testosterone<\/a> levels. Tell your doctor if you feel that Eligard is not having enough effect.<\/p>\n\n\n\nOther drugs and Eligard<\/h2>\n\n\n\n
Eligard may affect some other medicines used to treat heart rhythm disorders (eg quinidine, procainamide, amiodarone,e, 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 dependence), moxifloxacin (an antibiotic ), antipsychotics (used for severe mental illness)).
<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Eligard is not for women.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Fatigue, dizziness, and visual disturbances are possible side effects of treatment with Eligard or may be a consequence of the disease. If you are bothered by these side effects, be careful when driving or using machines.
<\/p>\n\n\n\n
3. How to use Eligard<\/h2>\n\n\n\n
Dosage<\/strong><\/p>\n\n\n\nAlways use Eligard exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\n
Unless your doctor prescribes otherwise, Eligard 7.5 mg is given once a month<\/strong>.
<\/p>\n\n\n\nThe injected solution forms a depot with an active substance under the skin from which a continuous release of the active substance leuprorelin acetate takes place for one month.
<\/p>\n\n\n\n
Additional tests<\/strong><\/p>\n\n\n\nEligard treatment should be monitored by your doctor by measuring specific clinical values \u200b\u200band by measuring the levels in the blood of so-called prostate-specific antigen(PSA).
<\/p>\n\n\n\n
Method of administration<\/strong><\/p>\n\n\n\nEligard should only be given by your doctor<\/strong> or nurse<\/strong> who is also prescribing the medicine.
<\/p>\n\n\n\nAfter preparation should ELIGARD is administered as a subcutaneous injection ( injection just under the skin). Intraarterial- (in an artery ) or intravenous (into a vein) injection should be carefully avoided. As with other subcutaneous injections, the injection site should be varied over time.<\/p>\n\n\n\n
If you use more Eligard than you should<\/h2>\n\n\n\n
As the injection is usually administered by your doctor or appropriately trained healthcare professional, no overdose is expected.
<\/p>\n\n\n\n
If a larger amount than intended is still administered, your doctor will monitor you specifically and give you additional treatment as needed.<\/p>\n\n\n\n
If you forget to use Eligard<\/h2>\n\n\n\n
Ask your doctor if you think your injection has been forgotten.<\/p>\n\n\n\n
If you stop using Eligard<\/h2>\n\n\n\n
As a rule, long-term treatment with Eligard is required for prostate cancer. Therefore, treatment should not be stopped even if the symptoms improve or disappear completely.
<\/p>\n\n\n\n
If treatment with Eligard is stopped prematurely, a worsening of disease-related symptoms may occur.
<\/p>\n\n\n\n
You should not stop treatment too early without first consulting your doctor.<\/strong>
<\/p>\n\n\n\nIf you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, Eligard can cause side effects, although not everybody gets them.
<\/p>\n\n\n\n
Side effects that have been experienced during treatment with Eligard are mainly caused by the specific effects of the active substance leuprorelin acetate, such as raising and lowering certain hormones. The most commonly described side effects are hot flashes (approximately 58% of patients), nausea, malaise, and fatigue as well as transient local irritation at the injection site.
<\/p>\n\n\n\n
A side effect when depositing<\/strong><\/p>\n\n\n\nDuring the first few weeks of treatment with Eligard, disease-related symptoms may increase, as there is usually a transient increase in testosterone levels in the blood at the beginning of treatment. Your doctor may therefore want to give you a suitable anti-androgen (a substance that inhibits the effect of testosterone) at the beginning of treatment to reduce any side effects (see also section 2. What you need to know before using Eligard, Complications when starting treatment<\/em> ).
<\/p>\n\n\n\nLocal side effect ar<\/strong><\/p>\n\n\n\nThe local side effects described after injection with Eligard are typically those commonly seen with similar subcutaneously injected medicines (medicines injected just under the skin). A slight burning sensation shortly after injection is very common. Tingling and pain at the injection site after injection are common, as are bruising and redness of the skin. Hardening of tissues and wounds is uncommon.
<\/p>\n\n\n\n
The local side effects after a subcutaneous injection are mild and are described as transient. The side effects do not occur between injections.
<\/p>\n\n\n\n
Very common side effects (may affect more than 1 user in 10)<\/em><\/p>\n\n\n\n- Hot flashes<\/li>
- Spontaneous bleeding in the skin and mucous membranes, redness<\/li>
- Fatigue, injection site reactions (see also Local side effects above)<\/em><\/li><\/ul>\n\n\n\n
Common side effects (may affect up to 1 in 10 people )<\/strong><\/em><\/p>\n\n\n\n- Inflammation of the nose and throat (cold symptoms)<\/li>
- Nausea, malaise, diarrhea, gastrointestinal inflammation (gastroenteritis\/colitis)<\/li>
- Itching, night sweats<\/li>
- Joint pain<\/li>
- Irregular urination (even at night), difficulty urinating, pain when urinating, decreased urine output<\/li>
- Sore breasts, swollen breasts, reduced testicles (loss), testicular pain, infertility, erection problems, decreased penis size<\/li>
- Stiffness (periods of excessive shaking and high fever), weakness<\/li>
- Prolonged bleeding time, altered blood values, low number of red blood cells<\/li><\/ul>\n\n\n\n
Uncommon side effects (may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n- Urinary tract infections, local skin infections<\/li>
- Exacerbation of diabetes<\/li>
- Abnormal dreams, depression, decreased sex drive<\/li>
- Dizziness, headache, altered sensitivity to touch, insomnia, effects on the sense of taste and smell<\/li>
- High blood pressure, low blood pressure<\/li>
- Respiratory distress<\/li>
- Constipation, dry mouth, indigestion, vomiting<\/li>
- Stickiness, increased sweating<\/li>
- Back pain, muscle cramps<\/li>
- Blood in the urine<\/li>
- Bladder cramps may go to the toilet more often than usual, inability to urinate<\/li>
- Enlargement of male breast tissue, impotence<\/li>
- Drowsiness, pain, fever<\/li>
- Weight gain<\/li>
- Balance disturbance, fraud<\/li>
- Muscle loss\/loss of muscle tissue after prolonged use<\/li><\/ul>\n\n\n\n
Rare side effects (may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\n- Abnormal involuntary movements<\/li>
- Sudden loss of consciousness, fainting<\/li>
- Gases in the stomach, belching<\/li>
- Hair loss, skin rash<\/li>
- Chest pain<\/li>
- Sores at the injection site<\/li><\/ul>\n\n\n\n
Very rare side effects (may affect up to 1 in 10,000 people)<\/em><\/p>\n\n\n\n- Tissue death at the injection site<\/li><\/ul>\n\n\n\n
Has been reported (occurs in an unknown number of users)<\/em><\/p>\n\n\n\n- Changes ( QT prolongation) in ECG ( electrocardiogram )<\/li>
- Inflammation of the lungs, lung disease<\/li><\/ul>\n\n\n\n
Other side effects ar<\/strong><\/p>\n\n\n\nOther side effects that have been described in the literature in connection with leuprorelin, the active substance in Eligard, are edema (accumulation of fluid, which leads to swollen hands and feet), pulmonary embolism (causes symptoms such as shortness of breath, difficulty breathing, and chest pain), palpitations, muscle weakness, chills, rash, impaired memory, and impaired vision. Increased signs of decreased bone tissue (osteoporosis) can be expected after long-term treatment with Eligard. Due to osteoporosis, the risk of fractures increases.
<\/p>\n\n\n\n
Severe allergic reactions, which cause difficulty breathing or dizziness, have been reported in rare cases after administration with drugs in the same class of drugs as Eligard.
<\/p>\n\n\n\n
Seizures have been reported after the administration of drugs in the same drug class as Eligard.
<\/p>\n\n\n\n
5. How to store Eligard<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.
<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
<\/p>\n\n\n\n
Storage<\/strong><\/p>\n\n\n\nStore in a refrigerator (2 \u00b0 C – 8 \u00b0 C).<\/p>\n\n\n\n
Store in the original package. Moisture sensitive.
<\/p>\n\n\n\n
The product should reach room temperature before injection. Remove from the refrigerator about 30 minutes before use. Once removed from the refrigerator, the product can be stored in its original packaging at room temperature for up to 4 weeks (below 25 \u00b0 C).
<\/p>\n\n\n\n
Once any of the tray packages have been opened, the product must be prepared immediately. After reconstitution, the product should be used immediately. For single use only.
<\/p>\n\n\n\n
Instructions for disposal of unused or expired packaging by Eligard<\/strong><\/p>\n\n\n\nMedicines 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.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n