General Information
What is Vigisom prolonged release 2mg used for?
Vigisom prolonged release tablets 2mg are used to improve sleep quality and morning alertness in patients over 55 years of age with poor quality of sleep. The active substance of Vigisom prolonged release tablets 2mg is melatonin (not of plant or animal origin), which belongs to a group of naturally occurring hormones produced in the body. Melatonin works by controlling the circadian rhythms and increasing the propensity to sleep.
How does Vigisom prolonged release 2mg work?
The active substance of Vigisom prolonged release tablets 2mg is melatonin (not of plant or animal origin), which belongs to a group of naturally occurring hormones produced in the body. Melatonin works by controlling the circadian rhythms and increasing the propensity to sleep.
What does Vigisom prolonged release 2mg contain?
The active ingredient that each Vigisom prolonged release tablet 2mg contains is 2 mg melatonin
Inactive ingredients include: • Ammonio methacrylate copolymer type B, • calcium hydrogen phosphate, • lactose monohydrate, • colloidal anhydrous silica, • purified talc • magnesium stearate
What are the side effects of Vigisom prolonged release 2mg
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Vigisom prolonged release tablet 2mg.
Vigisom prolonged release tablet 2mg has been shown to improve the sleep of most people aged over 55 years, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you. These are considered to be uncommon side effects (i.e., likely to occur in fewer than 1 in 100 patients): Irritability, nervousness, restlessness insomnia, abnormal dreams, anxiety, nightmares, migraine, lethargy, psychomotor hyperactivity (restlessness associated with increased activity), dizziness, somnolence (tiredness), headache, high blood pressure, (upper) abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, hyperbilirubinaemia (changes in the composition of your blood which could cause yellowing of the skin or eyes (jaundice), inflammation of the skin (dermatitis), night sweats, pruritis (itching), rash, dry skin, pain in extremities, menopausal symptoms, asthenia (feeling of weakness), chest pain, excretion of glucose in urine, excess proteins in the urine, abnormal liver function and weight increase.
The following events are considered to be rare (i.e., likely to occur in fewer than 1 in 1,000 patients): Shingles, reduced number of white blood cells in the blood, decreased number of platelets in the blood, high level of fatty molecules in the blood, severe chest pain due to angina, feeling your heartbeat (palpitations). low serum calcium levels in the blood, low sodium levels in the blood, altered mood, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, increased sex drive, depressed mood, depression, loss of consciousness or fainting, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, ‘pins and needles’ feeling (paresthesia) reduced visual acuity (visual impairment), blurred vision, watery eyes, dizziness when standing or sitting, vertigo, hot flushes, gastro- oesophageal reflux, gastrointestinal disorder, blistering in the mouth, tongue ulceration, gastrointestinal upset, vomiting, abnormal bowel sounds, flatulence (wind), salivary hypersecretion (excess saliva production), halitosis (bad breath), abdominal discomfort, gastric disorder, inflammation of the stomach lining, eczema, erythema (skin rash), hand dermatitis, psoriasis, pruritic rash (itchy rash), nail disorder, arthritis, muscle spasms, neck pain, night cramps, increased duration of erection, inflammation of the prostate gland, tiredness, pain, thirst, passing large volumes or urine, presence of red blood cells in the urine, urination during the night, increased liver enzymes, abnormal blood electrolytes and abnormal laboratory tests.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them
When should Vigisom prolonged release 2mg not be used?
Do not take Vigisom prolonged release tablets 2mg if you are allergic to it or any of the ingredients in this formulation. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin.
Do not take Vigisom prolonged release tablets 2mg if you have been drinking alcohol or intend to drink alcohol or believe that you may have alcohol, in your blood stream.
Do not take Vigisom prolonged release tablets 2mg if you are pregnant or breast-feeding. Vigisom prolonged release tablets 2mg has not been studied in pregnant or breast-feeding women.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may affect the way other medicines work. Some medicines and Vigisom prolonged release tablets 2mg may interfere with each other.
These include: • hypnotics and tranquilisers (e.g. benzodiazepine), • fluvoxamine, thioridazine and imipramine (used to treat depression or psychiatric problems), • oestrogen (contraceptives or hormone replacement therapy), • cimetidine and psoralens (used to treat skin problems e.g. psoriasis) • alcohol • caffeine The effect of adding Vigisom prolonged release tablets 2mg to other medicines used to treat insomnia has not been examined. It is not known if Vigisom prolonged release tablets 2mg will increase or decrease the effects of other treatments for insomnia. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Vigisom prolonged release tablets 2mg
How should Vigisom prolonged release 2mg be taken?
Swallow your tablet whole with a full glass of water. Do not crush, chew or divide your tablet. Take one tablet after food, 1-2 hours before you go to bed for up to 13 weeks, or as directed by your Health Professional.
Missed dose of Vigisom prolonged release 2mg
If you forget to take your tablet, take another as soon as you remember, before going to bed or wait until it is time for your next dose. Do not take a double dose to make up for a forgotten dose. If you are not sure what to do, talk to your Doctor or Pharmacist.
How should Vigisom prolonged release 2mg be stored?
Keep the medicine in a cool dry place where the temperature stays below 25°C