DEPAS 0.5 mg Tabletka powlekana

Treść ulotki

1. DEPAS 0.5 mg film-coated tablets, 1 mg film-coated tablets, 0.5 mg/ml oral drops, solution
   1. What is DEPAS and what is it for
   2. What you need to know before taking DEPAS
   3. How to take DEPAS
   4. Possible side effects
   5. How to store DEPAS
   6. Package contents and other information

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

etizolam

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is DEPAS and what is it for

DEPAS is a medicine that contains etizolam, an active ingredient belonging to the class of
benzodiazepines, drugs that reduce anxiety and help with sleep. Benzodiazepines are usually
used for serious disorders, which cause severe discomfort or prevent the performance of normal
daily activities.
DEPAS is used to treat:

• states of anxiety, which can manifest with a rapid heartbeat and agitation, difficulty concentrating or memory lapses, sleep disturbances, sweating, tremors;
• insomnia, a condition in which you have difficulty falling asleep or maintaining adequate sleep.

2. What you need to know before taking DEPAS

Do not take DEPAS if:

• you are allergic to the active ingredient or to other medicines belonging to the same class (benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6);
• you have severe breathing problems;
• you suffer from sleep apnea syndrome (pauses in breathing during sleep);
• you suffer from myasthenia gravis, a disease characterized by muscle weakness and fatigue;
• you have closed-angle glaucoma, a disease characterized by an increase in 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 dependencies on drugs or alcohol;
• 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 can cause coordination disorders, increasing the risk of falls.

Further information

• Mental side effects- contact your doctor if you experience side effects such as agitation, irritability, restlessness, aggression, delusion, anger, nightmares, hallucinations, behavioral changes. These side effects are more likely in children and the elderly.
• Amnesia(total or partial memory loss) - during therapy with DEPAS, you may have difficulty remembering recent events or memorizing new information (anterograde amnesia), especially after a few hours of taking the medicine. To reduce this risk, take DEPAS immediately before going to sleep.
• Tolerance- during treatment with DEPAS, you may notice a reduction in the effectiveness or duration of the sedative/hypnotic effect. If this should occur, contact your doctor who will assess the need to change your therapy. Do not increase the dose of DEPAS without consulting your doctor, because the use of high doses may cause drug dependence (see section 3 - “WARNING”).
• Dependence- during therapy with DEPAS, you may develop physical and psychological dependence on this medicine, i.e., the need to use it in ever-increasing doses (tolerance) and independently of its real need. The risk of dependence increases with increasing dose and duration of treatment, or if you have had dependencies on drugs or alcohol. For this reason, therapy with DEPAS should be as short as possible (see section 3 - “WARNING”).
• Withdrawal syndrome- if you have developed dependence and suddenly stop therapy with DEPAS or reduce the dose too quickly, symptoms due to withdrawal syndrome such as headache, muscle pain, anxiety, tension, restlessness, confusion, and irritability may occur. In severe cases, the following may occur: a feeling of perceiving the external world or oneself in an altered way (derealization and depersonalization), numbness and tingling of the extremities, increased sensitivity to light, noise, sounds, and physical contact, hallucinations, or seizures. Ifyou experience this condition, see your doctor(see section 3 - “If you stop taking DEPAS”).
• Rebound symptoms- treatment with DEPAS should be discontinued gradually, with a progressive decrease in the dose. Abrupt discontinuation of therapy may cause the reappearance or worsening of the symptoms (insomnia or anxiety) for which you started therapy (see section 3 - “If you stop taking DEPAS”).

Children and adolescents
In children and adolescents under 18 years of age, DEPAS should not be used.

Other medicines and DEPAS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines, as some medicines can interact with DEPAS or increase the risk of adverse events,
including serious ones.
In particular, contact your doctor before taking DEPAS if you are using:

• medicines that act on the nervous system, such as antipsychotics, sedatives, anxiolytics, hypnotics, anesthetics, sedative antihistamines, narcotic analgesics;
• medicines used to treat depression (antidepressants) such as fluvoxamine maleate or MAOIs;
• medicines used to treat epilepsy (antiepileptics); as these medicines can change the effect of DEPAS.

The concomitant use of DEPAS and opioids (strong painkillers, medicines for the treatment of dependence and
some medicines for cough) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be
considered only when other treatment options are not possible.
However, if your doctor prescribes DEPAS together with opioids, the dose and duration of concomitant treatment
must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow
your doctor's recommendation on dosage. It may be helpful to inform friends or family to pay attention
to the signs and symptoms listed above.
See your doctor if you experience these symptoms.

DEPAS with alcohol
Do not take alcohol or medicines that contain alcohol during treatment with this medicine, as
this could worsen some side effects on the nervous system (e.g., sedation,
drowsiness).

Pregnancy and breastfeeding
Do not take DEPAS during pregnancy or breastfeeding, unless specifically indicated by your doctor.
If you suspect or are planning a pregnancy, ask your doctor for advice before taking this
medicine.

Driving and using machines
DEPAS can cause sedation, memory loss, altered concentration, and muscle function. Be particularly careful before driving vehicles or using machinery.

DEPAS drops contains ethanol, sodium and propylene glycol
Ethanol
This medicine contains 123.8 mg of alcohol (ethanol) in each maximum dose (40 drops) which is equivalent to
2.06 mg/kg. The amount in volume of 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 equal to 40 drops) i.e.
essentially ‘sodium-free’.

Propylene glycol
This medicine contains approximately 3240 mg of propylene glycol per maximum daily dose (2 mg equal to 80
drops) equivalent to 54 mg/kg. If you are pregnant or breastfeeding, do not take this medicine unless
otherwise recommended by your doctor. The doctor may perform further checks during therapy. If you
suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by
your doctor. The doctor may perform further checks during therapy.

DEPAS tablets contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.

3. How to take DEPAS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
The doctor will establish the correct dose and the duration of treatment, based on the severity of your symptoms and your
general conditions (for example if you have problems with the liver, kidneys, lungs).

If you take DEPAS because you suffer from anxiety
The usual dose is:
half or 1 tablet of 0.5 mg (equal to 0.25 – 0.5 mg), 2-3 times a day

or
10-20 drops (equal to 0.25 – 0.5 mg), 2-3 times a day.
In severe cases, the doctor will prescribe a higher dose:
1 tablet of 1 mg or 2 tablets of 0.5 mg, 2 times a day (once in the morning and once in the
evening).

The doctor will indicate which tablet or how many drops to use.
The duration of treatment should be as short as possible and should not exceed 8-12 weeks.

If you take DEPAS because you suffer from insomnia
The usual dose is:
1 or 2 tablets of 1 mg or 2 - 4 tablets of 0.5 mg (equal to 1 – 2 mg), in the evening before going to bed;

or
40-80 drops (equal to 1 – 2 mg), in the evening before going to bed.

The doctor will indicate 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
The doctor will establish a lower dose than those indicated above, keeping it within the limits of 1.5 mg per
day.

WARNING:Contact your doctor if during treatment with DEPAS, you notice a reduction in efficacy
or the duration of the calming/sedative effect ( tolerance). Do not increase the dose of DEPAS without
consulting your doctor, because the use of high doses of this medicine may cause dependenceon
the drug (see paragraph 2 - “Further information”).

Method of administration
DEPAS tablets: take the tablets by mouth, swallowing them with a little water.
DEPAS drops: take the drops diluting them in a little water. To open the bottle, press the cap and
unscrew it normally at the same time; to close the bottle, screw the cap back on tightly.

If you take more DEPAS than you should
In case of accidental ingestion/intake of an excessive dose of DEPAS, immediately inform your
doctor or go to the nearest hospital.
In hospital you will be subjected to appropriate intervention protocols.
In case of taking a dose of DEPAS higher than the therapeutic dose, you may notice mental confusion
with altered senses (obnubilation) and lethargy. In severe cases, the following may occur: coordination
disorders, low blood pressure (hypotension), muscle weakness (hypotonia), difficulty
breathing or coma. Excessive doses of this medicine can also cause death.

If you forget to take DEPAS
Do not take a double dose to make up for a missed dose. Take the dose you forgot
as soon as you remember and continue with therapy normally.

If you stop taking DEPAS
Do not abruptly stop treatment with DEPAS, as rebound symptoms
or withdrawal syndromemay appear (see paragraph 2 - “Further information”). When it is necessary to stop
therapy, the doctor will gradually reduce the dose.
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 gets them.
manifest.

Immediately stop taking DEPASand contact your doctor if you experience:

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

Tell your doctor if you notice during therapy with DEPAS:

• drowsiness, reduced emotions, reduced alertness, confusion, difficulty speaking, fatigue, headache, dizziness;
• muscle weakness, loss of coordination of movements (ataxia);
• thirst, nausea, stomach or intestinal disorders;
• more or less sudden appearance of skin lesions (skin reactions), for example, color changes in patches or widespread (rash, erythema);
• changes in vision such as double vision, eye problems after exposure to light (photophobia), dry eyes, excessive blinking, persistent and involuntary closure of the eyelids (blepharospasm);
• changes in sexual desire, increased breast volume in men (gynecomastia);
• increased prolactin in the blood (hyperprolactinemia);
• nasal obstruction, difficulty breathing;
• feeling of heart in the throat (palpitations);
• sweating, swelling (edema);
• difficulty urinating.

Other side effects(see section 2 - “Further information”)
Some side effects that have occurred with other benzodiazepines may also occur
during treatment with DEPAS:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 does not require any particular storage conditions.
DEPAS oral drops, solution: this medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 ingredient is: etizolam.
DEPAS 0.5 mg film-coated tablets
One 0.5 mg tablet contains: 0.5 mg of etizolam.
The other ingredients are: magnesium stearate, lactose, microcrystalline cellulose, corn 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 ingredients are: microcrystalline cellulose, lactose, corn starch, talc, magnesium stearate,
macrogol 6000, hypromellose, titanium dioxide, dimethicone 200, aluminium indigotine 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 ingredients are: sodium saccharin, glycerol, orange flavour, lemon flavour, caramel flavour,
ethanol, propylene glycol.

Description of the appearance of DEPAS and package contents
DEPAS 0.5 mg film-coated tablets is available in a pack containing 30 film-coated
tablets that can be divided.
DEPAS 1 mg film-coated tablets is available in a pack containing 15 film-coated tablets.
DEPAS oral drops, solution is available in a 30 ml bottle fitted with a dropper, with a child-resistant
closure.

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

Manufacturer

Tablets
Abiogen Pharma S.p.A. – Officina di Produzione 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)