Humulin r

Patient Information Leaflet

Humulin R, 100 IU/mL, solution for injection in a cartridge
(Insulinum humanum)
Please 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 symptoms are the same as yours.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Humulin R is and what it is used for
2. Important information before using Humulin R
3. How to use Humulin R
4. Possible side effects
5. How to store Humulin R
6. Contents of the pack and other information

1. What Humulin R is and what it is used for

Humulin R contains human insulin as the active substance, which is used in the treatment of diabetes.
Diabetes is caused by the inability of the pancreas to produce insulin in amounts sufficient to
control blood glucose levels (blood sugar). Humulin R is used to maintain long-term control of
glucose levels. Humulin R is a fast-acting insulin.
Your doctor may recommend using Humulin R together with an insulin that has a longer duration of action. This will be decided by your doctor. When changing insulin, great care must be taken. Each type of insulin has a different symbol and colour on the packaging and cartridge to help distinguish them easily.

2. Important information before using Humulin R

Humulin R in cartridges is intended exclusively for subcutaneous injection using a reusable injection pen. If insulin administration by another method is necessary, consult a doctor.

When not to use Humulin R

• if symptoms indicating hypoglycaemia (low blood glucose levels) are experienced. Information on how to manage mild hypoglycaemia is provided later in this leaflet (see section A under point 4).
• if the patient is allergic to human insulin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Humulin R, talk to your doctor, pharmacist or nurse.

• If current treatment ensures good glycaemic control, warning signs of excessively low blood glucose concentration may not be noticeable. The warning symptoms are listed later in this leaflet. Meals should be timed carefully, and the frequency and overall level of physical activity should be planned accordingly. Blood glucose levels should also be monitored frequently by regular blood glucose testing.
• Some people who have experienced hypoglycaemia (low blood glucose) after switching from animal insulin to human insulin have reported that the warning symptoms of hypoglycaemia were less pronounced or completely different than before. If hypoglycaemia occurs frequently or if you have difficulty recognizing the warning symptoms of hypoglycaemia, consult your doctor.
• Inform your diabetes nurse, doctor or pharmacist if:
  • you have recently been ill;
  • you have kidney or liver disease;
  • you have increased physical exertion.
• Insulin requirements may also change after alcohol consumption.
• Inform your diabetes nurse, doctor or pharmacist if you are planning to travel abroad. Time zone differences may require adjustments in the timing of injections and meals.
• In some patients with type 2 diabetes who have heart disease or a history of stroke, cases of heart failure have been reported when pioglitazone was used together with insulin. Contact your doctor immediately if symptoms of heart failure occur, such as shortness of breath, sudden weight gain, or localized swelling.

Skin changes at the injection site
Change the injection site regularly to prevent skin changes such as lumps under the skin. Insulin injected into an area with lumps may not work properly (see "How to use Humulin R"). If insulin is currently being injected into an area with lumps, contact your doctor before changing the site. Your doctor may recommend more frequent blood glucose monitoring and may adjust the dose of insulin or other antidiabetic medications.

Humulin R and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your body's insulin requirement may change when taking the following medicines concomitantly:

• steroids,
• thyroid hormone replacement therapy,
• oral glucose-lowering agents (antidiabetic drugs),
• acetylsalicylic acid (aspirin),
• growth hormone,
• octreotide, lanreotide,
• selective β-adrenergic receptor agonists (e.g. ritodrine, salbutamol, terbutaline),
• β-adrenergic blocking agents (β-blockers),
• thiazides or certain antidepressants (monoamine oxidase inhibitors),
• danazol,
• certain angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
Insulin requirement usually decreases during the first three months of pregnancy and increases during the following six months. Women who are breastfeeding may need to adjust their insulin dose or eating habits.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
In the case of hypoglycaemia (low blood glucose), your ability to concentrate and reaction speed may be reduced. Keep this in mind in all situations where this could pose a risk to yourself or others (e.g. when driving a vehicle or operating mechanical equipment). Seek advice from your diabetes nurse or doctor regarding driving a car if:

• hypoglycaemia occurs frequently;
• warning signs of hypoglycaemia are weak or absent.

Important information about certain ingredients in Humulin R
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. is essentially "sodium-free".

3. How to use Humulin R

The 3 ml cartridge is intended for use only in 3 ml syringes. Do not use it in 1.5 ml syringes.
Always check the name and type of insulin on the cartridge label and packaging when purchasing
the medicine at the pharmacy. Make sure it is the Humulin product prescribed by your doctor.
This medicine must always be used exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. To avoid the possible transmission of disease, each cartridge must be used by only one person, even if the needle is changed.

Dosage

• Your doctor will determine the appropriate type of insulin, the amount of medicine, and the timing and frequency of injections. These instructions are intended solely for the individual patient. Follow your doctor's advice carefully and attend your diabetes clinic regularly.
• Changing the type of insulin used (for example, from animal to human insulin) may require a reduction or increase in dose. This change may affect only the first injection or may be introduced gradually over several weeks or months.
• Humulin R in cartridges is intended exclusively for subcutaneous injection using a reusable insulin pen. If insulin must be administered by another method, consult your doctor.

Preparing Humulin R medicine

• Humulin R is already dissolved in water and therefore does not require mixing. It should be used only when it looks like water. It must be clear, colorless, and free from particles or cloudiness. Check this before each injection.

Preparing the pen for use

• Wash your hands first. Disinfect the rubber membrane of the cartridge.
• Humulin R cartridges must be used only with Lilly insulin pens to ensure accurate dosing. They cannot be used with any other reusable injection pen.
• Follow the instructions provided with the pen. Insert the cartridge into the pen.
• Set the dose to 1 or 2 units. Then, holding the pen with the needle pointing upward, tap the side of the pen so that air bubbles move to the top. With the needle still pointing upward, press the injection mechanism until a drop of Humulin R appears at the needle tip. A few small air bubbles may remain inside the pen. These are harmless, but a large air bubble may result in inaccurate dosing.

Injecting Humulin R

• Before injection, disinfect the skin according to the instructions provided.
• Inject the medicine under the skin as instructed. Do not inject the medicine directly into a vein. After injection, leave the needle in the skin for five seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure the distance from the previous injection site is at least 1 cm. Rotate injection sites as instructed.

Do not administer Humulin R intravenously.
Humulin R should be injected according to the instructions provided by your doctor or diabetes nurse.

After injection

• After injecting the medicine, remove the needle from the pen using the outer needle cap. This helps maintain the sterility of the medicine, prevents insulin leakage, stops air from entering the pen, and helps prevent needle blockage. Never share your needles or pen with anyone else. Replace the cap back onto the pen.

Subsequent injections

• Leave the cartridge in the pen. Before each injection, select 1 or 2 units and press the injection mechanism while holding the pen upright until a drop of Humulin R appears from the needle. You can check how much medicine remains by looking at the indicator on the side of the cartridge. The distance between indicator marks corresponds to approximately 20 units. If the amount of insulin remaining is less than the prescribed dose, replace the cartridge.

Do not mix any other insulin with Humulin R in the cartridge. Do not reuse the cartridge once it is empty.
Using more Humulin R than prescribed
If more Humulin R is injected than prescribed, low blood glucose levels may occur. Check your blood glucose level (see section A under point 4).
Missing a dose of Humulin R
If a smaller dose of Humulin R than prescribed is administered, high blood glucose levels may occur. Check your blood glucose level. Do not inject a double dose to make up for a missed dose.
Stopping Humulin R
If less than the prescribed dose of Humulin R is used, blood glucose levels may increase. Do not change your insulin regimen unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or diabetes nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Human insulin may cause hypoglycaemia (low blood glucose levels). See further information on
hypoglycaemia below under the section "Common diabetes-related problems".
Possible adverse reactions
Generalised allergy occurs very rarely (in less than 1 in 10,000 patients). Symptoms include:

• drop in blood pressure • rash over the entire body
• difficulty breathing • wheezing
• rapid heartbeat • sweating

If any of these symptoms occur while using Humulin R, contact your doctor immediately.
Local allergy occurs frequently (in less than 1 in 10 patients). Symptoms may include redness, swelling or itching of the skin around the injection site. These symptoms usually disappear after a few days or weeks. If any of the above symptoms occur, inform your doctor.
Skin changes at the injection site
If insulin is injected too often into the same site, fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (less frequently than in 1 in 100 patients). Lumps under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis, frequency unknown). Insulin injected into an area with lumps may not work properly. Always rotate your injection site—this will help prevent these skin changes.
Oedema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the beginning of insulin treatment or during changes in therapy aimed at improving blood glucose control.
Common diabetes-related problems
A. Hypoglycaemia
Hypoglycaemia (low blood glucose) is a condition in which there is too little sugar in the blood. It may occur if the patient:

• takes too high a dose of Humulin R or another insulin;
• skips or delays a meal, or changes their diet;
• exercises too vigorously or works hard just before or after a meal;
• is ill (especially with an illness involving diarrhoea or vomiting);
• experiences changes in insulin requirements, or
• has worsening kidney or liver function disorders.

Alcohol and certain medicines may affect blood glucose levels.
Early symptoms of low blood glucose usually appear quickly and include:

• fatigue • rapid heartbeat
• nervousness or trembling • nausea
• headache • cold sweats

If you are unsure about recognising the warning signs of hypoglycaemia, avoid situations where you might endanger yourself or others (e.g. driving a car).
Do not use Humulin R if you have symptoms of hypoglycaemia warning signs (low blood glucose).
If blood glucose is low, eat glucose tablets, sugar or drink a sweet beverage. Then eat a piece of fruit, biscuits or a sandwich, as advised by your doctor, and rest. This usually suffices in cases of mild hypoglycaemia or minor insulin overdose. If the condition worsens, with shallow breathing and pale skin, contact your doctor immediately. Injection of glucagon may help in cases of severe hypoglycaemia. After glucagon injection, eat glucose tablets or sugar. If there is no improvement after glucagon administration, go to hospital. For information about glucagon, consult your doctor.
B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too high blood glucose) means the body is not receiving enough insulin. Hyperglycaemia may be caused by:

• not taking Humulin R or another insulin;
• injecting less insulin than prescribed by your doctor;
• eating very large meals compared to dietary requirements; or
• fever, infection, or stressful events.

Hyperglycaemia may lead to diabetic ketoacidosis. Early symptoms develop slowly over several hours or days. These symptoms include:

• drowsiness • loss of appetite
• flushed face • fruity odour on the breath
• thirst • nausea or vomiting.

Severe symptoms include difficulty breathing and rapid pulse. Seek medical help immediately.
Untreated hypoglycaemia (low blood glucose) or hyperglycaemia (high blood glucose) may lead to serious disturbances and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma or even death.
Three simple ways to avoid hypoglycaemia or hyperglycaemia:

• Always carry a spare injection device and a cartridge of Humulin R insulin.
• Always carry something that informs others that you have diabetes.
• Always carry sugar cubes.

C. Illness
During illness, especially when associated with nausea or vomiting, your body's insulin requirements may change. People with diabetes need insulin even when they are not eating normal meals. Perform urine or blood tests, follow general illness management guidelines, and contact your diabetes nurse or doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
Adverse reactions can also be reported to the marketing authorisation holder or its representative. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Humulin R

Keep the medicine out of the sight and reach of children.
Before first use, Humulin R should be stored in a refrigerator (2°C - 8°C). Do not freeze.
The used injection pen and cartridge should be stored at room temperature (below 30°C) and
used within 28 days. Do not store the used injection pen or cartridges in the refrigerator.
Do not place them near heat sources or direct sunlight.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice that it is discolored or if you see solid particles.
Humulin R may be used only if it appears water-like. Check the appearance of the insulin before each injection.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Humulin R contains

• The active substance is human insulin produced by recombinant DNA technology. It has the same structure as the natural hormone produced by the pancreas and therefore differs from animal insulins.
• The other ingredients are: m-cresol, glycerol, water for injections, 10% hydrochloric acid solution, and 10% sodium hydroxide solution (used to adjust pH).

What Humulin R looks like and contents of the pack
Humulin R is a sterile, clear, colourless, aqueous solution of soluble human insulin.
One millilitre of solution contains 100 International Units of insulin (100 IU/ml). Each cartridge contains 300 units (3 ml of solution).
Cartridges are supplied in packs of 5.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturers:
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France
Eli Lilly Italia S.p.A., Via A. Gramsci 731-733, 50019 Sesto Fiorentino, Italy

For further information, contact the representative of the Marketing Authorisation Holder:
Eli Lilly Polska Sp. z o.o.
ul. Żwirki i Wigury 18A
02-092 Warsaw, Poland
Tel: +48 22 440 33 00

This medicinal product is authorised 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, The Netherlands)
Huminsulin Normal für Pen 3 ml (Germany)
Humulin Regular (Cyprus, Greece, Portugal, Sweden)
Humulin S (Malta, Ireland, United Kingdom)
Humulin R (Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Italy, Poland, Romania, Slovenia)
Humulin R Cartridge (Czech Republic, Slovakia)