Patient leaflet - Melatonin Mylan 2 mg prolonged-release tablets

1. What Melatonin Mylan 2 mg prolonged-release tablets is and what it is used for

The active substance of Melatonin Mylan 2 mg prolonged-release tablets, melatonin, belongs to a natural group of hormones produced by the body.

Melatonin Mylan 2 mg prolonged-release tablets 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.

This product will be referred to as ‘this medicine’ in the remainder of the PIL.

2. What you need to know before

you take Melatonin Mylan 2 mg prolonged-release tablets Do not take Melatonin Mylan 2 mg prolonged-release 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 this medicine:

If you suffer from liver or kidney
problems. No studies on the use of this medicine in people with liver or kidney diseases have been performed, you should speak to your doctor before taking this medicine 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
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.
Other medicines and Melatonin Mylan 2 mg prolonged-release 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 Mylan 2 mg prolonged-release tablets with food, drink and alcohol

Take this medicine after you have eaten. Do not drink alcohol before, during or after taking this medicine because it reduces the effectiveness of this medicine.

Pregnancy and breast-feeding

Do not take this medicine 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

This medicine 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 Mylan 2 mg prolonged-release tablets contains lactose monohydrate. This medicine 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 Mylan

2 mg prolonged-release 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 tablet (2 mg) taken daily by mouth, after food, 1-2 hours before bedtime. This dosage may be continued for up to thirteen weeks.

system). No studies on the use of this medicine in people with auto-immune diseases have been performed; therefore, you should speak to your doctor before taking this medicine as its use is not recommended.

This medicine 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 this medicine less effective, because the components of tobacco smoke can increase the breakdown of melatonin by the liver.

You should swallow the tablet whole. This medicine should not be crushed or cut in half.

If you take more Melatonin Mylan 2 mg prolonged-release 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 Mylan 2 mg prolonged-release 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 Mylan 2 mg prolonged-release tablets

There are no known harmful effects if treatment is interrupted or ended early. The use of this medicine 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 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 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 Mylan 2 mg prolonged-release 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 carton (EXP). The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

6. Contents of the pack and other information

What Melatonin Mylan 2 mg prolonged-release 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, talc, silica, colloidal anhydrous, magnesium stearate

What Melatonin Mylan 2 mg prolonged-release tablets looks like and contents of the pack

This medicine is available as white to off-white, round, biconvex shaped tablets. Each carton 7, 20, 21 or 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan,

Potters Bar,

EN6 1TL,

UK.

Manufacturer

Viatris UK Healthcare Limited

Building 20,

Station Close,