Baldinas

Package leaflet: Information for the user

BALDINAS 1 mg/mL oral solution

melatonin
Please read all of this leaflet carefully before you start 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What BALDINAS is and what it is used for

The active substance of BALDINAS, melatonin, belongs to a group of natural hormones produced by the body.
This medicinal product is indicated in the following cases:

• For the short-term treatment of jet lag only in adults. The term jet lag refers to symptoms caused by time zone differences when travelling across several time zones.
• Insomnia with difficulty falling asleep in children and adolescents (aged 6 to 17 years) affected by attention deficit hyperactivity disorder (ADHD), when other healthy sleep routines have not been sufficient.

2. What you need to know before taking BALDINAS

Do not take BALDINAS

• 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 BALDINAS if you have:
epilepsy, as melatonin may increase or decrease the frequency of seizures.
an autoimmune disease (a condition in which the body is “attacked” by its own immune system)
diabetes or impaired glucose tolerance, as this medicine may increase blood glucose levels
impaired liver or kidney function
if you smoke. Smoking may reduce the effect of BALDINAS, as components of tobacco smoke can increase the breakdown of melatonin by the liver
if you are elderly
if you are a woman of childbearing age. Women of childbearing potential must use contraception during treatment with BALDINAS; see “Pregnancy, breastfeeding and fertility” for more information. However, the effectiveness of this medicine may be affected by certain contraceptives. See section “Other medicines and BALDINAS” for further information.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age for the treatment of jet lag, as safety and efficacy have not been established for this indication.
Insomnia with difficulty falling asleep in children with ADHD: do not administer this medicine to children under 6 years of age, as its safety and efficacy are unknown.

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

• Fluvoxamine (used to treat depression and obsessive-compulsive disorder)
• Psoralens (used to treat skin diseases, e.g. psoriasis)
• Cimetidine (used to treat stomach problems, such as ulcers)
• Estrogens (used in contraceptives or hormone replacement therapy)
• Rifampicin (used to treat tuberculosis)
• Carbamazepine (used to treat epilepsy)
• Benzodiazepines such as midazolam, temazepam, and non-benzodiazepine hypnotics such as zaleplon, zolpidem and zopiclone (used to induce sleep)
• Warfarin (an anticoagulant, used for treatment and prevention of blood clots)
• Quinolones (e.g. ciprofloxacin and norfloxacin) used in the treatment of bacterial infections
• Thioridazine (used to treat mental/mood disorders)
• Imipramine (used to treat depression)
• Nifedipine or beta-blockers (antihypertensives)
• NSAIDs (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen (for pain and inflammation).

Caffeine
Caffeine may increase the effect of BALDINAS, as it may reduce the breakdown of melatonin by the liver.
Smoking
Smoking may reduce the effect of BALDINAS, as it may increase the breakdown of melatonin by the liver. Consult your doctor if you (or your child) smoke, start or stop smoking during treatment.
BALDINAS and alcohol
Do not drink alcohol before, during or after taking BALDINAS, as this reduces the effectiveness of melatonin.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fertility and contraception for women of childbearing potential and girls
Women and girls of childbearing potential must use contraception during treatment with BALDINAS.
Since this medicine may affect the effectiveness of certain contraceptives (see “Other medicines and BALDINAS”), the choice of contraceptive should be discussed with a doctor.
Pregnancy
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
BALDINAS is not recommended if you (or your daughter) are pregnant. Melatonin crosses the placenta and there is insufficient information on the risk this may pose to the unborn child.
Breastfeeding
BALDINAS is not recommended if you are breastfeeding. Melatonin is excreted in breast milk and risk to breastfed infants cannot be excluded.
Driving and using machines
BALDINAS may cause drowsiness and impaired attention for several hours after ingestion. Therefore, this medicine should not be taken before driving or operating machinery.
BALDINAS contains benzyl alcohol and propylene glycol
This medicine contains 6 mg of benzyl alcohol and 52 mg of propylene glycol per mL.
Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
This medicine contains less than 1 mmol (23 mg) of sodium per mL, i.e. essentially ‘sodium-free’.

3. How to take BALDINAS

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults with jet lag
The recommended dose is 1–5 mL (equivalent to 1–5 mg) daily for a maximum of 5 days.
The dose may be increased up to 5 mg if there is insufficient relief of symptoms at lower doses.
Take the lowest dose that adequately relieves your symptoms and continue treatment for the shortest possible duration.
Take the first dose after arrival at your destination, at the time (local time) when you usually go to bed. On subsequent days, take BALDINAS at the time when you usually go to bed.
Do not take the oral solution before 8:00 PM or after 4:00 AM (local time), as the desired effect may not occur.
BALDINAS may be taken for up to 16 treatment cycles per year.

Use in children and adolescents with attention deficit hyperactivity disorder (ADHD)
The recommended dose is 1–2 mL (equivalent to 1–2 mg) daily, taken 30–60 minutes before bedtime.
If you do not observe improvement in your symptoms or those of your child, the doctor may adjust the dose up to a maximum of 5 mL (equivalent to 5 mg) daily, regardless of age.
The lowest effective dose should be taken for the shortest possible duration.
Treatment must be regularly monitored by a doctor (at least every 6 months) to assess whether it is still appropriate. The doctor should also regularly attempt, at least once a year, to discontinue treatment to determine whether it is still necessary.

Method of administration
BALDINAS is for oral use.
A 5 mL dosing spoon graduated at 1, 2, 3, 4, and 5 mL is provided in the package.
Do not consume food 1 hour before or 1 hour after taking BALDINAS.

Diabetes and impaired glucose tolerance
If you or your child has diabetes or impaired glucose tolerance, it is recommended to consume food 2 hours before and 2 hours after taking BALDINAS (see “Warnings and precautions”).

If you (or your child) take more BALDINAS than you (or your child) should
If you or your child takes an excessive dose of this medicine or if your child accidentally ingests it, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the container and any remaining solution with you. If you have any doubts about using this medicine, consult your doctor or pharmacist.

If you (or your child) forget to take BALDINAS
If you (or your child) forget to take a dose at bedtime and wake up during the night, take the missed dose no later than 4:00 AM.
Do not take a double dose to make up for a forgotten dose.

If you (or your child) stop taking BALDINAS
No harmful effects are known to occur if treatment is interrupted or prematurely discontinued. No withdrawal symptoms are known after stopping BALDINAS following completion of therapy.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you or your child experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:
Frequency not known (cannot be estimated from the available data):

• Hypersensitivity reaction (allergic reactions such as itching, difficulty breathing)
• Swelling of the deeper layers of the skin (angioedema)
• Swelling of the mouth and tongue (edema)

Other side effects that may occur are listed below.
Common (may affect up to 1 in 10 people):

• Headache
• Drowsiness

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

• Irritability, nervousness, restlessness
• Insomnia, abnormal dreams, nightmares, night sweats, anxiety, physical weakness, lack of energy and enthusiasm
• Migraine
• Dizziness
• Lethargy, restlessness associated with increased motor activity
• High blood pressure
• Mouth ulceration
• Dry mouth
• Nausea, abdominal pain, upper abdominal pain, indigestion
• Skin disorders (dermatitis, itching, rash, dry skin)
• Pain in arms and legs
• Menopausal symptoms
• Chest pain
• Excretion of glucose in urine, increased protein in urine
• Changes in blood composition that may cause yellowing of the skin or eyes
• Abnormal liver function tests
• Weight gain

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

• Shingles (herpes zoster)
• Reduced number of white blood cells in the blood
• Reduced number of platelets
• Low levels of calcium or sodium in the blood
• High levels of fats in the blood
• Mood changes, aggression, agitation, crying, feeling of confusion (disorientation), early morning awakening, increased sex drive (increased libido), low mood, depression, stress symptoms
• Fainting, memory disturbances, attention disorders, unpleasant sensation in the legs (restless legs syndrome), poor quality sleep, tingling sensation, fatigue, dream-like state
• Visual disturbances, blurred vision, increased tearing
• Feeling of dizziness or spinning sensation (vertigo), dizziness when standing or sitting
• Rapid heartbeat, chest pain due to angina pectoris, hot flushes
• Acid reflux, gastrointestinal disturbances, blistering in the mouth, tongue ulceration, vomiting, increased salivation, bad breath, flatulence, abdominal discomfort, inflammation of the stomach lining
• Skin disorders (eczema, erythema, hand dermatitis, psoriasis, generalized itchy rash) and nail problems
• Pain, arthritis, muscle spasms, neck pain, nocturnal cramps
• Production of large amounts of urine, presence of red blood cells in urine, need to urinate at night
• Prolonged erection (priapism)
• Inflammation or enlargement of the prostate (prostatitis)
• Feeling of thirst
• Increased levels of liver enzymes, abnormal blood electrolyte tests, abnormal laboratory tests

Frequency not known (cannot be estimated from the available data):

• Hypersensitivity reactions
• High blood glucose levels
• Localized swelling of the skin, swelling of the tongue, swelling of the mouth
• Spontaneous milk secretion from the breast (also in men)

Additional side effects in children and adolescents
Generally mild side effects with low frequency have been reported. The most common adverse effects were:

• headache
• hyperactivity
• dizziness
• abdominal pain.
  No serious side effects have been reported.

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after
Exp. The expiry date refers to the last day of that month.
Store below 30°C.
After first opening: use within 1 month and store below 25°C.
Keep in the original bottle to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What BALDINAS contains

• The active substance is melatonin. Each mL of solution contains 1 mg of melatonin.
• The other components are purified water, sucralose, benzyl alcohol, sodium ascorbate, propylene glycol (E1520), and strawberry flavour (containing propylene glycol (E1520)).

Description of the appearance of BALDINAS and package contents
This medicinal product is a clear yellow to light yellow solution with a strawberry flavour.
It is supplied in a 100 mL or 150 mL amber glass bottle with a plastic screw cap.
A 5 mL plastic dosing spoon graduated at 1, 2, 3, 4 and 5 mL is also included.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farma Group S.r.l.
Via Farfisa, 18
60021, Camerano (AN), Italy

Manufacturer
UAB Valentis
Moletu pl. 11, Vilniaus m. sav., Vilniaus m., LT-08409 Lithuania