Madar

Package leaflet: Information for the patient

Madar 10 mg coated tablets

nordazepam
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Madar is and what it is used for

Madar contains nordazepam, a benzodiazepine, and is indicated for the treatment of insomnia. Madar
should be used only when the disorder is severe, disabling and causes severe distress.

2. What you need to know before taking Madar

Do NOT take Madar

• if you are allergic to nordazepam or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a nerve and muscle disorder causing muscle weakness and fatigue (severe myasthenia gravis)
• if you have severe breathing problems (severe respiratory insufficiency)
• if you have severe liver problems (severe hepatic insufficiency)
• if you suffer from a condition causing frequent interruptions in breathing during sleep (sleep apnoea syndrome)

Warnings and precautions
Talk to your doctor or pharmacist before taking Madar.
Treatment with Madar must be carried out under direct medical supervision and should last for the shortest possible time. Your doctor will determine the most appropriate dose and duration of treatment for you. Treatment should be short-term, and your doctor will explain how to gradually reduce the dose before stopping.
When discontinuing Madar, the symptoms that led to treatment may reappear.
If treatment is prolonged, your doctor may prescribe blood tests and liver function checks.
Talk to your doctor:

• if you are elderly
• if you have long-standing breathing problems (chronic respiratory insufficiency)
• if you have a history of drug or alcohol abuse

This medicine may cause people to forget events occurring after taking it (anterograde amnesia). If any of the following adverse reactions occur, the medicine should be discontinued; therefore, contact your doctor if you experience:

• restlessness
• agitation
• irritability
• aggression
• delirium (misinterpretation of reality)
• rage
• nightmares
• hallucinations (seeing or hearing things that do not exist)
• psychosis (thought disorders)
• behavioral changes

After repeated use for several weeks, the medicine may lose its effectiveness in inducing sleep.
The use of benzodiazepines may lead to physical and psychological dependence on these medicines. The risk of dependence increases with dose and duration of treatment and is more common in patients with a history of drug or alcohol abuse.
Once physical dependence has developed, abruptly stopping treatment may result in withdrawal symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: derealization (feeling detached from the external world), depersonalization (feeling detached from one's own body), hyperacusis (increased sensitivity to sound), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures (neurological disturbances causing sudden, uncontrollable shaking movements without consciousness).

After stopping treatment, insomnia and anxiety may temporarily reappear, sometimes in a worsened form. In addition, other disturbances may arise, such as mood changes, restlessness, or sleep disturbances.
Since the risk of withdrawal or rebound symptoms is higher after abrupt discontinuation of treatment, your doctor will explain how to gradually reduce the dose until stopping completely.

Your doctor will evaluate the use of Madar in children and will prescribe it only if strictly necessary. The duration of treatment should be as short as possible.

Other medicines and Madar
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine. Inform your doctor if you are being treated with:

• antipsychotics (medicines used to treat mental disorders)
• hypnotics (medicines that induce sleep)
• anxiolytics or sedatives (medicines that reduce anxiety or cause sedation)
• antidepressants (medicines for the treatment of depression)
• narcotic analgesics (used to relieve pain)
• antiepileptics (medicines for the treatment of epilepsy, a condition characterized by uncontrollable body movements and loss of consciousness)
• anesthetics (medicines that reduce pain sensitivity and induce hypnosis)
• antihistamines (medicines used to treat allergies)

Concomitant use of Madar and opioid derivatives (potent painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes Madar together with another opioid derivative, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all opioid-derived medicines you are taking and strictly follow the dosing instructions provided by your doctor. It may be helpful to inform family members and friends to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur.

Madar and alcohol
Do not consume alcohol during treatment with Madar. Alcohol may increase the sedative effects of this medicine and impair your ability to drive or operate machinery.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Ask your doctor for advice regarding discontinuation of the medicine if you become pregnant or wish to become pregnant during treatment.
Do not take Madar during the first three months of pregnancy. After the first trimester, your doctor will prescribe Madar only if clearly needed.
If this medicine is prescribed at high doses for serious medical reasons during the last stage of pregnancy or during labor, the newborn may show at birth: hypothermia (low body temperature), hypotonia (reduced muscle tone), and moderate respiratory depression (slow and ineffective breathing).
Furthermore, the newborn may experience withdrawal and dependence symptoms at birth and in the following period.

Breastfeeding
Benzodiazepines are excreted in breast milk. Breastfeeding is not recommended while taking Madar.

Driving and using machines
Madar impairs the ability to drive or operate machinery.
Sedation, amnesia, impaired concentration, and altered muscle function may negatively affect your ability to drive or use machinery. If sleep duration has been insufficient, the likelihood of impaired alertness may be increased.

Madar contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Madar

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take one Madar tablet in the evening, before going to bed, or as otherwise prescribed by your
doctor.
Treatment for insomnia should be as short as possible. The duration of treatment varies from a few
days to two weeks, up to a maximum of four weeks, including a gradual withdrawal period.
In certain cases, after reassessing your health status, your doctor may decide to extend the treatment
duration indicated above.
Treatment should be initiated with the lowest recommended dose.
Do not exceed the maximum dose.
Your doctor will determine the appropriate dose and will evaluate whether a dose reduction is necessary if you:

• are elderly or debilitated
• have liver or kidney problems
• have brain disorders, such as arteriosclerotic disease
• have respiratory problems

At the beginning of treatment, you will be closely monitored by your doctor, who will prescribe the dose most suitable for your clinical condition.

If you take more Madar than you should
An overdose should not generally be life-threatening, unless it is taken together with other medicines acting on the brain (including alcohol). In case of accidental ingestion/overdose of Madar, contact your doctor immediately or go to the nearest hospital. Symptoms of overdose may include:

• mental confusion (impaired intellectual abilities)
• confusion
• lethargy (deep sleep and reduced response to stimuli)
• ataxia (reduced motor coordination and gait instability)
• hypotonia (reduced muscle tone)
• hypotension (low blood pressure)
• respiratory depression (slow and ineffective breathing)
• coma (loss of consciousness)
• death.

If you forget to take Madar
Do not take a double dose to make up for the missed dose.
If you stop taking Madar
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Do not stop treatment with Madar abruptly, as withdrawal or rebound symptoms may occur, meaning a worsening of the symptoms that led to starting treatment (see section “Warnings and precautions”). The dose of Madar must be gradually reduced. Consult your doctor before stopping treatment with Madar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur during treatment:

• daytime drowsiness
• emotional blunting (reduced ability to feel emotions)
• reduced alertness
• confusion
• fatigue
• headache
• dizziness
• muscle weakness
• ataxia (reduced motor and gait coordination)
• double vision.

These effects occur mainly at the beginning of treatment and usually disappear with continued administration. Other adverse reactions have been reported occasionally, including:

• gastrointestinal disturbances
• changes in sexual desire
• skin reactions

Rare cases have been reported of:

• constipation
• urinary incontinence
• tremors
• skin rashes
• hypotension (low blood pressure)
• paradoxical excitation states (unexpected excitement)
• nausea.

These effects usually disappear spontaneously within a few days or after adjusting the dose. Additionally, anterograde amnesia (difficulty in memorizing new information after taking the medicine) and behavioural changes may occur. The use of benzodiazepines may unmask a pre-existing depressive state. Benzodiazepines may cause reactions such as:

• restlessness
• agitation
• irritability
• aggressiveness
• delirium (misinterpretation of reality)
• anger
• nightmares
• hallucinations (seeing or hearing things that do not exist)
• psychosis (thought disorders)
• behavioural changes.

These reactions can be quite severe and are more likely in children and elderly patients.

Dependence
The use of benzodiazepines (even at therapeutic doses) may lead to physical dependence. Stopping treatment may worsen symptoms or cause withdrawal symptoms (see section “Warnings and precautions”). Psychological dependence may also occur. Abuse of benzodiazepines has been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 Madar

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Madar contains

• The active substance is nordazepam. Each coated tablet contains 10.0 mg of nordazepam.
• The other components are corn starch, light calcium carbonate, microcrystalline cellulose, carnauba wax, beeswax, colour E 132, gelatin, arabic gum, lactose, magnesium stearate, polyethylene glycol 4000, povidone, sucrose, talc.

Description of the appearance of Madar and the contents of the package
Each package contains 25 coated tablets.

Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer and responsible for final control
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia