Label: information for the user

Omnitrope 5mg/1.5ml injectable solution in cartridge

Omnitrope 10mg/1.5ml injectable solution in cartridge

Omnitrope 15mg/1.5ml injectable solution in cartridge

somatropin

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, pharmacist, or nurse.
• This medication has been prescribed only to 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, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Omnitrope is a recombinant human growth hormone (also known as somatropin). It has the same structure as natural human growth hormone, which is necessary for bone and muscle growth. It also helps to develop body tissues and muscles in the correct amounts. It is recombinant, meaning it is not produced from human or animal tissue.

Omnitrope is used in children to treat the following growth disorders:

• If you do not grow adequately and do not have enough natural growth hormone.
• If you have Turner syndrome, a genetic disorder in girls that can affect growth; your doctor will have told you if you have this condition.
• If you have chronic renal insufficiency. As the kidneys lose their ability to function normally, this can affect growth.
• If you were too small or underweight at birth. Growth hormone can help you grow more if you have not had a growth spurt or maintained normal growth by the age of four or later.
• If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone can help you grow more if you continue to grow and also improve your body composition. Excess fat will decrease and reduced muscle mass will improve.

Omnitrope is used in adults to

• Treat individuals with a pronounced deficiency of growth hormone. This can start in adulthood or continue from childhood.

If you were treated with Omnitrope for growth hormone deficiency in childhood, your growth hormone status will be re-examined after growth is complete. If a severe deficiency is confirmed, your doctor will propose continuing treatment with Omnitrope.

You should only receive this medication from a doctor who has experience with growth hormone and has confirmed your diagnosis.

Do not use Omnitrope

• if you are allergic (hypersensitive) to somatropin or any of the other components of Omnitrope.
• inform your doctor if you have an active tumor (cancer). Tumors must be inactive and you must have completed your antitumor treatment before starting Omnitrope treatment.
• inform your doctor if you have been prescribed Omnitrope to stimulate growth but you have already stopped growing (closed epiphyses).
• if you are severely ill (for example, postoperative complications after open-heart surgery, abdominal surgery, accidental trauma, acute respiratory insufficiency, or similar conditions). If you are going to have or have had major surgery, or if you are in the hospital for any reason, inform your doctor and remind other doctors you see that you are using growth hormone.

Warnings and precautions

Consult your doctor before starting to use Omnitrope.

• 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 are at risk of developing diabetes, your doctor must regularly monitor your blood glucose concentration during somatropin treatment.
• If you have diabetes mellitus, you must closely monitor your blood glucose concentration during somatropin treatment and discuss the results with your doctor to decide if you need to change your diabetes medication dose.
• After starting somatropin treatment, some patients may need to start thyroid hormone replacement therapy.
• If you are receiving thyroid hormone replacement therapy, you may need to adjust your thyroid hormone dose.
• If you experience increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting), you must inform your doctor.
• If you limp or start limping during somatropin treatment, you must inform your doctor.
• If you are receiving somatropin for growth hormone deficiency after a previous tumor (cancer), your doctor must regularly examine you to detect tumor recurrence or any other cancer.
• If you experience worsening abdominal pain, you must inform your doctor.
• Experience in patients over 80 years of age is limited. Older people may be more sensitive to somatropin action and may be more prone to adverse reactions.
• Omnitrope may cause pancreatitis, which causes severe abdominal and back pain. Contact your doctor if you or your child experience stomach pain after Omnitrope administration.
• Spinal curvature (scoliosis) may increase in any child during rapid growth. Your doctor will examine you (or your child) to detect signs of scoliosis during somatropin treatment.

Children with chronic renal insufficiency

• Your doctor must examine kidney function and growth rate before starting somatropin treatment. Kidney disease treatment must continue. Somatropin treatment must be interrupted in case of kidney transplant.

Children with Prader-Willi syndrome

• Your doctor will give you dietary restrictions to follow to control your weight.
• Your doctor will evaluate signs of upper airway obstruction, sleep apnea (where breathing is interrupted during sleep), or respiratory infection before starting somatropin treatment.
• During somatropin treatment, inform your doctor if you experience signs of upper airway obstruction (including starting to snore or worsening of snoring). Your doctor may need to examine you and may interrupt somatropin treatment.
• During treatment, your doctor will examine you to see if there are signs of scoliosis, a type of vertebral deformity.
• During treatment, if you experience a lung infection, inform your doctor so they can treat the infection.

Children born too small or underweight

• If you were too small or underweight at birth and you are between 9 and 12 years old, consult your doctor specifically about puberty and treatment with this medication.
• Treatment must continue until you have stopped growing.
• Your doctor will examine your glucose and insulin concentrations before starting treatment and every year during treatment.

Using Omnitrope with other medications

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

Particularly, inform your doctor if you are taking or have recently taken any of the following medications. Your doctor may need to adjust the dose of Omnitrope or the other medications:

• diabetes medications;
• thyroid hormones;
• medications to control epilepsy (anticonvulsants);
• ciclosporin (a medication that weakens the immune system after transplants);
• oral estradiol or other sex hormones;
• synthetic adrenal hormones (corticosteroids).

Your doctor may need to adjust the dose of these medications or the dose of somatropin.

Pregnancy and breastfeeding

You must not use Omnitrope if you are pregnant or trying to become pregnant.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because you may form benzyl alcohol in your body and cause side effects (called "metabolic acidosis").

Important information about some components of Omnitrope

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

Omnitrope 5 mg/1.5 ml injectable solution:

This medication contains 9 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of severe adverse effects, including respiratory problems (called "breathing syndrome") in young children.

You must not administer it to your newborn (up to 4 weeks old), unless your doctor recommends it.

If you have liver or kidney disease, consult your doctor or pharmacist. This is because you may form large amounts of benzyl alcohol in your body and cause side effects (called "metabolic acidosis").

Due to the presence of benzyl alcohol, the medication should not be administered to premature children or newborns. It may cause toxic reactions and allergic reactions in children up to 3 years old.

Do not use it for more than a week in young children (under 3 years old), unless your doctor or pharmacist advises you to.

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

The dose depends on your size, the condition for which you are receiving treatment and how well the growth hormone works in you. Everyone is different. Your doctor will advise you about your individualized dose of Omnitrope in milligrams (mg) from your body weight in kilograms (kg) or by your body surface, calculated from your height and weight in square meters (m2), as well as your treatment schedule. Do not change the dosage and treatment schedule without consulting your doctor.

The recommended dose is for:

Children with growth hormone deficiency:

0.025 to 0.035mg/kg of body weight per day or 0.7 to 1.0mg/m2of body surface per day. Higher doses may be used. When growth hormone deficiency continues during adolescence, Omnitrope should continue until physical development is complete.

Girls with Turner syndrome:

0.045 to 0.050mg/kg of body weight per day or 1.4mg/m2of body surface per day.

Children with chronic renal insufficiency:

0.045 to 0.050mg/kg of body weight per day or 1.4mg/m2of body surface per day. Higher doses may be needed if growth rate is too low. The dose may need to be adjusted after six months of treatment.

Children with Prader-Willi syndrome:

0.035mg/kg of body weight per day or 1.0mg/m2of body surface per day. The daily dosage should not exceed 2.7mg. Treatment should not be used in children who have almost stopped growing after puberty.

Children born smaller or with lower weight than expected and with growth disorder:

0.035mg/kg of body weight per day or 1.0mg/m2of body surface per day. It is essential to continue treatment until final height is reached. Treatment should be discontinued after the first year if it does not respond, or if final height has been reached and growth has stopped.

Adults with growth hormone deficiency:

If you continue to use Omnitrope after treatment during childhood, start with 0.2 to 0.5mg per day.

This dosage should be increased or decreased gradually based on blood test results, as well as clinical response and side effects.

If growth hormone deficiency begins during adult life, start with 0.15 to 0.3mg per day. This dosage should be increased gradually based on blood test results, as well as clinical response and side effects. The daily maintenance dose is rarely more than 1.0mg per day. Women may need higher doses than men. Dosage should be monitored every six months. People over 60years should start with a dose of 0.1to 0.2mg per day, which should be increased slowly as needed. The minimum effective dose should be used. The maintenance dose is rarely more than 0.5mg per day. Follow the instructions given by your doctor.

Omnitrope injection:

Inject the growth hormone more or less at the same time every day. Bedtime is a good time because it is easy to remember. Additionally, it is natural to have a higher concentration of growth hormone at night.

Omnitrope 5mg/1.5ml in a cartridge for SurePal5 is intended for multiple uses. It should only be administered with SurePal5, a specifically developed injectable device for use with Omnitrope 5mg/1.5ml injectable solution.

Omnitrope 10mg/1.5ml in a cartridge for SurePal10 is intended for multiple uses. It should only be administered with SurePal10, a specifically developed injectable device for use with Omnitrope 10mg/1.5ml injectable solution.

Omnitrope 15mg/1.5ml in a cartridge for SurePal15is intended for multiple uses. It should only be administered with SurePal15, a specifically developed injectable device for use with Omnitrope 15mg/1.5ml injectable solution.

Omnitrope is indicated for subcutaneous use. This means it is injected through a small needle for injection into the fatty tissue, below the skin. Most people inject in the thigh or buttocks. Place the injection in the site that your doctor has shown you. The skin fat may be reduced at the injection site. To avoid this, use a different site each time for injection. This gives the skin and the area below it time to recover from an injection before receiving another in the same site.

Your doctor should have already shown you how to use Omnitrope. Inject Omnitrope exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist.

How to inject Omnitrope:

The following instructions explain how to inject Omnitrope yourself. Read the instructions carefully and follow them step by step. Your doctor or nurse will show you how to inject Omnitrope. Do not attempt to inject yourself unless you are sure you understand the procedure and what is involved in the injection.

• Omnitrope is administered as an injection under the skin.
• Inspect the solution carefully before injecting it and use it only if it is clear and colorless.
• Change the injection site to minimize the risk of local lipoatrophy (reduction of fatty tissue under the skin).

If you use more Omnitrope than you should:

If you inject much more than you should, consult your doctor or pharmacist as soon as possible. Your blood sugar level may drop too low and then rise too high. You may feel shaky, sweaty, drowsy, or “not like yourself,” and you may faint.

If you forget to use Omnitrope:

Do not use a double dose to make up for missed doses. It is best to use growth hormone regularly. If you forget to use a dose, inject the next dose at the usual time the next day. Note the missed doses and inform your doctor at the next check-up.

If you interrupt treatment with Omnitrope:

Consult your doctor before stopping treatment with Omnitrope.

If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Very common and common side effects in adults may start in the first few months of treatment and may stop on their own or if the dose is reduced.

The very common side effects (that are likely to occur in more than 1 in 10patients) include the following:

• Joint pain
• Water retention (which presents as swelling of the fingers or ankles, for a brief period of time at the start of treatment)
• Redness, itching, or pain at the injection site)

The common side effects (that are likely to affect fewer than 1 in 10patients) include the following:

• Itchy skin rashes
• Skin eruption
• Numbness, tingling
• Stiffness of the arms and legs, muscle pain

In adults

• Pain or tingling sensation in the hands or forearms (known as carpal tunnel syndrome)

The uncommon side effects (that are likely to affect fewer than 1 in 100patients) include the following:

• Enlargement of the breasts (gynecomastia)
• Craving

The rare side effects (that are likely to affect fewer than 1 in 1,000patients) include the following:

In children

• Leukemia (has been observed in a small number of patients with growth hormone deficiency, some of whom had been treated with somatropin. However, there is no indication that the incidence of leukemia is higher in growth hormone receptor patients without predisposing factors)
• Increased intracranial pressure (which causes symptoms, such as intense headache, visual disturbances, or vomiting)

Unknown frequency (cannot be estimated from available data)

• Type 2 diabetes
• Decreased cortisol levels in the blood
• Facial swelling
• Headache
• Hypothyroidism

In adults

• Increased intracranial pressure (which causes symptoms, such as intense headache, visual disturbances, or vomiting)

Formation of antibodies against the injected growth hormone, but these do not appear to make the growth hormone stop working.

The skin around the injection site may become irregular or develop lumps, but this should not occur if injected in a different place each time.

There have been rare cases of sudden death in patients with Prader-Willi syndrome. However, these cases have not been related to treatment with Omnitrope.

Your doctor may consider a femoral head epiphysiodesis or Legg-Calvé-Perthes disease if you experience pain or discomfort in the hip or knee while being treated with Omnitrope.

Other possible side effects related to your treatment with growth hormone may include the following:

You (or your child) may have high blood sugar levels or low thyroid hormone levels. Your doctor can analyze this and, if necessary, prescribe the appropriate treatment. In rare cases, inflammation of the pancreas has been observed in patients treated with growth hormone.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

• Store and transport refrigerated (between 2°C and 8°C).
• Do not freeze.
• Store in the original packaging to protect it from light.
• After administration of the first injection, the cartridge must remain in the syringe and must be stored in a refrigerator, at a temperature of2to8°C, and it should only be used within a maximum of 28days.

Do not use Omnitrope if you observe that the solution is cloudy.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Omnitrope 5mg/1.5ml

• The active ingredient of Omnitrope is somatropin.

Each ml of solution contains 3.3mg of somatropin (which corresponds to 10UI).

One cartridge contains 5.0mg (which corresponds to 15UI) of somatropin in 1.5ml.

• The other components are:

Hydrogen phosphate monohydrate heptahydrate

Dihydrogen phosphate monosodium dihydrate

Manitol

Poloxamer 188

Benzyl alcohol

Water for injection

Composition of Omnitrope 10mg/1.5ml

• The active ingredient of Omnitrope is somatropin.

Each ml of solution contains 6.7mg of somatropin (which corresponds to 20UI).

One cartridge contains 10.0mg (which corresponds to 30UI) of somatropin in 1.5ml.

• The other components are:

Hydrogen phosphate monohydrate heptahydrate

Dihydrogen phosphate monosodium dihydrate

Glycine

Poloxamer 188

Phenol

Water for injection

Composition of Omnitrope 15mg/1.5ml

• The active ingredient of Omnitrope is somatropin.

Each ml of solution contains 10mg of somatropin (which corresponds to 30UI).

One cartridge contains 15.0 mg (which corresponds to 45UI) of somatropin in 1.5ml.

• The other components are:

Hydrogen phosphate monohydrate heptahydrate

Dihydrogen phosphate monosodium dihydrate

Sodium chloride

Poloxamer 188

Phenol

Water for injection

Appearance of the product and contents of the pack

Omnitrope is a transparent and colourless injectable solution.

Omnitrope 5mg/1.5ml solution for injection is for use only in SurePal5.

Omnitrope 10mg/1.5ml solution for injection is for use only in SurePal10.

Omnitrope 15mg/1.5ml solution for injection is for use only in SurePal15.

Packs containing 1, 5or 10cartridges.

Only some pack sizes may be marketed.

Marketing authorisation holder

Sandoz GmbH

Biochemiestr. 10

A-6250 Kundl

Austria

Manufacturer responsible

SandozGmbH

Biochemiestr. 10

A-6336Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestr. 10

A-6336 Langkampfen

Austria

Last review date of this leaflet: {MM/YYYY}.

For detailed information on this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu.

For further information on this medicinal product, please contact the local representative of the marketing authorisation holder: