1 mg / ml Oral solution

What Melatonin Unimedic Pharma is and what it is used for

Melatonin Unimedic Pharma contains the active substance melatonin, which is a hormone produced naturally by the body. The hormone helps to regulate the body’s day and night rhythm.

Melatonin Unimedic Pharma can be used for:

  • 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.
  • Treatment of sleep disorders in children and adolescents (6-17 years) with attention deficit hyperactivity disorder ( ADHD ) where other sleep support measures are not sufficient.

Melatonin contained in Melatonin Unimedic Pharma 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 use Melatonin Unimedic Pharma

Do not use Melatonin Unimedic Pharma

  • 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 you or your child take Melatonin Unimedic Pharma if you or your child have:

  • diabetes or impaired glucose tolerance, as this medicine may increase blood sugar (see section 3)
  • liver problems, as Melatonin Unimedic Pharma is not recommended for patients with liver problems.
  • kidney problems, as caution should be exercised when administering Melatonin Unimedic Pharma to patients with kidney problems.
  • an autoimmune disease (where the body is “attacked” by its own immune system).
  • epilepsy , as melatonin may increase or decrease the frequency of seizures.
  • Or if you are older.

Melatonin Unimedic 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.

Children and young people

Children under 6 years

Do not give this medicine to children under 6 years of age as it has not been tested and its effects are unknown.

Other medicines and Melatonin Unimedic Pharma

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

  • Fluvoxamine (used to treat depression and obsessive-compulsive disorder)
  • Quinolones (eg ciprofloxacin and norfloxacin) and rifampicin (used to treat bacterial infections)
  • Cimetidine (used to treat stomach problems such as stomach ulcers )
  • Methoxypsorenalen (used to treat skin conditions such as psoriasis )
  • Estrogen er (used as a contraceptive or hormone replacement)
  • Carbamazepine, phenytoin (used to treat epilepsy )
  • Theophylline (used to treat asthma )
  • Clozapine, haloperidol , olanzapine (used to treat schizophrenia)
  • Amitriptyline, imipramine, clomipramine (used to treat depression)
  • Ropivacaine (used to treat acute pain)
  • Tamoxifen (used to treat breast cancer)
  • Caffeine
  • Benzodiazepines and non-benzodiazepine- related hypnotics , such as zaleplon, zolpidem and zopiclone (used to induce sleep)
  • Nifedipine
  • Warfarin

Melatonin Unimedic Pharma with food, drink and alcohol

Smoking

Smoking may reduce the effect of Melatonin Unimedic Pharma as it may increase the breakdown of melatonin in the liver. Tell your doctor if you or your child smokes, starts, or stops smoking during treatment.

Alcohol

Do not drink alcohol before, during, or after taking Melatonin Unimedic Pharma, as alcohol may reduce the effect of melatonin on sleep.

Pregnancy, breastfeeding and fertility

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

Contraceptives for fertile women and young women

Women of childbearing potential should use contraceptives during treatment with Melatonin Unimedic Pharma. As this medicine may affect some contraceptives (see ‘Other medicines and Melatonin Unimedic Pharma’), the choice of contraceptive should be discussed with a doctor.

Pregnancy

Melatonin Unimedic Pharma is not recommended if you or your baby 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 Unimedic Pharma is 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.

Driving and using machines

Melatonin Unimedic Pharma 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.

Melatonin Unimedic Pharma contains methyl parahydrobenzoate and sodium

This medicine contains methyl parahydroxybenzoate which may cause an allergic reaction (possibly delayed).
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

How to use Melatonin Unimedic Pharma

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

Adults with jet lag

The recommended dose is 1-5 ml (equivalent to 1-5 mg) for a maximum of 5 days.

Recommended starting dose: 2 ml (equivalent to 2 mg)

Maximum recommended dose: 5 ml (equivalent to 5 mg) per day, for 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 oral solution should not be taken before 20:00 or after kl. 04.00.

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

Children and adolescents with ADHD

Recommended starting dose: 1-2 ml (equivalent to 1-2 mg) 30-60 minutes before bedtime. Maximum recommended daily dose: 5 ml (equivalent to 5 mg)

Dose one will be individually adjusted to a maximum of 5 ml (equivalent to 5 mg) daily, regardless of age. The lowest possible dose will be given.

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.

How to take Melatonin Unimedic Pharma

Melatonin Unimedic Pharma should be swallowed.

User instructions

  • Open the bottle by removing the bottle cap.
  • Push the adapter into the opening of the bottle.
  • Insert the syringe into the adapter opening and turn the bottle upside down. Measure the dose one prescribed by your doctor by slowly pulling out the plunger. Read dose one against the top edge of the plunger. Turn the bottle over correctly and remove the syringe.
  • You or the child should sit upright while taking Melatonin Unimedic Pharma. Aim the syringe at the inside of the cheek. Slowly push in the plunger and allow yourself or the baby to swallow naturally. Excessive administration of the drug can cause discomfort.
  • Clean the inside of the syringe after each use.

Diabetes
If you or your child have diabetes or impaired glucose tolerance, no food should be taken 2 hours before or after taking Melatonin Unimedic Pharma (see “Warnings and Precautions”).

If you or your child have taken too much Melatonin Unimedic Pharma
If you or your child have taken too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

Taking more than the recommended dose can make you or your child feel drowsy.

If you or your child stop taking Melatonin Unimedic Pharma

There are no known adverse effects if treatment is stopped or stopped. As far as is known, the use of Melatonin Unimedic Pharma does not give rise to any withdrawal effects when you stop the treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

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

If you, or your child, get any of these serious side effects, stop taking Melatonin Unimedic Pharma immediately and see a doctor:

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

  • Hypersensitivity reaction , (allergy-like reactions such as itching , difficulty breathing)
  • Swelling of the deep skin layer ( angioedema )
  • Swelling of the mouth and tongue ( edema ).

Common (may affect up to 1 in 10 people):

  • Headache
  • Somnolence

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

  • Irritation, nervousness, restlessness
  • Insomnia , abnormal dreams, nightmares, night sweats, anxiety, restlessness, physical weakness, lack of energy and enthusiasm
  • Migraine
  • Dizziness
  • High blood pressure
  • Cold sores
  • Dry mouth
  • Nausea, abdominal pain
  • Skin problems ( dermatitis , itching , rash, dry skin)
  • Pain in arms and legs
  • Menopausal symptoms
  • Chest pain
  • Excretion of glucose in the urine, too much protein in the urine
  • Changes in the composition of the blood that can cause yellowing of the skin and eyes
  • Deviating liver values
  • Weight gain

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

  • Shingles ( herpes zoster)
  • 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, anxiety, crying, stress symptoms, feeling confused, waking up early in the morning, increased sex drive (increased libido ), depression, depression
  • Fainting, memory loss, attention deficit disorder, dreamy state, restless legs syndrome, poor sleep quality, fatigue
  • Impaired visual acuity , blurred vision, increased tear flow
  • Dizziness, positional dizziness (dizziness when getting up or sitting down)
  • Palpitations, chest pain due to angina
  • Acid reflux, gastrointestinal upset, blisters in the mouth, sores on the tongue, stomach upset, vomiting, abnormal bowel sounds, increased salivation, bad breath, flatulence, abdominal discomfort, inflammation of the gastric mucosa
  • Different sensations in the skin, skin problems ( eczema , redness , psoriasis , rash), nail disorders, hot flashes
  • Pain, joint inflammation, muscle cramps, neck pain, nocturnal cramps
  • Increased amounts of urine, red blood cells in the urine, urination at night
  • Prolonged erection (priapism)
  • Inflammation or swelling of the prostate
  • Thirst
  • Elevated liver enzyme levels, abnormal salinity and abnormal laboratory tests

Has been reported (occurs in an unknown number of users, reported after use by adults):

  • Spontaneous milk secretion from the breast.

Additional side effects in children and adolescents

A low frequency of generally mild side effects has been reported. The most common side effects were headache, hyperactivity, dizziness, and abdominal pain. No serious side effects have been observed.

How to store Melatonin Unimedic Pharma

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 bottle after EXP. The expiration date is the last day of the specified month.

Melatonin Unimedic Pharma can be used for up to 6 months after opening the bottle.

This medicine does not require any specific temperature instructions. Store in the original bottle. 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 .
  • The other ingredients are glycerol (E422), sorbic acid, methyl parahydroxybenzoate (E218), sodium hydroxide and water

What the medicine looks like and contents of the pack

Melatonin Unimedic Pharma is a clear, colorless to the slightly yellowish oral solution.

100 ml solution in a brownish-yellow glass bottle with a white polypropylene cap. A dosing syringe and bottle adapter is included in the packaging of the bottle. The size of the syringe is 5 ml with a 0.2 ml graduation scale.

Pack size: 1 x 100 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Unimedic Pharma AB

Box 6216

102 34 Stockholm

Manufacturer

Unimedic AB

Box 91

864 21 Matfors

Muhammad Nadeem

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