2 mg prolonged-release tablet is
melatonin

What Mecastrin is and what it is used for

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

Mecastrin is used alone in the short-term treatment of primary insomnia (persistent difficulty falling asleep or continuing to sleep, or poor sleep quality) in patients 55 years of age and older. “Primary” means that insomnia has no known cause, such as any medical, mental, or environmental cause.

Melatonin contained in Mecastrin may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before taking Mecastrin

Do not take Mecastrin:

  • 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 or pharmacist before taking Mecastrin:

  • if you have liver or kidney problems. No studies on the use of Mecastrin in people with liver or kidney disease have been performed. You should talk to your doctor before taking Mecastrin, 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 that you have an autoimmune disease (when the body is “attacked” by its own immune system). No studies on the use of Mecastrin in people with autoimmune diseases have been performed. Therefore, you should talk to your doctor before taking Mecastrin, as its use is not recommended.
  • Mecastrin can make you feel drowsy. You should be careful if drowsiness affects you, as it may impair your ability to perform tasks such as driving.
  • Smoking can have a worse effect on Mecastrin, as the ingredients in tobacco smoke can increase the breakdown of melatonin in the liver.

Children and young people

Do not give this medicine to children aged 0 to 18 years, as it has not been tested on children, and its effects are not known.

Other medicines and Mecastrin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Such drugs may be:

  • fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralen (used to treat skin conditions such as psoriasis ), cimetidine (used to treat stomach problems such as stomach ulcers ), quinolones and rifampicin (used to treat bacterial infections), estrogen er (used as a contraceptive or replacement therapy in case of hormone deficiency) 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 antagonists / antagonists (such as medicines used to treat drug addiction), prostaglandin inhibitors -steroidal anti-inflammatory drugs), antidepressants, tryptophan and alcohol.
  • benzodiazepines and non-benzodiazepine-type hypnotics (drugs used to induce sleep such as zaleplon, zolpidem and zopiclone ).
  • thioridazine (used to treat schizophrenia) and imipramine (used to treat depression).

Mecastrin with food, drink and alcohol

Take Mecastrin after meals. Do not drink alcohol before, during, or after taking Mecastrin, as it reduces the effect of Mecastrin.

Pregnancy and breastfeeding

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.

Driving and using machines

Mecastrin can make you drowsy. If this happens, do not drive or use any machines. If you feel drowsy all the time, you need to talk to your doctor.

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.

Mecastrin contains lactose monohydrate

Mecastrin contains lactose monohydrates. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Mecastrin

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one tablet (2 mg) taken once a day by mouth after a meal, 1-2 hours before bedtime. This dosage can be maintained for up to thirteen weeks.

You must swallow the tablet whole. You must not crush or split the tablets.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following serious side effects, stop taking the medicine immediately and contact your doctor:

Uncommon (may affect up to 1 in 100 people):

  • Chest pain

Rare (may affect up to 1 in 1,000 people):

  • Unconsciousness or fainting
  • Severe chest pain due to angina
  • Palpitation
  • Depression
  • Impaired visual acuity
  • Dimsyn
  • Confusion (disorientation)
  • Dizziness (a feeling of dizziness or that it “spins”)
  • Red blood cells in the urine
  • Decreased number of white blood cells in the blood
  • Decreased platelet count , which increases the risk of bleeding or bruising
  • Psoriasis

If you get any of the following non-serious side effects, contact your doctor and/or see a doctor:

Uncommon (may affect up to 1 in 100 people):

Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraines, headaches, lethargy (lethargy, lack of energy), restlessness associated with increased activity, dizziness, drowsiness, high blood pressure, upper abdominal pain, stomach upset, sores in the mouth, dry mouth, nausea, changes in the composition of the blood that can cause yellowing of the skin and eyes, dermatitis, night sweats, itching, rash, dry skin, pain in the arms and legs, menopausal symptoms, feeling of weakness, secretion of glucose in the urine, too much protein in the urine, abnormal liver function and weight gain.

Rare (may affect up to 1 in 1,000 people):

Shingles , high levels of fats in the blood, low levels of calcium in the blood, low levels of sodium in the blood, changes in mood, aggression, anxiety, crying mildness, stress symptoms, waking up early in the morning, increased sexual drive, depression, memory loss, attention deficit disorder, attention deficit disorder , restless legs syndrome, poor sleep quality, numbness and tingling sensation, increased tear flow (watery eyes), dizziness (dizziness when getting up or sitting down), hot flashes, acid regurgitation, gastrointestinal upset, blisters in the mouth, sores on the tongue , stomach upset, vomiting, abnormal bowel sounds, flatulence, excessive salivation, bad breath, abdominal discomfort, stomach upset, inflammation of the gastric mucosa, eczema, skin rash, inflammation of the hands on the hands, itchy rash, nail disorders, joint inflammation, muscle cramps, neck pain, nocturnal cramps, prolonged erection which can be painful, inflammation of the prostate , fatigue, pain, thirst, large amounts of urine, urination at night, elevated liverworm saliva in the blood and abnormal laboratory tests.

Has been reported (occurs in an unknown number of users):

Hypersensitivity reaction, swelling of the mouth or tongue, swelling of the skin, and abnormal secretion of milk.

How to store Mecastrin

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 package. Sensitive to light.

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 . One prolonged-release tablet contains 2 mg of melatonin .
  • The other ingredients are lactose monohydrate , calcium hydrogen phosphate dihydrate, ammonio methacrylate copolymer, talc, colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and contents of the pack

Mecastrin is a white to the off-white, round, biconvex tablet. Diameter: 8.00 ± 0.20 mm. Pack sizes: 7, 10, 20, 21, 24, 30, 36 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm 

info@orifarm.com

Muhammad Nadeem

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