Prinolid 3,75 mg Injection

PRINOLID 3,75 is a synthetic hormone which can be used to reduce the levels of testosterone and estrogen circulating in the body. PRINOLID 3,75 is used to treat prostate cancer in men and to treat breast cancer in women.

PRINOLID 3,75 can also be used in women to manage endometriosis (often a painful disorder in which tissue similar to the tissue that normally lines the inside of your uterus grows outside your uterus), including pain relief, for up to six months.

Use in children: PRINOLID 3,75 is a synthetic hormone which can be used to reduce the levels of testosterone and estrogen circulating in the body. PRINOLID 3,75 is used to treat premature puberty caused by a release of certain hormones from the pituitary gland, namely central precocious puberty.

PRINOLID 3,75 should not be administered to you:

• If you or your child is hypersensitive (allergic) to leuprolide acetate, a similar medicine, the other ingredients of PRINOLID 3,75 (listed in section 6), or to synthetic gonadotropin releasing hormones or derivates.
• If you are pregnant, planning to become pregnant or are breastfeeding.
• If you have abnormal vaginal bleeding which you have not discussed with your doctor.
• If you are a pre- or perimenopausal women, for the treatment of breast cancer:
  • your estrogen levels must have been adequately suppressed with PRINOLID 3,75 before you start treatment with an aromatase inhibitors such as exemestane and should be checked every three months during combination treatment with PRINOLID 3,75 and an aromatase inhibitor (see ‘Warnings and precautions’ in the section below for more information).
• In girls with central precocious puberty who are pregnant or breastfeeding, or has undiagnosed vaginal bleeding.

Do not share medicines prescribed for you with any other person.

Route of administration: subcutaneous or intramuscular injection.

You will not be expected to give yourself PRINOLID 3,75. It will be given to you by a person who is qualified to do so. The injection will normally be given in your arm, thigh or abdomen. The injection site should be varied at regular intervals.

You will normally be given an injection once a month.

Prostate cancer: If you have prostate cancer, you will be given PRINOLID 3,75 once a month.

Endometriosis: If you have endometriosis, you will be given PRINOLID 3,75 for a period of six months only.

Breast cancer: If you have breast cancer, you will be given PRINOLID 3,75 once a month. PRINOLID 3,75 can be given in combination with tamoxifen or an aromatase inhibitor. A minimum of one injection of PRINOLID 3,75 should be given before you start treatment with an aromatase inhibitor or tamoxifen.

Use in children: Your child’s doctor will determine the starting dose based on your child’s weight. Depending on the central precocious puberty activity, your doctor may increase the dosage in the presence of inadequate suppression (e.g. vaginal bleeding). Your doctor will determine the minimal effective dose with the help of a blood test.

The duration of treatment depends on the clinical signs at the start of treatment or during the course of treatment and is decided by your doctor together with the legal guardian and, if appropriate, the treated child.

Your doctor will determine the bone age of the child in regular intervals.

In girls with bone maturation of older than 12 years and boys with bone maturation of older than 13 years your doctor will consider discontinuing the treatment, depending on the clinical effects in your child.

PRINOLID 3,75 can have side effects. Not all side effects reported for PRINOLID 3,75 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRINOLID 3,75, please consult your health care provider for advice.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• sever rash,
• itching,
• shortness of breath or difficulty in breathing.

These are all very serious side effects. If you have them, you may have had a serious reaction to PRINOLID 3,75. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• If you get a severe headache which does not get better when you take painkillers.
• If you suffer from any unexplained bruising or bleeding or feel generally unwell whilst taking PRINOLID 3,75. These could be symptoms of changes in the number of red or white blood cells.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Men: When men with prostate cancer first start treatment with PRINOLID 3,75, levels of testosterone can increase and in some people this may cause a temporary increase in local pain. In some cases, to prevent this from happening, your doctor may give you another type of medicine (anti-androgen medicine) before and just after your first PRINOLID 3,75 injection. If you do get worsening pain, weakness or loss of feeling in your legs or difficulty passing urine, contact your doctor immediately.

There may be an increased risk of loss of blood to the pituitary area (if you have an existing pituitary lesion), which may cause permanent damage. This occurs rarely.

Blood sugar levels may be altered during treatment with PRINOLID 3,75, which may affect control in diabetic patients and require more frequent monitoring.

If you have a blood test your doctor may notice a change in blood lipid (cholesterol) levels or in values for tests on how the liver is working. These changes do not usually cause any symptoms.

Frequent side effects:

• weight changes,
• hot flushes, hypotension and postural hypotension,
• sweating,
• muscle weakness,
• bone pain,
• loss of interest in sexual intercourse,
• inability to have an erection,
• a reduction in size and function of the testes,
• swelling of the penis, pain of the tested and prostate,
• pain, tiredness,
• skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers, skin damage),
• loss of appetite,
• difficulty sleeping,
• depression and headache,
• mood changes (with long-term use),
• nausea (feeling sick), vomiting, diarrhoea,
• abnormalities in blood tests, liver function or liver blood tests,
• skin rash, dry skin, itchy skin, hives, skin pigmentation, abnormal hair growth and excessive body hair,
• joint pain,
• swelling, tenderness, pain and enlargement of the breast tissue,
• swelling in your ankles.

Less frequent side effects:

• mood changes (with short-term use) and sleep disorders,
• dizziness,
• sleepiness and weakness,
• tingling in the hands or feet,
• muscle ache,
• weakness and pain in the legs,
• amblyopia (also called lazy eye), ear pain, tinnitus, and rhinitis,
• skin infection, hair loss, red bumpy rash,
• abnormal heart rhythm or beats, angina, hypertension, circulatory problems or diseases of the blood vessels, chest pain,
• nose bleeds, coughing up blood,
• painful or discomfort during urination, blood in urine, frequent urination, passing large volume of urine and urine retention.

Side effects with an unknown frequency:

• blood tests may show anaemia (low red cell counts), low counts in white cells or platelets,
• allergic reactions (may include symptoms of rash, itching, wheals or a serious allergic reaction which causes difficulty breathing or dizziness),
• changes in blood lipids (cholesterol) or blood sugar,
• paralysis,
• seizure,
• altered vision,
• heart failure, heart attack, pounding heartbeats,
• changes in ECG (QT prolongation),
• blood clots in lungs,
• high or low blood pressure,
• jaundice, abnormal liver function or liver injury,
• fracture of the spine,
• thinning of bone,
• difficulty passing urine,
• fever,
• inflammation of lungs or lung disease.

Women: Many of the side effects of PRINOLID 3,75 are related to the decrease in estrogen level. Estrogen level returns to normal after treatment is stopped. Common side effects include hot flushes, mood swings, depression and vaginal dryness.

As can happen naturally when women reach the menopause, PRINOLID 3,75 can cause a small amount of bone thinning.

Vaginal bleeding may occur during treatment.

If you have an existing pituitary lesion, there may be an increased risk of loss of blood to the area, which may cause permanent damage. This occurs rarely.

Blood sugar levels may be altered during treatment with PRINOLID 3,75, which may affect control in diabetic patients and require more frequent monitoring.

If you have a blood test your doctor may notice a change in blood lipid (cholesterol) levels or in values for tests on how the liver is working. These changes do not usually cause any symptoms.

Frequent side effects:

• difficulty sleeping, nervousness, anxiety,
• headaches,
• hot flushes and low blood pressure,
• weight changes,
• mood changes and changes in libido (sex drive),
• depression,
• tingling in hands or feet,
• dizziness,
• joint pain,
• muscle weakness,
• breast tenderness,
• changes in breast size,
• vaginal dryness or discharge, vaginal bleeding,
• menopausal symptoms, painful sexual intercourse,
• acne, eczema, hair growth or loss, excessive sweating, dry skin, and hives,
• altered or blurred vision,
• nausea, vomiting, diarrhoea, abdominal pain, constipation,
• swelling in ankles or skin reactions at the injection site (these include skin hardening, redness, pain, abscesses, swelling, nodules, ulcers and skin damage),
• changes in blood lipids (cholesterol).

Less frequent side effects:

• loss of appetite,
• pounding heartbeats,
• abnormalities in liver blood tests,
• muscle aches,
• fever,
• tiredness.

Side effects with an unknown frequency:

• blood tests may show anaemia (low red cell counts), low counts in white cells or platelets,
• allergic reactions (may include symptoms of rash, itching, wheals or a serious allergic reaction which causes difficulty breathing or dizziness),
• changes in blood sugar,
• paralysis,
• seizure,
• heart failure, heart attack, abnormal heart rhythm,
• blood clots in lungs,
• high or low blood pressure,
• jaundice, abnormal liver function or liver injury,
• fracture of the spine,
• thinning of bone,
• difficulty passing urine,
• inflammation of lungs or lung disease.

Store all medicines out of reach of children.

• Store at or below 30 °C.
• Protect from light.

Reconstituted suspension: Since PRINOLID 3,75 microspheres and its solvent contains no preservative, the reconstituted suspension should be used immediately after preparation and any unused portion should be discarded. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Discard the needle in an appropriate manner (i.e. medical sharps waste bin).