Zomacton 10 mg/ml powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zomacton 10 mg/ml powder and solvent for injectable solution

Somatropin

Read this entire leaflet carefully before you start using the medicine, as 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 personally and must not be given to other people, 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.

Contents of the leaflet:

1. What Zomacton is 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 other information

The information in this leaflet applies to you or to a child or adolescent under your care.

1. What Zomacton is and what it is used for

Zomacton contains the active substance somatropin, also known as growth hormone. Growth hormone is naturally produced in the body and plays a very important role in growth. Zomacton contains somatropin obtained from a pharmaceutical manufacturing facility.

Zomacton is used for long-term treatment of:

• Growth problems due to growth hormone deficiency in children;
• Growth problems due to Turner syndrome (a genetic disorder affecting females).

2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE ZOMACTON

Do not use Zomacton

• In children when bone growth is complete (closed epiphyses)
• Do not use Zomacton and inform your doctor if you have an active tumor (cancer). Tumors must be inactive and antitumor treatment must have been completed before starting treatment with Zomacton
• If you are allergic to any of the components of Zomacton or to any of the ingredients of this medicine (listed in section 6)
• If you are seriously ill due to the following complications: open-heart or abdominal surgery, major trauma from an accident, or respiratory failure
• In children with chronic renal disease following kidney transplantation

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Zomacton.

Treatment with Zomacton should only be initiated under the supervision of a specialist physician experienced in diagnosing patients with growth hormone deficiency.

• Zomacton contains a preservative called metacresol. In very rare cases, the presence of metacresol may cause muscle inflammation (swelling). If you experience muscle pain or pain at the injection site, inform your doctor.

• Patients with Prader-Willi syndrome should not be treated with Zomacton unless they also have growth hormone deficiency.

• If you have a family history of diabetes mellitus, your blood sugar levels should be regularly monitored by your doctor.

• If you are diabetic, strict blood glucose monitoring will be required and your dose may need to be adjusted to maintain diabetic control. Your doctor will inform you if this is necessary.

• If your growth hormone deficiency is due to a problem in your brain (intracranial lesion), you should be examined regularly to assess for possible worsening or recurrence of the condition. If this is confirmed, your doctor will inform you whether treatment with Zomacton needs to be discontinued.

• If you have previously had a serious illness such as cancer, treatment with Zomacton may cause the disease to reappear or worsen. Therefore, if you experience any symptoms that concern you, you should consult your doctor immediately.

• If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need to be adjusted.

• Treatment with Zomacton may lead to thyroid hormone deficiency, which may require treatment. To monitor this, your doctor will periodically check that your thyroid gland is functioning properly.

• Some children with growth hormone deficiency have developed leukemia (increased number of white blood cells in the blood), regardless of whether they received growth hormone treatment or not. However, there is no evidence that the incidence of leukemia is increased in patients without risk factors who are treated with growth hormone. No causal relationship with growth hormone treatment has been proven.

• If you develop complications following surgery, trauma, or acute respiratory failure.

• If you require surgery, have suffered a serious accident, or are severely ill, your doctor will review your treatment.

• Pancreatitis should be considered in children treated with somatropin who develop abdominal pain.

• Zomacton may cause inflammation of the pancreas, which causes severe abdominal and back pain. If you or your child develops stomach pain after receiving Zomacton, consult your doctor.

If you develop any of the following while being treated with Zomacton, contact your doctor or nearest medical facility urgently:

• Recurrent or severe headaches
• Vision problems
• Nausea and/or vomiting

Please consult your doctor immediately if you develop limping or hip or knee pain.

Use in athletes

This medicine contains somatropin, which may lead to a positive result in doping control tests.

Use of other medicines and Zomacton

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, inform your doctor if you are taking or have recently taken any of the following medicines. This is because your doctor may need to adjust the dose of Zomacton or of the other medicines:

• If you are being treated with steroids due to insufficient ACTH (adrenocorticotropic hormone) production. This is because steroid dosage usually needs to be adjusted while you are being treated with Zomacton.
• If you are being treated with high doses of androgens or other anabolic steroids, as they may reduce final height gain.
• If you are taking oral estrogens (e.g., contraceptives) or estrogen replacement therapy.
• If you are being treated with regularly prescribed medication, for example steroids, antiepileptic medication, or medication to suppress the immune system.
• If you are being treated with insulin, your dose may need to be adjusted to maintain diabetic control. Your doctor will inform you if this is necessary.

Pregnancy and breast-feeding

Zomacton must not be used during pregnancy or during breast-feeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Zomacton has no influence on the ability to drive or use machines.

3. How to use Zomacton

Follow exactly the administration instructions for Zomacton given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor or nurse will inform you of the correct dose for you. The dose is administered by subcutaneous injection (under the skin) using a syringe.

Dosage:

Growth hormone deficiency in children:

Your doctor will calculate the exact dose for you based on your body weight in kilograms (kg). The usual recommended dose is 0.17–0.23 mg per kg of body weight per week. This weekly amount may 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 (females only)

Your doctor will calculate the exact dose for you based on your body weight. A usual recommended dose is 0.33 mg per kg of body weight per week. This weekly amount may be divided into six or seven doses, equivalent to a daily dose of 0.05 mg per kg of body weight.

Reconstitution instructions

Zomacton is supplied as a powder and must be mixed only with the solvent (liquid) provided.

The 10 mg/ml solution for injection is prepared by mixing the Zomacton powder with 1 ml of solvent using a pre-filled syringe as described below.

1. You should wash your hands.
2. Remove the yellow plastic protective cap from the vial.
3. The top of the vial should be cleaned with an antiseptic solution or alcohol to prevent contamination of the contents. Do not touch the rubber stopper of the vial after cleaning.
4. Take the pre-filled syringe containing solvent. Remove the grey cap. Attach the reconstitution needle to the pre-filled syringe. Remove the needle cap.
5. Insert the needle into the center of the rubber stopper of the clean vial and into the vial, and slowly inject the solvent into the vial, directing the stream of liquid against the glass wall to avoid foaming.
6. Discard the syringe into a sharps disposal container.
7. Gently rotate the vial several times until the contents are completely dissolved. Do not shake.
8. If the solution is cloudy or contains particles, it must not be used. In case of cloudiness after refrigeration, allow the product to reach room temperature. If cloudiness persists, discard the vial and its contents.

The solution should be clear and colourless after reconstitution.

Reconstitution using a standard syringe

Step 5.

The vial should then be gently rotated until the powder has completely dissolved, forming a clear, colorless solution.

Place the reconstituted Zomacton vial upright in the refrigerator at 2°C to 8°C.

Avoid shaking or vigorous mixing. If the solution remains 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. If cloudiness persists, discard the vial and its contents.

Administration

The required dose of Zomacton 10 mg/mL is administered using a conventional syringe, as demonstrated to you by your healthcare professional at the clinic.

After reconstitution, perform the following steps for injection:

1. Wash your hands.
2. Clean the top of the vial with an alcohol swab to prevent contamination of its contents. Do not touch the rubber stopper after cleaning.
3. Turn the vial upside down, keeping the needle tip below the surface of the medication. Gently pull back the plunger until the prescribed amount of medication fills the syringe. If there is insufficient medication for a complete dose, reconstitute a new vial to make up the difference.
4. With the needle still in the inverted vial, gently tap the syringe to dislodge 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 as you would hold a pencil.
9. With your free hand, gently pinch the skin around the injection site between your fingers.
10. Insert the needle into the tissue beneath the skin surface at a 45° to 90° angle to minimize discomfort.
11. While holding the syringe in place, pull back slightly on the plunger (if blood appears in the syringe, this indicates that a blood vessel has been entered. Do not inject ZOMACTON. Remove the needle, discard all supplies, and return to step 1. Select and clean a new injection site). If no blood appears, slowly push the plunger until the syringe is empty.
12. Quickly withdraw the needle and apply pressure to the injection site with a sterile gauze pad. Dispose of the needle and syringe in a sharps disposal container.

Do not share your syringes, needles, or vials with anyone else. You could transmit an infection to them or become infected yourself. Any unused product or waste material must be disposed of according to local regulations.

Do not share your syringes, needles, or vials with anyone else. You could transmit an infection to them or become infected yourself.

Any unused product or waste material must be disposed of according to local regulations.

If you use more Zomacton than you should:

An overdose may cause low blood sugar (hypoglycemia), followed by high blood sugar (hyperglycemia).

If you or someone else has used more Zomacton than prescribed, contact your doctor or nearest hospital immediately. The effects of repeated overdose are unknown. Contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20, indicating the medication and amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If you forget to use Zomacton

If you miss a dose, do not worry. Resume your normal schedule and administer the next dose at its usual time.

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

You may experience hypoglycemia (low blood sugar levels), which can cause dizziness, confusion, and blurred vision. Although the long-term effectiveness of treatment will not be affected, you should consult your doctor if this occurs.

4. Possible adverse effects

Like all medicines, Zomacton may produce adverse effects, although not everyone experiences them.

Subcutaneous injection of growth hormone may cause gain or loss of fat, as well as bleeding and bruising (purple skin discoloration) at the injection site. Therefore, it is recommended to frequently rotate injection sites. Occasionally, patients have developed skin pain or itching at the injection site.

Very common adverse effects, affecting more than 1 in 10 treated patients: Adults only:

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

Common adverse effects, affecting between 1 and 10 in 100 treated patients: Children and adults:

• Hypothyroidism
• Immune reaction to growth hormone, which may be detected in a blood test (antibody formation)
• Headache
• Increased muscle tone stiffness (hypertonia)

Children only:

• Swelling due to fluid retention, especially in the hands and feet (Edema, peripheral edema)
• Injection site reactions
• Weakness (asthenia)
• Impaired glucose tolerance
• Joint pain (Arthralgia)
• Muscle pain (Myalgia)

Adults only:

• Stiffness in legs and/or arms
• Difficulty falling asleep and/or staying asleep (insomnia)

Uncommon adverse effects, affecting between 1 and 10 in 1,000 treated patients:

Children and adults:

• Anemia
• Rapid heartbeat (tachycardia)
• Sensation of dizziness (vertigo)
• Double vision (diplopia)
• Papilledema
• Vomiting, abdominal pain, flatulence, nausea
• Weakness
• Atrophy at injection site, bleeding at injection site, lump at injection site, hypertrophy
• Low blood sugar levels (hypoglycemia)
• Hyperphosphatemia (elevated blood phosphate levels)
• Muscle atrophy
• Bone pain
• Carpal tunnel syndrome
• Malignant neoplasm, neoplasm
• Somnolence
• Involuntary eye movements (nystagmus)
• Personality disorders
• Urinary incontinence, hematuria (blood in urine), polyuria (increased urine volume), increased urinary frequency, urinary abnormalities
• Injection site reactions (including lipodystrophy, skin atrophy, exfoliative dermatitis, urticaria, hirsutism, skin hypertrophy)
• Breast enlargement (gynecomastia)

Children only:

• Stiffness in legs and/or arms

Adults only:

• High blood pressure (hypertension)

Rare adverse effects, affecting between 1 and 10 in 10,000 treated patients:

Children and adults:

• Diarrhea
• Abnormal kidney function tests
• Type 2 diabetes mellitus
• Tingling or numbness in certain areas of the body (neuropathy)
• Fluid retention around the brain (manifested as recurrent or severe headache, blurred vision, and nausea and/or vomiting)
• Pain and rash at injection site

Children only:

• High blood pressure (hypertension)
• Difficulty falling asleep and/or staying asleep (insomnia)
• Numbness, tingling, burning, or prickling sensations in the skin (Paresthesia)

Very rare adverse effects, affecting fewer than 1 in 10,000 treated patients:

Children only:

• Leukemia (the occurrence appears to be no more frequent than in children in the general population).

Frequency not known (cannot be estimated from available data)

Children only:

• Facial swelling
• Itching of the skin (pruritus)
• Skin rash

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 Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zomacton

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

Do not use Zomacton after the expiry date stated on the container (EXP). The expiry date refers to the last day of the month indicated.

Store in a refrigerator at 2°C - 8°C; keep in the original packaging to protect from light.

After dissolving the powder in the provided solvent (reconstitution), store the vial upright at 2°C - 8°C (in the refrigerator).

After reconstitution, the solution should be used within 28 days. Any remaining solution in the vial must be discarded at the end of this period.

If cloudiness occurs after refrigeration, allow the solution to reach room temperature. If cloudiness persists or discoloration occurs, discard the vial and its contents.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE point. If you are unsure how to dispose of unused medicines or containers, ask your pharmacist. This helps protect the environment.

6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION

Composition of Zomacton

The active substance is somatropin 10 mg (10 mg/ml after reconstitution).

The other components are:

Powder: Mannitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate.

Solvent: Water for injection, metacresol.

What Zomacton looks like and contents of the pack

The product is a powder and solvent for injectable solution.

The powder is supplied in a vial and the solvent in a syringe. The powder is white to off-white. When dissolved in the provided solvent, a clear and transparent solution is formed.

Zomacton is available in packs of 1, 3 and 5, containing:

10 mg of somatropin in a vial and 1 ml of solvent in a syringe.

Not all pack sizes are marketed.

Marketing Authorization Holder:

FERRING S.A.U.

C/ del Arquitecto Sánchez Arcas nº3, 1º

28040 Madrid

Spain

Manufacturer: FERRING GmbH

Wittland 11, D-24109 Kiel

GERMANY

This medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under the following names:

Belgium ZOMACTON 10 mg/ml

Denmark ZOMACTON 10 mg

Finland ZOMACTON 10 mg/ml

France Zomacton 10 mg/ml

Germany ZOMACTON 10 mg/ml

Greece ZOMACTON 10 mg

Luxembourg ZOMACTON 10 mg/ml

Netherlands ZOMACTON 10 mg/ml

Spain ZOMACTON 10 mg

Sweden ZOMACTON 10 mg/ml

United Kingdom (Northern Ireland) ZOMACTON 10 mg

This text was approved in March 2026.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/