FELISON 15 mg Hard Capsule

Зміст інструкції

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

Felison 15 mg hard capsules, 30 mg hard capsules

flurazepam

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

1. What is Felison and what is it used for

Felison contains flurazepam which belongs to the group of medicines called “benzodiazepines”.
This medicine:

• reduces the time it takes to fall asleep;
• reduces the frequency of nighttime awakenings;
• increases the duration of sleep. Felison is used for the treatment of insomnia, for a short period. This medicine is only suitable if the disorder is severe and causes significant discomfort in daily life.

2. What you need to know before taking Felison

Do not take Felison

• if you are allergic to the active ingredient, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition in which your muscles are very weak or tired (myasthenia gravis);
• if you have serious breathing problems (severe respiratory failure);
• if you have a severe reduction in breathing (respiratory depression)
• if you have serious problems with your lungs (severe pulmonary insufficiency);
• if you have trouble breathing during sleep (sleep apnea syndrome);
• if you have serious liver problems (severe hepatic insufficiency), because it could lead to a serious brain disease (hepatic encephalopathy);
• if you have serious mental disorders that cause recurring thoughts against your will or fears (obsessive or phobic states)
• if you have a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (chronic psychosis)

If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, see section “Pregnancy, breastfeeding and fertility” before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Felison.
In particular, talk to your doctor before taking Felison if:

• you have a predisposition to addiction (history of drug and/or alcohol abuse). This medicine contains flurazepam which, in case of prolonged treatment with high doses, can cause physical and psychological dependence, which occurs particularly in patients with a history of alcohol and drug abuse. Dependence causes withdrawal symptoms when treatment is stopped abruptly (see section 3 “If you stop taking Felison”); abuse of benzodiazepines has been reported;
• you are elderly because the effects of benzodiazepines, such as flurazepam contained in this medicine, may increase the risk of falls;
• you have breathing problems (chronic respiratory insufficiency), because there is a risk of respiratory depression;
• you suffer from depression or anxiety associated with depression, because this medicine may increase thoughts of suicide;
• you have suffered from depression, because it may recur during treatment with this medicine;
• you suffer from liver failure (liver disease);
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis);
• you suffer from spinal or cerebellar ataxia (reduced coordination of movements and gait).

Development of tolerance
This medicine may lose some of its effectiveness following repeated use for several weeks, this phenomenon is called tolerance.

Personality disorders
If you have been diagnosed with a personality disorder and you or your caregiver notice the appearance of particular behaviors such as aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, anger, nightmares, hallucinations, and the appearance of depression with suicidal tendencies, consult your doctor who will establish the most appropriate therapeutic regimen. These events are more likely in the elderly and in children. (See section “Side effects”).

Memory disorders (amnesia)
The use of therapeutic or high doses of flurazepam can cause memory disorders. This effect may be associated with behavioral disturbances and occurs more often several hours after taking the medicine. Therefore, to reduce the risk, before taking this medicine, make sure you can have an uninterrupted period of sleep of 7-8 hours (see section “How to take Felison”).

Children
In children, this medicine should not be used unless strictly necessary and under the control of the doctor. The duration of treatment is established by the doctor and must be as short as possible.

Other medicines and Felison
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:

• other medicines that act on the central nervous system such as neuroleptics (psychotropic drugs), hypnotics (used to treat insomnia), anxiolytics (used to treat anxiety), antidepressants (used to treat depression), very potent analgesics (used against pain), antiepileptics (used to treat epilepsy), anticonvulsants (used to sedate convulsions), anesthetics (used for anesthesia), because they can increase the effects of this medicine, antihistamines (used to treat allergies);
• antihypertensives (used for the treatment of high blood pressure), beta-blockers (used to treat high blood pressure and heart problems);
• the concomitant use of Felison and opioids (strong painkillers, medicines for substitution therapy for dependence and some cough medicines) 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 alternative treatments are not possible. However, if your doctor has prescribed Felison together with opioids, the dose and duration of concomitant therapy must be limited by your doctor. Please inform your doctor of all opioid medicines you are taking and carefully follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to pay attention to the signs and symptoms indicated above. Contact your doctor if such symptoms occur;
• very potent analgesics (used against pain), because they can cause greater euphoria and this can increase the risk of addiction;
• theophylline or aminophylline (medicines used against bronchial asthma) because they can reduce the effects of Felison;
• medicines used to relax the muscles (muscle relaxants) because they can increase the relaxing effect of flurazepam;
• medicines that act on how the liver works because they can change the effects of Felison, for example:
• cimetidine (a medicine used in case of stomach ulcer)
• omeprazole (a medicine used to treat stomach diseases)
• disulfiram (a medicine used if you have problems with alcoholism)
• rifampicin (an antibiotic).

Felison with alcohol
This medicine should not be taken with alcohol because the sedative effect may be increased.
If you have abused alcohol in the past, your doctor will monitor you during treatment with Felison, as you are more likely to develop dependence on this medicine.
Taking alcohol with Felison can also lead to a serious impairment of the ability to drive vehicles and operate machinery (see section “Driving and using machines”).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Avoid taking Felison during pregnancy, do not take this medicine during the first and third trimester of pregnancy, unless it has been prescribed by your doctor.
Take this medicine only if your doctor has deemed it necessary and only under his control.
If you take this medicine regularly during the last period of pregnancy, your baby, once born, may have a lower body temperature (hypothermia), muscle weakness (hypotonia) and difficulty breathing (moderate respiratory depression).
If you have taken this medicine regularly during the last period of pregnancy, your baby may develop withdrawal symptoms after birth.
Breastfeeding
Do not take this medicine if you are breastfeeding. The flurazepam contained in this medicine passes into breast milk.
If your doctor decides to prescribe this medicine to you, you will be advised to stop breastfeeding.
Fertility
If you intend to become pregnant or suspect you are pregnant, consult your doctor who will assess the suspension of treatment with this medicine.

Driving and using machines
This medicine can make you feel deeply relaxed (sedation), memory loss and can alter your ability to concentrate and control your muscles. All these effects can impair your ability to drive vehicles or operate machinery.
Avoid driving even if your sleep duration is insufficient because you are likely to be less attentive.

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

3. How to take Felison

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The dose will be established by your doctor based on your condition. You may be prescribed doses
ranging from a minimum of 15 mg to a maximum of 60 mg.
Treatment will begin with the lowest dose sufficient to produce an effect.
Never exceed the maximum indicated dose.
When stopping treatment, the dose of the medicine must be gradually decreased.
The recommended dose in adultsis one 30 mg hard capsule before going to bed.
Before taking this medicine, you must allow for a period of rest or sleep of approximately 7-8
hours.

Use in children
This medicine should not be given to children unless your doctor has prescribed it because
they consider it necessary. The duration of treatment should be as short as possible.

Use in the elderly and debilitated patients
If you are elderly or particularly debilitated, the recommended dose at the beginning of therapy is one
15 mg hard capsule before going to bed.

Use in patients with liver or kidney problems
If you have a liver or kidney problem, your doctor will prescribe the most appropriate dose for you. You may
need to take lower doses than those indicated above.

Duration of treatment:
The duration of treatment can vary from a few days to two weeks, never exceeding 4
weeks including the period of gradual discontinuation of this medicine.
Your doctor will prescribe this medicine for the shortest possible time and will assess on a case-by-case
basis the need to prolong the treatment.
When stopping treatment, your doctor will gradually reduce the dose of the medicine. A
gradual reduction of the dose is important to avoid the risk of unpleasant symptoms
(see “If you stop taking Felison”).
Do not use this medicine continuously for long periods unless your doctor has prescribed it,
because it may lose effectiveness.
If this medicine has been prescribed for you for a long period, your doctor may prescribe regular
blood tests to assess the health of your liver.

If you take more Felison than you should
If you take a dose of Felison higher than the prescribed dose immediately inform your doctoror go
to the nearest hospital. Bring this leaflet and the packaging of this medicine with you, even
if it is empty.
Some of the symptoms of overdose may be: mental and sensory dulling
(obnubilation), confusion and deep sleep (lethargy). In more severe cases, the symptoms may
be: inability to coordinate movements (ataxia), decreased muscle tone
(hypotonia), difficulty articulating words (dysarthria), altered vision, altered muscle tone
(dystonia), low blood pressure (hypotension), blockage of the activity of the brain centers
that control breathing (respiratory depression) and can rarely lead to coma and very
rarely to death (the latter is more likely if you have taken alcohol or other drugs).

Treatment
The doctor, after evaluating the symptoms, will perform the appropriate supportive therapy (for example with
activated charcoal and/or gastric lavage). The doctor may consider the use of flumazenil
(a medicine that works by blocking the effects of benzodiazepines). If you are taking medicines for
treating depression or suffer from epilepsy, inform your doctor, as in these cases flumazenil must
be used with extreme caution.

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

If you stop taking Felison

• At the end of treatment with this medicine, the doctor will decide if you need to continue therapy.
• The dose and frequency of taking this medicine must be gradually reduced until treatment is discontinued. This allows the body to adjust to the absence of the medicine, and reduces the risk of unpleasant effects when treatment is stopped. Your doctor will tell you how to do it.
• Do not stop treatment abruptly.When stopping treatment, you may experience withdrawal symptoms such as headache, muscle pain, anxiety, tension, restlessness, confusion and irritability. In more severe cases, the following symptoms may appear: loss of sense of reality (derealization), altered self-perception (depersonalization), hypersensitivity to sounds (hyperacusis), sensation of numbness or tingling in hands and feet, hypersensitivity to light, noise and physical contact, hallucinations or seizures.
• Even insomnia that required treatment with this medicine may reappear in a more severe form (rebound phenomena). Other reactions such as mood changes, anxiety, restlessness or sleep disturbances may be added to this.
• Withdrawal syndrome can also occur if you replace this medicine, which contains a long-acting benzodiazepine, with a medicine containing a short-acting benzodiazepine

Never stop treatment with this medicine without
first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, tell your doctor immediately:

• Excitement, confusion, restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations, psychosis, behavioral changes, onset of depression with suicidal tendencies.

If you experience any of the following side effects tell your doctor:
If the dose is not correct, an excessive state of “calm” (sedation) can occur, which manifests
with the following side effects:

• drowsiness during the day, blunted emotions, decreased state of alertness, confusion, fatigue, headache, dizziness, muscle weakness, difficulty with movements (ataxia), double vision. These effects are more likely in elderly and debilitated patients, appearing more frequently at the beginning of treatment and tending to disappear as therapy progresses.

Other side effects with unknown frequency (frequency cannot be defined based on available data):

• emotional blunting (poor ability to experience emotions)
• drowsiness
• decreased alertness
• movement disorder with loss of coordination of muscles and joints (ataxia)
• dizziness caused by problems with the nervous system
• headache
• alteration or decrease in the sense of taste (dysgeusia)
• muscle weakness
• fatigue
• hypersensitivity (e.g. swelling of hands, feet, ankles, face, lips, tongue and/or throat which can lead to obstruction of the airways which could be fatal (angioedema))
• visual impairment (e.g. diplopia)
• dizziness caused by balance problems due to ear or labyrinth diseases
• low blood pressure (hypotension)
• respiratory depression
• abdominal pain
• nausea
• urinary retention
• alteration of sexual desire (libido disorders)
• skin reactions, itching, skin rashes
• yellowing of the skin and whites of the eyes (jaundice)
• increased liver enzymes
• memory loss (amnesia), which is more frequent at higher doses (see “Driving and using machines”)
• depression, which may be exacerbated by this medicine (see “Warnings and precautions”)
• problems with the stomach and intestines (gastrointestinal disorders), dry mouth
• vision disorders (accommodation disorders)
• blood changes: decrease in white blood cells (thrombocytopenia, leukopenia, agranulocytosis, pancytopenia, granulocytopenia)
• alteration of blood levels of transaminases, phosphatases and bilirubin
• dependence
• withdrawal symptoms (e.g. depression, nervousness, mood swings, rebound insomnia, sweating, diarrhea, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability)
• rebound symptoms (when the symptoms that led to treatment with flurazepam reappear in a more severe form after stopping treatment) e.g. mood changes, anxiety, restlessness or sleep disturbances
• paradoxical reactions (e.g. anxiety, sleep disturbances, insomnia, nightmares, delirium, emotional disorders)
• extrapyramidal disorders (e.g. rigidity, tremor at rest, few spontaneous movements/absence of spontaneous movements, slow and clumsy movements)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the 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 Felison

Do not store at a temperature above 25°C.
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.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Felison contains
Felison 15 mg hard capsules

• The active ingredient is flurazepam. Each capsule contains 16.4 mg of flurazepam hydrochloride (corresponding to 15 mg of flurazepam).
• The other ingredients are lactose monohydrate, tribasic calcium phosphate, corn starch, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), erythrosine (E 127).

Felison 30 mg hard capsules

• The active ingredient is flurazepam. Each capsule contains 32.8 mg of flurazepam hydrochloride (corresponding to 30 mg of flurazepam).
• The other ingredients are lactose monohydrate, tribasic calcium phosphate, corn starch, magnesium stearate, gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), erythrosine (E 127).

Description of the appearance of Felison and contents of the pack
Felison 15 mg hard capsules are presented in a box containing 30 hard capsules in PVC/Aluminum blisters.
Felison 30 mg hard capsules are presented in a box containing 30 hard capsules in PVC/Aluminum blisters.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)