FULL CMI

MELOTIN MR

Active ingredient(s): Melatonin

Consumer Medicine Information (CMI)

This leaflet provides important information about using MELOTIN MR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MELOTIN MR.

Where to find information in this leaflet:

1. Why am I using MELOTIN MR?
2. What should I know before I use MELOTIN MR?
3. What if I am taking other medicines?
4. How do I use MELOTIN MR?
5. What should I know while using MELOTIN MR?
6. Are there any side effects?
7. Product details

1. Why am I using MELOTIN MR?

MELOTIN MR contains the active ingredient melatonin. Melatonin is a naturally occurring hormone produced in the body.

It works by controlling the circadian rhythms and increasing the propensity to sleep.

MELOTIN MR is used for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 years of age or over

2. What should I know before I use MELOTIN MR?

Warnings

Do not use MELOTIN MR if:

• you are allergic to melatonin, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• Do not use in adults or children under 55 years of age.
• Alcohol should not be taken with melatonin. Do not take melatonin if you have been drinking alcohol, intend to drink alcohol or believe that you may have alcohol in your blood stream.

Check with your doctor or pharmacist if you:

• have any other medical conditions:
  - Liver problems
  - Kidney problems
  - An autoimmune disease
  - A hereditary problem of galactose intolerance, LAP lactase deficiency or glucose-galactose malabsorption
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

• Do not take melatonin if you are pregnant or breast-feeding.

This medicine has not been studied in pregnant or breast-feeding women.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and melatonin may interfere with each other. These include:

• hypnotics or tranquilisers (e.g. benzodiazepines)
• certain medicine used to treat mood disorders (e.g. fluvoxamine, thioridazine and imipramine)
• contraceptives or hormone replacement therapy containing oestrogen
• quinolones and rifampicin, used to treat infections
• carbamazepine, used to treat epilepsy
• cimetidine
• psoralens used to treat skin problems (e.g. psoriasis)
• alcohol
• caffeine

Some medicines may interfere with MELOTIN MR and affect how it works.

The effect of adding melatonin to other medicines used to treat insomnia has not been examined. It is not known if melatonin will increase or decrease the effects of other treatments for insomnia.

These medicines may be affected by melatonin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Medicines that may increase the effect of MELOTIN MR include:

• Quinolones
• Fluvoxamine
• 5- or 8-methoxypsoralen
• Cimetidine
• Oestrogens

Medicines that may reduce the effect of MELOTIN MR include:

• Carbamazepine and rifampicin

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MELOTIN MR.

4. How do I use MELOTIN MR?

How much to take / use

• The usual dose of melatonin is one tablet once a day.
  There is no evidence that taking more than the recommended dose will increase the effect of melatonin.
• Swallow the tablet whole with a glass of water.
  Do not crush, chew or divide your tablet.
  Each melatonin tablet has been specially designed to release the right dose of medicine while you sleep. If you crush, chew or divide the tablet they will not work properly
• Follow the instructions provided with the medicine.
• Do not exceed the recommended dosage.

When to take / use MELOTIN MR

• MELOTIN MR should be used at about the same time each day, about 1-2 hours before you go to bed.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
• Melatonin should be taken with food

Principles of good sleep hygiene:

• Go to bed and arise at the same time daily
• Engage in relaxing activities before bedtime
• Exercise regularly but not in the late evening
• Avoid eating meals or large snacks just before bedtime
• Eliminate daytime naps
• Avoid caffeine-containing drinks after midday
• Avoid alcohol or the use of nicotine late in the evening
• Minimise external disruption (e.g. light and noise)
• If you are unable to sleep, do not become anxious; leave the bedroom and participate in relaxing activities such as reading or listening to music until you are tired.

If you use too much MELOTIN MR

If you think that you have used too much MELOTIN MR, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using MELOTIN MR?

Things you should do

• If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking melatonin.
• If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
  It may affect other medicines used during surgery.
• If you become pregnant while taking melatonin, stop taking the tablets and tell your doctor immediately.

Remind any doctor, dentist or pharmacist you visit that you are using MELOTIN MR.

Things you should not do

• Do not take this medicine to treat any other complaints unless your doctor tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you
• Do not take more than the recommended dose unless your doctor tells you to.
• Do not drink alcohol before or after taking this medicine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MELOTIN MR affects you.

Melatonin rarely causes drowsiness. Nevertheless, it is not recommended to drive or operate machinery for 8 hours after you take it. Melatonin does not impair morning alertness, but if you suffer from drowsiness during the day you should consult your doctor.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Alcohol reduces the effectiveness of melatonin on sleep. The prolonged release characteristics of melatonin may result in immediate release of melatonin.

Looking after your medicine

• Keep your tablets in the pack until it is time to take them.
  If you take the tablets out of the pack, they may not keep well.
• Keep your medicine in a cool dry place where the temperature stays below 25°C. Keep it away from sunlight.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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 the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Uncommon side effects

Rare side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What MELOTIN MR contains

Do not take this medicine if you are allergic to any of these ingredients.

What MELOTIN MR looks like

MELOTIN MR is a white to off-white round bi-convex shaped tablet. (Aust R 250295).

Who distributes MELOTIN MR

Apotex Pty Ltd
16 Giffnock Avenue,
Macquarie Park, 2113 New South Wales
Australia

This leaflet was prepared in June 2021.

Published by MIMS August 2021

1 Name of Medicine

Melatonin.

2 Qualitative and Quantitative Composition

Melotin MR 2 mg modified release tablets.
The active ingredient in Melotin MR modified release tablets is a melatonin not of plant or animal origin.

Excipients with known effects.

3 Pharmaceutical Form

Melotin MR modified release tablets 2 mg.

4 Clinical Particulars

4.1 Therapeutic Indications

Monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

4.2 Dose and Method of Administration

Oral use. Tablets should be swallowed whole.
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food.

Renal insufficiency.

Hepatic impairment.

4.3 Contraindications

Melatonin modified release tablets are contraindicated in patients with a known hypersensitivity to any ingredient of the product (see Section 6.1 List of Excipients).

4.4 Special Warnings and Precautions for Use

Drowsiness.

Autoimmune diseases.

Excipients.

Gender.

Use in the elderly.

Use in hepatic impairment.

Use in renal impairment.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pharmacokinetic interactions.

Hepatic enzymes.

Quinolones.

Carbamazepine and rifampicin.

Fluvoxamine.

5- or 8-methoxypsoralen.

Cimetidine.

Cigarette smoking.

Oestrogens.

Other.

Pharmacodynamic interactions.

Alcohol.

Hypnotics.

Thioridazine and imipramine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Melatonin modified release tablets have negligible influence on the ability to drive and use machines. Nevertheless, patients should avoid engaging in hazardous activities (such as driving or operating machinery) after taking melatonin modified release tablets.

4.8 Adverse Effects (Undesirable Effects)

In clinical trials (in which a total of 1931 patients were taking melatonin modified release tablets and 1642 patients were taking placebo), 48.8% of patients receiving melatonin modified release tablets reported an adverse reaction compared with 37.8% taking placebo. Comparing the rate of patients with adverse reactions per 100 patient weeks, the rate was higher for placebo than melatonin modified release tablets (5.743 - placebo vs. 3.013 - melatonin modified release tablets). The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the melatonin modified release tablets and placebo treated groups. In the melatonin modified release tablets group, there were 72 cases (2.9% of the safety population) of adverse events leading to discontinuation of the patient. In the placebo group there were 62 cases (4.0% of the safety population) of adverse events leading to discontinuation of the patient. See Table 1.
The adverse reactions in Table 2 were reported in clinical trials and were defined as possibly, probably or definitely related to treatment. A total of 9.5% of subjects receiving melatonin modified release tablets reported an adverse reaction compared with 7.4% of subjects taking placebo. Only those adverse events occurring in subjects at an equivalent or greater rate than placebo have been included.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), Not known (cannot be established from the available data).

Post-marketing data.

Psychiatric disorders.

Reporting suspected adverse effects.

4.9 Overdose

In general, the main therapy for all overdoses is supportive and symptomatic care.

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Melatonin Receptor Agonists, ATC code: N05CH01.
Melatonin is a naturally occurring hormone produced by the pineal gland and is structurally related to serotonin. Physiologically, melatonin secretion increases soon after the onset of darkness, peaks at 2-4 am and diminishes during the second half of the night. Melatonin is associated with the control of circadian rhythms and entrainment to the light-dark cycle. It is also associated with a hypnotic effect and increased propensity for sleep.

Mechanism of action.

Rationale for use.

Clinical trials.

Long term safety.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

Gender.

Elderly.

Renal impairment.

Hepatic impairment.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ammonio methacrylate copolymer, calcium hydrogen phosphate, lactose monohydrate, colloidal anhydrous silica, purified talc, magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

PVC/PVDC/Al or Alu/Alu blister packs of 15, 21 or 30 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 3 Pharmacist Only Medicine.

Summary Table of Changes