Salvacil

Package Leaflet: Information for the Patient

Salvacyl, 11.25 mg,

powder and solvent for prolonged-release suspension for injection
Triptorelin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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 only. 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, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Salvacyl is and what it is used for
• 2. Important information before using Salvacyl
• 3. How to use Salvacyl
• 4. Possible side effects
• 5. How to store Salvacyl
• 6. Contents of the pack and other information

1. What Salvacyl is and what it is used for

Salvacyl contains triptorelin, which is similar to a hormone called gonadotropin-releasing hormone (GnRH analogue). It is a long-acting product that delivers 11.25 mg of triptorelin over more than twelve weeks. It works by reducing the level of male hormone, testosterone, in the body.
Salvacyl is used to reduce sexual desire in adult men with severe sexual deviations.
Treatment with Salvacyl should be initiated and supervised by a psychiatrist. Treatment should be carried out in combination with psychotherapy to limit deviant sexual behavior.

2. Important information before using Salvacyl

When not to use Salvacyl

• if you have severe osteoporosis (a condition that weakens the bones).
• if you are allergic to triptorelin or other medicines that regulate the production and release of sex hormones or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

At the start of treatment, the amount of testosterone in the body increases. This can lead to increased sexual desire. Your doctor may prescribe a medicine (an anti-androgen) to counteract this.
You should consult your doctor if:

• you experience depressive mood during treatment with Salvacyl. Cases of severe depression have been reported in patients taking Salvacyl. Your doctor may recommend monitoring for depression during treatment.
• you are taking anticoagulant medicines (blood thinners), as this may cause bruising at the injection site.
• you consume large amounts of alcohol, smoke, have osteoporosis (a condition that weakens the bones) or a family history of osteoporosis, have poor nutrition, or are taking antiepileptic medicines (for epilepsy or seizures) or glucocorticoids. When Salvacyl is used for a long time, there is a risk of bone weakening, especially in combination with these situations. To prevent bone fragility, you should lead a healthy lifestyle, not smoke, limit alcohol consumption, and engage in regular strength training exercises that strengthen the skeleton (e.g., walking, running, other sports that put stress on the skeleton). You should ensure adequate calcium and vitamin D intake in your diet.
• if you are scheduled to undergo a test of pituitary gland function in the near future. The result may be misleading during treatment with Salvacyl or after stopping treatment.
• if you experience sudden severe headache, vomiting, vision disturbances, or eye muscle paralysis. These can be signs of a benign pituitary tumor, which can occur during treatment with Salvacyl.
• if you have diabetes, heart disease, or blood vessel disease.
• all heart and blood vessel conditions, including rhythm disturbances (arrhythmia), should be treated with appropriate medications. The risk of rhythm disturbances may be increased during treatment with Salvacyl.
• medicines that lower testosterone levels can cause changes in the ECG related to rhythm disturbances (prolonged QT interval). When treatment is stopped, testosterone levels will return to their previous value, and sexual desire may increase again. Your doctor may prescribe another medicine to prevent this.

Children and adolescents

Salvacyl should not be given to newborns, infants, children, and adolescents.

Salvacyl and other medicines

If Salvacyl is taken with other medicines that change the release of pituitary hormones, you should attend additional medical check-ups.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Salvacyl may interact with some medicines used to treat rhythm disturbances (such as quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with certain other medicines (such as methadone used for pain relief or as a supportive treatment for detoxification in the treatment of narcotic addiction), moxifloxacin (as an antibiotic), antipsychotic medicines used in severe mental illnesses.

Pregnancy, breastfeeding, and fertility

Salvacyl is not intended for use in women.

Driving and using machines

You may feel dizzy, tired, and have vision problems, such as blurred vision. These are possible side effects of the medicine. If you experience any of these effects, do not drive or operate machinery.

Salvacyl contains sodium

Salvacyl contains less than 1 mmol (23 mg) of sodium per vial. This medicine is essentially sodium-free and can be used in a low-sodium diet.

3. How to use Salvacyl

Salvacyl is prepared and administered by a doctor or nurse.
The recommended dose is one vial of Salvacyl, given as a single intramuscular injection every twelve weeks.
If the effect of the treatment seems too strong or too weak, you should contact your doctor.
If you have any doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Salvacyl can cause side effects, although not everybody gets them.
Due to the change in testosterone levels in the body, many side effects can be expected. These include hot flashes and impotence.
In rare cases (1 in 1000 patients), a severe allergic reaction may occur, and frequently (may occur in more than 1 in 10 people), allergic reactions may occur. You should stop using Salvacyl and contact your doctor or go to the nearest emergency department immediately if you experience any of the following symptoms: difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, or rash, you should inform your doctor immediately.
Other side effects that may occur:

• Hot flashes
• Weakness
• Excessive sweating
• Back pain
• Numbness in the legs
• Decreased libido
• Impotence

Very common: may affect more than 1 in 10 people

• Nausea, dry mouth
• Pain, bruising, redness, and swelling at the injection site, muscle and bone pain, pain in the arms and legs, swelling (due to fluid retention in the body), abdominal pain
• Allergic reaction
• High blood pressure
• Weight gain
• Dizziness and headache
• Loss of libido, depression, mood changes

Common: may affect up to 1 in 10 people

• Increased platelet count
• Feeling of heartbeat
• Ringing in the ears, dizziness (feeling of spinning or spinning image)
• Blurred vision
• Abdominal pain, constipation, diarrhea, vomiting
• Drowsiness, severe chills with sweating and fever, insomnia, pain
• May affect the results of some blood tests (such as liver function tests)
• Increased blood pressure
• Weight loss
• Loss of appetite, increased appetite, gout (severe pain and swelling of the joints, usually the big toe), diabetes, high blood lipid levels
• Joint pain, cramps, muscle weakness, muscle pain, swelling, and tenderness, bone pain
• Numbness or tingling
• Insomnia, irritation
• Breast enlargement, breast pain, decreased testicular size and pain
• Breathing difficulties
• Acne, hair loss, itching, rash, redness of the skin, hives
• Waking up to urinate, problems with urination
• Nosebleeds

Rare: may affect up to 1 in 1000 people

• Purple or red discoloration of the skin
• Strange sensations in the eye or vision disturbances
• Bloated stomach, bloating, disturbed sense of taste
• Chest pain
• Difficulty standing
• Flu-like illnesses, fever
• Nasal congestion
• Increased levels of enzymes, e.g., in bones and liver
• Increased body temperature
• Stiffness of the joints, swelling of the joints, muscle and skeletal stiffness, inflammation of the bones and joints
• Memory disturbances
• Feeling of disorientation, decreased activity, elevated mood, or well-being
• Shortness of breath when lying down
• Blisters
• Low blood pressure

Frequency not known (cannot be estimated from the available data)

• Changes in ECG (prolonged QT interval),
• General discomfort,
• Anxiety,
• Urinary incontinence,
• In the case of an existing pituitary tumor, increased risk of bleeding into the pituitary gland.

During treatment with Salvacyl, an increase in white blood cell count may occur, as with other GnRH analogues.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Salvacyl

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, vial, and ampoule after: "EXP". The expiry date refers to the last day of the month stated.
Lot (batch number).
Do not store above 25°C.
Chemical and physical stability during use has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions, but this should not exceed 24 hours at a temperature between 2°C and 8°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Salvacyl contains

• The active substance is triptorelin. One vial of powder contains 11.25 mg of triptorelin as triptorelin embonate. The reconstituted suspension (2 ml) contains 11.25 mg of triptorelin as triptorelin embonate.
• The other ingredients are: Powder: poly(DL-lactic acid and glycolic acid), mannitol, sodium carmellose, and polysorbate 80. Solvent: water for injections.

What Salvacyl looks like and contents of the pack

Salvacyl is a white or almost white powder.
The solvent is a clear solution.
The pack contains:
1 vial of powder
1 ampoule of 2 ml solvent
1 syringe
2 needles

Marketing authorization holder and manufacturer

Marketing authorization holder
Ipsen Pharma
65 Quai Georges Gorse
92100 Boulogne Billancourt
France
Manufacturer
Ipsen Pharma Biotech
Parc d'activités du plateau de Signes
Chemin départemental n˚ 402
83870 Signes
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Sweden: Moapar 11.25 mg
Austria, Belgium, Netherlands, Ireland, Germany, Denmark, Finland, United Kingdom: Diphereline SR 11.25 mg
France: Decapeptyl LP
Greece, Norway: Salvapar
Poland: Salvacyl
For more information about this medicine, please contact the local representative of the marketing authorization holder:
Ipsen Poland Sp. z o.o.
ul. Chmielna 73
00-801 Warsaw
phone: 22 653 68 00
fax: 22 653 68 22
Date of last revision of the leaflet:October 2024
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Information intended for healthcare professionals only:

1 – PREPARING THE PATIENT BEFORE RECONSTITUTION OF THE MEDICINE

Prepare the patient, i.e., disinfect the buttock at the injection site. This should be done first, as the medicine should be injected immediately after reconstitution.

2 – PREPARING THE MEDICINE FOR INJECTION

The package contains 2 needles:

• Needle 1: 20 G (38 mm long) without a safety device, for reconstitution
• Needle 2: 20 G (38 mm long) with a safety device, for injection

Needle 1: 38 mm
Needle 2: 38 mm

The presence of bubbles on the surface of the lyophilizate is a normal appearance of the product.

2a

• Remove the ampoule containing the solvent. The liquid in the upper part of the ampoule should be moved to the main part of the ampoule by gently tapping it with your finger.
• Attach Needle 1 (without a safety device) to the syringe. Do not remove the needle cover yet.
• Break the ampoule at the marked point, upwards.
• Remove the cover from Needle 1. Insert the needle into the ampoule and draw the entire volume of the solvent into the syringe.
• Set the syringe with the solvent aside.

2b

• Remove the vial containing the powder. The powder in the upper part of the vial should be moved to the main part of the vial by gently tapping it with your finger.
• Remove the plastic cap from the vial.
• Take the syringe with the solvent again and insert the needle vertically into the rubber stopper of the vial. Slowly inject the solvent into it, trying to rinse the entire upper part of the vial.

2c

• Withdraw Needle 1 above the liquid level. Do not remove the needle from the vial. Prepare the suspension for injection by moving the vial from side to side. Do not turn the vial upside down.
• Make sure the movement lasts long enough to obtain a uniform, milky suspension for injection.

Important: Check if there are any remaining undissolved powder particles in the vial (if powder particles are present, continue mixing until they disappear).

2d

After obtaining a uniform suspension for injection, insert the needle to the end and, without turning the vial upside down, draw the entire volume of the suspension into the syringe. A small amount of suspension will remain in the vial; ignore it. The intended excess of suspension in the vial covers this remainder.

• Holding the colored connector, unscrew the needle. Remove the used Needle 1 and attach - screw on Needle 2 to the end of the syringe.
• Push the protective cover away from the needle and direct it towards the syringe cylinder. The protective cover will remain in this position.
• Remove the cover from the needle.
• Hold the syringe with the needle vertically to remove any air and then immediately perform the injection. Disinfect.

3 – INTRAMUSCULAR INJECTION

• To avoid the formation of lumps, the injection should be performed immediately into the previously disinfected buttock muscle.

4 – AFTER USE

• With one hand, activate the protective cover.
• Note: Always keep your finger behind the protective cover.

There are two alternative ways to activate the protective cover.

• Method A: push the cover towards the needle or
• Method B: push the cover against a flat surface.
• In both cases, press the cover down quickly and firmly until you hear a distinct click.
• Check if the entire needle is locked under the cover.

Used needles, unused suspension, or any waste should be disposed of in accordance with local regulations.

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