Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - camcevi

Document Subject

Generated Narrative: MedicinalProductDefinition mpd96fa44827f5ab161c32cbffe0ee34b9

identifier: http://ema.europa.eu/identifier/EU/1/22/1647/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: CAMCEVI 42 mg prolonged-release suspension for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d96fa44827f5ab161c32cbffe0ee34b9

identifier: http://ema.europa.eu/identifier/EU/1/22/1647/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - camcevi

Attesters

What is in this leaflet

1. What CAMCEVI is and what it is used for
2. What you need to know before you are given CAMCEVI
3. How you will be given CAMCEVI
4. Possible side effects
5. How to store CAMCEVI
6. Contents of the pack and other information

The active substance of CAMCEVI is leuprorelin which is a GnRH-agonist (a synthetic version of a natural homone called gonadotropin releasing hormone) and acts in the same way as the natural hormone to lower the level of the sex hormone testosterone in the body.

Prostate cancer is sensitive to hormones such as testosterone, and reducing testosterone levels helps control the growth of the cancer.

CAMCEVI is used to treat adult men who have:

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

DO NOT use CAMCEVI:

• if you are a woman or a child under the age of 18;
• if you are allergic to leuprorelin, or to similar medicines that affect your sex hormones (GnRH agonists); your doctor will help you identify these if necessary,
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• following surgical removal of your testicles. This medicine cannot further help to lower your testosterone levels once you have no testicles;
• as the only treatment if you suffer from symptoms related to pressure on the spinal cord or a tumour in the spinal column. In this case, CAMCEVI may only be used in combination with other medicines for prostate cancer.

Warnings and precautions

Seek urgent medical attention if you develop:

• sudden headache;
• vomiting;
• loss of, or double vision;
• loss of the ability to move the muscles in, or around, your eye;
• altered mental state;
• early symptoms of heart failure including * fatigue * swelling in your ankles; * increased need to urinate at night; * more severe symptoms such as rapid breathing, chest pain, and fainting. These may be signs of a condition called pituitary apoplexy, involving bleeding into, or impaired blood supply to the pituitary gland found at the base of the brain. Pituitary apoplexy can occur due to a tumor of the pituitary and can emerge rarely after starting treatment. Most cases occur within 2 weeks of the first dose, and some within the first hour.

Talk to your doctor, pharmacist or nurse before using CAMCEVI if you

• develop cardiovascular signs and symptoms such as fast chaotic heartbeats. These rapid heartbeats might cause you to faint or have fits (seizures);
• have heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are taking medicines for these conditions. The risk of these heart rhythm problems may get worse when using CAMCEVI. Your doctor may monitor your heart using an electrocardiogram (ECG);
• have prostate cancer which has spread into your spine or brain. Your doctor will monitor you more closely during first few weeks of treatment;
• suffer from diabetes mellitus (high blood sugar levels). CAMCEVI can make existing diabetes worse and therefore people with diabetes need more frequent testing of blood glucose levels.

Talk to your doctor, pharmacist or nurse during treatment with CAMCEVI if you

• experience a heart attack. Symptoms include chest pain, shortness of breath, dizziness and sweating;
• suffer from a stroke. Symptoms include your face dropping on one side, not being able to lift your arms and slurred speech;
• develop a bone fracture. Treatment with CAMCEVI can increase the risk for fractures due to osteoporosis (decrease in bone density);
• have a fit (convulsions);
• notice your blood sugar levels go up. Your doctor will monitor your blood glucose levels during treatment;
• have difficulty urinating. There could be a blockage in your urinary tube. Your doctor will closely monitor you during the first weeks of treatment;
• develop symptoms of spinal compression such as pain, numbness, or weakness in the arms, hands, legs, or feet. Your doctor will closely monitor you during your first few weeks of treatment.

Problems you may experience during the first weeks of treatment During the first weeks of treatment, there is generally a brief increase in the male sex hormone testosterone in the blood. This can lead to a temporary worsening in disease-related symptoms and also to new symptoms that you may not have experienced before. These especially include:

• bone pain;
• problems with urinating, pain, numbness, or weakness in the arms, hands, legs, or feet, or loss of bladder or bowel control as a result of spinal compression;
• blood in your urine. These symptoms usually lessen with ongoing treatment. If not, you should contact your doctor.

You may be given another medicine before starting CAMCEVI to help lessen the initial rise of testosterone in your blood. You may remain on this other medicine for a few weeks of CAMCEVI treatment.

If CAMCEVI does not help Some patients have tumours, that are not sensitive to lower levels of testosterone. Please talk to your doctor if you think that the effect of CAMCEVI is too weak.

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

CAMCEVI might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, sotalol, dofetilide and ibutilide) or might increase the risk of heart rhythm problems when used with some other medicines, such as methadone (used for pain relief and used as heroin substitute when treating drug addicts), moxifloxacin (an antibiotic), and antipsychotic medicines used for serious mental illnesses.

Pregnancy and breast-feeding This medicine is not intended for women.

Driving and using machines Tiredness, dizziness and visual disturbances may occur in people being treated with CAMCEVI. If you suffer from any of these side effects, do not drive, use tools or operate machines.

You will be given CAMCEVI as a single injection under your skin (subcutaneous), once every 6 months, by your doctor or nurse.

This medicine should only be given to you by your doctor or a nurse, who will ensure it is injected properly under the skin and not into a vein.

After injection the medicine becomes solid, and then slowly releases leuprorelin into your body over a 6-month period.

In combination with radiotherapy This medicine can be used before or at the same time as radiotherapy treatment for high-risk localised and locally advanced prostate cancer. High-risk localised means that the cancer is likely to spread beyond the prostate gland to nearby tissues, becoming locally advanced. Locally advanced means that the cancer has spread beyond the pelvis to nearby tissues such as lymph nodes.

Monitoring your treatment Your doctor will monitor your response to treatment with blood tests, including prostate-specific antigen (PSA).

If you receive more CAMCEVI than you should Since the injection is given to you by your doctor or appropriately trained staff, an overdose is unlikely. If you inadvertently receive too much medicine, your doctor will monitor you and give you additional treatment as required.

If a dose of CAMCEVI is forgotten Talk to you doctor if you believe that your six monthly dose of CAMCEVI has been forgotten.

Effects when treatment with CAMCEVI is stopped As a general rule, the therapy for prostate cancer with CAMCEVI requires long-term treatment. Therefore, therapy should not be stopped too soon, even if you see your symptoms improve or if they disappear completely. If the treatment is stopped too early, your symptoms may return. Do not stop the treatment early without talking with your doctor first.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek urgent medical attention if you develop:

• sudden headache;
• vomiting;
• loss of, or double vision;
• loss of the ability to move the muscles in, or around, your eye;
• altered mental state;
• early symptoms of heart failure including * fatigue * swelling in your ankles; * increased need to urinate at night; * more severe symptoms such as rapid breathing, chest pain, and fainting. These may be signs of a condition called pituitary apoplexy, involving bleeding into, or impaired blood supply to the pituitary gland found at the base of the brain. Pituitary apoplexy can occur due to a tumor of the pituitary and can emerge rarely after starting treatment. Most cases occur within 2 weeks of the first dose, and some within the first hour.

Initial side effects During the first week of treatment, there is generally a brief increase in the male sex hormone testosterone in the blood. This can lead to a temporary worsening in the disease-related symptoms and also to new symptoms that you may not have experienced before. These especially include:

• bone pain;
• problems with urinating, pain, numbness, or weakness in the arms, hands, legs, or feet, or loss of bladder or bowel control, which may be symptoms of spinal compression;
• blood in your urine. Your doctor may give you another medicine at the beginning of the treatment to reduce some of these initial side effects (See also section 2 Problems you may experience during first weeks of treatment).

Side effects at injection site You may experience the following side effects around the injection site, after your injection:

• mild burning and numbness immediately after the injection (very common: may affect more than 1 in 10 people)
• pain, bruising and stinging after the injection (common: may affect up to 1 in 10 people)
• itchiness and hardening of skin around injection site (uncommon: may affect up to 1 in 100 people)
• damage or sore on the skin at injection site (rare: may affect up to 1 in 1,000 people);

dead tissue at injection site (very rare, may affect up to 1 in 10,000 people).

These side effects are mild and do not last very long. They only occur at the time of your injection. If you get any of these side effects, talk to your doctor.

Very common side effects (may affect more than 1 in 10 people)

• hot flashes;
• bruising and/or redness of the skin;
• tiredness.

Common side effects (may affect up to 1 in 10 people)

• symptoms of common cold (nasopharyngitis))
• feeling sick (nausea), diarrhoea, inflammation of the stomach and intestines (gastroenteritis/colitis)
• itching
• night sweats
• joint pain, pain in arms and legs, muscle aches and pains
• needing to urinate more than normal, including during the night, difficulty in urinating, pain when urinating, not urinating enough or needing to urinate less frequently;
• tenderness and/or swelling of the breast, shrinking of testicles, pain in testicles, infertility, erectile dysfunction, reduced penis size;
• episodes of exaggerated shaking with high fever (rigors), weakness, generally feeling unwell (malaise)
• changes in blood laboratory results (prolonged bleeding time, changes in blood values, decreased red blood cells/low red blood cell count).

Uncommon side effects (may affect up to 1 in 100 people)

• urinary tract infection (UTI), local 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 your body, insomnia, abnormal change in taste and/or smell
• light-headedness andloss of balance (vertigo)
• changes in electrocardiogram (ECG) (QT prolongation
• 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, disturbed digestion, with symptoms as full stomach, pain in the stomach, belching, nausea, vomiting, burning feeling in the stomach (dyspepsia),, being sick (vomiting)
• feeling clammy and sweaty;
• back pain, muscle cramps;
• bladder spasms, blood in urine, over-active bladder (need to urinate before your bladder is full), unable to urinate;
• enlarged breasts, impotence, problems with testicles (e.g. swollen, red or warm scrotum, pain or discomfort in pelvic area
• sleepiness (lethargy), pain, fever
• changes in blood laboratory tests weight gain

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

• body moves in an uncontrollable and unintended way;
• fainting, collapsing;
• passing wind and burping;
• hair loss, pimples on skin;
• breast pain

Not known (frequency cannot be estimated from the available data)

• inflammation of lungs(interstitial lung disease)
• idiopathic intracranial hypertension (increased intracranial pressure around the brain characterised by headache, double vision and other visual symptoms and ringing or buzzing in one or both ears).

The following serious allergic reactions have been reported with medicines in the same group of medicines as CAMCEVI

• difficulty in breathing or dizziness (rarely).

The following side effects have been reported with other medicines containing leuprorelin

• swelling of hands and feet (oedema);
• symptoms of a pulmonary embolism (a blood clot in the vessels supplying the lungs), including chest pain, breathlessness, difficulty breathing and coughing up blood;
• a noticeably rapid, strong, or irregular heartbeat;
• weak muscles;
• chills;
• rash;
• impaired memory;
• impaired vision;
• muscle wasting/loss of muscle tissue after prolonged use.
• medical condition in which the bones become brittle and fragile called osteoporosis, and therefore there is a higher risk of bone fractures.

The following side effect has been reported with medicines in the same group of medicines as CAMCEVI

• seizures.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 outer packaging after 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 in order to protect from light. Prior to use allow CAMCEVI to reach room temperature (15 C to 25 C). This takes approximately 15 to 20 minutes.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What CAMCEVI contains

• The active substance is leuprorelin. One pre-filled syringe with prolonged-release suspension for injection contains leuprorelin mesilate equivalent to 42 mg leuprorelin.
• The other ingredients are Poly(D,L-lactide) and N-methylpyrrolidone.

What CAMCEVI looks like and contents of the pack CAMCEVI is a prolonged-release suspension for injection. The pre-filled syringe has an off-white to pale yellow viscous and opalescent suspension.

CAMCEVI is available in a pack containing: 1 pre-filled syringe, 1 needle and 1 Point-Lok needle protection device.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona, s/n,
Edifici Est 6 planta,
08039, Barcelona,
Spain

Manufacturer Accord Healthcare Polska Sp. z.o.o. Ul. Lutomierska 95-200, Pabianice Poland

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: