Syncrodin 3 mg film-coated tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

1. What Syncrodin is and what it is used for.
2. What you need to know before you take Syncrodin.
3. How to take Syncrodin.
4. Possible side effects.
5. How to store Syncrodin.
6. Contents of the pack and other information.

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

Talk to your doctor or pharmacist before taking Syncrodin

• if you have epilepsy. Melatonin may increase seizure frequency in patients with epilepsy.
• if you have an autoimmune disease (where the body is 'attacked' by its own immune system).
• if you have diabetes or impaired glucose tolerance, as this medicine may increase the level of glucose in your blood.
• if you suffer from significantly impaired liver function or kidney function.
• if you smoke. Smoking may reduce the effect of Syncrodin as components of tobacco smoke can increase the breakdown of melatonin by the liver.

Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy are unknown.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Fluvoxamine (used for the treatment of depression and obsessive-compulsive disorder), as fluvoxamine may increase the effect of melatonin.
• Psoralens (used for the treatment of skin disorders e.g. psoriasis), as psoralens may increase the effect of melatonin.
• Cimetidine (used for the treatment of stomach problems such as ulcers), as cimetidine may increase the effect of melatonin.
• Estrogens (used in contraceptives or hormone replacement preparations), as estrogens may increase the effect of melatonin.
• Quinolones (used in the treatment of bacterial infections), as quinolones may increase the effect of melatonin.
• Rifampicin (used in the treatment of bacterial infections), as rifampicin may decrease the effect of melatonin.
• Carbamazepine (used in the treatment of epilepsy), as carbamazepine may decrease the effect of melatonin.
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, e.g. midazolam, temazepam, and zaleplon, zolpidem, zopiclone), as melatonin may enhance the sedative effect of such medicines, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion).

• This medicine should not be taken with food (see Section 3).
• As alcohol can impair sleep and potentially worsen certain symptoms of jet-lag (e.g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed while taking this medicine.

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.

Pregnancy

Syncrodin is not recommended if you are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child. If you are a woman of childbearing potential you have to use contraception.

Breast-feeding

Syncrodin is not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the breast-fed infant or child cannot be excluded.

Fertility

Syncrodin is not recommended in women and men planning to have a baby as there is insufficient information on the effects of melatonin on female and male fertility.

Syncrodin may cause drowsiness and may decrease alertness for several hours after intake. Therefore, this medicine should not be taken prior to driving or using machines.

If you have taken more Syncrodin than recommended and you do not feel well, please contact your doctor, hospital or pharmacy.

The most common symptoms of overdose are drowsiness, headache, dizziness, and nausea.

If you forget to take a tablet(s) at bedtime and wake during the night you may take the forgotten dose but at no later than 04:00 hr.

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

If you stop taking Syncrodin, it will not have any harmful effects or withdrawal symptoms.

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

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

Uncommon side effects

(may affect up to 1 in 100 people)

• Chest pain.

Rare side effects

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

• Reduced number of white blood cells in the blood.
• Reduced number of blood platelets, which increases the risk of bleeding or bruising.
• Disorientation.
• Fainting.
• Visual impairment, including blurred vision.
• Feeling your heartbeat ('pounding chest').
• Blood (red blood cells) in the urine.

Not known

(frequency cannot be estimated from available data)

• Severe allergic reaction resulting in swelling of the tongue or lining of the mouth.

If you experience any of the following non-serious side effects contact your doctor or pharmacist:

Common side effects

(may affect up to 1 in 10 people)

• Headache.
• Drowsiness.

Uncommon side effects

(may affect up to 1 in 100 people)

• Irritability, nervousness, restlessness, abnormal dreams, anxiety.
• Dizziness.
• High blood pressure.
• Abdominal pain, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea.
• Itching, rash, dry skin.
• Excretion of glucose in the urine, excess protein in the urine.
• Feeling unwell.
• Weight increase.

Rare side effects

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

• High levels of certain fat molecules (triglycerides) in the blood.
• Altered mood, aggression, increased sex drive.
• Memory impairment, restless legs syndrome, 'pins and needles' sensation.
• Watery eyes.
• Hot flushes.
• Vomiting, wind, excess saliva, bad breath, inflammation of the stomach lining.
• Nail disorder.
• Arthritis, muscle spasms.
• Passing large volumes of urine.
• Prolonged erection that might be painful, inflammation of the prostate gland.
• Thirst.
• Abnormal levels of electrolytes in the blood.

Not known

(frequency cannot be estimated from available data)

• Hypersensitivity reactions.
• High blood glucose level.
• Flow of milk from the breasts (also in men).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You or your relatives can also report side effects directly via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is melatonin. Each tablet contains 3 mg melatonin.
• The other ingredients are: magnesium stearate, colloid silica anhydrous, maltodextrin, microcrystalline cellulose, croscarmellose sodium. Film coating: hypromellose.

Round, biconvex, clear-coated, white to off-white tablet. Size 7.5 mm.

Blister pack containing 10 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Local representative:

This medicinal product is authorised in the Member States of the EEA under the following names:

In Belgium it is marketed under the name Melatonine Pharma Nord 3 mg comprimés pélliculés / filmomhulde tabletten / Melatonin Pharma Nord 3 mg Filmtabletten

In Estonia it is marketed under the name Melatoniin Pharma Nord 3 mg õhukese polümeerikattega tabletid

In Hungary it is marketed under the name Melatonin Pharma Nord 3 mg filmtabletta

In Ireland it is marketed under the name Melatonin Pharma Nord 3 mg film-coated tablets

In Latvia it is marketed under the name MelatoninPharma nord 3 mg apvalkotās tabletes

In Lithuania it is marketed under the name Melatoninas Pharma Nord 3 mg plėvele dengtos tabletės

In the Netherlands it is marketed under the name Melatonine Pharma Nord 3 mg filmomhulde tablet

In Poland it is marketed under the name Melatonina Pharma Nord 3 mg tabletki powlekane

In Portugal it is marketed under the name Melatonina Pharma Nord 3 mg, comprimidos revestidos por película

In Spain it is marketed under the name Melatonite 3 mg comprimidos recubiertos con película

In the United Kingdom it is marketed under the name Syncrodin 3 mg film-coated tablets