What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20243/0003.


Syncrodin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Syncrodin 3 mg, film-coated tablets

melatonin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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.

What is in this leaflet:

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.

1. What Syncrodin is and what it is used for

Syncrodin contains the active substance melatonin. Syncrodin can be used for treatment of jet-lag in adults. Jet-lag can be recognized by sleep disturbances, daytime tiredness, fatigue, mild mental impairment, irritability and digestive system disturbances experienced after flying.

How Syncrodin works

Melatonin is a hormone produced by the body that synchronizes the body’s biological day-and-night rhythm. The biological rhythm can be disturbed by travelling across time zones. This is known as a jet-lag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Syncrodin can help restore the normal day-and-night rhythm and reduce the symptoms.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before you take Syncrodin

Do not take Syncrodin

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

Warnings and precautions

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.

Children and adolescents

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

Other medicines and Syncrodin

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).

Syncrodin with food and alcohol

  • 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.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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.

3. How to take Syncrodin

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults and elderly is 1 tablet daily for a maximum of 5 days. When the effect of Syncrodin is inadequate, 2 tablets can be taken simultaneously.

The first dose should be taken on arrival at destination at your usual bed-time. Intake on the following days should also be at your usual bed-time. Tablet(s) should not be taken before 20:00 hr or after 04:00 hr.

Tablets should be swallowed whole with water or other liquid (e.g. milk, fruit juice). Food should not be consumed 2 hours before or 2 hours after intake of Syncrodin.

Syncrodin 3 mg may be taken for a maximum of 16 treatment periods per year.

If you take more Syncrodin than you should

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 Syncrodin

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

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.

4. Possible side effects

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

Serious side effects

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.

Non-serious side effects

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).

Reporting of side effects

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.

5. How to store Melatonin Pharma Nord

  • 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 outer carton and blister after EXP. The expiry date refers to the last day of that month.
  • This medicine does not require any special temperature storage conditions.
  • Syncrodin should be stored in the original packaging in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Syncrodin contains

  • 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.

What Syncrodin looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Pharma Nord ApS
Tinglykke 4-6
DK-6500 Vojens
Denmark

Local representative:

Pharma Nord (UK) Ltd.
Telford Court
Morpeth
Northumberland
NE61 2DB
UK

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

This leaflet was last revised in 04/2020.

I-7679-7