2 mg prolonged-release tablet is 
melatonin

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Circadin is and what it is used for 
2. What you need to know before taking Circadin 
3. How to take Circadin 
4. Possible side effects 
5. How to store Circadin 
6. Contents of the packaging and other information 

1. What Circadin is and what it is used for

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

Circadin is used alone in the short-term treatment of primary insomnia (persistent difficulty falling asleep or continuing to sleep, or poor sleep quality) in patients 55 years of age and older. “Primary” means that the insomnia has no known cause, such as any medical, mental or environmental cause.

2. What you need to know before you take Circadin

Do not take Circadin

  • if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Circadin

  • if you have liver or kidney problems. No studies on the use of Circadin in people with liver or kidney disease have been performed. You should talk to your doctor before taking Circadin, as its use is not recommended.
  • if you have been told by your doctor that you have an intolerance to some sugars.
  • if you have been told that you have an autoimmune disease (when the body is “attacked” by its own immune system). No studies on the use of Circadin in people with autoimmune diseases have been performed. Therefore, you should talk to your doctor before taking Circadin, as its use is not recommended.
  • Circadin can make you feel drowsy. You should be careful if drowsiness affects you, as it may impair your ability to perform tasks such as driving.
  • Smoking can have a worse effect on Circadin, as the ingredients in tobacco smoke can increase the breakdown of melatonin in the liver.

Children and young people

Do not give this medicine to children aged 0 to 18 years, as it has not been tested on children and its effects are not known. Another medicine that contains melatonin may be more suitable to give to children between 2 and 18 years of age – consult a doctor or pharmacist.

Other medicines and Circadin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Such drugs may be:

  • fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralen (used to treat skin conditions such as psoriasis ), cimetidine (used to treat stomach problems such as stomach ulcers ), quinolones and rifampicin (used to treat bacterial infections), estrogen er (used as a contraceptive or replacement therapy for hormone deficiency) and carbamazepine (used to treat epilepsy ).
  • adrenergic agonists / antagonists (such as certain types of medicines used to control blood pressure by narrowing blood vessels, nasal decongestants, blood pressure-lowering medicines), opiate antagonists / antagonists (such as medicines used to treat drug addiction), prostaglandin inhibitors steroidal anti-inflammatory drugs), antidepressants, tryptophan and alcohol.
  • benzodiazepines and non-benzodiazepine-type hypnotics (drugs used to induce sleep such as zaleplon, zolpidem and zopiclone ).
  • thioridazine (used to treat schizophrenia) and imipramine (used to treat depression).

Circadin with food, drink and alcohol

Take Circadin after meals. Do not drink alcohol before, during or after taking Circadin, as it reduces the effect of Circadin.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Circadin can make you drowsy. If this happens, do not drive or use any machines. If you feel drowsy all the time, you need to talk to your doctor.

Circadin contains lactose monohydrate

Circadin contains lactose monohydrate . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Circadin.

3. How to take Circadin

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one Circadin tablet (2 mg) taken once a day by mouth after a meal, 1-2 hours before bedtime. This dosage can be maintained for up to thirteen weeks.

You must swallow the tablet whole. Do not crush or split the Circadin tablets.

If you take more Circadin than you should

If you have accidentally taken too much of your medicine, you must contact your doctor or pharmacist as soon as possible.

If you take more than the recommended daily dose, you may feel drowsy.

If you forget to take Circadin

If you forget to take your tablet, take one as soon as you remember, before going to sleep, or wait until it is time to take your next dose . Then you can continue as usual.

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

If you stop taking Circadin

There are no known adverse effects if treatment is stopped or stopped early. As far as is known, the use of Circadin does not give rise to any withdrawal effects when stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

If you get any of the following serious side effects , stop taking the medicine immediately and contact your doctor:

Uncommon: (may affect up to 1 in 100 people)

  • Chest pain

Rare: (may affect up to 1 in 1,000 people)

  • Unconsciousness or fainting
  • Severe chest pain due to angina
  • Palpitation
  • Depression
  • Impaired visual acuity
  • Dimsyn
  • Confusion (disorientation)
  • Dizziness (a feeling of dizziness or that it “spins”)
  • Red blood cells in the urine
  • Decreased number of white blood cells in the blood
  • Decreased platelet count , which increases the risk of bleeding or bruising
  • Psoriasis

If you get any of the following non-serious side effects, contact and / or see a doctor:

Uncommon: (may affect up to 1 in 100 people)

Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraines , headaches, lethargy (lethargy, lack of energy), restlessness associated with increased activity, dizziness, drowsiness, high blood pressure , upper abdominal pain, stomach upset, sores in the mouth, dry mouth , nausea, changes in the composition of the blood that may cause yellowing of the skin and eyes, dermatitis, night sweats, itching , rash, dry skin, pain in the arms and legs, menopausal symptoms, feeling of weakness, secretion of glucose in urine, too much protein in the urine, abnormal liver function and weight gain.

Rare: (may affect up to 1 in 1,000 people)

Shingles , high levels of fats in the blood, low levels of calcium in the blood, low levels of sodium in the blood, altered mood, aggression, anxiety, crying mildness, stress symptoms, waking up early in the morning, increased sexual drive, depression, memory loss, attention deficit disorder, attention deficit , restless legs syndrome, poor sleep quality, sensation of numbness and tingling, increased tear flow (watery eyes), positional dizziness (dizziness when getting up or sitting down), hot flashes, acid regurgitation, gastrointestinal upset, blisters in the mouth, sores on the tongue , upset stomach, vomiting, abnormal bowel sounds, flatulence, excessive salivation, bad breath, abdominal discomfort, upset stomach, inflammation of the gastric mucosa, eczema, skin rash, inflammation of the hands on the hands, itchy rash, nail disorders, joint inflammation, muscle cramps, neck pain, nocturnal cramps, prolonged erection which can be painful, inflammation of the prostate , fatigue, pain, thirst, large amounts of urine, urination at night, elevated liverworm saliva in the blood and abnormal laboratory tests.

No known frequency: (cannot be calculated from the available data)

Hypersensitivity reaction , swelling of the mouth or tongue, swelling of the skin and abnormal secretion of milk.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Circadin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in the original package. Sensitive to 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.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and contents of the pack

Circadin 2 mg prolonged-release tablets are white to off-white, round, biconvex tablets. A carton of tablets contains a blister of 7, 20 or 21 tablets, or a carton of two blisters of 15 tablets each (pack of 30 tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux

75002 Paris

France

Email: regulatory@neurim.com

Manufacturer:

Manufacturers responsible for batch release in the EEA:

Temmler Pharma GmbH & Co. KG

Temmlerstrasse 2

35039 Marburg

Germany

Qualiti (Burnley) Limited

Walshaw Mill

Talbot Street

Briercliffe

Burnley

Lancashire BB10 2HW

UK

Iberfar – Indústria Pharmacêutica SA

Rua Consiglieri Pedroso, no 121-123 – Queluz de Baixo

Barcarena, 2734-501

Portugal

Rovi Pharma Industrial Services, SA

Via Complutense, 140

Alcalá de Henares

Madrid, 28805

Spain

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienTakeda BelgiumTel: +32 2 464 06 11Takeda-Belgium@takeda.com LithuaniaRAD Neurim Pharmaceuticals EEC SARLTel: +33 185149776 (FR)email: neurim@neurim.com
BulgariaRAD Neurim Pharmaceuticals EEC LimitedPhone: +44 7563543352 (UK)email: neurim@neurim.com Luxembourg / LuxemburgTakeda BelgiumPhone: +32 2 464 06 11 (BE)Takeda-Belgium@takeda.com
Czech RepublicRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com HungaryRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com
DenmarkTakeda Pharma A / STel: +45 46 77 11 11 MaltaRAD Neurim Pharmaceuticals EEC Limited+44 7563543352 (UK)email: neurim@neurim.com
GermanyMEDICE Arzneimittel Pütter GmbH & Co. KGTel: +49 (0) 2371 9370info@medice.de The NetherlandsTakeda Nederland bvTel: +31 23 566 8777nl.medical.info@takeda.com
EestiRAD Neurim Pharmaceuticals EEC SARLTel: +33 185149776 (FR)email: neurim@neurim.com NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com
GreeceTAKEDA ΕΛΛΑΣ AE:Ηλ: +30 210 6387800gr.info@takeda.com AustriaSANOVA PHARMA GesmbHTel: + 43 (01) 80104-0email: sanova.pharma@sanova.at
SpainEXELTIS HEALTHCARE SLTfno: +34 91 7711500 PolandMEDICE Arzneimittel Pütter GmbH & Co. KGTel .: + 48- (0) 22 642 2673email: office@medice.pl
FranceBIOCODEXTel: +33 (0) 1 41 24 30 00email: webar@biocodex.fr PortugalItalfarmaco, ProdutosPharmacists, Lda.Tel. +351 214 342 530e-mail: geral@itf-farma.pt
CroatiaRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com RomaniaRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com
IrelandFlynn Pharma LimitedTel: +44 (0) 1438 727822 (UK)medinfo@flynnpharma.com SloveniaRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicRAD Neurim Pharmaceuticals EEC LimitedTel: +44 7563543352 (UK)email: neurim@neurim.com
ItalyFidia Farmaceutici SpATel: +39 049 8232222e-mail: info@fidiapharma.it Finland / FinlandTakeda OyPuh / Tel: +358 20 746 500
ΚύπροςRAD Neurim Pharmaceuticals EEC Limited:Ηλ: +44 7563543352 (UK)email: neurim@neurim.com
LatviaRAD Neurim Pharmaceuticals EEC SARLTel: +33 185149776 (FR)email: neurim@neurim.com United KingdomFlynn Pharma LimitedTel: +44 (0) 1438 727822medinfo@flynnpharma.com

Muhammad Nadeem

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