• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Humatrope is and what it is used for
2. What you need to know before you use Humatrope
3. How to use Humatrope
4. Possible side effects
5. How to store Humatrope
6. Contents of the pack and other information

• Treatment of children and adolescents with any of the following growth disorders:
  • Insufficient production of growth hormone (Growth hormone deficiency),
  • Absence of all or some of the X-sex chromosomes in females with short stature (Turner syndrome),
  • A condition in which the kidneys are damaged (chronic problems with the way the kidneys work) in children before puberty with growth retardation,
  • Small at birth (SGA = Small for gestational age) with failure to catch-up height by 4 years of age or later,
  • An alteration to a gene called SHOX (SHOX deficiency).
• Treatment of adults who have confirmed growth hormone deficiency beginning in either childhood or adulthood.

• if you are allergic (hypersensitive) to somatropin or any of the other ingredients of Humatrope (e.g. metacresol, glycerol in the solvent), see section 6.
• and tell your doctor if you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Humatrope.
• if you have already stopped growing and want to promote further growth in height (closed growth plates at the end of long bones). Your doctor will examine you to decide if you still require Humatrope after your bones have stopped growing.
• if you are very ill and require intensive medical care for a serious heart or abdominal operation, being treated for multiple injuries from an accident, or require mechanical breathing treatment following acute lung failure.

Talk to your doctor or pharmacist before using Humatrope.

If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.

If you have been treated for growth hormone deficiency during childhood, your doctor will re-examine you for growth hormone deficiency to decide if you require further Humatrope treatment during adulthood.

If you have completed previous anti-tumour therapy, a scan of your brain may be required before the start of Humatrope treatment. You should be examined regularly to make sure that the tumour does not come back or start growing.

A higher risk for having a second tumour (benign and malignant) has been reported in patients that survived their cancer and were treated with somatropin. Of these second tumours, in particular, brain tumours were the most common.

If you have symptoms such as frequent or bad headache, with nausea and/or vision problems occur, tell your doctor immediately. Your doctor should perform an examination of the eyes to look for evidence of increased brain pressure. Depending on the results of this examination, treatment with Humatrope may have to be interrupted.

If you develop a limp or pain in the hip, please ask your doctor for advice. During periods of growth, you may develop bone disorders in your hips.

If you start treatment, Humatrope can affect the amount of thyroid hormones in your blood. If the thyroid hormone level is low, it may reduce your response to Humatrope. Therefore, you must have regular thyroid function tests regardless whether you receive thyroid hormone therapy or not.

If you are a child, make sure that you continue treatment until the end of growth has been reached.

If you take a higher than prescribed dose of Humatrope, you may experience overgrowth of some parts of your body such as ears, nose, jaw, hands and feet. Overdose may also lead to increased levels of blood sugar and sugar in the urine. Always use Humatrope as recommended by your doctor.

If you have growth disorder due to kidney damage, treatment with Humatrope should be stopped prior to kidney transplantation.

If you have acute critical illness, your treating doctor should be notified. Deaths have been reported in patients receiving somatropin during critical illness.

If you are growth hormone deficient and also have Prader-Willi syndrome (a genetic disorder), your doctor should examine you for breathing problems and airway infections before starting Humatrope treatment, especially if you are overweight, have previously experienced severe breathing problems (especially during sleep), or suffered infection of the lungs or airways. If during treatment you have signs of breathing problems (snoring), treatment should be interrupted and the cause assessed by your doctor.

Humatrope may affect the way your body handles sugar from food and drink by interfering with the way your body uses insulin. Therefore, if you take Humatrope, your doctor should check if your body is dealing with the sugars correctly.

If you have diabetes mellitus, your insulin dose may need to be adjusted after starting Humatrope treatment. Your doctor will check the amount of sugar in your blood and may adjust your diabetes therapy.

If you have a growth disorder associated with being born small for gestational age, your blood sugar and insulin levels will be checked before starting the treatment and regularly during treatment.

Elderly patients (over 65 years) may be more sensitive to Humatrope and may be prone to side effects.

Humatrope may cause an inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if you or your child develops stomach ache after taking Humatrope.

Scoliosis (an increase in sideways curvature of the spine) may progress in any child during rapid growth. Signs of scoliosis should be monitored during treatment.

Tell your doctor or pharmacist if you are using, have recently used or are planning to use any other medicines.

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

• medicines for the treatment of diabetes mellitus which may have to be adjusted.
• adrenal steroid hormone (glucocorticoid), such as cortisone or prednisolone; your doctor may need to adjust the dose because the combination of these medicines with Humatrope may reduce the effect of both treatments.
• oestrogen taken orally or other sex hormones, as it may affect the response to growth hormone treatment. If there is a change to the way oestrogen is taken (e.g. oral to transdermal: through the skin); Humatrope dose may need to be adjusted.
• medicines to prevent seizure (anticonvulsants) or cyclosporine.

Humatrope should not be used during pregnancy, unless your doctor tells you to do so. If you become pregnant, tell your doctor immediately.

It is not known whether somatropin enters the breast milk. If you are breast-feeding, or intend to breast-feed, please ask your doctor for advice before using Humatrope.

Humatrope has no known effect on ability to drive or use machines.

This medicine contains less than 1 mmol sodium (23mg) per daily dose, that is to say essentially sodium-free.

Your doctor will advise you on your dosage and administration schedule. Do not change your dosage without talking to your doctor.

Usually, treatment with Humatrope is a long term treatment; your doctor may need to adjust your dose over time depending on your body weight and response to treatment. In general, the dose is calculated according to the following recommendations and administered once daily:

• Growth hormone deficiency:
  0.025–0.035 mg/kg body weight daily,
• Turner syndrome:
  0.045–0.050 mg/kg body weight daily,
• Chronic problems with the way the kidneys work:
  0.045–0.050 mg/kg body weight daily,
• Small for gestational age at birth:
  0.035 mg/kg body weight daily. Treatment should be discontinued after the first year of treatment if the growth rate is insufficient,
• SHOX gene deficiency:
  0.045-0.050 mg/kg body weight daily.

Growth hormone deficiency in adults:

Treatment should be started with a low dose of 0.15–0.30 mg daily. Lower starting doses may be required in older and overweight patients. The starting dose may be increased gradually according to your individual requirements. Total daily dose usually does not exceed 1 mg.

Dose requirements may decline with increasing age. Women, especially those on oral oestrogen replacement, may require higher doses than men.

If you have injected more Humatrope than you should have, please ask your doctor for advice.

• If you have injected too much Humatrope, initially your blood sugar may decrease and become too low (hypoglycaemia) and subsequently increase and become too high (hyperglycaemia).
• If you inject too much Humatrope over a longer period (years), you may experience overgrowth of some parts of your body such as ears, nose, jaw, hands and feet (acromegaly).

Do not inject a double dose to make up for a forgotten dose. Continue with the prescribed dosage. If you forget to inject Humatrope and have any doubts about what to do, please contact your doctor.

Please ask your doctor for advice before stopping treatment. Interruption or early stopping of treatment with Humatrope may impair the success of the Humatrope treatment.

If you get any of the side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via

United Kingdom (Great Britain and Northern Ireland):

or search for MHRA Yellow Card in the Google Play or Apple App Store,

Malta:

By reporting side effects you can help provide more information on the safety of this medicine.

Powder in a cartridge

The active substance is somatropin. Each cartridge contains 6 mg, 12 mg or 24 mg depending on the strength. When reconstituted:

• Humatrope 6 mg gives 2.08 mg somatropin per ml solution
• Humatrope 12 mg gives 4.17 mg somatropin per ml solution
• Humatrope 24 mg gives 8.33 mg somatropin per ml solution

The other ingredients are: mannitol, glycine, dibasic sodium phosphate.

[Phosphoric acid or sodium hydroxide (or both) may have been used in the manufacturing process to adjust acidity].

Sterile Diluent Syringe

The pre-filled solvent syringe contains: glycerol, metacresol, water for injection. [Hydrochloric acid or sodium hydroxide (or both) may have been used in the manufacturing process to adjust acidity].

Humatrope 6 mg:

• 1 cartridge with white powder for solution for injection,
• 3.17 ml of clear colourless solvent solution in a pre-filled syringe
  Pack size of 1, 5 and 10

Humatrope 12 mg:

• 1 cartridge with white powder for solution for injection,
• 3.15 ml of clear colourless solvent solution in a pre-filled syringe
  Pack size of 1, 5 and 10

Humatrope 24 mg:

• 1 cartridge with white powder for solution for injection,
• 3.15 ml of clear colourless solvent solution in a pre-filled syringe.
  Pack size of 1, 5 and 10

Not all pack sizes may be available in your country

You will require five items:

1. Humatrope cartridge of the correct strength
2. A syringe filled with diluent
3. A CE-marked Humatrope pen
4. A sterile pen needle, and
5. An alcohol swab

Wash your hands before you continue with the next steps

*Note: The liquid is colourless. It is shown here as blue for illustration purposes only.

Step 1 Unpacking

• You must only mix Humatrope with the diluent provided. Never mix it with anything else unless your doctor tells you to.
• Please read the user manual that comes with your pen. This will remind you what you have been taught by your doctor or health care professional.
• Please follow the instruction underneath the diagrams

1a Remove ALL contents from the tray. Note: This product is designed for left or right handed use. Please feel free to use whichever hand is most comfortable for you.

1b Grasp Needle Cover, which is at the bottom of the Diluent Syringe.

1c Remove Needle Cover and discard. DO NOT depress Plunger yet. It is okay if a drop of fluid is lost. It is not necessary to release air from the Diluent Syringe.

Step 2&3 Connecting the cartridge

2 Hold cartridge, Black Triangles up. Align the cartridge and Diluent Syringe in a straight line. DO NOT insert the cartridge at an angle.

3 PUSH the cartridge STRAIGHT in until it stops AND the Black Triangles ARE COVERED. You may hear or feel a click. DO NOT twist the cartridge.

Step 4 Mixing Humatrope

4a Hold the Diluent Syringe and the cartridge together with TWO HANDS. Push and release the Plunger 2 or 3 times until the Diluent is in the cartridge.

4b Remove thumb from the Plunger and check that the Diluent Syringe is empty (it is normal for small drops of Diluent to remain in the Diluent Syringe).

Step 5&6 Release Cartridge and Discard Diluent

5 With thumb OFF the plunger, pull the cartridge from the Diluent Syringe.

6 Place the End Cap on a hard, flat surface. Push the Diluent Syringe onto the End Cap and immediately discard the Diluent Syringe as instructed by your healthcare professional.

Step 7 Gently Mix

• Mix the solution by gently rotating the cartridge 10 times. DO NOT SHAKE THE CARTRIDGE. Let the cartridge sit for 3 minutes, then inspect the solution carefully.
• If the solution is cloudy or contains particles, gently mix the cartridge another 10 times. Let the cartridge sit for 5 more minutes. If the solution remains cloudy or contains particles DO NOT USE THE CARTRIDGE.

Step 8 Injecting Humatrope using a suitable pen injection system

• If the solution is clear, your cartridge is now ready to be attached to the suitable Humatrope pen.
• Put the cartridge in the pen (see the user manual for the pen)
• Always use a new sterile needle for each injection
• Wipe the skin thoroughly with an alcohol swab. Let the skin dry.
• Set the correct dose (see the user manual of the pen)
• Inject slowly under the skin (subcutaneous) in the way you have been taught by your doctor.
• Remove the needle from the skin and safely dispose of the needle, as you have been shown by your doctor or health care professional.
• Keep your pen with the rest of the Humatrope in the fridge. Do not use any Humatrope left over in the pen after 28 days of mixing.

Humatrope is a trademark of Eli Lilly and Company Limited