Patient leaflet - Melatonin 1 mg / ml oral solution

1. What Melatonin Oral Solution is and what it is used for

This medicine contains melatonin, which is a hormone produced naturally by the body. The hormone helps regulate the body’s day- and night rhythm.

This medicine can be used for:

Short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling across several time zones.
Insomnia in children and adolescents (6-17 years of age) with attention deficit hyperactivity disorder (ADHD) where healthy sleeping routines have not worked well enough.

2. What you need to know before you take Melatonin Oral Solution

Do not take Melatonin Oral Solution

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 using Melatonin Oral Solution

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 oral solution as components of tobacco smoke can increase the breakdown of melatonin by the liver.

Children under 6 years of age

Do not give this medicine to children below the age of 6 years as it has not been tested and its effects are unknown.

Melatonin Oral Solution 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

Pregnancy

This medicine 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 woman of childbearing potential you should use contraception.

Breast-feeding

This medicine is not recommended if you are breast-feeding. Melatonin is passed into human breast milk, and a risk to the breast-fed child cannot be excluded.

Fertility

Melatonin oral solution 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

This medicine 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 Oral Solution contains

Sodium methyl parahydroxybenzoate (E219): This medicine contains 1.4 mg sodium methyl parahydroxybenzoate per 1 ml, which nay cause allergic reactions (possibly delayed).
Sodium ethyl parahydroxybenzoate (E215): This medicine contains 0.7 mg sodium ethyl parahydroxybenzate per 1 ml, which may cause allergic reactions (possibly delayed).
Propylene glycol (E1520): This medicine contains 150 mg propylene glycol per 1 ml.
Ethanol: This medicine contains less than 0.3 micrograms/ml. This small amount of alcohol in this medicine will not have any noticeable effects.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially ‘sodium-free’.

3. How to take Melatonin Oral Solution

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults with jet lag

The recommended dose for adults and elderly is 2 mg (2 ml) daily for a maximum of 5 days. When the effect of Melatonin oral solution is inadequate, 5 mg (5 ml) can be taken.

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. The oral solution should not be taken before 20:00 hours or after 04:00 hours.

Food should not be consumed 2 hours before or 2 hours after intake of Melatonin oral solution.

Melatonin oral solution may be taken for a maximum of 16 treatment periods per year.

Insomnia in children and adolescents with ADHD

The recommended starting dose is 1-2 mg (1-2 ml) before bedtime.

If there is no improvement in your or your child’s symptoms, your doctor may increase the dose to find the most suitable dose for you or your child. The maximum daily dose that you or your child will receive is 5 mg.

Treatment should be followed up regularly by a doctor (at least every 6 months is recommended) to see if it is still appropriate. Treatment should be interrupted once a year to see if treatment is still needed.

Package leaflet: Information for the patient

Melatonin 1 mg/ml Oral Solution

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

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
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.

Instruction for use

A 5 ml graduated oral syringe and a “Press-In” Bottle Adapter (PIBA) are provided with the medicine.

1.
Push the plastic screw cap down while turning it
anti-clockwise.
2. Remove the unscrewed cap.
3.
Open the bottle and at first use, insert the adapter
firmly into the bottle neck.
4.
The plunger of the syringe should be at the bottom-
most position to remove any air.
5. Insert the syringe firmly into the adaptor.
6.
Turn the bottle upside down in order to fill the
syringe.
7.
While holding the syringe in place, pull the plunger
down gently and the medicine should be drawn to the correct mark on the syringe.
8.
Turn the bottle upright again, and remove the filled
syringe from the adaptor with gentle twisting.
9.
Place the syringe inside your mouth (against the
cheek) and press the plunger slowly to release the medicine.
10.
After use, the bottle cap must be replaced, leaving
the adaptor in place.
11.
The syringe should be rinsed and washed with cold
or warm water and dried completely before the next use.

If you take more Melatonin Oral Solution than you/they should

If you or your child have taken more Melatonin oral solution 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 Oral Solution

If you forget to take your dose at bedtime and wake during the night you may take the forgotten dose but at no later than 04:00 hours.

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

If you stop taking Melatonin Oral Solution

If you stop taking Melatonin oral solution, 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.

If you or your child experience any of the following serious side effects, stop taking the medicine and tell your doctor immediately.

Allergic reactions such as:
o sudden wheeziness or difficulty in breathing
o swelling of the eyelids, face, lips, tongue or throat
o rash or itching, especially affecting your whole body.

Other side effects

Common (may affect up to 1 in 10 people):

Headache
Sleepiness

Uncommon (may affect up to 1 in 100 people):

Irritability, nervousness, restlessness
Abnormal dreams, night sweats, anxiety, lack of energy and enthusiasm
Migraine
Dizziness
High blood pressure
Abdominal pain, mouth ulcers, dry mouth, nausea
Skin disorders (dermatitis, pruritus, rash, dry skin)
Pain in arms and legs
Menopausal symptoms
Chest pain
Excretion of glucose in the urine, excess protein in the urine
Abnormal liver function tests
Increased weight
Rare (may affect up to 1 in 1,000 people):
- Shingles (herpes zoster)
- Reduced number of white blood cells in the blood
- Reduced number of blood platelets
- High levels of blood fats
- Changes in mood, aggression, agitation, crying, stress symptoms, feeling confused (disorientation), increased sex drive (increased libido), depressed mood, depression
- Fainting, memory impairment, disturbance in attention, uncomfortable sensation in legs (restless legs syndrome), poor quality sleep, tiredness (fatigue)
- Visual impairment, blurred vision, increase tearing
- A feeling of dizziness or spinning (vertigo), dizziness when standing or sitting
- Faster heartbeats, angina pectoris
- Acid reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, increased salivation, bad breath, wind, abdominal discomfort, inflammation of the stomach lining
- Abnormal skin sensations (paresthesia), skin disorders (eczema, erythema, psoriasis), nail disorder, sudden feeling of heat (hot flush)
- Pain, arthritis, muscle spasms, neck pain, night cramps
- Passing large volumes of urine, presence of red blood cells in the urine, need to urinate at night
- Prolonged erection (priapism), swelling of the prostate (prostatitis)
- Thirst
- Increased liver enzymes, abnormal blood electrolytes, abnormal laboratory tests

Not known (frequency cannot be estimated from available data)

Spontaneous flow of milk from the chest
Hign blood sugar

Additional side effects in children and adolescents

A low frequency of generally mild side effects has been reported. The most common adverse effects were headache, hyperactivity, a feeling of dizziness or “spinning” (vertigo) and abdominal pain. No serious adverse 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 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 Oral Solution

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 bottle and carton after EXP. The expiry date refers to the last day of that month.

Store in the original container in order to protect from light. After first opening, use within 4 months.

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 to protect the environment.

6. Contents of the pack and other information

What Melatonin Oral Solution contains

The active substance is melatonin
The other ingredients are sodium methyl parahydroxybenzoate, sodium ethyl
parahydroxybenzoate, glycerol, propylene glycol, citric acid monohydrate, sodium citrate, sucralose, strawberry flavour (containing propylene glycol (E1520), lactic acid (E270), triacetin (E1518) and ethanol), and purified water

What Melatonin Oral Solution looks like and contents of the pack

This medicine is a clear, colourless/yellowish solution in an amber glass bottle sealed with a child-resistant and tamper evident cap. A 5 ml plastic dosing syringe and adaptor are also included in the carton.

Pack size: 150 ml.

Marketing Authorisation Holder

Aristo Pharma GmbH

Wallenroder Strasse 8-10

13435 Berlin

Germany

Manufacturer

Labomed Pharmaceutical Company S.A.

Metaxa Ioanni, 84.

Kropia, 19441

Greece

This leaflet was last revised in 07/2026.

GI1561000-03/UK/0726 XXXXXXXX/X

Customer Aristo Pharma GmbH

Product Name Melatonin 1 mg oral solution

Market United Kingdom (UK)

Language/s English

Manufacturer code: N/A

Our Ref Melatonin_1mg_oral_solution_PIL_UK_ver05 — (** to

follow final proof)

Issue 05

Date 22 July 2026

SPECIFICATION

DETAILS

Origination 14 May 2025 — (as Issue 01)

Dimensions 190 x 420 mm

Border 10 mm

Font details Main title: Frutiger LT Std - 75 Black - 18pt

Sub-titles: Frutiger LT Std - 75 Black — 11pt Body copy: Frutiger LT Std - 55 Roman — 9pt

Colours Black - K

Prescription needed?	Yes, prescription-only medicine (POM)
Active substance	Melatonin
Strength	1 mg / ml
Pharmaceutical form	Oral solution Clear, colourless/yellowish solution with characteristic strawberry odour.
How is it taken	Oral, Gastroenteral
Excipients	Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215), Glycerol (E422), Propylene glycol (E1520), Citric acid monohydrate, Sodium citrate, Sucralose, Strawberry flavour (containing propylene glycol (E1520), lactic acid (E270), triacetin (E1518) and ethanol), Purified water
Is it available?	Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life	30 months (unopened). After first opening, use within 4 months.
Storage	Store in the original container in order to protect from light.
Drug group (ATC)	Hypnotics and sedatives, melatonin receptor agonists N Nervous system drugs N05 Psycholeptics N05C Hypnotics and sedatives N05CH Melatonin receptor agonists, hypnotics and sedatives N05CH01 melatonin
Marketing authorisation	PL 40546/0258 (first authorised 12 August 2026)
Marketing authorisation holder	Aristo Pharma GmbH
Codes	BNF 04010100

Melatonin 1 mg / ml oral solution – patient leaflet, side effects, dosage