Lucrin Depot 3,75 mg

LUCRIN DEPOT 3,75 mg PDS is a GnRH agonist, which inhibits gonadotropin (a hormone) secretion. LUCRIN DEPOT 3,75 mg PDS is used in men to treat prostate cancer, in women for the treatment of endometriosis and breast cancer, and in children to treat central precocious puberty.

LUCRIN DEPOT 3,75 mg PDS should not be administered to you:

• If you are hypersensitive (allergic) to GnRH, GnRH agonist analogues or any of the other ingredients (see section 6).
• If you have undiagnosed, abnormal vaginal bleeding.
• If you are or may become pregnant while receiving LUCRIN DEPOT 3,75 mg PDS.
• If you are breastfeeding (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you engage in sexual intercourse: Although LUCRIN DEPOT 3,75 mg PDS causes periods to stop, it is not a contraceptive. You should use non-hormonal contraceptives (i.e. barrier methods), while you are taking LUCRIN DEPOT 3,75 mg PDS.
• During the first weeks of treatment: You may experience an increase in clinical signs and symptoms during the first few days of therapy. These can be treated by your doctor and may get less with continued therapy.
• If you have a history of or risk factors for QT prolongation or are receiving any medicine that might prolong the QT interval: Please consult your doctor.

In men:

• If you have a history of high blood sugar, diabetes, and/or high cholesterol, your doctor should monitor you closely for metabolic syndrome/changes.

In children:

• Bone loss (decreased bone mineral density) may occur during the treatment of early onset of puberty (central precocious puberty) with LUCRIN DEPOT 3,75 mg PDS. However, after the treatment is stopped, bone loss is reversed and may come back to normal levels in late adolescence.
• Pseudotumor cerebri (PTC)/idiopathic intracranial hypertension (a condition characterized by increased blood pressure in your head/brain) has been reported in kids receiving this medicine (LUCRIN DEPOT 3,75 mg PDS), but it cannot be ruled out that it may also occur in adults. Monitor/watch your child for signs and symptoms of PTC, including headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea. Contact your doctor immediately and take your child to an ophthalmologist (an eye specialist) to find out if there is papilledema (pressure in or around the brain which causes the part of the optic nerve inside the eye to swell). If papilledema is present, this means your child has PTC and immediate treatment is necessary.

Other medicines and LUCRIN DEPOT 3,75 mg PDS:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Interactions with other medicines are not expected to occur.

The recommended dose is 3,75 mg given monthly as an intramuscular or subcutaneous injection. You should periodically change the site where you are given your injection. Do not share medicines prescribed for you with any other person.

If you are administered more LUCRIN DEPOT 3,75 mg PDS than you should receive Since a healthcare professional will administer this medicine, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you stop using LUCRIN DEPOT 3,75 mg PDS If you stop your therapy and after LUCRIN DEPOT 3,75 mg PDS has cleared your system, you should notice full reversibility of hormone suppression.

LUCRIN DEPOT 3,75 mg PDS can have side effects. Not all side effects reported for LUCRIN DEPOT 3,75 mg PDS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LUCRIN DEPOT 3,75 mg PDS, please consult your health care professional for advice. Most side effects are mild to moderate however, some may be serious and require treatment. If you notice any of the following after taking LUCRIN DEPOT 3,75 mg PDS, stop taking LUCRIN DEPOT 3,75 mg PDS and tell your doctor immediately or go to the nearest hospital:

• Swelling of hands, feet, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing;
• Rash or itching;
• Changes in the way your heart beats;
• Chest pain;
• Shortness of breath;
• Numbness in arms and legs;
• Unexpected or unusual heavy bleeding;
• Extreme weakness;
• Fainting;
• Yellowing of the skin and eyes.

These are all serious side effects. You may need immediate medical attention. Tell your doctor as soon as possible if you notice any of the following after taking LUCRIN DEPOT 3,75 mg PDS:

• Mental impairment including thoughts of suicide or depression;
• Nausea;
• Headaches;
• Dizziness;
• Tiredness;
• Light-headedness;
• Loose stools;
• Loss of appetite;
• Abnormal vaginal odour;
• Body aches and pain;
• Fever;
• Dry mouth with thirst.

The symptoms described above can be signs of some of the serious side effects, which have been observed after using LUCRIN DEPOT 3,75 mg PDS. Additional side effects are listed below. The frequently observed side effects reported in breast cancer patients:

• Frequent: headache; dizziness; nausea; swelling, redness and pain of the skin; increased sweating; injection site induration; injection site pain and feeling hot; increased appetite; abnormal weight gain; abnormal loss of weight; mood swings; nervousness; difficulty in sleeping; feelings of hopelessness and sadness; hot flushes; joint pain; back pain, general physical health deterioration; fever; common cold; urinary tract infection; iron deficiency anaemia; decreased appetite; sleep disorder; anxiety; vision blurred; cough; trouble having a bowel movement; vomiting; diarrhoea; abdominal pain; bone pain; neck pain; muscular weakness; chest pain; swelling; swelling of legs, feet and arms; feeling tired; injection site reaction
• Less frequent: upper respiratory tract infection, loss of appetite

The frequently observed side effects reported in patients with endometriosis:

• Frequent: feelings of hopelessness and sadness; lack of interest in sex; headaches; dizziness; nausea; acne; skin reactions; nervousness; difficulty in sleeping; abnormal weight; widening of blood vessels; vaginal infection; anxiety; abnormal loss of weight; tingling or numbness in hands or feet; gastrointestinal disorder; excess, unwanted hair growth; oily skin appearance; joint disorders; breast disorder; swelling; swelling of legs, feet and arms; lack of strength and energy; trouble having a bowel movement; nausea and vomiting; diarrhoea; dry mouth; abdominal pain; neck pain; joint pain; back pain; pain; chest pain; injection site pain; chills; thirst
• Less frequent: infection; loss of appetite; increased appetite; personality disorder; delusion; thinking abnormal; eye disorder; eye pain; the area around the stomach is larger than normal; urinary incontinence; breast enlargement; overly full or swollen breast; face swelling; generalised swelling; injection site reaction

The frequently observed side effects reported in patients with prostate cancer:

• Frequent: widening of blood vessels; increased sweating; swelling of legs, feet and arms; problems breathing; nausea; vomiting; impotence; testicular disorder; pain; loss of appetite, lack of interest in sex; diarrhoea; joint pain; injection site pain
• Less frequent: lack of strength and energy; a runny, stuffy nose; abnormal weight gain; difficulty in sleeping; feelings of hopelessness and sadness; ear pain; bone pain; pain in the muscles; chest pain; chills

The frequently observed side effects reported in patients with central precocious puberty:

• Frequent: rash; acne; injection site reaction with abscess; pain; growth retardation; abnormal weight gain; headache; widening of blood vessels
• Less frequent: infection; a runny, stuffy nose; influenza; inflammation of the throat; sinusitis; hypersensitivity; precocious puberty; swelling in the thyroid gland; increased appetite; nervousness; feelings of hopelessness and sadness; trouble having a bowel movement; nausea and vomiting; unable to control bladder/urine

Some people taking gonadotropin releasing hormone (GnRH) agonists like LUCRIN DEPOT 3,75 mg PDS have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:

• crying
• irritability
• restlessness (impatience)
• anger

A condition characterized by increased blood pressure in your head/brain

Other side effects have been observed after taking LUCRIN DEPOT 3,75 mg PDS. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of LUCRIN DEPOT 3,75 mg PDS. You can also report side effects to AbbVie (Pty) Ltd via this e-mail address: [email protected]

Keep medicine out of the reach and sight of children. Store at or below 25 ºC (room temperature). Do not refrigerate or freeze. Store in the original container in order to protect from light. The suspension should be discarded if not used immediately after reconstitution. Extra diluent is provided. Any unused diluent remaining should be discarded.