Humulina 30:70 Kwikpen 100 IU/mL injection suspension

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

HUMULINA 30:70 KwikPen 100UI/ml injectable suspension

(Human insulin)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, since 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.

Contents of this leaflet

1. What Humulina 30:70 KwikPen is and what it is used for
2. What you need to know before you use Humulina 30:70 KwikPen
3. How to use Humulina 30:70 KwikPen
4. Possible side effects
5. How to store Humulina 30:70 KwikPen
6. Contents of the pack and other information

1. What Humulina 30:70 KwikPen is and what it is used for

Humulina 30:70 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 30:70 is used for long-term blood glucose control. It is a pre-mixed suspension of fast-acting and long-acting insulin. Its prolonged action is due to the inclusion of protamine sulfate in the suspension.

Your doctor may instruct you to use Humulina 30:70 KwikPen in combination with another slower-acting insulin. Each insulin comes with its own package leaflet providing information about it. Do not change your insulin unless your doctor tells you to. Be cautious if switching from one insulin to another. Each type of insulin has a different color and symbol on the packaging and on the pen to help you easily distinguish them.

2. What you need to know before using Humulina 30:70 KwikPen

Humulina 30:70 in a prefilled pen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.

Do not use Humulina 30:70 KwikPen:

• If you think you are beginning to experience hypoglycemia (low blood sugar). Later in this leaflet, you will find instructions on how to treat mild hypoglycemia (see section 4, part 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

Talk to your doctor, pharmacist, or nurse before using Humulina 30:70 KwikPen.

• If your blood sugar levels are well controlled with your current insulin, 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 symptoms, consult your doctor.
• If you answer YES to any of the following questions, inform your doctor, pharmacist, or nurse:
  • Have you been ill recently?
  • 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 a history of previous stroke, treated with pioglitazone and insulin, have experienced the development of heart failure. Inform your doctor as soon as possible if you experience 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 sites to avoid skin changes such as lumps under the skin. Insulin may not work as effectively if injected into an area with lumps (see How to use Humulina 30:70 KwikPen). Contact your doctor if you are currently injecting into such an area before starting to inject in a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin or the dose of your other antidiabetic medications.

Using Humulina 30:70 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:

• Corticosteroids,
• 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,
• certain 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 that could pose a risk to yourself 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 30:70 contains Sodium

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

3. How to use Humulina 30:70 KwikPen

Always check the name and type of insulin on the packaging and on the label of the pre-filled pen when you receive it from the pharmacy. Make sure you receive the Humulina 30:70 KwikPen that your doctor has prescribed for you.

Follow exactly the dosing instructions provided 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.

Dose

• Your doctor has told you which insulin to use, how much, and when and how often to inject it. These instructions are intended specifically for you. Follow them exactly and attend your diabetes clinic regularly.
• If you switch from one type of insulin to another (for example, from animal to human), you may need to use more or less than before. This may apply only to the first injection or may involve a gradual adjustment over several weeks or months.
• Humulina 30:70 in a pre-filled pen is intended only for subcutaneous injection (just under the skin). Consult your doctor if you need to administer insulin by another method.

Preparing Humulina 30:70 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 bead to assist mixing. Do not shake vigorously, as foam may form, which could interfere with accurate dose measurement. 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 sides of the cartridge, giving it a frost-like appearance. Check this each time before injecting.

Preparing the KwikPen for use (See User Manual)

• First, wash your hands.

• Read the instructions on how to use your pre-filled insulin pen KwikPen and follow them carefully. The following are some general guidelines.

• 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 the pen. Small air bubbles may remain in the KwikPen, which are harmless, but if the air bubble is too large, your injection dose may be less accurate.

Injecting Humulina 30:70

• 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 outer needle cap. This will keep the insulin sterile and prevent leakage. It will also prevent air from entering the KwikPen and help avoid needle clogging. Do not share your needles or your KwikPen. Replace the 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 into your disposable pen. Once the KwikPen is empty, do not reuse it. Dispose of the pen properly; your pharmacist or nurse will advise you how to do this.

If you use more Humulina 30:70 than you should

If you use more Humulina 30:70 than prescribed, your blood sugar may drop. Check your blood sugar (see section 4, subsection A).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to use Humulina 30:70 KwikPen

If you use less Humulina 30:70 than prescribed, your blood sugar levels may rise. Check your blood sugar. Do not inject a double dose to make up for a missed dose.

If you stop using Humulina 30:70 KwikPen

If you use less Humulina 30:70 than prescribed, 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 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 will experience 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 30:70, inform your doctor immediately.

Local allergy: This is common (affects less than 1 in 10 patients treated). In some patients, the injection site may become red, swollen, or itchy. These symptoms usually 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, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohipertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work well if injected into a lumpy area. Change your injection site regularly 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 changes in treatment 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 can happen if:

• you use too much Humulina 30:70 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 requirement; or
• you have worsening liver or kidney problems.

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

Do not use Humulina 30:70 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, consume 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 you develop shallow breathing and pale skin, contact your doctor immediately. A glucagon injection may be used to treat 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 30:70 or other insulin;
• taking less insulin than prescribed by your doctor;
• eating much more than allowed by your diet; or
• fever, infection, or emotional stress.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop 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 30:70 available.
• Always carry identification indicating that 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 you normally do. Perform urine or blood tests, follow the instructions 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 30:70 KwikPen

Keep this medicine out of the sight and reach of children.

Before first use, store your Humulina 30:70 KwikPen in the refrigerator (between 2 °C and 8 °C). Do not freeze. Once in use, keep your Humulina 30:70 KwikPen at room temperature (below 30 °C) for up to 28 days. Do not store the pen in use in the refrigerator. Do not place it near heat sources or 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 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 or expired containers and medicines to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Humulina 30:70 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. Humulina 30:70 is a premixed suspension containing 30% insulin dissolved in water and 70% insulin combined 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 contents of the Humulina 30:70 KwikPen pack

Humulina 30:70 KwikPen 100 UI/ml injectable suspension is a sterile, white suspension containing 100 units of human insulin per milliliter (100 UI/ml).

Each Humulina 30:70 KwikPen contains 300 units (3 milliliters).

Humulina 30:70 KwikPen is available in packs of 5, 6, or 10 (2 x 5) units.

Only certain pack sizes may be marketed.

The Humulina 30:70 in your KwikPen device is identical to Humulina 30:70 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Huminsulin “Lilly” Profil III KwikPen (Austria)

Humuline 30/70 KwikPen (Belgium, Luxembourg)

Huminsulin Profil III KwikPen (Germany)

Humulina 30:70 KwikPen (Spain)

Humulin M3 KwikPen (Greece, Ireland, Lithuania, Romania, Slovenia, United Kingdom)

Umuline profil 30 KwikPen 100 UI/ml (France)

Humulin M3 (30/70) KwikPen (Czech Republic, Slovakia)

Date of the most recent review of this leaflet: August 2020.

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