Consumer medicine information

Hypnodorm 1 mg Tablets

Flunitrazepam

BRAND INFORMATION

Brand name

Hypnodorm

Active ingredient

Flunitrazepam

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Hypnodorm 1 mg Tablets.

1. Why am I taking HYPNODORM?


HYPNODORM contains the active ingredient flunitrazepam. HYPNODORM is used to treat severe cases of insomnia (trouble sleeping).
For more information, see Section 1. Why am I taking HYPNODORM? in the full CMI.

2. What should I know before I take HYPNODORM?


Do not take HYPNODORM if you have ever had an allergic reaction to flunitrazepam, any other benzodiazepine, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take HYPNODORM? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with HYPNODORM and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take HYPNODORM?

  • The dose varies from patient to patient. Your doctor will decide the right dose for you.
  • HYPNODORM should only be taken when you go to bed.

More instructions can be found in Section 4. How do I take HYPNODORM? in the full CMI.

5. What should I know while taking HYPNODORM?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking HYPNODORM.
  • Use HYPNODORM exactly as prescribed by your doctor.
  • Call your doctor straight away if you become pregnant while taking HYPNODORM.
Things you should not do
  • Do not take HYPNODORM for a longer time than your doctor has prescribed.
  • Do not stop taking HYPNODORM, or change the dose, without checking with your doctor.
  • Do not take HYPNODORM to treat any other conditions unless your doctor tells you to.
  • Do not give HYPNODORM to anyone else, even if they have the same condition as you.
Driving or using machines
  • Do not drive or operate machinery until you know how HYPNODORM affects you. HYPNODORM may cause drowsiness, dizziness or lightheadedness in some people
Drinking alcohol
  • Alcohol may increase the effects of HYPNODORM and should be avoided while you are being treated with HYPNODORM.
Looking after your medicine
  • Store it in a cool dry place away below 30°C.
  • Keep your tablets in the bottle until it is time to take them.

For more information, see Section 5. What should I know while taking HYPNODORM? in the full CMI.

6. Are there any side effects?


Less serious side effects: tiredness or drowsiness, hangover feeling in the morning, headache, confusion, dizziness, unsteadiness when walking, stomach upsets, dry mouth, slurred speech. Serious side effects: skin rash, fast heartbeat, muscle weakness, aggressive behaviour, delusions, hallucinations, sudden excitation or anxiety, severe sleep disturbances, nightmares, loss of memory, swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Hypnodorm

Active ingredient

Flunitrazepam

Schedule

S8

 

1 Name of Medicine

Flunitrazepam.

2 Qualitative and Quantitative Composition

Each Hypnodorm tablet contains 1 mg flunitrazepam as the active ingredient.
Excipients with known effect. Sugars as lactose, and trace amounts of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Flunitrazepam 1 mg tablets. 12.6 x 6 mm, oval, convex, green film-coated tablet. Debossed ''FM/1'' on one side and an alpha symbol on the other.

4 Clinical Particulars

4.9 Overdose

Symptoms. Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression, ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, coma and, very rarely, death.
Treatment. In the management of overdosage with any medication, it should be borne in mind that multiple agents may have been taken.
Following overdosage with flunitrazepam tablets, activated charcoal should be given to reduce absorption. General symptomatic and supportive measures are recommended. Hypotension and respiratory depression should be managed according to general principles.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication. The benzodiazepine antagonist flumazenil may be used in hospitalised patients for the reversal of acute benzodiazepine effects. Please consult the flumazenil product information prior to usage.
If excitation occurs in patients following overdosage, barbiturates should not be used.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Studies have not been performed to assess the mutagenic potential of flunitrazepam.
Carcinogenicity. Studies have not been performed to assess the carcinogenic potential of flunitrazepam.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Chemical name: 5-(2-fluorophenyl)-1,3- dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin 2 one.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUNIT.gif Molecular formula: C16H12FN3O3.
Molecular weight: 313.3.
Flunitrazepam is a pale yellow crystalline solid, sparingly soluble in water, slightly soluble in alcohol.
CAS number. 1622-62-4.

7 Medicine Schedule (Poisons Standard)

S8 (Controlled Drug).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/HYPNODST.gif