Miprosed 5mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you or your child experiences any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Miprosed 5mg/ml Oral Solution but it will be referred to as ‘Miprosed’ throughout this leaflet.

1. What Miprosed is and what it is used for
2. What you need to know before you or your child use Miprosed
3. How to give Miprosed
4. Possible side effects
5. How to store Miprosed
6. Contents of the pack and other information

• an allergy (hypersensitivity) to midazolam, to any other benzodiazepines (such as diazepam) or to any of the other ingredients of this medicine (listed in section 6)
• severe liver disease
• a disorder of the nerves or muscles that have severe muscle weakness (myasthenia gravis)
• severe breathing problems
• a condition that temporarily stops breathing during sleep (sleep apnea syndrome)

Do not use this medicine if any of the above apply to the patient. If you are not sure, talk to your doctor or pharmacist before using Miprosed.

Miprosed should be administered only by experienced physicians in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the recognition and management of expected adverse events including respiratory and cardiac resuscitation.

Talk to the doctor, nurse or pharmacist before Miprosed is given if the person who is going to receive it:

• has a mild, moderate or long-term illness (such as breathing, kidney, liver or heart problems)
• has poor overall health
• abuses or has in the past abused drugs or alcohol
• is younger than 6 months.

Tell the doctor or pharmacist if the patient who is going to receive Miprosed is using, has recently used or might use any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Miprosed can affect the way some other medicines work. Also, some medicines can affect the way Miprosed works.

In particular, tell the doctor or nurse or pharmacist if the patient who is going to receive Miprosed is taking any of the following:

• narcotic analgesics (e.g. fentanyl)
• herbal medicines (e.g. St. Johns Wort)
• medicines for epilepsy (e.g. carbamazepine, phenytoin)
• medicines for high blood pressure and angina (e.g. diltiazem and verapamil)
• medicines for indigestion, acid reflux or ulcer treatment (e.g. cimetidine, ranitidine and omeprazole)
• medicines for asthma (e.g. theophylline, aminophylline and other xanthine’s)
• medicines used to treat Parkinson’s disease (e.g. levodopa)
• muscle relaxants (e.g. baclofen)
• medicines used for nausea and/or vomiting (e.g. nabilone and aprepitant)
• medicines for fungal infections (e.g. ketoconazole, voriconazole, fluconazole, itraconazole and posaconazole)
• certain antibiotics (rifampicin, macrolide antibiotics e.g. erythromycin and clarithromycin)
• medicines used to treat HIV called protease inhibitors (e.g. saquinavir)
• medicines used for high cholesterol (e.g. atorvastatin)
• medicines used to treat depression that make your child sleepy (sedative antidepressants)
• other medicines for the treatment of depression (antidepressant, e.g. fluvoxamine)
• medicines used for the treatment of involuntary urine loss (e.g. propiverine).

Using Miprosed together with other sedative/hypnotic medicines may cause increased sleepiness or breathing problems. Examples of sedative/hypnotic medicines include medicines used to treat mood or mental disorders, barbiturates, propofol, ketamine, etomidate, medicines used to treat allergies and some classes of medicine used to treat high blood pressure.

Concomitant use of Miprosed and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if the doctor does prescribe Miprosed together with opioids, the dose and duration of concomitant treatment should be limited by the doctor.

Please tell the doctor about all opioid medicines patient is taking and follow the doctor’s dose recommendation closely. It could be helpful to inform the patient’s friends or relatives to be aware of the signs and symptoms stated above. Contact the doctor when patient is experiencing such symptoms.

Do not use this medicine if any of the above apply to the patient. If you are not sure, talk to the doctor, nurse or pharmacist before using Miprosed.

Grapefruit juice and drinks containing caffeine should be avoided as they can affect the way that Miprosed works.

The patient should not drink alcohol while taking Miprosed. Alcohol may increase the sedative effects of Miprosed and make the patient sleepier.

• If your child is pregnant, thinks she might be pregnant or is planning to have a baby, then contact your child’s doctor before your child take this medicine
• If your child is breastfeeding, she should be told not to breastfeed in the first 24 hours after taking Miprosed because midazolam passes into breast milk in small amount.

Miprosed may make the patient feel sleepy, forgetful, affect the level of concentration and reduce muscle function. This may negatively affect their performance at skilled tasks such as driving a vehicle or operating machinery.

After receiving this medicine, the patient should not drive or operate machinery until they have fully recovered.

This medicine contains less than 1 mmol sodium (23 mg) in each ml of solution, that is to say essentially ‘sodium-free’.

This medicine must be taken by mouth.

This medicine will be given to your child by a healthcare provider. It is administered in an environment with the right equipment for monitoring your child and treating possible side effects.

This medicine cannot be taken independently.

Your child should be accompanied by an adult upon discharge and leave the treatment room only after receiving authorisation from the doctor.

If anyone has taken an overdose of Miprosed (that is more than the doctor has prescribed), seek medical help immediately. If a patient is accidently given or takes too much Miprosed, then he/she may feel drowsy, confused, lethargic and in more serious cases this may involve lack of voluntary muscle movement, low muscle tone, low blood pressure, breathing difficulties. Taking more Miprosed than you should may also rarely cause coma and very rarely cause death.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is midazolam.

Each ml of oral solution contains 5mg midazolam.

The other ingredients are sucralose, glycerol (E422), hydrochloric acid, dilute, orange flavour (contains propylene glycol (E1520)), sodium hydroxide (for pH adjustment) and purified water.

Miprosed is a clear colourless to pale yellow coloured oral solution. It is supplied in a carton containing one 15ml amber glass bottle with 7.5ml oral solution with a tamper evident, child resistant, white plastic cap with polypropylene inner, polyethylene outer and an expanded polyethylene (EPE) liner. The pack also contains a 1ml oral syringe with 0.01ml graduations and a 5ml oral syringe with 0.1ml graduations together with a syringe adaptor.

POM

If this leaflet is hard to see or read, please call +44 (0) 208 515 3700 for help.

This medicinal product is authorised in the Member States of the EEA under the following names:

NL: Miprosed 5mg/ml Drank

DK: Miprosed

MT: Miprosed 5mg/ml Oral Solution