HUMULINA REGULAR 100 IU/ML INJECTABLE SOLUTION IN VIAL

2. What you need to know before you use Humulina Regular

Do not useHumulina Regular:

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

Warnings and precautions

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

• 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 levels are too low. The warning signs are listed later in this leaflet. You should think carefully about when to eat, how often to exercise, and how intensely. You should also check your blood sugar levels very carefully by doing frequent blood sugar tests.
• Some people who have had low blood sugar (hypoglycemia) after switching from animal insulin to human insulin have reported that the early warning symptoms were less obvious or different. If you frequently have low blood sugar or have trouble recognizing the symptoms, talk to 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 plan to travel abroad. The time difference between countries may mean that your injections and meals need to be done at different times than when you are at home.
• Some patients who have had type 2 diabetes for a long time and have heart problems or have had a previous stroke, treated with pioglitazone and insulin, have experienced the development of 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 localized swelling (edema).

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 very well if it is injected into a swollen area (see How to use Humulina Regular). Contact your doctor if you are currently injecting into a swollen area, before starting to inject into a different area. Your doctor may tell you to check your blood sugar levels more closely and adjust your insulin or the dose of your other diabetes medications.

Using Humulina Regular 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 hypoglycemic agents (diabetes medication),
• acetylsalicylic acid (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 (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 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 plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

• have frequent episodes of low blood sugar,
• have trouble recognizing the symptoms of low blood sugar or do not recognize them.

Humulina Regular contains sodium

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

3. How to use Humulina Regular

Always check the name and type of insulin on the package and on the vial label when you get it from the pharmacy. Make sure you get theHumulinathat your doctor has told you to use.

Follow the instructions for administering this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult your doctor or pharmacist again.

Dose

• 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 switch from one type of insulin to another (e.g., from animal to human), you may need to use more or less than before. This may only be for the first injection or may be a gradual change over several weeks or months.
• Inject Humulina Regular under the skin. You should only inject it into a muscle if your doctor has told you to.

Preparing Humulina Regular

• Humulina Regular is already dissolved in water, so you do not need to mix it. But you should only use it if it looks like water. It should be clear and colorless and free of solid particles. Check this every time you inject it.

InjectingHumulina Regular

• First, wash your hands.
• Before injecting, clean the skin as you have been told. Clean the rubber stopper, but do not remove it.
• Use a new and sterile syringe and needle to prick the rubber stopper and load the amount of Humulina Regular you need. Your doctor or nurse will tell you how to do this. Do not share your needles or syringes.
• Inject under the skin, as you have been taught. Do notinject directly into a vein. After injection, keep the needle in the skin for 5 seconds to make sure you have administered the full dose. Do not rub the injection site. Make sure you inject at least 1 centimeter away from where you last injected and "alternate" injection sites as you have been taught.
• Your doctor will tell you if you need to mix Humulina Regular with Humulina NPH. If, for example, you need to inject a mixture, load the syringe with Humulina Regular before loading it with the long-acting insulin. Inject the liquid as soon as you have mixed it. Repeat this every time you need to inject a mixture. You should not normally mix Humulina Regular with a mixture of human insulins. Never mix Humulina Regular with insulins from other manufacturers or with animal insulins.
• You should not inject Humulina Regular into a vein. Inject Humulina Regular as your doctor or nurse has taught you. Only your doctor can inject Humulina Regular into a vein. They will only do this under special circumstances, such as during surgery or if you are ill and your blood sugar levels are too high.

If you use moreHumulina Regularthan you should

If you use more Humulina Regular 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, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to useHumulina Regular

If you use less Humulina Regular 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 forgotten doses.

If you stop usingHumulina Regular

If you use less Humulina Regular 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 about the use of this medicine, 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 low blood sugar (hypoglycemia). See more information about hypoglycemia below in the subsection "Common diabetes problems".

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 have this type of allergy to insulin with Humulina Regular, 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, talk to your doctor.

Changes in the skin at the injection site:

If you inject insulin too frequently in the same spot, the fatty tissue can shrink (lipoatrophy) or become thicker (lipohypertrophy) (can affect up to 1 in 100 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this is unknown). Insulin may not work very well if it is injected into a swollen area. Change the injection site to help avoid these skin changes.

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

Common diabetes problems

• Low blood sugar (hypoglycemia)

Low blood sugar (hypoglycemia) means that there is not enough sugar in the blood. This can 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 have a change in your need for insulin; or
• you have liver or kidney problems that get worse.

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

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

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

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

If your blood sugar level is low, take glucose tablets, sugar, or drink 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 low blood sugar or a small overdose of insulin. If you get worse and your breathing becomes shallow and your skin becomes pale, tell your doctor immediately. An injection of glucagon can treat severe low blood sugar. 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.

• High blood sugar and diabetic ketoacidosis.

High blood sugar (hyperglycemia) means that your body does not have enough insulin.

High blood sugar can be caused by:

• not taking your Humulina Regular 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.

High blood sugar 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 low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia) 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 low blood sugar or high blood sugar are:

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

• Illness

If you are ill, especially when 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 normally do. Do urine or blood tests, follow the rules that you have been told to follow in these cases, and tell your doctor or nurse.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Humulina Regular

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

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

You can keep your "in-use" vial at room temperature (below 30°C) for up to 28 days. Do not leave it near a heat source or in the sun.

Do not use this medicine after the expiry date stated on the package and on the label. The expiry date is the last day of the month stated.

Do not use this medicine if you notice it is colored or contains solid particles. Onlyuse it if it looks like water. Check this every time you inject it.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition ofHumulina Regular

• 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 other componentsare metacresol, glycerol, 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 Container Contents of Humulina Regular

Humulina Regular 100 UI/ml injectable solution is a sterile, transparent, and colorless aqueous solution that contains 100 units of human insulin in each milliliter (100 UI/ml). Each vial contains 1,000 units (10 milliliters).

Humulina Regular 100 UI/ml is presented in a container of 1 vial or 2 vials or in multiple containers of 5 (5 x 1) vials. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:

Huminsulin “Lilly” Normal (Austria)

Umuline Rapide 100 UI/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 Last Revision of this Leaflet: August 2020.

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