Enanton Depot Dual 3.75 mg powder and solvent for solution for injection, pre-filled syringe, Enanton Depot Dual 11.25 mg powder and liquid for injection, suspension,pre-filled syringe 
Leuprorelin acetate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Enanton Depot Dual is and what it is used for 
2. What you need to know before you use Enanton Depot Dual 
3. How to use Enanton Depot Dual 
4. Possible side effects 
5. How to store Enanton Depot Dual 
6. Contents of the pack and other information 

1. What Enanton Depot Dual is and what it is used for

Enanton Depot Dual is a medicine that is given as an injection under the skin. The drug contains leuprorelin acetate, which is a synthetic hormone that reduces testosterone and estrogen levels in the body.

It is used to treat prostate cancer and endometriosis. In children (girls under 9 years of age and boys under 10 years of age) the drug is used to treat premature puberty (central pubertas praecox ).

2. What you need to know before using Enanton Depot Dual

Do not use Enanton Depot Dual

At the beginning of treatment for prostate cancer or endometriosis, the symptoms of the disease may temporarily worsen.

Do not use Enanton Depot Dual

– if you are allergic to leuprorelin acetate or any of the other ingredients of this medicine (listed in section 6).

– if you have abnormal genital bleeding that has not been examined by a doctor

– if you are pregnant or think you may be pregnant, or if you are breast-feeding

Warnings and cautions

Tell your doctor if you have any of the following:

  • Cardiovascular disease including cardiac arrhythmias ( arrhythmia ), or if you are taking medication for this. The risk of heart arrhythmias may be increased when using Enanton Depot Dual.
  • If you have epilepsy, other seizures, or have had seizures in the past.
  • Depression, which can be severe, has been reported in patients taking leuprorelin. Tell your doctor if you are taking Enanton Depot Dual and develop a depressed mood.

Prostate cancer:

Talk to your doctor, pharmacist, or nurse before using Enanton Depot Dual:

– if you have impaired kidney function

– if you suffer from narrowing of the urinary tract

– if you suffer from spinal cord compression

– if you have diabetes mellitus

– if you have an increased risk of metabolic diseases or cardiovascular disease

– if you have an increased risk of osteoporosis (osteoporosis).

Endometriosis:

Talk to your doctor, pharmacist, or nurse before using Enanton Depot Dual:

– if you are of childbearing potential. Your doctor will inform you about the type of contraceptive you should use.

– If you have osteoporosis (osteoporosis) or if you have an increased risk of developing this condition.

Children and young people

Should abscesses occur at the injection site, your baby’s hormone levels will be monitored as the uptake of leuprorelin from the injection site may be reduced.

If the child has a brain tumor, your doctor will decide if treatment with Enanton Dual Depot is appropriate.

In girls, bleeding from the abdomen, spotting and discharge may occur after the first injection. This is a sign that the levels of the hormones are falling. Contact your doctor if vaginal bleeding persists after the first/second month of treatment.

The skeleton may be weakened during treatment with Enanton Depot Dual. After the end of treatment, the growth of bones continues and in the late teens, the skeleton does not seem to have been affected by the treatment.

In some cases, displacement of the femoral growth area is seen when the treatment is stopped, this may be due to lower levels of female sex hormones ( estrogen ) during the treatment.

Other medicines and Enanton Depot Dual

Enanton Depot Dual 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, for example. methadone (used for pain and in the treatment of drug addiction), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness).

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

Pregnancy, breastfeeding, and fertility

Do not use Enanton Depot Dual if you are pregnant or think you may be. The fetus may likely be affected. Fertile women should use effective non-hormonal contraception during treatment.

Do not use Enanton Depot Dual if you are breast-feeding. There is no information on whether leuprorelin passes into breast milk.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The preparation can cause fatigue and dizziness and may therefore affect your ability to drive or use tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Enanton Depot Dual contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is almost sodium-free.

3. How to use Enanton Depot Dual

Dosage

Dose one and the treatment time is determined by your doctor who adapts it for you.

The medicine is given as an injection under the skin to you by healthcare professionals. The injection site should be varied from time to time. The skin around the injection site must not be massaged.

Prostate cancer:

One dose is given once a month (Enanton Depot Dual 3.75 mg) or every three months (Enanton Depot Dual 11.25 mg). Treatment should not be discontinued to improve the disease.

Endometriosis:

One dose is given once a month (Enanton Depot Dual 3.75 mg). Treatment begins between the first and fifth day of menstruation. The treatment time is normally 6 months.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

Use for children and adolescents

Treatment of premature puberty

Treatment of children should be supervised by a pediatric endocrinologist.

Dosage is adjusted individually depending on the symptoms. The treatment is a long-term treatment and the injections should be given at regular intervals once a month or every three months. A shift of the injection day by a few days does not affect the result of the treatment.

Recommended starting dose:

Children weighing 20 kg or more: One dose (1 ml) Enanton Depot Dual 3.75 mg once a month or one dose (1 ml) Enanton Depot Dual 11.25 mg every three months.

Children weighing less than 20 kg: Enanton Depot Dual 3.75 mg and 11.25 mg should not be used as the pre-filled syringe is not suitable for doses less than 1 ml.

Depending on the symptoms, the doctor may increase the dose if the child does not respond adequately to the treatment (eg bleeding from the abdomen). During the treatment, the doctor can determine which dose is right with the help of blood tests.

The treatment time is determined by the doctor together with the guardian and, if appropriate, the treated child. The treatment time depends on symptoms at the beginning and during the treatment as well as the development of your child’s skeleton.

In girls, pregnancy should be ruled out before starting treatment. Pregnancy during treatment should be avoided but may occur. In such cases, a doctor should be consulted.

If you use more Enanton Depot Dual then you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. Possible side effects

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

Contact a doctor immediately or go to the nearest hospital if you experience any of the following symptoms – these may be signs of serious side effects and you may need urgent medical attention:

  • swelling of the lips and larynx, difficulty breathing, hives, itching.

This may be a sign of a severe allergic reaction. This has been reported in rare cases in adults (occurs in less than 1 in 1,000 users) and in very rare cases in children (occurs in less than 1 in 10,000 users).

Prostate cancer:

At the beginning of treatment, the symptoms of the disease may temporarily worsen, which may lead to bone pain, symptoms of the urinary tract, weakness in the legs, and ant crawling, in more than 5 out of 100 users. Also, male users may experience changes in their metabolism (eg increased blood sugar levels or worsening diabetes ) or an increased risk of cardiovascular disease.

Common (affects more than 1 user in 100):

Mood swings, depression. Hemorrhoids. Feeling of warmth. Sweating. Decreased sex drive, impotence, reduced testicle size. The reaction at the injection site. Elevated levels of the liver enzyme lactate dehydrogenase in the blood.

Uncommon (affects less than 1 user in 100):

Anemia decreased platelet count. Weight changes, decreased appetite, elevated blood levels of total cholesterol and triglycerides, sugar, potassium, and uric acid. Headache, dizziness, and crawling. Deafness, tinnitus. ECG changes, enlarged heart. Swelling of the face. Nausea, vomiting. Elevated liver values, jaundice. Skin inflammation, increased hair growth on the head, rash, itching. Joint pain, leg pain, pain in the shoulders, lower back, arms, or legs. Need to urinate frequently, blood in the urine elevated amounts of urea in the blood. Breast augmentation, pelvic floor discomfort. Difficulty walking, swelling due to fluid retention ( edema ), feeling of pressure over the chest, stiffness, feeling sick, tiredness, fever. Pain, hardening, or redness at the injection site.

Rare (affects less than 1 user in 1,000):

Blood clot. Blood clots in the lungs. Diarrhea. Muscle pain decreased bone mass. Boil at the injection site.

Very rare (affects less than 1 user in 10,000): 

Bleeding and tissue death in the pituitary gland.

Has been reported (occurs in an unknown number of users):

Cramps. Changes ( QT prolongation) in ECG ( electrocardiogram ). Inflammation of the lungs, lung disease.

Endometriosis:

Common (affects more than 1 user in 100):

Inflammation of the uterus. Weight changes. Mood swings. Headache, sleep problems, dizziness, and crawling, sweating. Hemorrhoids, feeling of heat. Joint pain, leg pain, stiffness in the shoulders. Feeling of dryness in the abdomen.

Uncommon (affects less than 1 user in 100):

Changes in the blood picture (increased number of red blood cells, decreased number of white blood cells and platelets, prolonged coagulation time). Elevated levels of phosphorus, urea, calcium, potassium, liver enzyme, cholesterol, and triglycerides in the blood. Reduced appetite. Irritation, depression, mood swings, depression. Numbness in arms and legs, carpal tunnel syndrome, decreased sex drive. Visual disturbances. Tinnitus. Palpitation. Increased blood pressure. Nausea, vomiting, abdominal pain, feeling of the enlarged abdomen, diarrhea, constipation, inflammation of the oral mucosa, numbness in the lips. Acne, dry skin, hair loss, increased hair, nail changes, rashes, itching. stiffness in the joints, low back pain, decreased bone mass, muscle aches, leg pain. More frequent need to urinate, discomfort when urinating. Elevated levels of urea in the blood. Irregular bleeding, pain during intercourse, increased discharge, ovarian overstimulation, swelling, or decreased breast tissue. Pain, hardening, and redness at the injection site. Fatigue, malaise, chest discomfort, fluid retention, thirst.

Rare (affects less than 1 user in 1,000):

Blood clot. Blood clots in the lungs. Jaundice. Boil at the injection site.

Very rare (affects less than 1 user in 10,000): 

Bleeding and tissue death in the pituitary gland.

Has been reported (occurs in an unknown number of users):

Cramps. Inflammation of the lungs, lung disease.

Side effects are in children

At the start of treatment, there may be a short-term increase in the levels of sex hormones, followed by a decrease to levels that can be seen before puberty. Due to this, side effects can occur especially at the beginning of treatment.

In girls with premature puberty, bleeding from the abdomen, spotting and discharge may occur after the first injection. Bleeding from the abdomen that occurs after the first month of treatment should be examined by a doctor.

Common side effects (affects more than 1 user in 100):

  • Mood swings
  • Headache
  • Abdominal pain, abdominal cramps
  • Nausea, vomiting
  • Finns ( acne )
  • Bleeding from the genitals
  • Splashes
  • Relocations
  • Injection site reactions

Very rare side effects (affects less than 1 user in 10,000):

  • Bleeding and tissue death in the pituitary gland.

Has been reported (occurs in an unknown number of users):

  • Cramps
  • Inflammation of the lungs, lung disease.

5. How to store Enanton Depot Dual

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Store in a cold place. Do not freeze.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. dat. The expiration date is the last day of the specified month.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is leuprorelin acetate 3.75 mg and 11.25 mg respectively.

Other ingredients are:

Powder (3.75 mg): gelatin, DL-lactide-glycolide copolymer 75:25 mol% and mannitol.

Powder (11.25 mg): poly (DL-lactide) and mannitol.

Liquid: mannitol, carmellose sodium, polysorbate 80, concentrated acetic acid (for adjustment), water for injections.

What the medicine looks like and the contents of the pack

The pre-filled syringe is a two-chamber syringe with white powder in the anterior chamber and clear colorless liquid in the posterior chamber.

The medicine is delivered in packs of cardboard containing:

Enanton Depot Dual 3.75 mg

1 pre-filled syringe with an associated injection needle (23 G) and safety guard.

3 pre-filled syringes with an associated injection needle (23 G) and safety guard.

Enanton Depot Dual 11.25 mg

1 pre-filled syringe with an associated injection needle (23 G) and safety guard.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Orion Corporation

Orionvägen 1

FI-02200 Espoo

Finland

Manufacturer:

Orion Corporation, Orion Pharma

Orionvägen1

FI-02200 Espoo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Orion Pharma AB

medinfo@orionpharma.com

Muhammad Nadeem

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