Circadin 2 mg prolonged-release tablets

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.

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.

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.

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.

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 Circadin contains

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg melatonin.
• The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.

What Circadin looks like and contents of the pack

Circadin 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets. Each carton of tablets contains one blister strip of 20 or 21 tablets, or alternatively in a carton containing two blister strips of 15 tablets each (30 tablet pack). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

RAD Neurim Pharmaceuticals EEC Limited
One Forbury Square
The Forbury
Reading
Berkshire RG1 3EB
United Kingdom
e-mail: neurim@neurim.com

Manufacturer:

Sites responsible for Batch Release in the EEA:-

Penn Pharmaceutical Services Ltd
Units 23-24 Tafarnaubach Industrial Estate
Tredegar
Gwent
NP22 3AA
UK

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
D-73614 Schorndorf
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder

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This leaflet was last approved in {MM/YYYY}.