Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - melatonin

Document Subject

Generated Narrative: MedicinalProductDefinition mpa1ae178fa1feba2157e2ad80fb8616d6

identifier: http://ema.europa.eu/identifier/EU/1/22/1694/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Melatonin Neurim 2 mg prolonged-release tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-a1ae178fa1feba2157e2ad80fb8616d6

identifier: http://ema.europa.eu/identifier/EU/1/22/1694/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - melatonin

Attesters

What is in this leaflet:

1. What Melatonin Neurim is and what it is used for
2. What you need to know before you take Melatonin Neurim
3. How to take Melatonin Neurim
4. Possible side effects
5. How to store Melatonin Neurim
6. Contents of the pack and other information

The active substance of Melatonin Neurim, melatonin, belongs to a natural group of hormones produced by the body.

Melatonin Neurim 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.

Do not take Melatonin Neurim

• 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 Neurim.

• If you suffer from liver or kidney problems. No studies on the use of Melatonin Neurim in people with liver or kidney diseases have been performed, you should speak to your doctor before taking Melatonin Neurim 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 Neurim in people with auto- immune diseases have been performed; therefore, you should speak to your doctor before taking Melatonin Neurim as its use is not recommended.
• Melatonin Neurim 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 Neurim 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 Neurim 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 Neurim with food, drink and alcohol Take Melatonin Neurim after you have eaten. Do not drink alcohol before, during or after taking Melatonin Neurim, because it reduces the effectiveness of Melatonin Neurim.

Pregnancy and breast-feeding Do not take Melatonin Neurim 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 Neurim 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 Neurim contains lactose monohydrate. Melatonin Neurim 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.

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 Neurim 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 Neurim tablets should not be crushed or cut in half.

If you take more Melatonin Neurim 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 Neurim 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 Neurim There are no known harmful effects if treatment is interrupted or ended early. The use of Melatonin Neurim 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.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

Do not store above 25 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 to protect the environment.

What Melatonin Neurim 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 Neurim looks like and contents of the pack Melatonin Neurim 2 mg prolonged-release tablets are available as white to off-white round bi-convex shaped tablets. Each carton of tablets contains one blister strip of 7, 20 or 21 tablets, or alternatively in a carton containing two blister strips of 15 tablets each (30 tablet pack). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux 75002 Paris France e-mail: regulatory@neurim.com

Manufacturer:

Sites responsible for Batch Release in the EEA:-
Iberfar Ind stria Farmac utica S.A. Estrada Consiglieri Pedroso Queluz De Baixo Barcarena 2734-Portugal

Rovi Pharma Industrial Services, S.A. V a Complutense, Alcal de Henares Madrid, 28Spain

This leaflet was last revised in {month/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: