Voquili

Package Leaflet: Information for the User

VOQUILY, 1 mg/mL, Oral Solution

Melatonin

Read the Leaflet Carefully Before Taking the Medicine or Giving it to a Child, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you or your child experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is VOQUILY and what is it used for

VOQUILY contains the active substance melatonin, which is a hormone produced naturally in the body. This hormone helps regulate the body's circadian rhythm. VOQUILY may be used for insomnia in children and adolescents (6-17 years) with Attention Deficit Hyperactivity Disorder (ADHD) when sleep hygiene measures have been unsuccessful.

2. Important information before taking VOQUILY

When not to take VOQUILY

Warnings and precautions

Before taking VOQUILY, discuss with your doctor or pharmacist

Children under 6 years of age

This medicine should not be given to children under 6 years of age, as safety and efficacy have not been established.

VOQUILY and other medicines

Tell your doctor or pharmacist about all medicines you or your child are taking, or have recently taken, and about any medicines you plan to take. This includes:

• fluvoxamine (used to treat depression and obsessive-compulsive disorders), as it may increase the effect of melatonin
• psoralens (used to treat skin diseases, such as psoriasis), as psoralens may increase the effect of melatonin
• cimetidine (used to treat stomach disorders such as ulcers), as cimetidine may increase the effect of melatonin
• estrogens (used in contraceptive medicines and hormone replacement therapy), as estrogens may increase the effect of melatonin
• quinolones (used to treat bacterial infections), as quinolones may increase the effect of melatonin
• rifampicin (used to treat bacterial infections), as rifampicin may reduce the effect of melatonin
• smoking, which may reduce the effect of melatonin
• carbamazepine (used to treat epilepsy), as carbamazepine may reduce the effect of melatonin
• beta-blockers (used to treat high blood pressure), as these medicines may reduce the effect of melatonin
• nifedipine (used to treat high blood pressure), as melatonin may reduce the effect of nifedipine
• benzodiazepine and non-benzodiazepine sedatives (medicines used to induce sleepiness, e.g. midazolam, temazepam, zaleplon, zolpidem, zopiklon), as melatonin may increase the sedative effect of these medicines and increase some side effects of zolpidem (morning sleepiness, nausea, confusion)
• warfarin (an anticoagulant medicine), as melatonin may affect the anticoagulant effect of warfarin
• thioridazine (used to treat mental disorders/mood disorders), as both medicines taken together may increase sleepiness and make it difficult to perform tasks
• imipramine (used to treat mental disorders/mood disorders), as both medicines taken together may increase sleepiness and make it difficult to perform tasks
• caffeine (a stimulant), as melatonin interacts with caffeine.

Taking VOQUILY with food, drink, and alcohol

• Do not drink alcohol before taking VOQUILY, during treatment, or after taking it, due to increased sleepiness when taking alcohol with melatonin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Contraceptive measures for women and girls of childbearing age Women and girls of childbearing age should use contraceptive measures while taking VOQUILY. As some contraceptive measures may increase melatonin levels in the body, the choice of contraceptive method should be discussed with a doctor (see "VOQUILY and other medicines"). Pregnancy Do not take VOQUILY if you are pregnant. Melatonin passes through the placenta, and there is insufficient information on the possible risk to the unborn child. Breastfeeding Do not take VOQUILY if you are breastfeeding. Melatonin passes into human milk, and it cannot be excluded that it may affect the breastfed child.

Driving and using machines

VOQUILY may cause sleepiness and reduced alertness for several hours after taking. Therefore, do not take this medicine before driving or operating machinery.

VOQUILY contains sorbitol and propylene glycol

This medicine contains 140 mg of sorbitol in 1 mL. Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should contact your doctor before taking this medicine. This medicine contains 150 mg of propylene glycol in 1 mL.

3. How to take VOQUILY

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended starting dose is 1-2 mL (1-2 mg) 30-60 minutes before bedtime. The dose is determined individually, up to a maximum of 5 mL (5 mg) per day, regardless of age. Use the smallest possible dose. Treatment should be regularly reviewed by a doctor (at least every 6 months) to assess whether it is still necessary. Treatment should be interrupted once a year to check if it is still necessary. DiabetesIf you have diabetes or glucose tolerance disorders, do not eat for 2 hours before taking VOQUILY and for 2 hours after taking it, see "Warnings and precautions".

Instructions for use

VOQUILY should be swallowed with a glass of water. Do not eat for 1 hour before taking the medicine and for 1 hour after taking it. A 10 mL oral syringe with 0.5 mL gradations and a "push-in" adapter for the bottle are included with the product.

• Open the bottle and, when using it for the first time, push the adapter into the bottle opening (1-2).
• Insert the syringe into the adapter (2-3) and turn the bottle upside down.
• Draw up the correct volume of medicine from the inverted bottle (4).
• Put the bottle back upright and remove the filled syringe from the adapter (5).
• Slowly push the contents of the syringe into the mouth and swallow the medicine (6).
• Clean the syringe and close the bottle with the cap (the adapter remains in place).

Taking more VOQUILY than you should

If you or your child accidentally take too much of this medicine, or if, for example, a child swallows some by mistake, contact a doctor or pharmacist immediately. The most common symptoms of overdose are: sleepiness, headache, dizziness, and nausea.

Forgetting to take VOQUILY

If you forget to take a dose before bedtime and wake up during the night, you may take the missed dose, but no later than 4:00 a.m. Do not take a double dose to make up for a forgotten dose.

Stopping VOQUILY treatment

No harmful effects have been reported with stopping or ending treatment. It has not been shown that taking VOQUILY causes any withdrawal effects after treatment is stopped. If you have any further questions about the use of this medicine, ask 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 experience any of the following serious side effects, tell your doctor immediately and stop taking this medicine.

Frequency not known

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

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

• Headache
• Sleepiness

Uncommon side effects(may affect up to 1 in 100 people)

• Irritability, nervousness, restlessness, insomnia
• Unusual dreams, nightmares, night sweats, anxiety, anxiety disorder, weakness, lack of energy and enthusiasm
• Migraine
• Dizziness
• High blood pressure
• Abdominal pain, mouth ulcers, dry mouth, nausea
• Skin disorders (dermatitis, itching, rash, dry skin)
• Pain in hands and feet
• Menopausal symptoms
• Chest pain
• Glucose in urine, excessive protein in urine
• Blood changes that may cause yellowing of the skin and eyes
• Abnormal liver function tests
• Weight gain

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

• Shingles (herpes zoster)
• Decreased white blood cell count
• Decreased platelet count
• Low calcium or sodium levels in the blood
• High fat levels in the blood
• Mood changes, aggression, restlessness, crying, tension, disorientation, premature waking, increased sex drive, decreased mood, depression
• Fainting, memory disorders, concentration disorders, sleepiness, unpleasant feeling in the legs (restless legs syndrome), poor sleep quality, fatigue
• Vision disorders, blurred vision, increased tearing
• Feeling of dizziness or spinning (of labyrinthine origin), dizziness when standing up or sitting down
• Rapid heartbeat, chest pain due to angina
• Acid reflux, stomach and intestine disorders, mouth ulcers, tongue ulcers, stomach upset, vomiting, unusual bowel sounds, increased saliva production, bad breath, bloating, feeling of discomfort in the abdomen, stomach inflammation
• Unusual skin sensations (paresthesia), skin disorders (rash, redness, psoriasis), nail disorders, sudden feeling of heat (hot flashes)
• Pain, joint inflammation, muscle cramps, neck pain, nocturnal cramps
• Excessive urination, presence of red blood cells in urine, need to urinate at night
• Prolonged erection (priapism), prostate swelling (prostatitis)
• Thirst
• Increased liver enzyme levels, abnormal electrolyte levels in the blood, abnormal laboratory test results

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

• Spontaneous milk flow from the breast (also in men)

Additional side effects in children and adolescentsThe reported side effects, mostly mild, had a low frequency. The most common side effects were headache, hyperactivity, feeling of dizziness or "spinning" (of labyrinthine origin), and abdominal pain. No serious side effects were observed.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact details for reporting side effects" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VOQUILY

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 carton and on the label after "Expiry date". The expiry date refers to the last day of that month. Store in the original package to protect from light. There are no special storage instructions for this medicine. Shelf-life after first opening: 6 months. 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 protect the environment.

6. Contents of the pack and other information

What VOQUILY contains

• 1 mL of the medicine contains 1 mg of melatonin.
• The other ingredients are:
• Propylene glycol, liquid sorbitol 70% (non-crystallizing), sucralose, strawberry flavor (containing propylene glycol), purified water, concentrated hydrochloric acid (for pH adjustment).

What VOQUILY looks like and contents of the pack

VOQUILY is a clear, colorless to yellowish solution with a strawberry flavor. The medicine is packed in an orange glass bottle with a child-resistant plastic cap and a tamper-evident seal. Each carton contains a 10 mL oral syringe with 0.5 mL gradations and a "push-in" adapter for the bottle. Pack sizes: 60 mL or 150 mL. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Clinigen Healthcare B.V.
Schiphol Boulevard 359
WTC Schiphol Airport
D Tower 11 floor
1118BJ Schiphol
Netherlands
Tel.: +48223075718

Manufacturer

Rafarm S.A.
Thesi Pousi-Xatzi
Agiou Louka
Paiania Attiki
19002 Paiania Attiki
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
VOQUILY 1 mg/ml Lösung zum Einnehmen
Belgium
Voquily 1 mg/ml drank solution buvable Lösung zum Einnehmen
France
VOQUILY 1 mg/ml solution buvable
Germany
VOQUILY 1 mg/ml Lösung zum Einnehmen
Hungary
VOQUILY 1 mg/ml belsőleges oldat
Ireland
Voquily 1 mg/ml oral solution
Italy
VOQUILY 1 mg/ml soluzione orale
Netherlands
VOQUILY 1 mg/ml drank
Poland
VOQUILY
Spain
VOQUILY 1 mg/ml solución oral
Sweden
Voquily

Date of last revision of the leaflet: