Melatonin Orifarm 2 mg Film Coated Tablets
What Is Melatonin Orifarm And What Melatonin Orifarm Used For?
Melatonin Orifarm contains the active substance melatonin. Melatonin Orifarm can be used for short-term treatment of jet lag in adults. Jet lag is characterized by sleep disorders, daytime fatigue, mild cognitive symptoms, irritability, and gastrointestinal disorders after air travel.
How Melatonin Orifarm works?
Melatonin is a hormone produced by the body and synchronizes the body’s circadian rhythm or biological clock. The circadian rhythm can be disturbed when traveling over several time zones.
This is called jet lag. The symptoms and their severity vary between different people, but they are generally worse and last longer the more time zones are passed. Melatonin Orifarm can help restore the normal circadian rhythm and relieve symptoms.
Melatonin in Orifarm may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or healthcare professional for further questions, and always follow their instructions.
What You Need To Know Before Using Melatonin Orifarm?
Do Not Take Melatonin Orifarm:
- If you are allergic to melatonin or any other ingredients of Melatonin Orifarm (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Melatonin Orifarm.
- If you have epilepsy, Melatonin may increase the frequency of seizures in patients with epilepsy .
- If you have an autoimmune disease (where the body is “attacked” by its immune system).
- If you have diabetes or impaired glucose tolerance, as Melatonin Orifarm may increase your blood sugar.
- If you suffer from impaired liver or kidney function.
- If you smoke, smoking may reduce the effect of Melatonin Orifarm as the ingredients in tobacco smoke may increase the breakdown of melatonin in the liver.
Children And Young People:
Do not give Melatonin Orifarm to children and adolescents between 0 and 18, as its safety and efficacy are unknown to this patient population.
Other Medicines And Melatonin Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.
- Fluvoxamine (used to treat depression and obsessive-compulsive disorder).
- Psoralenes (used to treat skin conditions such as psoriasis ).
- Cimetidine (used to treat stomach upsets such as stomach ulcers ).
- Estrogen er (used in contraception and replacement therapy for hormone deficiency).
- Quinolones (used to treat bacterial infections).
- Rifampicin (used to treat bacterial infections).
- Carbamazepine (used to treat epilepsy ).
- Benzodiazepines and non-benzodiazepine-type hypnotics (medicines used to induce sleep, such as midazolam, temazepam and zaleplon, zolpidem, zopiclone ) as melatonin may increase the sedative effect of such medicines and aggravate specific side effects of zolpidem (morning tiredness, nausea and confusion).
- Warfarin (blood thinner) because melatonin can affect the effect of the blood thinner warfarin .
Melatonin Orifarm With Food, Drink And Alcohol:
Melatonin Orifarm should not be taken with food. As alcohol may impair your sleep and potentially aggravate specific symptoms of jet lag, e.g.
- Headache
- Morning tiredness
- Difficulty concentrating
It is recommended that you do not consume alcohol while taking Melatonin Orifarm.
Pregnancy, Breastfeeding And Fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking Melatonin Orifarm.
Pregnancy:
Melatonin Orifarm is not recommended if you are pregnant. Melatonin passes through the placenta, and there is insufficient information about the risk this may pose to the unborn baby.
Breast-feeding:
Melatonin Orifarm is not recommended if you are breastfeeding. Melatonin is excreted in human milk, and it cannot be ruled out that there is a risk to the breastfeeding infant or baby.
Fertility:
Melatonin Orifarm is not recommended for women and men who are planning to have children as there is insufficient information on the effects of melatonin on female and male fertility.
Driving And Using Machines:
Melatonin Orifarm may cause drowsiness and diminished attention for several hours after ingestion. Therefore, this medicine should not be taken before driving or using machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How To Take Melatonin Orifarm?
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended dose for adults and the elderly is 1 tablet (2 mg) daily for 5 days. If the effect of Melatonin Orifarm is insufficient, the dose can be increased by taking 2 tablets (4 mg) or up to 3 tablets (6 mg) simultaneously. The dose that alleviates the symptoms should be taken as soon as possible.
- The first dose should be taken after arriving at the destination at the local time you usually go to bed. Intake the following days should also occur when you normally go to bed. The tablet or tablets should not be taken before 20:00 or after kl. 04.00.
- The tablets should be swallowed whole with water. Food should not be consumed 2 hours before or 2 hours after taking Melatonin Orifarm.
- Melatonin Orifarm can be taken for a maximum of 16 treatment periods per year.
- The notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
Possible Melatonin Orifarm Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them. Stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people):
- General malaise, susceptibility to inflammation ( infections ), especially sore throat and fever due to changes in the blood (low levels of white blood cells )
- Bleeding from skin and mucous membranes, as well as bruising due to changes in the blood (low platelet count )
- Fainting
Other possible side effects: Common (may affect up to 1 in 10 people):
- Headache
- Drowsiness
Uncommon (may affect up to 1 in 100 people):
- Irritability
- Nervousness
- Restlessness
- Abnormal dreams
- Anxiety
- Dizziness
- High blood pressure
- Stomach pain
- Indigestion
- Cold sores
- Dry mouth
- Nausea
- Itching
- Rash
- Dry skin
- Excretion of glucose in the urine
- Excess protein in the urine
- Chest pain
- Malaise
- Weight gain
Rare (may affect up to 1 in 1,000 people):
- Increased risk of atherosclerosis due to increased levels of fats ( triglycerides ) in the blood
- Mood swings, aggression, disorientation, increased sex drive
- Impaired memory function, rest-less legs syndrome
- Sensation of numbness and tingling
- Visual impairment, including blurred vision
- Watery eyes
- Palpitation
- Hot flashes
- Vomiting
- Gas
- Overproduction of saliva
- Bad breath
- Inflammation of the gastric mucosa
- Nail diseases
- Joint pain
- Muscle cramps
- Large amounts of urine, blood in the urine
- Prolonged
- Painful erection
- Inflammation of the prostate gland
- Thirst
- Abnormal electrolyte content in the blood
Has been reported (occurs in an unknown number of users):
- Hypersensitivity reaction
- Increased urination frequency, thirst, fatigue due to high blood sugar levels
- Swelling of the mucous membrane of the mouth or tongue
- Excretion of milk from the breasts
How To Store Melatonin Orifarm?
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date on the carton after EXP. The expiration date is the last day of the specified month.
- Store in the original jar. Sensitive to light. Moisture sensitive.
- No special temperature instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is melatonin 2 mg.
- The other ingredients are microcrystalline cellulose (E460), maltodextrin, colloidal anhydrous silica (E551), magnesium stearate (E470b), croscarmellose sodium (E468), hypromellose (E464).
What The Medicine Looks Like And Contents Of The Pack?
- Appearance
- Melatonin Orifarm is white/off-white to beige, biconvex, round film-coated tablets with a notch on one side and “2” on the other. Diameter: 8 mm.
- Package contents
- Tablet jar with lid containing desiccant.
- Pack size: 30 film-coated tablets.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
or
Vimeo A / S
Lodshusvej 11
4230 Skælskør
Denmark
This medicinal product is authorized under the European Economic Area under the names:
Netherlands: Melatonin Orifarm
Denmark: Melatonin Alternova
Sweden: Melatonin Orifarm
Norway: Melatonin Orifarm