11.25 mg powder and solvent for solution for injection, depot
suspension triptorelin
What Moapar is and what it is used for
Mopar contains triptorelin, which is similar to a hormone called gonadotropin-releasing hormone ( GnRH analog). It is a long-acting dosage form that slowly releases 11.25 mg of triptorelin over twelve weeks. The drug works by lowering the levels of the male hormone et testosterone in the body.
Moapar is used to reduce the sexual drive of adult men who have severe sexual disorders.
Treatment with Moapar should be started and checked by a psychiatrist. The treatment should be given in combination with psychotherapy to reduce deviant sexual behavior.
What you need to know before using Moapar
Do not use Moapar
– if you suffer from severe osteoporosis (a disease that weakens the skeleton)
– if you are allergic to triptorelin, other medicines that regulate the production and release of sex hormones, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
At the beginning of the treatment, the testosterone level in your body increases. This could lead to an increase in sexual drive. Your doctor may prescribe you a medicine (an anti-androgen ) to counteract this effect.
Talk to your doctor:
- if you become depressed while taking Moapar. Depression, which can be severe, has been reported in patients using Moapar.
- if you are taking anticoagulants (medicines that inhibit the ability of the blood to clot) as you may get bruises at the injection site.
- if you drink a lot of alcohol, smoke, have osteoporosis (a condition that weakens the bones), or have osteoporosis in the family, eat a poor diet or take anticonvulsant drugs (medicines for epilepsy or seizures) or cortisone ( corticosteroids ). Prolonged use of Moapar increases the risk of developing osteoporosis, especially if some of the above factors are present. To prevent osteoporosis, a healthy lifestyle such as not smoking, reduced alcohol consumption and regular exercise that strains and strengthens the skeleton (eg walking, running or other sports that put a strain on the skeleton) are recommended. Adequate intake of calcium and vitamin D should also be ensured.
- if you are to undergo a diagnostic test of the gonadal function of the pituitary gland. The result can be misleading during treatment and after treatment with Moapar.
- if you experience sudden headaches, vomiting, vision problems and paralysis of the eye muscles. This may be a sign of a benign pituitary tumor that may become apparent during treatment with Moapar.
- if you have diabetes or problems with your heart or blood vessels.
- if you have cardiovascular disease including arrhythmias , or if you are taking medication for it. The risk of suffering from heart rhythm disorders may be increased when using Moapar.
When the treatment is stopped, the testosterone will return to normal levels and your sexual drive may increase again. Therefore, your doctor may give you another medicine to control this effect.
Children and young people
Moapar is not indicated for use in newborns, infants, children, and adolescents.
Other drugs and Moapar
If Moapar is taken with medicines that affect the release of hormones from the pituitary gland, your doctor may need to perform additional checks.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Moapar may affect certain other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm disorders when used with other medicines (eg methadone (used for pain and in case of treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).
Pregnancy, breastfeeding and fertility
Moapar should not be used by women.
Driving and using machines
You may feel dizzy, tired, or have vision problems such as blurred vision. There may be side effects of the treatment. If you get any of these side effects, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Moapar contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per vial. The drug is almost “sodium-free”, and can be taken by patients on a low-sodium diet.
How to use Moapar
Moapar is made in order and is always given to you by a doctor or nurse.
The usual dose is 11.25 mg Moapar (in a vial ), which is given as a single injection into a muscle every twelve weeks.
If you have the impression that the effect of Moapar is too strong or too weak, talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Many of these side effects are expected when the testosterone level in your body changes. These effects include hot flashes and impotence.
In rare cases (may affect up to 1 in 1,000 people) you may have a severe allergic reaction and it is common (may affect up to 1 in 10 people) to experience allergic reactions. Stop using Moapar and contact a doctor immediately or see the nearest emergency department if you experience any of the following symptoms: difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, or skin rash.
Other side effects that may occur:
Very common, may affect more than 1 user in 10:
- Hot flashes
- Impotence
- Excessive sweating
- Back pain
- Tingling and crawling in the legs
- Decreased sexual desire
- Impotence
Common, may affect 1 in 10 users:
- Nausea, dry mouth
- Pain, bruising, redness and swelling at the injection site, musculoskeletal pain, pain in arms and legs, fluid accumulation in the body ( edema ), pain in the lower abdomen
- Allergic reaction
- High blood pressure
- Weight gain
- Dizziness, headache
- Decreased sexual desire, depression, mood swings
Uncommon, may affect 1 in 100 people:
- Increased platelet count
- Palpitation
- Earring ( tinnitus ), feeling that the surroundings are moving
- Dimsyn
- Stomach pain, constipation, diarrhea, vomiting
- Drowsiness, chills associated with sweating and fever, drowsiness, pain
- Effects on certain blood tests (including elevated liver function tests)
- High blood pressure
- Weight loss
- Loss of appetite, increased appetite, gout (severe pain and swelling of the joints usually in the big toe), diabetes , high blood fats
- Joint pain, muscle cramps, muscle weakness, muscle pain, swelling and tenderness, skeletal pain
- Tingling and numbness
- Difficulty sleeping, irritation
- Breast augmentation in men, chest pain, reduced testicles, testicular pain
- Breathing difficulties
- Acne , hair loss, itching , rash, redness, hives
- Waking up at night to empty the bladder, difficulty emptying the bladder
- Nasal blood
Rare may affect up to 1 in 1,000 people:
- Discolored skin (red or purple)
- Abnormal sensation in the eyes, blurred vision or changes in vision
- Stretched abdomen, gas formation, altered sense of taste
- Chest pain
- Difficulty standing up
- Flu-like symptoms , fever
- Inflammation of the nose / throat
- Increase in an enzyme found in e.g. bones and liver
- Elevated body temperature
- Stiff joints, joint swelling, stiffness in muscles and bones, bone and joint inflammation
- Impaired memory
- Confusion, decreased activity, feeling of elation
- Shortness of breath when lying down
- Blisters
- Low blood pressure
Has been reported, occurs in an unknown number of users:
- Changes ( QT prolongation) in ECG ( electrocardiogram )
- General malaise
- Concern
- Urine leakage
- An increased risk of bleeding in the area, if an existing pituitary tumor
As with other GnRH analogs, an increase in the number of folded blood cells can be seen in patients treated with Moapar 11.25 mg.
How to store Moapar
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 carton, vial, and ampoule after “EXP.”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before administration is the responsibility of the user and would normally not be longer than 24 hours at 2 ° C to 8 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is triptorelin.
One vial of powder contains 11.25 mg triptorelin as triptorelin embonate.
The completed suspension (2 ml) contains 11.25 mg of triptorelin as triptorelin embonate.
Other ingredients are:
Powder: poly- (d, l-lactide coglycolide), mannitol, carmellose sodium, and polysorbate 80.
Diluent: Water for injections.
What the medicine looks like and contents of the pack
Moapar is a white to yellowish powder.
The diluent is a clear solution.
The package contains:
1 vial of powder
1 ampoule with 2 ml of diluent
1 disposable syringe
2 needles
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Media Health
Les Fjords – Immeuble Oslo
19 avenue de Norvège
91953 Courtaboeuf Cedex
France
Local representative
Institut Synthesis Institute (IPSEN) AB
164 51 Kista
Manufacturer
Ipsen Pharma Biotech
Signs Plateau Activity Park
Departmental Road No. 402
83870 Signe
France
Belgium, Germany, Denmark, Finland, the Netherlands, the United Kingdom, Austria, Ireland, Poland,
France: Salvacyl LP
Norway, Greece: Salva