Roipnol

Package leaflet: Information for the user

Roipnol 1 mg film-coated tablets

Flunitrazepam
Please read all of this leaflet carefully before you take 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 Roipnol is and what it is used for
2. What you need to know before taking Roipnol
3. How to take Roipnol
4. Possible side effects
5. How to store Roipnol
6. Contents of the pack and other information

1. What Roipnol is and what it is used for

Roipnol contains the active substance flunitrazepam and belongs to the class of benzodiazepines (psychoactive drugs) with hypnotic and sedative action.
This medicine is used in adults for the short-term treatment of insomnia.
Benzodiazepines are indicated only when the disorder is severe, disabling, or causes the individual severe distress.
Consult your doctor if you do not feel better or if you feel worse after 2 weeks.

2. What you need to know before taking Roipnol

Do not take Roipnol

• if you are allergic to flunitrazepam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from severe myasthenia gravis (a disease characterized by severe muscle weakness).
• if you suffer from severe respiratory insufficiency.
• if you have breathing problems during sleep (sleep apnoea).
• if you have severe liver problems (severe hepatic insufficiency).

Roipnol must not be used in children (see "Children and adolescents").
Warnings and precautions
Talk to your doctor or pharmacist before taking Roipnol.
Concomitant use of Roipnol with alcohol or central nervous system (CNS) depressant medicines
Avoid concomitant use of Roipnol with alcohol and medicines that depress CNS function (see
“Other medicines and Roipnol” and “Roipnol with alcohol”).
Such combinations may increase the effects of Roipnol, including possible profound sedation and
respiratory and/or cardiovascular depression.
History of alcohol or drug abuse
Take Roipnol with extreme caution if you have previously abused alcohol or drugs.
Benzodiazepines are not indicated for the treatment of mental illnesses (psychotic disorders).
Depressive symptoms (suicidal risk) may be exacerbated if appropriate treatment of the psychotic
disorder (with antidepressants) is not undertaken.
Hypersensitivity (allergy)
In predisposed individuals, hypersensitivity reactions may occur, such as rash (sudden skin
redness), angioedema (sudden swelling of the skin and mucous membranes), or
hypotension (low blood pressure).
Tolerance
After repeated use for several weeks, a loss of effectiveness of the medicine may occur.
Rebound insomnia
Upon discontinuation of treatment, a transient syndrome may occur in which the symptoms that
led to benzodiazepine treatment reappear in a worsened form, along with the return of
insomnia (rebound insomnia). This may be accompanied by other reactions, including
mood changes, anxiety, and restlessness. Since the risk of withdrawal or rebound symptoms is
higher after abrupt discontinuation of treatment, gradual dose reduction is recommended.
Amnesia
Benzodiazepines may cause anterograde amnesia (difficulty in memorizing new
information).
This condition occurs most frequently in the first few hours after taking the medicine,
and therefore, to reduce risks, ensure you sleep undisturbed for 7–8 hours (see section 4
“Possible side effects”).
Paradoxical psychiatric reactions
The use of benzodiazepines may induce paradoxical reactions such as restlessness, agitation, irritability,
aggression, delusions, anger, nightmares, hallucinations, psychosis, inappropriate behaviour, and other
undesirable behavioural effects. If this occurs, discontinue use of the medicine. Such
reactions are more frequent in the elderly (see section 4 “Possible side effects”).
Dependence
Chronic (long-term) use of benzodiazepines and similar substances, even at therapeutic doses, may
lead to physical and psychological dependence on these drugs (see section 4 “Possible
side effects”). The risk of dependence increases with dose and duration of treatment. This
risk is greater if you have previously abused alcohol and/or drugs.
To minimize the risk of dependence, benzodiazepines should be prescribed only after
careful medical evaluation, and treatment duration should be as short as possible (see section 3 “How to take Roipnol”). Longer treatments should be decided by the doctor after careful reassessment of your health condition.
Discontinuation
Once physical dependence has developed, abrupt discontinuation of treatment will
be accompanied by withdrawal symptoms and rebound phenomena (temporary recurrence of symptoms
for which treatment was initiated). These may include headache, muscle pain, severe anxiety, tension, tremor, restlessness, confusion, irritability, and rebound insomnia. In severe cases, the following symptoms may occur:
derealization (feeling of distorted perception of the external world), depersonalization
(persistent or recurring sensations of being detached from one's body or mental processes),
hyperacusis (hearing disorder), numbness and tingling in the extremities, hypersensitivity
(excessive sensitivity) to light, noise, and physical contact, hallucinations, or epileptic seizures (see
“If you stop taking Roipnol”).
When short-acting benzodiazepines are used, withdrawal symptoms may occur between doses, particularly at high doses.
Elderly
Use Roipnol with caution if you are elderly, due to the risk of sedation and/or muscle-relaxant
effects that may lead to falls, often with serious consequences.
Dosages recommended for the elderly are lower than those recommended for adults (see
section 3 “How to take Roipnol”).
The risk of falls and fractures is also increased, regardless of age, if sedative medicines or alcohol are taken simultaneously.
Impaired liver function
Use Roipnol with caution if you have liver problems (hepatic impairment); in such cases the
dosage should be reduced (see section 3 “How to take Roipnol”).
If you suffer from severe hepatic insufficiency, you must not be treated with benzodiazepines due to the risk
of encephalopathy.
Chronic respiratory insufficiency
If you have respiratory problems (chronic respiratory insufficiency), the dosage of Roipnol must be
reduced due to the risk of respiratory depression (inability of the respiratory system to ensure
adequate gas exchange) (see section 3 “How to take Roipnol”).
Impaired kidney function
If you have kidney problems, a reduced dose should be administered.
Children and adolescents
The use of Roipnol is reserved exclusively for adults and therefore must not be used in children
(see “Do not take Roipnol”).
Other medicines and Roipnol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
Concomitant use of Roipnol and opioids (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 Roipnol together with opioids, the dose and duration of
concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the
doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
Avoid taking Roipnol together with medicines such as antipsychotics, neuroleptics (used in the treatment of psychoses), hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics (medicines that reduce pain sensation), antiepileptics (anticonvulsants), anaesthetics (medicines that reduce sensitivity), and sedative antihistamines (antiallergic medicines). Such combinations may intensify sedative effects on the central nervous system, respiration, and blood pressure.
With narcotic analgesics, an enhanced euphoric effect of the narcotic may occur, increasing the risk of psychological dependence.
Taking Roipnol with medicines that may increase the activity of benzodiazepines and similar
substances may lead to an enhanced effect of Roipnol. Some of these medicines are:

• Azole antifungals such as fluconazole, ketoconazole, itraconazole.
• Cimetidine (anti-ulcer medicine).
• HIV protease inhibitors (used in the treatment of HIV).
• Gemfibrozil / PPAR-α agonist (a medicine used to lower blood fat levels).
• Macrolide antibiotics such as erythromycin, clarithromycin, telithromycin.
• Nefazodone / SNRI (antidepressant).
• Statins (medicines used to lower blood fat levels).
• Verapamil / Ca-antagonist (a medicine mainly used to lower blood pressure).
• Grapefruit juice.

Roipnol may be administered concomitantly with oral antidiabetic and anticoagulant medicines.
Roipnol and alcohol
Avoid concomitant use of Roipnol with alcohol (see “Warnings and precautions”).
Such combination may intensify sedative effects on the central nervous system, respiration, and/or heart and blood pressure.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on flunitrazepam to assess its safety during pregnancy.
Avoid prolonged administration of Roipnol during the third trimester of pregnancy.
If, for serious medical reasons, flunitrazepam is administered during the late stages of pregnancy or
during labour, effects on the newborn may occur such as hypothermia (reduced body temperature), hypotonia (reduced muscle tone), and moderate respiratory depression due to
the action of the medicine.
If you have taken benzodiazepines for a long time during late pregnancy, your
baby may develop physical dependence and withdrawal symptoms in the postnatal period (see
“Warnings and precautions”).
The risk of malformations after administration of therapeutic doses of benzodiazepines during early
pregnancy appears to be low, but some studies have shown evidence of an increased risk of cleft palate.
Breastfeeding
Do not take flunitrazepam if you are breastfeeding, as benzodiazepines are excreted in breast milk
(see “Do not take Roipnol”).
Fertility
If you are a woman of childbearing age and plan to become pregnant or suspect you are pregnant, contact your
doctor regarding discontinuation of the medicine.
Driving and using machines
The use of Roipnol may negatively affect your ability to drive vehicles or operate machinery
due to sedation, amnesia, reduced concentration, and impaired muscle function. Insufficient sleep duration may increase the likelihood of altered alertness.
Roipnol 1 mg film-coated tablets contain lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking
this medicine.

3. How to take Roipnol

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The recommended daily dose is 0.5–1 mg of flunitrazepam.
In exceptional circumstances, the dose may be increased to a maximum of 2 mg per day.
Treatment should start with the lowest recommended dose. Do not exceed the maximum dose.
Take the medicine at bedtime. The tablet may be divided into equal doses.
Treatment should be as short as possible. Generally, treatment duration ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including the period of gradual withdrawal.
In certain cases, it may be necessary to further extend treatment; such extension must be decided by the doctor after careful reassessment of your health status.
When starting treatment, you should be informed that therapy will be of limited duration and that the dosage should be progressively reduced.
Moreover, it is important that you are informed about the possibility of rebound phenomena, in order to minimize the anxious reaction that the possible occurrence of such symptoms may trigger upon discontinuation of the medicine (see "Warnings and precautions").
When using short-acting benzodiazepines, withdrawal-related symptoms may occur between doses, particularly at higher dosages (see "Warnings and precautions").

Elderly
If you are elderly, you should take half the dose indicated for adults (see "Warnings and precautions").

Renal impairment
If you have kidney problems, you should receive a lower dose, individually adjusted.

Hepatic impairment
If you have liver problems, you should take a reduced dose (see "Warnings and precautions").

Chronic respiratory insufficiency
If you have respiratory problems, you should take a reduced dose (see "Warnings and precautions").

Paediatric population
Roipnol must not be used in children.

If you take more Roipnol than you should
If you take an excessive dose of Roipnol, contact your doctor immediately or go to the nearest hospital.
Benzodiazepines commonly cause lethargy (drowsiness), ataxia (loss of muscle coordination), dysarthria (motor speech disorder), and nystagmus (involuntary eye movement).
An overdose of Roipnol, when taken alone, is rarely life-threatening unless other centrally acting depressant drugs, including alcohol, are also taken. However, it may cause areflexia (absence of reflexes), apnoea (cessation of breathing), hypotonia (reduced muscle tone), hypotension, cardiorespiratory depression, and coma.
In case of an overdose, vital signs must be monitored and appropriate supportive measures initiated (such as activated charcoal or gastric lavage).
In cases of severe central nervous system depression, flumazenil, a benzodiazepine antagonist, may be administered under strict medical supervision. Flumazenil must be used with extreme caution in the presence of drugs that may lower the seizure threshold (e.g. tricyclic antidepressants).

If you forget to take Roipnol
Do not take a double dose to make up for the forgotten dose.

If you stop taking Roipnol
Do not stop taking this medicine without first consulting your doctor, as you may experience a temporary worsening of the symptoms that led to treatment with benzodiazepines (see "Warnings and precautions").
Once physical dependence has developed, abrupt discontinuation of treatment will lead to withdrawal symptoms and rebound phenomena. These may include headache, muscle pain, severe anxiety, tension, restlessness, confusion, irritability, and rebound insomnia. In severe cases, the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations, or epileptic seizures (see "Warnings and precautions").
Treatment should therefore be discontinued gradually.

If you have any doubts 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 will experience them.
Most side effects occur mainly at the beginning of treatment and generally resolve with continued administration.
Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Hypersensitivity reactions, including rash, angioedema (see "Warnings and precautions")
• Confusional state
• Emotional disturbances
• Changes in libido (sexual desire)
• Emergence of pre-existing depression
• Paradoxical reactions such as restlessness, agitation, irritability, aggression, mania, anger, nightmares, hallucinations, psychosis, inappropriate behaviour and other behavioural adverse effects (see "Warnings and precautions")
• Physical dependence: abrupt discontinuation of treatment may lead to withdrawal or rebound phenomena (see "Warnings and precautions")
• Abuse (see "Warnings and precautions")
• Daytime drowsiness (somnolence)
• Headache
• Dizziness
• Reduced alertness
• Ataxia (progressive loss of muscular coordination)
• Anterograde amnesia, which may occur even at therapeutic doses and increases with higher dosages (see "Warnings and precautions"). Amnesic effects may be associated with behavioural changes.
• Hypotension
• Heart failure (reduced heart function)
• Cardiac arrest
• Respiratory depression (see "Warnings and precautions")
• Diplopia (double vision)
• Gastrointestinal disturbances
• Skin reactions
• Muscle weakness
• Urinary problems (urinary retention, urinary incontinence, dysuria)
• Fatigue
• Falls
• Fractures

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Roipnol

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 and to the product in its original unopened packaging, properly stored.
This medicine does not require any special storage precautions.
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 Roipnol contains
Each film-coated tablet contains:
The active substance is flunitrazepam 1 mg.
The other components are:
In the core: anhydrous lactose, microcrystalline cellulose, hypromellose, povidone K 90 F, sodium starch glycolate, indigotine, magnesium stearate (Ph. Eur.).
In the coating: hypromellose, ethylcellulose, talc, titanium dioxide, yellow iron oxide, triacetin, indigotine.
Description of the appearance of Roipnol and packaging contents
Film-coated tablets.
Blister pack containing 10 divisible tablets.
Marketing Authorization Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany