Package leaflet: Information for the patient

Felison 15 mg hard capsules, 30 mg hard capsules

flurazepam
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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Felison is and what it is used for
What you need to know before taking Felison
How to take Felison
Possible side effects
How to store Felison
Contents of the pack and other information

1. What Felison is and what it is used for

Felison contains flurazepam, which belongs to a group of medicines called "benzodiazepines".
This medicine:

reduces the time needed to fall asleep;
reduces the frequency of nocturnal awakenings;
increases total sleep duration.

Felison is used for the short-term treatment of insomnia. This medicine is suitable only when the condition is severe and causes marked distress in daily life.

2. What you should know before taking Felison

Do not take Felison

if you are allergic to the active substance, to benzodiazepines, or to any of the other ingredients of this medicine (listed in section 6);
if you suffer from a condition causing severe muscle weakness or fatigue (myasthenia gravis);
if you have severe respiratory problems (severe respiratory insufficiency);
if you have severe respiratory depression (respiratory depression);
if you have severe lung problems (severe pulmonary insufficiency);
if you have breathing difficulties during sleep (sleep apnoea syndrome);
if you have severe liver problems (severe hepatic insufficiency), as this may lead to a serious brain disorder (hepatic encephalopathy);
if you have severe mental disorders causing recurrent unwanted thoughts or fears (chronic obsessive or phobic states);
if you have a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (chronic psychosis).

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, please see section “Pregnancy, breastfeeding and fertility” before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Felison.

In particular, consult your doctor before taking Felison if:

you have a predisposition to dependence (history of drug and/or alcohol abuse). This medicine contains flurazepam, which, when used long-term at high doses, may lead to physical and psychological dependence, particularly in patients with a history of alcohol or drug abuse. Dependence may cause withdrawal symptoms if treatment is stopped abruptly (see section 3 “If you stop taking Felison”); benzodiazepine abuse has been reported;
you are elderly, as the effects of benzodiazepines such as flurazepam may increase the risk of falls;
you have respiratory problems (chronic respiratory insufficiency), as there is a risk of respiratory depression;
you suffer from depression or anxiety associated with depression, as this medicine may increase suicidal thoughts;
you have previously suffered from depression, as it may recur during treatment with this medicine;
you have hepatic insufficiency (liver disease);
you have a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (psychosis);
you suffer from spinal or cerebellar ataxia (reduced coordination of movement and gait).

Tolerance development
This medicine may lose some of its effectiveness after repeated use over several weeks; this phenomenon is known as tolerance.

Personality disorders
If you have been diagnosed with a personality disorder and you or your caregiver notice the emergence of unusual behaviours such as aggressive outbursts, excitement, confusion, restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, or the onset of depression with suicidal tendencies, consult your doctor, who will determine the most appropriate treatment. These events are more likely in elderly patients and children. (See section “Undesired effects”.)

Memory disturbances (amnesia)
Therapeutic or high doses of flurazepam may cause memory disturbances. This effect may be associated with behavioural disturbances and usually occurs several hours after taking the medicine. To reduce the risk, ensure you can have an uninterrupted 7–8 hour sleep period before taking this medicine (see section “How to take Felison”).

Children
This medicine should not be used in children unless strictly necessary and under medical supervision. The duration of treatment will be determined by the doctor and should 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, inform your doctor if you are taking:

other medicines acting 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), strong analgesics (used for pain), antiepileptics (used to treat epilepsy), anticonvulsants (used to suppress seizures), anaesthetics (used for anaesthesia), as they may enhance the effects of this medicine, antihistamines (used to treat allergies);
antihypertensives (used to treat 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 opioid dependence replacement therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no alternative treatments are possible. However, if your doctor has prescribed Felison together with opioids, the dose and duration of concomitant therapy must be limited by the doctor. Please inform your doctor about all opioid medicines you are taking and carefully follow the doctor’s dosing recommendations. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if such symptoms occur;
strong analgesics (used for pain), as they may cause increased euphoria, increasing the risk of dependence;
theophylline or aminophylline (medicines used for bronchial asthma), as they may reduce the effects of Felison;
medicines used to relax muscles (muscle relaxants), as they may enhance the muscle-relaxing effect of flurazepam;
medicines that affect liver function, as they may alter the effects of Felison, for example:
- cimetidine (a medicine used for stomach ulcers);
- omeprazole (a medicine used to treat stomach disorders);
- disulfiram (a medicine used if you have alcohol dependence);
- rifampicin (an antibiotic).

Felison and alcohol
Do not take this medicine with alcohol, as the sedative effect may be increased.
If you have previously abused alcohol, your doctor will monitor you closely during treatment with Felison, as you are more likely to develop dependence on this medicine.
Taking alcohol with Felison may also severely impair your ability to drive or operate machinery (see section “Driving and using machines”).

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

Pregnancy
Avoid taking Felison during pregnancy. Do not take this medicine during the first and third trimesters of pregnancy unless specifically prescribed by your doctor.
Take this medicine only if your doctor considers it necessary and only under medical supervision.
If you take this medicine during late pregnancy or during labour, the newborn baby may experience low body temperature (hypothermia), muscle weakness (hypotonia), and breathing difficulties (moderate respiratory depression).
If you have taken this medicine regularly during late 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, you will be advised to stop breastfeeding.

Fertility
If you are planning to become pregnant or think you may be pregnant, consult your doctor, who will assess whether treatment with this medicine should be discontinued.

Driving and using machines
This medicine may cause deep relaxation (sedation), memory loss, and may impair your ability to concentrate and control your muscles. All these effects may impair your ability to drive or operate machinery.
Avoid driving even if your sleep duration is insufficient, as you are likely to be less alert.

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

3. How to take Felison

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose based on your condition. You may be prescribed doses ranging from a minimum of 15 mg to a maximum of 60 mg.
Treatment will start with the lowest dose sufficient to produce an effect.
Never exceed the maximum recommended dose.
When stopping treatment, the dose of this medicine should be gradually reduced.
The recommended dose in adults is one 30 mg hard capsule taken before going to bed.
Before taking this medicine, ensure you have a rest or sleep period of approximately 7–8 hours.

Use in children
This medicine should not be given to children unless specifically prescribed by a doctor when deemed necessary. The duration of treatment should be as short as possible.

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

Use in patients with liver or kidney problems
If you have liver or kidney problems, 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 may vary from a few days to two weeks, and should never exceed 4 weeks, including the period of gradual discontinuation of this medicine.
Your doctor will prescribe this medicine for the shortest possible time and will evaluate, on a case-by-case basis, whether there is a need to extend the treatment.
When stopping treatment, your doctor will gradually reduce the dose of the medicine. Gradual dose reduction 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 prescribed by your doctor, as it may lose effectiveness.
If this medicine has been prescribed for a long-term treatment, your doctor may prescribe regular blood tests to monitor your liver function.

If you take more Felison than you should
If you take a dose of Felison higher than prescribed, contact your doctor immediately or go to the nearest hospital. Bring this leaflet and the medicine packaging with you, even if empty.
Some symptoms of overdose may include: mental and sensory dullness (obnubilation), confusion, and deep sleep (lethargy). In more severe cases, symptoms may include: inability to coordinate movements (ataxia), reduced muscle tone (hypotonia), difficulty speaking (dysarthria), blurred vision, altered muscle tone (dystonia), low blood pressure (hypotension), suppression of brain centers controlling respiration (respiratory depression), and may rarely lead to coma and, very rarely, to death (the latter being more likely if alcohol or other drugs have been taken).

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

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, your doctor will decide whether you need to continue therapy.
The dose and frequency of this medicine should be gradually reduced until treatment is stopped. This allows your body to adjust to the absence of the medicine and reduces the risk of unpleasant effects when stopping treatment. Your doctor will advise you on how to do this.
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 occur: loss of sense of reality (derealization), altered self-perception (depersonalization), hypersensitivity to sound (hyperacusis), numbness or tingling sensations in hands and feet, hypersensitivity to light, noise, and physical touch, hallucinations, or epileptic seizures.
The insomnia that led to treatment with this medicine may also return in a more severe form (rebound phenomena). This may be accompanied by other reactions such as mood changes, anxiety, restlessness, or sleep disturbances.
Withdrawal syndrome may also occur if you switch from this medicine, which contains a long-acting benzodiazepine, to a medicine containing a short-acting benzodiazepine. Never stop treatment with this medicine without first consulting your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, tell your doctor immediately:
Serious side effects more likely in children and elderly patients:

Excitation, confusion, restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, behavioural changes, onset of depression with suicidal tendencies.

Tell your doctor if any of the following side effects occur:
If the dose is incorrect, an excessive state of "calmness" (sedation) may occur, manifesting as the following side effects:

Daytime drowsiness, blunted emotions (emotional blunting), reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, difficulty in movement (ataxia), double vision. These effects are more likely in elderly and debilitated patients, occur more frequently at the beginning of treatment, and tend to disappear as therapy continues.

Other side effects with unknown frequency (frequency cannot be estimated from the available data):

Emotional poverty (reduced ability to feel emotions)
Drowsiness
Reduced alertness
Movement disorder with loss of coordination of muscles and joints (ataxia)
Dizziness due to nervous system disorders
Headache
Altered or reduced sense of taste (dysgeusia)
Muscle weakness
Fatigue
Hypersensitivity (e.g. swelling of hands, feet, ankles, face, lips, tongue and/or throat, which may lead to airway obstruction that could be fatal (angioedema))
Visual disturbances (e.g. diplopia)
Dizziness due to balance problems from ear or labyrinth disorders
Low blood pressure (hypotension)
Respiratory depression
Abdominal pain
Nausea
Urinary retention
Changes in sexual desire (libido disorders)
Skin reactions, itching, skin rashes
Yellowish discoloration 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 use of machines")
Depression, which may be worsened by this medicine (see "Warnings and precautions")
Stomach and intestinal problems (gastrointestinal disturbances), dry mouth
Visual disturbances (accommodation disorders)
Blood disorders: decrease in white blood cells (thrombocytopenia, leucopenia, agranulocytosis, pancytopenia, granulocytopenia)
Changes in blood levels of transaminases, phosphatase and bilirubin
Dependence
Withdrawal symptoms (e.g. depression, nervousness, mood changes, rebound insomnia, sweating, diarrhoea, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability)
Rebound symptoms (when 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 disturbances)
Extrapyramidal disorders (e.g. rigidity, resting tremor, reduced or absent spontaneous movements, slow and clumsy movements)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via 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 above 25°C.
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 dispose of medicines 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 Felison contains
Felison 15 mg hard capsules

The active substance is flurazepam. Each capsule contains 16.4 mg of flurazepam monohydrochloride (equivalent to 15 mg of flurazepam).
The other components are monohydrate lactose, tribasic calcium phosphate, maize 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 substance is flurazepam. Each capsule contains 32.8 mg of flurazepam monohydrochloride (equivalent to 30 mg of flurazepam).
The other components are monohydrate lactose, tribasic calcium phosphate, maize 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 supplied in a box containing 30 hard capsules in PVC/aluminum blisters.
Felison 30 mg hard capsules are supplied in a box containing 30 hard capsules in PVC/aluminum blisters.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. – via Cavour, 70 – 27035 Mede (PV)