HUMULINA NPH KWIKPEN 100 IU/ML INJECTABLE SUSPENSION

2. What you need to know before you use Humulina NPH KwikPen

Humulina NPH in a pre-filled pen is only intended for injection under the skin. Consult your doctor if you need to inject the insulin by a different method.

Do not use Humulina NPH KwikPen:

• If you think you are starting to have low blood sugar (hypoglycaemia).Later in this leaflet, it is explained how to treat mild hypoglycaemia (see section 4, subsection A).
• If you are allergic to human insulin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Humulina NPH KwikPen.

• If your blood sugar levels are well controlled with the insulin you are currently using, you may not feel the warning symptoms when your blood sugar level falls too low. The warning signs are listed later in this leaflet. You should think carefully about when to have your meals, how often to exercise, and how intensely. You should also check your blood sugar levels very carefully and frequently.
• Some people who have had hypoglycaemia (low blood sugar) after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you frequently have hypoglycaemia or have difficulty recognising the symptoms, consult your doctor.
• If your answer to any of the following questions is YES, tell your doctor, pharmacist, or nurse.
• • Have you been ill recently?
  • Do you have kidney or liver problems?
  • Are you doing more exercise than usual?
• If you drink alcohol, the amount of insulin you need may also change.
• You should also tell your doctor, pharmacist, or nurse if you are planning to travel abroad. The time difference between countries may affect when you take your injections and meals.
• Some patients with type 2 diabetes who have been treated with pioglitazone and insulin have experienced heart failure. Tell your doctor as soon as possible if you have signs of heart failure, such as unusual shortness of breath or rapid weight gain or localised swelling (oedema).

Changes in the skin at the injection site:

You should rotate the injection site to avoid changes in the skin, such as lumps under the skin. Insulin may not work as well if it is injected into a lumpy area (see How to use Humulina NPH KwikPen). Contact your doctor if you are currently injecting into a lumpy area, before you start injecting into a different area. Your doctor may tell you to check your blood sugar levels more closely and adjust your insulin dose or the dose of your other diabetes medicines.

Using Humulina NPH KwikPen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

• have frequent episodes of hypoglycaemia,
• have difficulty recognising the symptoms of hypoglycaemia or do not recognise them.

Humulina NPH contains sodium

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

3. How to use Humulina NPH KwikPen

Always check the name and type of insulin in the packaging and on the label of the pre-filled pen when you get it from the pharmacy. Make sure you get the Humulina NPH KwikPen that your doctor has told you to use.

Follow the instructions for administering this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. To prevent possible disease transmission, each pen must be used by you only, even if the needle is changed.

Dose

• Humulina NPH is usually 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 the type of insulin (e.g. from animal to human), you may need to use more or less than before. This may be just for the first injection or it may be a gradual change over several weeks or months.
• Humulina NPH in a pre-filled pen is only intended for injection under the skin. Consult your doctor if you need to inject the insulin by a different method.

Preparing Humulina NPH KwikPen

• Move the KwikPen between the palms of your hands 10 times and turn it upside down 10 times immediately before use to resuspend the insulin, until the contents appear uniformly cloudy or milky. If this does not happen, repeat the procedure until the contents are well mixed. The pen cartridges contain a glass ball to facilitate mixing. Do notshake vigorously to avoid creating foam, as this may interfere with the correct dose measurement. The pen cartridges should be examined frequently and should not be used if there are deposits or white solid particles stuck to the bottom or walls of the cartridge, giving it a frosted appearance. Check this every time you inject.

Getting 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 any air bubbles are released from your KwikPen. Small air bubbles may remain in the pen, but they are not harmful, but if the air bubble is too large, it may affect the accuracy of your dose.

Injecting Humulina NPH

• Before injecting, clean the skin as you have been instructed. Inject under the skin as you have been taught. Do notinject directly into a vein. After the injection, keep the needle in the skin for 5 seconds to make sure you have taken the full dose. Do not rub the area where you have just injected. Make sure you inject at least 1 cm away from where you last injected and “rotate” the injection sites as you have been taught.

After the injection

• Once you have injected, remove the needle from the KwikPen using the outer needle cap. This will keep the insulin sterile and prevent air from entering the pen and the needle from getting blocked. Do not share your needles or KwikPen.Put the cap back on the KwikPen.

Further 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 pen carefully; your pharmacist or nurse will tell you how to do this.

If you use more Humulina NPH than you should

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 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 become too high. Check your blood sugar level. Do not inject a double dose to make up for a forgotten dose.

If you stop using 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 further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Human insulin may cause hypoglycaemia (low blood sugar). See more information on hypoglycaemia below in the subsection “Common problems of diabetes”.

Possible side effects

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

If you think you are having this type of allergic reaction to insulin with Humulina NPH, tell your doctor immediately.

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

Changes in the skin at the injection site:

If you inject insulin too often in the same area, the fatty tissue under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency is not known). Insulin may not work as well if it is injected into a lumpy area. Change the injection site to help avoid these changes in the skin.

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

Common problems of diabetes

• Hypoglycaemia

Hypoglycaemia (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 miss 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 diarrhoea or vomiting);
• you have a change in your need for insulin; or
• you have kidney or liver problems that get worse.

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

The first symptoms of low blood sugar usually come on quickly and include:

Until you are confident that you recognise the warning signs of hypoglycaemia, avoid situations like driving a car, as hypoglycaemia may pose a risk to you or others.

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

If your blood sugar level is low, take glucose tablets, sugar, or a sugary drink. Then take some fruit, biscuits, or a snack, as your doctor has told you, and rest. This should help you recover from mild hypoglycaemia or a small overdose of insulin. If you get worse and your breathing becomes shallow and your skin pales, tell your doctor immediately. An injection of glucagon can treat severe hypoglycaemia. Take glucose or sugar after the glucagon injection. If you do not respond to glucagon, go to the hospital. Ask your doctor about glucagon.

• Hyperglycaemia and diabetic ketoacidosis.

Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin.

Hyperglycaemia can be caused by:

• not taking your Humulina NPH or other insulin;
• taking less insulin than your doctor told you to;
• eating much more than your diet allows;
• having a fever, infection, or emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms start slowly over several hours or days. The symptoms include:

Severe symptoms are heavy breathing and a fast pulse. Get medical help immediately.

If hypoglycaemia (low blood sugar) or hyperglycaemia (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 hypoglycaemia or hyperglycaemia are:

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

• Illness

If you are ill, especially if you have nausea or vomiting, you may need to adjust the amount of insulin you use. You need to keep taking insulin even when you are not eating as you usually do. Do urine or blood tests, follow the instructions you have been given for these situations, and tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Humulina NPH KwikPen

Keep this medicine 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 30°C) for up to 28 days. Do not keep your pen "in use" in the refrigerator. Do not leave it near a heat source or in the sun.

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

Do not use this medicine if you notice that there are accumulations of material or white solid particles stuck to the bottom or walls of the cartridge, giving it a frosty appearance. Check it every time you inject.

Medicines should not be thrown away via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging contents and additional information

Composition ofHumulina NPH KwikPen

• The active ingredientis human insulin. Human insulin is obtained in the laboratory by "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 in Humulina NPH is presented in suspension form along with protamine sulfate.

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

Appearance of the product and packaging contents of Humulina NPH KwikPen

Humulina NPH KwikPen 100 UI/ml injectable suspension is a white and sterile suspension, containing 100 units of human insulin per milliliter (100 UI/ml).

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

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

Only some packaging sizes may be marketed.

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 manufacturer

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

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 under 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)

Umuline NPH KwikPen (France)

Date of the last revision of this prospectus: August 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/