Humulina Regular 100 IU/mL solution for injection in vial

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

HUMULINA REGULAR 100UI/ml solution for injection in a vial

(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 adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Humulina Regular is and what it is used for

Humulina Regular contains human insulin as the active substance, which is used to treat diabetes. You have diabetes if your pancreas does not produce enough insulin to control your blood glucose (blood sugar) levels. Humulina Regular is used for long-term blood glucose control. Humulina Regular is a rapid-acting insulin preparation.

Your doctor may instruct you to use Humulina Regular together with a 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 package and vial to help you easily distinguish them.

2. What you need to know before using Humulina Regular

Do not use Humulina Regular:

• If you think you are beginning to have hypoglycaemia (low blood sugar). Later in this leaflet you will find instructions on 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

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

• 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 should carefully consider when to eat meals, how often to exercise, and how intense your exercise should be. You should also monitor your blood sugar levels very carefully by frequently checking your blood glucose.
• Some people who have experienced 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 experience hypoglycaemia 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 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 differences between countries may require you to adjust the timing of your injections and meals compared to 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 develop 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 effectively if injected into a lumpy area (see How to use Humulina Regular). Contact your doctor if you are currently injecting into a lumpy area, before switching to a different injection site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.

Using Humulina Regular 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 hypoglycaemics (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, breast-feeding, 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 breast-feeding, you may need to adjust your insulin dose or your diet.

If you are pregnant or breast-feeding, 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 hypoglycaemia (low blood sugar). Please remember this in any situation where it 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 hypoglycaemia,
• difficulty perceiving the symptoms of hypoglycaemia, or cannot perceive them at all.

Humulina Regular 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 Humulin Regular

Always check the name and type of insulin on the package and vial label when you receive it from the pharmacy. Make sure you are receiving the Humulin your doctor has prescribed for you.

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

• Your doctor has told you which insulin to use, how much, and when and how often to inject it. These instructions are intended only 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 insulin), you may need to use more or less than before. This may affect only your first injection or may involve a gradual adjustment over several weeks or months.
• Inject Humulin Regular under the skin. You should inject it into muscle only if specifically instructed by your doctor.

Preparing Humulin Regular

• Humulin Regular is already dissolved in water, so it does not need to be mixed. However, use it only if it appears like water—clear, colorless, and free of solid particles. Check its appearance every time before injecting.

Injecting Humulin Regular

• First, wash your hands.
• Before injecting, clean the skin thoroughly as you have been instructed. Clean the rubber stopper of the vial, but do not remove it.
• Use a new, sterile syringe and needle to pierce the rubber stopper and draw up the required amount of Humulin Regular. Your doctor or nurse will show you how to do this. Do not share your needles or syringes.
• 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 to inject at least 1 centimeter away from your last injection site, and rotate injection sites as instructed.
• Your doctor will tell you if you need to mix Humulin Regular with Humulin NPH. If, for example, you need to inject a mixture, draw up Humulin Regular into the syringe before adding the long-acting insulin. Inject the mixture as soon as it is prepared. Repeat this procedure each time you need to inject a mixed dose. Normally, Humulin Regular should not be mixed with a premixed formulation of human insulins. Humulin Regular must never be mixed with insulins produced by other manufacturers or with animal insulins.
• Do not inject Humulin Regular into a vein. Inject Humulin Regular only as taught by your doctor or nurse. Only your doctor may administer Humulin Regular intravenously, and only under special circumstances such as surgery or if you are ill and your glucose levels are too high.

If you use more Humulin Regular than you should

If you use more Humulin Regular 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 Humulin Regular

If you use less Humulin Regular 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 Humulin Regular

If you use less Humulin Regular 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 everybody gets them.

Human insulin can cause hypoglycaemia (low blood sugar). See further information on hypoglycaemia 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 Regular, inform your doctor immediately.

Local allergy: This is common (affects fewer 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 effectively if injected into an area with lumps. 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 changes 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 Regular 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 requirements; 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 that 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 Humulin Regular 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, some 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, contact your doctor immediately. An injection of glucagon can treat a rather 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 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 Humulin Regular 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 may lead to diabetic ketoacidosis. The initial 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 headache, nausea, vomiting, dehydration, loss of consciousness, coma, or even death.

*Three simple steps to prevent hypoglycemia or hyperglycemia are:

• Always keep extra syringes and an additional vial of Humulina Regular on hand.
• 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 if you are not eating as you normally do. Perform urine or blood tests, follow the guidelines provided to you 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 through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Humulin Regular

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

Before first use, store your Humulin Regular in the refrigerator (between 2 °C and 8 °C). Do not freeze.

You may keep your vial in use at room temperature (below 30 °C) for up to 28 days. Do not place it near a heat source or expose it to direct sunlight.

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

Do not use this medicine if you notice it is discolored or contains solid particles. Only use it if its appearance is like that of water. Check this each time before injecting.

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

6. Contents of the pack and other information

Composition of Humulina Regular

• 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 other components are metacresol, glycerol, and water for injections. During manufacturing, sodium hydroxide and/or hydrochloric acid may have been used to adjust the pH.

Appearance of the product and contents of the pack of Humulina Regular

Humulina Regular 100 IU/ml solution for injection is a sterile, clear, colourless aqueous solution containing 100 units of human insulin per millilitre (100 IU/ml). Each vial contains 1,000 units (10 millilitres).

Humulina Regular 100 IU/ml is available in packs containing 1 vial or 2 vials, or multiple packs of 5 (5 x 1) vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer:

• Lilly S.A., Avda. de la Industria nº 30. 28108 Alcobendas, Madrid. Spain.
• Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Huminsulin “Lilly” Normal (Austria)

Umuline Rapide 100 IU/ml (France)

Humuline Regular (Belgium, Luxembourg)

Huminsulin Normal 100 (Germany)

Humulin Regular (Denmark, Greece, Sweden)

Humulina Regular (Spain)

Humulin S (Ireland, United Kingdom)

Humulin R (Czech Republic, Italy, Romania)

Date of the most recent revision 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/