HUMULIN 100/UI/ML Инъекционный раствор

Содержание инструкции

1. HUMULIN R (Regolare) 100 IU/ml injectable solution in a vial
   1. What is Humulin R and what is it used for
   2. What you need to know 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
2. HUMULIN I (Isofano) 100 IU/ml injectable suspension in a vial
   1. What is Humulin I and what is it used for
   2. What you need to know before using Humulin I
   3. How to use Humulin I
   4. Possible side effects
   5. How to store Humulin I
   6. Contents of the pack and other information
3. HUMULIN 30/70 (Mixture) 100 IU/ml injectable suspension in a vial
   1. What is Humulin 30/70 and what is it used for
   2. What you need to know before using Humulin 30/70
   3. How to use Humulin 30/70
   4. Possible side effects
   5. How to store Humulin 30/70
   6. Package contents and other information
4. HUMULIN R (Regolare) 100 IU/ml injectable solution in cartridge
   1. What is Humulin R and what is it used for
   2. What you need to know before using Humulin R
   3. How to use Humulin R
   4. Possible side effects
   5. How to store Humulin R
   6. Package contents and other information
5. HUMULIN I (Isofano) 100 IU/ml injectable suspension in cartridge
   1. What is Humulin I and what is it used for
   2. What you need to know before using Humulin I
   3. How to use Humulin I
   4. Possible side effects
   5. How to store Humulin I
   6. Package contents and other information
6. HUMULIN 30/70 (Mixture) 100 IU/ml injectable suspension in cartridge
   1. What is Humulin 30/70 and what is it used for
   2. What you need to know before using Humulin 30/70
   3. How to use Humulin 30/70
   4. Possible side effects
   5. How to store Humulin 30/70
   6. Package contents and other information

HUMULIN R (Regolare) 100 IU/ml injectable solution in a vial

(human insulin)
Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Humulin R is and what it is used for
• 2. What you need to know before you use 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 is Humulin R and what is it used for

The active ingredient contained in Humulin R is human insulin which is used for the therapy of diabetes.
The disease, diabetes, arises from the fact that the pancreas does not produce insulin in sufficient quantity to
control the level of glucose in the blood. Humulin R is used to control glucose in the
long term. Humulin R is a fast-acting insulin preparation.
The doctor may prescribe you to use Humulin R as well as a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Be very
careful when changing the type of insulin. Each type of insulin has a different color and a symbol on the
package and the vial so that you can easily see the difference.

2. What you need to know before using Humulin R

Do not use Humulin R

• If you believe you are experiencing hypoglycemia (low blood sugar).Further instructions on how to manage mild hypoglycemia are included later in this leaflet (see section A of paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin R.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay

close attention to the timing of meals, frequency and intensity of physical exercise. You should also
monitor your blood sugar level frequently by measuring it.

• Some people who switched from animal insulin to human insulin have reported that the warning symptoms of hypoglycemia (low blood sugar) were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been recently ill?
• Do you have problems with your liver or kidneys?
• Are you doing more exercise than usual?
• Your insulin needs may change if you consume alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with type 2 diabetes mellitus diagnosed for a long time and with heart disease or a previous stroke who were treated with pioglitazone and insulin have reported the development of heart failure. Tell 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:
The injection site must be rotated to prevent skin changes, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject it into an area with nodules
(see paragraph How to use Humulin R). If you are currently injecting into an area with nodules, see
your doctor before starting to inject into another area. Your doctor may advise you to
check your blood glucose more carefully and adjust the dose of insulin or other antidiabetic medicines.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin R
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:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta-stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in the
six months thereafter. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, or suspect you may be pregnant, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience hypoglycemia
(low blood sugar). Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using
machinery).
You should consult the nurse at the diabetes center or your doctor about whether it is appropriate to drive if
you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin R contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin R

Always check the package and the vial label for the name and type of insulin
that you receive from the pharmacist. Make sure the Humulin package corresponds
to what your doctor has prescribed.
Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.

Dosage

• Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Administer the Humulin R injection under the skin. You should only perform an intramuscular injection following a specific indication from your doctor.

Preparation of Humulin R

• Humulin R is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.

Injection of Humulin R

• First, wash your hands.
• Before administering the injection, disinfect the skin according to the instructions you have received. Disinfect the rubber stopper of the vial, but do not remove it.
• Use a sterile syringe and needle to puncture the rubber stopper and draw up the amount of Humulin R needed for injection. Your doctor or the diabetes center will show you

exactly how to do it. You must absolutely not share your syringes and needles with others.

• Inject the medicine subcutaneously, as you have been taught. Do notinject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the previous one and remember to rotate the injection site, as you have been told.
• Your doctor will tell you if you need to mix Humulin R with Humulin I. For example, if you need to inject a mixture, draw Humulin R into the syringe before drawing up the long-acting insulin .Inject the mixture immediately after preparing it. Repeat the same operations exactly every time. As a rule, you should not mix Humulin R with pre-mixed human insulins. Never mix Humulin R with insulins from other manufacturers or with animal insulins.
• You must not administer Humulin R intravenously. Inject Humulin R as your doctor or the nurse at the diabetes center has taught you. Only your doctor can administer Humulin R intravenously. He will do this only in particular circumstances such as surgery or if you are ill and your blood sugar levels are too high.

If you use more Humulin R than you should
If you use more Humulin R than you should, a decrease in blood sugar levels may occur.
Check your blood sugar level (see point A in section 4).

If you forget to use Humulin R
If you use less Humulin R than you should, an increase in blood sugar levels may occur.
Check your blood sugar level. Do not inject a double dose to make up for the
missed dose.

If you stop treatment with Humulin R
If you use less Humulin R than you should, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Humaninsulin can cause hypoglycemia (low blood sugar). See further information on hypoglycemia below, in the sub-paragraph “Common diabetes problems”.
Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). Symptoms include:
low blood pressure
difficulty breathing
rapid heartbeat
skin rash all over the body
dyspnea
sweating
If you believe that Humulin R is causing you this type of insulin allergy, inform your doctor immediately.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the injection site may appear red, swollen, and itchy. Usually, this reaction disappears within a few days or weeks. If this occurs, inform your doctor.
Changes to the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well if you inject into an area with nodules. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (e.g., swelling of the arms, ankles; fluid retention), particularly at the beginning of insulin therapy or during a modification of therapy to improve glycemic control.

Common diabetes problems

• A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
• an excessive dose of Humulin R or another insulin;
• a delay or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medications can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia appear quickly and include:
fatigue
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as driving a vehicle, in which hypoglycemia could endanger you or others.

Do not use Humulin R if you feel that hypoglycemia (low blood sugar) is occurring.
If your blood sugar is low, eat glucose tablets, sugar, or drink a sugary beverage. Then eat fruit, biscuits, or a sandwich, as suggested by your doctor, and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and are short of breath and your skin is pale, inform your doctor immediately. A glucagon injection can treat fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not get a positive response with glucagon, you must be hospitalized. Ask your doctor for information on the use of glucagon.

• B.Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body.
Hyperglycemia can be caused by:

• failure to take Humulin R or another insulin;
• taking a dose of insulin lower than that prescribed by your doctor;
• eating a much larger amount of food than allowed by your diet;
• fever, infection, or strong emotion.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear slowly, over many hours or days. They include:
feeling sleepy
redness of the face
thirst
loss of appetite
breath with a fruity odor
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical attention.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) that is not treated adequately can become very serious and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma, and even death.

Three simple behaviorsto avoid hypoglycemia or hyperglycemia are:

• Always keep some syringes and a vial of Humulin R in stock.
• Always carry a document indicating that you are diabetic.
• Always carry sugar with you.
• C.IllnessIf you are ill, especially if you feel or are unwell, your insulin needs may vary. Even when you are not eating normally, you still need insulin.Perform a urine and blood test; when you are unwell, follow the precautions you already know and inform the nurse at the diabetes center or your doctor.

Reporting side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to adverse. Reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Humulin R

Keep this medicine out of the sight and reach of children.
Before use, store Humulin R in a refrigerator (2°C - 8°C). Do not freeze.
During use, store the vial at room temperature (below 30°C) for a period of up to
28 days. Do not keep it near a heat source or in direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice that it is coloured or contains solid particles. You must use it only
if its appearance is the same as that of water. Check all of this before each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humulin R contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins.
• The excipientsare metacresol, glycerol and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of the appearance of Humulin R and contents of the pack
Humulin R (Regular) 100 IU/ml solution for injection is a sterile, clear and
colourless aqueous solution and contains 100 units of insulin per millilitre (100 IU/ml). Each vial contains 1,000
units (10 millilitres).
Humulin R 100 IU/ml is available in a pack of 1 vial, 2 vials or in a
multipack of 5 vials (containing 5 packs of 1 vial).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733 - 50019 Sesto Fiorentino (FI), Italy
Humulin R in vial is manufactured by:

• Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Huminsulin „Lilly“ Normal (Austria)
Umuline rapide 100 IU/ml (France)
Humuline Regular (Belgium, Luxembourg)
Huminsulin Normal 100 (Germany)
Humulin Regular (Denmark, Greece, Sweden)
Humulina Regular (Spain)
Humulin S (Ireland, United Kingdom)
Humulin R (Czech Republic, Italy, Romania)

HUMULIN I (Isofano) 100 IU/ml injectable suspension in a vial

(human insulin)
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Humulin I is and what it is used for
• 2. What you need to know before you use Humulin I
• 3. How to use Humulin I
• 4. Possible side effects
• 5. How to store Humulin I
• 6. Contents of the pack and other information

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

The active substance contained in Humulin I is human insulin which is used for the therapy of diabetes.
The disease, diabetes, derives from the fact that the pancreas does not produce insulin in an adequate quantity to
control the level of glucose in the blood. Humulin I is used to control glucose in the long
term. Its action is prolonged due to the presence of protamine sulfate in the suspension.
The doctor may prescribe you the use of Humulin I as well as that of a rapid-acting insulin. Each correct use. Do not change the type of insulin unless prescribed by your doctor. Be very careful
when changing the type of insulin. Each type of insulin has a different color and a symbol on the packaging
and on the vial so that you can easily see the difference.

2. What you need to know before using Humulin I

Do not use Humulin I

• If you believe you are experiencing hypoglycemia (low blood sugar).Further instructions on how to manage mild hypoglycemia are included later in this leaflet ( see section A of paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin I.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is getting too low. The warning signs are listed later in this leaflet. You must pay

close attention to the timing of your meals, the frequency and intensity of your exercise. You should also
monitor your blood sugar level frequently by measuring it.

• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been recently ill?
• Do you have problems with your liver or kidneys?
• Are you doing more exercise than usual?
• Your insulin needs may change if you consume alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with type 2 diabetes mellitus diagnosed for a long time and with heart disease or a previous stroke who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell 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).

Changes to the skin at the injection site:
The injection site must be rotated to prevent changes to the skin, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject it into an area with nodules
(see paragraph How to use Humulin I). If you are currently injecting into an area with nodules, see
your doctor before starting to inject into another area. Your doctor may advise you to
check your blood sugar more carefully and adjust the dose of insulin or other antidiabetic medicines.
For those who exercise: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin I
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Your insulin needs may change if you are taking:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta -stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in the
six months that follow. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
Your ability to concentrate and react may be impaired if you experience hypoglycemia
(low blood sugar). Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using
machinery). You should consult your nurse at the diabetes center or your doctor about whether it is safe to drive if you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin I contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin I

Always check the package and the vial label for the name and type of insulin
that you receive from the pharmacist. Make sure the Humulin package corresponds
to what your doctor has prescribed.
Use this medicine following your doctor's or pharmacist's instructions exactly. If you have
any doubts, ask your doctor or pharmacist.

Dosage

• Normally, you should inject Humulin I as a basal insulin. Regarding the amount, timing and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Inject Humulin I under the skin. You must not administer the medicine using another route of administration. Under no circumstances must Humulin I be administered intravenously.

Preparation of Humulin I

• Before use, vials containing Humulin I must be rotated between the palms of your hands several times to return the insulin completely into suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. Do notshake vigorously, as this maneuver may cause foaming which may compromise the correct measurement of the dose. The vials must be examined frequently and must not be used if floating residue or white particles adhering to the bottom or walls of the vial are observed, which give it an icy appearance. Check all of this before each injection.

Injection of Humulin I

• First, wash your hands.
• Before making the injection, disinfect the skin according to the instructions you have received. Disinfect the rubber stopper of the vial, but do not remove it.
• Use a sterile syringe and needle to puncture the rubber stopper and draw up the amount of Humulin I that you need to inject. Your doctor or diabetes center will show you exactly how to do it. You must absolutely not share your syringes and needles with others.
• Inject the medicine subcutaneously, as you have been taught. Do notinject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used previously and remember to rotate the injection site, as you have been told.
• Your doctor will tell you if you need to mix Humulin R with Humulin I. For example, if you need to inject a mixture, draw Humulin R into the syringe before drawing up the long-acting insulin .Inject the mixture immediately after preparing it. Repeat the same operations exactly every time. Normally you should not mix Humulin I with already mixed human insulins. You should never mix Humulin I with insulins from other manufacturers or with animal insulins.
• You must not administer Humulin I intravenously. Inject Humulin I as your doctor or the nurse at the diabetes center has taught you.

If you use more Humulin I than you should
If you use more Humulin I than you should, a decrease in blood sugar level may occur.
Check your blood sugar level (see point A in section 4).

If you forget to use Humulin I
If you use less Humulin I than you should, an increase in blood sugar level may occur.
Check your blood sugar level. Do not inject a double dose to compensate for
forgetting the dose.

If you stop taking Humulin I
If you use less Humulin I than you should, an increase in blood sugar level may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts 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.
Humaninsulin can cause hypoglycemia (low blood sugar). See further
information on hypoglycemia below, in the sub-paragraph “Common diabetes problems”.

Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). Symptoms include:
low blood pressure
difficulty breathing
rapid heartbeat
skin rash all over the body
dyspnea
sweating
If you think Humulin I is causing you this type of insulin allergy, tell your
doctor immediately.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the injection site may become red, swollen and itchy. Usually, this reaction disappears in
a few days or weeks. If this happens, tell your doctor.
Changes to the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or
thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also
be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; the
frequency with which this occurs is not known). Insulin may not work as well if you inject it into
an area with lumps. Change the injection site with each injection to prevent these skin changes.
Edema (e.g. swelling of the arms, ankles; fluid retention) has been reported, in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood sugar control.

Common diabetes problems

• A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
• an excessive dose of Humulin I or another insulin;
• a delayed or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.

Do not use Humulin I if you think you are developing hypoglycemia (low
blood sugar).
If your blood sugar is low, eat glucose tablets, sugar or take
a sugary drink. Then eat a fruit, biscuit or sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a moderate overdose of insulin
If you notice that you are getting worse and are short of breath and your skin is pale, tell your
doctor immediately. A glucagon injection can treat quite severe hypoglycemia.
Take glucose or sugar after the glucagon injection. If you do not get a positive response with
glucagon, you must be admitted to hospital. Ask your doctor about the use of
glucagon.

• B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
• not taking Humulin I or another insulin;
• taking a dose of insulin lower than prescribed by your doctor;
• eating a much larger amount of food than allowed by your diet;
• fever, infection or severe emotional stress.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate
medical attention.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar)
not treated properly can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death.

Three simple habitsto avoidhypoglycemia or hyperglycemia are:

• Always keep some syringes and a vial of Humulin I in stock
• Always carry a document indicating that you have diabetes.
• Always carry sugar with you.
• C.IllnessIf you are ill, especially if you feel or are unwell, your insulin needs may change. Evenwhen you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and tell the nurse at the diabetes centre or your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly to
adverse. Reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Humulin I

Keep this medicine out of the sight and reach of children.
Before use, store Humulin I in a refrigerator (2°C - 8°C). Do not freeze. During use
store the vial at room temperature (below 30°C) for a period of up to 28 days. Do not
keep it near a source of heat or in direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the vial, which give it an icy appearance. Check all of this
before each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Humulin I contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins. The human insulin present in Humulin I is available in a suspension together with protamine sulfate.
• The excipientsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of the appearance of Humulin I and contents of the pack
Humulin I (Isophane) 100 IU/ml injectable suspension is a sterile white suspension and contains
100 units of insulin per millilitre (100 IU/ml). Each vial contains 1,000 units (10 millilitres).
Humulin I 100 IU/ml is available in a pack of 1 vial, 2 vials or in a multiple pack of 5 vials (containing 5 packs of 1 vial).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733 - 50019 Sesto Fiorentino (FI), Italy
Humulin I in a vial is manufactured by:

• Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
• Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Huminsulin „Lilly“ Basal (Austria)
Humuline NPH (Belgium, Luxembourg)
Humulin N (Czech Republic)
Huminsulin Basal (NPH) 100 (Germany)
Humulin NPH (Denmark, Greece, Sweden)
Humulina NPH (Spain)
Humulin I (Ireland, Italy, United Kingdom)
Umuline NPH (France)

HUMULIN 30/70 (Mixture) 100 IU/ml injectable suspension in a vial

(human insulin)
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Never give it to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Humulin 30/70 and what is it used for

The active ingredient contained in Humulin 30/70 is human insulin which is used for the therapy of diabetes.
The disease, diabetes, derives from the fact that the pancreas does not produce insulin in an adequate quantity to
control the level of glucose in the blood. Humulin 30/70 is used to control glucose in the
long term. It is a premixed suspension of rapid-acting insulin and prolonged-acting insulin.
Its action is prolonged due to the presence of protamine sulfate in the
suspension.
The doctor may prescribe its use of Humulin 30/70 as well as that of a prolonged-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Pay close
attention when changing the type of insulin. Each type of insulin has a different color and a symbol on the
package and on the vial so that you can easily see the difference.

2. What you need to know before using Humulin 30/70

Do not use Humulin 30/70

• If you believe you are developing hypoglycemia (low blood sugar).Further instructions on how to manage mild hypoglycemia are contained in this leaflet ( see section A of paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin 30/70.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is getting too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of your meals, the frequency and intensity of your physical exercise. You should also monitor your blood sugar level frequently by measuring it.
• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you experience hypoglycemia frequently, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been recently ill?
• Do you have problems with your liver or kidneys?
• Are you doing more physical exercise than usual?
• Your insulin requirement may change if you consume alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with type 2 diabetes mellitus diagnosed for a long time and with heart disease or a previous stroke who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell 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).

Changes to the skin at the injection site:
The injection site must be rotated to prevent changes to the skin, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject it into an area with nodules
(see paragraph How to use Humulin 30/70). If you are currently injecting into an area with
nodules, talk to your doctor before starting to inject into another area. Your doctor may
advise you to check your blood sugar more carefully and adjust your dose of insulin or other antidiabetic medicines.
For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin 30/70
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your insulin requirements may change if you are taking:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta -stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in the
six months following. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, 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 experience hypoglycemia
(low blood sugar). Keep this in mind in all situations where you could put yourself or others at risk (e.g. driving a vehicle or using
machinery). You should consult the nurse at the diabetes center or your doctor about whether it is safe to drive if you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin 30/70 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin 30/70

Always check the package and the label of the vial for the name and type of insulin
that you receive from the pharmacist. Make sure the Humulin package corresponds
to what your doctor has prescribed.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Dosage

• Regarding quantity, timing and frequency of administration, follow exactly the doctor's instructions: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Administer Humulin 30/70 by subcutaneous injection. The medicine must not be administered using another route of administration. Under no circumstances must Humulin 30/70 be administered intravenously.

Preparation of Humulin 30/70

• Before use, vials containing Humulin 30/70 must be rotated between the palms of your hands several times to return the insulin completely into suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the aforementioned procedure until the components are mixed. Do notshake vigorously, as this maneuver may cause foam formation that may compromise the correct measurement of the dose. Vials should be examined frequently and should not be used if you observe

floating residues or white particles adhering to the bottom or walls of the vial, which
give it an icy appearance. Check all this before each injection.

Injection of Humulin 30/70

• First, wash your hands.
• Before administering the injection, disinfect the skin according to the instructions received. Disinfect the rubber stopper of the vial, but do not remove it.
• Use a sterile syringe and needle to puncture the rubber stopper and draw the amount of Humulin 30/70 needed for injection. Your doctor or diabetes center will show you exactly how to do it. You must absolutely not share yoursyringes and needles with others.
• Inject the medicine subcutaneously, as you have been taught. Do notinject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.

If you use more Humulin 30/70 than you should
If you use more Humulin 30/70 than you should, a decrease in blood sugar levels may occur.
Check your blood sugar level (see point A in section 4).

If you forget to use Humulin 30/70
If you use less Humulin 30/70 than you should, an increase in blood sugar levels may occur.
Check your blood sugar level. Do not inject a double dose to compensate for
forgetting the dose.

If you stop treatment with Humulin 30/70
If you use less Humulin 30/70 than you should, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Humaninsulin can cause hypoglycemia (low blood sugar). See further
information on hypoglycemia below, in the sub-paragraph “Common diabetes problems”.

Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). The symptoms are:
low blood pressure
difficulty breathing
rapid heartbeat
skin rash all over the body
dyspnea
sweating
If you believe that Humulin 30/70 is causing you this type of insulin allergy, tell your
doctor immediately.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the injection site may become red, swollen and itchy. Usually, this reaction disappears in
a few days or weeks. If this happens, tell your doctor.
Changes to the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or
thicker (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin can
also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the
frequency with which this occurs is not known). Insulin may not work as well if you inject it in
an area with lumps. Change the injection site with each injection to prevent these skin changes.
Edema (e.g. swelling of the arms, ankles; fluid retention) has been reported, in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.

Common diabetes problems

• A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
• an excessive dose of Humulin 30/70 or another insulin;
• a delay or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
tiredness
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.

Do not use Humulin 30/70 if you feel you are developing a situation of hypoglycemia (low
blood sugar level).
If your blood sugar is low, eat glucose tablets, sugar or drink
a sugary drink. Then eat fruit, biscuits or a sandwich, as suggested by your doctor and rest. This is often enough to counteract mild hypoglycemia, or a moderate overdose of insulin.
If you notice that you are getting worse and are short of breath and your skin is turning pale, tell
your doctor immediately. A glucagon injection can treat quite severe hypoglycemia.
Take glucose or sugar after the glucagon injection. If you do not get a positive response with
glucagon, you must be admitted to hospital. Ask your doctor for information about the use of
glucagon.

• B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
• not taking Humulin 30/70 or another insulin;
• taking a dose of insulin lower than prescribed by your doctor;
• eating a much larger amount of food than allowed by your diet;
• fever, infection or strong emotion.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical
attention.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) not treated properly can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death.

Three simple behaviorsto avoid hypoglycemia or hyperglycemia are:

• Always keep some syringes and a vial of Humulin 30/70 in stock
• Always carry a document indicating that you are diabetic.
• Always carry sugar with you.
• C.IllnessIf you are ill, especially if you feel or are unwell, your insulin requirements may change. Evenwhen you are not eating normally, you still need insulin.Test your urine and blood; when you are unwell, follow the precautions you already know and inform the diabetes center nurse or your doctor.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly to
adverse. Reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Humulin 30/70

Keep this medicine out of the sight and reach of children.
Before use, store Humulin 30/70 in a refrigerator (2°C - 8°C). Do not freeze. During use
store the vial at room temperature (below 30°C) for a period of up to 28 days. Do not
keep it near a heat source or in direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and the carton. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the vial, which give it a frosted appearance. Check all this
before each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Humulin 30/70 contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins. Humulin 30/70 is a premixed suspension containing 30% of insulin in aqueous solution and 70% of insulin with protamine sulfate.
• The excipientsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of Humulin 30/70 and package contents
Humulin 30/70 (Mixture) 100 IU/ml injectable suspension is a sterile white suspension and contains
100 units of insulin per millilitre (100 IU/ml). Each vial contains 1,000 units (10 millilitres).
Humulin 30/70 100 IU/ml is available in a pack of 1 vial, 2 vials or in a
multipack of 5 vials (containing 5 packs of 1 vial).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733 - 50019 Sesto Fiorentino (FI), Italy
Humulin 30/70 in a vial is manufactured by:

• Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
• Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
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)

HUMULIN R (Regolare) 100 IU/ml injectable solution in cartridge

(human insulin)
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Humulin R is and what it is used for
• 2. What you need to know before you use 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 is Humulin R and what is it used for

The active substance contained in Humulin R is human insulin which is used for the therapy of diabetes.
The disease, diabetes, derives from the fact that the pancreas does not produce insulin in an adequate quantity to
control the level of glucose in the blood. Humulin R is used to control glucose in the
long term. Humulin R is a fast-acting insulin preparation.
The doctor may prescribe you to use Humulin R as well as a long-acting insulin.
its correct use. Do not change the type of insulin unless prescribed by your doctor. Pay close
attention when changing the type of insulin. Each type of insulin has a different color and a symbol on the
package and on the cartridge so that you can easily see the difference.

2. What you need to know before using Humulin R

Humulin R in cartridges is only suitable for subcutaneous injections with a reusable pen
Talk to your doctor if you need to inject insulin in another way.
Do not use Humulin R

• If you think you are developing hypoglycemia (low blood sugar).Further instructions for dealing with mild hypoglycemia are contained in this leaflet (see section A of paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin R.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level frequently by measuring it.
• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the warning signs of the hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been recently ill?
• Do you have liver or kidney problems?
• Are you doing more exercise than usual?
• Your insulin needs may change if you drink alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with long-standing type 2 diabetes mellitus and heart disease or a previous stroke who have been treated with pioglitazone and insulin have reported the development of heart failure. Tell 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).

Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject it into an area with nodules
(see paragraph How to use Humulin R). If you are currently injecting into an area with nodules, consult
your doctor before starting to inject into another area. Your doctor may ask you to
check your blood sugar more carefully and adjust the dose of insulin or other antidiabetic medicines.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin R
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:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta-stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in the
six months following. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience hypoglycemia
(low blood sugar). Be aware of this potential problem in all situations in
which you could put yourself or others at risk (e.g. driving a vehicle or using
machinery). You should consult the nurse at the diabetes center or your doctor about whether it is safe to drive if you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin R contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin R

The 3 ml cartridge must only be used with 3 ml pens. Do not use with 1.5 ml pens.
Always check the package and cartridge label for the name and type of insulin
you receive from the pharmacist. Make sure the Humulin package corresponds
to what your doctor has prescribed.
Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, ask your doctor or pharmacist. To prevent possible transmission of diseases, each
cartridge must be used only by you, even if the needle inserted into the delivery device
is changed.

Dosage

• Regarding quantity, timing and frequency of administration, follow your doctor's instructions exactly: they apply only to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Humulin R in cartridges is only suitable for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin in another way.

Preparation of Humulin R

• Humulin R is already dissolved in water, so you do not need to mix it. However, be careful to use it onlyif its appearance is the same as that of water. The solution must be clear, colorless and free of solid particles. Check all of this before each injection.

Pen preparation

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• You must use Humulin R cartridges only with Lilly insulin pens to ensure thecorrect dose is administered.
• Follow the instructions enclosed with the pen. Insert the cartridge into the pen.
• Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to cause air bubbles to escape. With the pen still pointing upwards, press the injection button until a drop of Humulin R comes out of the needle. Some small air bubbles may remain in the pen; these are not dangerous, but if they are too large they may make the dose to be injected less accurate.

Injection of Humulin R

• Before giving the injection, disinfect the skin according to the instructions you have received.
• Inject the medicine subcutaneously, as you have been taught. Do notinject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you have made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.
• You must not administer Humulin R intravenously. Inject Humulin R as your doctor or the nurse at the diabetes center has taught you. Only your doctor can administer Humulin R intravenously. This will only be done in special circumstances such as surgery or if you are ill and your blood sugar levels are too high.

After the injection

• As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humulin R sterile, prevent leakage of the medicine, stop air from entering the pen and prevent the needle from becoming blocked. You must absolutely not share your needles or your pen with others. Reposition the cap on the pen.

Subsequent injections

• Leave the cartridge in the pen. Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humulin R comes out of the needle. You can assess how much Humulin R remains in the cartridge by observing its level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.

Do not mix any other insulin into a Humulin R cartridge. Once the cartridge is
empty, do not reuse it.
If you use more Humulin R than you should
If you use more Humulin R than you should, a decrease in blood sugar levels may occur.
Check your blood sugar level (see point A in paragraph 4).

If you forget to use Humulin R
If you use less Humulin R than you should, an increase in blood sugar levels may occur.
Check your blood sugar level. Do not inject a double dose to make up for the
missed dose.

If you stop treatment with Humulin R
If you use less Humulin R than you should, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of 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.
Humaninsulin can cause hypoglycaemia (low blood sugar). See further
information on hypoglycaemia below, in the sub-paragraph “Common diabetes problems”.

Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). The symptoms are:
low blood pressure
difficulty breathing
rapid heartbeat
skin rash all over the body
dyspnoea
sweating
If you think that Humulin R is causing you this type of insulin allergy, tell your
doctor immediately.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the point of
injection may become red, swollen and itchy. Usually, this reaction disappears in
a few days or weeks. If this happens, tell your doctor.
Changes in the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or
thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin may
also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the
frequency with which this occurs is not known). Insulin may not work as well if you inject it in
an area with nodules. Change the injection site with each injection to prevent these skin changes.
Edema (e.g. swelling of the arms, ankles; fluid retention) has been reported, in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.

Common diabetes problems

• A.HypoglycaemiaHypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycaemia can be caused by:
• an excessive dose of Humulin R or another insulin;
• a delay or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhoea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medicines can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycaemia come on quickly and include:
tiredness
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognise the warning symptoms of hypoglycaemia, avoid situations, such as
driving a vehicle, in which hypoglycaemia could put you or others at risk.

Do not use Humulin R if you feel you are developing a situation of hypoglycaemia (low
blood sugar).
If your blood sugar is low, eat glucose tablets, sugar or drink
a sugary drink. Then eat fruit, biscuits or a sandwich, as advised by your doctor and rest. This is often enough to counteract mild hypoglycaemia, or a moderate overdose of insulin.
If you feel you are getting worse and are short of breath and your skin is pale, tell your
doctor immediately. An injection of glucagon can treat quite severe hypoglycaemia.
Take glucose or sugar after the glucagon injection. If you do not get a positive response with
glucagon, you must be admitted to hospital. Ask your doctor about the use of
glucagon.

• B.Hyperglycaemia and diabetic ketoacidosisHyperglycaemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycaemia can be caused by:
• not taking Humulin R or another insulin;
• taking a dose of insulin lower than that prescribed by your doctor;
• eating a much larger amount of food than allowed by your diet;
• fever, infection or severe emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly, over
many hours or days. They include:
feeling sleepy
flushed face
thirst
loss of appetite
breath smelling of fruit
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate
medical attention.
Hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar)
that is not treated properly can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma and even death.

Three simple behavioursto avoid hypoglycaemia or hyperglycaemia are:

• Always keep some syringes and a vial of Humulin R in stock
• Always carry a document indicating that you have diabetes.
• Always carry some sugar with you.
• C.Illness

If you have an illness, especially if you feel unwell, your insulin needs may change. Even
when you are not eating normally, you still need insulin.Test your urine and blood; when you are ill, follow the precautions you already know and inform the nurse
at the diabetes centre or your doctor.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly to
adverse . By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Humulin R

Keep this medicine out of the sight and reach of children.
Before use, store Humulin R in a refrigerator (2°C - 8°C). Do not freeze. During use
store the pen and cartridge at room temperature (below 30°C) for a period of up to 28
days. Do not store the pen and cartridges you are using in the refrigerator. Do not keep the product near
a source of heat or direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice that it is coloured or contains solid particles. You must only use it only
if its appearance is the same as that of water. Check all of this before each injection.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Humulin R contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins.
• The excipientsare metacresol, glycerol and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of Humulin R and package contents
Humulin R (Regular) 100 IU/ml solution for injection is a sterile, clear and
colourless aqueous solution and contains 100 units of insulin per millilitre (100 IU/ml). Each cartridge contains 300
units (3 millilitres).
The cartridges are available in packs of 5 and 10 cartridges.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733, 50019 Sesto Fiorentino (FI), Italy.
Humulin R in cartridge is manufactured by:
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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Huminsulin „Lilly“ Normal (Austria)
Umuline Rapide 100 IU/ml (France)
Humuline Regular (Belgium, Luxembourg, 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)

HUMULIN I (Isofano) 100 IU/ml injectable suspension in cartridge

(human insulin)
Read this leaflet carefully before you start using this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Humulin I is and what it is used for
• 2. What you need to know before you use Humulin I
• 3. How to use Humulin I
• 4. Possible side effects
• 5. How to store Humulin I
• 6. Contents of the pack and other information

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

The active ingredient contained in Humulin I is human insulin which is used for the therapy of diabetes.
The disease, diabetes, derives from the fact that the pancreas does not produce insulin in an adequate quantity to
control the level of glucose in the blood. Humulin I is used to control glucose in the long term. Its action is prolonged due to the presence of protamine sulfate in the suspension.
The doctor may prescribe you the use of Humulin I as well as that of a rapid-acting insulin. Each correct use. Do not change the type of insulin unless prescribed by your doctor. Be very careful
when changing the type of insulin. Each type of insulin has a different color and a symbol on the package
and on the cartridge so that you can easily see the difference.

2. What you need to know before using Humulin I

Humulin I in cartridges is only suitable for subcutaneous injections with a reusable pen.
Talk to your doctor if you need to inject insulin in a different way.
Do not use Humulin I

• If you believe you are developing hypoglycemia (low blood sugar).Further instructions on how to manage mild hypoglycemia can be found later in this leaflet ( see section A of paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin I.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, frequency and intensity of physical exercise. You should also monitor your blood sugar level frequently by measuring it.
• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the warning signs of a hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been recently ill?
• Do you have problems with your liver or kidneys?
• Are you doing more exercise than usual?
• Your insulin needs may change if you consume alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with long-standing type 2 diabetes mellitus and heart disease or a previous stroke who have been treated with pioglitazone and insulin have reported 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).

Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject it into an area with nodules
(see paragraph How to use Humulin I). If you are currently injecting into an area with nodules, consult
your doctor before starting to inject into another area. Your doctor may advise you to
check your blood sugar more carefully and adjust your dose of insulin or other antidiabetic medicines.
For those who exercise: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin I
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Your insulin needs may change if you are taking:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta -stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in
the following six months. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience hypoglycemia
(low blood sugar). Be aware of this potential problem in all situations in
which you may put yourself or others at risk (e.g. driving a vehicle or using
machinery). You should consult your diabetes center nurse or doctor about whether it is safe to drive if you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin I contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin I

The 3 ml cartridge must only be used with 3 ml pens. Do not use with 1.5 ml pens.
Always check the package and cartridge label for the name and type of insulin
delivered to you by the pharmacist. Make sure the Humulin package corresponds
to the one prescribed by your doctor.
Always use this medicine following the instructions of your doctor or pharmacist exactly.
If you have any doubts, consult your doctor or pharmacist. To prevent possible transmission of diseases,
each cartridge must be used only by you, even if the needle inserted into the delivery device is changed.

Dosage

• Normally, you should inject Humulin I as a basal insulin. Regarding the quantity, timing, and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example, from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Humulin I in cartridges is only suitable for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin by another method.

Preparation of Humulin I

• Immediately before use, the cartridges containing Humulin I must be rotated 10 times between the palms of your hands and inverted 180° for 10 times to return the insulin to suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with
  a small glass ball that facilitates mixing. Do notshake vigorously, as this
  maneuver may cause foam to form, which may compromise the correct measurement
  of the dose. The cartridges should be examined frequently and should not be used
  if floating residue or white particles are observed adhering to the bottom or walls of the
  cartridge, giving it an icy appearance. Check all of this before each
  injection.

procedimento fino a che i componenti risultino essere miscelati. Le cartucce sono provviste di
una piccola biglia di vetro che agevola il mescolamento. Nonagitare con forza, poiché tale
manovra può causare la formazione di schiuma che può compromettere la corretta misurazione
della dose. Le cartucce devono essere esaminate frequentemente e non devono essere utilizzate
se si osservano residui galleggianti o particelle bianche aderenti al fondo o alle pareti della
cartuccia, che conferiscono ad essa un aspetto ghiacciato. Controlli tutto questo prima di ogni
iniezione.

Preparation of the pen

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• You must use Humulin I cartridges only with Lilly insulin pens to ensure theadministration of the correct dose.
• Follow the instructions enclosed with the pen. Put the cartridge into the pen.
• Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to dislodge any air bubbles. With the pen still pointing upwards, press the injection button until a drop of Humulin I comes out of the needle. Some small air bubbles may have remained in the pen; they are not dangerous, but if they are too large they may make the dose to be injected less accurate.

Injection of Humulin I

• Before giving the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.

After the injection

• As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humulin I sterile, prevent leakage of the medicine, stop air from entering the pen, and prevent the needle from becoming clogged. You must absolutely not share your needles or your pen with others. Reposition the cap on the pen.

Subsequent injections

• Leave the cartridge in the pen. Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humulin I comes out of the needle. You can assess how much Humulin I remains in the cartridge by observing its level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.

Do not mix any other insulin into a Humulin I cartridge. Once the cartridge is
empty, do not reuse it.
If you use more Humulin I than you should
If you use more Humulin I than you should, a decrease in blood sugar levels may occur.
Check your blood sugar level (see point A in section 4).

If you forget to use Humulin I
If you use less Humulin I than you should, an increase in blood sugar levels may occur.
Check your blood sugar level. Do not inject a double dose to make up for the
forgotten dose.

If you stop treatment with Humulin I
If you use less Humulin I than you should, an increase in blood sugar levels may occur.
Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts about the use of this product, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Humaninsulin can cause hypoglycemia (low blood sugar). See further information on hypoglycemia below, in the sub-paragraph “Common diabetes problems”.

Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). Symptoms include:
low blood pressure
difficulty breathing
rapid heartbeat
skin rash all over the body
dyspnea
sweating
If you believe that Humulin I is causing you this type of insulin allergy, immediately inform your doctor.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the injection site may become red, swollen, and itchy. Usually, this reaction disappears within a few days or weeks. If this occurs, inform your doctor.
Changes in the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which it occurs is unknown). Insulin may not work as well if you inject it into an area with nodules. Change the injection site with each injection to prevent these skin changes.
Edema (e.g., swelling of the arms, ankles; fluid retention) has been reported, particularly at the beginning of insulin therapy or during a modification of therapy to improve blood glucose control.

Common diabetes problems

• A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
• an excessive dose of Humulin I or another insulin;
• a delay or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medications can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia appear quickly and include:
fatigue
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as driving a vehicle, where hypoglycemia could put you or others at risk.

Do not use Humulin I if you feel you are developing a situation of hypoglycemia (low blood sugar).
If your blood sugar is low, eat glucose tablets, sugar, or drink a sugary beverage. Then eat fruit, biscuits, or a sandwich, as suggested by your doctor, and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin. If you notice that you are getting worse and are short of breath and your skin is turning pale, inform your doctor immediately. A glucagon injection can treat fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If you do not get a positive response with glucagon, you must be hospitalized. Ask your doctor for information about the use of glucagon.

• B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
• failure to take Humulin I or another insulin;
• taking a dose of insulin lower than that prescribed by your doctor;
• eating a much larger amount of food than allowed by your diet;
• fever, infection, or strong emotion.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms appear slowly, over many hours or days. They include:
feeling sleepy
facial flushing
thirst
loss of appetite
breath with a fruity odor
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical attention.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) that is not adequately treated can become very serious and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma, and even death.

Three simple behaviorsto avoid hypoglycemia or hyperglycemia are:

• Always keep some syringes and a vial of Humulin I in stock
• Always carry a document indicating that you are diabetic.
• Always carry sugar with you.
• C.IllnessIf you are ill, especially if you feel or are unwell, your insulin needs may vary. Even when you are not eating normally, you still need insulin.Do a urine and blood test; when you are unwell, follow the precautions you already know and inform the nurse at the diabetes center or your doctor.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to adverse. Reporting side effects you can contribute to providing more information about the safety of this medicine.

5. How to store Humulin I

Keep this medicine out of the sight and reach of children.
Before use, store Humulin I in a refrigerator (2°C - 8°C). Do not freeze. During use
store the pen and cartridge at room temperature (below 30°C) for a period of up to 28
days. Do not store the pen and cartridges you are using in the refrigerator. Do not keep the product near
a source of heat or in direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice the presence of floating residues or white particles adhering to the
bottom or walls of the cartridge, which give it a frosted appearance. Check all
this before each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Humulin I contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins. The human insulin present in Humulin I is available in a suspension together with protamine sulfate.
• The excipientsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of Humulin I and package contents
Humulin I (Isophane) 100 IU/ml injectable suspension is a sterile white suspension and contains
100 units of insulin per millilitre (100 IU/ml). Each cartridge contains 300 units (3 millilitres).
The cartridges are available in packs of 5 and 10 cartridges.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733, 50019 Sesto Fiorentino (FI), Italy.
Humulin I in cartridge is manufactured by:
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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Huminsulin „Lilly“ Basal (Austria)
Humuline NPH (Belgium, Luxembourg, Netherlands)
Humulin N (Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovenia)
Humulin N (NPH) Cartridge (Czech Republic, Slovakia)
Huminsulin Basal (NPH) für Pen 3 ml (Germany)
Humulin NPH (Cyprus, Greece, Norway, Portugal, Sweden)
Humulin I (Ireland, Italy, Malta, United Kingdom)
Umuline NPH (France)

HUMULIN 30/70 (Mixture) 100 IU/ml injectable suspension in cartridge

(human insulin)
Read this leaflet carefully before you use this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Humulin 30/70 and what is it used for

The active ingredient contained in Humulin 30/70 is human insulin which is used for the therapy of diabetes.
The disease, diabetes, derives from the fact that the pancreas does not produce insulin in an adequate quantity to
control the level of glucose in the blood. Humulin 30/70 is used to control glucose in the
long term. It is a premixed suspension of rapid-acting insulin and prolonged-acting insulin.
Its action is prolonged due to the presence of protamine sulfate in the
suspension.
The doctor may prescribe its use of Humulin 30/70 as well as that of a prolonged-acting insulin.
correct use. Do not change the type of insulin unless prescribed by your doctor. Pay close
attention when changing the type of insulin. Each type of insulin has a different color and a symbol on the
package and on the cartridge so that you can easily see the difference.

2. What you need to know before using Humulin 30/70

Humulin 30/70 in cartridges is only suitable for subcutaneous injections with a reusable pen.
Talk to your doctor if you need to inject insulin in another way.
Do not use Humulin 30/70

• If you believe that a situation of hypoglycemia (low blood sugar) is developing.Further on in this leaflet there are instructions on how to manage mild hypoglycemia ( see section A in paragraph 4).
• If you are allergic to human insulin or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Humulin 30/70.

• If your blood glucose level is well controlled with the insulin therapy you are currently using, you may not notice the warning signs when your blood sugar level is dropping too low. The warning signs are listed later in this leaflet. You must pay close attention to the timing of meals, the frequency and intensity of exercise. You should also monitor your blood sugar level by measuring it frequently.
• Some people who have experienced hypoglycemia (low blood sugar) after switching from animal insulin to human insulin have reported that the warning signs of the hypoglycemic reaction were less noticeable or different. If you frequently experience hypoglycemia, or have difficulty recognizing it, talk to your doctor.
• If the answer to any of the following questions is YES, tell your doctor, pharmacist or nurse at the diabetes center.
• Have you been ill recently?
• Do you have problems with your liver or kidneys?
• Are you doing more exercise than usual?
• Your insulin requirement may change if you consume alcohol.
• Also, inform your doctor, pharmacist or nurse at the diabetes center if you are planning to travel abroad. Differences in time zones between countries may result in a change in the timing of insulin injections and meals, compared to when you are at home.
• Some patients with type 2 diabetes mellitus diagnosed for a long time and with heart disease or a previous stroke who have been treated with pioglitazone and insulin have reported 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).

Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of nodules
under the skin. Insulin may not work as well as it should if you inject into an area with nodules
(see paragraph How to use Humulin 30/70). If you are currently injecting into an area with
nodules, consult your doctor before starting to inject into another area. Your doctor may
ask you to check your blood glucose more carefully and adjust the dose of insulin or other antidiabetic medicines.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Other medicines and Humulin 30/70
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Your insulin requirements may change if you are taking:

• glucocorticoids
• thyroid hormone replacement therapy
• oral hypoglycemic agents (antidiabetic medicines)
• acetylsalicylic acid (aspirin)
• growth hormone
• octreotide, lanreotide
• beta -stimulants (e.g. ritodrine, salbutamol, terbutaline)
• beta-blockers
• thiazides and some antidepressants (monoamine oxidase inhibitors)
• danazol
• some angiotensin converting enzyme (ACE) inhibitors (e.g. captopril, enalapril) or angiotensin II receptor antagonists.

Pregnancy, breastfeeding and fertility
The insulin requirement generally decreases during the first trimester of pregnancy and increases in
the following six months. If you are breastfeeding, you may need to adjust the amount of insulin you are
taking or your diet.
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Your ability to concentrate and react may be reduced if you experience a hypoglycemic reaction
(low blood sugar). Be aware of this potential problem in all situations where you may put yourself or others at risk (e.g. driving a vehicle or using
machinery). You should consult the nurse at the diabetes center or your doctor about whether it is safe to drive if you:

• experience frequent episodes of hypoglycemia
• have reduced or absent warning signs of hypoglycemia

Humulin 30/70 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.

3. How to use Humulin 30/70

The 3 ml cartridge must only be used with 3 ml pens. Do not use with 1.5 ml pens.
Always check the package and cartridge label for the name and type of insulin
you receive from the pharmacist. Make sure the Humulin package matches
the one prescribed by your doctor.
Use this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. To prevent possible transmission of diseases, each
cartridge must only be used by you, even if the needle inserted into the delivery device
is changed.

Dosage

• Regarding quantity, timing, and frequency of administration, follow your doctor's instructions exactly: they apply only to you. Follow them exactly and have yourself checked periodically at the diabetes center.
• If you change the type of insulin you are using (for example, from animal insulin to human insulin), you may need a different amount of medication (more or less) than before. The change may occur with the first injection, or may be carried out gradually over a period of weeks or months.
• Humulin 30/70 in cartridges is only suitable for subcutaneous injections with a reusable pen. Talk to your doctor if you need to inject insulin by another method.

Preparation of Humulin 30/70

• Immediately before use, the cartridges containing Humulin 30/70 must be rotated 10 times between the palms of your hands and inverted 180° for 10 times to return the insulin to suspension until it appears uniformly cloudy or milky. If this does not happen, repeat the above procedure until the components are mixed. The cartridges are equipped with a small glass ball that facilitates mixing. Do notshake vigorously, as this maneuver may cause foam to form, which may compromise accurate dose measurement. The cartridges should be examined frequently and should not be used if floating debris or white particles adhering to the bottom or walls of the cartridge are observed, giving it an icy appearance. Check all of this before each injection.

Preparation of the pen

• First, wash your hands. Disinfect the rubber membrane of the cartridge.
• You must use Humulin 30/70 cartridges only with Lilly insulin pens to ensure thecorrect dose is administered.
• Follow the instructions enclosed with the pen. Insert the cartridge into the pen.
• Set the dose to 1 or 2 units. Then hold the pen with the needle inserted pointing upwards and tap the side of the pen to cause air bubbles to escape. With the pen still pointing upwards, press the injection button until a drop of Humulin 30/70 comes out of the needle. Some small air bubbles may remain in the pen; they are not dangerous, but if they are too large, they may make the dose to be injected less accurate.

Injection of Humulin 30/70

• Before administering the injection, disinfect the skin according to the instructions you have received. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 5 seconds to be sure you have injected the entire dose. Do not rub the skin area where you made the injection. Make sure the injection site is at least one centimeter away from the one used last time and remember to rotate the injection site, as you have been told.

After the injection

• As soon as you have finished the injection, remove the needle from the pen using the outer cap of the needle. This will allow you to keep Humulin 30/70 sterile, prevent leakage of the medicine, stop air from entering the pen, and prevent the needle from becoming clogged. You must not absolutely share your needles or your pen with others. Reposition the cap on the pen.

Subsequent injections

• Leave the cartridge in the pen. Before each subsequent injection, select 1 or 2 units and press, activating it, the injection mechanism holding the pen pointing upwards until a drop of Humulin 30/70 comes out of the needle. You can assess how much Humulin 30/70 remains in the cartridge by observing its level on the side of it. The distance between each line corresponds to approximately 20 units. If there is not enough left for the next dose, change the cartridge.

Do not mix any other insulin into a Humulin 30/70 cartridge. Once the
cartridge is empty, do not reuse it.
If you use more Humulin 30/70 than you should
If you use more Humulin 30/70 than you should, a decrease in blood sugar levels may occur. Check your blood sugar level (see point A in paragraph 4).

If you forget to use Humulin 30/70
If you use less Humulin 30/70 than you should, an increase in blood sugar levels may occur. Check your blood sugar level. Do not inject a double dose to make up for a missed dose.

If you stop treatment with Humulin 30/70
If you use less Humulin 30/70 than you should, an increase in blood sugar levels may occur. Do not change the type of insulin unless prescribed by your doctor.
If you have any doubts 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 everyone will experience them.
Humaninsulin can cause hypoglycemia (low blood sugar). See further information on hypoglycemia below, in the sub-paragraph “Common diabetes problems”.

Possible side effects
Systemic allergyis very rare (affects less than 1 in 10,000 people). Symptoms include:
low blood pressure
difficulty breathing
rapid heartbeat
rash all over the body
dyspnea
sweating
If you believe that Humulin 30/70 is causing you this type of insulin allergy, inform your doctor
immediately.
Local allergyis common (affects less than 1 in 10 people). In some people, the skin at the injection site may appear red, swollen, and itchy. Usually, this reaction disappears within
a few days or weeks. If this occurs, inform your doctor.
Changes to the skin at the injection site:
If you inject insulin too often in the same place, the fatty tissue may become thinner (lipoatrophy) or
thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also
be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the
frequency with which this occurs is unknown). Insulin may not work well if you inject it into
an area with nodules. Change the injection site with each injection to prevent these skin changes.
Edema has been reported (e.g., swelling of the arms, ankles; fluid retention), in
particular at the beginning of insulin therapy or during a change in therapy to improve
blood glucose control.

Common diabetes problems

• A.HypoglycemiaHypoglycemia (low blood sugar) means that there is not enough sugar in the blood. Hypoglycemia can be caused by:
• an excessive dose of Humulin 30/70 or another insulin;
• a delay or missed meal, or a change in diet;
• excessive exercise or physical work performed immediately before or after a meal;
• an infection or other illness (especially diarrhea or vomiting);
• a change in insulin requirements;
• worsening of pre-existing kidney or liver disease.

Alcohol and some medications can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia appear quickly and include:
fatigue
nervousness or agitation
headache
rapid heartbeat
feeling unwell
cold sweat
If you are unable to recognize the warning signs of hypoglycemia, avoid situations, such as
driving a vehicle, where hypoglycemia could put you or others at risk.

Do not use Humulin 30/70 if you believe you are experiencing hypoglycemia (low
blood sugar level).
If your blood sugar is low, eat glucose tablets, sugar, or drink
a sugary beverage. Then eat fruit, biscuits, or a sandwich, as suggested by your doctor, and rest. This is often enough to counteract mild hypoglycemia, or a modest overdose of insulin.
If you notice that you are getting worse and are short of breath and your skin is turning pale, inform
your doctor immediately. A glucagon injection can treat fairly severe hypoglycemia.
Take glucose or sugar after the glucagon injection. If you do not get a positive response with
glucagon, you must be hospitalized. Ask your doctor for information on the use of
glucagon.

• B.Hyperglycemia and diabetic ketoacidosisHyperglycemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycemia can be caused by:
• failure to take Humulin 30/70 or another insulin;
• taking a dose of insulin lower than that prescribed by your doctor;
• eating a quantity of food much higher than allowed by the diet;
• fever, infection, or strong emotion.

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms develop slowly, over
many hours or days. They include:
feeling drowsy
flushed face
thirst
loss of appetite
breath with a fruity odor
feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek immediate medical attention.
Hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) not treated adequately can become very serious and cause headache, nausea, vomiting,
dehydration, loss of consciousness, coma, and even death.

Three simple behaviorsto avoid hypoglycemia or hyperglycemia are:

• Always keep some syringes and a vial of Humulin 30/70 on hand
• Always carry a document indicating that you are diabetic.
• Always carry sugar with you.
• C.IllnessIf you are ill, especially if you feel or are unwell, your insulin needs may vary. Evenwhen you are not eating normally, you still need insulin.Check your urine and blood; when you are unwell, follow the precautions you already know and inform the nurse at the diabetes center or your doctor.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor, pharmacist, or nurse. You can also report side effects directly to
adverse. Reporting side effects can help provide more information about
the safety of this medicine.

5. How to store Humulin 30/70

Keep this medicine out of the sight and reach of children.
Before use, store Humulin 30/70 in a refrigerator (2°C - 8°C). Do not freeze. During use
store the pen and cartridge at room temperature (below 30°C) for a period of up to 28
days. Do not store the pen and cartridges you are using in the refrigerator. Do not keep the product near
a source of heat or in direct sunlight.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice floating residues or white particles adhering to the
bottom or walls of the cartridge, which give it a frosted appearance. Check all
this before each injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Humulin 30/70 contains

• The active substanceis human insulin. Human insulin is prepared in the laboratory using a technology called “recombinant DNA”. It has the same structure as the natural hormone produced by the pancreas. It is therefore different from animal insulins. Humulin 30/70 is a premixed suspension containing 30% of insulin in aqueous solution and 70% of insulin with protamine sulfate.
• The excipientsare protamine sulfate, metacresol, phenol, glycerol, disodium phosphate heptahydrate, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used during the manufacturing process to adjust the pH.

Description of the appearance of Humulin 30/70 and contents of the pack
Humulin 30/70 (Mixture) 100 IU/ml injectable suspension is a sterile white suspension and contains
100 units of insulin per millilitre (100 IU/ml). Each cartridge contains 300 units (3 millilitres).
The cartridges are available in packs of 5 and 10 cartridges.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation is held by Eli Lilly Italia S.p.A., Via Gramsci
731/733, 50019 Sesto Fiorentino (FI), Italy.
Humulin 30/70 in cartridge is manufactured by:
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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Huminsulin „Lilly“ Profil III 100 I.E./ml (Austria)
Humuline 30/70 (Belgium, Luxembourg, Netherlands)
Huminsulin Profil III für Pen 3 ml (Germany)
Humulin M3 (Bulgaria, Croatia, Cyprus, Ireland, Lithuania, Malta, Portugal, Romania, Slovenia, United
Kingdom)
Humulin 30/70 (Italy)
Umuline profil 30 (France)
Humulin M3 (30/70) (Greece, Hungary, Poland)
Humulin M3 (30/70) Cartridge (Czech Republic, Slovakia)