1 mg, 2 mg, 3 mg, 4 mg, 5 mg tablets
melatonin

What Melatonin AGB is and what it is used for

The active substance in Melatonin AGB, melatonin, belongs to a group of natural hormones that are produced by the body. The hormone helps to regulate the body’s day and night rhythm.

Melatonin AGB is used in:

  • short-term treatment of jet lag in adults. Jet lag refers to the symptoms caused by the time difference when traveling over several time zones.
  • insomnia in children and adolescents 6-17 years with ADHD where other sleep support measures are not sufficient.

Melatonin contained in Melatonin AGB 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 you take Melatonin AGB

Do not take Melatonin AGB:

  • 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 AGB if you have:

  • diabetes or impaired glucose tolerance, as this medicine may increase blood sugar levels
  • liver or kidney problems
  • an autoimmune disease (when the body is “attacked” by its own immune system)
  • epilepsy
  • or if you are older.

Melatonin AGB 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 a car.

Smoking

Smoking can have a worse effect on Melatonin AGB. If you smoke, start or stop smoking, your doctor may need to adjust your dose.

Melatonin AGB with food and alcohol

Food should not be consumed 2 hours before or 2 hours after taking Melatonin AGB tablets. Do not drink alcohol while taking Melatonin AGB, as it may reduce the effect of melatonin on sleep.

Children and young people

Melatonin AGB is not intended for use in children under 6 years of age.

Other medicines and Melatonin AGB

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Melatonin AGB can affect or be affected if taken at the same time as certain other medicines for:

  • Depression (eg fluvoxamine, citalopram )
  • Difficulty sleeping (eg zolpidem)
  • Epilepsy (carbamazepine, phenytoin )
  • Gastric ulcer (cimetidine, omeprazole, lansoprazole)
  • Skin diseases (psoralenes)
  • Heart disease (verapamil)
  • High blood pressure (nifedipine, beta-blocker )
  • Bacterial infections (rifampicin, ciprofloxacin , norfloxacin)
  • Prevention and treatment of blood clots ( warfarin )
  • Contraceptives containing ethinyl estradiol and progestogen
  • Hormone therapy due to menopausal symptoms
  • Pain and inflammation (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid and ibuprofen )

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, do not use Melatonin AGB.

Pregnancy

Melatonin AGB tablets are 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. If you are a woman of childbearing potential, you should use contraception.

Breast-feeding

Melatonin AGB tablets are not recommended if you are breastfeeding. Melatonin is excreted in breast milk and it can not be ruled out that there is a risk to the breast-fed baby.

Fertility

Melatonin AGB tablets are 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 AGB can make you drowsy. If this happens, do not drive or use 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 AGB

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

If you have impaired kidney function or are older, your doctor may need to adjust your dose downwards.

Adults with jet lag

The recommended dose is 1 to 5 mg for a maximum of 5 days.


Take dose one at bedtime at the destination when traveling over at least 5 time zones, especially when traveling in an easterly direction. The tablets should not be taken before 20:00 or after kl. 04.00.

Melatonin AGB may be taken for a maximum of 16 treatment periods per year for the treatment of jet lag.

Children and adolescents 6-17 years with ADHD with insomnia

The recommended starting dose is 1 to 2 mg 30-60 minutes before bedtime. If no improvement is seen in your / your child’s symptoms, your doctor may increase the dose of Melatonin AGB to find the most appropriate dose for you / your child. The maximum daily dose that you / your child will receive is 5 mg.

Treatment should be followed up regularly by a doctor (at least every 6 months recommended) to see if it is still appropriate. Treatment breaks should be made once a year to see if treatment is still needed.

The tablet can be crushed in connection with ingestion and mixed with water.

Food should not be consumed 2 hours before or 2 hours after taking Melatonin AGB tablets.

Possible side effects

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

If you get any of these serious side effects, stop taking Melatonin AGB immediately and see a doctor:

  • Hypersensitivity reaction , swelling of the face, swelling of the mouth, swelling of the tongue
  • Chest pain

Common side effects: may affect up to 1 in 10 people

  • Headache
  • Somnolence

Uncommon side effects: may affect up to 1 in 100 people

  • Irritability, nervousness, restlessness, anxiety
  • Insomnia, abnormal dreams, nightmares
  • Migraine , dizziness, nausea
  • Drowsiness and lack of energy, restlessness associated with increased activity
  • High blood pressure
  • Abdominal pain, stomach upset, mouth sores, dry mouth
  • Changes in the composition of the blood that can cause yellowing of the skin and eyes
  • Inflammation of the skin, itching , rash, dry skin, night sweats
  • Pain in arms and legs
  • Excretion of glucose in the urine, too much protein in the urine
  • Menopausal symptoms
  • Feeling of weakness, chest pain
  • Weight gain

Rare side effects: may affect up to 1 in 1,000 people

  • Shingles
  • Decreased number of white blood cells in the blood
  • Decreased number of platelets in the blood
  • Low levels of calcium or sodium in the blood
  • High levels of fats in the blood
  • Altered mood, aggression, restlessness associated with increased activity, weeping, stress symptoms, difficulty orienting oneself, waking up early in the morning, increased sexual drive, depression, depression
  • Fainting, memory loss, attention deficit disorder, dreaming state, restless legs syndrome, poor sleep quality, skin sensations, hallucinations
  • Impaired visual acuity , blurred vision, increased tear flow
  • Dizziness, positional dizziness (dizziness when getting up or sitting down)
  • Chest pain due to angina, palpitations
  • Hemorrhoids
  • Acid reflux, gastrointestinal upset, blisters in the mouth, sores on the tongue, stomach upset, vomiting, abnormal bowel sounds, flatulence, increased salivation, bad breath, abdominal discomfort, inflammation of the gastric mucosa
  • Eczema , skin rash, inflammation of the hands on the hands, itchy rash, psoriasis , nail disorders
  • Arthritis, muscle cramps, neck pain, nocturnal cramps
  • Increased amounts of urine, urination at night, red blood cells in the urine
  • Prolonged erection – which can be painful – unrelated to sexual stimulation, inflammation of the prostate
  • Fatigue, pain, thirst
  • Elevated liver enzyme levels, abnormal salinity and abnormal laboratory tests

Adverse reactions that have been reported: occur in an unknown number of users

  • Hypersensitivity reaction , swelling of the face, swelling of the mouth, swelling of the tongue
  • Abnormal secretion of breast milk
  • Hallucinations (sensory disturbances eg seeing, feeling or hearing something that does not exist)
  • High blood sugar level

How to store Melatonin AGB

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C 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 1 mg, 2 mg, 3 mg, 4 mg or 5 mg.
  • The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate and magnesium stearate.

What the medicine looks like and contents of the pack

Melatonin AGB 1 mg is a white, round biconvex tablet with embossing “1” on one side, tablet size 9.5 x 3.8 mm.

Melatonin AGB 2 mg is a white, round biconvex tablet with imprint “2” on one side, tablet size 9.5 x 3.8 mm.

Melatonin AGB 3 mg is a white, round biconvex tablet with imprint “3” on one side, tablet size 9.5 x 3.8 mm.

Melatonin AGB 4 mg is a white, round biconvex tablet with embossing “4” on one side, tablet size 9.5 x 3.8 mm.

Melatonin AGB 5 mg is a white, round biconvex tablet with embossing “5” on one side, tablet size 9.5 x 3.8 mm.

Melatonin AGB is available in a jar of 30 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AGB-Pharma AB

Scheeletorget 1, Medicon Village

223 81 Lund

Muhammad Nadeem

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