Patient leaflet - Melatonin Teva XL 2 mg prolonged release tablets
What Melatonin Teva XL is and what it is used for
The active substance of Melatonin Teva XL, melatonin, belongs to a natural group of hormones produced by the body.
Melatonin Teva XL is used on its own for the short-term treatment of primary insomnia (persistent difficulty in getting to sleep or staying asleep, or poor quality of sleep) in patients aged 55 years and older. ‘Primary’ means that the insomnia does not have any identified cause, including any medical, mental or environmental cause.
What you need to know before you take Melatonin Teva XL
Do not take Melatonin Teva XL:
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 Teva XL:
if you suffer from liver or kidney
problems. No studies on the use of Melatonin Teva XL in people with liver or kidney diseases have been performed, you should speak to your doctor before taking Melatonin Teva XL as its use is not recommended.
if you have been told by your
doctor that you have an
intolerance to some sugars
if you have been told you suffer
from an autoimmune disease (where the body is ‘attacked’ by its own immune system). No studies on the use of Melatonin Teva XL in people with
auto-immune diseases have been performed; therefore, you should speak to your doctor before taking Melatonin Teva XL as its use is not recommended.
Melatonin Teva XL can make you
feel drowsy, you should be careful if the drowsiness affects you as it may impair your ability on tasks such as driving.
smoking may make Melatonin
Teva XL less effective, because the components of tobacco smoke can increase the
breakdown of melatonin by the liver.
Children and adolescents
Do not give this medicine to children between the ages of 0 to 18 years as it has not been tested and its effects are unknown. Another medicine containing melatonin may be more appropriate for administration to children between the ages of 2 to 18 - please ask your doctor or pharmacist for advice.
Other medicines and Melatonin Teva XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
These medicines include:
fluvoxamine (used for the
treatment of depression and obsessive compulsive disorder), psoralens (used in the treatment of skin disorders e.g. psoriasis), cimetidine (used in the treatment of stomach problems such as ulcers), quinolones and
rifampicin (used in the treatment of bacterial infections),
oestrogens (used in
contraceptives or hormone replacement therapy) and carbamazepine (used in the treatment of epilepsy).
adrenergic agonists/antagonists
(such as certain types of medicines used to control blood pressure by constricting blood vessels, nasal decongestants, blood pressure lowering medicines), opiate
agonists/antagonists (such as medicinal products used in the treatment of drug addiction), prostaglandin inhibitors (such as nonsteroidal anti-inflammatory medicines), antidepressant medication, tryptophan and alcohol.
benzodiazepines and
non-benzodiazepine hypnotics (medicines used to induce sleep such as zaleplon, zolpidem and zopiclone)
- thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
Melatonin Teva XL with food, drink and alcohol
Take Melatonin Teva XL after you have eaten. Do not drink alcohol before, during or after taking Melatonin Teva XL, because it reduces the effectiveness of Melatonin Teva XL.
Pregnancy and breast-feeding
Do not take Melatonin Teva XL if you are pregnant; think you may be pregnant, trying to become pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Melatonin Teva XL may cause drowsiness. If you are affected, you should not drive or operate
machinery. If you suffer from continued drowsiness, then you should consult your doctor.
Melatonin Teva XL contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Melatonin Teva XL
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 is one Melatonin Teva XL tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime. This dosage may be continued for up to thirteen weeks. You should swallow the tablet whole. Melatonin Teva XL tablets should not be crushed or cut in half.
If you take more Melatonin Teva XL than you should
If you have accidentally taken too much of your medicine, contact your doctor or pharmacist as soon as possible.
Taking more than the recommended daily dose may make you feel drowsy.
If you forget to take Melatonin Teva XL
If you forget to take your tablet, take another as soon as you remember, before going to sleep, or wait until it is time to take your next dose, then go on as before.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Melatonin Teva XL
There are no known harmful effects if treatment is interrupted or ended early. The use of Melatonin Teva XL is not known to cause any withdrawal effects after treatment completion. What is in this leaflet
Package leaflet:
Information for the patient
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
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 the medicine and contact your doctor immediately:
Uncommon: may affect up to 1 in 100 people
- chest pain.
Rare: may affect up to 1 in 1000 people
- loss of consciousness or fainting
- severe chest pain due to angina
- feeling your heartbeat
- depression
- visual impairment
- blurred vision
- disorientation
vertigo (a feeling of dizziness or
“spinning”)
presence of red blood cells in the
urine
reduced number of white blood
cells in the blood
reduced blood platelets, which
increases risk of bleeding or bruising
- psoriasis.
If you experience any of the following non-serious side effects contact your doctor and/or seek medical advice:
Uncommon: may affect up to 1 in 100 people
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, tiredness, high blood pressure, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in the composition of your blood which could cause yellowing of the skin or eyes, inflammation of the skin, night sweats, itching, rash, dry skin, pain in extremities, menopausal symptoms, feeling of weakness, excretion of glucose in the urine, excess proteins in the urine, abnormal liver function and weight increase.
Rare: may affect up to 1 in 1000 people
Shingles, high level of fatty
molecules in the blood, low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, early morning awakening, increased sex drive, depressed mood, memory
impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling, watery eyes, dizziness when standing or sitting, hot flushes, acid reflux, stomach disorder, blistering in the mouth, tongue ulceration, stomach upset, vomiting, abnormal bowel sounds, wind, excess saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms, neck pain, night cramps, prolonged erection that might be painful, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes of urine, urinating during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.
Frequency not known: cannot be established from the available data
Hypersensitivity reaction, swelling of mouth or tongue, swelling of the skin and abnormal milk secretion.
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 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.
How to store Melatonin Teva XL
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 after EXP. The expiry date refers to the last day of that month.
Blisters
Do not store above 25°C. Store in the original package in order to protect from light.
Container
Do not store above 30°C. 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.
Contents of the pack and other information
What Melatonin Teva XL contains
The active substance is melatonin. Each
prolonged-release tablet contains 2 mg melatonin.
- The other ingredients are ammonio methacrylate copolymer type B, calcium hydrogen phosphate dihydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
What Melatonin Teva XL looks like and contents of the pack
Melatonin Teva XL Prolonged-release Tablets are white to off-white, oval tablets with ‘A6’ debossed on one side.
Blister packs (PVC/PVDC/Al)
Melatonin Teva XL is available in blisters of 20, 21, 30, 60 or 90 prolonged-release tablets.
Blister packs
(PVC/PE/PVDC/PE/PVC/Al)
Melatonin Teva XL is available in blisters of 20, 21, 30 or 90 prolonged-release tablets.
HDPE container
Melatonin Teva XL is available in a tablet container containing 100 prolonged release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitza, 2600, Bulgaria
This leaflet was last revised in August 2025.
PL 00289/2202
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