Label: Information for the User

HUMULINA REGULAR 100UI/ml injectable solution in vial

(Human Insulin)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What isHumulina Regularand how it is used

2. What you need to knowbefore starting to useHumulina Regular

3. How to useHumulina Regular

4. Possible adverse effects

5. Storage ofHumulina Regular

6. Contents of the package andadditional information

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

Your doctor may tell you to use Humulina Regular along with a longer-acting insulin. Each insulin contains its own leaflet that will inform you about this. Do not change your insulin unless your doctor tells you to. Be careful if you change your insulin. Each type of insulin has a different color and symbol on the packaging and vial so that you can easily distinguish them.

No useHumulina Regular:

• If you think you are starting to have hypoglycemia (low blood sugar).More information on how to treat a mild hypoglycemia is provided later in this leaflet (see section 4, subsection A).(see section 4, subsection A).
• If you are allergic to human insulin or to any of the other components of this medicine (listed in section 6).(listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Humulina Regular.

• If your blood sugar levels are well controlled with the insulin you are currently using, you may not feel the warning signs when your blood sugar drops to very low levels. You should carefully consider when to take meals, how often to exercise and how intensely. You should also carefully control your blood sugar levels by frequently checking your blood glucose.
• Some people who have had hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the early warning signs were less obvious or different. If you frequently have hypoglycemia 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 been ill recently?
  • Do you have problems with your kidneys or liver?
  • 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. The time difference between countries may require you to take your injections and meals at different times than when you are at home.
• Some patients with type 2 diabetes who have had heart problems or who have had a previous 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 or rapid weight gain or localized swelling (edema).

Changes in the skin at the injection site:

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. Insulin may not work well if 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 advise you to check your blood sugar levels more closely, and to adjust your insulin or your other diabetes medications.

Use of Humulina Regular with other medicines

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

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

• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycemics (oral diabetes medications),
• 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 (ACE inhibitors) (e.g. captopril, enalapril) or angiotensin II receptor blockers.

Pregnancy, breastfeeding and fertility

The amount of insulin you normally need 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

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

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

Humulina Regular contains Sodium

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

Always check the name and type of insulin in the vial and label when you receive it from the pharmacy. Make sure you get the Humulin that your doctor has prescribed for you.Humulinthat your doctor has prescribed for you.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

• Your doctor has told you which insulin to use, how much, when, and how often to inject yourself. These instructions are only for you. Follow them exactly and attend your diabetes clinic regularly.
• If you change the type of insulin (for example from animal to human), you may need to use more or less than before. This may be only in the first injection or it may be a gradual change over several weeks or months.
• Inject Humulin Regular under the skin. You should only inject it into a muscle if your doctor has told you to.

Preparing Humulin Regular

• Humulin Regular is already dissolved in water, so it does not need to be mixed. But you must only use it if its appearance is like water. It should be transparent and colorless and without solid particles. Check it every time you inject.

Injecting Humulin Regular

• First, wash your hands.
• Before injecting, clean the skin as you have been told. Clean the rubber stopper of the vial, but do not remove it.
• Use a new and sterile syringe and needle to pierce the rubber stopper and load the amount of Humulin 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 not inject directly into a vein.After the injection, keep the needle in the skin for 5 seconds to make sure the entire dose is administered. Do not rub the area where you just injected. Make sure to inject at least 1 centimeter away from where you injected last time and "alternate" the injection sites as you have been taught.
• Your doctor will tell you if you need to mix Humulin Regular with Humulin NPH. If, for example, you need to inject a mixture, load the syringe with Humulin Regular before doing so with the long-acting insulin. Inject the liquid as soon as you have mixed it. Repeat the same every time you need to inject a mixture. Normally, you should not mix Humulin Regular with a mixture of human insulins. Never mix Humulin Regular with insulins produced by other manufacturers or with animal insulins.
• You should not inject Humulin Regular into a vein. Inject Humulin Regular as your doctor or nurse has taught you. Only your doctor can inject Humulin Regular into a vein. Only they will 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 more Humulin Regular than you should

If you use more Humulin Regular than you should, your blood sugar may decrease.Check your blood sugar (see section 4, subsection A).

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to use Humulin Regular

If you use less Humulin Regular than you should, your blood sugar levels may increase. Check your blood sugar.Do not inject a double dose to compensate for the missed doses.

If you interrupt treatment with Humulin Regular

If you use less Humulin 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 other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Possible side effects

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

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

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

Changes in skin at the injection site:

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

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

Common problems of diabetes

A.Hypoglycemia

Hypoglycemia (low blood sugar) means 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 insulin needs; or
• you have liver or kidney problems that worsen.

Alcohol and some 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 sure of recognizing the warning signs, 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.

If your blood sugar is low, take glucose tablets, sugar, or drink a sweetened beverage. Then take something to eat, such as fruit, cookies, or a snack, as your doctor has instructed, and rest. This should help you recover from mild or small insulin overdose hypoglycemia. If it worsens and your breathing is shallow and your skin is pale, inform your doctor immediately. A glucagon injection can treat 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 on glucagon.

B.Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (high blood sugar) means your body does not have enough insulin.

Hyperglycemia can be caused by:

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

Hyperglycemia can cause diabetic ketoacidosis. The first symptoms begin slowly over several hours or days. The symptoms include the following:

Severe symptoms include rapid breathing and a rapid pulse.Seek medical help immediately.

If hypoglycemia (low blood sugar) or hyperglycemia (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 steps to avoid hypoglycemia or hyperglycemia are:

• Always have extra syringes and a vial of Humulina Regular.
• Always carry something that identifies you as a diabetic patient.
• Always carry sugar with you.

C.Illness

If you are ill, especially when you have nausea or vomiting, you may vary the amount of insulin you need.You need to continue taking insulin even when you are not eating as you normally do.Perform urine or blood tests, follow the guidelines that have been indicated for you to perform in these cases, and inform your doctor or nurse.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

You can maintain your vial “in use” at room temperature (below30°C) for 28 days. Do not leave it near a heat source or in direct sunlight.

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

Do not use this medicationif you observe thatit is coloredorif it containssolid particles.Onlyuse it if its appearanceis like water. Check it every time you inject it.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition ofHumulina Regular

• Theactive principleis human insulin. Human insulin is obtained in the laboratoryby “recombinant DNA technology” and has the same structure as the natural hormone produced by the pancreas. Therefore, it is different from animal insulins.

• Theother 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 contents of the Humulina Regular packaging

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

Humulina Regular 100UI/ml is presented in a 1 vial or 2 vials or in multiple packaging of 5 (5 x 1) vials.Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

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

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

Huminsulin“Lilly”Normal(Austria)

Umuline Rapide 100UI/ml (France)

Humuline Regular (Belgium, Luxembourg)

Huminsulin Normal 100 (Germany)

HumulinRegular (Denmark, Greece, Sweden)

Humulina Regular (Spain)

Humulin S (Ireland, United Kingdom)

Humulin R (Czech Republic, Italy, Romania)

Last review date of this leaflet: August 2020.

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