HUMULINA 30:70 100 IU/ML SUSPENSION FOR INJECTION IN VIAL

Introduction

Package Leaflet: Information for the User

HUMULINA30:70 100UI/ml injectable suspension in vial

(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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Humulina 30:70 contains the active substance human insulin, which is used to treat diabetes. You have diabetes if your pancreas does not produce enough insulin to control your blood sugar level. Humulina 30:70 is used for long-term blood sugar control. It is a premixed suspension of fast-acting and long-acting insulin. Its action is prolonged by the inclusion of protamine sulfate in the suspension.

Your doctor may tell you to use Humulina 30:70 with a slower-acting insulin. Each insulin has its own package leaflet that will tell you about it. 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 tell them apart.

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

Do not useHumulina30:70:

• If you think you are starting to have hypoglycemia (low blood sugar).Later in this leaflet, you will find out 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 30:70.

• 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 hypoglycemia (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 have hypoglycemia 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).

Skin changes at the injection site:

You should rotate the injection site to avoid skin changes, 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 30:70). 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 30:70 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 hypoglycemics (diabetes medication),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• beta-2 stimulants (e.g., ritodrine, salbutamol, or terbutalina),
• 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 hypoglycemia (low blood sugar). Please keep this in mind 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 whether it is safe for you to drive if you:

• have frequent episodes of hypoglycemia,
• have difficulty recognizing the symptoms of hypoglycemia or do not recognize them.

Humulina 30:70 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 30:70

Always check the name and type of insulin on the packaging 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 told by your doctor or pharmacist. If you are unsure, talk to 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 change the type of insulin (e.g., from animal to human), you may need to use more or less than before. This may be just for the first injection or may be a gradual change over several weeks or months.
• Inject Humulina 30:70 under the skin. Do not administer it using any other route. Under no circumstances should Humulina 30:70 be injected into a vein.

Preparing Humulina30:70

• Vials containing Humulina 30:70 should be moved several times between the palms of your hands before use to resuspend the insulin until it appears uniformly cloudy or milky. Do notshake vigorously to avoid creating foam, as this can interfere with the correct measurement of the dose. Vials should be examined frequently and should not be used if there are accumulations of material or white solid particles stuck to the bottom or walls of the vial, giving it a frosty appearance. Check this every time you inject.

InjectingHumulina30:70

• First, wash your hands.
• Before injecting, clean your skin as you have been instructed. Clean the rubber stopper on the vial but do not remove it.
• Use a new and sterile syringe and needle to puncture the rubber stopper and load the amount of Humulina 30:70 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 the injection, keep the needle in the skin for 5 seconds to make sure you have administered the full dose. Do not rub the area where you have just injected. Make sure you inject at least 1 centimeter away from where you last injected and "alternate" injection sites as you have been taught.

If you use moreHumulina30:70than you should

If you use more Humulina 30:70 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 useHumulina30:70

If you use less Humulina 30:70 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 usingHumulina30:70

If you use less Humulina 30:70 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 using 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 can causehypoglycemia(low blood sugar). See more information about hypoglycemia below in the subsection "Common diabetes problems".

Possible side effects

Systemic allergy:it 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 30:70, tell your doctor immediately.

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

Skin changes 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 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.

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

Common diabetes problems

• Hypoglycemia

Hypoglycemia (low blood sugar) means that 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 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 hypoglycemia can pose a risk to you or others.

Do not use Humulina30:70 if you think you are starting to have hypoglycemia (low blood sugar).

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 hypoglycemia or a small overdose of insulin. If you get worse and your breathing becomes shallow and your skin pales, tell your doctor immediately. An injection of glucagon 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 about glucagon.

• Hyperglycemia and diabetic ketoacidosis.

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

Hyperglycemia can be caused by:

• not taking your Humulina 30:70 or other insulin;
• taking less insulin than your doctor has told you;
• eating much more than your diet allows; or
• having a fever, infection, or emotional stress.

Hyperglycemia 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 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 stepsto avoid hypoglycemia or hyperglycemia are:

• Always carry extra syringes and a vial of Humulina 30:70 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 usually 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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Storage of Humulina 30:70

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

Before the first use, store your Humulina 30:70 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 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 medicine if you notice accumulations of material or white solid particles stuck to the bottom or walls of the vial, giving it a frosty appearance. Check this every time you inject.

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

6. Container contents and additional information

Composition ofHumulina30:70

• 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. Humulina 30:70 is a premixed suspension that contains 30% dissolved insulin in water and 70% insulin with protamine sulfate.

• The other componentsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate 7H2O, zinc oxide, 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 Humulina30:70

Humulina 30:70 100 UI/ml injectable suspension is a white and sterile suspension, containing 100 units of human insulin in each milliliter (100 UI/ml). Each vial contains 1,000 units (10 milliliters).

Humulina 30:70 100 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” Profil III (Austria)

Humuline 30/70 (Belgium, Luxembourg)

Humulin M3 (Ireland, United Kingdom)

Humulin 30/70 (Italy)

Umuline profil 30 (France)

Humulin M3 (30/70) (Greece)

Humulina 30:70 (Spain)

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/