Humulina NPH Kwikpen 100 IU/ml suspension for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

HUMULINA NPH KwikPen 100UI/ml injectable suspension

(Human insulin)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Humulina NPH KwikPen is and what it is used for

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

Your doctor may instruct you to use Humulina NPH KwikPen together with a rapid-acting insulin. Each insulin has its own package leaflet providing information about it. Do not change your insulin unless your doctor tells you to. Be cautious if switching insulins. Each type of insulin has a different color and symbol on the packaging and pen to help you easily distinguish them.

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

Humulina NPH in a prefilled pen is intended only for injection just under the skin. Consult your doctor if you need to inject insulin by another method.

Do not use Humulina NPH KwikPen:

• If you think you are beginning to have hypoglycemia (low blood sugar). Later in this leaflet, you will be advised how to treat mild hypoglycemia (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

Talk to your doctor, pharmacist, or nurse before using Humulina NPH KwikPen.

• If your blood sugar levels are well controlled with the insulin you currently use, you may not feel the warning symptoms when your blood sugar drops too low. The warning signs are listed later in this leaflet. You must carefully consider when to eat meals, how often and how intensely you exercise. You should also monitor your blood sugar levels very carefully by frequently checking your blood glucose.
• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that early warning symptoms were less obvious or different. If you frequently experience hypoglycemia or have difficulty recognizing the symptoms, consult your doctor.
• If you answer YES to any of the following questions, inform your doctor, pharmacist, or nurse:
  • Have you recently become ill?
  • Do you have kidney or liver problems?
  • Are you exercising more 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. Time zone differences between countries may require you to take your injections and meals at different times than when you are at home.
• Some patients with long-standing type 2 diabetes and heart problems or who have previously had a 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, rapid weight gain, or localized swelling (edema).

Skin changes at the injection site:

You should rotate your injection site to avoid skin changes such as lumps under the skin. Insulin may not work as well if 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 starting to inject into a different area. Your doctor may advise you to monitor your blood sugar levels more closely and adjust your insulin or the dose of your other antidiabetic medications.

Using Humulina NPH KwikPen with other medicines

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

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

• Steroids,
• thyroid hormone replacement therapy,
• oral hypoglycemics (antidiabetic medications),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta2-stimulants (e.g., ritodrine, salbutamol, or terbutaline),
• beta-blockers,
• thiazides or certain antidepressants (monoamine oxidase inhibitors),
• danazol,
• some angiotensin-converting enzyme inhibitors (ACE inhibitors) (e.g., captopril, enalapril) or angiotensin II receptor blockers.

Pregnancy, breastfeeding, and fertility

The amount of insulin you normally need usually 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Your ability to concentrate and react may be reduced if you experience hypoglycemia (low blood sugar). Please remember this in any situation where it might pose a risk to you or others (e.g., driving a car or operating machinery). You should consult your doctor or nurse about whether it is safe for you to drive if you have:

• frequent episodes of hypoglycemia,
• difficulty perceiving the symptoms of hypoglycemia or do not perceive them at all.

Humulina NPH contains Sodium

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

3. How to use Humulina NPH KwikPen

Always check the name and type of insulin on the packaging and on the label of the prefilled pen when you receive it from the pharmacy. Make sure you are receiving the Humulina NPH KwikPen that your doctor has prescribed for you.

Follow exactly the dosing instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. To prevent the possible transmission of disease, each pen must be used only by you, even if the needle is changed.

Dosage

• Humulina NPH should normally 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 intended specifically for you. Follow them exactly and attend your diabetes clinic regularly.
• If you switch insulin types (e.g., from animal to human), you may need to use more or less than before. This may occur only with the first injection or may involve a gradual adjustment over several weeks or months.
• Humulina NPH in a prefilled pen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.

Preparing Humulina NPH KwikPen

• Immediately before use, roll the KwikPen between the palms of your hands 10 times and invert it 10 times to resuspend the insulin, until the contents appear uniformly cloudy or milky. If this does not occur, repeat the procedure until the contents are well mixed. The pen cartridges contain a glass ball to aid mixing. Do not shake vigorously, as foam may form, which can interfere with accurate dosing. Cartridges should be examined frequently and must not be used if there are accumulations of material or white solid particles adhering to the bottom or walls of the cartridge, giving it a frost-like appearance. Check this each time you inject.

Preparing the KwikPen for use (See User Manual)

• First, wash your hands.

• Read the instructions on how to use your prefilled insulin pen. Follow the instructions carefully. The following are some guidelines to follow.

• Use a new needle each time. (Needles are not included.)

• Prime your KwikPen before each use. This ensures that insulin flows properly and removes air bubbles from your KwikPen. Small air bubbles may remain in the KwikPen, which are not harmful, but if the air bubble is too large, your injection dose may be less accurate.

Injecting Humulina NPH

• Before injecting, clean the skin thoroughly as instructed. Inject under the skin as you have been taught. Do not inject directly into a vein. After injection, keep the needle in the skin for 5 seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure you inject at least 1 centimeter away from your last injection site and rotate injection sites as instructed.

After injection

• After injecting, unscrew the needle from the KwikPen using the needle's outer cap. This keeps the insulin sterile and prevents leakage. It also prevents air from entering the KwikPen and helps avoid needle clogging. Do not share your needles or your KwikPen. Replace the pen cap 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 remains by holding the KwikPen with the needle pointing downward. The cartridge scale shows approximately how many units are left.
• Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not reuse it. Dispose of the pen carefully; your pharmacist or nurse will advise you how to do this.

If you use more Humulina NPH than you should

If you use more Humulina NPH than prescribed, your blood sugar may drop. Check your blood sugar (see section 4, part 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 prescribed, your blood sugar levels may rise. Check your blood sugar. Do not inject a double dose to make up for missed doses.

If you stop using Humulina NPH KwikPen

If you use less Humulina NPH than prescribed, your blood sugar levels may become too high. Do not change your insulin unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Human insulin can cause hypoglycemia (low blood sugar). See further information on hypoglycemia below in the subsection “Common diabetes problems”.

Possible adverse effects

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

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

Local allergy: common (affects fewer than 1 in 10 treated patients). In some patients, the injection site may become red, swollen, or itchy. Usually, these symptoms disappear within a few days or weeks. If this happens to you, consult your doctor.

Skin changes at the injection site:

If you inject insulin too frequently in the same place, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also occur due to the buildup of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown). Insulin may not work well if injected into a lumpy area. Rotate your injection sites to help prevent these skin changes.

Edema (e.g., swelling of arms, ankles, fluid retention) has been reported, particularly at the beginning of insulin treatment or during a change in therapy aimed at improving blood glucose control.

Common diabetes-related problems

A. Hypoglycemia

Hypoglycemia (low blood sugar) means there is not enough sugar in the blood. This may 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 experience a change in your insulin requirement; or
• you have worsening liver or kidney problems.

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

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

Until you are certain you recognize the warning symptoms, avoid situations such as driving a car, since hypoglycemia may pose a risk to you or to others.

Do not use Humulina NPH if you think you are beginning to experience hypoglycemia (low blood sugar).

If your blood sugar is low, take glucose tablets, sugar, or drink a sugary beverage. Afterwards, eat a piece of fruit, biscuits, or a snack as directed by your doctor, and rest. This will likely help you recover from mild hypoglycemia or a minor overdose of insulin. If your condition worsens and your breathing becomes shallow and your skin turns pale, inform your doctor immediately. An injection of glucagon may treat a rather severe hypoglycemia. Take glucose or sugar after the glucagon injection. If there is no response to glucagon, go to the hospital. Ask your doctor for information about glucagon.

B. Hyperglycemia and diabetic ketoacidosis.

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

Hyperglycemia may be caused by:

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

Hyperglycemia may lead to diabetic ketoacidosis. Early symptoms begin slowly over several hours or days. Symptoms include the following:

Severe symptoms include labored breathing and rapid pulse. Seek immediate medical assistance.

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

Three simple steps to avoid hypoglycemia or hyperglycemia are:

• Always keep extra syringes and an additional vial of Humulina NPH available.
• Always carry identification indicating you are a diabetic patient.
• Always carry sugar with you.

C. Illness

If you become ill, especially if you experience nausea or vomiting, the amount of insulin you need may change. You must continue taking insulin even when you are not eating as usual. Perform urine or blood tests, follow the guidelines you have been given for such situations, and inform your doctor or nurse.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, 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. Once in use, keep your Humulina NPH KwikPen at room temperature (below 30°C) for up to 28 days. Do not store the pen in use in the refrigerator. Do not leave it near a heat source or in direct sunlight.

Do not use this medicine after the expiry date stated on the packaging and label. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice clumps of material or white solid particles attached to the bottom or sides of the cartridge, giving it a frost-like appearance. Check this each time before injecting.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Humulina NPH KwikPen

• The active substance is human insulin. Human insulin is produced in the laboratory using recombinant DNA technology and has the same structure as the natural hormone produced by the pancreas. Therefore, it differs from animal insulins. The human insulin in Humulina NPH is formulated as a suspension together with protamine sulfate.

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

Appearance of the product and pack contents of Humulina NPH KwikPen

Humulina NPH KwikPen 100 UI/ml injectable suspension is a sterile, white 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 available in packs of 5, 6, or 10 (2 x 5) units.

Only certain pack sizes may be commercially available.

The Humulina NPH in your KwikPen is identical to Humulina NPH in cartridges. In the KwikPen device, the cartridge cannot be separated from the rest of the pen. 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 most recent review of this leaflet: August 2020.

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