MIDAZOM 0.5 Nasal Spray 5ml

Introduction About MIDAZOM 0.5 NASAL SPRAY

MIDAZOM 0.5 NASAL SPRAY contains Midazolam, which belongs to the group of
medicines called benzodiazepines (sedatives). MIDAZOM 0.5 NASAL SPRAY is used to
manage sudden repetitive attacks of fits (epilepsy). Epilepsy (fits) is a
central nervous system (neurological) disorder which affects the brain creating
a disturbance in nerve cells and electrical activity leading to sudden,
uncontrolled body movements. Epilepsy can be triggered by sleep deprivation,
stress, missing medications, illness with fever or using alcohol and other
nonmedical drugs.

Before using MIDAZOM 0.5 NASAL SPRAY, inform your doctor if you have chronic
respiratory problems, myasthenia gravis (muscle weakness), a history of drug
abuse or depression, narrow-angle glaucoma, sleep apnoea syndrome (sleep
disorder in which breathing stops and starts repeatedly), kidney, heart, liver
problems.

MIDAZOM 0.5 NASAL SPRAY is generally not recommended during pregnancy especially
in the last trimester and breastfeeding, unless deemed necessary. MIDAZOM 0.5
NASAL SPRAY should be used with caution in elderly patients and children.
MIDAZOM 0.5 NASAL SPRAY has a few side effects like nausea, vomiting, headache,
drowsiness, runny nose, throat irritation, nasal discomfort and dizziness in
some cases. If any of these symptoms worsen, contact your doctor for advice.

Uses Of MIDAZOM 0.5 NASAL SPRAY

MIDAZOM 0.5 NASAL SPRAY nasal spray is used for emergencies to stop cluster
seizures (episodes of increased seizure activity) in adults and children 12
years of age and older who are taking other medications to manage epilepsy
(seizures).

How MIDAZOM 0.5 NASAL SPRAY Works

MIDAZOM 0.5 NASAL SPRAY contains midazolam which works by increasing a
particular chemical messenger in the brain that acts as a natural nerve-calming
agent (GABA) resulting in sedative, hypnotic (sleep-inducing), anxiolytic
(anti-anxiety), anticonvulsant and muscle relaxant properties. Hence MIDAZOM 0.5
NASAL SPRAY helps manage fits by stabilizing the altered, electrical activity of
nerve cells in the brain.

How to use MIDAZOM 0.5 NASAL SPRAY

Use MIDAZOM 0.5 NASAL SPRAY as advised by your physician. MIDAZOM 0.5 NASAL
SPRAY is for nasal use only. Your doctor will decide the correct dose and
duration for you depending on your age, body weight and disease condition.

Side Effects Of MIDAZOM 0.5 NASAL SPRAY

Common

• nausea
• vomiting
• headache
• drowsiness
• runny nose
• throat irritation
• nasal discomfort

Uncommon

• hypersensitivity reactions
• feeling confused
• feeling very happy or excited (euphoria)
• loss of libido
• feeling depressed
• restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, or inappropriate behaviour
• feeling tired or sleepy or being sedated for a long time
• difficulty co-ordinating muscles
• temporary loss of memory
• seeing double
• stomach upsets
• skin reactions including rash
• muscle weakness
• fatigue
• an increased risk of falling and fractures in the elderly

Rare

Stop using MIDAZOM 0.5 NASAL SPRAY and contact your doctor immediately if you
experience any of the following side effects:

• signs of heart attack symptoms like include chest pain
• breathing problems, sometimes causing the breathing to stop
• excessive sleepiness (sedation)

How To Manage Side Effects

Nasal discomfort:

Try to take steam inhalation. Do not take any other medication without
consulting your doctor.

Nausea:

Try to relax and rest. Eat and drink slowly or try to have smaller and more
frequent meals. If symptoms do not improve, contact your doctor.

Headache:

Try a cold pack or use a heating pad or hot compress. Ease pressure on your
scalp or head. Dim the lights. Hydrate yourself and practice relaxation.

Warning & Precautions

!### Pregnancy

MIDAZOM 0.5 NASAL SPRAY is generally not recommended for use in pregnant women
unless considered clearly necessary. Consult your doctor before using it.

!### Breastfeeding

MIDAZOM 0.5 NASAL SPRAY is generally not recommended for use in breastfeeding
women as it may pass through the breast milk. Consult your doctor before using
it.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy after using MIDAZOM 0.5
NASAL SPRAY.

!### Alcohol

Do not drink alcohol if you are using MIDAZOM 0.5 NASAL SPRAY. This is because
alcohol may make you feel very sleepy and cause problems with your breathing.

!### Kidney

MIDAZOM 0.5 NASAL SPRAY should be used with caution in patients with kidney
diseases. Consult your doctor before using MIDAZOM 0.5 NASAL SPRAY.

!### Liver

MIDAZOM 0.5 NASAL SPRAY should be used with caution in patients with liver
diseases. Consult your doctor before using MIDAZOM 0.5 NASAL SPRAY.

!### Allergy

Do not use MIDAZOM 0.5 NASAL SPRAY if you are allergic to midazolam. Allergic
reactions to MIDAZOM 0.5 NASAL SPRAY are rare but may show as an itchy rash.
Very rarely, a severe allergic reaction may occur causing a sudden onset of
swelling of the face and neck, and shortness of breath.

!### Lungs

MIDAZOM 0.5 NASAL SPRAY should be used with caution in patients with respiratory
diseases. Consult your doctor before using MIDAZOM 0.5 NASAL SPRAY.

!### Heart Disease

MIDAZOM 0.5 NASAL SPRAY should be used with caution in patients with heart
diseases. Consult your doctor before using MIDAZOM 0.5 NASAL SPRAY.

Others

MIDAZOM 0.5 NASAL SPRAY is not recommended for use if you:

• have acute narrow-angle glaucoma

Before using MIDAZOM 0.5 NASAL SPRAY, inform your doctor if you:

• regularly take recreational drugs or drink large amounts of alcohol or have had problems with alcohol or drug abuse in the past
• suffer from mental disorders including depression, psychosis, or schizophrenia

Use in paediatrics:

MIDAZOM 0.5 NASAL SPRAY is used with caution for use in children and
adolescents. Consult your doctor before using it.

Use in geriatrics:

MIDAZOM 0.5 NASAL SPRAY should be used with caution in elderly (65 years and
above) patients. Consult your doctor for advice.

Interactions

A. Drug-Drug interactions:

Before using MIDAZOM 0.5 NASAL SPRAY, inform your doctor if you are taking any
of the following medicine:

• medicines for depression (Ex. citalopram)
• hypnotic medicines, to make you sleep (Ex. zopiclone)
• sedatives to make you feel calm or sleepy (Ex. barbiturates, benzodiazepines)
• tranquilliser medicines for anxiety or to help you sleep (Ex. pentobarbital)
• carbamazepine or phenytoin (these may be used for fits or seizures)
• rifampicin to manage tuberculosis
• medicines for HIV called protease inhibitors (Ex. saquinavir)
• antibiotics to manage infection (Ex. erythromycin or clarithromycin)
• medicines to manage fungal infections (Ex. ketoconazole, voriconazole, fluconazole, itraconazole,)
• strong pain killers (Ex. ketorolac)
• antihistamines to manage allergic reactions (Ex. cetirizine)
• any kind of herbal medicine for depression
• medicines for high blood pressure (Ex. diltiazem)

Overdosage:

If you or anyone else accidentally used too much of MIDAZOM 0.5 NASAL SPRAY,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose may include feeling sick (nausea), vomiting, dizziness, slowing of
breathing, drowsiness or coma, slurred speech, loss of balance, and slow
reactions.

Synopsis

Drug	:	Midazolam
Pharmacological Category	:	Benzodiazepines
Therapeutic Indication	:	General anaesthesia, conscious sedation
Dosage Forms	:	Tablet, nasal spray, injection, syrup

More Information

• Keep MIDAZOM 0.5 NASAL SPRAY out of reach from children
• Store at room temperature

FAQs About MIDAZOM 0.5 NASAL SPRAY

What are the uses of MIDAZOM 0.5 NASAL SPRAY?

MIDAZOM 0.5 NASAL SPRAY contains Midazolam which belongs to the group of
medicines called benzodiazepines (sedatives). MIDAZOM 0.5 NASAL SPRAY is used to
manage sudden repetitive attacks of fits (epilepsy). Epilepsy (fits) is a
central nervous system (neurological) disorder which affects the brain creating
a disturbance in nerve cells and electrical activity leading to sudden,
uncontrolled body movements. Epilepsy can be triggered by sleep deprivation,
stress, missing medications, illness with fever, or using alcohol or other
nonmedical drugs.

How to use MIDAZOM 0.5 NASAL SPRAY?

Use MIDAZOM 0.5 NASAL SPRAY as advised by your physician. MIDAZOM 0.5 NASAL
SPRAY is for nasal use only. Your doctor will decide the correct dose and
duration for you depending on your age, body weight and disease condition.

Does MIDAZOM 0.5 NASAL SPRAY has any side effects?

MIDAZOM 0.5 NASAL SPRAY has few side effects like any other medicine. The
symptoms include nausea, vomiting, headache, drowsiness, runny nose, throat
irritation, and nasal discomfort. If any of these symptoms become worsen,
contact your doctor for advice.

Can we use MIDAZOM 0.5 NASAL SPRAY for pregnant women?

If you are pregnant or think you may be pregnant or are planning to have a baby,
ask your doctor for advice before using MIDAZOM 0.5 NASAL SPRAY. It is generally
not recommended during pregnancy and breastfeeding. Consult your doctor for
advice.

How does MIDAZOM 0.5 NASAL SPRAY work?

MIDAZOM 0.5 NASAL SPRAY contains midazolam which works by increasing a
particular chemical messenger in the brain that acts as a natural nerve-calming
agent (GABA) resulting in sedative, hypnotic (sleep-inducing), anxiolytic
(anti-anxiety), anticonvulsant, and muscle relaxant properties. Hence MIDAZOM
0.5 NASAL SPRAY helps manage fits by stabilizing the altered, electrical
activity of nerve cells in the brain.