Label: Information for the user

HUMULINA NPH KwikPen 100UI/ml injectable suspension

(Human insulin)

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 do not appear in this label. See section 4.

1. What isHumulina NPH KwikPenand how it is used

2. What you need to knowbefore starting to useHumulina NPH KwikPen

3. How to useHumulina NPH KwikPen

4. Possible adverse effects

5. Storage ofHumulina NPH KwikPen

6. Contents of the package and additional informationl

Humulina NPH KwikPen is a pre-filled pen that contains human insulin as the active ingredient, used to treat diabetes. You have diabetes if your pancreas does not produce enough insulin to control your blood glucose level (blood sugar). Humulina NPH is used for long-term glucose control. Its action is prolonged by the inclusion of protamine sulfate in the suspension.

Your doctor may tell you to use Humulina NPH KwikPen along with a rapid-acting insulin. Each insulin contains its own leaflet that will inform you about this. Do not change your insulin unless your doctor tells you to. Be careful if you change insulin. Each type of insulin has a different color and symbol on the packaging and on the pen to help you differentiate them easily.

Humulin NPH in a pre-filled pen is only indicated for injection just under the skin. Consult your doctor if you need to inject insulin by another method.

No useHumulin NPH KwikPen:

• If you think you are starting to have hypoglycemia (low blood sugar).More information on how to treat a mild hypoglycemia is provided later in this leaflet (see section 4, subsection A).(see section 4, subsection A).
• If you are allergic to human insulin or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Humulin NPH KwikPen.

• If your blood sugar levels are well controlled with the insulin you are currently using, you may not feel the warning signs when your blood sugar level drops too low. You should carefully consider when to take meals, how often to exercise and with what intensity. You should also carefully control your blood sugar levels by frequently checking your blood glucose.
• Some people who have had hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the early warning signs were less obvious or different. If you frequently have hypoglycemia or have difficulty recognizing the symptoms, consult your doctor.
• If your answer to any of the following questions is YES, inform your doctor, pharmacist or nurse.
• • Have you been ill recently?
  • Do you have problems with your kidneys or liver?
  • Are you doing more exercise than usual?
• If you consume alcohol, the amount of insulin you need may also change.
• You should also inform your doctor, pharmacist or nurse if you plan to travel abroad. The time difference between different countries may mean that your injections and meals need to be taken at different times than when you are at home.
• Some patients with type 2 diabetes who have had the condition for a long time and who have heart problems or who have had a previous stroke, treated with pioglitazone and insulin, have experienced the development of heart failure. Inform your doctor as soon as possible if you have signs of heart failure, such as unusual shortness of breath or a rapid increase in weight or localized swelling (edema).

Changes in the skin at the injection site:

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. The insulin may not work well if it is injected into a swollen area (see How to use Humulin NPH KwikPen). Contact your doctor if you are currently injecting into a swollen area, before starting to inject into a different area. Your doctor may advise you to check your blood sugar levels more closely, and to adjust the insulin or the dose of your other diabetes medications.

Use of Humulin NPH KwikPen with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Your insulin needs may change if you are taking any of the following:

• Glucocorticoids,
• thyroid hormone replacement therapy,
• oral hypoglycemic agents (oral diabetes medications),
• aspirin,
• growth hormone,
• octreotide,lanreotide,
• beta-2 stimulants (e.g. ritodrine, salbutamol or terbutaline),
• beta-blockers,
• thiazides or some antidepressants (monoamine oxidase inhibitors),
• danazol,
• some angiotensin-converting enzyme inhibitors (ACE inhibitors) (e.g. captopril, enalapril) or angiotensin II receptor blockers.

Pregnancy, lactation and fertility

The amount of insulin you normally need decreases during the first three months of pregnancy and increases during the remaining six months. If you are breastfeeding, you may need to adjust your insulin dose or diet.

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Your ability to concentrate and react may be reduced if you suffer from hypoglycemia (low blood sugar). Please remember this in all situations where you may be a risk to yourself or others (e.g. driving a car or operating machinery). You should consult your doctor or nurse about the advisability of driving if you have:

• episodes of hypoglycemia that occur frequently,
• difficulty perceiving the symptoms of hypoglycemia or not perceiving them.

Humulin NPH contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

Always check the name and type of insulin in the package and on the pre-filled pen label when you receive it from the pharmacy. Make sure you get the Humulina NPH KwikPen that your doctor has prescribed for you.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. To prevent the possible transmission of diseases, each pen must be used only by you, even if the needle is changed.

Dosage

• Humulina NPH should be injected as your basal insulin. Your doctor has told you which insulin to use, how much, when, and how often to inject. These instructions are only for you. Follow them exactly and attend your diabetes clinic regularly.
• If you change from one type of insulin (for example, from animal to human), you may need to use more or less than before. This may be only in the first injection or it may be a gradual change over several weeks or months.
• Humulina NPH in pre-filled pen is only indicated for injection just below the skin. Consult your doctor if you need to inject insulin by another method.

Preparing Humulina NPH KwikPen

• Move the KwikPen between the palms of your hands 10 times and turn it 10 times immediately before use to resuspend the insulin, until the contents appear uniformly cloudy or milky. If this does not occur, repeat this procedure until the contents mix well. The cartridges of the pens contain a glass bead to facilitate mixing.Do notshake vigorously to avoid foam formation, as this may interfere with the correct measurement of the dose. The cartridges of the pens should be examined frequently and not used if there are accumulations of material or white solid particles adhering to the bottom or walls of the cartridge, giving a frost-like appearance.Check it every time you inject.

Leaving the KwikPen ready for use (See User Manual)

• First, wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Follow the instructions carefully. Here are some guidelines to follow.

• Use a new needle. (Needles are not included).
• Prime your KwikPen before each use. This ensures that the insulin comes out and the air bubbles are released from your KwikPen. There may be small air bubbles in the KwikPen, which are not harmful, but if the air bubble is too large, your injection dose may not be as accurate.

Injecting Humulina NPH

• Before injecting, clean the skin as instructed.Inject under the skin, as instructed.Do notinject directly into a vein. After the injection, keep the needle in the skin for 5 seconds to ensure that the entire dose is administered. Do not rub the area where you just injected. Make sure to inject at least 1 centimeter away from where you injected last time and "alternate" the injection sites as instructed.

After the injection

• Once you have injected, unscrew the needle from the KwikPen using the outer cap of the needle. This will keep the insulin sterile and prevent it from coming out. It will also prevent air from entering the KwikPen and the needle from becoming clogged.Do not share your needles or your KwikPen.Put the cap back on the KwikPen.

Subsequent injections

• Always use a new needle for each injection. Before each injection, remove any air bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing down. The scale on the cartridge shows approximately how many units are left.
• Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Dispose of the KwikPen carefully; your pharmacist or nurse will tell you how to do it.

If you use more Humulina NPH than you should

If you use more Humulina NPH than you should, your blood sugar may decrease.Check your blood sugar(see section 4, subsection A).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to use Humulina NPH KwikPen

If you use less Humulina NPH than you should, your blood sugar levels may increase. Check your blood sugar. Do not inject a double dose to compensate for the missed doses.

If you interrupt treatment with Humulina NPH KwikPen

If you use less Humulina NPH than you should, your blood sugar levels may become too high. Do not change your insulin unless your doctor tells you to.

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

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

Human insulin may causehypoglycemia(low blood sugar). See more information about hypoglycemia below in the subsection “Common problems of diabetes”.

Possible side effects

Systemic allergy:is very rare (affects less than 1 in 10,000 treated patients). The symptoms are as follows:

If you think you have this type of allergy to insulin with Humulina NPH, inform your doctor immediately.

Local allergy:is common (affects less than 1 in 10 patients treated).In some patients, the injection area becomes red, swollen, or itchy. These symptoms usually disappear in a few days or weeks. If this happens, consult your doctor.

Changes in skin at the injection site:

If insulin is injected too frequently in the same place, the fatty tissue may shrink (lipatrophy) or become thicker (lipohypertrophy) (may affect up to 1 in 100 people). Bumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a thickened area. Change the injection site to help prevent these skin changes.

Edema (e.g. swelling of arms, ankles, fluid retention) has been reported, especially at the beginning of treatment with insulin or during a change in treatment to improve blood sugar control.

Common problems of diabetes

A.Hypoglycemia

Hypoglycemia (low blood sugar) means that there is not enough sugar in the blood. This can happen if:

• you use too much Humulina NPH or other insulin;
• you skip or delay meals or change your diet;
• you exercise or work too hard just before or after a meal;
• you have an infection or illness (especially diarrhea or vomiting);
• you have a change in your insulin needs; or
• you have liver or kidney problems that worsen.

Alcohol and some other medications can affect your blood sugar levels.

The first symptoms of low blood sugar usually appear quickly and include the following:

Until you are sure of recognizing the warning signs, avoid situations such as driving a car, as low blood sugar can pose a risk to you or others.

Do not use Humulina NPH if you think you are starting to have low blood sugar (low blood sugar).

If your blood sugar is low, take glucose tablets, sugar, or drink a sweetened beverage. Then take something to eat, such as fruit, cookies, or a snack, as your doctor has instructed, and rest. This should help you recover from mild or small insulin overdose hypoglycemia. If it worsens and your breathing is shallow and your skin is pale, inform your doctor immediately. A glucagon injection can treat severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not respond to glucagon, go to the hospital. Ask your doctor for information on glucagon.

B.Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (high blood sugar) means that your body does not have enough insulin.

Hyperglycemia can be caused by:

• not taking your Humulina NPH or other insulin;
• taking less insulin than your doctor has prescribed;
• eating more than your diet allows; or
• fever, infection, or emotional stress.

Hyperglycemia can cause diabetic ketoacidosis. The first symptoms begin slowly over several hours or days. The symptoms include the following:

Severe symptoms include rapid breathing and rapid pulse.Get medical help immediately.

If hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) are not treated, they can be very serious and cause headaches, nausea, vomiting, dehydration, loss of consciousness, coma, or even death.

Three simple stepsto avoid hypoglycemia or hyperglycemia are:

• Always have extra syringes and a vial of Humulina NPH.
• Always carry something that identifies you as a diabetic patient.
• Always carry sugar with you.

C.Illness

If you are ill, especially when you have nausea or vomiting, you may vary the amount of insulin you need.You need to continue taking insulin even when you are not eating as you normally do.Perform urine or blood tests, follow the guidelines that have been indicated for you to perform in these cases, and inform your doctor or nurse.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse 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.

Before first use, store your Humulina NPH KwikPen in the refrigerator (between 2?C and 8?C).Do not freeze.Keep your Humulina NPH KwikPen “in use” at room temperature (below 30ºC) for up to 28 days. Do not store your pen “in use” in the refrigerator. Do not leave it near a heat source or in direct sunlight.

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

Do not use this medicationif you observe accumulations of material or white solid particles adhered to the bottom or walls of the cartridge, giving it an appearance similar to frost. Check it each time you inject.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition ofHumulina NPH KwikPen

• Theactive principleis human insulin. Human insulin is obtained in the laboratoryby “recombinant DNA technology” and has the same structure as the natural hormone produced by the pancreas. Therefore, it is different from animal insulins. The human insulin of Humulina NPH is presented in the form of a suspension along with protamine sulfate.

• Theother componentsare protamine sulfate, metacresol, phenol, glycerol, sodium dihydrogen phosphate 7H2O, zinc oxide and water for injectable preparations. During manufacture, sodium hydroxide and/or hydrochloric acid may have been used to adjust the acidity.

Appearance of the product and contents of the Humulina NPH KwikPen package

Humulina NPH KwikPen 100UI/ml injectable suspension is awhite and sterile suspension, containing 100 units of human insulin in each milliliter (100 UI/ml).

Each Humulina NPH KwikPen contains 300 units (3 milliliters).

Humulina NPH KwikPen is presented in a package of 5, 6 or 10 (2 x 5) units.

Only some package sizes may be commercially available.

The Humulina NPH in your KwikPen is the same as the Humulina NPH in cartridges. In the KwikPen, the cartridge cannot be separated from the rest of the device. When the KwikPen is empty, it cannot be reused.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:Lilly S.A., Avda. de la Industria, nº 30. 28108 Alcobendas, Madrid. Spain.

Responsible manufacturer:

Lilly France, S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

This medicine is authorized in the member states of the European Economic Area with the following names:

Huminsulin“Lilly”Basal KwikPen (Austria)

Humuline-KwikPen NPH (Belgium, Luxembourg, Netherlands)

Humulin N KwikPen (Estonia, Hungary, Latvia, Lithuania, Slovenia, Romania)

Huminsulin Basal (NPH) KwikPen (Germany)

Humulin NPH KwikPen (Denmark, Finland, Greece, Iceland, Norway, Sweden)

Humulin N (NPH) KwikPen (Czech Republic, Slovakia)

Humulina NPH KwikPen (Spain)

Humulin I KwikPen (Ireland, United Kingdom)

UmulineNPH KwikPen (France)

Last review date of this leaflet: August 2020.

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/