Suprefact 1 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Suprefact 1 mg/ml solution for injection

Buserelin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Suprefact is and what it is used for
2. What you need to know before using Suprefact
3. How to use Suprefact
4. Possible side effects
5. Storage of Suprefact
6. Contents of the pack and other information

1. What Suprefact is and what it is used for

It belongs to a group of medicines called hormonal drugs, as the active substance buserelin is a compound capable of mimicking the action of a hormone. The result is the inhibition of gonadotropin (sex hormone) release in men and the stimulation of ovulation in women.

In men, this medicine is prescribed for the treatment of advanced prostate cancer when it is responsive to hormonal therapy, but it is not applicable after total orchidectomy (surgical removal of both testicles).

In women, this medicine is prescribed to stimulate the ovulation process, as a complementary treatment in an in vitro fertilization program.

2. What you need to know before starting to use Suprefact

Do not use Suprefact

• if you are allergic to buserelin or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumour disease that does not respond to hormonal treatment.
• if you have undergone orchidectomy (surgical removal of the testicles).
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Suprefact:

• since it is recommended to use an antiandrogen medication (a drug that blocks the action of testosterone) together with Suprefact, starting a few days before Suprefact administration.

  • if you have known metastases (e.g., in the spinal cord), as the combined use of an antiandrogen medication may prevent complications arising from treatment with Suprefact (see section 4).

• if you have risk factors for cardiovascular disease (heart diseases) or for diabetes.

• if you have any condition affecting the heart or blood vessels, or are being treated for such conditions, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Suprefact Injection.

• if you habitually have high blood pressure, as blood pressure control may be affected by treatment (see section 4).

• if you have a reduced number of red blood cells or feel increased fatigue (anemia).

  • if you are diabetic, as metabolic control may be affected by treatment (see section 4).
  • if you have a metabolic bone disease or have other risk factors for osteoporosis such as chronic alcohol abuse, smoking, family history of osteoporosis, or long-term treatment with anticonvulsants or corticosteroids.
  • if you have ever had depression, as there is a risk of recurrence or worsening of existing depression (see section 4).
  • if you are being treated with Suprefact to stimulate ovulation. Before starting treatment, a pregnancy test should be performed.
  • if you are receiving Suprefact injectable solution together with gonadotropins to stimulate ovulation, as a set of symptoms known as “ovarian hyperstimulation syndrome” may occur, which requires strict medical supervision.

Cases of depression have been reported in patients using Suprefact, which could be severe. If you are using Suprefact and develop depressive mood, inform your doctor.

Other medicines and Suprefact

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, consult your doctor:

If you take Suprefact together with antidiabetic medicines, their effect may be reduced.

If you take Suprefact together with sex hormones, your doctor will determine the appropriate dosage to achieve optimal overall effect.

Suprefact may interfere with certain medicines used to treat heart rhythm problems (for example: quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medicines (for example: methadone (used for pain relief and for detoxification from other medicines), moxifloxacin (an antibiotic), antipsychotics (used to treat severe mental illnesses)).

Pregnancy, breastfeeding and fertility

Suprefact must not be administered to pregnant women (see "Do not use Suprefact").

Suprefact must not be used in women who are breastfeeding (see "Do not use Suprefact").

Consult your doctor or pharmacist before using this medicine.

Children and adolescents

Its use is not recommended in children because its effect in this population group is unknown.

Patients over 65 years of age

No specific studies have been conducted in this population group.

Driving and use of machines

You should be aware that concentration and reaction time may be impaired due to the occurrence of dizziness, which may affect your ability to drive vehicles or operate machinery.

Consult your doctor or pharmacist before using any medicine.

Suprefact contains benzyl alcohol and sodium

This medicine contains 10 mg of benzyl alcohol in each ml of injectable solution.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medicine contains less than 23 mg of sodium (1 mmol) per millilitre of injectable solution; hence, it is essentially "sodium-free".

3. How to use Suprefact

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Injections should be spaced out as evenly as possible throughout the day, at regular time intervals.

In prostate cancer, you will be administered 0.5 ml of Suprefact injectable solution three times daily by subcutaneous route. From the eighth day of treatment with Suprefact injectable solution, your doctor will instruct you to continue with Suprefact nasal.

If your doctor has prescribed Suprefact injectable solution as an additional treatment to stimulate ovulation, you will be administered 0.3 ml of solution twice daily by subcutaneous route. Treatment will begin on the first or second day of the cycle, or around day 21 if pregnancy has been ruled out.

If you feel that the effect of Suprefact is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of your treatment with Suprefact. Do not stop treatment prematurely, as this could worsen your condition.

If you use more Suprefact than you should

If you have used more Suprefact than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the name of the medicine and the amount used. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

In case of overdose, you may experience fatigue, headache, nervousness, hot flushes, dizziness, nausea, abdominal pain, leg swelling, and breast pain.

If you forget to use Suprefact

Do not use a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Flushing, impotence, breast enlargement in men (without pain), and swelling in ankles and feet may occur.

You may experience discomfort or local reactions at the injection site.

In women, menstrual-like bleeding may appear during the first weeks of treatment. Occasionally, it may also occur in later weeks of treatment. Other possible effects include flushing, increased sweating, vaginal dryness, pain during intercourse, decreased sexual desire, and, with long-term treatment, reduced bone mass.

In women, the following symptoms have sometimes occurred, although they have not been definitively linked to the use of Suprefact: breast enlargement or reduction with discomfort, brittle nails, acne, dry skin, occasional vaginal discharge, and occasional edema (fluid retention) in the face and extremities.

In women, milk secretion from the breasts, stomach pain, abdominal pain, paresthesia (tingling) in arms and legs, and dry eyes (which may cause irritation if contact lenses are worn) may also occur.

During the initial phase of treatment, ovarian cysts may develop, although this does not negatively affect ovarian stimulation prior to ovulation induction.

Inform your doctor or pharmacist if any of the following adverse effects are severe or last for more than a few days:

Frequent (may affect up to 1 in 10 people)

• Mood changes and depression (with long-term treatment)
• Headache
• Pain or local reactions at the injection site.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions such as skin redness, itching, or skin rash
• Mood changes and depression (with short-term treatment)
• Drowsiness, dizziness
• Constipation
• Fatigue.

Rare (may affect up to 1 in 1,000 people)

• Allergic asthma with dyspnea (difficulty breathing); in isolated cases, it may cause a severe allergic reaction that could be life-threatening
• Nervousness, emotional instability, anxiety
• Sleep disturbances, memory and concentration difficulties
• Palpitations
• Increased blood pressure if you are hypertensive
• Nausea, vomiting, diarrhea
• Increased or decreased body hair and hair growth.

Very rare (may affect up to 1 in 10,000 people)

• Development of a benign tumor in the pituitary gland (mucosa lining the inside of the nose). It is also possible that tumor-related pain may slightly increase
• Decreased platelet count (blood cells involved in clotting) or decreased white blood cells in the blood
• Increased thirst and appetite changes. Additionally, decreased glucose tolerance may occur; if you are diabetic, you should consult your doctor (see “Warnings and precautions”)
• Visual disturbances, such as blurred vision and sensation of pressure behind the eyes
• Tinnitus and other hearing disorders
• Muscle discomfort and pain. You may also have an increased risk of bone fractures due to decreased bone density.

Frequency not known (cannot be estimated from available data)

• Changes in the electrocardiogram (ECG) (prolongation of the QT interval)
• In women with uterine fibroids, degeneration of these fibroids
• When used to treat prostate cancer, LHRH analogues may increase the risk of cardiovascular disease (such as heart attack and stroke), diabetes, or anemia (reduction in red blood cells causing fatigue).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Suprefact

Store below 25 ºC. Do not freeze. Keep in the outer packaging to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Suprefact

• The active substance is buserelin (as buserelin acetate). Each vial contains 5.5 ml of injectable solution, at a concentration of 1.05 mg/ml of buserelin acetate (equivalent to 1.0 mg/ml of buserelin).
• The other components are: benzyl alcohol, sodium dihydrogen phosphate dihydrate, sodium chloride, sodium hydroxide, and water for injections.

Appearance of the product and contents of the pack

Suprefact is a clear, colourless injectable solution. It is supplied in a transparent glass vial with a dark grey rubber stopper, aluminium cap, and plastic button.

Each carton contains 2 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer:

Sanofi-Aventis Deutschland GmbH
Brüningstraße 50
Frankfurt am Main
Germany

OR

Famar Health Care Services Madrid, S.A.U.
Avda. de Leganés, 62
28923 Alcorcón (Madrid)
Spain

OR

Laboratorios Farmalan S.A.
Calle La Vallina S/n, Polígono Industrial Navatejera
Villaquilambre, 24193 León
Spain

Local Representative

Laboratorios Rubió, S.A.
Industria, 29
Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain

****Date of the most recent revision of this leaflet: February 2016****

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.