SYNCROPINE 3 mg Coated Tablet

Зміст інструкції

1. Syncropine 3 mg tablets, 5 mg tablets
   1. What is Syncropine and what is it used for
   2. What you need to know before taking Syncropine
   3. How to take Syncropine
   4. Possible side effects
   5. How to store Syncropine
   6. Package Contents and Other Information

Syncropine 3 mg tablets, 5 mg tablets

melatonin

Read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, speak to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is Syncropine and what is it used for

Syncropine contains the active ingredient melatonin, which belongs to a group of natural hormones produced
by the body. Melatonin helps to regulate the body's sleep-wake cycle.
Syncropine is used for:
The short-term treatment of jet lag in adults starting from 18 years of age. The term jet lag refers to
the symptoms caused by the time difference during the crossing of different time zones
(when travelling east or west).
Insomnia with difficulty falling asleep in children and adolescents (from 6 to 17 years) with attention deficit hyperactivity disorder (ADHD), in cases where a healthy sleep routine has not been
sufficient.
Syncropine is particularly suitable for adult travellers crossing 5 or more time zones, especially to the
east, and who have already suffered from jet lag symptoms on previous trips.

2. What you need to know before taking Syncropine

Do not take Syncropine:
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 Syncropine if you suffer from:
diabetes or reduced glucose tolerance, as this medicine may increase blood glucose levels
liver or kidney problems
an autoimmune disease (where the body is “attacked” by its own immune system)
epilepsy. Melatonin may increase the frequency of seizures in patients with epilepsy.
or if you are elderly.
Smoking may reduce the effectiveness of Syncropine, as components of tobacco smoke may promote the
degradation of melatonin by the liver.
During treatment with Syncropine, women of childbearing potential must use effective contraceptive methods. For
more details, see the section "Pregnancy and breastfeeding". This medicine may however be
affected by some contraceptives, see the section “Other medicines and Syncropine” for more
information

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age for the short-term treatment
of jet lag. Do not give the medicine to children under 6 years of age.

Syncropine with food and alcohol
It is recommended not to eat food 2 hours before or 2 hours after taking Syncropine. Do not drink
alcohol before, during or after taking Syncropine, as alcohol may reduce the effectiveness of
melatonin.

Other medicines and Syncropine
Tell your doctor or pharmacist if you are taking, have recently taken or might take other
medicines, including those available without a prescription.
Taking Syncropine with the following medicines may affect the functioning of Syncropine or other
medicines:

• warfarin and other anticoagulants, e.g. dabigatran, rivaroxaban, apixaban and edoxaban (used to prevent blood clots). In this case, it may be necessary to monitor INR (blood coagulation test) more specifically
• antidepressants, e.g. fluvoxamine, imipramine
• ciprofloxacin, norfloxacin and rifampicin (used to treat bacterial infections)
• carbamazepine and phenytoin (used to treat epilepsy)
• 5-methoxpsoralene or 8-methoxpsoralene (5-MOP or 8-MOP) (used to treat skin diseases such as psoriasis)
• medicines for pain and inflammation (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid and ibuprofen)
• benzodiazepines and non-benzodiazepine hypnotics (medicines used to promote sleep such as zaleplon, zolpidem and zopiclone)
• cimetidine for ulcers
• verapamil (for heart conditions)
• antihypertensives (nifedipine, beta-blockers)
• thioridazine (for schizophrenia)
• contraceptives containing ethinylestradiol and progestins
• hormone replacement therapy for problems related to menopause.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy,
ask your doctor for advice before taking this medicine.

Contraception in women of childbearing potential
During treatment with Syncropine, women of childbearing potential must use effective contraceptive methods.
This medicine may however be affected by some contraceptives; for further information see the
section “Other medicines and Syncropine”. Consult your doctor for the choice of contraceptives.

Pregnancy
Syncropine is not recommended during pregnancy. Melatonin crosses the placenta and there is
insufficient information on the risks to the unborn child.

Breastfeeding
Syncropine is not recommended during breastfeeding. Melatonin is excreted in breast milk and a
risk to the breastfed child cannot be excluded.

Driving and using machines
Syncropine may cause drowsiness and reduce attention for several hours after taking it. Therefore, this
medicine should not be taken before driving or using machines.

Syncropine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Syncropine

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor
or pharmacist.

Adults with jet lag
The standard recommended dose is one 3 mg tablet once a day for a maximum of 4 days.
Take the tablet at bedtime, according to local time, starting on the day of arrival at
destination.
If the standard dose of 3 mg does not provide adequate relief from symptoms, you can take a 5 mg tablet instead of the 3 mg one. The 5 mg tablet should not be taken in addition to the 3 mg tablet
(i.e. not on the same day), but a higher dose can be taken on subsequent days.
The maximum daily dose is 5 mg. The maximum duration of treatment is 4 days.
The timing of melatonin administration is important. The dose should be taken at bedtime (according to local time). The tablets should not be taken before 8.00 PM or after 4.00 AM.

Children and adolescents from 6 to 17 years with insomnia with difficulty falling asleep associated with ADHD
Treatment with melatonin should be titrated to the minimum effective dose. Syncropine can be
used when the minimum effective dose has been established at 3 or 5 mg. The tablet should be taken 30-60
minutes before bedtime. The maximum daily dose is 5 mg.
Treatment should be monitored by the doctor at regular intervals (the frequency is indicated by the doctor) to
assess that it is still the appropriate treatment.
The tablet can be crushed before taking and mixed with cold water.
It is recommended not to consume food 2 hours before or 2 hours after the time of taking Syncropine tablets.

If you take more Syncropine than you should
If you or your child has taken an excessive dose of the medicine or if a child or adolescent has accidentally taken
this medicine, always contact your doctor or hospital to assess the risks and receive
further instructions.
Taking a dose higher than the recommended daily dose may cause drowsiness.

If you forget to take Syncropine
If you forget to take a dose before bedtime and wake up during the night, you can take the forgotten dose
as long as it is no later than 4.00 AM.
Do not take a double dose to make up for a missed dose.

If you stop taking Syncropine
No negative effects are known caused by stopping or interrupting treatment. The use of
Syncropine does not cause any known withdrawal symptoms once treatment is finished. If you have any doubts
about using 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.
If you experience any of the following serious side effects, stop taking Syncropine and
contact your doctor immediately:
Uncommon ( may affect up to 1 in 100 people):
chest pain
Rare ( may affect up to 1 in 1,000 people):
loss of consciousness or fainting
severe chest pain due to angina
awareness of your heartbeat
depression
impaired vision
disorientation
dizziness (lightheadedness or “spinning”)
blood in the urine
decreased number of white blood cells in the blood
decreased number of platelets in the blood, which increases the risk of bleeding or bruising
psoriasis
Frequency not known ( the frequency cannot be estimated from the available data):
hypersensitivity reaction
skin swelling
If you experience any of the following non-serious side effects, contact your doctor and/or seek
medical advice:
Common ( may affect up to 1 in 10 people):
headache
drowsiness
Uncommon ( may affect up to 1 in 100 people):
irritability, nervousness, restlessness, anxiety
insomnia, abnormal dreams, nightmares
migraine, dizziness, nausea
lethargy (fatigue) and lack of energy, restlessness associated with hyperactivity
high blood pressure
abdominal pain, indigestion, mouth ulceration, dry mouth
changes in blood composition that can cause yellowing of the skin or
eyes
skin inflammation, itching, rash, dry skin, night sweats
pain in the extremities
glucose excretion in the urine, excess protein in the urine
menopause symptoms
weakness
increased body weight.
Rare ( may affect up to 1 in 1,000 people):
Herpes zoster
low levels of calcium or sodium in the blood
high levels of fat molecules in the blood
mood changes, aggression, agitation associated with hyperactivity, crying spells, stress symptoms,
early morning awakening, increased sexual drive, depressed mood
memory impairment, attention disorders, dream state, restless legs syndrome, poor sleep quality, tingling sensation, hallucinations
blurred vision, watery eyes
dizziness when standing up or sitting down
hot flashes
acid reflux, stomach discomfort, blisters in the mouth, tongue ulceration, stomach pain, vomiting, abnormal abdominal noises, gas, excessive saliva production, bad
breath, abdominal discomfort, inflammation of the stomach lining
eczema, rash, hand dermatitis, itchy rash, nail disorders
arthritis, muscle spasms, neck pain, night cramps
large urine volumes, need to urinate during the night
prolonged - potentially painful - erection in the absence of sexual stimulation, prostate inflammation
fatigue, pain, thirst
increased liver enzymes, electrolyte abnormalities in the blood and laboratory test abnormalities.
Frequency not known ( the frequency cannot be estimated from the available data):
swelling of the face, swelling of the mouth or tongue
abnormal milk secretion
hyperglycemia.

Additional side effects in children and adolescents
A low frequency of generally mild adverse reactions has been reported in children and adolescents.
The most common side effects were headache, hyperactivity, dizziness and abdominal pain. No serious
side effects have been observed.

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 can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Syncropine

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 label, blister and carton.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature.
Store the blister in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Syncropine Contains

• The active ingredient is melatonin 3 mg or 5 mg.
• The other ingredients are magnesium stearate (E470b), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), sodium croscarmellose (E468).

Description of the appearance of Syncropine and package contents
3 mg: Round, biconvex tablets, white or off-white in colour, with approximate dimensions of 6.0 x
2.5 mm.

5 mg: Round, biconvex tablets, white or off-white in colour, with approximate dimensions of 7.0 x
3.2 mm.
Presence of a score line on both sides. The score line is solely to facilitate
swallowing and not to divide the tablet into equal doses.
Syncropine 3 mg and 5 mg tablets are available in a carton containing transparent blisters made of polyvinyl chloride (PVC) and polyethylene (PE) coated with polyvinylidene chloride (PVDC), sealed with
aluminium foil (Al).
Package size: 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pierpaoli Exelyas srl
Corso Concordia 11, 20129, Milan,
Italy

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo, Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo, Finland

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy Syncropine
Finland Syncropine