COMPENDIUM 3 mg Hard Capsules

Зміст інструкції

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

COMPENDIUM

1.5mghard capsules
3 mg hard capsules
2.5 mg/ml oral drops, solution
Bromazepam
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 they have the same symptoms as you, as it may 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 Compendium is and what it is used for
• 2. What you need to know before you take Compendium
• 3. How to take Compendium
• 4. Possible side effects
• 5. How to store Compendium
• 6. Contents of the pack and other information

1. What is Compendium and what is it used for

Compendium contains the active ingredient bromazepam, belonging to the class of
medicines called benzodiazepine derivatives.”
Compendium is used in adultsfor the treatment of:

• anxiety, states of emotional tension and other manifestations associated with anxiety
• insomnia, only when severe and causes discomfort in normal daily life.

2. What you need to know before you take Compendium

Do not take Compendium

• if you are allergic to bromazepam or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to benzodiazepines (medicines similar to bromazepam)
• if you suffer from severe respiratory failure (severe reduction of respiratory system activity)
• if you suffer from a severe liver disease;
• if you suffer from myasthenia gravis (severe disease that affects the muscles and manifests with weakness and fatigue)
• if you suffer from sleep apnea syndrome (temporary cessation of breathing during sleep)
• narrow-angle glaucoma (eye disease caused by an increase in the pressure of the fluid contained within the eye)
• if you abuse alcohol
• if you abuse medicines:
• hypnotics, sedatives and medicines used to promote sleep
• narcotic analgesics, medicines for the treatment of acute or chronic pain of high intensity
• psychotropics, medicines used for mental disorders and/or depression.

Warnings and precautions
Talk to your doctor or pharmacist before taking Compendium.
In particular, tell your doctor if:

• you suffer from depression or anxiety related to depression or have suicidal tendencies (attempting to kill yourself), because Compendium may worsen your condition and the tendency to suicide
• you have had problems with drug or alcohol abuse in the past
• you suffer from chronic respiratory failure (reduced activity of the respiratory system)
• you suffer from kidney failure (reduced kidney function)
• you suffer from heart failure (reduced heart function), in this case the doctor will subject you to regular checks during therapy with Compendium
• you suffer from low blood pressure, in this case the doctor will subject you to regular checks during therapy with Compendium
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis).

Development of tolerance
Following repeated use of this medicine for a few weeks, a
decrease in its effectiveness (tolerance) may occur. If after a few weeks it seems to you that the
medicine does not work as well as at the beginning of treatment, consult your doctor.

Development of dependence
The use of high doses and/or for prolonged periods of bromazepam can cause physical and
psychic dependence.
This risk is higher if you have previously abused medicines, drugs or alcohol, as
you are more likely to develop habit and dependence on this medicine.
The possibility of dependence is reduced if you use Compendium at the appropriate dose,
as prescribed by the doctor and with a short-term treatment (see section 3 “How
to take Compendium”).

If you are elderly
If you are elderly, take Compendium with caution and under the supervision of your doctor.
This medicine may increase the risk of falls due to undesirable effects such as
ataxia (reduced motor and gait coordination), muscle weakness, dizziness,
drowsiness, fatigue, and tiredness. Furthermore, the elderly more frequently experience
undesirable effects such as restlessness, agitation, irritability, and aggressiveness (see
section “Possible side effects”).

Children and adolescents
Donot give this medicine to children and adolescents (0-18 years) withoutfirst consulting
the doctor.
Bromazepam, like other medicines similar to bromazepam, should only be given to children in
cases of actual need and under the direct supervision of the doctor, who will assess the use of
the medicine based on their conditions. In any case, the duration of treatment will be as
short as possible.

Other medicines and Compendium
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines together with
Compendium because caution is necessary:

• medicines that reduce and block the activity of the central nervous system. Avoidthe simultaneous use of Compendium with the following medicines as it may increase the risk of developing undesirable effects such as deep sedation (physical and mental relaxation similar to that caused by anesthetics) and severe reduction of respiratory and/or cardiac function:
• medicines used for some mental illnesses (antipsychotics/neuroleptics)
• sedatives and medicines used to promote sleep (hypnotics)
• medicines that cause physical and mental torpor (anxiolytics/sedatives)
• medicines for the treatment of depression (antidepressants) medicines for the treatment of acute or chronic pain of high intensity (opioids, narcotic analgesics, sedatives for cough, substitute treatments). The concomitant use of Compendium and opioids increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and can be life-threatening. . The concomitant use should only be considered if other treatment options are not possible. However, if your doctor prescribes Compendium together with opioids, the dose and duration of concomitant therapy will be defined by the doctor. Inform your doctor of all opioid medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform friends or family that you are aware of the signs and symptoms described above. Contact your doctor if you experience these symptoms. Narcotic analgesics can cause an increase in euphoria leading to increased psychic dependence.
• medicines for the treatment of epilepsy (antiepileptics)
• anesthetics
• medicines to counteract allergic reactions (sedating antihistamines)
• cimetidine(medicine used in case of stomach ulcer) because they can increase the effects of Compendium;
• theophylline or aminophylline(medicines used against bronchial asthma), because they can decrease the effects of Compendium;
• medicines that act on the metabolism of Compendium, because they can increase the effects of Compendium, for example:
• medicines to treat fungal infections (azole antifungals)
• medicines to treat HIV (protease inhibitors)
• some antibiotics (macrolides).

Compendium and alcohol
Donot drink alcohol while taking Compendium because the simultaneous intake of
alcohol and Compendium can cause undesirable effects such as sedation and severe reduction of
respiratory and/or cardiac function (see section “Do not take Compendium”).
If you have abused alcohol in the past, your doctor will monitor you during
treatment with Compendium, as you are more likely to develop dependence on this
medicine.
The intake of alcohol with Compendium can also lead to a serious impairment of
the ability to drive vehicles and use machinery (see section “Driving and operating machinery”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy

Do not takeCompendium during pregnancy without consulting your doctor first.
Available data indicate that the use of bromazepam:

• in the first 3 months of pregnancy can cause a malformation of the lip called “cleft lip” (oral cleft) in the newborn
• in the last 6 months of pregnancy can cause a decrease in fetal movements and a variability of the fetal heart rate.

If, for serious health reasons, your doctor decides to prescribe this medicine
during the last period of pregnancy, the newborn may also manifest, even at low doses
of the medicine, the symptoms of the "floppy baby" syndrome such as:

• axial hypotonia (reduction of muscle tone)
• problems with sucking leading to reduced weight gain. These signs are temporary, but can last from 1 to 3 weeks. In case of taking high doses and/or for long periods of Compendium during the last period of pregnancy, the newborn may manifest:
• depression of breathing
• temporary cessation of breathing (apnea)
• lowering of body temperature (hypothermia)
• symptoms of physical dependence or withdrawal with increased excitability, agitation and tremor. These effects can be observed a few days after birth.

If treatment with Compendium is necessary during the last part of pregnancy,
the doctor will avoid the use of high doses and/or for long periods and after the birth of the baby
will monitor the possible presence of withdrawal symptoms in the baby

Breastfeeding
Bromazepam is excreted in breast milk, therefore breastfeeding is not
recommended during treatment with Compendium.

Driving and operating machinery
Donot drive vehicles or operate machinery if you experience
undesirable effects such as sedation (physical and mental relaxation similar to that caused
by anesthetics), amnesia (memory disorders), alteration of concentration and
muscle function during treatment with Compendium. Furthermore, these effects are aggravated if you take alcohol together
with Compendium (see section “Compendium and alcohol”).
Your vigilance may be altered especially if you have not slept for a
sufficient time after taking Compendium.

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

Compendium oral drops, solution contains propylene glycol
This medicine contains 1141 mg of propylene glycol per dose, equivalent to 951 mg/ml.

3. How to take Compendium

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults
The doctor will establish the dose and frequency most suitable for you, in order to avoid any possible intake of an excessive dose of this medicine. Generally, the doctor will start with the lowest recommended dose and may, if necessary, increase it gradually.
The average recommended dose is:

• hard capsules: 1-2 capsules of 1.5 mg 2-3 times a day; or 1 capsule of 3 mg 2-3 times a day
• oral drops: 15-30 oral drops 2-3 times a day.

If you are elderly or suffer from liver disorders or suffer from chronic respiratory disorders
If you are elderly or suffer from liver disorders or suffer from chronic respiratory disorders, the doctor will assess whether to prescribe you lower doses than those indicated above.

Duration of treatment
The doctor will prescribe you the shortest possible duration of treatment.
Depending on the indication for which the doctor has prescribed this medicine, the duration of treatment is as follows:

• anxiety:generally, the overall duration of treatment does not exceed 8/12 weeks, including a period of gradual discontinuation
• insomnia:generally, the duration of treatment varies from a few days to 2 weeks, up to a maximum of 4 weeks, including a period of gradual discontinuation. In certain cases, the doctor, after re-evaluating your health status, may decide to extend the treatment duration indicated above. During the discontinuation period of treatment with Compendium, the doctor will explain how to gradually reduce the dose of this medicine in order to reduce the risk of withdrawal and rebound symptoms. (see paragraph “If you stop taking Compendium” and “Possible side effects”).

If you take more Compendium than you should
In case of accidental ingestion/intake of an excessive dose of Compendium, immediately notify your doctor or go to the nearest hospital.

Symptoms
If you accidentally take a dose of medicine higher than the prescribed one, there are rarely life-threatening dangers, as long as it is taken alone (alcohol increases the depressive effects on the nervous system).
In mild cases, the symptoms in case of accidental ingestion/intake of an excessive dose of Compendium may be:

• drowsiness
• mental confusion
• lethargy (continuous sleep and reduced response to normal stimuli). In more severe cases, the symptoms may be:
• ataxia (reduced motor and gait coordination)
• hypotonia (reduced muscle tone)
• hypotension (low blood pressure)
• depression of breathing and/or heart activity
• coma
• death.

In addition, you may experience the following symptoms:

• dysarthria (speech disorder)
• nystagmus (oscillatory eye movements)
• difficulty speaking
• areflexia (lack of reflexes)
• apnea (temporary cessation of breathing).

Treatment
The doctor, after evaluating the symptoms, will carry out the appropriate supportive therapy (for example with activated charcoal and/or gastric lavage).
The doctor may consider the use of flumazenil (a medicine that acts by blocking the effect of benzodiazepines). If you are taking medicines to treat depression or suffer from epilepsy, inform your doctor, as in these cases flumazenil must be used with extreme caution.
For further information on the correct use of this medicine, consult your doctor.

If you forget to take Compendium
Donot take a double dose to make up for a missed dose.

If you stop taking Compendium

• Donot stop taking Compendium suddenly without first consulting your doctor.
• The doctor will gradually reduce the dose during the phase of discontinuation of therapy.
• Abrupt discontinuation of this medicine can cause:
• withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability
• rebound symptoms(when the symptoms that led to treatment with bromazepam reappear in a more severe form after discontinuation of treatment) such as mood changes, anxiety, restlessness or sleep disturbances
• serious symptomssuch as: feeling detached or estranged from oneself or from the outside world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise and physical contact, perception of things that do not exist in reality (hallucinations), seizures.
• other symptoms: depression, insomnia, sweating, persistent feeling of tinnitus (ringing in the ears), involuntary body movements, vomiting, paresthesia (tingling sensation), altered perceptions, abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (feeling of increased heartbeats), tachycardia (increased heart rate), panic attacks, dizziness, accentuation of reflexes, loss of ability to remember recent events, hyperthermia (increased body temperature).
• These symptoms occur especially if you have developed a physical dependence on this medicine (see paragraph “Warnings and precautions”).

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 everyone will experience them.
Contact your doctor immediatelyif you experience any of the following seriousside effects during treatment with Compendium; your doctor will explain how to stopusing the
medicine:

• depression
• restlessness
• agitation
• irritability
• aggression
• delusion
• anger
• nightmares
• perception of things that are not real (hallucinations)
• behavioral changes
• psychosis (a mental disorder that causes altered perception of reality, thought disorders, mental confusion). These reactions are more common in children and the elderly, or if you suffer from a brain disorder that causes reduced mental function (organic cerebral syndrome).

In addition, during treatment with Compendium, as with any drug, you may experience the following side effects whose frequency cannot be established based on the available data:

Effects affecting the heart

• reduced heart function (heart failure)
• heart attack (cardiac arrest).

Effects affecting the eyes

• double vision (diplopia). This side effect occurs mainly at the beginning of therapy and usually disappears with subsequent administrations
• blurred vision.

Effects affecting the stomach and intestines

• nausea and vomiting. These side effects occur mainly at the beginning of therapy and usually disappear with subsequent administrations
• constipation.

Effects affecting various parts of the body

• fatigue. This side effect occurs mainly at the beginning of therapy and usually disappears with subsequent administrations

Effects affecting the body's defense system

• allergic reaction and/or severe allergic reaction (anaphylactic/anaphylactoid). The allergic reaction can manifest with swelling that can affect the tongue and/or throat and that can lead to obstruction of the airways, which could be fatal (angioedema), but also with shortness of breath (dyspnea), throat closure, or nausea and vomiting.

Trauma

• falls and fractures. The risk of falls and fractures is increased if you are taking other sedative medicines (medicines that cause physical and mental dullness) or alcohol at the same time, or if you are elderly.

Effects affecting the mind

• confusional state. This side effect occurs mainly at the beginning of therapy and usually disappears with subsequent administrations
• emotional disorders. This side effect occurs mainly at the beginning of therapy and usually disappears with subsequent administrations
• drug dependence/abuse (see section “Warnings and precautions”)
• withdrawal symptoms (see sections “Warnings and precautions” and “If you stop taking Compendium”)
• altered sexual desire
• memory disorders/amnesia. These side effects can occur even at recommended doses, the risk increases with higher doses. This effect may be associated with behavioral disorders. This effect occurs more often several hours after taking the medicine and, therefore, to reduce the risk, before taking this medicine you must ensure that you can have a sufficient period of uninterrupted sleep of a few hours (see section “How to take Compendium”).

Effects affecting the kidneys and urinary tract

• inability of the urinary bladder to empty completely (urinary retention)
• condition characterized by accumulation of water in the body and reduced levels of sodium in the blood (syndrome of inappropriate secretion of antidiuretic hormone).

Effects affecting the muscles

• muscle weakness. This side effect occurs mainly at the beginning of therapy and usually disappears with subsequent administrations

Effects affecting the nervous system
The following side effects occur mainly at the beginning of therapy and
usually disappear with subsequent administrations:

• drowsiness
• decreased alertness
• fatigue
• headache
• dizziness
• lightheadedness
• reduced motor and gait coordination (ataxia).

Effects affecting the respiratory system

• respiratory depression
• temporary cessation of breathing (apnea) and worsening of nocturnal apnea

Effects affecting the skin

• skin rash
• itching
• redness of the skin accompanied by itching (urticaria).

Effects affecting the liver

• yellowing of the skin and whites of the eyes (jaundice).

Diagnostic tests

• increased levels of bilirubin, transaminases and alkaline phosphatase in the blood (substances produced by the liver).

Effects affecting the blood

• thrombocytopenia (reduction of platelets in the blood)
• agranulocytosis (reduction of white blood cells in the blood)
• pancytopenia (reduction of all cells present in the blood).

Other side effects that have been reported with other medicines belonging to the benzodiazepine class, such as Compendium, and which therefore may be potential side effects of Compendium as well:

Effects affecting various parts of the body

• rebound symptoms (when the anxiety and insomnia that led to treatment with bromazepam reappear in a more severe form after stopping treatment). These side effects generally occur during the phase of discontinuation of treatment, and especially after abrupt discontinuation of treatment. To reduce these side effects, do not abruptly stop treatment and consult your doctor who will tell you how to gradually reduce the dose (see sections “If you stop taking Compendium” and “How to take Compendium”)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can contribute to providing more information on
the safety of this medicine.

5. How to store Compendium

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 pack after Exp.
The expiry date refers to the last day of that month.

Hard capsules: store at a temperature below 30  C.

Oral drops: does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Compendium contains

Compendium 1.5 mg hard capsules

• the active ingredient is: bromazepam (1 hard capsule contains 1.5 mg of bromazepam)
• the other ingredients are: lactose(see paragraph “Compendium capsules contain lactose”), corn starch, talc, magnesium stearate, titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Compendium 3 mg hard capsules

• the active ingredient is: bromazepam (1 hard capsule contains 3 mg of bromazepam)
• the other ingredients are: lactose(see paragraph “Compendium capsules contain lactose”), corn starch, talc, magnesium stearate, titanium dioxide (E171), indigotine (E132), gelatin.

Compendium 2.5 mg/ml oral drops, solution

• active ingredient: bromazepam (1 ml of solution contains 2.5 mg of bromazepam)
• the other ingredients are: sodium saccharin, disodium edetate, blackcurrant flavour, raspberry flavour, purified water, propylene glycol.

Description of the appearance of Compendium and contents of the packs

Hard capsules
It is presented in white/yellow 1.5 mg and white/blue 3 mg hard capsules for oral use,
packaged in blisters in a carton of 30 capsules.

Oral drops
It is presented as a clear solution contained in a 20 ml dropper bottle, with
child-resistant closure.

Marketing Authorisation Holder
POLIFARMA S.p.A. - Viale dell’Arte, 69 - 00144 ROMA.

Manufacturer
ISTITUTO DE ANGELI S.r.l., Località Prulli 103/C – 50066 Reggello (FI)