Morfeo

Package Leaflet: Information for the Patient

Morfeo, 10 mg, Hard Capsules

Zaleplon

Read the package leaflet carefully before taking the medicine, 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Morfeo and what is it used for

Morfeo belongs to a group of medicines called benzodiazepine-like drugs, which are sleep-inducing substances.
Morfeo is used for the short-term treatment of insomnia characterized by difficulty falling asleep. The medicine is recommended only for patients with severe disorders that prevent them from leading a normal life or cause significant discomfort.
Treatment usually lasts from a few days to two weeks. If sleep problems persist after stopping the medicine, you should consult your doctor again.

2. Important information before taking Morfeo

When not to take Morfeo:

• if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6)
• if you have sleep apnea (pauses in breathing for short periods during sleep)
• if you have severe kidney or liver function disorders
• if you have myasthenia gravis (muscle weakness or fatigue)
• if you have breathing problems or chest diseases

If you are not sure if any of the above conditions apply to you, consult your doctor.
Morfeo should not be used in children and adolescents under 18 years of age.

Warnings and precautions

Before taking Morfeo, discuss it with your doctor or pharmacist.

• Never drink alcohol during treatment with Morfeo. Alcohol may enhance the sedative effects of all sleep-inducing medicines.
• Be extra careful if you have a history of drug or alcohol addiction.
• When taking sleep-inducing medicines, including Morfeo, there is a risk of developing dependence. In such cases, sudden withdrawal of the medicine may be accompanied by withdrawal symptoms, such as headaches, muscle pain, severe anxiety, tension, restlessness, and irritability.
• Do not take Morfeo, or other sleep-inducing medicines, for longer than your doctor recommends.
• Do not take a second dose of the medicine during the same night.
• If sleep problems do not improve or worsen after starting Morfeo, consult your doctor.
• After taking a sleep-inducing medicine, temporary memory loss (amnesia) and lack of coordination may occur. Therefore, for at least 4 hours after taking the medicine, you should not engage in any activities.
• Somnambulism (sleepwalking), such as eating or driving in a state of incomplete consciousness, may occur, after which you may not remember the event. If such an event occurs, inform your doctor immediately.
• When taking sleep-inducing medicines, symptoms such as anxiety, excitement, irritability, aggression, lack of logical thinking, delusions, outbursts of anger, nightmares, depersonalization, hallucinations, psychosis, inadequate behavior, and other undesirable behavioral reactions and behavioral disorders may occur. These reactions may be caused by the active substance, mental or physical disorders, or may be spontaneous. The likelihood of these reactions is higher in the elderly. If these symptoms occur, consult your doctor immediately.
• Rare cases of severe allergic reactions have been reported. The symptoms of an allergic reaction may include: rash, itching, difficulty breathing, or swelling (edema) of the face, lips, throat, or tongue, nausea, or vomiting. If any of these events occur, inform your doctor immediately.

Children and adolescents

Morfeo should not be used in children and adolescents under 18 years of age.

Elderly patients

Elderly patients may be more sensitive to the effects of sleep-inducing products, and therefore, it is not recommended to use Morfeo 10 mg in this population.

Morfeo and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This also applies to medicines that are available without a prescription. Some of them may cause drowsiness and should not be used during treatment with Morfeo.
Taking Morfeo with other medicines that affect the central nervous system may enhance drowsiness. Remember that such a combination of medicines may also cause drowsiness the next day. These medicines include:

• medicines used in mental disorders (antipsychotics, sleep-inducing, anxiolytic, and/or sedative, antidepressant),
• medicines used to treat severe pain (opioid analgesics),
• medicines used to treat seizures (antiepileptics),
• anesthetics and medicines used to treat allergies (sedating antihistamines).

Tell your doctor if you are taking cimetidine (a medicine used to treat stomach disorders), erythromycin, rifampicin (an antibiotic), carbamazepine, or phenobarbital.
Opioids
Concomitant use of Morfeo and opioids (strong painkillers, medicines used in substitution therapy for addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this risk, concomitant use of these medicines can only be considered when other treatment options are not possible.
If your doctor prescribes Morfeo with opioids, they should limit the dose and duration of concomitant use.
Tell your doctor about all opioid medicines you are taking and strictly follow the dosage recommendations. It may be helpful to inform friends or family about the risk, so they are aware of the possibility of these signs and symptoms. If these symptoms occur, consult your doctor.

Morfeo with food, drink, and alcohol

It is not recommended to take Morfeo during or immediately after a large meal, as the effect of the medicine may be delayed. Swallow the capsule with a small amount of water.
Never drink alcohol during treatment with Morfeo (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Morfeo should not be used during pregnancy and breastfeeding due to the lack of sufficient data on the safety of the medicine during this period.

Driving and using machines

Morfeo may cause drowsiness, impaired concentration or memory, and impaired muscle function. These symptoms may be more severe if you sleep less than 7-8 hours after taking the medicine or if you are already taking another medicine that depresses the central nervous system or if you drink alcohol (see "Morfeo and other medicines"). In such cases, it is not recommended to drive or operate machinery, including the next day.

Morfeo contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.

Morfeo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Morfeo

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adult administration

The usual dose of the medicine is 10 mg per day. Morfeo should be taken immediately before going to bed or after lying down and at least 4 hours before the planned wake-up time.
Do not take a second dose of the medicine during the same night. Do not exceed the recommended daily dose of 10 mg.

Method of administration:

Swallow the capsule with a small amount of water. It is not recommended to take the medicine during or immediately after a meal, as the effect of the medicine may be delayed.

Taking a higher dose of Morfeo than recommended Immediately consult your doctor and inform them of the number of capsules taken. In case of doubts about the use of the medicine, consult your doctor or pharmacist.

Taking too much of the medicine can quickly lead to drowsiness resulting in coma.
After an overdose, the following symptoms may occur:

• drowsiness, disorientation, lethargy,
• ataxia (lack of coordination),
• hypotonia (low blood pressure),
• low blood pressure, breathing difficulties,
• rarely coma and very rarely death.

Missing a dose of Morfeo

If you miss a dose, take the next capsule at the usual time and continue taking the medicine as before. Do not take a double dose to make up for the missed dose.

Stopping treatment with Morfeo

After stopping the treatment, the initial insomnia may return, and symptoms such as mood changes, anxiety, and restlessness may occur. If these symptoms occur, consult your doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Morfeo can cause side effects, although not everybody gets them.
If you experience any of the following side effects or any other changes in your health, inform your doctor as soon as possible.
The frequency of side effects is defined as follows:

Common(occurring in more than 1 in 100, but less than 1 in 10 patients):

• drowsiness
• memory disorders
• tingling sensation, e.g., in limbs (paresthesia)
• painful menstruation

Uncommon(occurring in more than 1 in 1000, but less than 1 in 100 patients):

• dizziness
• weakness
• coordination disorders
• balance disorders and/or loss of balance (ataxia)
• decreased concentration
• apathy
• depression
• disorientation
• depersonalization (feeling of detachment or separation from oneself and reality)
• hallucinations
• double vision or other vision problems
• increased sensitivity to noise (hyperacusis)
• smell disorders (olfactory hallucinations)
• speech disorders, including slurred speech
• visual field disorders
• numbness, e.g., of limbs (hypoesthesia)
• nausea
• decreased appetite
• increased sensitivity to light (photosensitivity)
• malaise

Rare(occurring in less than 1 in 10,000 patients):

• allergic reactions (sometimes severe), sometimes breathing difficulties, requiring immediate medical attention. The symptoms of an allergic reaction may also include rash, itching, or swelling of the face, lips, throat, or tongue.

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

• blood tests have shown elevated levels of transaminases (a group of liver enzymes), which may indicate liver function disorders
• somnambulism
• angioedema

Psychological and paradoxical reactions
It is known that after taking benzodiazepines or products with similar effects to benzodiazepines, the following symptoms may occur: anxiety, excitement, irritability, decreased inhibition, aggression, lack of logical thinking, delusions, outbursts of anger, nightmares, depersonalization, hallucinations, psychosis, inadequate behavior, behavior inconsistent with the person's character, extroverted behavior, and other undesirable behavioral reactions and behavioral disorders.
These reactions are more likely to occur in the elderly.
If any of the side effects worsen or other side effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Morfeo

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Morfeo contains

• The active substance of the medicine is zaleplon. Each capsule contains 10 mg of zaleplon.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, magnesium stearate. Capsule shell: gelatin, iron oxide black (E 172), erythrosine (FD&C red 3) (E 127), iron oxide red (E 172), titanium dioxide (E 171), indigo carmine (FD&C blue 2) (E 132).

What Morfeo looks like and contents of the pack

Morfeo 10 mg is a turquoise-pink hard capsule.
The capsules are packed in PVC/Aluminum blisters with a leaflet, in a cardboard box.
The pack contains: 10, 20, or 30 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: