Delorazepam Ratiopharm Italia

Italy
Brand name Delorazepam Ratiopharm Italia
Form tablets
Active substance / Dosage
DELORAZEPAM
Prescription type Prescription only
ATC code
N05BA
Registration number 035998
Manufacturer TEVA B.V.

Table of Contents

Package leaflet: Information for the patient

Delorazepam ratiopharm Italia 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 1 mg/ml oral drops, solution

Equivalent medicinal product
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, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Delorazepam ratiopharm Italia is and what it is used for

Delorazepam ratiopharm Italia contains delorazepam, a substance that belongs to a group of
medicines called benzodiazepines, used to relieve severe emotional and
psychological distress causing significant discomfort and sometimes interfering with normal daily activities.
This medicine is therefore indicated for the treatment of:

  • anxiety, tension states, and other disorders associated with anxiety (somatic or psychiatric);
  • sleep disorders (insomnia).

2. What you need to know before taking Delorazepam ratiopharm Italia

Do not take Delorazepam ratiopharm Italia

  • if you are allergic to the active substance, to other similar medicines (other benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
  • if you suffer from a disease causing muscle weakness and fatigue (Myasthenia gravis);
  • if you have severe breathing problems (severe respiratory insufficiency);
  • if you have severe liver problems (severe hepatic insufficiency or hepatic encephalopathy);
  • if you have breathing difficulties during sleep (sleep apnea);
  • if you suffer from a disease characterized by a marked increase in eye pressure (narrow-angle glaucoma);
  • if you are in a state of drunkenness (acute alcohol intoxication);
  • if you have taken excessive doses (intoxication) of medicines with central nervous system depressant activity, such as analgesics, psychotropics, antidepressants, hypnotics, neuroleptics, and lithium;
  • during pregnancy, unless your doctor considers it strictly necessary;
  • during breastfeeding;
  • together with alcoholic beverages;
  • to treat a child or adolescent under 18 years of age, unless your doctor considers it strictly necessary.

Warnings and precautions
Talk to your doctor or pharmacist before taking Delorazepam ratiopharm Italia.
Avoid taking this medicine if you are taking medicines that depress the central nervous system (central nervous system depressants), unless absolutely necessary, as taking these medicines together could cause excessive sedation (deep sedation) or serious effects on breathing (respiratory depression).
Pay special attention and consult your doctor before taking Delorazepam ratiopharm Italia:

  • if you are elderly or debilitated;
  • if your respiratory function is impaired (chronic respiratory insufficiency). Your doctor may decide to reduce the dose.
  • if you need to administer it to a child or adolescent under 18 years of age;
  • if you have previously abused alcohol or drugs;
  • if your kidney function is impaired (severe renal insufficiency);
  • if you have heart problems (heart failure);
  • if your blood pressure is low;
  • if you suffer from a psychotic illness (a severe mental condition in which a person loses contact with reality and the ability to think and judge clearly), or if you suffer from depression or anxiety states associated with depression.

Additionally, you must stop treatment and contact your doctor immediately if any of the following occur:
behavioral disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, transient loss of consciousness (syncope), and sleepwalking. These reactions are more frequent in children and the elderly (see section “Possible side effects”).
Duration of treatment
Treatment duration should be as short as possible and must not exceed 4 weeks for insomnia treatment and 8–12 weeks for anxiety treatment, including a gradual discontinuation period.
The treatment period may be extended following careful reassessment of your health status by your doctor.
Tolerance
If after several weeks of treatment with this medicine you feel that the medicine no longer has an effect on your symptoms, consult your doctor.
Dependence and withdrawal
While taking benzodiazepines or similar medicines, such as delorazepam, there may be a risk of developing dependence, i.e., an uncontrollable need to continue taking the medicine. This risk increases with higher doses and longer treatment duration. This phenomenon is more likely if you have previously abused drugs or alcohol.
If you develop dependence, you must avoid stopping treatment abruptly, as withdrawal symptoms may occur, such as:

  • headache, muscle pain;
  • extreme anxiety, tension, restlessness, confusion, and irritability.

In severe cases of withdrawal, derealization (feeling that things are unreal), depersonalization (feeling of detachment from the surrounding environment), sound intolerance (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise, and physical contact, hallucinations (seeing or hearing things that do not exist), or epileptic seizures (neurological disturbances causing sudden, uncontrolled movements) may also occur.
Other symptoms may include: depression, insomnia, sweating, ringing in the ears (persistent tinnitus), involuntary movements, vomiting, altered sensation (paresthesia), perceptual disturbances, abdominal and muscle cramps, tremor, muscle pain (myalgia), agitation, palpitations, changes in heart rhythm (tachycardia), panic attacks, dizziness, increased tendon reflexes (hyperreflexia), short-term memory loss, and hyperthermia.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine (such as delorazepam) to a short-acting one. Therefore, switching from one benzodiazepine to another is not recommended. Your doctor will advise you on the most appropriate treatment for your case.
It is important to know that after stopping treatment with this medicine, the same symptoms for which you were being treated may reappear, sometimes even more intensely than before (rebound symptoms).
Since withdrawal or rebound symptoms are more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose until treatment is discontinued in order to minimize the occurrence of such symptoms (mood changes, anxiety, restlessness, and sleep disturbances).
Amnesia
Benzodiazepines may cause anterograde amnesia (memory loss that does not affect past memories but severely impairs the ability to memorize new information).
This phenomenon occurs more frequently several hours after taking the medicine; therefore, to reduce the risk, ensure you can sleep uninterrupted for 7–8 hours after taking Delorazepam ratiopharm Italia.
Children
The use of benzodiazepines in children and adolescents under 18 years of age is not recommended unless the doctor considers it strictly necessary. In such cases, treatment duration should be as short as possible.
Other medicines and Delorazepam ratiopharm Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pay particular attention and inform your doctor if you are taking any of the following medicines:

  • antipsychotics (neuroleptics) and antidepressants used to treat mental disorders;
  • hypnotics used to promote sleep;
  • anxiolytics/sedatives used to treat anxiety;
  • certain strong painkillers (narcotic analgesics) which may cause excessive well-being when taken with Delorazepam ratiopharm Italia. This may increase your need to continue taking these medicines (dependence);
  • antiepileptics used for epilepsy;
  • anesthetics used during surgical procedures;
  • antihistamines with sedative effects used to treat allergies;
  • medicines capable of inhibiting certain liver enzymes (especially cytochrome P450); your doctor will inform you if any of these are among the medicines you are taking;
  • theophylline and aminophylline used for asthma and certain types of airway obstruction, respectively;
  • medicines containing alcohol.

Concomitant use of delorazepam and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, potentially endangering the patient's life.
For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Delorazepam ratiopharm Italia together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s recommendations on dosage carefully. 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.
Delorazepam ratiopharm Italia and alcohol
DO NOT consume alcohol or other medicines containing alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If your doctor considers it strictly necessary, you may take Delorazepam ratiopharm Italia during the last stages of pregnancy or during labor (at high doses); in this case, your baby may show low body temperature (hypothermia), loss of muscle strength (hypotonia), breathing difficulties at birth, low blood pressure (hypotension), and impaired muscle tone (infantile hypotonia).
If Delorazepam ratiopharm Italia has been taken regularly during the last stages of pregnancy, your baby may show signs of physical dependence and withdrawal symptoms.
Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.
Driving and using machines
Delorazepam ratiopharm Italia may impair your ability to drive vehicles or operate machinery, as amnesia, sedation, concentration disturbances, and muscle weakness may occur during treatment. Additionally, if you have not rested sufficiently, the risk of impaired attention is higher.
Finally, remember that consuming alcohol during treatment with this medicine enhances the sedative effect of delorazepam, causing pronounced drowsiness and further reduced attention.
Delorazepam ratiopharm Italia tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Delorazepam ratiopharm Italia 1 mg tablets contain Sunset Yellow (E110): may cause allergic reactions.
Delorazepam ratiopharm Italia 1 mg/ml oral drops, solution contains ethanol (alcohol):
this medicine contains approximately 200 mg of alcohol (ethanol) per 2 ml dose (equivalent to 52 drops).
A 2 ml dose of this medicine is equivalent to about 5 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Delorazepam ratiopharm Italia 1 mg/ml oral drops, solution contains 1.8 g of propylene glycol per 2 ml dose (equivalent to 52 drops).
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
If you are pregnant, or if you suffer from liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
Delorazepam ratiopharm Italia in tablets and oral drops contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Delorazepam ratiopharm Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to do so.
Your doctor will determine the correct dose for you based on your health condition, aiming to establish the lowest effective dose in your case.
Do not exceed the maximum dose prescribed by your doctor. During treatment, your doctor may adjust the dosage: always follow the prescribed dosage carefully and never exceed the dose recommended by your doctor.

Anxiety, tension, and other anxiety-related disorders
The duration of treatment should be as short as possible and generally should not exceed 8–12 weeks, including a gradual withdrawal period.
In certain cases, your doctor may decide to extend the treatment after re-evaluating your health condition.

Tablets:
The recommended dose for adults is 1 tablet of 0.5 mg or 1 mg, taken 2–3 times daily.
In hospital treatment, the dose may be increased up to 1 tablet of 1 mg or 2 mg, 2–3 times daily. The tablet can be divided into two equal doses.

Oral drops:
The recommended dose for adults is 13–26 drops, taken 2–3 times daily.
In hospital treatment, the dose may be increased up to 26–52 drops, 2–3 times daily.

Insomnia
The duration of treatment should be as short as possible and generally ranges from a few days to 2 weeks, up to a maximum of 4 weeks, including a gradual withdrawal period. In certain cases, your doctor may decide to extend the treatment after re-evaluating your health condition.
For the treatment of insomnia, the medicine should be taken just before going to bed.

Tablets:
The recommended dose for adults is 1 tablet of 0.5 mg, 1 mg, or 2 mg taken in the evening before bedtime, according to your doctor's instructions. The tablet can be divided into two equal doses.

Oral drops:
The recommended dose for adults is 13–26–52 drops taken in the evening before bedtime, according to your doctor's instructions.
13 drops of Delorazepam Ratiopharm Italia oral drops correspond to 0.5 mg of delorazepam.

Method of administration
The drops should be diluted with a small amount of water. Do not take drops or tablets together with alcoholic beverages.

If you take more Delorazepam ratiopharm Italia than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Taking an excessive dose of delorazepam together with other medicines that depress the central nervous system or with alcohol may result in a fatal outcome.
Symptoms of overdose may include marked slowing (depression) of the central nervous system, with symptoms such as temporary loss of sensory and intellectual functions (mental clouding, confusion), drowsiness, fatigue, severe muscle problems (ataxia), visual disturbances, lethargy, and in more severe cases, deep sleep, unconsciousness, severe muscle problems (ataxia, hypotonia), low blood pressure, breathing difficulties, rarely coma, and very rarely death.

If you forget to take Delorazepam ratiopharm Italia
Do not take a double dose to make up for the missed dose.

If you stop taking Delorazepam ratiopharm Italia
Do not stop treatment with Delorazepam ratiopharm Italia suddenly or without first consulting your doctor, as withdrawal or rebound symptoms may occur (see section “Warnings and precautions”).

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.
Stop taking the medicine and contact your doctor immediately if you experience:

  • behavioural disturbances such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, transient loss of consciousness (syncope), and sleepwalking. These reactions are more frequent in children and elderly patients;
  • skin rash, itching, difficulty in breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of severe allergic reactions (anaphylactic shock).

To help you recognize some of the side effects, it may be helpful to inform a relative or a close friend
that you are taking this medicine and ask them to read this leaflet. You may ask them to alert you if
they notice any changes in your behaviour.

Other side effects, which may occur at the beginning of treatment and usually decrease in intensity or
disappear with continued treatment or by reducing the dose, may include:

Very common (may affect more than 1 in 10 people)

  • severe muscle problems (ataxia).

Common (may affect up to 1 in 10 people)

  • confusion, reduced alertness and progressive reduction in intellectual and sensory responsiveness (emotional blunting);
  • drowsiness;
  • sedation;
  • changes in heart rate (tachycardia);
  • muscle weakness (asthenia);
  • fatigue.

Uncommon (may affect up to 1 in 100 people)

  • changes in sexual desire.

Rare (may affect up to 1 in 1,000 people)

  • reduction in the number of white blood cells in the blood (agranulocytosis) and in the number of blood cells called platelets (thrombocytopenia);
  • reduction in the number of all blood cells (pancytopenia);
  • SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion, a hormonal imbalance
    leading to low sodium levels in the blood);
  • disinhibition;
  • euphoria;
  • suicidal thoughts and suicide attempt;
  • tremors, dizziness, headache;
  • difficulty in speech articulation (dysarthria);
  • amnesia;
  • coma;
  • double vision (diplopia);
  • blurred vision;
  • low blood pressure (hypotension);
  • nausea;
  • constipation;
  • increased bilirubin levels;
  • yellowing of the skin and whites of the eyes (jaundice);
  • increased levels of certain liver enzymes (transaminases, alkaline phosphatase);
  • skin rash;
  • hair loss (alopecia);
  • involuntary loss of urine (urinary incontinence);
  • reduced body temperature (hypothermia).

Frequency not known (cannot be estimated from the available data)

  • changes in appetite;
  • reduced sodium levels in the blood (hyponatremia);
  • anxiety, agitation and sleep disorders;
  • convulsions (involuntary, sudden and uncontrolled movements causing body agitation and spasms);
  • epileptic seizures (neurological disturbances causing sudden, uncontrolled movements);
  • balance disorders;
  • changes in attention and concentration levels;
  • disorientation;
  • breathing difficulties (respiratory depression);
  • worsening of breathing problems during sleep (sleep apnoea);
  • apnoea;
  • autonomic manifestations (nausea, vomiting, palpitations, cold sweating, anxiety or distress);
  • worsening of pre-existing breathing problems (pulmonary obstructive disease);
  • gastrointestinal disorders;
  • skin reactions;
  • depression (pre-existing or emerging during treatment).

During use of the medicine, the following side effects may also occur (see also section “Warnings and
precautions”):

  • memory loss (anterograde amnesia), sometimes associated with changes in behaviour;
  • physical and psychological dependence, leading to excessive and uncontrolled use of the medicine (abuse);
  • withdrawal or rebound phenomena upon discontinuation of treatment.

In some cases, relative overdose may occur (the administered dose of the medicine is within the therapeutic range, but its blood concentrations are increased). Symptoms such as severe muscle problems (ataxia), difficulty in speech articulation (dysarthria), urinary retention, dizziness, tremors, skin rash, and changes in libido may rarely be observed.
These symptoms normally resolve spontaneously within a few days or upon dose adjustment (according to the doctor's recommendations).

Reporting of side effects
If you experience any side effect, 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: http://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 Delorazepam ratiopharm Italia

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Use Delorazepam ratiopharm Italia 1 mg/ml oral drops, solution within 12 months after the first opening of the bottle; any unused portion must be discarded.
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 any medicine 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 Delorazepam ratiopharm Italia contains
Delorazepam ratiopharm Italia 0.5 mg tablets

  • The active substance is delorazepam. One tablet contains 0.5 mg of delorazepam.
  • The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (Type A), anhydrous colloidal silica, magnesium stearate and sodium docusate.

Delorazepam ratiopharm Italia 1 mg tablets

  • The active substance is delorazepam. One tablet contains 1 mg of delorazepam.
  • The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (Type A), anhydrous colloidal silica, magnesium stearate, sodium docusate and sunset yellow FCF (E110).

Delorazepam ratiopharm Italia 2 mg tablets

  • The active substance is delorazepam. One tablet contains 2 mg of delorazepam.
  • The other components are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch (Type A), anhydrous colloidal silica, magnesium stearate, sodium docusate and erythrosine (E127).

Delorazepam ratiopharm Italia 1 mg/ml oral drops, solution

  • The active substance is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
  • The other components are: ethanol 96 percent, glycerol, purified water, glicasol N, sodium saccharin and propylene glycol.

Description of the appearance of Delorazepam ratiopharm Italia and package contents
Delorazepam ratiopharm Italia tablets are supplied in a box containing 20 divisible tablets in blisters.
Delorazepam ratiopharm Italia 1 mg/ml oral drops, solution is supplied in a box containing a 20 ml bottle of solution.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Canton Moretti, 29 - 10015 Ivrea (TO) - Italy