Label: Information for the user

HUMULINA 30:70 KwikPen 100UI/ml injectable suspension

(Human insulin)

Read this label carefully before starting to use this medicine, 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 medicine has been prescribed only for 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 do not appear in this label. See section 4.

1. What isHumulina 30:70 KwikPenand how it is used

2. What you need to knowbefore starting to useHumulina 30:70 KwikPen

3. How to useHumulina 30:70 KwikPen

4. Possible adverse effects

5. Storage ofHumulina 30:70 KwikPen

6. Contents of the package and additional information

Humulina 30:70 KwikPen is a pre-filled pen that contains human insulin as the 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 30:70 is used for long-term glucose control. It is a pre-mixed suspension of rapid-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 KwikPen along with another long-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 pen so that you can easily distinguish them.

Humulina 30:70 in a pre-filled pen is only indicated for injection just below the skin. Consult your doctor if you need to inject insulin by another method.

No useHumulina 30:70 KwikPen:

• 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).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Humulina 30:70 KwikPen.

• 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 level drops too low. The warning signs are listed later in this leaflet. 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 is YES to any of the following questions, inform your doctor, pharmacist or nurse.
• • Have you been ill recently?
  • Do you have problems with your kidneys or liver?
  • Are you doing more exercise 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 different countries may mean that your injections and meals need to be taken 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. The insulin may not work well if it is injected into a swollen area (see How to use Humulina 30:70 KwikPen). 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 the insulin or the dose of your other diabetes medications.

Use of Humulina 30:70 KwikPen 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:

• Glucocorticoids,
• thyroid hormone replacement therapy,
• oral hypoglycemic agents (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, lactation 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 vary your insulin dose or diet.

If you are pregnant or breastfeeding, or if you think you might be 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 suffer from hypoglycemia (low blood sugar). Please remember this in all situations where it may be a cause of risk for you or for 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 hypoglycemia that are frequent,
• difficulty perceiving the symptoms of a hypoglycemia or do not perceive them.

Humulina 30:70 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 container and on the label of the pre-filled pen when you obtain it from the pharmacy. Make sure you get the Humulina 30:70 KwikPen that your doctor has instructed you to use.

Follow exactly the administration instructions for this medication as indicated 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.

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 from one 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.
• Humulina 30:70 in pre-filled pen is only indicated for injection just below the skin. Consult your doctor if you need to inject insulin by another method.

Preparing Humulina 30:70 KwikPen

• Move the KwikPen between the palms of your hands 10 times and invert it 10 times immediately before use to resuspend the insulin, until the contents appear uniformly cloudy or milky. If this does not occur, repeat the procedure until the contents mix well. The cartridges of the pens contain a glass bead to facilitate mixing.Do notshake vigorously to avoid foam formation, as this may interfere with the correct measurement of the dose. The cartridges of the pens should be examined frequently and should not be used if there are accumulations of material or white solid particles adhering to the bottom or walls of the cartridge, giving it a frost-like appearance.Check it each time you inject.

Leaving the KwikPen ready for use (See User Manual)

• First, wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Follow the instructions carefully. Here are some guidelines to follow.

• Use a new needle. (Needles are not included).

• Purge your KwikPen before each use. This ensures that the insulin comes out and the air bubbles are released from your KwikPen. There may be small air bubbles in the KwikPen, which are not harmful, but if the air bubble is too large, it may affect the accuracy of your injection dose.

Injecting Humulina 30:70

• Before injecting, clean the skin as instructed. Inject under the skin, as instructed. Do notinject directly into a vein. After the injection, keep the needle in the skin for 5 seconds to ensure that 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 instructed.

After the injection

• Once you have injected, remove the needle from the KwikPen using the outer cap of the needle. This will keep the insulin sterile and prevent it from coming out. It will also prevent air from entering the KwikPen and the needle from becoming clogged.Do notshare your needles or your KwikPen.Put the cap back 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 is left by holding the KwikPen with the needle down. The scale on the cartridge shows approximately how many units are left.
• Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it again. Dispose of the KwikPen carefully; your pharmacist or nurse will tell you how to do it.

If you use more Humulina 30:70 than you should

If you use more Humulina 30:70 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 forget to use Humulina 30:70 KwikPen

If you use less Humulina 30:70 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 Humulina 30:70 KwikPen

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 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 on hypoglycemia below in the subsection “Common problems with 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 30:70, report it immediately to your doctor.

Local allergy:is common (affects fewer than 1 in 10 treated patients).In some patients, the injection area 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). Bumps 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.

Swelling (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 with 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 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 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 hypoglycemia can pose a risk to you or others.

Do not use Humulina 30:70 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, report it immediately to your doctor. 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 30:70 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.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 steps to avoid hypoglycemia or hyperglycemia are:

• Always have extra syringes and a vial of Humulina 30:70.
• 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 report to your doctor or nurse.

Reporting 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 Vigilance 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 Humulina 30:70 KwikPen in a refrigerator (between 2°C and 8°C).Do not freeze.Keep your Humulina 30:70 KwikPen “in use” at room temperature (below 30°C) for up to 28 days. Do not store your pen “in use” in the refrigerator. 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 medication if you observe that there are accumulations of material or white solid particles adhered to the bottom or walls of the cartridge, giving it an appearance similar to frost.Check it each time you inject.

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

Composition ofHumulina 30:70 KwikPen

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

• Theother componentsare protamine sulfate, metacresol, phenol, glycerol, sodium dihydrogen 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 contents of the Humulina 30:70 KwikPenKwikPen

Humulina 30:70 KwikPen 100UI/ml injectable suspension is awhite and sterile suspension, containing 100 units of human insulin in each milliliter (100 UI/ml).

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

Humulina 30:70 KwikPen is presented in a pack of 5, 6 or 10 (2 x 5) units.

Only some pack sizes may be commercially available..

The Humulina 30:70 in your KwikPen is the same as 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 responsible manufacturer

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

Responsible 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 with 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)

Umulineprofil 30 KwikPen 100UI/ml (France)

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

Last review date 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 Medical Devices (AEMPS)http://www.aemps.gob.es/