Indications:
Midazolam Desitin is a buccal solution containing midazolam. Midazolam belongs to a group of medicines known as benzodiazepines. Midazolam Desitin is used to stop a sudden, prolonged seizure in infants, toddlers, children and adolescents (aged 3 months to less than 18 years).

In infants aged 3 to 6 months, it should only be given in a hospital where the patient can be monitored and where resuscitation equipment is available.

The patient's doctor should give the patient's parents or caregivers instructions on how to administer Midazolam Desitin and what to do if the seizure does not stop.

Contraindications:
Do not administer Midazolam Desitin if the patient has:
- Allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine.

Precautions:
Before administering Midazolam Desitin if the patient has:

Pregnancy and breastfeeding:
Task:
If the patient to be given this medicine is pregnant or breast-feeding, thinks she may be pregnant or is planning to become pregnant, ask your doctor for advice before taking this medicine.
Taking high doses of Midazolam Desitin during the last 3 months of pregnancy can cause abnormal heartbeats in the fetus. Babies born after taking this medicine during labor may also have decreased sucking reflexes, difficulty breathing, hypothermia, and low muscle tone at birth.
Breastfeeding:
Tell your doctor if you are breast-feeding. Although small amounts of Midazolam Desitin may pass into breast milk, it may not be necessary to stop breast-feeding. Your doctor will decide whether you can breast-feed after receiving this medicine.

Driving and using machines:
Midazolam Desitin may make the patient sleepy, forgetful or affect their ability to concentrate or coordinate themselves. This may affect their ability to perform activities such as driving, cycling or using machines.
After taking this medicine, the patient should not drive, cycle or use machinery until fully recovered. Please talk to your doctor if you need further advice.

Method of administration:
Always take this medicine exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure. The patient's doctor should give the patient's parents or caregivers instructions on how to take Midazolam Desitin and what to do if the seizure does not stop.

Dosage:
Your doctor will prescribe the dose of Midazolam Desitin that is appropriate for your child's needs, generally based on the child's age. The different doses each have a different color, shown on the box, tube and syringe containing the medicine.

If you have any further questions on this medicine, ask your doctor, pharmacist or nurse.

Composition:
- The active substance is midazolam.
- 2.5 mg - Each 2.5 mg pre-filled syringe for oral administration contains 2.5 mg midazolam (as hydrochloride) in 0.5 ml solution.
- 5 mg - Each 5 mg pre-filled syringe for oral administration contains 5 mg midazolam (as hydrochloride) in 1 ml solution.
- 7.5 mg - Each 7.5 mg pre-filled syringe for oral administration contains 7.5 mg midazolam (as hydrochloride) in 1.5 ml solution.
- 10 mg - Each 10 mg pre-filled syringe for oral administration contains 10 mg midazolam (as hydrochloride) in 2 ml solution.
- The other ingredients are sodium chloride, purified water, hydrochloric acid and sodium hydroxide (for pH adjustment).

Presentation:
4 pre-filled syringes

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.