Patient leaflet - Melatonin 3 mg capsules
1. What Melatonin Capsules are and what they are used for
Melatonin Capsules contain the active substance melatonin. Melatonin Capsules can be used for the 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 Melatonin Capsules work
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 jet-lag. The symptoms and their severity vary between individuals but are generally worse and last longer the more time zones are crossed. Melatonin Capsules 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 Melatonin Capsules
Do not take Melatonin Capsules:
- If you are allergic to melatonin or any of the other ingredients of this medicine (listed in Section 6: Further information)
Warnings and Precautions
Talk to your doctor or pharmacist before taking Melatonin Capsules:
- 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 Melatonin Capsules 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 Melatonin Capsules
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, zaleplon, zolpidem and zopiclone), as melatonin may enhance the sedative effect of such drugs, and may enhance certain side effects of zolpidem (morning sleepiness, nausea, confusion) • Warfarin (anticoagulants), as melatonin may influence the effect of the anticoagulant warfarin
Melatonin Capsules with food, drink 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
Melatonin Capsules are 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
Melatonin Capsules are not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the sucking child cannot be excluded.
Fertility
Melatonin Capsules are 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
Melatonin Capsules 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.
Melatonin 2 mg, 3 mg and 5 mg Capsules contain sodium
These medicines contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
3. How to take Melatonin Capsules
Always take this medicine as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults, including the elderly, is 3 mg daily for a maximum of 5 days. The dose may be increased to 5 mg or 6 mg (2 capsules of 3 mg taken simultaneously) when the effect of Melatonin Capsules is inadequate. A lower dose of 2 mg may be sufficient for some individuals.
The first dose should be taken on arrival at the destination at your usual bed-time. Intake on the following days should also be at your usual bed-time. The capsules should not be taken before 20:00 hr or after 04:00 hr.
The capsules 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 Melatonin Capsules.
Melatonin Capsules may be taken for a maximum of 16 treatment periods per year.
If you take more Melatonin Capsules than you should
If you have taken more Melatonin Capsules 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 Melatonin Capsules
If you forget to take a capsule 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 Melatonin Capsules
If you stop taking Melatonin Capsules, it will not have any harmful effects or withdrawal symptoms. If you have any further questions on the use of this product, ask your doctor or pharmacist.
PATIENT INFORMATION LEAFLET
Melatonin 2 mg, 3 mg & 5 mg Capsules
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 (may affect up to 1 in 100 people)
- Chest pain
Rare (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 the 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 1000 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 can also report side effects directly via 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 Capsules
This medicinal product does not require any special storage conditions. Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Melatonin Capsules contain:
Melatonin 2 mg Capsules
Each Melatonin 2 mg Capsules contains 2 mg of the active substance melatonin. The other ingredients are: Mannitol, Povidone, Sodium Starch Glycolate, Colloidal Anhydrous Silica, Magnesium Stearate.
The capsule shell of Melatonin 2 mg Capsules contains: Gelatin, Titanium Dioxide (E171) and Indigotine (E132).
Printing ink contains: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Ammonia solution concentrated, Black Iron Oxide, Potassium Hydroxide, Purified water.
Melatonin 3 mg Capsules
Each Melatonin 3 mg Capsules contains 3 mg of the active substance melatonin. The other ingredients are: Mannitol, Povidone, Sodium Starch Glycolate, Colloidal Anhydrous Silica, Magnesium Stearate.
The capsule shell of Melatonin 3 mg Capsules contains: Gelatin, Titanium Dioxide (E171).
Printing ink contains: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Ammonia solution concentrated, Black Iron Oxide, Potassium Hydroxide, Purified water.
Melatonin 5 mg Capsules
Each Melatonin 5 mg Capsules contains 5 mg of the active substance melatonin. The other ingredients are: Mannitol, Povidone, Sodium Starch Glycolate, Colloidal Anhydrous Silica, Magnesium Stearate.
The capsule shell of Melatonin 5 mg Capsules contains: Gelatin, Titanium Dioxide (E171) and Indigotine (E132).
Printing ink contains: Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Ammonia solution concentrated, Black Iron Oxide, Potassium Hydroxide, Purified water.
What Melatonin Capsules look like and contents of the pack: Melatonin 2 mg Capsules: are approximately 14 mm long, opaque hard gelatin capsules, with a white body and blue cap, printed Mel 2 on the body in black ink containing white to off white granular powder.
Melatonin 3 mg Capsules: are approximately 16 mm long, opaque hard gelatin capsules, with a white body and white cap printed Mel 3 on the body in black ink containing white to off white granular powder.
Melatonin 5 mg Capsules: are size approximately 19 mm long, opaque hard gelatin capsules, with a blue body and blue cap printed Mel 5 on the body in black ink containing white to off white granular powder.
They are packed in aluminium blisters. Each blister contains 10 capsules.
Pack sizes: 10, 14, 28, 30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Siinovia® (UK) Ltd, Unit 1b, 142 Johnson Street, London, UB2 5FD, UK
Manufacturers
Rx Farma Ltd, Unit 3, Colonial Way, Watford, Hertfordshire, WD24 4YR, UK
This leaflet was last revised in July 2026.
For information in large print, Braille or on CD, email info@siinovia.com