Humulina 30:70 100 IU/ml suspension for injection in vial

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

HUMULINA 30:70 100 IU/ml injection 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, 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 30:70 is and what it is used for
2. What you need to know before using Humulina 30:70
3. How to use Humulina 30:70
4. Possible adverse effects
5. How to store 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 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 level (blood sugar). Humulina 30:70 is used for long-term blood glucose control. It is a premixed suspension of both fast-acting and long-acting insulin. Its prolonged action is achieved by the inclusion of protamine sulfate in the suspension.

Your doctor may instruct you to use Humulina 30:70 together with a slower-acting insulin. Each insulin has its own package leaflet providing information about this. 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 packaging and vial to help you easily distinguish them.

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

Do not use Humulina 30:70:

• If you think you are starting to have hypoglycaemia (low blood sugar). Later in this leaflet, you will find instructions on how to treat mild hypoglycaemia (see section 4, part 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 30:70.

• If your blood sugar levels are well controlled with your current insulin, you may not feel the warning symptoms when your blood sugar drops to too low levels. The warning signs are listed later in this leaflet. You must carefully consider when to eat meals, how often and how intensely you exercise. 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 you answer YES to any of the following questions, 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 stroke, treated with pioglitazone and insulin, have experienced the development of heart failure. Inform your doctor as soon as possible if you experience 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 30:70). Contact your doctor if you are currently injecting into a lumpy area before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and adjust your insulin dose or other antidiabetic medications.

Using Humulina 30:70 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:

• Steroids,
• 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,
• some 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 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 you 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,
• have difficulty perceiving or do not perceive the symptoms of hypoglycaemia.

Humulina 30:70 contains Sodium

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

3. How to use Humulina 30:70

Always check the name and type of insulin on the packaging and label of the vial when you obtain it from the pharmacy. Make sure you receive the Humulina your doctor has prescribed for you to use.

Follow exactly the dosing instructions for 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 specifically 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), you may need to use more or less than before. This may apply only to the first injection or may involve a gradual adjustment over several weeks or months.
• Inject Humulina 30:70 under the skin. Do not administer it by any other route. Under no circumstances should Humulina 30:70 be injected directly into a vein.

Preparing Humulina 30:70

• Vials containing Humulina 30:70 must be rolled several times between the palms of the hands before use to resuspend the insulin until it has a uniformly cloudy or milky appearance. Do not shake vigorously, to avoid foaming, which may interfere with accurate dose measurement. Vials should be frequently inspected and must not be used if there are accumulations of material or white solid particles adhering to the bottom or sides of the vial, giving it a frost-like appearance. Check this each time before injecting.

Injecting Humulina 30:70

• First, wash your hands.
• Before injecting, clean the skin thoroughly as 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 Humulina 30:70. 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 you inject at least 1 centimeter away from the previous injection site and rotate injection sites as instructed.

If you use more Humulina 30:70 than you should

If you use more Humulina 30:70 than prescribed, your blood sugar may drop. Check your blood sugar (see section 4, subsection A).

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to use Humulina 30:70

If you use less Humulina 30:70 than prescribed, your blood sugar levels may rise. Check your blood sugar. Do not inject a double dose to make up for missed doses.

If you stop using Humulina 30:70

If you use less Humulina 30:70 than prescribed, your blood sugar levels may become too high. Do not change your insulin unless your doctor tells you to do so.

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 everyone experiences them.

Human insulin can cause hypoglycemia (low blood sugar). See further information on hypoglycemia 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 30:70, inform your doctor immediately.

Local allergy: This is common (affects less 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, consult your doctor.

Skin changes at the injection site:

If you inject insulin too frequently in the same place, fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy) (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 a lumpy area. Rotate your injection sites to help prevent these skin changes.

Cases of edema (e.g., swelling of arms, ankles, fluid retention) have been reported, particularly at the beginning of insulin treatment or during changes in treatment 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 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 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 sure 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 Humulina 30:70 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, consume some fruit, biscuits, or a snack as directed by your doctor, and rest. This will likely help you recover from mild hypoglycemia or a minor insulin overdose. If your condition worsens and you have shallow breathing and pale skin, inform your doctor immediately. A glucagon injection may treat a more severe hypoglycemia. Take glucose or sugar after the glucagon injection. If there is no response 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 Humulina 30:70 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 can lead to diabetic ketoacidosis. Early 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 left untreated, they can become 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 keep extra syringes and an additional vial of Humulina 30:70 available.
• 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 usual. Perform urine or blood tests, follow the guidelines you have been given 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, 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 first use, store your Humulina 30:70 in the refrigerator (between 2 °C and 8 °C). Do not freeze.

Once in use, the vial may be kept 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 packaging and label. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice clumps or white solid particles attached to the bottom or sides of the vial, giving it a frost-like appearance. Check this each time before injecting.

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

6. Contents of the pack and other information

Composition of Humulina 30:70

• 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. Humulina 30:70 is a premixed suspension containing 30% soluble insulin and 70% insulin combined with protamine sulfate.

• The other components are protamine sulfate, metacresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide, and water for injections. During manufacturing, sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity.

Appearance of the product and contents of the container of Humulina 30:70

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

Humulina 30:70 100 UI/ml is available in packs containing 1 vial, 2 vials, or multiple packs of 5 (5 x 1) vials. Only certain pack sizes may be commercially available.

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