Diphereline sr 3,75
Poland
Table of Contents
- Package leaflet: Information for the user
- 1. What Diphereline SR 3.75 is and what it is used for
- 2. Important information before using Diphereline SR 3.75
- 3. How to use Diphereline SR 3.75
- 4. Possible adverse reactions
- 5. How to store Diphereline SR 3.75
- 6. Contents of the pack and other information
- Information intended exclusively for medical professionals:
Package leaflet: Information for the user
Diphereline SR 3.75
3.75 mg
powder and solvent for prolonged-release suspension for injection
Triptorelinum
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Diphereline SR 3.75 is and what it is used for
- What you need to know before you use Diphereline SR 3.75
- How to use Diphereline SR 3.75
- Possible side effects
- How to store Diphereline SR 3.75
- Contents of the pack and other information
1. What Diphereline SR 3.75 is and what it is used for
This medicine contains triptorelin. Triptorelin belongs to a group of medicines known as gonadotropin-releasing hormone (GnRH) analogues. One of its actions is to reduce the production of sex hormones in the body.
Prolonged administration of triptorelin, after an initial stimulation, leads to suppression of gonadotropin hormones (FSH and LH) secretion, resulting ultimately in inhibition of testicular and ovarian function.
Another mechanism of action of the drug is also indicated: a direct effect on the testes and ovaries by reducing the sensitivity of their receptors to the hormone stimulating sex hormone release (gonadoliberin).
Diphereline SR 3.75 is indicated for:
- Prostate cancer Treatment of prostate cancer when reduction of testosterone concentration to castration levels (characteristic of absence of gonadal function) is required. The beneficial effect of treatment is more pronounced and frequent if the patient has not previously received any other hormonal treatment.
- Breast cancer in premenopausal and postmenopausal women when hormonal treatment is indicated.
- Central precocious puberty (before the age of 8 in girls and before the age of 10 in boys).
- Endometriosis of genital organs and external endometriosis (stage I to IV). Treatment should not be continued for longer than 6 months (see section 4.8). Initiation of a second treatment cycle with triptorelin or another GnRH analogue is not recommended.
- Uterine fibroids Treatment of uterine fibroids in the context of preoperative preparation or in patients not qualified for surgical intervention.
- Female infertility
Adjunctive treatment in combination with gonadotropins (hMG, FSH, hCG) to induce ovulation, in preparation for in vitro fertilization and embryo transfer into the uterus.
2. Important information before using Diphereline SR 3.75
When not to use Diphereline SR 3.75
- if the patient is allergic to triptorelin, gonadorelin (GnRH), other GnRH analogues, or any of the other ingredients of this medicine (listed in section 6)
- if the patient has had premature gonadotropin-independent puberty
- if the patient is pregnant or breastfeeding
Warnings and precautions
Before starting treatment with Diphereline SR 3.75, discuss this with your doctor or
pharmacist.
In adults, long-term treatment with triptorelin may cause bone weakening (osteoporosis)
associated with an increased risk of bone fractures. Inform your doctor if the patient has any of
the following risk factors, as the doctor may recommend taking bisphosphonates (medicines used
to treat osteoporosis) to manage bone loss.
Risk factors may include:
- presence of osteoporosis in the patient or in the patient’s immediate family;
- alcohol abuse, smoking, malnutrition;
- long-term use of medicines that may cause bone loss, such as antiepileptic drugs or corticosteroids (e.g. hydrocortisone, prednisolone).
There have been reports of depression, including severe depression, in patients
receiving Diphereline SR 3.75. If depressive moods occur during treatment with Diphereline SR 3.75,
inform your doctor.
If seizures occur, inform your doctor immediately. Seizures have been reported in patients
receiving triptorelin or similar medicines. These occurred in patients with or without a prior history
of epilepsy.
During treatment with Diphereline SR 3.75, a pituitary gland enlargement (benign tumour) that
the patient was previously unaware of may become apparent. Symptoms include sudden headache,
vomiting, visual disturbances, and eye muscle paralysis.
Men
In patients receiving anticoagulant medicines, bruising may occur at the injection site.
At the beginning of treatment, increased testosterone levels have been observed. This may
worsen tumour-related symptoms. In such cases, contact your doctor. The doctor may prescribe
an additional medicine (antiandrogen) to prevent worsening of these symptoms.
If the patient develops urinary obstruction or spinal cord compression due to tumour spread, the
doctor will closely monitor the patient during the first few weeks of treatment. If difficulty urinating,
bone pain, weakness in the lower limbs, or tingling sensations occur, contact your doctor immediately for evaluation and appropriate treatment.
Triptorelin does not further reduce testosterone levels in patients who have undergone orchidectomy (removal of the testes).
Diagnostic test results for gonadal function of the pituitary and reproductive organs, performed during or after discontinuation of Diphereline SR 3.75 therapy, may be misleading.
Inform your doctor if the patient has heart or blood vessel diseases, including heart rhythm disorders (arrhythmia), or if the patient is taking medicines used to treat heart rhythm disorders. The risk of heart rhythm disorders may increase during treatment with Diphereline SR 3.75.
Medicines that lower testosterone levels may cause ECG changes related to heart rhythm disorders (prolongation of the QT interval).
Inform your doctor if the patient has diabetes and/or heart disease.
Treatment with GnRH analogues, including Diphereline 3.75 mg, may increase the risk of anaemia (defined as a decrease in red blood cell count).
Women
Uterine fibroids and endometriosis
Vaginal bleeding may occur during the first month of treatment. After this, menstruation usually stops. If bleeding occurs after the first month of treatment, inform your doctor.
Menstruation should return 2–3 months after the last injection. If treatment is not being used due to infertility, a non-hormonal method of contraception should be used during the first month of treatment and after the last injection.
If the patient has submucosal fibroids (benign tumours of the uterine muscle located beneath the mucous membrane), Diphereline SR 3.75 may cause bleeding during the first 6–10 weeks of treatment as fibroids degenerate. If heavy or unusual bleeding or pain occurs, contact your doctor immediately.
Infertility in women
The treatment effect may be significantly enhanced in a small number of predisposed patients.
The treatment effect may vary between different patients receiving the same doses,
and in some cases, between different cycles in the same patient.
Using gonadotropins in combination with this medicine to treat infertility may cause ovarian enlargement or ovarian hyperstimulation, manifesting as pelvic and/or abdominal pain and/or breathing difficulties. In such cases, contact your doctor immediately.
Breast cancer in premenopausal and postmenopausal women
Treatment with Diphereline SR 3.75 may be useful in cases where other treatment methods have not achieved a clinical response or have lost effectiveness.
Children
In girls with precocious puberty, vaginal bleeding may occur during the first month of treatment.
Inform your doctor if there is evidence of a progressing brain tumour, as this may influence the doctor’s decision on treatment.
After stopping treatment with Diphereline SR 3.75 mg, signs of puberty will reappear in the patient.
In girls, menstruation usually returned about one year after stopping treatment.
The doctor should rule out the possibility that precocious puberty is caused by other diseases.
Bone mineral content decreases during treatment but returns to normal values after treatment is stopped.
After stopping treatment, a hip joint disorder (juvenile femoral head epiphysiolysis) may occur, causing hip stiffness, weakness, and/or severe groin pain radiating to the thigh. In such cases, consult your doctor.
If a child experiences severe or recurring headaches, vision problems, or ringing or buzzing in the ears, contact your doctor immediately (see section 4).
If you have concerns regarding any of the situations described above, discuss them with your doctor.
Diphereline SR 3.75 and other medicines
Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Diphereline SR 3.75 may affect the action of other medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol) or may increase the risk of heart rhythm disorders when taken together with other medicines (e.g. methadone used for pain relief or as part of detoxification in drug addiction), moxifloxacin (an antibiotic), or antipsychotic medicines used to treat severe mental illnesses.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Diphereline SR 3.75 must not be used during pregnancy or while breastfeeding.
Diphereline SR 3.75 should not be used when attempting to become pregnant (unless Diphereline SR 3.75 is part of infertility treatment).
Driving and operating machinery
Dizziness, fatigue, or vision problems such as blurred vision may occur during treatment.
These symptoms may be side effects of treatment or related to the underlying disease. If any of these side effects occur, do not drive or operate machinery.
Diphereline SR 3.75 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".
3. How to use Diphereline SR 3.75
The medicine will be administered by the attending physician or nurse at a dose appropriate for the patient, depending on the indication for which it was prescribed.
Treatment of children: the dose should be adjusted according to body weight.
Children with body weight above 30 kg: one intramuscular injection every 4 weeks (28 days).
Children with body weight from 20 to 30 kg: two-thirds of the dose by intramuscular injection every 4 weeks (28 days), i.e. administer two-thirds of the volume of the prepared suspension.
Children with body weight below 20 kg: half the dose by intramuscular injection every 4 weeks (28 days), i.e. administer half the volume of the prepared suspension.
Do not discontinue treatment without consulting your doctor.
Use of a higher than recommended dose of Diphereline SR 3.75
In case of overdose, symptomatic treatment is indicated.
4. Possible adverse reactions
Like any medicine, Diphereline SR 3.75 may cause adverse reactions, although not everyone will
experience them.
In rare cases, a severe allergic reaction (angioedema, anaphylactic reaction) may occur. If symptoms
such as difficulty swallowing or breathing, dizziness, swelling of the lips, face, throat or tongue, or
rash develop, contact your doctor immediately.
Men
Many of the adverse reactions can be expected to result from changes in testosterone levels in the
body. These include hot flushes, impotence and reduced libido.
Very common – adverse reactions occurring in more than 1 out of 10 patients
- Hot flushes
- Weakness
- Excessive sweating
- Back pain
- Pricking sensation in the lower limbs
- Decreased sexual drive
- Impotence
Common – adverse reactions occurring in no more than 1 out of 10 patients
- Nausea, dry mouth
- Pain, bruising, redness and swelling at the injection site
- Muscle and bone pain, pain in arms and legs, swelling (fluid accumulation in tissues), lower abdominal pain
- High blood pressure
- Allergic reaction
- Increase in body weight
- Dizziness, headache
- Loss of sexual drive, depression, mood changes
Uncommon – adverse reactions occurring in no more than 1 out of 100 patients
- Increased platelet count
- Palpitations
- Tinnitus, dizziness, blurred vision
- Abdominal pain, constipation, diarrhoea, vomiting
- Lethargy, chills, somnolence, pain
- Changes in results of certain laboratory tests (including increased values of parameters indicating liver function), elevated arterial blood pressure
- Decrease in body weight
- Loss of appetite, increased appetite, gout (severe pain and swelling of joints, most commonly affecting the big toe), diabetes, high levels of fats in the blood
- Joint pain, muscle cramps, muscle weakness, muscle pain, swelling of ankles, feet or fingers, bone pain
- Tingling and numbness
- Sleep disturbances, irritability
- Breast enlargement in men, breast pain (tenderness), testicular atrophy, testicular pain
- Shortness of breath
- Acne, hair loss, itching, rash, skin redness, urticaria
- Frequent urination at night, urinary disorders
- Nosebleeds
Rare – adverse reactions occurring in no more than 1 out of 1000 patients
- Red or purple skin discoloration
- Unusual sensations in the eye, blurred or disturbed vision
- Feeling of fullness in the abdomen, bloating, taste disturbances
- Chest pain
- Difficulty maintaining a standing position
- Influenza-like symptoms, fever
- Severe allergic reaction (anaphylactic reaction) which may cause dizziness or breathing difficulties, facial or throat swelling
- Nasal mucositis, pharyngitis
- Joint stiffness, joint swelling, musculoskeletal stiffness, degenerative joint disease
- Memory loss
- Confusion, decreased activity, excitement
- Shortness of breath in the lying position
- Skin blisters
- Low blood pressure
Adverse reactions reported after marketing authorization:
- Severe allergic reaction causing swelling of the face, tongue and neck, dizziness or breathing difficulties (Quincke's edema, anaphylactic shock)
- Changes in ECG (prolongation of QT interval)
- General malaise, anxiety
- Urinary incontinence
- In patients with an existing pituitary tumour, increased risk of pituitary haemorrhage
- Anaemia (reduction in red blood cells)
As with other GnRH analogues, an increase in white blood cell count may be observed in patients
treated with Diphereline SR 3.75.
In patients receiving long-term treatment with a GnRH analogue in combination with radiotherapy,
there may be an increased number of adverse reactions, mainly gastrointestinal and those related to
radiotherapy.
Women
Many of the adverse reactions can be expected to result from changes in oestrogen levels in the body.
Very common – adverse reactions occurring in more than 1 out of 10 patients
- Headache
- Decreased sexual drive, mood swings, sleep disturbances
- Breast discomfort
- Pain during or after sexual intercourse, vaginal bleeding
- Pelvic pain, vaginal dryness, ovarian enlargement
- Ovarian hyperstimulation syndrome (with ovarian enlargement and fluid retention)
- Excessive sweating, acne, seborrhoea, hot flushes
- Weakness
Common – adverse reactions occurring in no more than 1 out of 10 patients
- Breast pain
- Muscle cramps, joint pain, pain in arms and legs
- Increase in body weight
- Nausea, abdominal pain or discomfort
- Depression (with long-term treatment), nervousness
- Pain, bruising, redness and swelling at the injection site
- Swelling of ankles, feet and fingers
- Allergic reaction
- Dizziness
Uncommon – adverse reactions occurring in no more than 1 out of 100 patients
- Palpitations
- Dizziness
- Dry eyes, blurred vision
- Bloating, vomiting, dry mouth, flatulence, oral ulceration
- Decrease in body weight, decreased appetite, fluid retention
- Back pain, muscle pain
- Taste disturbances, loss of sensation
- Transient loss of consciousness, memory loss, lack of concentration
- Tingling or numbness, involuntary muscle movements
- Mood changes, anxiety, disorientation, depression
- Bleeding after intercourse, bladder prolapse, irregular menstruation, painful menstruation, heavy menstrual bleeding
- Small ovarian cysts which may cause pain, vaginal discharge
- Breathing difficulties, nosebleeds
- Hair loss, dry skin, excessive body hair growth, brittle nails, itching, rash
Adverse reactions reported after marketing authorization (frequency unknown):
- General malaise, fever
- Seizures
- High blood pressure
- Severe allergic reaction causing swelling of the face, tongue and neck, dizziness or breathing difficulties (Quincke's edema, anaphylactic shock)
- Changes in certain blood test parameters (including increased activity of certain enzymes)
- Muscle weakness
- Confusion, unusual eye sensations and/or visual disturbances
- Absence of menstruation
- Diarrhoea
- In patients with an existing pituitary tumour, increased risk of pituitary haemorrhage
- Urticaria
During infertility treatment, gonadotrophins in combination with Diphereline SR 3.75 may cause
pelvic and/or abdominal pain and shortness of breath. If such symptoms occur, inform your doctor
immediately.
Symptoms for which endometriosis treatment was indicated (pelvic pain, painful menstruation) may
worsen at the beginning of treatment, but should subside within one to two weeks. This may occur
even if treatment is effective. Inform your doctor immediately if this happens.
Children
Very common – adverse reactions occurring in more than 1 out of 10 patients
- In girls, vaginal bleeding may occur during the first month of treatment
Common – adverse reactions occurring in no more than 1 out of 10 patients
- Abdominal pain
- Pain, bruising, redness and swelling at the injection site
- Headache, hot flushes
- Increase in body weight, acne
- Allergic reaction
Uncommon – adverse reactions occurring in no more than 1 out of 100 patients
- Blurred vision
- Vomiting, constipation, nausea
- Obesity
- Neck pain, breast pain
- Mood changes, malaise
- Nosebleeds
- Itching, rash or urticaria
Adverse reactions reported after marketing authorization (frequency unknown):
- High blood pressure
- Seizures
- Abnormal vision
- Severe allergic reaction causing swelling of the face, tongue and neck, dizziness or breathing difficulties (Quincke's edema, anaphylactic shock)
- Changes in certain blood test parameters, including hormone levels
- Muscle pain
- Mood disturbances, depression, nervousness
- Idiopathic intracranial hypertension (increased pressure inside the skull around the brain, characterized by headache, double vision and other visual disturbances, and ringing or buzzing in the ears)
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.
5. How to store Diphereline SR 3.75
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Expiry date (EXP)
Batch number (Lot)
Store below 25°C.
6. Contents of the pack and other information
What Diphereline SR 3.75 contains
The active substance is triptorelin in the form of triptorelin acetate. One vial contains 3.75 mg of triptorelin.
Other ingredients are:
- Vial with powder: poly(lactic-co-glycolic acid) polymer, mannitol, sodium carboxymethylcellulose, polysorbate 80
- Ampoule with solvent: mannitol, water for injections
What Diphereline SR 3.75 looks like and contents of the pack
Powder and solvent for preparation of a prolonged-release suspension for injection.
Vial with powder and ampoule with solvent.
Carton containing 1 vial, 1 ampoule, 1 syringe (polypropylene) and 2 needles.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ipsen Pharma
70 rue Balard
75015 Paris
France
Manufacturer
Ipsen Pharma Biotech
Parc d’Activités du Plateau de Signes
Chemin départemental no. 402
83870 Signes
France
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Ipsen Poland Sp. z o.o.
ul. Chmielna 73
00-801 Warsaw
tel.: 22 653 68 00
fax: 22 653 68 22
Date of the most recent revision of the leaflet: April 2025
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Information intended exclusively for medical professionals:
Dosage and administration
Prostate cancer
Two dosage regimens are possible:
- Subcutaneous injection of Diphereline 0.1 mg for immediate release once daily for 7 consecutive days, followed by one intramuscular injection of Diphereline SR 3.75 on day 8, then every four weeks.
- Or intramuscular injection of Diphereline SR 3.75 every four weeks.
In patients with metastatic castration-resistant prostate cancer, not amenable to surgical treatment, who are receiving triptorelin and are eligible for treatment with androgen biosynthesis inhibitors, triptorelin therapy should be continued.
Breast cancer in pre- and postmenopausal women when hormonal treatment is indicated
One intramuscular injection of Diphereline SR 3.75 every four weeks. Do not discontinue treatment without consulting a physician.
Central precocious puberty (before age 8 in girls and before age 10 in boys)
Treatment of children with triptorelin should be conducted under the comprehensive supervision of a pediatric endocrinologist, pediatrician, or endocrinologist experienced in the treatment of central precocious puberty.
- Children with body weight above 30 kg: one intramuscular injection every 4 weeks (28 days).
- Children with body weight between 20 and 30 kg: two-thirds of the dose by intramuscular injection every 4 weeks (28 days), i.e., administer two-thirds of the volume of the prepared suspension.
- Children with body weight below 20 kg: half the dose by intramuscular injection every 4 weeks (28 days), i.e., administer half the volume of the prepared suspension.
Endometriosis
Treatment should be initiated within the first five days of the menstrual cycle.
- Dosing regimen: one intramuscular injection of Diphereline SR 3.75 every 4 weeks.
- Duration of treatment: depends on the initial stage of endometriosis and observed clinical (functional and anatomical) changes during treatment. Generally, treatment should last for at least 4 months and no more than 6 months. Initiation of a second course of treatment with triptorelin or any other GnRH analogue is not recommended.
Uterine fibroids
Treatment must be initiated within the first five days of the menstrual cycle. Diphereline SR 3.75 should be administered every four weeks. In patients scheduled for surgical intervention, treatment is carried out for 3 months. In patients not eligible for surgery, treatment is limited to six months.
Female infertility
One vial of Diphereline SR 3.75 is administered intramuscularly on day 2 of the cycle. Gonadotropin administration should begin after pituitary desensitization has been achieved (serum estrogen concentration below 50 pg/mL), usually about 15 days after injection of Diphereline SR 3.75.
In women, the specialist must carefully assess the justification for prolonged administration beyond six months to determine whether the expected benefit outweighs the potential adverse effects associated with prolonged suppression of estrogen production, particularly on bone.
Strictly follow the physician's instructions and do not discontinue treatment without consulting a physician.
The medication is administered as an intramuscular injection after immediate preparation.
Note: It is important that the injection be performed strictly according to the recommended method of use.
RECONSTITUTION INSTRUCTIONS FOR THE MEDICINAL PRODUCT
| 1 – PATIENT PREPARATION BEFORE DRUG RECONSTITUTION | |
| Patient preparation involves disinfecting the planned injection site on the buttock. The patient should be prepared for injection before reconstituting the drug, as the drug must be administered immediately after reconstitution. | |
2 – PREPARATION OF THE DRUG FOR INJECTION  | |
The package contains two needles:
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The presence of bubbles on the surface of the lyophilisate is a normal appearance of the product. The following steps must be performed consecutively without interruption. | |
2a
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2b
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2c
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2d
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| 3 – INTRAMUSCULAR ADMINISTRATION |  |
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| 4 – AFTER USE |  |
| Method A Method B  |
