Depas: detailed information

Patient Information Leaflet

DEPAS 0.5 mg film-coated tablets, 1 mg film-coated tablets, 0.5 mg/ml oral drops, solution

etizolam
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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What DEPAS is and what it is used for

DEPAS is a medicine containing etizolam, an active substance belonging to the class of benzodiazepines, drugs which reduce anxiety and help sleep. Benzodiazepines are usually used for severe disorders that cause significant distress or interfere with the performance of normal daily activities.
DEPAS is used to treat:

anxiety states, which may manifest with rapid heartbeat and agitation, difficulty concentrating or memory lapses, sleep disturbances, sweating, tremors;
insomnia, a condition characterized by difficulty falling asleep or maintaining adequate sleep.

2. What you should know before taking DEPAS

Do not take DEPAS if:

you are allergic to the active substance or to other medicines in the same class (benzodiazepines), or to any of the other ingredients of this medicine (listed in section 6);
you have severe respiratory problems;
you suffer from sleep apnoea syndrome (pauses in breathing during sleep);
you suffer from severe myasthenia gravis, a disease characterised by muscle weakness and fatigue;
you have closed-angle glaucoma, a disease characterised by increased pressure inside the eye with possible worsening of vision;
you have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking DEPAS if:

you have or have had drug or alcohol dependence;
you have kidney problems;
you have liver problems;
you have had psychiatric disorders or brain diseases;
you suffer from depression;
you have suicidal thoughts;
you have breathing difficulties;
you have heart problems;
you have reduced muscle tone (hypotonia);
you are elderly, as this medicine may cause coordination disturbances, increasing the risk of falls.

Other information

Mental side effects – contact your doctor if you experience side effects such as agitation, irritability, restlessness, aggression, delusions, anger, nightmares, hallucinations, or changes in behaviour. These side effects are more likely in children and the elderly.
Amnesia (total or partial memory loss) – during treatment with DEPAS, you may have difficulty remembering recent events or storing new information (anterograde amnesia), especially a few hours after taking the medicine. To reduce this risk, take DEPAS immediately before going to bed.
Tolerance – during treatment with DEPAS, you may notice a reduction in the effectiveness or duration of the sedative/hypnotic effect. If this occurs, contact your doctor, who will assess whether your treatment needs to be changed. Do not increase the dose of DEPAS without consulting your doctor, as using higher doses may lead to drug dependence (see section 3 - “WARNING”).
Dependence – during treatment with DEPAS, you may develop physical and psychological dependence on this medicine, meaning a need to use it in increasingly higher doses (tolerance) and independently of actual medical need. The risk of dependence increases with higher doses, longer treatment duration, or if you have previously had drug or alcohol dependence. For this reason, treatment with DEPAS should be as short as possible (see section 3 - “WARNING”).
Withdrawal syndrome – if you have developed dependence and suddenly stop taking DEPAS or reduce the dose too quickly, symptoms due to withdrawal syndrome may occur, such as headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability. In severe cases, symptoms may include altered perception of the external world or of oneself (derealization and depersonalization), numbness and tingling in the extremities, increased sensitivity to light, noise, sounds, and physical contact, hallucinations, or epileptic seizures. If you experience this condition, consult your doctor (see section 3 - “If you stop taking DEPAS”).
Rebound symptoms – treatment with DEPAS should be discontinued gradually, with a progressive reduction in dose. Abruptly stopping treatment may cause the return or worsening of symptoms (insomnia or anxiety) for which treatment was started (see section 3 - “If you stop taking DEPAS”).

Children and adolescents
DEPAS must not be used in children and adolescents under 18 years of age.
Other medicines and DEPAS
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, as some medicines may interact with DEPAS or increase the risk of adverse events, even serious ones.
In particular, contact your doctor before taking DEPAS if you are using:

medicines acting on the central nervous system, such as antipsychotics, sedatives, anxiolytics, hypnotics, anaesthetics, sedative antihistamines, narcotic analgesics;
medicines used to treat depression (antidepressants), such as fluvoxamine maleate or MAO inhibitors (MAOIs);
medicines used to treat epilepsy (antiepileptics), as these may alter the effect of DEPAS.

Concomitant use of DEPAS 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. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes DEPAS 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 such symptoms.
DEPAS and alcohol
Do not consume alcohol or medicines containing alcohol during treatment with this medicine, as this could worsen certain adverse effects on the central nervous system (e.g. sedation, drowsiness).
Pregnancy and breastfeeding
Do not take DEPAS during pregnancy or breastfeeding, unless specifically instructed by your doctor.
If you suspect you are pregnant or are planning a pregnancy, consult your doctor before taking this medicine.
Driving and using machines
DEPAS may cause sedation, memory loss, impaired concentration, and altered muscle function. Exercise particular caution before driving or operating machinery.
DEPAS drops contain ethanol, sodium, and propylene glycol
Ethanol
This medicine contains 123.8 mg of alcohol (ethanol) per maximum dose (40 drops), equivalent to 2.06 mg/kg. The volume amount in this medicine is equivalent to less than 4 ml of beer or 2 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per maximum dose (1 mg equals 40 drops), i.e. essentially 'sodium-free'.
Propylene glycol
This medicine contains approximately 3240 mg of propylene glycol per maximum daily dose (2 mg equals 80 drops), equivalent to 54 mg/kg. If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment. If you have liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
DEPAS tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DEPAS

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor.
Your doctor will determine the correct dose and duration of treatment based on the severity of your symptoms
and your general condition (for example, if you have problems with the liver, kidneys, or lungs).
If you are taking DEPAS for anxiety
The usual dose is:
half or 1 tablet of 0.5 mg (equivalent to 0.25 – 0.5 mg), 2-3 times daily
or
10-20 drops (equivalent to 0.25 – 0.5 mg), 2-3 times daily.
In severe cases, your doctor will prescribe a higher dose:
1 tablet of 1 mg or 2 tablets of 0.5 mg, twice daily (once in the morning and once in the evening).
Your doctor will tell you which tablet or how many drops to use.
The duration of treatment should be as short as possible and must not exceed 8–12 weeks.
If you are taking DEPAS for insomnia
The usual dose is:
1 or 2 tablets of 1 mg or 2–4 tablets of 0.5 mg (equivalent to 1–2 mg), taken in the evening before going to bed;
or
40–80 drops (equivalent to 1–2 mg), taken in the evening before going to bed.
Your doctor will tell you which tablet or how many drops to use.
The duration of treatment ranges from a few days to 2 weeks, up to a maximum of 4 weeks.
Elderly patients
Your doctor will prescribe a lower dose than those indicated above, staying within the limits of 1.5 mg per day.
ATTENTION: Contact your doctor if during treatment with DEPAS you notice a reduction in the effectiveness
or duration of the calming/sedative effect (tolerance). Do not increase the dose of DEPAS without consulting your doctor, as using high doses of this medicine may lead to dependence on the drug (see section 2 – “Other information”).
Method of administration
DEPAS tablets: take the tablets orally, swallowing them with a little water.
DEPAS drops: take the drops diluted in a small amount of water. To open the bottle, press down on the cap and at the same time unscrew it normally; to close the bottle, screw the cap back on tightly.
If you take more DEPAS than you should
In case of accidental ingestion or overdose of DEPAS, contact your doctor immediately or go to the nearest hospital.
In hospital, appropriate intervention procedures will be initiated.
If you take a dose of DEPAS higher than the therapeutic dose, you may experience mental confusion with altered senses (drowsiness) and lethargy. In severe cases, symptoms may include coordination problems, low blood pressure (hypotension), muscle weakness (hypotonia), breathing difficulties, or coma. Overdoses of this medicine may also result in death.
If you forget to take DEPAS
Do not take a double dose to make up for a missed dose. Take the missed dose as soon as you remember, then continue your treatment as normal.
If you stop taking DEPAS
Do not stop treatment with DEPAS abruptly, as rebound symptoms or withdrawal syndrome may occur (see section 2 – “Other information”). When it is necessary to discontinue therapy, your doctor will gradually reduce the dose.
If you have any questions 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 everybody gets them.

Stop taking DEPAS immediately and contact your doctor if you experience:

severe breathing difficulties, possibly with altered consciousness and mental status (carbon dioxide narcosis);
fever, muscle stiffness, difficulty swallowing, increased heart rate (tachycardia), changes in blood pressure, sweating, possible signs of Neuroleptic Malignant Syndrome;
breathing difficulties, fever and cough, possible signs of pneumonia;
muscle weakness and pain, increased creatine kinase and myoglobin in blood and urine, possible signs of muscle damage (rhabdomyolysis);
yellowing of the skin or eyes (jaundice), changes in liver function tests such as increased bilirubin, increased transaminases, increased alkaline phosphatase.

Tell your doctor if, during treatment with DEPAS, you notice:

drowsiness, reduced emotions, decreased alertness, confusion, difficulty speaking, fatigue, headache, dizziness;
muscle weakness, loss of coordination (ataxia);
thirst, nausea, stomach or intestinal disturbances;
sudden or gradual appearance of skin lesions (skin reactions), for example discolouration in spots or widespread (rash, erythema);
vision changes such as double vision, eye problems after light exposure (photophobia), dry eyes, excessive blinking, persistent and involuntary eyelid closure (blepharospasm);
changes in sexual desire, breast enlargement in men (gynaecomastia);
increased blood prolactin levels (hyperprolactinaemia);
nasal congestion, difficulty breathing;
sensation of a racing heartbeat (palpitations);
sweating, swelling (oedema);
difficulty urinating.

Other side effects (see section 2 - "Further information")
Some side effects observed with other benzodiazepines may also occur during treatment with DEPAS:

insomnia and anxiety (rebound symptoms);
dependence and withdrawal syndrome;
memory loss (anterograde amnesia);
psychiatric side effects;
recurrence of pre-existing depression.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.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 DEPAS

Keep this medicine out of the sight and reach of children.
DEPAS tablets: this medicine requires no special storage conditions.
DEPAS oral drops, solution: this medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. 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 DEPAS Contains
The active substance is: etizolam.

DEPAS 0.5 mg Film-coated Tablets
One 0.5 mg tablet contains: 0.5 mg of etizolam.
The other components are: magnesium stearate, lactose, microcrystalline cellulose, maize starch, talc,
hypromellose, titanium dioxide, macrogol 6000, dimethicone 200.

DEPAS 1 mg Film-coated Tablets
One 1 mg tablet contains: 1 mg of etizolam.
The other components are: microcrystalline cellulose, lactose, maize starch, talc, magnesium stearate,
macrogol 6000, hypromellose, titanium dioxide, dimethicone 200, aluminium indigo carmine lake.

DEPAS 0.5 mg/ml Oral Drops, Solution
1 drop of DEPAS contains: 25 mcg of etizolam; 10 drops contain: 0.25 mg of etizolam.
The other components are: sodium saccharin, glycerol, orange flavour, lemon flavour, caramel flavour,
ethanol, propylene glycol.

Description of the Appearance of DEPAS and Contents of the Pack
DEPAS 0.5 mg film-coated tablets are available in a carton containing 30 film-coated, divisible tablets.
DEPAS 1 mg film-coated tablets are available in a carton containing 15 film-coated tablets.
DEPAS oral drops, solution are available in a 30 ml bottle with dropper, equipped with a child-resistant cap.

Marketing Authorization Holder
Viatris Italia S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer
Tablets
Abiogen Pharma S.p.A. – Production Plant in Ospedaletto (PI)
ITC Production S.r.l. - Via Pontina Km 29, 00071 Pomezia (RM)
Oral Drops, Solution
ITC Production S.r.l. - Via Pontina Km 29, 00071 Pomezia (RM)