Patient Leaflet Updated 17-Feb-2026 | Orion Pharma (UK) Limited
Melatonin Orion 3 and 5 mg Tablets
Melatonin Orion 3 mg tablets
Melatonin Orion 5 mg tablets
melatonin
1. What Melatonin Orion is and what it is used for
2. What you need to know before you take Melatonin Orion
3. How to take Melatonin Orion
4. Possible side effects
5. How to store Melatonin Orion
6. Contents of the pack and other information
Melatonin Orion contains the active substance melatonin which belongs to a group of natural hormones produced by the body. Melatonin helps regulate the body’s day and night rhythm.
Melatonin Orion is used for:
Melatonin Orion might be suitable to adult travellers flying across 5 or more time zones, particularly in an easterly direction, and if they have experienced jet lag symptoms on previous journeys.
Talk to a doctor or pharmacist before taking Melatonin Orion if you have:
Smoking may make Melatonin Orion less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.
Women of childbearing potential should use contraception during treatment with Melatonin Orion. See section “Pregnancy and breast-feeding” for more information This medicinal product may however be affected by certain contraceptives, see the section “Other medicines and Melatonin Orion” for more information.
This medicine is not recommended for children or adolescents below 18 years of age in short-term treatment of jet lag. Do not give this medicine to children below 6 years of age.
Food should not be consumed 2 hours before or 2 hours after intake of Melatonin Orion tablets. Do not drink alcohol before, during or after taking Melatonin Orion, as it may reduce the effect of melatonin.
Tell a doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including non-prescription medicines.
If Melatonin Orion is taken at the same time as the following medicines, it can affect the way that Melatonin Orion or the other medicine works:
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.
Contraceptives for fertile women
Fertile women should use contraceptives under the Melatonin Orion treatment. This medicinal product may however be affected by certain contraceptives, see the section “Other medicines and Melatonin Orion” for more information. Discuss with a doctor for choice of contraceptives.
Pregnancy
Melatonin Orion 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.
Breast-feeding
Melatonin Orion is not recommended if you are breast-feeding. Melatonin is passed into human milk, and a risk to the breast-fed child cannot be excluded.
Melatonin Orion 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.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The standard dose is one 3 mg tablet taken once a day for a maximum of 4 days. Take the tablet at local bedtime, starting on the arrival at destination.
If the standard dose of 3 mg does not adequately alleviate symptoms you can take one 5 mg tablet instead. 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 may be taken on the following days.
Maximal daily dose is 5 mg. Maximum duration of treatment is 4 days.
Timing of melatonin intake is important. The dose should be taken at bedtime (in the local time). The tablets should not be taken before 20:00 hr or after 04:00 hr.
Melatonin treatment should be titrated up to the lowest effective dose. Melatonin Orion can be used when the lowest effective dose has been established to be 3 or 5 mg taken 30–60 minutes before bedtime.
Treatment should be followed up regularly by a doctor (your doctor tells you how often) to see if it is still appropriate.
The tablet can be crushed before intake and mixed with cold water.
Food should not be consumed 2 hours before or 2 hours after intake of Melatonin Orion tablets.
If you or your child has accidentally taken too much medicine or if a child or adolescent has ingested the medicine by mistake, contact a doctor or hospital to assess the risks and to get additional instructions.
Taking more than the recommended daily dose may make you feel drowsy.
If you forget to take a dose 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 forgotten dose.
There are no known harmful effects if treatment is interrupted or ended. The use of Melatonin Orion is not known to cause any withdrawal effects after treatment completion.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 Melatonin Orion and contact a doctor immediately:
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1 000 people):
Not known (frequency cannot be estimated from the available data):
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):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1 000 people):
Not known (frequency cannot be estimated from the available data):
Side effects in children and adolescents
A low frequency of in general mild adverse reactions have been reported in children and adolescents. The most common side effects have been headache, hyperactivity, dizziness, and abdominal pain. No serious side effects have been observed.
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 via the Yellow Card Scheme at 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.
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 special temperature storage conditions.
Blister: Keep the blister in the outer carton in order to protect from light.
Bottle: Store in the original package in order to protect from light
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
3 mg: White to whitish coloured round biconvex tablets, with approximate size of 6.0 x 2.5 mm.
5 mg: White to whitish coloured round biconvex tablets, with approximate size of 7.0 x 3.2 mm. A scoreline on both sides. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Melatonin Orion 3 mg and 5 mg tablets are available in a carton containing PVC/PE/PVDC/AL blister packs of 10, 30, 50 and 60 tablets.
Melatonin Orion 3 mg and 5 mg tablets are available in HDPE bottles closed with HDPE closures.
Pack sizes:
3 mg: 100 tablets.
5 mg: 100 tablets.
Not all pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2026
DNO 090017ff82a18f24
9th Floor, The Blade, Abbey Square, Reading, RG1 3BE, UK
https://www.orionpharma.co.uk
+44 (0)1635 520 300
+44 (0)1635 520 300
orionukar&[email protected]
