BALDINAS 1 mg /Ml Oral Solution

Зміст інструкції

1. BALDINAS 1 mg/mL oral solution
   1. What is BALDINAS and what is it 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

BALDINAS 1 mg/mL oral solution

melatonin

Read this leaflet carefully before taking this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, 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 you take 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 is BALDINAS and what is it used for

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

• For the short-term treatment of jet lag in adults only. The term jet lag refers to the symptoms caused by the time difference when travelling across different time zones.
• Difficulty falling asleep insomnia in children and adolescents (aged between 6 and 17 years) with attention deficit/hyperactivity disorder (ADHD), in cases where 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 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 (where the body is “attacked” by its own immune
system)
diabetes or impaired glucose tolerance, as this medicine may increase glucose
levels in the blood
impaired liver or kidney function
if you smoke. Smoking may reduce the effect of BALDINAS as components of tobacco smoke
may increase the breakdown of melatonin by the liver
if you are elderly
if you are a woman of childbearing potential. Women of childbearing potential should use contraception during
treatment with BALDINAS, see “Pregnancy, breastfeeding and fertility” for more
information. However, the effect of this medicine may be affected by some
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 give 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)
• Oestrogens (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, treatment and prevention of blood clots)
• Quinolones (for example 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 decrease 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. Talk to your doctor if you (or your child) smoke, start or stop
smoking during treatment.

BALDINAS with alcohol
Do not drink alcohol before, during and after taking BALDINAS as this reduces the effectiveness of
melatonin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Fertility and contraceptives for women of childbearing potential and girls
Women and girls of childbearing potential should use contraception during treatment with BALDINAS.
As this medicine may affect the effect of some contraceptives (see “Other medicines and
BALDINAS”), the choice of contraceptive should be discussed with a doctor.

Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice 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 entails to the unborn child.

Breastfeeding
BALDINAS is not recommended if you are breastfeeding. Melatonin is excreted in breast
milk and the risk to breastfed babies 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. Ask your doctor or pharmacist if you are in
pregnancy or breastfeeding or if you have a liver or kidney disease. This is because large amounts of
benzyl alcohol can 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults with jet lag
The recommended dose is 1-5 mL (equivalent to 1-5 mg) per day for a maximum of 5 days.
The dose may be increased to 5 mg if there is insufficient relief of symptoms at lower doses.
Take the lowest dose that can adequately relieve your symptoms and continue treatment for the
shortest possible period.
The first dose should be taken after arrival at your destination, at the time (local time) when you
usually go to bed. Also, on subsequent days, take BALDINAS at the time you usually
go to bed.
The oral solution should not be taken before 8:00 PM or after 4:00 AM (local time) as
the desired effect may be absent.
BALDINAS can be taken for a maximum of 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) per day to be taken 30-60 minutes before going to
bed.
If you do not observe an improvement in your/your child’s symptoms, the doctor may adjust the dose
up to a maximum of 5 mL (equivalent to 5 mg) per day, regardless of age.
The lowest dose that is effective should be taken for the shortest possible period.
Treatment should be regularly followed up by a doctor (at least every 6 months) to assess whether it is
still appropriate. The doctor should also attempt to interrupt treatment on a regular basis,
at least once a year, to see if it is still necessary.
Method of administration
BALDINAS is for oral use.
The package contains a 5 mL measuring spoon graduated at 1, 2, 3, 4 and 5 mL.
Do not consume food 1 hour before or 1 hour after taking BALDINAS.
Diabetes and impaired glucose tolerance
If you or your child have 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/your child should
If you or your child take an excessive dose of the medicine or if your child has ingested the medicine
by mistake, contact your doctor or pharmacist immediately or go to the emergency room
of the nearest hospital. Bring the bottle and any remaining solution with you. If you have any doubts
about the use of 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 forgotten dose no later than 4:00 AM.
Do not take a double dose to make up for a missed dose.

If you (or your child) stop taking BALDINAS
No harmful effects are known in case of interruption or premature discontinuation of treatment. No
withdrawal symptoms of BALDINAS are known after completion of therapy.
If you have any doubts about the use of 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 or your child experiences any of the following serious side effects, stop taking the
medicine and seek immediate medical attention:

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

• Swelling of the deeper layers of the skin (angioedema)
• Swelling of the mouth and tongue (oedema)

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 and difficulty digesting
• Skin diseases (dermatitis, itching, rash, dry skin)
• Pain in the arms and legs
• Menopause symptoms
• Chest pain
• Glucose excretion in urine, increased protein in urine
• Changes in blood composition that can 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
• Elevated blood fat levels
• Mood swings, aggression, agitation, crying, feeling confused (disorientation), early morning awakening, increased sexual desire (increased libido), depressed mood, depression, stress symptoms
• Fainting, memory problems, attention problems, unpleasant sensation in the legs (restless legs syndrome), poor sleep quality, tingling sensation, fatigue, dreamy state
• Impaired vision, blurred vision, increased tearing
• Feeling of dizziness or spinning (vertigo), dizziness when standing up or sitting down
• Fast heartbeat, chest pain due to angina pectoris Hot flushes
• Acid reflux, gastrointestinal disorders, blistering of the mouth, ulceration of the tongue, vomiting, increased salivation, bad breath, flatulence, abdominal discomfort, inflammation of the stomach lining
• Skin problems (eczema, erythema, hand dermatitis, psoriasis, widespread and itchy rash) and nail problems
• Pain, arthritis, muscle spasms, neck pain, night 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, altered blood electrolyte tests and altered laboratory tests.

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

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

Further side effects in children and adolescents
Side effects generally mild and 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 get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 which is stated on the label and on the packaging after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
After first opening: use within 1 month and store at a temperature below 25°C.
Store in the original container to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BALDINAS contains

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

Description of the appearance of BALDINAS and contents of the pack
This medicine is a transparent solution of colour from light yellow to yellow with a strawberry flavour.
It is supplied in an amber glass bottle of 100 mL or 150 mL, with a plastic screw cap.
A plastic 5 mL measuring spoon graduated at 1, 2, 3, 4 and 5 mL is also provided.
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