Melatonin 2 mg Hard Capsules Melatonin 3 mg Hard Capsules – patient leaflet, side effects, dosage

1. What Melatonin is and what it is used for

Melatonin Hard Capsules contain the active substance melatonin. Melatonin can be used for treatment of jet lag in adults. Jet lag can be recognised by sleep disturbances, daytime tiredness, fatigue, mild mental impairment, irritability and digestive system disturbances experienced after flying.

How Melatonin works

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 can help restore the normal day-and-night rhythm and reduce the symptoms.

! 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, 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 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 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 have to use contraception.

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

Do not take Melatonin:

! if you are allergic to melatonin or any of the other

ingredients of this medicine (listed in section 6).

Breast-feeding

Melatonin is not recommended if you are breast-feeding. Melatonin is excreted in human milk, and a risk to the suckling child cannot be excluded.

Fertility

Melatonin 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Melatonin: ! 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 as components of tobacco smoke can increase the breakdown of melatonin by the liver.

Driving and using machines

Melatonin 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 contain azorubine Melatonin 2 mg Hard Capsules contain azorubine which may cause allergic reactions.

Melatonin 3 mg Hard Capsules contain ponceau 4R

Melatonin 3 mg Hard Capsules contain ponceau 4R which may cause allergic reactions.

3. How to take Melatonin

Children and adolescents

Do not give this medicine to children and adolescents between 0 and 18 years as its safety and efficacy are unknown.

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

Other medicines and Melatonin

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

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 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 bedtime. Intake on the following days should also be at your usual bedtime. The capsules should not be taken before 20:00 hr or after 04:00 hr.

160 mm

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.

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

If you take more Melatonin than you should

If you have taken more Melatonin 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

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 forgotten dose.

If you stop taking Melatonin

If you stop taking Melatonin, 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.

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 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 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 1,000 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

ENV01 ! 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 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

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 30°C.

Store in the original package 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 contains

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, colloidal anhydrous silica, magnesium stearate. ! The capsule shell of Melatonin 2 mg Hard Capsules contains: brilliant blue, yellow iron oxide, azorubine, black iron oxide, titanium dioxide (E171), polyethylene glycol 4000, water, gelatin. ! The printing ink contains Shellac (E904), Potassium

Hydroxide, Black Iron Oxide (E172).

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, colloidal anhydrous silica, magnesium stearate. ! The capsule shell of Melatonin 3 mg Hard Capsules contains: brilliant blue, yellow iron oxide, ponceau 4R, black iron oxide, titanium dioxide (E171), polyethylene glycol 4000, water, gelatin. ! The printing ink contains Shellac (E904), Potassium

Hydroxide, Black Iron Oxide (E172).

What Melatonin looks like and contents of the pack

Melatonin 2 mg Hard Capsules: Light green/grey hard gelatine size 4 capsule with “2” printed on the capsule's cap.

Melatonin 3 mg Hard Capsules: Dark green/grey hard gelatine size 4 capsule with "3" printed on the capsule's cap.

They are packed in PVC/PE/PVDC blister packs. Each blister pack contains 7,10 or 14 capsules.

Pack size: 10, 14, 28, 30 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

Fine Foods & Pharmaceuticals NTM S.p.A Via Grignano, 43 - 24041 Brembate (Bergamo) Italy

This leaflet was last revised in July 2024.