IPNOVEL 15 mg /3 Ml Injectable Solution

Зміст інструкції

1. Ipnovel 15 mg/3 ml injectable solution
   1. WHAT IS IPNOVEL AND WHAT IS IT USED FOR
   2. BEFORE YOU ARE GIVEN IPNOVEL
   3. HOW IPNOVEL IS ADMINISTERED
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IPNOVEL
   6. OTHER INFORMATION

Ipnovel 15 mg/3 ml injectable solution

midazolam

Read this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects become serious, or if you notice any side effects not listed in this leaflet, tell your doctor or nurse.

Contents of this leaflet:

• 1. What Ipnovel is and what it is used for
• 2. Before you are given Ipnovel
• 3. How Ipnovel is given
• 4. Possible side effects
• 5. How to store Ipnovel
• 6. Further information

1. WHAT IS IPNOVEL AND WHAT IS IT USED FOR

Ipnovel contains a medicine called midazolam. This belongs to a group of medicines called
‘benzodiazepines’.
Ipnovel acts quickly causing you to feel sleepy or fall asleep. It also makes you calm and relaxes your
muscles.
Ipnovel is used in adults:

• As a general anesthetic to induce sleepiness or maintain sleep.

Ipnovel is also used in adults and children:

• To make them calm and sleepy if they are in intensive care. This is called ‘sedation’.
• Before and during a medical examination or procedure during which they need to stay awake. It makes them calm and sleepy. This is called ‘conscious sedation’.
• To make them calm and sleepy before they are given an anesthetic.

2. BEFORE YOU ARE GIVEN IPNOVEL

Ipnovel should not be given to you if

• You are allergic (hypersensitive) to midazolam or any of the excipients of the product (listed in Section 6: Further information).
• You are allergic to other benzodiazepines, such as diazepam or nitrazepam.
• You have severe difficulty breathing and are to be given Ipnovel for ‘conscious sedation’. Ipnovel should not be given to you if any of the above applies to you. If you are unsure, talk to your doctor or nurse before you are given this medicine.

Take particular care with Ipnovel
Tell your doctor or nurse before you are given Ipnovel if:

• You are over 60 years old.
• You have a chronic illness, for example breathing problems, kidney, liver or heart disorders.
• You have an illness that makes you feel very weak, exhausted and lacking in energy.
• You have a condition called ‘myasthenia gravis’, which is characterised by muscle weakness.
• You suffer from sleep apnea.
• You have ever had problems with alcohol.
• You have ever had problems with drugs. If any of the above applies to you (or you are unsure), talk to your doctor or nurse before you are given Ipnovel.

If this medicine is to be given to your child:

• Talk to your doctor or nurse if any of the above applies to your child.
• In particular, tell your doctor or nurse if your child has heart or breathing problems.

Taking Ipnovel with other medicines
Tell your doctor or nurse if you are taking or have recently taken any other medicines,
including those available without a prescription and herbal medicines. This is because Ipnovel can change the way
other medicines work. Other medicines can also change the way Ipnovel works.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• Medicines for depression.
• Sleeping pills (to help you sleep).
• Sedatives (to calm you or make you sleepy).
• Tranquilizer medicines (for anxiety or to help you sleep).
• Carbamazepine or phenytoin (these can be used for convulsions or seizures).
• Rifampicin (for tuberculosis).
• Medicines for HIV called ‘protease inhibitors’ (such as saquinavir).
• Antibiotics called ‘macrolides’ (such as erythromycin and clarithromycin).
• Medicines for the treatment of fungal infections (such as ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole).
• Strong painkillers.
• Atorvastatin (for high cholesterol).
• Antihistamines (for allergic reactions).
• St John's Wort (a herbal medicine for depression).
• Medicines for high blood pressure called ‘calcium channel blockers’ (such as diltiazem). If any of the above applies to you (or you are unsure), talk to your doctor or nurse before you are given Ipnovel.

Alcohol
Do not drink alcohol if you have been given Ipnovel. This is because it can make you very sleepy and cause
breathing problems.

Pregnancy and breastfeeding

• Tell your doctor before you are given Ipnovel if you are pregnant or think you might be. The doctor will decide if this medicine is suitable for you.
• After you have been given Ipnovel, do not breastfeed for 24 hours. This is because Ipnovel can pass into your milk.

Driving and using machines

• After taking Ipnovel, do not drive or use tools or machines until your doctor tells you that you can.
• This is because Ipnovel can make you sleepy or impair your memory. It can also affect your concentration and coordination. This may make you unable to drive or use tools and machines.
• After treatment, you must be accompanied home by an adult who can supervise you.

Important information about some of the excipients of Ipnovel
Ipnovel is essentially ‘sodium-free’, as it contains less than 1 mmol of sodium (23 mg) per
glass bottle (vial).

3. HOW IPNOVEL IS ADMINISTERED

Ipnovel will be administered to you by a doctor or nurse. It will be administered in a place where there is
equipment available to monitor you and treat any undesirable effects. This could be a
hospital, a clinic, or an outpatient clinic. In particular, your breathing, heart and
circulation will be monitored.
The use of Ipnovel is not recommended in newborns and children under 6 months of age. In any case, if the doctor deems it
necessary, he/she may administer it to a newborn or a child under 6 months of age in intensive care.

How Ipnovel will be administered to you
Ipnovel will be administered to you in one of the following ways:

• By slow injection into a vein (intravenous injection).
• Through an intravenous drip into one of your veins (intravenous infusion).
• By injection into the muscle (intramuscular injection).
• For rectal administration.

How much Ipnovel will be administered to you
The dose of Ipnovel varies from patient to patient. The doctor will decide how much to administer. It depends on age,
weight and general health condition. Furthermore, it depends on the reason why you need the medicine, how
you respond to treatment, and also whether you will be given other medicines at the same time.

After you have been administered Ipnovel
After treatment, you need to be accompanied home by an adult who can monitor you.
This is because Ipnovel can make you feel sleepy or impair your memory. It can also affect your
concentration and coordination.
If Ipnovel is administered to you for a long period, such as in intensive care, your body may begin
to get used to the medicine. This means that it may be less effective.

If you are administered more Ipnovel than you should
The medicine will be given to you by the doctor or nurse. This means that it is unlikely that you will be given
too much. However, if you are given too much by mistake, you may observe the following:

• Feeling sleepy and loss of coordination and reflexes.
• Difficulty speaking and involuntary eye movements.
• Low blood pressure. This may make you feel dizzy or lightheaded.
• Slowing or stopping of breathing or heartbeat and loss of consciousness (coma).

Long-term treatment with Ipnovel for sedation in intensive care
If you have been administered Ipnovel for a long period, the following may happen:

• It may begin to be less effective.
• You may develop a dependence on the medicine and experience withdrawal symptoms when you stop taking it (see section ‘Stopping Ipnovel’ below).

Stopping Ipnovel
If you have been administered Ipnovel for a long period, such as in intensive care, you may experience withdrawal symptoms when you stop
taking it. These include:

• Mood changes.
• Seizures (convulsions).
• Headache.
• Muscle pain.
• Problems with sleep (insomnia).
• Strong feeling of worry (anxiety), tension, fatigue, confusion or bad temper (irritability).
• Seeing and possibly hearing things that are not actually present (hallucinations). Your doctor will gradually reduce the dosage. This will help to block the withdrawal symptoms you experience.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ipnovel can cause side effects, although not everybody gets them. The following side effects have been reported (frequency not known; cannot be estimated based on the available data).

Stop taking Ipnovel and see a doctor immediately if you experience any of the following side effects. They may be life-threatening and you may urgently need medical treatment:

• A severe allergic reaction (anaphylactic shock). Signs may include sudden redness, itchy rash or hives and swelling of the face, lips, tongue or other parts of the body. You may also have shortness of breath, wheezing or difficulty breathing.
• Heart attack (cardiac arrest). Signs may include chest pain.
• Breathing problems, which have sometimes led to breathing stopping.
• Muscle spasm around the airways, causing choking. Potentially fatal side effects are more likely to occur in adults over 60 years of age and in people who already have breathing or heart problems. These side effects are also more likely to occur if the medicine is injected too quickly or at a high dose.

Other possible side effects:
Nervous system and mental problems

• Reduced attention.
• Feeling confused.
• Feeling of extreme happiness or excitement (euphoria).
• Changes in sexual desire.
• Feeling tired or sleepy or being sedated for a long period.
• Seeing or possibly hearing things that are not really there (hallucinations).
• Headache
• Dizziness.
• Difficulty coordinating muscles.
• Seizures in premature babies and infants.
• Temporary memory loss. The duration depends on how long Ipnovel has been given to you. Occasionally this has lasted for a long period.
• Feeling agitated, nervous, angry or aggressive. You may also have muscle spasms or shaking that you cannot control (tremors). These effects are more likely to occur if you have been given a high dose of Ipnovel or if it was given too quickly. They are also more likely to occur in children and the elderly.

Heart and circulation

• Fainting.
• Slow heartbeat.
• Flushing of the face and neck.
• Low blood pressure. This can make you feel dizzy or lightheaded.

Breathing

• Hiccups.
• Shortness of breath.

Mouth, stomach and intestines

• Dry mouth.
• Constipation.
• Feeling sick (nausea) or being sick (vomiting).

Skin

• Itchy skin.
• Rash, including swollen rash (hives).
• Redness, pain, blood clots or swelling of the skin at the injection site.

General

• Allergic reactions including skin rash and wheezing.
• Withdrawal symptoms (see above section 3 ‘Stopping Ipnovel’)
• Falls and fractures. The risk of fractures is increased in patients taking other medicines known to cause sleepiness (for example sedatives or hypnotics), or alcohol.

Elderly people

• Elderly people taking benzodiazepines, such as Ipnovel, have an increased risk of falling and breaking bones.
• Potentially fatal side effects are also more likely to occur in adults over 60 years of age.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE IPNOVEL

• The doctor or pharmacist is responsible for the storage of Ipnovel. They are also responsible for the correct disposal of any unused Ipnovel.
• Keep Ipnovel out of the reach and sight of children.
• Do not use Ipnovel after the expiry date which is reported on the packaging. The expiry date refers to the last day of the month.
• Do not use Ipnovel if the vial or packaging is damaged.
• Keep the vials in the outer packaging to protect the medicine from light.

6. OTHER INFORMATION

What contains Ipnovel

• The active ingredient is midazolam (as midazolam hydrochloride). Each ml of liquid contains 5 mg of midazolam (as midazolam hydrochloride).
• The excipients are sodium chloride, hydrochloric acid, sodium hydroxide and water for injectable preparations.

Description of the appearance of Ipnovel and contents of the pack
Ipnovel is presented in a transparent glass vial (bottle). It is a clear and colorless liquid (‘injectable solution’).
The following packs are available:
Glass vials of 3 ml: pack of 1.
Not all pack sizes may be marketed

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer responsible for batch release
DELPHARM MILANO S.R.L.
Via Carnevale, 1
20090 Segrate (MI)
Roche S.p.A.
Viale G.B. Stucchi, 110
20900 Monza (MB)