Rohypnol flunitrazepam 2mg Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this manual. You might need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not give this to anyone else. It may harm them, even if their signs of illness are the same as yours.                                                                                                                                                  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

https://erasolutionrbv.com/product/rohypnol-flunitrazepam-2mg/

What does this booklet contain ?

1. What is ROHYPNOL 2 mg, scored film-coated tablet and in which cases it is used?

2. What should I know before taking ROHYPNOL 2 mg film-coated tablet?

3. How to take ROHYPNOL 2 mg, film-coated tablet?

4. What are the possible side effects?

5. How to store ROHYPNOL 2 mg, film-coated tablet?

6. Package contents and other information.

1. WHAT ROHYPNOL 2 mg, scored film-coated tablet IS AND WHAT IT IS USED FOR?

Pharmacotherapeutic group – ATC code: N05CD03

HYPNOTIC AND SEDATIVE.

This medication belongs to the class of benzodiazepines.

This medication is recommended for the treatment of insomnia.

2. BEFORE YOU TAKE ROHYPNOL 2 mg, scored film-coated tablet? List of information needed before taking the medication

If your doctor has informed you of an intolerance to certain sugars, contact your doctor before taking this medicine.

Do not take ROHYPNOL 2 mg film-coated tablet:

• if you are allergic to the active substance (s) or to any of the other ingredients of this medication mentioned in section 6.

• if you suffer from myasthenia gravis (a disease characterized by severe muscle weakness).

• if you have severe respiratory failure (severe lung disease).

• if you have sleep apnea syndrome (breathing pauses during sleep).

• if you have severe liver failure (liver disease).

• if you have had any problems with medication, drug or alcohol abuse.

Warnings and Precautions·

The use of this medicine is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

• This medicine does not treat depression. If you suffer from depression, this medicine should not be used alone because it will allow the depression to progress with persistence or an increased risk of suicide.

Before treatment, tell your doctor

·If you have kidney failure (your kidneys are not working properly),

·If you have liver disease that persists,

·If you have ever had problems with alcohol, drugs or drug abuse,

·If you have respiratory failure (lung disease),

If you have ever had depression and / or have attempted suicide.

In this case, your doctor will have to set up a reinforced medical follow-up.

Warnings

If loss of effectiveness occurs with repeated use of the drug, do not increase the dose.

Risk of dependence:

This treatment can lead, especially in the event of prolonged use, to a state of physical and psychological dependence.

The risk of dependence increases with the dose and duration of treatment; it is also higher if you have ever had alcohol and / or drug abuse problems.

Addiction can occur even in the absence of these contributing factors.

During treatment

Memory problems as well as alterations in psychomotor functions are likely to appear within hours of taking the drug. In particular, treatment over a long period or at high doses may cause reversible conditions such as ataxia (trouble walking) and diplopia (double vision).

To reduce these risks, it is advisable to take the drug immediately before bedtime. (see Frequency administration) and get in the most favorable conditions for an uninterrupted sleep duration of about 7 to 8 hours.

In some subjects, this medication may cause reactions contrary to the desired effect: insomnia, nightmares, restlessness, nervousness, euphoria or irritability, tension, changes in consciousness, or even potentially dangerous behavior (aggression towards oneself or those around them , as well as behavioral disorders and automatic acts).

If one or more of these reactions occur, contact your doctor as soon as possible.

Use in the elderly

Benzodiazepines and related products should be used with caution in the elderly, because of the risk of drowsiness and / or muscle relaxation which can promote falls, with often serious consequences in this population.

Precautions for use

This drug treatment alone cannot resolve the difficulties associated with insomnia. You should seek advice from your doctor. It will show you the behaviors that can promote sleep.

Insomnia can indicate another disorder, physical or psychiatric.

Taking this medication requires reinforced medical monitoring, especially in cases of chronic liver disease, alcoholism and respiratory failure.

If insomnia persists or worsens after a short period of treatment, consult your doctor.

Other medicines and ROHYPNOL 2 mg, scored film-coated tablet

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Food and drinks

The consumption of alcohol is strictly discouraged during the treatment.

Pregnancy, breastfeeding and fertility

Pregnancy and fertility

This medication is not recommended during pregnancy. If you discover that you are pregnant or wish to be pregnant, consult your doctor to reassess the benefit of the treatment.

If you are taking ROHYPNOL during the 1st trimester of pregnancy: There is a lot of data showing no malformation of benzodiazepines. However, some studies have described a potentially increased risk of the occurrence of cleft lip and palate in newborns compared to the risk present in the general population. A cleft lip and palate (sometimes called a “cleft lip”) is a birth defect caused by incomplete fusion of the palate and upper lip. According to these data, the incidence of cleft lip and palate in newborns is less than 2/1000 after exposure to benzodiazepines during pregnancy, while the expected rate in the general population is 1/1000.

If you take ROHYPNOL in the 2nd and / or 3rd trimester of pregnancy, decreased active fetal movement and variability in fetal heart rate may occur.

If you take ROHYPNOL at the end of pregnancy, inform the medical team, the newborn may be monitored: muscle weakness (axial hypotonia), feeding difficulties (sucking disorders leading to low weight gain ), hyperexcitability, restlessness or tremors may occur in the newborn, these disorders being reversible. In high doses, respiratory failure or apnea, a drop in the core body temperature (hypothermia) could also occur in the newborn.

If your baby has one or more of these symptoms at or after birth, contact your doctor and / or midwife.

Feeding with milk

This drug passes into breast milk: therefore, breast-feeding is not recommended. Ask your doctor or pharmacist for advice before taking any medicine.

In general, during pregnancy and breastfeeding, always seek the advice of your doctor or pharmacist before using any medication.

Driving and using machines

This medication can cause drowsiness and decreased alertness. These effects are worsened by alcohol consumption. Be very careful. Do not drive without the advice of a healthcare professional.

ROHYPNOL 2 mg, film-coated tablet contains

This medicine contains lactose.

3. HOW TO TAKE ROHYPNOL 2 mg film-coated tablet?

Dosage

THIS MEDICINE IS ONLY FOR ADULTS.

The dosage is strictly individual and the usual doses may vary. Either way, your doctor will try to find the minimum dose that is right for you.

In all cases, follow your doctor’s prescription.

Administration mode

Oral route.

Swallow this medicine with a glass of water.

Frequency of administration

Take your medicine immediately before bedtime.

Duration of the treatment

The duration of treatment should be as short as possible and should not exceed 2 weeks

(see Warnings).

If insomnia persists, see your doctor.

If you take more ROHYPNOL 2 mg film-coated tablet than you should:

In case of massive intake, the signs of overdose are manifested, mainly, by deep sleep which can go as far as coma depending on the amount ingested.

Immediately consult your doctor or pharmacist.

If you forget to take ROHYPNOL 2 mg film-coated tablet:

Take the next dose the next day at the usual time. Do not take a double dose to make up for the dose you forgot to take.

If you stop taking ROHYPNOL 2 mg film-coated tablet:

Abruptly stopping this treatment can cause the appearance of a WITHDRAWAL phenomenon. This is characterized by the appearance, in a few hours or a few days, of signs such as severe anxiety, insomnia, muscle pain, but one can also observe restlessness, irritability, headaches, numbness or tingling of the extremities, abnormal sensitivity to noise, light or physical contact, etc.

The modalities for stopping treatment should be defined with your doctor.

The very PROGRESSIVE reduction of the doses and the spacing of the catches represent the best prevention of this phenomenon of withdrawal. This period will be longer as the treatment has been prolonged.

Despite the gradual decrease in doses, a mild REBOUND phenomenon may occur, with TRANSITIONAL reappearance of symptoms (insomnia) which had justified the initiation of treatment.

In all cases, consult your doctor or pharmacist.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS ?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects depend on the dose used and the individual sensitivity of each person.

Most side effects occur mainly at the start of treatment and usually go away with prolonged administration.

The following side effects may occur with the administration of flunitrazepam (with an undetermined frequency: cannot be estimated from the available data).

Effects on the immune system

· Allergic reactions to the drug, including rash (pimples / redness on the skin), angioedema (swelling of the face) and low blood pressure (low blood pressure).

Psychiatric effects (on the brain)

· Confusional state (loss of landmarks in time or space), memory impairment, affective disorder, libido disorders (decreased sexual desire),

·Pre-existing depression may be revealed,

· Paradoxical reactions such as psychomotor instability, tension, agitation, irritability, aggressiveness, delirium, anger, nightmares, insomnia. hallucinations, psychosis (serious personality disorder of which the patient is unaware), behavioral disturbances and other undesirable effects on behavior,

• Physical and psychological dependence: abrupt stopping of treatment can lead to a withdrawal syndrome (symptoms related to the patient’s addiction to the drug) or a rebound phenomenon (reappearance or worsening of the insomnia for which the treatment had been taken. prescribed) even at therapeutic doses (see section 4.4),

• Abuse (taking the drug over time and / or in excessive doses).

Effects on the nervous system

· Somnolence during the day and particularly in the elderly, headache (headache), dizziness, decreased alertness, ataxia (trouble walking), drunkenness,

· Anterograde amnesia (not remembering events after taking the drug) is possible at therapeutic doses, the risk increasing with the dose. Amnesic effects may be associated with behavioral disturbances or changes in consciousness (see section 4.4).

Cardiac disorders (effects on the heart)

· Heart failure (malfunction of the heart), cardiac arrest.

Respiratory ailments

·  Respiratory depression (severe difficulty in breathing).

Eye disorders (effects on the eyes)

· Diplopia (double vision).

Gastrointestinal disorders (effects on the digestive tract)

· Gastrointestinal disorders.

Effects on the skin and subcutaneous tissue

· Skin reactions (pimples, redness), itchy or not (itchy or not).

Musculoskeletal disorders (effects on muscles)

· Hypotonia (decreased muscle tone), muscle weakness.

General disorders

· Asthenia, Tired

Lesions, poisoning

· An increased risk of falls and fractures has been reported in patients treated with benzodiazepines. This risk increases with concomitant use of sedatives (including alcoholic beverages) and in the elderly.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers – Website: https://www.erasolutionrbv.com

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ROHYPNOL 2 mg film-coated tablet?

Keep this medication out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the package. The expiration date refers to the last day of that month.Pas de précautions particulières de conservation.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with any unused medicine. These measures will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What ROHYPNOL 2 mg contains, scored film-coated tablet

· The active substance (s) is (are):

Flunitrazépam…………………………………………………………………………………………………………. 2,0 mg

For a scored film-coated tablet.

· The other component (s) is (are):

Microcrystalline cellulose, anhydrous lactose, hypromellose, povidone, sodium carboxymethyl starch, indigotin (E 132), magnesium stearate, ethyl cellulose, talc, titanium dioxide (E 171), iron oxide yellow (E 172), glycerol triacetate.

What ROHYPNOL 2 mg, scored film-coated tablet looks like and contents of the pack

This medication is in the form of a scored film-coated tablet. Box of 7 or 100.

Marketing authorization holder

CHEPLAPHARM ARZNEIMITTEL GMBH

BAHNHOFSTR. 1A

17498 MESEKENHAGEN

GERMANY

Marketing authorization operator

Not declared / to be declared later

Maker

ROCHE

Z.A.C DE LA GARENNE

AVENUE FAIDHERBE

93110 ROSNY-SOUS-BOIS

FRANCE

Names of the drug in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]