Morfeo

Package leaflet: Information for the patient

Morfeo, 10 mg, hard capsules
Zaleplon
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.

Table of contents

1. What Morfeo is and what it is 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 Morfeo is and what it is used for

Morfeo belongs to a group of medicines known as benzodiazepine-like drugs, which are
substances with hypnotic (sleep-inducing) action.
Morfeo is a medicine used for the short-term treatment of insomnia characterized by difficulty
in falling asleep. It is recommended only for patients with severe disturbances that
prevent normal daily life or cause significant distress.
Treatment usually lasts from a few days up to two weeks. If sleep problems persist after
stopping the medicine, you should contact your doctor again.

2. Important information before using Morfeo

When not to take Morfeo:

• if the patient is allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6)
• if the patient has sleep apnoea (pauses in breathing for short periods during sleep)
• if the patient has severe kidney or liver problems
• if the patient has myasthenia gravis (muscle weakness or fatigue)
• if the patient has breathing problems or chest diseases

If the patient is unsure whether any of the above conditions apply, medical advice should be sought.
Morfeo must not be used in children and adolescents under 18 years of age.

Warnings and precautions
Before starting treatment with Morfeo, discuss it with your doctor or pharmacist.

• Alcohol must never be consumed during treatment with Morfeo. Alcohol may increase the adverse effects of all sleep medicines.
• Extreme caution is required if the patient has previously been dependent on drugs or alcohol.
• When using medicines belonging to the group of hypnotics, including Morfeo, there is a risk of developing dependence. In such cases, abrupt discontinuation of the medicine may be accompanied by withdrawal symptoms such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability.
• Morfeo or other sleeping medicines must not be taken for longer than prescribed by the doctor.
• A second dose of the medicine must not be taken during the same night.
• If insomnia symptoms do not improve or worsen within a short time after starting Morfeo, contact your doctor.
• Temporary memory loss (amnesia) and lack of coordination may occur after taking a sleeping medicine. Therefore, the patient should not engage in any activities for at least 4 hours after taking the medicine.
• Sleepwalking (somnambulism) may occur, for example, eating or driving a vehicle while not fully awake, with no memory of the event afterwards. If such an event occurs, inform your doctor immediately.
• During treatment with sleeping medicines, symptoms such as restlessness, excitement, irritability, aggression, inability to think logically, hallucinations, outbursts of anger, nightmares, depersonalization, illusions, psychosis, inappropriate behaviour, extraversion inconsistent with the person's character, and other undesirable behavioural reactions and behavioural disorders may occur. These reactions may be caused by the active substance, or by mental or physical disorders, or may occur spontaneously. The likelihood of such reactions is higher in elderly patients. If these symptoms occur, contact your doctor immediately.
• Rare cases of severe allergic reactions have been reported. Symptoms of an allergic reaction may include: rash, itching, difficulty breathing, or swelling (oedema) of the face, lips, throat or tongue, nausea or vomiting. If any of these events occur, contact your doctor immediately.

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

Elderly patients
Elderly patients may be more sensitive to the effects of sleeping medicines, and therefore use of Morfeo 10 mg is not recommended in this population.

Morfeo with other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines you plan to take. This includes medicines available without a prescription. Some of these may cause drowsiness and should not be used during treatment with Morfeo.
Taking Morfeo together with other medicines affecting the central nervous system may increase drowsiness. It should be noted that such combination may also cause drowsiness the following day. These medicines include:

• medicines used in mental disorders (antipsychotics, hypnotics, anxiolytics and/or sedatives, antidepressants),
• medicines used to treat severe pain (opioid analgesics),
• medicines used in the treatment of seizures (antiepileptics),
• anaesthetics and medicines used to treat allergies (antihistamines with sedative effect).

Inform your treating doctor or pharmacist if you are taking cimetidine (a medicine used for stomach disorders), erythromycin, rifampicin (antibiotic), carbamazepine, or phenobarbital.

Opioids
Concomitant use of Morfeo and opioids (strong painkillers, medicines used in substitution treatment of addiction, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Due to the described risks, concomitant use of these medicines should be considered only when other treatment options are not possible.
If your doctor prescribes Morfeo together with opioids, the dose and duration of concomitant use should be minimized.
Inform your doctor about all opioid medicines you are taking and strictly follow dosing instructions. It may be helpful to inform friends or family about the risks so they are aware of the possible signs and symptoms. If such symptoms occur, contact your doctor immediately.

Morfeo, food, drink and alcohol
It is not recommended to take Morfeo during or immediately after a heavy meal, as the effect of the medicine may be delayed. Swallow the capsule with a small amount of water.
Alcohol must never be consumed during treatment with Morfeo (see section: "Warnings and precautions").

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Morfeo should not be used during pregnancy and breastfeeding due to insufficient data on safety during these periods.

Driving and using machines
Morfeo may cause drowsiness, impaired concentration or memory, and disturbances in muscle function. These symptoms may worsen if the patient sleeps less than 7–8 hours after taking the medicine, or if the patient is already taking another medicine that depresses the central nervous system, or if alcohol is consumed (see: "Morfeo with other medicines"). In such cases, driving or operating machinery, including the following day, is not recommended.

Morfeo contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Morfeo

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Use in adults
The usual dose is 10 mg once daily. Morfeo should be taken only immediately before going to bed or after going to bed, and at least 4 hours before the planned time of waking up.
A second dose must not be taken during the same night. The daily dose should not exceed 10 mg.
Method of administration:
The capsule should be swallowed whole with a small amount of water. It is not recommended to take the medicine during or immediately after a meal, as this may delay its effect.
Accidental overdose of Morfeo
Seek immediate medical advice and inform the doctor about the number of capsules taken. If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Taking too high a dose may rapidly lead to drowsiness progressing to coma.
Symptoms of overdose may include:

• drowsiness, disorientation, lethargy,
• ataxia (lack of coordination),
• hypotonia (reduced muscle tone),
• hypotension, respiratory disturbances,
• rarely coma and very rarely death.

Missed dose of Morfeo
If you miss a dose, take the next capsule at your usual time and continue as before. Do not take a double dose to make up for a missed dose.
Stopping Morfeo
After discontinuation of the medicine, the original 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following reactions occur, or other changes in health status, inform your doctor as quickly as possible.
The frequency of adverse reactions has been defined as follows:

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

• drowsiness
• memory disturbances
• tingling sensations, e.g., in limbs (paraesthesia)
• painful menstruation

Uncommon (occurring in more than 1 in 1,000 but less than 1 in 100 patients):

• dizziness
• weakness
• motor coordination disturbances
• disturbances and/or loss of balance (ataxia)
• reduced concentration
• apathy
• depression
• disorientation
• depersonalization (feeling detached or separated from oneself and reality)
• hallucinations
• double vision or other vision problems
• increased sensitivity to noise (hyperacusis)
• disturbances of smell (olfactory hallucinations)
• speech disturbances, including slurred speech
• visual field disturbance
• numbness, e.g., in limbs (hypoesthesia)
• nausea
• decreased appetite
• increased sensitivity to light (sunlight, UV rays)
• malaise

Very rare (occurring in fewer than 1 in 10,000 patients):

• allergic reactions (sometimes life-threatening), occasionally breathing difficulties, requiring immediate medical intervention. Symptoms of allergic reaction may also include rash, itching, or swelling of the face, lips, throat, or tongue.

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

• elevated transaminase levels (a group of liver enzymes) observed in blood tests, which may indicate liver function disturbances
• sleepwalking
• angioedema

Psychiatric and paradoxical reactions
It is known that after taking benzodiazepines or products with benzodiazepine-like effects, the following symptoms may occur: anxiety, agitation, irritability, lowered inhibition, aggression, inability to think logically, delusions, angry outbursts, nightmares, depersonalization, hallucinations, psychoses, inappropriate behaviour, behaviour inconsistent with the person's character, extroverted behaviour, and other behavioural effects.
The occurrence of such symptoms is more likely in elderly individuals.
If any of the adverse reactions worsen, or if other adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Morfeo

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation:
EXP.
The expiry date refers to the last day of the stated month.
Medicines must 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 Morfeo contains

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

What Morfeo looks like and contents of the pack
Morfeo 10 mg is turquoise-pink hard capsules.
The capsules are packed in PVC/Aluminum blisters with a leaflet, in a cardboard box.
Pack contents: 10, 20 or 30 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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