Label: information for the user

GENOTONORM MINIQUICK 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, 2.0 mgpowder and solvent for injectable solution

somatropin

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any effect not mentioned in this label, inform your doctor or pharmacist.

Genotonorm Miniquick is a recombinant human growth hormone (also known as somatropin). It has the same structure as human growth hormone, which is necessary for the growth of bones and muscles. It also helps to develop fat and muscle tissue in adequate amounts. The fact that it is recombinant means that it does not come from human or animal tissue.

Genotonorm Miniquick is used in children for the treatment of growth disorders:

• If you do not grow at an adequate rate or if you do not have enough growth hormone of your own.
• In the case of Turner syndrome. Turner syndrome is a chromosomal alteration that occurs in girls and can affect growth – your doctor will indicate if you have it.
• In the case of chronic renal insufficiency. If the kidney loses its ability to function properly, growth can be affected.
• In the case of Prader-Willi syndrome (a chromosomal alteration). Growth hormone will help you grow if you are still in the growth period and will also improve body composition. Excess fat will decrease and muscle mass loss will improve.
• If you were born small or with low weight. Growth hormone may help you grow if you have not been able to reach or maintain normal growth by the age of 4 or later.

Genotonorm Miniquick is used in adults for the treatment of people with a marked deficiency of growth hormone. This can start in adulthood, or it may have started in childhood and continued into adulthood.

If you have been treated with Genotonorm Miniquick for growth hormone deficiency during childhood, your growth hormone should be reevaluated after completing the growth phase. If a severe growth hormone deficiency is confirmed, your doctor will recommend continuing treatment with Genotonorm Miniquick.

This medication can only be prescribed by a doctor with experience in treating growth hormone and who has confirmed your diagnosis.

Do not use Genotonorm Miniquick and contact your doctor if

• You are allergic (hypersensitive) to somatropin or to any of the other components of Genotonorm Miniquick.
• You have an active tumor (cancer). Tumors must be inactive and you must have completed antitumor treatment before starting treatment with Genotonorm.

• You are severely ill (for example, complications after open-heart surgery, abdominal surgery, acute respiratory failure, accidental trauma, or a similar situation). If you are about to undergo or have undergone major surgery or are about to be admitted to the hospital for any reason, tell your doctor and remind other doctors who examine you that you use growth hormone.
• You have already completed your growth period (closed epiphyses) and were prescribed Genotonorm Miniquick to stimulate growth.

Be especially careful with Genotonorm Miniquick and contact your doctor

• If you have a risk of developing diabetes, your doctor will monitor your blood sugar levels during treatment with Genotonorm Miniquick.
• If you have diabetes, you must carefully monitor your blood sugar levels during treatment with Genotonorm Miniquick and see the results with your doctor to determine if you need to change the dose of your diabetes medications.
• After starting treatment with Genotonorm, some patients may need to begin treatment with thyroid hormone.
• If you are receiving thyroid hormone treatment, you may need to adjust the dose of thyroid hormone.
• If you are receiving growth hormone treatment to stimulate growth and limp, or if you start limping due to hip pain during growth hormone treatment, you must inform your doctor.
• If you experience an increase in intracranial pressure (with symptoms such as severe headaches, vision problems, or vomiting) you must inform your doctor about it.
• If you are receiving Genotonorm Miniquick for a deficiency of growth hormone after a previous tumor (cancer), you must undergo regular follow-up for possible recurrences of the tumor or any other cancer.
• If you experience abdominal pain that becomes more intense, you must inform your doctor.
• Experience in patients over 80 years of age is limited. Older people may be more sensitive to the action of Genotonorm Miniquick, and therefore may be more prone to developing adverse effects.

Children with chronic renal insufficiency:

• Your doctor will examine your renal function and growth rate before starting treatment with Genotonorm Miniquick. Your renal disease treatment must continue. Treatment with Genotonorm Miniquick should be suspended in case of kidney transplant.

Children with Prader-Willi syndrome:

• Your doctor will give you dietary restrictions to control your weight.
• Your doctor will perform an examination before starting treatment with Genotonorm Miniquick to determine if you have upper airway obstruction, sleep apnea (when breathing is interrupted during sleep), or respiratory infections.
• If during treatment you present signs of upper airway obstruction (including the onset or increase of snoring), your doctor will need to examine you and may interrupt treatment with Genotonorm Miniquick.
• During treatment, your doctor will monitor any signs of scoliosis, a type of spinal deformity.
• If during treatment you develop a lung infection, inform your doctor so that they can treat the infection.

Children born small or with low birth weight:

• If you were born small or with low birth weight and are between 9 and 12 years old, consult your doctor specifically about puberty and treatment with this product.
• Your doctor will perform blood sugar and insulin analyses before starting treatment and once a year while it lasts.
• Treatment must continue until you complete your growth phase.

Use in athletes

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Genotonorm.

If you are receiving glucocorticoid replacement treatment, you must consult your doctor regularly as you may need to adjust your glucocorticoid dose.

Inform your doctor if you are using:

• Diabetes medications
• Thyroid hormones
• Synthetic adrenal hormones (corticosteroids)
• Oral or other sex hormones
• Ciclosporin (a medication that weakens the immune system after a transplant)
• Anticonvulsants (medications for epilepsy control)

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

Pregnancy and lactation

Do not use Genotonorm if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Consult your doctor before using this medication while breastfeeding.

Consult your doctor or pharmacist before using any medication.

Genotonorm Miniquick contains sodium

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

Recommended Dose

The dose depends on your body surface area, the pathology for which you are being treated, and how your growth hormone works. Each person is different. Your doctor will inform you of your individualized dose of Genotonorm Miniquick in milligrams (mg) wellin accordance with your body weight in kilograms (kg) or your calculated body surface area based on your height and weight in square meters (m2), as well as your treatment schedule. Do not change or discontinue the dose or treatment schedule without consulting your doctor.

Children with growth hormone deficiency:

0.025-0.035mg/kg of body weight per day or 0.7-1.0 mg/m2of body surface area per day. Higher doses may be used. When growth hormone deficiency continues into adolescence, treatment with Genotonorm should be continued until physical development is complete.

Children with Turner syndrome:

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

Children with chronic renal insufficiency:

0.045-0.050mg/kg of body weight per day or 1.4 mg/m2of body surface area per day. If growth velocity is too low, higher doses may be necessary. Dose adjustment may be required after 6 months of treatment.

Children with Prader-Willi syndrome:

0.035mg/kg of body weight per day or 1.0 mg/m2of body surface area per day. The daily dose should not exceed 2.7 mg. This treatment should not be used in children whose growth phase has practically ended after puberty.

Small for gestational age or growth-retarded children:

0.035mg/kg of body weight per day or 1.0 mg/m2of body surface area per day. It is essential to continue treatment until final height is reached. Treatment should be discontinued after the first year if there is no response or if final height is reached and growth has stopped.

Adults with growth hormone deficiency:

If you continue to use Genotonorm Miniquick after treatment during childhood, start with a dose of 0.2-0.5 mg per day. This dose should be increased or decreased gradually based on analytical results, as well as clinical response and adverse effects.

If growth hormone deficiency begins during adulthood, start with 0.15-0.3mg per day. This dosing should be increased gradually based on analytical results, as well as clinical response and adverse effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months. Patients over 60 years old should start with doses of 0.1-0.2 mg per day and gradually increase as needed. Use the minimum effective dose. The maintenance dose rarely exceeds 0.5 mg per day. Follow the instructions provided by your doctor.

Genotonorm Miniquick Injection

Genotonorm Miniquick is administered subcutaneously. This means it is injected through a small needle into the fatty tissue, just below the skin. Your doctor will teach you how to use Genotonorm Miniquick. Always use Genotonorm Miniquick as instructed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Please read the “Instructions for use” at the end of this prospectus for information on how to use Genotonorm Miniquick.If you cannot remember how to administer the injection, do not attempt to give yourself the injection. Ask your doctor to re-teach you.

You can remove the growth hormone from the refrigerator 30 minutes before injection. This allows it to warm up a bit and makes the injection more comfortable.

Remember to wash your hands and clean the skin before injecting.

Administer the growth hormone injection at the same time every day. A good time is before bedtime, as it is easy to remember. It is also normal to have a higher level of growth hormone at night.

Most patients use the thighs or buttocks for the injection. Administer the injection where your doctor has instructed you. The fatty tissue under the skin may decrease in size at the injection site. To avoid this, change the injection site each time. This will give your skin and the area under the skin time to recover between injections before injecting in the same spot again.

If you use more Genotonorm Miniquick than you should

If you inject more than you should, consult your doctor or pharmacist immediately. Blood sugar levels may drop suddenly and then increase to very high levels. You may feel agitated, sweaty, drowsy, or feel strange and may feel dizzy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone91 5620420, indicating the medication and the amount ingested.

If you forget to administer Genotonorm Miniquick

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

It is better to administer the growth hormone regularly. If you forget to administer a dose, administer the next injection at the corresponding time the next day. Note the missed injections and inform your doctor at the next review.

If you interrupt treatment with Genotonorm Miniquick

Consult your doctor before interrupting treatment with Genotonorm Miniquick.

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

Like all medications, Genotonorm Miniquick may cause side effects, although not everyone will experience them.

Common and very common side effects in adults may begin in the first few months of treatment and disappear spontaneously or when the dose is reduced.

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

Adults:

• Joint pain.
• Fluid retention (manifesting as swollen fingers or ankles).

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

Children:

• Joint pain.
• Redness, itching, or temporary pain at the injection site.

Adults:

• Numbness/tingling.
• Pain or burning sensation in the hands or underarms (known as carpal tunnel syndrome).
• Stiffness in arms and legs, muscle pain.

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

Children:

• Leukemia (notified in a small number of patients with growth hormone deficiency, some of whom have received somatropin treatment. However, there is no evidence that leukemia incidence is increased in growth hormone receptor patients without predisposing factors).
• Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
• Numbness/tingling.
• Rash.
• Itching.
• Hives on the skin with itching.
• Muscle pain.
• Enlargement of the breast (gynecomastia).
• Fluid retention (manifesting as swollen fingers or ankle swelling, for a short period at the beginning of treatment).

Adults:

• Enlargement of the breast (gynecomastia).

Unknown frequency: cannot be estimated from available data:

• Type 2 diabetes.
• Swelling of the face.
• Headache.
• Decreased cortisol hormone concentrations in the blood.

Children:

• Stiffness in arms and legs.

Adults:

• Increased intracranial pressure (causing symptoms such as severe headache, vision problems, or vomiting).
• Rash.
• Itching.
• Hives on the skin with itching.
• Redness, itching, or pain at the injection site.

Formation of antibodies against the injected growth hormone, although this does not appear to affect the action of the growth hormone.

The skin around the injection site may become rough and irregular, but this should not occur if the injection is made in a different location each time.

Rare cases of sudden death in patients with Prader-Willi syndrome have been reported. However, no relationship has been established between these cases and treatment with Genotonorm Miniquick.

If you experience discomfort or pain in your hip or knee while receiving treatment with Genotonorm, your doctor may consider the possibility of suffering from femoral epiphysiolysis or Legg-Calvé-Perthes disease.

Other possible side effects related to growth hormone treatment are as follows.

You (or your child) may experience an increase in blood sugar levels or decreased thyroid hormone concentrations. Your doctor may perform tests to determine this and, if necessary, prescribe appropriate treatment. Occasionally, pancreatitis has been reported 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

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

Before reconstitution

Store in the refrigerator (2°C-8°C). Do not freeze. Store the syringe in the outer packaging to protect it from light.

Before opening, the product may be stored outside the refrigerator for a maximum period of 6 months at a temperature not exceeding 25°C. The date when the medication is removed from the refrigerator and the new expiration date must be noted on the outer packaging. This new expiration date must never exceed the date initially indicated on the outer packaging. If you have not used the medication before the new expiration date, discard it.

After reconstitution

Use immediately or store in the refrigerator (2°C-8°C) for a maximum of 24 hours. Do not freeze. Store the syringe in the outer packaging to protect it from light.

Do not use this medication if you observe particles or if the solution is not transparent.

Never throw needles or empty syringes in regular trash. When you have finished using the needle, dispose of it carefully in a special container for needles, so that no one can use it or get injured.

Medications should not be thrown down the drain or in regular trash. Deposit the packaging and unused medications at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. In this way, you will help protect the environment.

Composition of Genotonorm Miniquick

• The active ingredient is somatropin*.
• A vial contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2.0 mg of somatropin* in0.25ml after reconstitution, which corresponds to a concentration of 0.8 mg, 1.6 mg, 2.4 mg, 3.2 mg, 4.0 mg, 4.8 mg, 5.6 mg, 6.4 mg, 7.2 mg, and 8.0 mg/ml.
• The other components of the powder are: glycine (E640), mannitol (E421), anhydrous sodium phosphate (E339), and anhydrous disodium dihydrogen phosphate (E339) (see section 2 “Genotonorm Miniquick contains sodium”).
• The ingredients of the solvent are: water forinjectable preparations and mannitol (E421).

*Obtained inEscherichia colicells by DNA recombinant technology.

Appearance of Genotonorm Miniquickand contents of the package

Powder and solvent for solution for injection, in a double-chamber vial that contains the powder in one section and the solvent in the other (0.2mg/0.25 ml, 0.4mg/0.25 ml, 0.6mg/0.25 ml, 0.8mg/0.25 ml, 1.0 mg/0.25 ml, 1.2mg/0.25 ml, 1.4 mg/0.25 ml, 1.6 mg/0.25 ml, 1.8 mg/0.25 ml, or 2.0 mg/0.25ml). The vial is contained in a syringe. Package sizes: 4, 7, or 28 syringes.

Only some package sizes may be commercially available.

The powder is white and the solvent is transparent.

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid), Spain.

Responsible for Manufacturing

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870

Puurs-Sint-Amands

Belgium

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Genotropin Miniquick: Austria, Denmark, Germany, Greece, Ireland, Italy, Portugal, Sweden, United Kingdom (Northern Ireland).

Genotonorm Miniquick: Belgium, France, Luxembourg, Spain.

Last review date of this leaflet:May 2024

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

INSTRUCTIONS FOR USE OF GENOTONORM MINIQUICK

Genotonorm Miniquick is a syringe used to mix and administer a single dose of Genotonorm (growth hormone).

Genotonorm Miniquick is presented preloaded with a double-chamber vial and a needle. If you need additional needles, ask for the same Becton Dickinson Micro-finas needles that are supplied with Miniquick. The injection volume is always0.25ml.

Genotonorm Miniquick is disposable; after administering the dose, dispose of it as described in step 6.

The lower drawing identifies its different components.

The Genotonorm Miniquick vial contains the growth hormone powder in one chamber and the solvent in the other. When the plunger is turned clockwise, the growth hormone powder and the solvent mix, and the powder dissolves.

1. Remove the paper covering the injection needle..Place the needle firmly until it hits the rubber stopper.Turn the Genotonorm Miniquick needle clockwise until it cannot turn anymore.

1. Hold Genotonorm Miniquick with the needle pointing up. Turn the plunger clockwise until it reaches the top.

DO NOT SHAKE the solution. Mixgently. If the solution is shaken, it may foam with the growth hormone and damage the active ingredient.Check that the solution is transparent and use only transparent and particle-free solutions.

1. Remove the outer and inner needle caps.

1. Pinch firmly the area where the injection will be given and insert the needle.

1. Inject by pressing the plunger as far as possible to inject all the contents of Genotonorm Miniquick. Wait a few seconds before removing the needle, to allow enough time for all the growth hormone to be injected.

1. After the injection, do not try to cap the needle with the cap. Dispose of the syringe with the needle, and the outer and inner needle caps, following the usual procedures or the instructions given by your doctor or pharmacist.

QUESTIONS AND ANSWERS