CIRCADIN®

CIRCADIN®

Active ingredient: Melatonin

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Consumer Medicine Information (CMI)

This leaflet provides important information about using CIRCADIN. 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 CIRCADIN.

Where to find information in this leaflet:

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

1. Why am I using CIRCADIN?

CIRCADIN contains the active ingredient Melatonin. The active substance of CIRCADIN, melatonin, belongs to a group of naturally occurring hormones produced in the body.

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

CIRCADIN is used to improve sleep quality and morning alertness in patients over 55 years of age with poor quality of sleep.

2. What should I know before I use CIRCADIN?

Warnings

Do not use CIRCADIN 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.

• you have been drinking alcohol or intend to drink alcohol or believe that you may have alcohol, in your blood stream.
• you are pregnant or breast-feeding. CIRCADIN has not been studied in pregnant or breast-feeding women.

Check with your doctor or pharmacist if you:

• have or have had the following medical conditions:
  – suffer from liver problems
  – suffer from kidney problems
  – If you suffer from an autoimmune disease
  – have a rare hereditary problem of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption
• take any medicines for any other condition
• Do not give CIRCADIN to a child or adolescent. There is no experience with its use in children or adolescents under 18 years old.

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

Do not take CIRCADIN if you are pregnant or breast-feeding. CIRCADIN 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 may interfere with CIRCADIN and affect how it works.

These include:

• hypnotics and tranquilisers (e.g. benzodiazepine),
• fluvoxamine, thioridazine and imipramine (used to treat depression or psychiatric problems),
• oestrogen (contraceptives or hormone replacement therapy),
• cimetidine and psoralens (used to treat skin problems e.g. psoriasis)
• alcohol
• caffeine

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

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

4. How do I use CIRCADIN?

How much to take / use

• The standard dose of CIRCADIN is one tablet once a day. There is no evidence that taking more than the recommended dose will increase the effect of CIRCADIN.
• Swallow your tablet whole with a full glass of water.
• Do not crush, chew or divide your tablet.
• Each CIRCADIN 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 CIRCADIN

• CIRCADIN should be used after food, 1-2 hours before you go to bed.

If you forget to use CIRCADIN

CIRCADIN should be used regularly at the same time each day. If you miss your dose at the usual time, take another as soon as you remember, before going to bed or wait until it is time for your next dose.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much CIRCADIN

If you think that you have used too much CIRCADIN, 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 CIRCADIN?

Things you should do

Call your doctor straight away if you:

• If you become pregnant while taking CIRCADIN, stop taking the tablets and tell your doctor immediately.
• Remind any doctor, dentist or pharmacist you visit that you are using CIRCADIN.

Things you should not do

• Do not give CIRCADIN 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 use this medicine to treat any other complaints 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 CIRCADIN affects you.

CIRCADIN rarely causes drowsiness, nevertheless it is not recommended to drive or operate machinery for 8 hours after you take it. CIRCADIN 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.

Do not drink alcohol before or after taking this medicine.

Looking after your medicine

• Keep CIRCADIN away from sunlight.
• Store below 25°C.

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 about side effects.

Uncommon side effects

Less serious side effects

What to do

Psychiatric Disorders Irritability, nervousness, restlessness insomnia, abnormal dreams, anxiety, nightmares Nervous System Disorders Migraine, lethargy, psychomotor hyperactivity (restlessness associated with increased activity), dizziness, somnolence (tiredness), headache Vascular Disorders High blood pressure Gastrointestinal Disorders Abdominal pain (upper), indigestion, mouth ulceration, dry mouth, nausea Hepatobiliary Disorders Hyperbilirubinaemia (changes in the composition of your blood which could cause yellowing of the skin or eyes (jaundice) Skin and Subcutaneous Tissue Disorders Inflammation of the skin (dermatitis), night sweats, pruritis (itching), rash, dry skin Musculoskeletal and Connective Tissue Disorders Pain in extremities Reproductive System and Breast Disorders Menopausal symptoms General Disorders and Administration Site Conditions Asthenia (feeling of weakness), chest Pain Renal and Urinary Disorders Excretion of glucose in urine, excess proteins in the urine Investigations Liver Function Test Abnormal, weight increase

Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Rare side effects

Serious side effects

What to do

Infections and Infestations Shingles Blood and Lymphatic System Disorders Reduced number of white blood cells in the blood, decreased number of platelets in the blood Cardiac Disorders Severe chest pain due to angina, feeling your heartbeat (palpitations). Immune System Disorders Hypersensitivity reaction Metabolism and Nutrition Disorders High level of fatty molecules in the blood, low serum calcium levels in the blood, low sodium levels in the blood Psychiatric Disorders Altered mood, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased sex drive, depressed mood, depression Nervous System Disorders Loss of consciousness or fainting, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling (paresthesia) Eye Disorders Reduced visual acuity (visual impairment), blurred vision, watery eyes Ear and Labyrinth Disorders Dizziness when standing or sitting, vertigo Vascular Disorders Hot flushes Gastrointestinal Disorders Gastro-oesophageal reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, gastrointestinal upset, vomiting, abnormal bowel sounds, flatulence (wind), salivary hypersecretion (excess saliva production), halitosis (bad breath), abdominal discomfort, gastric disorder, inflammation of the stomach lining Skin and Subcutaneous Tissue Disorders Eczema, erythema (skin rash), hand dermatitis, psoriasis, pruritic rash (itchy rash), nail disorder Musculoskeletal and Connective Tissue Disorders Arthritis, muscle spasms, neck pain, night cramps Reproductive System and Breast Disorders Increased duration of erection, inflammation of the prostate gland General Disorders and Administration Site Conditions Tiredness, pain, thirst Renal and Urinary Disorders Passing large volumes or urine, presence of red blood cells in the urine, urination during the night Investigations Increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What CIRCADIN contains

Active ingredient (main ingredient)	Each CIRCADIN 2 mg tablet contains 2 mg melatonin as the active ingredient
Other ingredients (inactive ingredients)	Ammonio methacrylate copolymer type B, calcium hydrogen phosphate, lactose, colloidal anhydrous silica, purified talc magnesium stearate.

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

What CIRCADIN looks like

CIRCADIN tablets are white to off-white round bi-convex shaped tablets (Aust R 153959).

Who distributes CIRCADIN

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065

This leaflet was prepared in January 2021.