Sloremina

Package leaflet: Information for the patient

SLOREMINA 2 mg prolonged-release tablets

melatonin
Generic 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SLOREMINA is and what it is used for

The active substance of SLOREMINA, melatonin, belongs to a group of natural hormones produced by the body.
This medicinal product 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 the insomnia has been identified, including any medical, mental or environmental cause.

2. What you need to know before taking SLOREMINA

Do not take SLOREMINA

• 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 SLOREMINA

• If you have liver or kidney problems. Studies on the use of this medicine in patients with liver or kidney disease have not been conducted; consult your doctor before taking this medicine, as its use is not recommended.
• If your doctor has told you that you have 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 the use of this medicine in patients with autoimmune diseases have not been conducted; therefore, consult your doctor before taking this medicine, as its use is not recommended.
• This medicine may cause drowsiness; be cautious if you experience drowsiness, as it may impair your ability to perform activities such as driving vehicles.
• Smoking may reduce the effectiveness of this medicine, 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, another melatonin-containing medicine may be more appropriate; please consult your doctor or pharmacist.

Other medicines and SLOREMINA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
These include:

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin diseases such as psoriasis), 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, or medicines to lower blood pressure), opioid agonists/antagonists (such as medicines used in the treatment of 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).

SLOREMINA with food, drinks, and alcohol
Take this medicine after eating. Do not consume alcohol before, during, or after taking this medicine, as it may reduce the medicine's effectiveness.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine may cause drowsiness. If this occurs, do not drive or operate machinery. If you experience prolonged drowsiness, consult your doctor.

SLOREMINA contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take SLOREMINA

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 tablet (2 mg) to be taken daily by mouth, 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. The tablets must not be crushed or split.

If you take more SLOREMINA than you should
If you have accidentally taken an excessive dose of this medicine, contact your doctor or pharmacist as soon as possible.
Taking more than the recommended daily dose may cause drowsiness.

If you forget to take SLOREMINA
If you forget to take a tablet, take it as soon as you remember, before going to sleep, or wait until it is time for the next dose and then continue as before.
Do not take a double dose to make up for the forgotten dose.

If you stop taking SLOREMINA
No harmful effects are known in case of interruption or premature discontinuation of treatment. No withdrawal symptoms are known after completion of therapy with this medicine.

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 heart beats)
• Depression
• Visual impairment
• Blurred vision
• Disorientation
• Dizziness (sensation of dizziness or "spinning")
• Presence of red blood cells in the urine
• Reduced number of white blood cells in the blood
• Reduction in platelets, increasing the risk of bleeding or bruising
• Psoriasis

If you experience any of the following non-serious side effects, 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, glucose excretion in urine, excess protein in urine, abnormal liver function, and weight gain.

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following 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 SLOREMINA

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.
Blisters:
Do not store above 25°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 SLOREMINA contains

• The active substance is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
• The other ingredients are: ammonium methacrylate copolymer type B, dibasic calcium phosphate dihydrate, lactose monohydrate (see section 2 “SLOREMINA contains lactose monohydrate”), silica (anhydrous colloidal), talc and magnesium stearate.

Description of the appearance of SLOREMINA and the contents of the pack
SLOREMINA prolonged-release tablets are oval, white to off-white tablets,
measuring 5.2 mm x 10 mm, with “A6” engraved on one side.
SLOREMINA is available in blisters containing 30 prolonged-release tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
PIAM Farmaceutici S.p.A.
Via Fieschi, 8 - 16121 GENOA
Italy

Manufacturer
Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa
Bulgaria