2 mg film-coated tablets
melatonin

What Melatonin Orifarm is and what it is 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, 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 contained in Melatonin Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any 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 of the other ingredients of this medicine (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 own immune system).
  • If you have diabetes or impaired glucose tolerance, as this medicine 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 this medicine to children and adolescents between 0 and 18 years of age, as its safety and efficacy are not known to this patient population.

Other medicines and Melatonin Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any 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 certain 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 certain symptoms of jet lag (eg headache, morning tiredness, and difficulty concentrating), it is recommended that you do not consume alcohol while taking this medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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 a maximum of 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) at the same time. The dose that alleviates the symptoms sufficiently should be taken for the shortest possible time.

The first dose should be taken after arrival at the destination at the time you normally go to bed, local time. Intake the following days should also take place at the time 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 side effects

Like all medicines, this medicine can cause side effects, 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 the sight and reach of children.

Do not use this medicine after the expiry date which is stated 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 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 side. 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

Muhammad Nadeem

Leave a Reply