The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: melatoninOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Melatonin 5mg Hard Capsules

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Melatonin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Melatonin

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Melatonin Hard Capsules contain the active substance melatonin. Melatonin Hard Capsules 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 Melatonin Hard 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 jetlag. The symptoms and their severity vary between individuals, but are generally worse and last longer the more time zones are crossed. Melatonin Hard 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 it

e Melatonin Hard Capsules

Do not take Melatonin Hard Capsules

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 Melatonin Hard 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 Hard 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 Hard 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, and zaleplon, zolpidem, 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 Hard 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 Hard 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 woman of childbearing potential you have to use contraception.

Breast-feeding Melatonin Hard 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 Hard 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 Hard 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 Hard Capsules and Melatonin 5 mg Hard 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 it

Melatonin Hard Capsules

Always take this medicine exactly 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 Hard Capsules is inadequate. A lower dose of 2 mg may be sufficient for some individuals. 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 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 Hard Capsules. Melatonin Hard Capsules may be taken for a maximum of 16 treatment periods per year. If you take more Melatonin Hard Capsules than you should If you have taken more Melatonin Hard 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 Hard 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 Hard Capsules If you stop taking Melatonin Hard 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. 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 1000 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 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 it

Melatonin Hard Capsules

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 carton and label after EXP. The expiry date refers to the last day of that month. Store below 25oC. Keep in the outer carton 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. 6.

Contents of the pack and other information

What Melatonin Hard Capsules contain Melatonin 2 mg Hard Capsules –

Each capsule of Melatonin 2 mg Hard Capsules contains 2 mg of the active substance melatonin. The other ingredients are: Cellulose, Microcrystalline, Povidone K30, Maltodextrin and Magnesium Stearate. The capsule shell of Melatonin 2 mg Hard Capsules contains: Gelatin, Titanium Dioxide (E171) and indigotine – FD&C blue 2 (including sodium) (E132).

Melatonin 3 mg Hard Capsules

Each capsule of Melatonin 3 mg Hard Capsules contains 3 mg of the active substance melatonin.
The other ingredients are: Cellulose, Microcrystalline, Povidone K30, Maltodextrin and Magnesium Stearate.
The capsule shell of Melatonin 3 mg Hard Capsules contains: Gelatin and Titanium Dioxide (E171). Melatonin 5 mg Hard Capsules

Each capsule of Melatonin 5 mg Hard Capsules contains 5 mg of the active substance melatonin.
The other ingredients are: Cellulose, Microcrystalline, Povidone K30, Maltodextrin and Magnesium Stearate.
The capsule shell of Melatonin 5 mg Hard Capsules contains: Gelatin, Titanium Dioxide (E171) and indigotine – FD&C blue 2 (including sodium) (E132). What Melatonin Hard Capsules look like and contents of the pack Melatonin 2 mg Hard Capsules: are size 3, opaque hard gelatin capsules, with a white body and light blue cap. Melatonin 3 mg Hard Capsules: are size3, opaque hard gelatin capsules, with a white body and white cap. Melatonin 5 mg Hard Capsules: are size 1, opaque hard gelatin capsules, with a light blue body and light blue cap. They are packed in PVC/PVDC/aluminium blisters. Each blister contains 7 or 10 capsules. Pack sizes: 10, 14, 28, 30 hard capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder Colonis Pharma Ltd 25 Bedford Square, Bloomsbury, London, WC1B 3HH, United Kingdom Manufacturer RAFARM SA Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki, 19002, PO Box 37, Greece This leaflet was last revised in August 2021.

For information in large print, Braille or on CD, telephone 01892 739403.

Frequently asked questions about Melatonin 5mg Hard Capsules

How do I take Melatonin 5mg Hard Capsules?

Melatonin 5mg Hard Capsules comes as capsule containing 5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Melatonin 5mg Hard Capsules?

The active substance in Melatonin 5mg Hard Capsules is melatonin.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Melatonin 5mg Hard Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Melatonin 5mg Hard Capsules without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: melatonin
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Melatonin (39 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Melatonin Hard Capsules are indicated for short-term treatment of jet-lag in adults.

4.2. Posology and method of administration

Posology

The standard dose is 3 mg daily for a maximum of 5 days. The dose may be increased to 5 mg or 6 mg if the standard dose does not adequately alleviate symptoms. The dose that adequately alleviates symptoms should be taken for the shortest period. A lower dose of 2mg may be sufficient for some individuals.

The first dose should be taken on arrival at destination at the habitual bed-time.

Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on re-synchronisation following jet-lag, Melatonin Hard Capsules should not be taken before 20:00 hr or after 04:00 hr at destination.

Food can enhance the increase in plasma melatonin concentration (see Section 5.2). Intake of melatonin with carbohydrate-rich meals may impair blood glucose control for several hours (see Section 4.4). It is recommended that food is not consumed 2 h before and 2 h after intake of Melatonin Hard Capsules.

Melatonin Hard Capsules may be taken for a maximum of 16 treatment periods per year.

Elderly

As the pharmacokinetics of melatonin (immediate release) is comparable in young adults and elderly persons in general, no specific dosage recommendations for elderly persons are provided (see Section 5.2).

Renal impairment

There is only limited experience regarding the use of Melatonin Hard Capsules in patients with renal impairment. Caution should be exercised if melatonin is used by patients with renal impairment. Melatonin Hard Capsules are not recommended for patients with severe renal impairment (see Section 5.2).

Hepatic impairment

There is no experience regarding the use of Melatonin Hard Capsules in patients with hepatic impairment. Limited data indicate that plasma clearance of melatonin is significantly reduced in patients with liver cirrhosis. Melatonin Hard Capsules are not recommended in patients with moderate or severe hepatic impairment (see Section 5.2).

Paediatric population

The safety and efficacy of Melatonin Hard Capsules in children and adolescents aged 0 – 18 years have not been established. Melatonin Hard Capsules should not be used in children and adolescents due to safety and efficacy concerns (see Sections 4.4 and 5.1).

Method of administration

For oral use. Capsules should be swallowed whole with fluid.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Melatonin may cause drowsiness. Therefore, the product should be used with caution, if the effects of drowsiness are likely to be associated with a risk to patient safety.

Melatonin may increase seizure frequency in patients experiencing seizures (e.g. epileptic patients). Patients suffering from seizures must be informed about this possibility before using Melatonin Hard Capsules. Melatonin may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects.

Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin. There are no data regarding use of Melatonin Hard Capsules in patients with autoimmune diseases. Melatonin Hard Capsules are not recommended in patients with autoimmune diseases.

Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours. Melatonin Hard Capsules should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after meal by persons with significantly impaired glucose tolerance or diabetes.

Only limited data are available on the safety and efficiency of melatonin in patients with renal impairment or hepatic impairment. Melatonin Hard Capsules are not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.

Paediatric population

Melatonin 2 mg Hard Capsules and Melatonin 5 mg Hard Capsules contain sodium.

These medicines contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.

4.5. Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults.

Pharmacokinetic interactions

• Melatonin is metabolised mainly by the hepatic cytochrome P450 CYP1A enzymes, primarily CYP1A2. Therefore, interactions between melatonin and other active substances as a consequence of their effect on CYP1A enzymes are possible.

• Caution is indicated in patients treated with fluvoxamine, since this agent increases melatonin levels (17-fold higher AUC and 12-fold higher serum Cmax) by inhibiting its metabolism via CYP1A2 and CYP2C19. This combination should be avoided.

• Caution is indicated in patients taking 5- or 8-methoxypsoralen (5 or 8- MOP), since this agent increases melatonin levels by inhibiting its metabolism.

• Caution is indicated in patients taking cimetidine, since this agent increases plasma melatonin levels by inhibiting its metabolism by CYP2D.

• Caution should be exercised in patients receiving estrogen therapy (e.g. in the form of contraceptives or hormone replacement therapy), since estrogens increase melatonin level by inhibiting its metabolism, primarily via inhibition of CYP1A2.

• CYP1A2 inhibitors (such as quinolones) may increase systemic melatonin levels.

• CYP1A2 inducers (such as carbamazepine and rifampicin) may reduce plasma concentrations of melatonin.

• Cigarette smoking may decrease melatonin levels due to induction of CYP1A2.

Pharmacodynamic interactions

• Melatonin may enhance the sedative effect of benzodiazepines (e.g. midazolam, temazepam) and non-benzodiazepine hypnotics (e.g. zaleplon, zolpidem, zopiclone). In a study of jet-lag therapy the combination of melatonin and zolpidem resulted in a higher incidence of morning sleepiness, nausea, and confusion, and reduced activity during the first hour after getting up, compared to zolpidem alone.

• Melatonin may affect the anticoagulation activity of warfarin.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data for the use of melatonin in pregnant women.

Exogenous melatonin readily crosses the human placenta.

Animal studies are insufficient with respect to reproductive toxicity (see Section 5.3).

Melatonin Hard Capsules are not recommended during pregnancy or in women of childbearing potential not using contraception.

Breast-feeding

There is insufficient data on the excretion of melatonin / metabolites in human milk. Endogenous melatonin is secreted in human milk.

Available pharmacodynamic / toxicological data in animals have shown excretion of melatonin / metabolites milk (see Section 5.3).

A risk to the suckling child cannot be excluded.

Melatonin Hard Capsules should not be used during breast-feeding.

Fertility

High doses of melatonin and use for longer periods than indicated may compromise fertility in humans.

Animal studies are insufficient with respect to effects on fertility (see Section 5.3).

Melatonin Hard Capsules are not recommended in women and men planning pregnancy.

4.7. Effects on ability to drive and use machines

Melatonin has a moderate influence on the ability to drive and use machines. Melatonin may cause drowsiness and may decrease alertness for several hours, therefore use of Melatonin Hard Capsules is not recommended prior to driving and using machines.

4.8. Undesirable effects

Summary of the safety profile

Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently report adverse effects when melatonin is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are also the adverse effects reported most frequently when typical clinical doses of melatonin have been taken for periods of several days to several weeks by healthy persons and patients.

Tabulated list adverse reactions

The following adverse reactions to melatonin in general have been reported in clinical trials or spontaneous case reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class

Very Common

(≥ 1/10)

Common

(≥1/100 to <1/10)

Uncommon

(≥1/1,000 to <1/100)

Rare

(≥1/10,000 to <1/1,000)

Not known: (cannot be established from the available data)

Blood and lymphatic system disorders

leucopenia, thrombocytopenia

Immune system disorders

hypersensitivity reaction

Metabolism and nutrition disorders

hypertriglyceridaemia

hyperglycaemia

Psychiatric disorders

irritability, nervousness, restlessness, abnormal dreams, anxiety

mood altered, aggressive behaviour, disorientation, libido increased

Nervous system disorders

headache, somnolence

dizziness

syncope (fainting), memory impairment, restless legs syndrome, paraesthesia

Eye disorders

visual acuity reduced, vision blurred, lacrimation increased

Cardiac disorders

palpitations

Vascular disorders

hypertension

hot flushes

Gastrointestinal disorders

abdominal pain, upper abdominal pain, dyspepsia, oral ulcers, dry mouth, nausea

vomiting, flatulence, salivary hypersecretion, halitosis, gastritis

Skin and subcutaneous tissue disorders

pruritus, rash, dry skin

nail disorder

tongue edema, edema of the oral mucosa

Musculoskeletal and connective tissue disorders

arthritis, muscle spasms

Renal and urinary disorders

glycosuria, proteinuria

polyuria, haematuria

Reproductive system and breast disorders

priapism, prostatitis

galactorrhoea

General disorders and administration site conditions

chest pain, malaise

thirst

Laboratory and other examinations

weight increased

blood electrolytes abnormal

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Drowsiness, headache, dizziness, and nausea are the most commonly reported signs and symptoms of overdose with oral melatonin.

Ingestion of daily doses of up to 300 mg of melatonin did not cause clinically significant adverse reactions.

Flushes, abdominal cramps, diarrhoea, headache, and scotoma lucidum have been reported after ingestion of extremely high melatonin doses (3000 – 6600 mg) for several weeks.

General supportive measures should be employed. Gastric lavage and administration of activated charcoal can be considered.

Clearance of the active substance is expected within 12 hours of ingestion.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

CIRCADIN 2mg prescriptionMELATONINUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

Melatonina LEK-AMMelatoninum · taken by mouth
CircadinMelatoninum · taken by mouth
MelabiorytmMelatoninum · taken by mouth
SentalMelatoninum · taken by mouth
Melatonina PolfarmexMelatoninum · taken by mouth
SlenytoMelatoninum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Melatonin 5mg Hard Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

Medicines containing Melatonin

📋 Official guidance mentioning this medicine

→ Melatonin for treating sleep disorders in adults who are blind (NICE · 2021)

Pharmacy Guide