Circadin 2 mg prolonged-release tablets

 

What is it and how is it used?

The active substance of Circadin, melatonin, belongs to a natural group of hormones produced by the body.

Circadin is used as monotherapy for the short-term treatment of primary insomnia (difficulty in getting to sleep or staying asleep, or poor quality of sleep for at least one month), characterised by poor quality of sleep in patients aged 55 years and older.

What do you have to consider before using it?

Do not take Circadin

  • if you are allergic (hypersensitive) to melatonin or any of the other ingredients of Circadin.

Take special care with Circadin

  • if drowsiness is likely to cause a risk to your safety;
  • if you suffer from any liver problems;
  • if you suffer from kidney problems;
  • if you suffer from any autoimmune disease (where the body is ‘attacked’ by its own immune system).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription BEFORE you start the treatment as they may affect the action of Circadin. These medicines include hypnotics and tranquilisers (e.g. benzodiazepines), 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).

Taking Circadin with food and drink
Take Circadin after you have eaten. Do not drink alcohol before, during or after taking Circadin.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
It is not recommended to take Circadin if you are pregnant or suspect that you may be pregnant. It is not recommended to take Circadin if you are breast feeding.

Driving and using machines
Circadin may cause drowsiness. If you are affected, you should not drive or operate machinery. If you suffer from continued drowsiness, then you should consult your doctor.

Important information about some of the ingredients of Circadin
Each prolonged-release tablet contains 80 mg of lactose-monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Circadin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose is one Circadin tablet taken daily by mouth, after food, 1-2 hours before bedtime. This dosage may be continued for up to thirteen weeks. You should swallow the tablet whole. Circadin tablets should not be crushed or cut in half.

If you take more Circadin than you should
If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.

Taking more than the recommended daily dose may make you feel drowsy.

If you forget to take Circadin
If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Circadin
There are no known harmful effects if treatment is interrupted or ended early. The use of Circadin is not known to cause any withdrawal effects after treatment completion.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Circadin can cause side effects, although not everybody gets them. The following events are considered to be uncommon (i.e. likely to occur in fewer than 1 in 100 patients):

Irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, migraine, lethargy, restlessness associated with increased activity, dizziness, tiredness, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, changes in the composition of your blood which could cause yellowing of the skin or eyes, inflammation of the skin , night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, chest pain, excretion of glucose in the urine, excess proteins in the urine, abnormal liver function and weight increase.

The following events are considered to be rare (i.e., likely to occur in fewer than 1 in 1,000 patients):

Shingles, reduced number of white blood cells in the blood, decreased number of platelets in the blood, high level of fatty molecules in the blood, severe chest pain due to angina, feeling your heartbeat , low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased sex drive, depressed mood, depression, loss of consciousness or fainting, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling, visual impairment, blurred vision, watery eyes, dizziness when standing or sitting, vertigo, hot flushes, acid reflux, stomach disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, psoriasis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, prolonged erection that might be painful, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes of urine, presence of red blood cells in the urine, urinating during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Circadin after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Circadin is a medicine that contains the active substance melatonin. It is available as white prolonged-release tablets (2 mg). ‘Prolonged-release’ means that melatonin is released slowly from the tablet over a few hours.

What is it used for?

Circadin is used on its own for the short-term treatment of primary insomnia (poor quality of sleep) in patients aged 55 years or over. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Circadin is one tablet a day, taken one to two hours before bedtime and after food. This dose can be continued for up to 13 weeks.

How does it work?

The active substance in Circadin, melatonin, is a naturally occurring hormone, which is normally produced by a gland in the brain called the pineal gland. Melatonin is involved in co-ordinating the body’s sleep cycle by acting on cells in specific areas of the brain and helping to bring about sleep. Its levels in the blood normally increase after the onset of darkness and peak in the middle of the night. Older people may produce less melatonin, leading to the development of insomnia. By replacing the hormone, Circadin increases blood levels of melatonin, helping them to sleep. Because Circadin tablets release melatonin slowly over a few hours, they mimic the natural production of melatonin in the body.

How has it been studied?

Circadin has been compared with placebo (a dummy treatment) in three main studies involving a total of 681 patients aged over 55 years with primary insomnia. The main measure of effectiveness was the number of patients who reported a significant improvement in their quality of sleep and ability to function normally on the following day, after three weeks of treatment. The patients assessed the severity of their symptoms using a standard questionnaire.

An additional study compared the effects of Circadin and placebo for up to six months.

What benefits has it shown during the studies?

Circadin was more effective than placebo at improving quality of sleep and the patients’ ability to function normally on the following day. When the results of all three studies were looked at together, 32% of the patients taking Circadin (86 out of 265) reported a significant improvement in symptoms after three weeks, compared with 19% of those taking placebo (51 out of 272).

The additional study showed that Circadin was more effective than placebo for at least 13 weeks.

What is the risk associated?

Side effects with Circadin are not common. However, the following side effects are seen in between 1 and 10 patients in 1,000: irritability, nervousness, restlessness, insomnia, abnormal dreams, anxiety, migraine, lethargy (lack of energy), psychomotor hyperactivity (restlessness with increased activity), dizziness, somnolence (sleepiness), hypertension (high blood pressure), abdominal pain (stomach ache), dyspepsia (heartburn), mouth ulcers, dry mouth, hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells, which can cause yellowing of the skin and eyes), dermatitis (skin inflammation), night sweats, pruritus (itching), rash, dry skin, pain in the extremities (arms and legs), symptoms of the menopause, asthenia (weakness), chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests and increased weight. For the full list of all side effects reported with Circadin, see the Package Leaflet.

Circadin can cause drowsiness, so it should be used with caution if this could pose a risk to safety, including in people who need to drive or use machines. Patients should avoid alcohol before, during and after taking Circadin.

Circadin should not be used in people who may be hypersensitive (allergic) to melatonin or any of the other ingredients.

Why has it been approved?

The CHMP decided that, although Circadin has only been shown to have a small effect in a relatively small number of patients, its benefits are greater than its risks. The Committee recommended that Circadin be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Circadin to Rad Neurim Pharmaceuticals EEC Limited on 29 June 2007. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Circadin, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2010.