Patient leaflet - Melatonin Medreich 2 mg prolonged-release tablets
1. What Melatonin Medreich is and what it is used for
The active substance of Melatonin Medreich is melatonin and it belongs to a natural group of
hormones produced by the body.
Melatonin Medreich 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.
2. What you need to know before you take Melatonin Medreich
Do not take Melatonin Medreich
- 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 Medreich:
If you have liver problems. No studies on the use of melatonin in people with liver diseases have
been performed, you should speak to your doctor before taking Melatonin Medreich as its use is
not recommended.
- If you have kidney problems, you should speak to your doctor before taking Melatonin Medreich.
- If you have an intolerance to some sugars.
If you have an autoimmune disease (where the body is ‘attacked’ by its own immune system). No
studies on the use of melatonin in people with auto-immune diseases have been performed;
therefore, you should speak to your doctor before taking Melatonin Medreich as its use is not
recommended.
Melatonin 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 Medreich 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 Medreich
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 (used in the treatment of bacterial infections)
- rifampicin (used to treat tuberculosis)
- oestrogens (used in contraceptives or hormone replacement therapy, see “Pregnancy and breast-feeding”)
- 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 medicines 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)
- imipramine (for the treatment of depression).
Melatonin Medreich with food, drink and alcohol
Take Melatonin Medreich after you have eaten. Do not drink alcohol before, during or after taking
Melatonin Medreich, because it reduces the effectiveness of the medicine.
Pregnancy and breast-feeding
Do not take Melatonin Medreich if you are pregnant, think you may be pregnant, trying to become pregnant or breast-feeding. Ask your doctor for advice before using this medicine.
Pregnancy
Melatonin Medreich is not recommended if you are pregnant or if you are planning to have a baby.
Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child.
Breast-feeding
Melatonin Medreich 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.
Driving and using machines
Melatonin Medreich 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 Medreich 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 medicine.
3. How to take Melatonin Medreich
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 Medreich tablet (2 mg) taken daily by mouth, after food,
1-2 hours before bedtime. This dosage may be continued for up to thirteen weeks.
Oral use. Tablets should be swallowed whole to maintain its prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.
If you take more Melatonin Medreich 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.
Package leaflet: Information for the user Melatonin Medreich 2 mg prolonged-release tablets
melatonin
P2P150734 If you forget to take Melatonin Medreich
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 Medreich
There are no known harmful effects if treatment is interrupted or ended early. The use of melatonin
is 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 other 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, sleepiness
- 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 (angioedema)
- 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 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 Medreich
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 (EXP). The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Medreich contains
- The active substance is melatonin. Each prolonged-release tablet contains 2 mg melatonin.
- The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate (E 341), ammonio methacrylate copolymer type B, talc (E 553b), colloidal anhydrous silica (E 551) and magnesium stearate (E 407b).
What Melatonin Medreich looks like and contents of the pack
The prolonged-release tablets are white to off-white, round, biconvex shaped with a diameter of 8 mm. The tablets are uncoated and plain on both sides.
The tablets are packed in PVC/PE/PVDC-Aluminium blister packs.
Pack size: 30 tablets
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 04/2024
To request a copy of this leaflet in Braille, or large print please call, 02088311580 (UK only)
Please be ready to give the following information:
Product name License Number Melatonin Medreich 2 mg PL 21880/0354 prolonged-release tablets
P2P150734