Patient leaflet - Melatonin Neurim 2 mg prolonged-release tablets
1. What Melatonin Neurim is and what it is used for
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.
2. What you need to know before you take Melatonin Neurim
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.
3. How to take Melatonin Neurim
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.
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)
- 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
- Abnormal laboratory tests Rare: (may affect up to 1 in 1000 people)
Frequency not known: (cannot be established from the available data)
- Hypersensitivity reaction
- swelling of mouth or tongue
- swelling of the skin
- 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 Neurim
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.
6. Contents of the pack and other information
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:
Iberfar, Indústria Farmacêutica, S.A.
Estrada Consiglieri Pedroso, 123
Queluz de Baixo
Barcarena, 2734-501
Portugal
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Flynn Pharma Limited
Tel: +44 (0) 1438 727822
medinfo@flynnpharma.com
This leaflet was last revised in 07/2023. 01046082-V2
Package Leaflet: Information for the patient
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section
4.
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.
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.
- 1. What Melatonin Neurim is and what it is used for
- 2.
What you need to know before
you take Melatonin Neurim Melatonin Neurim 2 mg prolonged-release tablets
melatonin
130 mm
315 mm Página 1
All dimensions in millimeters Página 2
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
- 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
- How to take Melatonin Neurim
Possible side effects
130 mm
315 mm All dimensions in millimeters Página 3
- 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
- Abnormal laboratory tests
Frequency not known: (cannot be established from the available data)
- Hypersensitivity reaction
- Swelling of mouth or tongue
- Swelling of the skin
- 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.
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:
Rovi Pharma Industrial Services, S.A. Vía Complutense, 140
Alcalá de Henares
Madrid, 28805
Spain
This leaflet was last revised in 07/2023
Other sources of information
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Flynn Pharma Limited
Tel: +44 (0) 1438 727822
medinfo@flynnpharma.com
- 5.
How to store Melatonin Neurim
- 6. Contents of the pack and other information
130 mm
315 mm All dimensions in millimeters Página 4
130 mm
315 mm All dimensions in millimeters