Delorazepam Almus

Patient Information Leaflet

DELORAZEPAM ALMUS 1 mg/ml oral drops, solution

Equivalent medicine
Please read all of 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 they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DELORAZEPAM ALMUS is and what it is used for

DELORAZEPAM ALMUS contains the active substance delorazepam, which belongs to a group of
medicines called benzodiazepines.
Benzodiazepines are used to relieve severe anxiety states, which cause significant distress to the individual.
This medicine is indicated for the treatment of:

• anxiety, tension, and other anxiety-related disorders;
• sleep disorders (insomnia).

2. What you should know before taking DELORAZEPAM ALMUS

Do not take DELORAZEPAM ALMUS

• if you are allergic to delorazepam, to other similar medicines (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6)
• if you have myasthenia gravis, a disease causing muscle weakness and fatigue
• if you have severe respiratory insufficiency
• if you have severe liver problems (hepatic insufficiency)
• if you have breathing difficulties during sleep (sleep apnea)
• if you have a type of eye disease called narrow-angle glaucoma
• if you have alcohol intoxication or intoxication from other medicines that depress the central nervous system (hypnotics, analgesics, neuroleptics, antidepressants, lithium)
• if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding)

Warnings and precautions
Talk to your doctor or pharmacist before taking DELORAZEPAM ALMUS.
Be cautious when using this medicine, as it may cause serious, life-threatening breathing problems
(respiratory depression) and severe allergic reactions (anaphylactic/anaphylactoid reactions) associated with swelling
of the tongue, larynx, and throat, which may lead to breathing and swallowing difficulties (angioedema),
shortness of breath (dyspnea), throat closure, nausea, and vomiting. These events have been reported
after taking the first dose or subsequent doses of benzodiazepines. Your doctor will continuously assess the need to
continue treatment and, in case of angioedema, will advise you not to restart the treatment.
Take this medicine with caution and always under medical supervision in the following cases:

• If you are elderly. In this case, your doctor may decide to reduce the dose to avoid undesirable effects such as muscle weakness, dizziness, drowsiness, fatigue, tiredness, and progressive loss of muscle coordination (ataxia), which may increase the risk of falls and fractures.
• If you have respiratory problems (respiratory insufficiency). In this case, your doctor may decide to reduce the dose.
• If you have severe liver problems (hepatic insufficiency) or suffer from mental confusion due to liver failure (hepatic encephalopathy).
• If you have severe kidney problems (renal insufficiency).
• If you have low blood pressure or heart problems (cardiac insufficiency). In this case, your doctor may decide to perform regular check-ups.
• If you suffer from depression or have previously abused alcohol or drugs.

Tolerance: If after a few weeks the medicine seems less effective than at the beginning of treatment, consult your doctor.
Dependence: When taking this medicine, there is a risk of dependence, meaning the need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously suffered from psychiatric disorders or have abused drugs or alcohol. Drug dependence may occur even at therapeutic doses and even if you have no risk factors.
Withdrawal: When stopping DELORAZEPAM ALMUS abruptly or with a rapid dose reduction, you may experience withdrawal or rebound symptoms (such as headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability), even if you have taken the medicine at recommended doses and for a short period.
To minimize these symptoms, a gradual dose reduction is recommended. Withdrawal symptoms may appear within the first few days after stopping treatment.
Withdrawal symptoms may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, and increased body temperature (hyperthermia).
Amnesia: Anterograde amnesia may occur. This is more frequent several hours after taking the medicine. To reduce the risk of amnesia (memory loss), ensure an uninterrupted sleep of 7–8 hours.
Behavioral reactions: In some patients, a syndrome involving various memory and behavioral disturbances may occur, such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations (seeing or hearing things that do not exist), psychosis (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly), and behavioral changes. This syndrome may be accompanied by potentially dangerous behaviors for oneself or others, such as unusual behavior, self-harm (self-injury), and aggression (especially towards people trying to limit one's activities). If you experience behavioral disturbances, stop taking the medicine immediately (see section 4. Possible side effects). These reactions are more frequent in children and elderly patients.
Benzodiazepines are not recommended for psychotic disorders and should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.

Children and adolescents
In children and adolescents under 18 years of age, DELORAZEPAM ALMUS should be used only when absolutely necessary, and the duration of treatment should be as short as possible.

Other medicines and DELORAZEPAM ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially cautious and inform your doctor if you are taking the following medicines:

• antipsychotics (neuroleptics) and antidepressants, used to treat psychiatric disorders
• hypnotics, medicines used to promote sleep
• anxiolytics, tranquillizers, and sedatives, used to treat anxiety
• certain strong painkillers (opioids), which may cause increased feelings of well-being when taken with DELORAZEPAM ALMUS. This may increase your desire to continue taking these medicines (dependence).
• antiepileptics, used for epilepsy
• antihistamines with sedative effects, used to treat allergies
• anesthetics, used during surgery
• medicines that increase or decrease the metabolism of delorazepam
• theophylline and aminophylline, used to treat asthma or other respiratory diseases.

The concomitant use of DELORAZEPAM ALMUS and opioids (strong analgesics, medicines for addiction treatment, 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 other treatment options are available.
However, if your doctor prescribes DELORAZEPAM ALMUS 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 carefully follow your doctor’s dosage recommendations. 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 such symptoms.

DELORAZEPAM ALMUS and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine. This negatively affects your ability to drive or operate machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take DELORAZEPAM ALMUS during pregnancy, as it may harm the unborn child.
If your doctor considers it necessary for you to take this medicine during the late stages of pregnancy, your baby may develop the floppy infant syndrome, characterized by low body temperature, loss of muscle tone, and breathing difficulties.
If DELORAZEPAM ALMUS has been taken regularly during the late stages of pregnancy, your baby may develop physical dependence and withdrawal symptoms.
If you start treatment with DELORAZEPAM ALMUS and are of childbearing age, consult your doctor both if you plan to become pregnant and if you suspect you are pregnant, as it will be necessary to discontinue the medicine.

Breastfeeding
Do not take this medicine if you are breastfeeding, as delorazepam passes into breast milk.

Driving and using machines
The use of DELORAZEPAM ALMUS may affect your ability to drive or operate machinery, as you may feel confused, forgetful, drowsy, or experience muscle tone problems. These effects are more pronounced if you have not had sufficient sleep. If this occurs, avoid driving or operating machinery. Consuming alcohol during treatment with this medicine negatively affects your ability to drive or operate machinery.

DELORAZEPAM ALMUS oral drops contain ethanol (alcohol)
This medicine contains 13% vol alcohol (96% ethanol), i.e., 104 mg per dose (equivalent to 26 drops – 1 ml), corresponding to 2.6 ml of beer and 1.0 ml of wine per dose. The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 761 mg of propylene glycol per dose (equivalent to 26 drops – 1 ml).
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, breastfeeding, or have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per dose (equivalent to 26 drops – 1 ml), i.e., essentially "sodium-free".

3. How to take DELORAZEPAM ALMUS

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 adjust the dose according to your needs.
Treatment of anxiety, tension, and other anxiety-related disorders: the dose varies according to your
needs, as prescribed by your doctor: the recommended average dose is 13–26 drops, 2 or 3 times daily.
In neuropsychiatry, the dose may be increased to 26–52 drops, 2 or 3 times daily, as prescribed by your doctor.
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 evaluating your health condition.
Treatment of insomnia: the dose varies according to your needs, as prescribed by your doctor: the
recommended average dose is 13 drops or 26 drops or 52 drops per day, taken in the evening before going to bed, diluted with a small amount of water.
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 evaluating your health condition.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Your doctor will regularly monitor your condition at the beginning of treatment in order to reduce, if necessary, the dose or frequency of administration.
Use in elderly patients and in patients with kidney or liver problems
In elderly and debilitated patients, a reduced dose should be administered, with close monitoring of the patient.
If you take more DELORAZEPAM ALMUS than you should
If you (or someone else) have taken an excessive dose of DELORAZEPAM ALMUS or if you suspect that a
child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause severe depression of the central nervous system, with symptoms such as fatigue, progressive loss of muscle coordination (ataxia), visual disturbances, confusion, drowsiness, unconsciousness, reduced muscle tone (hypotonia), low blood pressure (hypotension), breathing difficulties (respiratory depression), depression of the nervous system which may worsen leading to coma and death.
Bring this leaflet, the bottle, and its packaging to the hospital or doctor so they know which medicine has been taken.
If you forget to take DELORAZEPAM ALMUS
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.
If you stop taking DELORAZEPAM ALMUS
Do not stop treatment with DELORAZEPAM ALMUS suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur.
If your doctor decides to discontinue treatment, they will gradually reduce your dose to minimize withdrawal symptoms, such as:

• headache, muscle pain, tension
• severe anxiety, confusion, restlessness, irritability
• in severe cases of withdrawal, derealization (feeling that things are not real), 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 are not real), or epileptic seizures. Other symptoms include: depression, insomnia, sweating, persistent ringing in the ears (tinnitus), involuntary movements, vomiting, altered sensation in hands and feet (paresthesia), altered perception, abdominal and muscle pain, tremor, muscle inflammation (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia).

Treatment must be discontinued gradually; otherwise, the symptoms for which you were being treated may return even more intensely than before (rebound insomnia and anxiety). The risk of developing these symptoms is higher if you stop taking DELORAZEPAM ALMUS suddenly. You may also experience mood changes, anxiety, restlessness, and sleep disturbances.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience:

• depression and behavioural reactions such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations (seeing or hearing things that are not there), psychosis (a serious mental condition in which a person loses touch with reality and the ability to think and judge clearly), changes in behaviour. If you experience these side effects, treatment must be stopped immediately. These reactions are more likely to occur in children and elderly patients (see section Warnings and precautions).

The following side effects may also occur:
Very common (may affect more than 1 in 10 people):

• loss of muscle coordination (ataxia)

Common (may affect up to 1 in 10 people):

• confusion, reduced alertness
• reduced emotional responsiveness
• drowsiness, sedation
• increased heart rate (tachycardia)
• muscle weakness
• fatigue, reduced muscle strength (asthenia)

Uncommon (may affect up to 1 in 100 people):

• changes in sexual desire

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

• decrease in platelets (thrombocytopenia), decrease in white blood cells (agranulocytosis), decrease in all blood cells (pancytopenia)
• alteration in antidiuretic hormone secretion (SIADH)
• disinhibition, euphoria, self-harming behaviour (suicidal ideation/attempts)
• tremors, dizziness, headache (cephalalgia), speech problems (dysarthria/difficulty in articulating speech), memory loss, coma
• paradoxical reactions and amnesia (see section Warnings and precautions)
• double vision, blurred vision
• reduced blood pressure (hypotension)
• nausea, constipation
• jaundice, a condition characterised by yellowing of the skin and whites of the eyes
• increased liver enzyme levels (transaminases), increased bilirubin, increased alkaline phosphatase
• skin rash, hair loss (alopecia)
• involuntary loss of urine (incontinence)
• reduced body temperature (hypothermia)

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

• sudden potentially life-threatening allergic reactions (anaphylactic/anaphylactoid reactions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing (angioedema)
• changes in appetite, reduced levels of sodium in the blood (hyponatremia)
• anxiety, agitation, sleep disturbances
• seizures, epileptic fits, disturbances in balance, attention and concentration, disorientation
• respiratory depression, apnoea, breathing difficulties during sleep (sleep apnoea), worsening of lung diseases (pulmonary obstructive disease)
• stomach and intestinal disorders
• skin reactions
• dependence on the medicine, drug abuse, withdrawal symptoms (see sections Warnings and precautions and If you stop taking DELORAZEPAM ALMUS)

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 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 DELORAZEPAM ALMUS

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 packaging after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, stored correctly.
Oral drops should be used within 12 months of first opening the bottle. Any remaining product should be discarded.
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 ALMUS contains

• The active substance is delorazepam. 1 ml of solution contains 1 mg of delorazepam.
• The other components are: ethanol 96%, glycerol, purified water, ammonium glycyrrhizinate, sodium saccharin, propylene glycol.

Description of the appearance of DELORAZEPAM ALMUS and contents of the pack
Pack containing 1 bottle of 20 ml oral solution.
Marketing Authorization Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa
Manufacturer
Doppel Farmaceutici S.r.l. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
ABC Farmaceutici SpA - Canton Moretti, 29 - 10090 San Bernardo d’Ivrea (TO)