Ipnovel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ipnovel 15 mg/3 ml injection 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 of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform 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 administered
4. Possible side effects
5. How to store Ipnovel
6. Further information

1. WHAT IPNOVEL IS AND WHAT IT IS USED FOR

Ipnovel contains a medicine called midazolam. This belongs to a group of medicines known as
'benzodiazepines'.
Ipnovel acts quickly, making you feel sleepy or causing sleep. It also calms you and relaxes your muscles.
Ipnovel is used in adults:

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

Ipnovel is also used in adults and children:

• To make them calm and drowsy if they are in intensive care. This is called 'sedation'.
• Before and during a medical examination or procedure during which they need to remain awake. It makes them calm and drowsy. This is called 'conscious sedation'.
• To make them calm and drowsy before administration of an anaesthetic.

2. BEFORE IPNOVEL IS ADMINISTERED TO YOU

Do not be given Ipnovel if

• You are allergic (hypersensitive) to midazolam or to any of the excipients in this medicine (listed in Section 6: Further information).
• You are allergic to other benzodiazepines, such as diazepam or nitrazepam.
• You have severe breathing difficulties and are due to receive Ipnovel for "conscious sedation". Ipnovel must not be administered to you if any of the above apply. If you are unsure, speak with your doctor or nurse before this medicine is administered.

Take special care with Ipnovel
Inform your doctor or nurse before Ipnovel is administered if:

• You are over 60 years old.
• You have a chronic illness, for example, respiratory, renal, hepatic, or cardiac disorders.
• You have a condition that makes you feel very weak, fatigued, and lacking energy.
• You have a disease called 'myasthenia gravis', characterized by muscle weakness.
• You suffer from sleep apnoea.
• You have ever had problems with alcohol.
• You have ever had problems with drugs. If any of the above apply to you (or you are unsure), speak with your doctor or nurse before Ipnovel is administered.

If this medicine is to be given to your child:

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

Taking Ipnovel with other medicines
Inform your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription and herbal medicines. This is because Ipnovel may alter the effects of other medicines, and other medicines may alter the way Ipnovel works. In particular, inform your doctor or nurse if you are taking any of the following medicines:

• Medicines for depression.
• Hypnotic medicines (to help you sleep).
• Sedatives (to calm or make you drowsy).
• Tranquillizers (for anxiety or to help you sleep).
• Carbamazepine or phenytoin (these may be used for seizures or fits).
• Rifampicin (for tuberculosis).
• HIV medicines called 'protease inhibitors' (such as saquinavir).
• Antibiotics called 'macrolides' (such as erythromycin and clarithromycin).
• Medicines for 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 remedy for depression).
• Medicines for high blood pressure called 'calcium channel blockers' (such as diltiazem). If any of the above apply to you (or you are unsure), speak with your doctor or nurse before Ipnovel is administered.

Alcohol
Do not drink alcohol if you have been administered Ipnovel. This is because it may cause excessive drowsiness and breathing problems.

Pregnancy and breastfeeding

• Inform your doctor before Ipnovel is administered if you are pregnant or think you may be pregnant. Your doctor will decide whether this medicine is suitable for you.
• After Ipnovel has been administered, do not breastfeed for 24 hours. This is because Ipnovel may pass into your breast milk.

Driving and using machines

• After taking Ipnovel, do not drive or operate tools or machinery until your doctor tells you it is safe to do so.
• This is because Ipnovel may cause drowsiness or impair memory. It may also affect your concentration and coordination, making you unable to drive or use tools and machinery safely.
• After treatment, you must be accompanied home by an adult who can supervise you.

Important information about some excipients in 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 a nurse. It will be given in a place where equipment is available to monitor you and treat any adverse effects. This could be a hospital, clinic, or outpatient facility. In particular, your breathing, heart, and circulation will be monitored.
The use of Ipnovel is not recommended in neonates and children under 6 months of age. However, if the doctor considers it necessary, it may be administered to a neonate or 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 infusion into one of your veins (intravenous infusion).
• By injection into the muscle (intramuscular injection).
• By 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 based on your age, weight, and general health condition. In addition, it depends on the reason you need the medicine, how you respond to treatment, and whether you are receiving other medicines at the same time.
After Ipnovel has been administered to you
After treatment, you must be accompanied home by an adult who can monitor you. This is because Ipnovel may cause drowsiness or impair your memory. It may also affect your concentration and coordination.
If Ipnovel is administered to you for a prolonged period, such as in intensive care, your body may begin to get used to the medicine. This means it could become less effective.
If you are given more Ipnovel than you should have
The medicine will be administered by a doctor or nurse, which makes it unlikely that you will receive too much. However, if you are accidentally given too much, you may experience the following:

• Drowsiness and loss of coordination and reflexes.
• Difficulty speaking and involuntary eye movements.
• Low blood pressure. This may make you feel dizzy or lightheaded.
• Slowed or stopped breathing or heartbeat, and unconsciousness (coma).

Long-term treatment with Ipnovel for sedation in intensive care
If Ipnovel has been administered to you for a prolonged period, the following may occur:

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

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

• Mood changes.
• Seizures.
• Headache.
• Muscle pain.
• Sleep problems (insomnia).
• Strong feelings of worry (anxiety), tension, fatigue, confusion, or irritability.
• Seeing and possibly hearing things that are not really there (hallucinations).
  Your doctor will gradually reduce the dose. This will help prevent or reduce the withdrawal symptoms you may experience.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Ipnovel can cause adverse reactions, although not everyone experiences them. The following adverse reactions have been reported (frequency not known; cannot be estimated from the available data).
Stop taking Ipnovel and seek immediate medical attention if you experience any of the following adverse reactions.
They may be life-threatening, and you may require urgent medical treatment:

• Severe allergic reaction (anaphylactic shock). Signs may include sudden redness, itchy or swollen rash (urticaria), and swelling of the face, lips, tongue, or other parts of the body. You may also experience shortness of breath, wheezing, or difficulty breathing.
• Heart attack (cardiac arrest). Signs may include chest pain.
• Breathing problems, which in some cases have led to respiratory arrest.
• Muscle spasm around the airways causing suffocation. Potentially fatal adverse reactions are more likely to occur in adults over 60 years of age and in individuals who already have respiratory or cardiac problems. These adverse reactions are also more likely if the medicine is injected too quickly or at a high dose.

Other possible adverse reactions:
Nervous system and mental problems

• Reduced attention.
• Confusion.
• Feeling of extreme happiness or excitement (euphoria).
• Changes in sexual desire.
• Feeling tired, drowsy, or sedated for a prolonged period.
• Seeing or possibly hearing things that are not really there (hallucinations).
• Headache.
• Dizziness.
• Difficulty with muscle coordination.
• Seizures (convulsions) in premature infants and infants.
• Temporary memory loss. The duration depends on how long Ipnovel was administered. Occasionally, this has lasted for a prolonged period.
• Feeling restless, nervous, irritable, or aggressive. You may also experience muscle spasms or involuntary muscle tremors (tremors). These effects are more likely if you have been given a high dose of Ipnovel or if it was administered too quickly. They are also more likely in children and elderly individuals.

Heart and circulation

• Fainting.
• Slow heart rate.
• Flushing of the face and neck (hot flushes).
• Low blood pressure. This may cause dizziness or lightheadedness.

Respiration

• Hiccups.
• Shortness of breath.

Mouth, stomach, and intestines

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

Skin

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

General

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

Elderly patients

• Elderly individuals taking benzodiazepines such as Ipnovel have an increased risk of falling and fracturing bones.
• Potentially fatal adverse reactions are also more likely in adults over 60 years of age.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
You can also report adverse reactions directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IPNOVEL

• Ipnovel should be stored by the doctor or pharmacist. They are also responsible for the proper disposal of any unused Ipnovel.
• Keep Ipnovel out of the reach and sight of children.
• Do not use Ipnovel after the expiry date stated on the carton. The expiry date refers to the last day of the specified 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 Ipnovel contains

• The active substance 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 injections.

Description of the appearance of Ipnovel and contents of the pack
Ipnovel is a clear, colourless solution in a transparent glass vial (bottle).
The following pack sizes are available:
3 ml glass vials: pack size of 1.
Not all pack sizes may be marketed.

Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

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

This summary of product characteristics was last approved on .