Label: information for the user

Suprefact 1 mg/ml injectable solution

Buserelin

Read this label carefully before starting to use this medication, as it contains important information for you.

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

1. What is Suprefact and for what it is used

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

3. How to use Suprefact

4. Possible adverse effects

5. Storage of Suprefact

6. Contents of the package and additional information

It belongs to a group of medications called hormones, as the active ingredient buserelina is a substance capable of simulating the action of a hormone. The result is the inhibition of the release of gonadotropins (sex hormones) in men and the stimulation of ovulation in women.

In men, this medication is prescribed to treat advanced prostate cancer when it is capable of responding to hormonal treatment, but it is not applicable after total orchiectomy (surgical removal of both testicles).

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

Do not use Suprefact

• If you are allergic to buserelin or any of the other components of this medication (listed in section 6).
• If you have a tumoral disease that does not respond to hormonal treatment.
• If you have undergone orchiectomy (surgical removal of testicles).
• If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to use Suprefact:

- as it is recommended to use an antiandrogen medication (a medication that cancels the action of testosterone) along with Suprefact, starting its administration a few days before.

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

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

- if you have any heart or blood vessel disease or are being treated for it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when using Suprefact Injectable.

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

- if you have decreased red blood cell count or feel an increase in fatigue (anemia).

• If you are diabetic, as metabolic control may be affected by treatment (see section 4).
• If you have a bone metabolic disease or have other risk factors for osteoporosis such as chronic alcohol abuse, smoking, family history of osteoporosis, or are on long-term treatment with anticonvulsants or corticosteroids.
• If you have ever suffered from depression, as there is a risk of relapse or worsening of an existing depression (see section 4).
• If you are administered Suprefact to stimulate ovulation. Before starting administration, it is recommended to perform a pregnancy test.
• If you are receiving Suprefact injectable solution along with gonadotropins to stimulate ovulation, as a series of symptoms called "hyperestimulatory syndrome" may appear, requiring strict supervision by your doctor.

Depression cases have been reported in patients using Suprefact, which could be severe. If you are using Suprefact and develop a depressive mood, inform your doctor.

Other medications and Suprefact

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, consult your doctor:

If you take Suprefact along with antidiabetic medications, the action of these medications may decrease.

If you take Suprefact along with sex hormones, your doctor will establish the appropriate dose to achieve optimal overall effect.

Suprefact may interfere with some medications used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g. methadone (used for pain relief and detoxification of other medications), moxifloxacine (an antibiotic), antipsychotics (used to treat severe mental illnesses).

Pregnancy, breastfeeding, and fertility

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

Suprefact should not be used in breastfeeding women (see "Do not use Suprefact").

Consult your doctor or pharmacist before using this medication.

Children and adolescents

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

Patients over 65 years old

No specific studies have been conducted in this population.

Driving and operating machinery

You should be aware that dizziness and altered reaction time may occur, affecting your ability to drive vehicles or operate machinery.

Consult your doctor or pharmacist before using any medication.

Suprefact contains benzyl alcohol and sodium

This medication contains 10 mg of benzyl alcohol per 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 medication contains less than 23 mg of sodium (1 mmol) per milliliter of injectable solution; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication.

It is recommended to distribute the injections throughout the day, at the most regular time intervals possible.

In prostate cancer, you will be administered 0.5 ml of Suprefact injectable solution 3 times a day subcutaneously. 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 adjunctive treatment to stimulate ovulation, you will be administered 0.3 ml of solution 2 times a day subcutaneously. Treatment will begin on the first or second day of the cycle, or around day 21 if a pregnancy has been ruled out.

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

Your doctor will instruct you on the duration of your treatment with Suprefact. Do not discontinue your treatment beforehand, as this could worsen your condition.

If you use more Suprefact than you should

If you have used more Suprefact than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

In case of overdose, you may feel fatigue, headache, nervousness, hot flashes, dizziness, nausea, abdominal pain, swelling in the legs, and breast pain.

If you forgot to use Suprefact

Do not use a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

They may include hot flashes, impotence, breast enlargement in men (no pain is involved) and swelling in the ankles and feet.

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

In women, it may cause bleeding similar to menstruation in the first weeks of treatment. Occasionally, it may appear in the following weeks of treatment. It may also cause hot flashes, increased sweating, vaginal dryness, pain during intercourse, decreased sexual desire and, in long-term treatments, bone density loss.

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

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

In the initial phase of treatment, ovarian cysts may appear, although this would not have a negative effect on ovulation stimulation for induction preparation.

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

Frequent (may affect up to 1 in 10 people)

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

Occasional (may affect up to 1 in 100 people)

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

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

• Allergic asthma with dyspnea (difficulty breathing) and in isolated cases may cause severe allergic reactions that can put your life at risk
• Nervousness, emotional instability, anxiety
• Sleep disturbances, memory and concentration disturbances
• Palpitations
• Increased blood pressure if you are hypertensive
• Nausea, vomiting, diarrhea
• Increased or decreased hair and body hair.

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

• Appearance of some benign tumors in the pituitary (nasal mucosa). It is also possible that the tumor pain may increase slightly
• Decreased platelet count (blood cells involved in coagulation) or white blood cells in the blood
• Increased thirst and appetite disturbances. Additionally, you may observe a decrease in glucose tolerance, 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 in the ears and other auditory disorders
• Muscle pain and discomfort. You may also be at a higher risk of bone fractures due to bone density loss.

Frequency unknown (cannot be estimated from available data)

• Changes in the electrocardiogram ECG (prolongation of the QT interval)
• In women with uterine fibroids, degeneration of the same
• When used to treat prostate cancer, LHRH analogs may increase the risk of cardiovascular disease (such as heart attack and stroke), diabetes or anemia (decrease in the number of red blood cells that makes you feel tired).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 25 °C. Do not freeze. Store in the outer packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Composition of Suprefact

- The active principle is buserelin (as acetate of buserelin). Each vial contains 5.5 ml of injectable solution, at a concentration of 1.05 mg/ml of acetate of buserelin (equivalent to 1.0 mg/ml of buserelin).

- The other components are: benzyl alcohol, dihydrogen phosphate of sodium dihydrate, sodium chloride, sodium hydroxide, and water for injectable preparations.

Aspect of the product and content of the container

Suprefact is a transparent injectable solution. It is presented in a transparent glass vial with a grey rubber stopper and an aluminum/propylene capsule.

Each box contains 2 vials.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization :

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for the manufacture:

Sanofi-Aventis Deutschland GmbH

Brüningstraße 50

Frankfurt am Main

Germany

O

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Local Representative

Laboratorios Rubió, S.A.

Industria, 29

Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet: February 2016

Other sources of information

Detailed information about this medicine is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS) http://www.aemps.gob.es/