Consumer medicine information

Melatonin MR-Teva 2 mg Modified release tablets

Melatonin

BRAND INFORMATION

Brand name

Melatonin MR-Teva

Active ingredient

Melatonin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Melatonin MR-Teva 2 mg Modified release tablets.

1. Why am I using Melatonin MR-TEVA?


Melatonin MR-TEVA contains the active ingredient melatonin. Melatonin MR-TEVA is used to improve sleep quality and morning alertness in patients over 55 years of age with primary insomnia with poor quality of sleep. For more information, see Section 1. Why am I using Melatonin MR-TEVA? in the full CMI.

2. What should I know before I use Melatonin MR-TEVA?


Do not use if you have ever had an allergic reaction to Melatonin MR-TEVA or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist 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 use Melatonin MR-TEVA? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Melatonin MR-TEVA 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 use Melatonin MR-TEVA?

  • Take Melatonin MR-TEVA only when prescribed by your doctor or pharmacist. Follow the instructions provided with the medicine.
  • The standard dose of Melatonin MR-TEVA is one tablet once a day. Do not exceed the recommended dosage.

More instructions can be found in Section 4. How do I use Melatonin MR-TEVA? in the full CMI.

5. What should I know while using Melatonin MR-TEVA?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Melatonin MR-TEVA.
  • If you become pregnant or start breastfeeding while taking Melatonin MR-TEVA, stop taking the tablets and tell your doctor or pharmacist immediately.
Things you should not do
  • Do not give Melatonin MR-TEVA to anyone else, even if they have the same condition as you.
  • Do not take more than the recommended dose unless your doctor or pharmacist tells you to.
  • Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.
Driving or using machines
  • It is not recommended to drive or operate machinery for 8 hours after you take it.
Drinking alcohol
  • Do not take Melatonin MR-TEVA if you have been drinking alcohol or intend to drink alcohol or believe that you may have alcohol, in your blood stream.
Looking after your medicine
  • Store it in a cool dry place away from moisture, heat or sunlight where the temperature stays below 25°C
  • Keep your tablets in the blister pack until it is time to take them.

For more information, see Section 5. What should I know while using Melatonin MR-TEVA? in the full CMI.

6. Are there any side effects?


All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See Section 6. Are there any side effects? in the full CMI for detailed information on side effects and, if you need to, ask your doctor or pharmacist if you have any further questions.

BRAND INFORMATION

Brand name

Melatonin MR-Teva

Active ingredient

Melatonin

Schedule

S4

 

1 Name of Medicine

Melatonin.

2 Qualitative and Quantitative Composition

Melatonin MR-Teva 2 mg modified release tablets.
The active ingredient in Melatonin MR-Teva modified release tablets is a melatonin, not of plant or animal origin.
Excipient with known effect. Contains lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Modified release tablet.
White to off-white, oval, biconvex tablets.

4 Clinical Particulars

4.9 Overdose

In general, the main therapy for all overdoses is supportive and symptomatic care.
Symptoms. No case of overdose has been reported. Melatonin MR-Teva has been administered at 5 mg daily doses in clinical trials over 12 months without significantly changing the nature of the adverse reactions reported.
Administration of daily doses of up to 300 mg of melatonin without causing clinically significant adverse reactions have been reported in the literature.
If overdose occurs, drowsiness is to be expected.
Treatment. Clearance of the active substance is expected within 12 hours after ingestion. No special treatment is required.
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. Results from a standard battery of in vitro and in vivo assays showed no evidence of a genotoxic potential for melatonin.
Carcinogenicity. An oral lifetime carcinogenicity study with melatonin in rats showed an increased incidence of thyroid follicular cell adenomas in males at doses around 700-fold the recommended clinical dose, based on body surface area. No neoplastic tissue histopathology was examined at lower doses and therefore the no-effect dose could not be determined. These effects were associated with liver enzyme induction in this species and are unlikely to be relevant to humans.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Melatonin is a slightly off-white, odourless crystalline powder. Melatonin is very slightly soluble in water and in dilute hydrochloric acid.
Chemical structure. Chemical name: N-[2-(5-Methoxyindol-3-yl) ethyl]acetamide.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMELATO.gif Molecular formula: C13H16N2O2.
Molecular weight: 232.27.
pKa: 12.3 - 12.7.
CAS number. 73-31-4.

7 Medicine Schedule (Poisons Standard)

Schedule 3. Pharmacist Only Medicine, 7 (sample pack), 15, 21, and 30 tablets.
Schedule 4. Prescription Medicine, 60 tablets.

Summary Table of Changes

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