Melatonin Adoh

Patient Information Leaflet

Melatonina ADOH 2 mg, prolonged-release tablets

Melatonin
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Melatonina ADOH is and what it is used for
2. What you need to know before taking Melatonina ADOH
3. How to take Melatonina ADOH
4. Possible side effects
5. How to store Melatonina ADOH
6. Contents of the pack and other information

1. What Melatonina ADOH is and what it is used for

The active substance of Melatonina ADOH, melatonin, belongs to a group of natural hormones
produced by the body.
Melatonina ADOH is used alone for the short-term treatment of primary insomnia
(persistent difficulty in falling asleep or maintaining sleep, or poor sleep quality)
in patients aged 55 years and over. "Primary" means that no cause for insomnia has been identified, including any medical, mental, or environmental cause.

2. What you need to know before taking Melatonin ADOH

Do not take Melatonin ADOH

• if you are allergic to melatonin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonin ADOH.

• If you have liver or kidney problems. Studies on the use of Melatonin ADOH in people with liver or kidney disease have not been conducted; consult your doctor before taking Melatonin ADOH, as its use is not recommended.
• If your doctor has diagnosed you with an intolerance to certain sugars.
• If you have been diagnosed with an autoimmune disease (a condition in which the body is “attacked” by its own immune defenses). Studies on Melatonin ADOH in patients with autoimmune diseases have not been conducted; therefore, consult your doctor before taking Melatonin ADOH, as its use is not recommended.
• Melatonin ADOH may cause drowsiness; be cautious if you experience drowsiness, as this may impair your ability to perform tasks such as driving.
• Smoking may reduce the effectiveness of Melatonin ADOH, since components of tobacco smoke can increase the liver’s metabolism of melatonin.

Children and adolescents
Do not administer this medicine to children aged 0 to 18 years, as it has not been tested and its effects are unknown. In children aged between 2 and 18 years, it might be more appropriate to use another melatonin-containing medicine; consult your doctor or pharmacist for advice.
Other medicines and Melatonin ADOH
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These medicines include:

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin disorders, e.g. psoriasis (reddish, scaly skin patches)), cimetidine (used to treat stomach problems such as ulcers), quinolones and rifampicin (used to treat bacterial infections), estrogens (used in contraceptives or hormone replacement therapy), and carbamazepine (used to treat epilepsy).
• Adrenergic agonists/antagonists (such as certain medicines used to control blood pressure by constricting blood vessels, nasal decongestants, medicines to lower blood pressure), opioid agonists/antagonists (such as medicines used to treat substance dependence), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan, and alcohol.
• Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, such as zaleplon, zolpidem, and zopiclone).
• Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).

Melatonin ADOH with food, drinks, and alcohol
Take Melatonin ADOH after eating. Do not consume alcohol before, during, or after taking Melatonin ADOH, as alcohol reduces its effectiveness.
Pregnancy and breastfeeding
Do not take Melatonin ADOH if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Melatonin ADOH may cause drowsiness. If this occurs, do not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.
Melatonin ADOH contains lactose monohydrate
Melatonin ADOH contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Melatonin ADOH

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one Melatonin ADOH tablet (2 mg) taken orally every
day after a meal, 1–2 hours before going to bed. This dosage may be maintained for
up to thirteen weeks.
The tablet must be swallowed whole. Melatonin ADOH tablets must not be crushed or
split.
If you take more Melatonin ADOH than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or
pharmacist immediately.
If you have taken a dose higher than the maximum recommended dose, you may
experience drowsiness.
If you forget to take Melatonin ADOH
If you forget to take a tablet, take it as soon as you remember, provided it is still before bedtime; otherwise, wait until the time for your next dose and continue as usual.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Melatonin ADOH
No harmful effects are known to occur in case of interruption or premature discontinuation of treatment.
No withdrawal symptoms associated with stopping Melatonin ADOH after completion of therapy are known.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

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

• Chest pain

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

• Loss of consciousness or fainting
• Severe chest pain caused by angina
• Palpitations (awareness of heartbeats)
• Depression
• Vision changes (including reduced vision)
• Blurred vision
• Disorientation
• Dizziness (sensation of spinning)
• Presence of red blood cells in the urine
• Reduced number of white blood cells in the blood
• Reduction in platelets, leading to increased bleeding or bruising
• Psoriasis (reddish, scaly patches on the skin)

If any of the following non-serious side effects occur, consult your doctor and/or seek medical advice:

Uncommon: (may affect up to 1 in 100 people)
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity, dizziness, fatigue, hypertension, upper abdominal pain, indigestion, mouth ulceration, dry mouth, nausea, changes in blood composition that may cause yellowing of the skin or eyes, skin inflammation, night sweats, itching, rash, dry skin, limb pain, menopausal symptoms, feeling of weakness, presence of glucose in the urine, excess protein in the urine, abnormalities in liver function tests, and weight gain.

Rare: (may affect up to 1 in 1,000 people)
Herpes zoster (shingles), increased levels of fats in the blood, low levels of serum calcium, low sodium levels in the blood, mood changes, aggression, agitation, crying, stress symptoms, early morning awakening, increased libido (increased sexual desire), depressed mood, memory impairment, attention disorders, dream-like state, restless legs syndrome, poor quality of sleep, tingling sensation, increased tear production, postural dizziness (dizziness upon standing or sitting up), hot flushes, acid reflux, stomach disturbances, mouth ulcers, tongue ulcers, stomach discomfort, vomiting, intestinal noises, intestinal gas, excessive saliva production, bad breath, abdominal pain, stomach disorders, inflammation of the gastric mucosa, eczema, skin rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, night cramps, prolonged erection which may be painful, prostate inflammation, tiredness, pain, thirst, increased urine production, nocturnal urination, increased liver enzymes, abnormalities in blood electrolyte tests, and abnormal laboratory test results.

Frequency not known: (cannot be estimated from the available data)
Hypersensitivity reaction, swelling of the mouth or tongue, skin swelling, and abnormal milk production.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Melatonin ADOH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not store above 30 °C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Melatonina ADOH contains

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other ingredients are: monohydrate lactose, calcium hydrogen phosphate dihydrate, ammonium methacrylate copolymer Type B, silica (anhydrous colloidal) (E551), talc (E553b) and magnesium stearate (E470b).

Description of the appearance of Melatonina ADOH and pack contents
Melatonina ADOH 2 mg prolonged-release tablets are available as 8 mm, white to almost white, round, biconvex tablets. Each carton contains three white blister strips with 10 tablets each (pack of 30 tablets). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
ADOH B.V.
Godfried Bomansstraat 31
6543 JA Nijmegen
The Netherlands

Manufacturer:
MIPHARM S.p.A.
Via Bernardo Quaranta, 12
20141 Milano (MI)
Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy Melatonina ADOH 2 mg, prolonged-release tablets
The Netherlands Melatonine ADOH 2 mg, tabletten met verlengde afgifte