00 64 EL Win Medica Pharmaceutical S.A. Tel: : +30 210 7488 821

More detailed information on this medicinal product is available on the website of the European Medicines Agency:
http://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:

Before administering CAMCEVI, follow the instructions provided to ensure
correct preparation of the medicinal product.
Important:before using CAMCEVI, allow the medicinal product to reach room temperature (from 15 °C to 25 °C). The use of gloves is recommended during administration.
CAMCEVI contains:

• a blister containing:
• A sterile pre-filled syringe and a sterile safety needle.

Assembled pre-filled syringe:

Step 1 – Preparation of the medicinal product
Step 2 – Syringe assembly:

o Wait for the medicinal product to reach room temperature and inspect its contents Remove CAMCEVI from the refrigerator. a Before using CAMCEVI, allow the medicinal product to reach room temperature (from 15 °C to 25 °C). This will take approximately 15-20 minutes. Using a flat, clean and dry surface, open the box and remove the blister container and the bag. Remove the pre-filled syringe of CAMCEVI (A) from the blister container. Remove the safety needle (B) from the bag. Examine all the contents of the pack. Do not use if any component is damaged. l Check the expiry date printed on the syringe. Do not use if the expiry date has passed. d Visually inspect the medicinal product before use. The pre-filled syringe should contain a viscous and opalescent suspension ranging in colour from whitish to light yellow. Do not use if foreign particles are present inside the syringe body.

Insert the needle a t I a i z

l Remove the grey cap from the syringe (A). Insert the needle (B) into the end of the syringe (A) by pushing and rotating clockwise by about three-quarters of a turn until the needle is firmly attached. Do not overtighten the needle. Discard the pre-filled syringe of CAMCEVI if breakage occurs after excessive rotation.

Step 3 - Administration:

Prepare the injection site Administer the drug

o c Choose an injection site in the upper or central abdomen that has sufficient soft or flaccid subcutaneous tissue and has not been used recently. It is necessary to change the injection site periodically. Clean the injection site with an alcohol swab. DO NOT inject into areas with muscular or fibrous subcutaneous tissue or into points that may be rubbed or compressed (e.g. with a belt or clothing). Remove the cap from the needle (B). Grasp the skin and form a skin fold with your fingers at the injection site. Insert the needle at a 90° angle, then release the skin fold. Inject the entire contents of the syringe with a slow but continuous movement, then withdraw the needle at the same 90° angle used for insertion. Intra-arterial or intravenous injections must be strictly avoided.

Step 4 – Disposal of the needle and pre-filled syringe

Needle protection Activation Activation with the thumb on a surface

o Immediately after removing the needle from the injection site, activate the safety cap using a finger/thumb or a flat surface by pushing the cap until it completely covers the needle tip and locks into place. An audible and tactile “click” indicates a locked position. Check that the safety cap is fully engaged. After use, dispose of the used syringe with the protected needle in a suitable container for sharp objects. Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with local regulations.

Activation with the thumb	Activation on a surface