Flunox

Package leaflet: Information for the patient

Flunox 15 mg hard capsules, 30 mg hard capsules

Flurazepam monohydrochloride
Read this entire 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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
  Contents of this leaflet:

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

1. What Flunox is and what it is used for

Flunox contains flurazepam, a medicine that produces sedation (physical and mental relaxation) and sleep.
Flunox is indicated for short-term treatment of insomnia.
Only when the condition is severe, disabling, or causes the patient severe distress.
Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Flunox

Do not take Flunox

• if you are allergic to flurazepam or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to benzodiazepines (medicines similar to flurazepam)
• 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 failure)
• if you have severe liver problems (severe hepatic insufficiency)
• if you suffer from a condition causing frequent interruptions in breathing during sleep (sleep apnea syndrome)

Warnings and precautions
Talk to your doctor or pharmacist before taking Flunox.

The duration of treatment should be as short as possible. Your doctor will determine the most appropriate dose and duration of treatment for you and will explain how to gradually reduce the dose before stopping. When stopping Flunox, the symptoms that led to treatment may reappear.
If treatment is prolonged, your doctor may prescribe blood tests and decide whether liver function should also be evaluated.

In particular, consult your doctor if:

• you have long-standing breathing problems (chronic respiratory insufficiency)
• you have previously abused drugs or alcohol
• you are elderly

After repeated use for several weeks, the medicine may partially lose its effectiveness in inducing sleep. This phenomenon is known as tolerance. The use of flurazepam may lead to physical and psychological dependence. This risk is higher with high doses and/or prolonged use of flurazepam, or if you have previously abused alcohol or drugs. In case of dependence on flurazepam, your doctor will stop treatment by gradually reducing the dose of this medicine. Indeed, abruptly stopping treatment may cause withdrawal symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability. In severe cases, derealization (a sensation of altered perception of the external world), depersonalization (a sensation of detachment from one's own body and the external world), hyperacusis (increased auditory sensitivity), numbness and tingling in arms and legs, hypersensitivity to light, noise, and physical contact, hallucinations (seeing or hearing non-existent things), or epileptic seizures (neurological disturbances causing sudden, uncontrollable jerking movements and loss of consciousness) may occur.

Rebound symptoms (when symptoms such as insomnia, which prompted flurazepam treatment, reappear in a more severe form after stopping treatment). Rebound symptoms may be accompanied by other adverse effects such as mood changes, anxiety, restlessness, or sleep disturbances. In some cases, withdrawal symptoms may also occur between doses, especially if you are taking a high dose of Flunox. Your doctor will inform you not to replace this medicine with another similar one, as this may increase the risk of withdrawal symptoms. See sections “If you stop taking Flunox” and “Possible side effects”.

This medicine may cause you to forget events that occur 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
• anger
• nightmares
• hallucinations (seeing or hearing things that do not exist)
• psychosis (thought disturbances)
• behavioral changes

These reactions are more frequent in children and the elderly.

If you are elderly, the risk of experiencing adverse effects increases; therefore, your doctor will prescribe a reduced dose of this medicine (see “How to take Flunox”).

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

Other medicines and Flunox
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, inform your doctor if you are taking the following medicines:

• medicines that reduce the activity of the central nervous system:

  • antipsychotics (medicines for mental disorders)
  • hypnotics (medicines for insomnia)
  • anxiolytics (medicines for anxiety)
  • sedatives (medicines for physical and mental relaxation)
  • antidepressants (medicines for depression)
  • narcotic analgesics (medicines to temporarily and reversibly suppress pain)
  • antiepileptics (medicines for epilepsy)
  • anesthetics (medicines that reduce pain sensitivity and induce sedation)
  • antihistamines (medicines for allergies)

• medicines that affect how the liver works

Opioids: The concomitant use of Flunox and opioid derivatives (strong 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 possible. However, if your doctor prescribes Flunox 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 using 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.

Flunox and alcohol
Avoid consuming alcohol during treatment with Flunox. Alcohol may increase the sedative effect and negatively affect your ability to drive or operate machinery (see section “Driving and using machines”). If you have previously abused alcohol, the risk of developing dependence on Flunox is higher (see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Avoid taking this medicine during the first 3 months of pregnancy.
After the first 3 months of pregnancy, take this medicine only if strictly necessary and under direct medical supervision.

If, for serious medical reasons, this medicine is prescribed at high doses during the last stage of pregnancy or during labor, the newborn may show hypothermia (decreased body temperature), hypotonia (reduced muscle tone), and moderate respiratory depression (ineffective and slow breathing). Furthermore, infants born to mothers who took Flunox for a prolonged period during the later stages of pregnancy may develop physical dependence and may experience withdrawal symptoms after birth.

Avoid breastfeeding during treatment with this medicine, as flurazepam passes into breast milk.

Driving and using machinery
Flunox affects your ability to drive and operate machinery.

Avoid driving or operating machinery requiring particular attention and vigilance if you experience sedation, amnesia, impaired concentration, or altered muscle function.

Additionally, if your sleep duration has been insufficient, the likelihood of impaired vigilance increases.

The sedative effect may increase if you take this medicine with alcohol (see “Flunox and alcohol”).

Flunox contains lactose (milk sugar)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Flunox

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• The usual recommended dose is 1 capsule of 15 mg in the evening before going to bed. After taking this medicine, you must allow a period of approximately 7–8 hours for rest or sleep.
• In more severe cases, your doctor may start your treatment with 1 capsule of 30 mg and, when possible, switch you to the lower dose. In this case, your doctor will explain how to gradually reduce the dose to avoid withdrawal and rebound symptoms. See section “Warnings and precautions”.
• Do not exceed the maximum dose prescribed by your doctor. If you are elderly, your dose will be determined by your doctor. If you suffer from chronic respiratory diseases, your doctor will evaluate whether to reduce the dose of this medicine due to the risk of respiratory depression.

Duration of treatment
The duration of treatment is generally from a few days up to 2 weeks, and up to a maximum of 4 weeks, including a period of gradual discontinuation. Treatment should be as short as possible. In certain cases, your doctor may decide whether to extend the treatment beyond 4 weeks after reassessing your health status.

If you take more Flunox than you should
If you accidentally ingest or take an excessive dose of Flunox, contact your doctor immediately or go to the nearest hospital.
In mild cases, symptoms may include obtundation (reduced sensory and intellectual capacity associated with disorientation), confusion, and lethargy (a state of deep sleep with reduced responsiveness to stimuli).
In more severe cases, symptoms may include ataxia (reduced coordination of movement and gait), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (slow and ineffective breathing), rarely coma, and very rarely death.
An overdose is generally not life-threatening unless you have taken this medicine together with other medicines that reduce central nervous system activity, including alcohol.
If you have taken an excessive dose of Flunox and are conscious, inform your doctor and specify whether you have also taken other medicines or alcohol together with Flunox.

If you forget to take Flunox
Do not take a double dose to make up for the missed capsule.

If you stop taking Flunox
If you have any doubts about using this medicine, consult your doctor or pharmacist.

• Do not stop treatment with Flunox without first consulting your doctor, as abruptly stopping this medicine may cause:
• Withdrawal symptoms, such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
• Rebound symptoms: symptoms such as insomnia, which led to treatment with flurazepam, may return in a more severe form after stopping treatment. These symptoms are especially likely if you have developed physical dependence on this medicine (see section “Warnings and precautions”).
• Your doctor will gradually reduce your dose during the discontinuation phase.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
During treatment, the likelihood of adverse reactions occurring is higher if you are elderly or debilitated.
The possible adverse reactions are listed below:

• daytime drowsiness
• blunting of emotions (reduced ability to experience emotions)
• reduced alertness
• headache
• dizziness
• decreased muscle tone
• ataxia (reduced motor coordination and impaired gait)
• confusion
• fatigue
• double vision

These effects occur mainly at the beginning of treatment and usually disappear with continued use. Flurazepam and similar medicines may also cause reactions such as:

• restlessness
• agitation
• irritability
• aggression
• delirium
• anger
• nightmares
• hallucinations
• psychosis
• behavioural changes

The use of flurazepam or medicines similar to flurazepam may unmask an underlying depression. Rare cases have been reported of:

• nausea
• vomiting
• stomach and intestinal disturbances
• palpitations (awareness of increased heart rate)
• skin rashes
• changes in sexual desire

Additionally, the following may occur:

• anterograde amnesia (difficulty in memorizing information occurring after taking the medicine)
• behavioural disturbances
• physical and psychological dependence

See section “Warnings and precautions”.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Flunox

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 packaging after Exp. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Flunox contains
15 mg capsules

• The active substance is: flurazepam hydrochloride 15 mg
• The other components are: maize starch, lactose (see section “Flunox contains lactose”), talc, anhydrous colloidal silica, magnesium stearate; capsule components: gelatin, red iron oxide, titanium dioxide, black iron oxide.

30 mg capsules

• The active substance is: flurazepam hydrochloride 30 mg
• The other components are: maize starch, lactose (see section “Flunox contains lactose”), talc, anhydrous colloidal silica, magnesium stearate; capsule components: gelatin, red iron oxide, titanium dioxide.

Description of the appearance of Flunox and package contents
Flunox is available as hard capsules of 15 mg or 30 mg for oral use. The 15 mg capsules are packaged in blisters in a carton pack containing 30 capsules. The 30 mg capsules are packaged in blisters in a carton pack containing 20 capsules. Not all pack sizes may be marketed.

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

Manufacturer
Teofarma S.r.l. - Viale Certosa, 8/A - 27100 Pavia