FLUNOX 30 mg Hard Capsule

Зміст інструкції

1. Flunox 15 mg hard capsules, 30 mg hard capsules
   1. What is Flunox and what is it used for?
   2. What you need to know before you take Flunox
   3. How to take Flunox
   4. Possible side effects
   5. How to store Flunox
   6. Contents of the pack and other information

Flunox 15 mg hard capsules, 30 mg hard capsules

Flurazepam hydrochloride

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Flunox and what is it used for?

Flunox contains flurazepam, a medicine that induces sedation (physical and mental relaxation) and sleep.
Flunox is indicated for the short-term treatment of insomnia.
only when the disorder is severe, disabling, or subjects the individual to severe distress.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Flunox

Do not take Flunox

• if you are allergic to flurazepam or 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 disease that causes muscle weakness and fatigue (myasthenia gravis)
• if you have serious breathing problems (severe respiratory failure) if you have serious liver problems (severe hepatic failure)
• if you suffer from a condition that causes frequent interruptions of breathing during sleep (sleep apnea syndrome) Warnings and precautionsConsult your doctor or pharmacist before taking Flunox.

The duration of therapy should be as short as possible. The doctor will establish the dose and duration of treatment
most suitable for you and will explain how to gradually reduce the dose until discontinuation. When stopping Flunox, the symptoms that led to treatment may reappear.
In case of prolonged treatment, the doctor will prescribe blood tests and decide whether it will also be
necessary to evaluate liver function.
In particular, consult your doctor if:

• you have suffered from breathing problems for a long time (chronic respiratory failure)
• 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 called tolerance. The use of flurazepam can develop physical and psychological dependence. This risk is greater with the use of high doses and/or for prolonged periods of flurazepam or if you have previously abused alcohol or drugs. In the case of dependence on flurazepam, the doctor will stop the treatment by gradually reducing the dose of this medicine. Abrupt discontinuation of treatment can, in fact, cause withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, derealization (sensation of altered perception of the external world), depersonalization (sensation of detachment from one's body and the external world), hyperacusis (increased auditory sensitivity), numbness and tingling in arms and legs, hypersensitivity to light, noise, physical contact, hallucinations (seeing or hearing things that do not exist) or epileptic seizures (neurological alterations that cause sudden and uncontrollable shaking movements and a state of unconsciousness) may occur. rebound symptoms(when the symptoms, such as insomnia, that led to treatment with flurazepam 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 in the interval between one dose and the next, especially if you are taking a high dose of Flunox. The doctor will inform you that you should not 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 can make you forget things that happen after taking it (anterograde amnesia). If you experience the following adverse reactions, 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 disorders)
• behavioral changes These reactions are more common in children and the elderly.

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

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

Other medicines and Flunox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking the following medicines:

• medicines that reduce the activity of the central nervous system::
• antipsychotics (medicines to treat mental disorders)
• hypnotics (medicines for insomnia)
• anxiolytics (medicines to treat anxiety)
• sedatives (medicines for physical and mental relaxation)
• antidepressants (medicines to treat depression)
• narcotic analgesics (medicines to temporarily and reversibly suppress pain).
• antiepileptics (medicines to treat epilepsy)
• anesthetics (medicines that reduce pain sensitivity and induce sedation),
• antihistamines (medicines for allergies) medicines that affect liver function Opioids:The concomitant use of Flunox and opioid derivatives (potent painkillers, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not 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. Tell your doctor about all opioid-derived drugs you are taking and strictly follow your doctor's dosage instructions. It may be helpful to inform relatives and friends to be aware of the signs and symptoms above. Contact your doctor if these symptoms occur. Flunox with alcoholAvoid drinking alcohol during treatment with Flunox. Alcohol can increase rand the sedative effect and negatively affect the ability to drive or operate machinery (see section “Driving and using machines”). If you have previously abused alcohol, the risk of developing a dependence on Flunox is greater (see section “Warnings and precautions”). Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

If, for serious medical reasons, this medicine is prescribed to you at high doses during the last period of
pregnancy or during labor, the newborn may experience hypothermia (decrease in body temperature), hypotonia (reduction of muscle tone) and moderate respiratory depression (ineffective and
slow breathing). In addition, newborns born to mothers who have taken Flunox for a prolonged period in the advanced stages
of pregnancy may develop physical dependence and may experience withdrawal symptoms after
birth.
Avoid taking this medicine during the first 3 months of pregnancy.
After the first 3 months of pregnancy, take this medicine only if necessary and
under the direct control of your doctor.

Avoidbreastfeeding during treatment with this medicine, as Flurazepam passes into breast milk.

Driving and using machines
Flunox impairs the ability to drive and operate machinery.

Avoiddriving or using machinery that requires particular attention and vigilance if you experience.
sedation, amnesia, altered concentration and muscle function.
In addition, if the duration of sleep has been insufficient, the likelihood that vigilance is impaired increases.
The sedative effect may be increased if you take this medicine with alcohol (see “Flunox with alcohol”).

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

3. How to take Flunox

Take this medicine following exactly as indicated 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 bedtime. After taking this medicine, you should allow for a period of approximately 7-8 hours to rest or sleep.
• In more severe cases, your doctor will start treatment with 1 capsule of 30 mg and, when possible, will continue with the lower dose. In this case, your doctor will explain how to gradually reduce the dose to avoid the appearance of withdrawal and rebound symptoms. See paragraph “Warnings and precautions”.
• Do not exceed the maximum dose prescribed by your doctor. If you are elderly, the dose is established by your doctor. If you suffer from chronic respiratory diseases, your doctor will assess whether to reduce the dose of this medicine due to the risk of respiratory depression. Duration of treatmentThe duration of treatment generally varies from a few days to 2 weeks, up to a maximum of 4 weeks, and includes a period of gradual discontinuation. The treatment will be as short as possible. In certain cases, the doctor will decide whether to extend the duration of treatment beyond 4 weeks, after re-evaluating your health condition. If you take more Flunox than you shouldIn case of accidental ingestion/intake of an excessive dose of Flunox, immediately inform your doctor or go to the nearest hospital. In mild cases, symptoms include obtundation (reduction of sensory and intellectual abilities associated with a sense of disorientation), confusion, and lethargy (deep sleep with reduced response to stimuli). In more severe cases, symptoms may include ataxia (reduced coordination of movements and gait), hypotonia (reduced muscle tone), hypotension (low blood pressure), respiratory depression (slow and ineffective respiratory activity), rarely coma, and very rarely death. An overdose does not pose a risk to life unless you have taken this medicine together with medicines that reduce the activity of the central nervous system, including alcohol. If you have taken an excessive dose of Flunox and are conscious, inform your doctor specifying whether you have also taken other medicines or alcohol with Flunox. If you forget to take FlunoxDo not take a double dose to make up for the missed capsule. If you stop taking FlunoxIf you have any doubts about the use of this medicine, consult your doctor or pharmacist.
• Do notstop treatment with Flunox without first consulting your doctor, as abrupt discontinuation of this medicine can cause:
• withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability
• rebound symptomssymptoms, such as insomnia, which led to treatment with flurazepam reappear in a more severe form after discontinuation of treatment). These symptoms occur especially if you have developed a physical dependence on this medicine (see paragraph “Warnings and precautions”).
• The doctor will gradually reduce the dose during the phase of suspension of therapy.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During therapy, the probability of side effects occurring will be greater if you are elderly or debilitated:
The possible side effects are listed below:

• drowsiness during the day
• blunting of emotions (reduced ability to experience emotions)
• reduced alertness
• headache
• dizziness
• decreased muscle tone
• ataxia (reduced motor and gait coordination).
• Confusion
• Fatigue
• Double vision These effects usually occur at the beginning of therapy and usually disappear with subsequent doses. Flurazepam and similar medicines can also cause reactions such as:
• restlessness
• agitation
• irritability
• aggression
• delirium
• anger
• nightmares
• hallucinations
• psychosis
• behavioral changes The use of flurazepam, or medicines similar to flurazepam, can make an existing depression evident. Rare cases of
• nausea
• vomiting
• stomach and intestinal disorders
• palpitations (sensation of increased heartbeats)
• skin rashes.
• changes in sexual desire Furthermore, the following may occur
• anterograde amnesia (difficulty memorizing information after taking the medicine) and behavioral disturbances
• physical and psychological dependence See section “Warnings and precautions”. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 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 pack after Exp. The expiry date
refers to the last day of that month.
Store at a temperature below 25  C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines
that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Flunox contains

15 mg capsules

• the active ingredient is: flurazepam hydrochloride 15 mg
• the other ingredients are: corn 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 ingredient is: flurazepam hydrochloride 30 mg
• the other ingredients are: corn 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 contents of the packFlunox is presented in hard capsules of 15 mg or 30 mg for oral use. The 15 mg capsules are packaged in blisters in a carton of 30 capsules. The 30 mg capsules are packaged in blisters in a carton of 20 capsules. Not all pack sizes may be available. Marketing Authorisation HolderTeofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV).

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