Melacryst 3 mg 20 oro-dispersible film

Melacryst 3 mg 20 dispersible films

Description:

Oral soluble films containing melatonin 3 mg are useful in the treatment of sleep disorders, such as the late sleep phase. They also provide relief from insomnia and sleep disturbance.

It is used to treat insomnia and improve sleep disorders in the circadian rhythm. It is taken under the supervision of the attending physician.

Ingredients:

Each Film Contains:

Melatonin 3 mg

Indications:

• Helps increase the total sleep time (aspect of sleep quality) in people suffering from sleep restriction or altered sleep schedule, e.g. shift-work and jet lag.

• is indicated as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

Properties:

-Has been shown to be a safe and effective method to improve sleep onset latency, duration and quality.

-Produced a statistically significant improvement in sleep efficiency and wake time after sleep onset was shorter. Sleep latency decreased.

-Mimicking natural response to endogenous Melatonin.

-Faster onset of action due to higher bioavailability than any other exogenous form.

-Naturally occurring sleeping aid.

-No rebound, withdrawal or 'hangover' effects.

-No CNS depressing action.

-Non-addictive, Non-scheduled, without abuse potential.

-Easy administration and No water needed.

Method of administration:

The Orodispersible film should be taken orally. It should be placed on the tongue where it dissolves rapidly, so that it can be easily swallowed with or without water, according to patient preference.

Dosage:

Adults: Dissolve one Orodispersible on the tongue daily at bedtime.

Directions for use:

Important: Do not handle the Orodispersible film with wet hands!

a) Take the pouch, locate the arrow mark at top of the pouch sides and hold the pouch with this side facing up. The pouch is sealed here.

b) Gently peel both parts of the pouch apart at the arrow mark. Now you can hold each between your thumb and your index finger using one hand for each part.

c) Carefully tear both parts of the pouch into opposite directions until they are separated. The Orodispersible film is now visible and placed on one of the separated pouch parts.

d) Take the Orodispersible film with dry fingers out of the pouch and put it in your mouth directly on your tongue. It will dissolve rapidly, so that it can be easily swallowed. Water may be used if desired.

Contraindications:

• Patients with known hypersensitivity to Melatonin or any of the excipients.

• Patients taking immunosuppressive drugs.

• Pregnancy and breastfeeding.

• Patients should not drive or use machinery for 5 hours after taking melatonin.

Special warnings and precautions for use:

Melacryst may cause drowsiness. Therefore the product should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety.

If symptoms persist continuously for more than 4 weeks (chronic insomnia), patients should consult their health care practitioner. Patients should consult a healthcare practitioner prior to use if they have liver or kidney disease.

Pregnancy:

In view of the lack of clinical data, use in pregnant women and by women intending to become pregnant is not recommended.

Breastfeeding:

Endogenous melatonin was measured in human breast milk thus exogenous melatonin is probably secreted into human milk. Breast-feeding is not recommended in women under treatment with melatonin.

Effects on ability to drive and use machines:

Patients should not drive or use machinery for 5 hours after taking melatonin.

Side Effects:

Very Rare:

Intablity, nervousness, restlessness, Insomnia, abnormal dreams, nightmares, anxiety

Mood altered, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, libido increased, depressed mood, Migraine, headache, Syncope, memory lethargy, psychomotor impairment, hyperactivity, disturbance in dizziness, somnolence attention, dreamy state, restless legs syndrome, poor quality sleep,Visual acuity reduced, vision blurred, Vertigo positional.

Dermatis, Eczema, erythema, Angioedema, sweats, rash, hand dermatitis, pruritus generalized,psoriasis, rash, dry skin.

Neck pain, night cramps, Asthenia, chest pain, Fatigue, pain, thirst, Liver function test abnormal, weight increased.

Storage:

Store at a temperature not exceeding 30°C, in a dry place, out of reach of children.

Package:

Carton box containing 20 orodispersible film each oro-dispersible film packed in a four layer pouch from outside to inside + inner leaflet.