Patient leaflet - Melatonin Milpharm 2 mg prolonged-release tablets
1. What Melatonin Milpharm tablets are and what they are used for
The active substance of Melatonin Milpharm tablets, melatonin, belongs to a natural group of hormones produced by the body.
Melatonin Milpharm tablets are 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.
2. What you need to know before you take Melatonin Milpharm tablets
Do not take Melatonin Milpharm tablets
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 Milpharm tablets.
If you suffer from liver or kidney problems.
No studies on the use of Melatonin Milpharm tablets in people with liver or kidney diseases have been performed, you should speak to your doctor before taking Melatonin Milpharm tablets 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 Milpharm tablets in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking Melatonin Milpharm tablets as its use is not recommended.
Melatonin Milpharm tablets 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 Milpharm
tablets 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 Milpharm tablets
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 Milpharm tablets with food, drink and alcohol
Take Melatonin Milpharm tablets after you have eaten. Do not drink alcohol before, during or after taking Melatonin Milpharm tablets, because it reduces the effectiveness of Melatonin Milpharm tablets.
Pregnancy and breast-feeding and fertility
Do not take Melatonin Milpharm tablets 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 Milpharm tablets 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 Milpharm tablets contains lactose monohydrate.
Melatonin Milpharm tablets contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Melatonin Milpharm tablets
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 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 Milpharm tablets should not be crushed or cut in half.
If you take more Melatonin Milpharm tablets 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 Milpharm tablets
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 Milpharm tablets
There are no known harmful effects if treatment is interrupted or ended early. The use of Melatonin Milpharm tablets are not known to cause any withdrawal effects after treatment completion.
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 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 or nurse. 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 Yelow 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 Milpharm tablets
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 label and carton after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
What Melatonin Milpharm tablets contains
- The active substance is melatonin. Each prolonged-release tablet contains 2 mg melatonin.
- The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer (Type-B), silica (colloidal anhydrous), talc and magnesium stearate.
What Melatonin Milpharm tablets looks like and contents of the pack
Melatonin Milpharm tablets are white to off-white, uncoated, round shaped biconvex tablets, plain on both sides. Melatonin Milpharm tablets are available in blister packs (i.e. white opaque PVC/PVdC – Aluminum blister).
Pack sizes:
Blister pack: 30 tablets
Marketing Authorisation Holder
Milpharm Limited
1 Roundwood Avenue
Stockley Park, Uxbridge
UB11 1AF
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
1 Roundwood Avenue
Stockley Park, Uxbridge
UB11 1AF
United Kingdom