6.6 Instructions for use and handling

6.6 Instructions for use and handling

Insulin preparations, which have been frozen, must not be used.

Insulin suspensions should not be used if they do not appear uniformly white and cloudy after resuspension.

• 7. MARKETING AUTHORISATION HOLDER

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

MARKETING AUTHORISATION NUMBERS

ANNEX II

• A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

• B. CONDITIONS OF THE MARKETING AUTHORISATION

A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND

MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE

Name and address of the manufacturer of the biological active substance

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

Name and address of the manufacturers responsible for batch release

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

Denmark

B CONDITIONS OF THE MARKETING AUTHORISATION

CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medical prescription

OTHER CONDITIONS

the European Commission about the marketing on.

zinc chloride, zinc acetate, sodium chloride, methyl parahydroxyben­zoate, sodium acetate, sodium

zinc chloride, zinc acetate, sodium chloride, methyl parahydroxyben­zoate, sodium acetate, sodium

Medicinal product subject to medical prescription

zinc chloride, zinc acetate, sodium chloride, methyl parahydroxyben­zoate, sodium acetate, sodium

Monotard

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

j____________­__;_____________________­____________♦ Gg

Monotard 40 IU/ml Suspension for injection in a vial

Suspension for injection in a vial. Insulin human, rDNA.

Monotard is a zinc suspension consisting of a mixture of amorphous and crystalline particles (ratio 3:7).

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 40 IU of insulin human. 1 vial contains 10 ml equivalent to 400 IU.

Monotard also contains zinc chloride, zinc acetate, sodium chloride, methyl parahydroxy benzoate, sodium actetate, sodium hydroxide, hydrochloric acid and water for injections.

The suspension for injection comes as a white, cloudy aqueous suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).

The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

• 1 What Monotard is

Monotard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe.

Monotard is a long-acting insulin. This means that it will start to lower your blood sugar about 2 *A hours after you take it, and the effect will last for approximately 24 hours. Monotard is often given in combination with fast-acting insulins.

2 Before you use MonotardDo not use Monotard► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos

► If you have ever had an allergic reaction to this insulin product or any of the ingredients (see box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look out for the signs of allergy in 5 Possible side effects.

Take special care with Monotard

• ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

• ► If you are drinking alcohol: watch for signs of a hypo

• ► If you are exercising more than usual or if you want to change your usual diet

• ► If you are ill: carry on taking your insulin

• ► If you are going abroad: travelling over time zones may affect your insulin needs

• ► If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby’s

• ► If you are breastfeeding: there’s no risk to the baby, but you may need to adjust your insulin and your diet

• ► If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Other medicines and Monotard

Many medicines affect the way glucose works in your body and they may influence your insulin dose.

Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not-prescribed.

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.

3 Using Monotard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advice carefully. This leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Before using Monotard

► Make sure it is the right type of insulin

► Disinfect the rubber membrane with surgical spirit.

Do not use Monotard

► If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If it isn’t in perfect condition when you get the vial, return the vial to your supplier

• ► If it hasn’t been stored correctly or been frozen (see 6 How to store Monotard)

• ► If it’s not uniformly white and cloudy when it’s mixed.

How to use this insulin

Monotard is for injection under the skin (subcutaneous or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection is the front of your thighs. If convenient, the front of your waist (abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

Monotard vials are for use with insulin syringes with the corresponding unit scale.

To inject Monotard on its own

• Before first use and just before injecting this insulin, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw air into the syringe, in the same amount as the dose of insulin you need
• Inject the air into the vial: push the needle through the rubber stopper and press the plunger
• Turn the vial and syringe upside down
• Draw the right dose of insulin into the syringe
• Pull the needle out of the vial
• Make sure there is no air left in the syringe: point the needle upwards and push the air out
• Check you have the right dose
• Inject straight away.
• Before first use and just before injecting Monotard, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw as much air into the syringe as the dose of Monotard you need. Inject the air into the Monotard vial, then pull out the needle
• Draw as much air into the syringe as the dose of fast acting insulin you need. Inject the air into the fast acting insulin vial. Then turn the vial and syringe upside down
• Draw the right dose of fast acting insulin into the syringe. Pull the needle out of the vial. Make sure there is no air left in the syringe: point the needle upwards and push the air out. Check the dose

Now push the needle into the vial of Monotard. Then turn the vial and syringe upside down Draw the right dose of Monotard into the syringe. Pull the needle out of the vial. Make sure there’s no air left in the syringe, and check the dose Inject the mixture straight away.

Always mix fast acting and long acting insulin in this order.

Inject the insulin

• Inject the insulin under the skin. Use the injection technique advised by your nurse
• Keep the needle under your skin for at least 6 seconds to make sure the full dose has been delivered.

4 What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include d sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. It could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death

If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin
• If you eat too little or miss a meal
• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of a hyperglycaemia

• Having forgotten to take your insulin
• Repeatedly taking less insulin than you need
• An infection or a fever
• Eating more than usual
• Less exercise than usual.

5 Possible side effects

Like all medicines, Monotard can have side effects.

Common side effects (up to 10%)

Low or high blood sugar (hypo or hyperglycaemia). Taking too much or too little Monotard may cause respectively hypo or hyperglycaemia. See the advice in 4 What to do in an emergency.

Rare side effects (up to 0.1%)

Vision problems. When you first start your insulin treatment, it m reaction usually disappears.

Changes at the injection site. Reactions (redness, swelling, itching) at the injection site may occur and will normally disappear during use. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

Signs of allergy. Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions). These usually go away after a few weeks of taking your insulin. If they do not go away, see your doctor.

Seek medical advice straight away:

If signs of allergy spread to other parts of your body, or

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Monotard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Monotard.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon goes away.

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or pharmacist.

6 How to store Monotard

Keep out of the reach and sight of children.

Monotard vials that are not being used are to be stored in the fridge at 2°C – 8°C, away from the freezer compartment. Do not freeze.

Monotard vials that are being used or about to be used are not to be kept in the fridge. You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light.

Monotard should be protected from excessive heat and sunlight.

Do not use Monotard after the expiry date stated on the label and the carton.

Leaflet last approved on

Monotard

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

j____________­__;_____________________­____________♦ Gg

Monotard 100 IU/ml Suspension for injection in a vial

Suspension for injection in a vial. Insulin human, rDNA.

Monotard is a zinc suspension consisting of a mixture of amorphous and crystalline particles (ratio 3:7).

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU.

Monotard also contains zinc chloride, zinc acetate, sodium chloride, methyl parahydroxy benzoate, sodium acetate, sodium hydroxide, hydrochloric acid and water for injections.

The suspension for injection comes as a white, cloudy aqueous suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).

The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

-          .0

• 1 What Monotard is

Monotard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Monotard is a long-acting insulin. This means that it will start to lower your blood sugar about 2 *A hours after you take it, and the effect will last for approximately 24 hours. Monotard is often given in combination with fast-acting insulins.

2 Before you use MonotardDo not use Monotard► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos

► If you have ever had an allergic reaction to this insulin product or any of the ingredients (see box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look out for the signs of allergy in 5 Possible side effects.

Take special care with Monotard

• ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

• ► If you are drinking alcohol: watch for signs of a hypo

• ► If you are exercising more than usual or if you want to change your usual diet

• ► If you are ill: carry on taking your insulin

• ► If you are going abroad: travelling over time zones may affect your insulin needs

• ► If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby’s

• ► If you are breastfeeding: there’s no risk to the baby, but you may need to adjust your insulin and your diet

• ► If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Other medicines and Monotard

Many medicines affect the way glucose works in your body and they may influence your insulin dose.

Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not-prescribed.

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.

3 Using Monotard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advic leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, y adjusted by your doctor.

Before using Monotard

► Make sure it is the right type of insulin

► Disinfect the rubber membrane with surgical spirit.

Do not use Monotard

If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If it

isn’t in perfect condition when you get the vial, return the vial to your supplier If it hasn’t been stored correctly or been frozen (see 6 How to store Monotard) If it’s not uniformly white and cloudy when it’s mixed.

How to use this insulin

Monotard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection is the front of your thighs. If convenient, the front of your waist (abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

Monotard vials are for use with insulin syringes with the corresponding unit scale.

To inject Monotard on its own

• Before first use and just before injecting this insulin, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw air into the syringe, in the same amount as the dose of insulin you need
• Inject the air into the vial: push the needle through the rubber stopper and press the plunger
• Turn the vial and syringe upside down
• Draw the right dose of insulin into the syringe
• Pull the needle out of the vial
• Make sure there is no air left in the syringe: point the needle upwards and push the air out
• Check you have the right dose
• Inject straight away.
• Before first use and just before injecting Monotard, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw as much air into the syringe as the dose of Monotard you need. Inject the air into the Monotard vial, then pull out the needle
• Draw as much air into the syringe as the dose of fast acting insulin you need. Inject the air into the fast acting insulin vial. Then turn the vial and syringe upside down
• Draw the right dose of fast acting insulin into the syringe. Pull the needle out of the vial.
• Make sure there is no air left in the syringe: point the needle upwards and push the air out.

Check the dose

Now push the needle into the vial of Monotard. Then turn the vial and syringe upside down Draw the right dose of Monotard into the syringe. Pull the needle out of the vial. Make sure there’s no air left in the syringe, and check the dose Inject the mixture straight away.

Always mix fast acting and long acting insulin in this order.

Inject the insulin

• Inject the insulin under the skin. Use the injection technique advised by your nurse
• Keep the needle under your skin for at least 6 seconds to make sure the full dose has been delivered.

4 What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include d sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. It could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death

If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin
• If you eat too little or miss a meal
• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of a hyperglycaemia

• Having forgotten to take your insulin
• Repeatedly taking less insulin than you need
• An infection or a fever
• Eating more than usual
• Less exercise than usual.

5 Possible side effects

Like all medicines, Monotard can have side effects.

Common side effects (up to 10%)

Low or high blood sugar (hypo or hyperglycaemia). Taking too much or too little Monotard may cause respectively hypo or hyperglycaemia. See the advice in 4 What to do in an emergency.

Rare side effects (up to 0.1%)

Vision problems. When you first start your insulin treatment, it m reaction usually disappears.

Changes at the injection site. Reactions (redness, swelling, itching) at the injection site may occur and will normally disappear during use. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

Signs of allergy. Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions). These usually go away after a few weeks of taking your insulin. If they do not go away, see your doctor.

Seek medical advice straight away:

If signs of allergy spread to other parts of your body, or

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Monotard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Monotard.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon goes away.

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or pharmacist.

6 How to store Monotard

Keep out of the reach and sight of children.

Monotard vials that are not being used are to be stored in the fridge at 2°C – 8°C, away from the freezer compartment. Do not freeze.

Monotard vials that are being used or about to be used are not to be kept in the fridge. You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light.

Monotard should be protected from excessive heat and sunlight.

Do not use Monotard after the expiry date stated on the label and the carton.

Leaflet last approved on

Monotard

Read all of this leaflet carefully before you start using your insulin. Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

j____________­__;_____________________­____________♦ Gg

Monotard 100 IU/ml Suspension for injection in a vial

Suspension for injection in a vial. Insulin human, rDNA.

Monotard is a zinc suspension consisting of a mixture of amorphous and crystalline particles (ratio 3:7).

The active substance is insulin human made by recombinant biotechnology.

1 ml contains 100 IU of insulin human. 1 vial contains 10 ml equivalent to 1000 IU.

Monotard also contains zinc chloride, zinc acetate, sodium chloride, methyl parahydroxy benzoate, sodium acetate, sodium hydroxide, hydrochloric acid and water for injections.

The suspension for injection comes as a white, cloudy aqueous suspension in packs of 1 or 5 vials of 10 ml (not all packs may be marketed).

The marketing authorisation holder and manufacturer is Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark.

– .0

• 1 What Monotard is

Monotard is human insulin to treat diabetes. It comes in a 10 ml vial that you use to fill a syringe. Monotard is a long-acting insulin. This means that it will start to lower your blood sugar about 2 *A hours after you take it, and the effect will last for approximately 24 hours. Monotard is often given in combination with fast-acting insulins.

2 Before you use MonotardDo not use Monotard► If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos

► If you have ever had an allergic reaction to this insulin product or any of the ingredients (see box, below left). Some people are allergic to the ingredient methyl parahydroxy benzoate. Look out for the signs of allergy in 5 Possible side effects.

Take special care with Monotard

• ► If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

• ► If you are drinking alcohol: watch for signs of a hypo

• ► If you are exercising more than usual or if you want to change your usual diet

• ► If you are ill: carry on taking your insulin

• ► If you are going abroad: travelling over time zones may affect your insulin needs

• ► If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby’s

• ► If you are breastfeeding: there’s no risk to the baby, but you may need to adjust your insulin and your diet

• ► If you drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Other medicines and Monotard

Many medicines affect the way glucose works in your body and they may influence your insulin dose.

Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not-prescribed.

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.

3 Using Monotard

Talk about your insulin needs with your doctor and diabetes nurse. Follow their advic leaflet is a general guide.

If your doctor has switched you from one type or brand of insulin to another, y adjusted by your doctor.

Before using Monotard

► Make sure it is the right type of insulin

► Disinfect the rubber membrane with surgical spirit.

Do not use Monotard

If the protective cap is loose or missing. Each vial has a protective, tamperproof plastic cap. If it

isn’t in perfect condition when you get the vial, return the vial to your supplier If it hasn’t been stored correctly or been frozen (see 6 How to store Monotard) If it’s not uniformly white and cloudy when it’s mixed.

How to use this insulin

Monotard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection is the front of your thighs. If convenient, the front of your waist (abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

Monotard vials are for use with insulin syringes with the corresponding unit scale.

To inject Monotard on its own

• Before first use and just before injecting this insulin, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw air into the syringe, in the same amount as the dose of insulin you need
• Inject the air into the vial: push the needle through the rubber stopper and press the plunger
• Turn the vial and syringe upside down
• Draw the right dose of insulin into the syringe
• Pull the needle out of the vial
• Make sure there is no air left in the syringe: point the needle upwards and push the air out
• Check you have the right dose
• Inject straight away.
• Before first use and just before injecting Monotard, shake the vial up and down at least 10 times and roll the vial between your hands. Repeat this procedure if necessary until the liquid is uniformly white and cloudy
• Draw as much air into the syringe as the dose of Monotard you need. Inject the air into the Monotard vial, then pull out the needle
• Draw as much air into the syringe as the dose of fast acting insulin you need. Inject the air into the fast acting insulin vial. Then turn the vial and syringe upside down
• Draw the right dose of fast acting insulin into the syringe. Pull the needle out of the vial.
• Make sure there is no air left in the syringe: point the needle upwards and push the air out.

Check the dose

Now push the needle into the vial of Monotard. Then turn the vial and syringe upside down Draw the right dose of Monotard into the syringe. Pull the needle out of the vial. Make sure there’s no air left in the syringe, and check the dose Inject the mixture straight away.

Always mix fast acting and long acting insulin in this order.

Inject the insulin

• Inject the insulin under the skin. Use the injection technique advised by your nurse
• Keep the needle under your skin for at least 6 seconds to make sure the full dose has been delivered.

4 What to do in an emergency

If you get a hypo

A hypo means your blood sugar level is too low.

The warning signs of a hypo may come on suddenly and can include d sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you get any of these signs: eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.

Don’t take any insulin if you feel a hypo coming on.

Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

Tell people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. It could choke you.

If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death

If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Using glucagon

You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

• If you take too much insulin
• If you eat too little or miss a meal
• If you exercise more than usual.

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity smell of the breath.

If you get any of these signs: test your blood sugar level; test your urine for ketones if you can; then seek medical advice straight away.

These may be signs of a very serious condition called diabetic ketoacidosis. If you don’t treat it, this could lead to diabetic coma and death.

Causes of a hyperglycaemia

• Having forgotten to take your insulin
• Repeatedly taking less insulin than you need
• An infection or a fever
• Eating more than usual
• Less exercise than usual.

5 Possible side effects

Like all medicines, Monotard can have side effects.

Common side effects (up to 10%)

Low or high blood sugar (hypo or hyperglycaemia). Taking too much or too little Monotard may cause respectively hypo or hyperglycaemia. See the advice in 4 What to do in an emergency.

Rare side effects (up to 0.1%)

Vision problems. When you first start your insulin treatment, it m reaction usually disappears.

Changes at the injection site. Reactions (redness, swelling, itching) at the injection site may occur and will normally disappear during use. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

Signs of allergy. Very rarely, people get redness, swelling or itching around the area of the insulin injection (local allergic reactions). These usually go away after a few weeks of taking your insulin. If they do not go away, see your doctor.

Seek medical advice straight away:

If signs of allergy spread to other parts of your body, or

If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.

You may have a very rare serious allergic reaction to Monotard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Monotard.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon goes away.

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or pharmacist.

6 How to store Monotard

Keep out of the reach and sight of children.

Monotard vials that are not being used are to be stored in the fridge at 2°C – 8°C, away from the freezer compartment. Do not freeze.

Monotard vials that are being used or about to be used are not to be kept in the fridge. You can carry them with you and keep them at room temperature (below 25°C) for up to 6 weeks.

Always keep the vial in the outer carton when you’re not using it in order to protect it from light.

Monotard should be protected from excessive heat and sunlight.

Do not use Monotard after the expiry date stated on the label and the carton.

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