Leaflet: information for the user

Zomacton 4 mg powder and solvent for solution for injection

Somatropin

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1. What is Zomacton and what it is used for

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

3. How to use Zomacton

4. Possible side effects

5. Storage of Zomacton

6. Contents of the pack and additional information

Zomacton contains the active ingredient somatropin, also known as growth hormone. Growth hormone is naturally produced in the body. It has a very important function in growth. Zomacton contains somatropin obtained in a pharmaceutical manufacturing facility.

Zomacton is indicated for long-term treatment of:

• Children with short stature due to insufficient production of growth hormone

Short stature associated with Turner Syndrome (a genetic disorder affecting women).

Do not use Zomacton

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• in children with closed epiphyses (when bone growth is complete)
• do not use Zomacton and inform your doctor if you have an active tumor (cancer). Tumors must remain inactive and you must have completed your antitumor treatment before starting your treatment with Zomacton
• in premature children or newborns due to the presence of benzyl alcohol as an excipient
• in patients who are seriously ill due to complications, for example, open-heart or abdominal surgery, multiple trauma from an accident, or respiratory failure
• in children with chronic kidney disease after kidney transplantation

Warnings and precautions

• Zomacton, containing benzyl alcohol as an excipient, may cause toxic and allergic reactions in children and those under 3 years old and should not be administered to premature children or newborns.
• Patients with Prader-Willi syndrome should not be treated with Zomacton unless they also have growth hormone deficiency.
• Treatment with Zomacton must be initiated and directed by a specialist doctor, experienced in diagnosing patients with growth hormone deficiency.
• If you have a family history of diabetes mellitus, your blood sugar levels must be analyzed at intervals by your doctor. If you are diabetic, you will require strict control of your blood glucose levels and your dose will need to be adjusted to maintain diabetic control. Your doctor will inform you if necessary.

• If you are a patient with growth hormone deficiency as a result of a head injury, you must be examined frequently to see the evolution or recurrence of the disease. If this is confirmed, your doctor will inform you if you need to interrupt treatment with Zomacton
• Please consult your doctor if you develop symptoms or signs of relapse due to a previous malignant disease.
• If you are receiving glucocorticoid replacement therapy, you must consult your doctor regularly as it may be necessary to adjust your glucocorticoid dose.
• If you develop any of the following while on treatment with Zomacton, contact your doctor or nearest assistance department urgently:
• intense or repeated headaches
• vision problems
• nausea and/or vomiting

• Treatment with Zomacton may lead to thyroid hormone deficiency, which may require replacement therapy. To control it, your doctor will perform periodic checks to ensure that your thyroid gland is functioning correctly.
• Some children with growth hormone deficiency have developed leukemia (an increase in the number of white blood cells in the blood), having received or not received growth hormone treatment. However, there is no evidence that the incidence of leukemia is increased in patients without risk factors treated with growth hormone. No cause-and-effect relationship has been proven with growth hormone treatment.
• Please consult your doctor immediately if you develop limpness or pain in the hip, knee, or ankle.
• If you suffer from complications after surgery, trauma, or acute respiratory failure, consult your doctor.
• If you require surgery, are seriously injured in an accident, or are severely ill, your doctor will review your treatment.
• Zomacton may cause pancreatitis, which causes intense pain in the abdomen and back. If you, or your child, develop stomach pain after administering Zomacton, consult your doctor.

Use in athletes

This medication contains somatropin, which may produce a positive result in doping control tests.

Use of Zomacton with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicationincluding over-the-counter medications.

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Patients treated with glucocorticoids should carefully adjust their dose as glucocorticoids may inhibit the gradual growth effect of somatropin. If you are being treated with steroids due to insufficient ACTH (adrenocorticotropic hormone) production, inform your doctor.

Androgens, estrogens, and anabolic steroids may accelerate bone maturation and therefore may reduce the final increase in height.

Patients with diabetes may need to adjust their insulin dose as somatropin may induce insulin resistance.

Inform your doctor if you are being treated with regular prescription medication, e.g., steroids, epilepsy medication, or immunosuppressive medication.

Pregnancy and breastfeeding

There is no experience of use in pregnant women. Zomacton should not be used during pregnancy. It is unknown whether Zomacton passes through breast milk. Zomacton should not be used during breastfeeding.

Driving and operating machinery

Zomacton has no or insignificant influence on the ability to drive or operate machinery.

Zomacton contains benzyl alcohol

This medication should not be administered to premature children or newborns because it contains 9 mg/ml of benzyl alcohol. It may cause toxic and allergic reactions in children under 3 years old.

This medication contains less than 23 mg (1 mmol) of sodium chloride, so it is considered essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.This medication should be used exactly as directed by your doctor or pharmacist. If you are unsure about how to use this medication, consult your doctor or pharmacist for further instructions.

Your doctor or nurse will decide with you the most suitable method of administration and provide you with instructions for use according to the method used. Your doctor or nurse will inform you of the correct dose for you. The dose is administered subcutaneously (under the skin) with a syringe or with a device with a needle, Ferring-Pen.

Dosage:

Growth Hormone Deficiency in Children

Your doctor will calculate the exact dose for you, based on your body weight. Generally, a dose of 0.17 – 0.23 mg per kg of body weight per week is recommended. This weekly amount can be divided into six or seven doses, corresponding to a daily injection of 0.02 – 0.03 mg per kg of body weight. The maximum recommended weekly dose is 0.27 mg per kg of body weight, equivalent to daily injections of up to approximately 0.04 mg per kg of body weight.

Turner Syndrome (only for women)

Your doctor will calculate the exact dose for you, based on your body weight. A dose of 0.33 mg per kg of body weight per week is generally recommended. This weekly amount can be divided into 6 – 7 doses, corresponding to a daily injection of 0.05 mg per kg of body weight.

Instructions for Reconstitution:

The powder must be dissolved only with the solvent provided.

Two concentrations can be prepared depending on the volume of solvent used. Your doctor will inform you which concentration to use.

• For administration with a syringe or Ferring-Pen, use 1.3 ml of solventfor a concentration of 3.3 mg/ml (taking into account the total content of the vial, which is greater than 4 mg). The reconstituted powder and solvent for injectable solution must be administered with a syringe.
• For administration using only a syringe, use 3.2 ml of solvent for a concentration of 1.3 mg/ml (taking into account the total content of the vial, which is greater than 4 mg). The reconstituted powder and solvent for injectable solution must be administered with a syringe.

The reconstitution must be carried out in accordance with good practice standards, particularly with regard to asepsis.

1. Hands must be washed.

2 a. Attach the needle to the graduated syringe.

2 b. Remove the protective cover from the vial.

c. Clean the top of the vialwith an alcohol-soaked swab.Do not touch the rubber stopper after cleaning it.

3. Break the top of the solvent ampoule. Remove the plastic wrapping from the needle. Make sure the plunger is fully pushed before inserting the needle into the ampoule.

Lentily draw the required volume into the syringe.

4. Place the needle in the clean rubber stopper and inside the vial, and inject the solvent slowly into the vial, directing the liquid stream against the glass wall to avoid foam formation.

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5. The vial must be gently rotated until the contents have dissolved completely to obtain a clear and colorless solution.

Since the powder contains mainly proteins, avoid vigorous agitation of the vial.

If after mixing the solution is cloudy or contains particles, the vial and its contents must be discarded. In case of cloudiness after refrigeration, allow the solution to reach room temperature (25°C). If the cloudiness persists or coloration appears, discard the vial and its contents.

The solution must be used within a maximum of 14 days after reconstitution if stored in the refrigerator.

Any unused solution from the vial must be discarded at the end of the 14-day storage period.

Administration Instructions:

The clear and transparent solution must then be administered subcutaneously as shown in the clinical use with a syringe or Ferring-Pen.

After reconstitution, the following steps must be taken for injection.

1.Hands must be washed

2. The top of the container must be cleaned with an alcohol-soaked swab to avoid contamination of its contents. Do not touch the rubber stopper after cleaning it

3. Place the vial upside down, keeping the top of the needle below the surface of the medication. Gently pull the plunger until the prescribed amount of medication fills the syringe. If there is not enough medication for a complete dose, reconstitute a new vial to compensate for the difference.

4. With the needle still in the vial, gently tap the syringe to loosen any air bubbles.

5. Remove the needle from the vial and carefully replace the needle cap until ready to inject.

6. Thoroughly clean the injection site with alcohol.

7. Check that the syringe contains the correct dose.

8. Remove the needle cap and hold the syringe in the same way as holding a pencil.

9. With the free hand, gently pinch the skin around the injection site between the fingers.

10. Insert the needle into the tissue under the skin surface at an angle of 45?to 90?to reduce discomfort.

11. Holding the syringe in place, pull back (if there is blood in the syringe, it means it has entered a blood vessel. Do not inject ZOMACTON. Remove the needle, discard all supplies, and go back to step 1. Choose and clean a new injection site). If no blood appears, slowly push the plunger until the syringe is empty

12. Quickly remove the needle and apply pressure to the injection site with a sterile gauze. Discard the needle and syringe in a puncture-proof container.

Do not share your syringes, needles, or vials with anyone else. You may infect them or contract an infection from them.

Any unused product or waste must be disposed of in accordance with local requirements.

The Ferring Pen (device with needle) is not included in the packaging.

Specific instructions for use of the Ferring Pen are provided in the package insert that is supplied with the injector.

If you use more Zomacton than you should

A overdose may cause hypoglycemia (low blood sugar) and subsequently hyperglycemia (high blood sugar).

In case of overdose, contact your doctor or nearest hospital immediately or call the Toxicology Information Service, phone 915 620 420 indicating the medication and the amount used. The effects of repeated overdosing are unknown.

If you forget to use Zomacton

In case of missed dose, do not worry. Continue normally and administer the next dose at your usual time.

You may experience hypoglycemia (low blood sugar levels). Although long-term treatment effectiveness will not be affected, you should consult your doctor if this happens.

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

The subcutaneous administration of growth hormone may cause loss or gain of fat at the injection site. Therefore, it is recommended to change the injection site frequently. In rare cases, patients developed pain or itching at the injection site.

Very common side effects (may affect more than 1 in 10 patients treated):

Only adults:

• Swelling due to fluid retention, especially in the hands and feet (Edema)
• Mildly increased blood sugar levels (hyperglycemia)
• Joint pain (Arthralgia)
• Muscle pain (Myalgia)
• Headache
• Numbness, tingling, burning, or crepitus in the skin (Paresthesia)

Common side effects (may affect up to 1 in 10 patients treated):

Children and adults:

• Hypothyroidism
• Immune reaction to growth hormone, which may appear in a blood test (formation of antibodies)
• Headache
• Increased muscle tone (hypertonia)

Only children:

• Swelling due to fluid retention, especially in the hands and feet (edema, peripheral edema)
• Reactions at the injection site
• Weakness (asthenia)
• Modified glucose tolerance
• Joint pain (arthritis)
• Muscle pain (myalgia)

Only adults:

• Rigidity in the legs and/or arms
• Difficulty falling asleep and/or difficulty staying asleep (insomnia)

Uncommon side effects(may affect up to 1 in 100 patients treated):

Children and adults:

• Anemia
• High heart rate (tachycardia)
• Sensation of spinning (vertigo)
• Diplopia (double vision)
• Papilledema (swelling of the optic disc)
• Vomiting, abdominal pain, flatulence, nausea
• Weakness
• Atrophy at the injection site, bleeding at the injection site, nodule at the injection site, hypertrophy
• Low blood sugar levels (hypoglycemia)
• Hyperphosphatemia (elevated phosphate levels in the blood)
• Muscle atrophy
• Bone pain
• Carpal tunnel syndrome
• Malignant neoplasia, neoplasia
• Drowsiness
• Involuntary eye movements (nystagmus)
• Personality disorders
• Urinary incontinence, hematuria (blood in the urine), polyuria (increased urine volume), increased frequency of urination, urinary anomalies
• Reactions at the injection site (including lipodystrophy, skin atrophy, exfoliative dermatitis, urticaria, hirsutism, skin hypertrophy).
• Enlargement of the breast (gynecomastia)

Only children:

• Rigidity in the legs and/or arms

Only adults:

• High blood pressure (hypertension)

Rare side effects (may affect up to 1 in 1,000 patients treated):

Children and adults:

• Diarrhea
• Abnormal renal function tests
• Type 2 Diabetes Mellitus
• Numbness or tingling in certain areas of the body (neuropathy)
• Fluid retention around the brain (manifests as repeated or intense headache, blurred vision, and/or nausea and/or vomiting)

Only children:

• High blood pressure (hypertension)
• Difficulty falling asleep and/or difficulty staying asleep (insomnia)
• Numbness, tingling, burning, or crepitus in the skin (paresthesia)

Very rare side effects(may affect up to 1 in 10,000 patients treated):

Only children:

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 to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep 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.

Store in refrigerator at2°C-8°C; store in the original packaging to protect it from light.

After reconstitution, the solution can be stored for a maximum of 14 days in the refrigerator (2ºC-8ºC). Store the vial in an upright position.

Any unused solution from the vial must be discarded at the end of the 14-day storage period.

In case of turbidity after refrigeration, allow the solution to reach room temperature (25ºC). If turbidity persists, or discoloration appears, discard the vial and its contents.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zomacton

The active ingredient is somatropin: 4 mg in a vial, corresponding to a concentration of 1.3 mg/ml or 3.3 mg/ml after reconstitution.

The other components are:

Powder: Mannitol

Solvent: 9 mg/ml of benzyl alcohol, sodium chloride, and water for injection

Zomacton contains less than 1 mmol of sodium (23 mg) per dose, so it is considered essentially "sodium-free".

Appearance of the product and contents of the package.

Zomacton is a powder and solvent for injectable solution.

Powder in a vial (4 mg of somatropin) and solvent in an ampoule (3.5 ml) in three types of packaging:

- packaging of 1, 5 or 10 vials or,

- with a syringe and a needle.

Package of 5 vials

Not all packaging is marketed.

The powder is white to off-white in color. After reconstitution, the solution is clear and transparent.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Ferring S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Responsible for manufacturing:

Ferring GmbH

Wittland 11, D-24109 Kiel

Germany

This medicine is authorized in the members of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

AustriaZOMACTON 4 mg -Powder and solvent for the preparation of an injection solution

BelgiumZomacton

DenmarkZomacton

FinlandZomacton

FranceZomacton 4 mg

GermanyZomacton 4 mg

GreeceZomacton

IrelandZomacton

ItalyZomacton

LuxembourgZomacton

NetherlandsZomacton 4 mg

PortugalZomacton

SpainZomacton

SwedenZomacton

United Kingdom (Northern Ireland)Zomacton

Last review date of this leaflet: September 2021.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/