SERPAX 15 mg Tablet

Зміст інструкції

1. Serpax 15 mg tablets, 30 mg tablets
   1. What is Serpax and what is it used for
   2. What you need to know before taking Serpax
   3. How to take Serpax
   4. Possible side effects
   5. How to store Serpax
   6. Contents of the pack and other information

Serpax 15 mg tablets, 30 mg tablets

oxazepam

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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Serpax and what is it used for

Serpax contains the active ingredient oxazepam, which belongs to a class of medicines called
“benzodiazepines”, which act on states of anxiety and have calming properties.
Serpax is used in adultsfor the treatment of anxiety and the physical and mental manifestations associated
with anxiety (e.g. tension).
Medicines of the same class as Serpax (benzodiazepines) are indicated only when the disorder is severe,
disabling or leads to significant distress.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Serpax

Do not take Serpax

• if you are allergic to oxazepam or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to medicines of the same class as Serpax (benzodiazepines);
• if you suffer from sleep apnea syndrome (temporary cessation of breathing during sleep);
• if you suffer from severe respiratory failure and lung failure (serious breathing problems);
• if you suffer from myasthenia gravis (an autoimmune disease that affects the muscles and manifests with weakness and fatigue);
• if you suffer from severe liver failure (serious liver problems);
• if you suffer from spinal or cerebral ataxia;
• if you are pregnant or think you may be pregnant and if you are breastfeeding with breast milk (see section “Pregnancy and breastfeeding”).

Do not givethis medicine to children and adolescents (0-18 years).

Warnings and precautions
Consult your doctor or pharmacist before taking Serpax.
In particular, consult your doctor or pharmacist before taking Serpax if you think that any of the following
conditions apply to you:

• suffer from breathing problems, for example chronic obstruction of the lungs;
• suffer from depression;
• suffer from a psychiatric illness;
• suffer from reduced liver function;
• if you suffer from a thyroid disease;
• if you are not taking medicines for a diagnosed thyroid disorder;
• suffer from narrow-angle glaucoma (an eye disease caused by an increase in the pressure of the fluid contained within the eye);
• if you have had angioedema reactions in the past while taking medicines of the benzodiazepine class;
• if you suffer from conditions in which a reduction in blood pressure can cause cardiovascular or cerebrovascular complications.

If you have to take Serpax for a long time (chronic therapy), your doctor will prescribe blood tests to
check if there are alterations of the blood cells and check liver function.

Development of tolerance
Following repeated use of this medicine for a few weeks, a decrease in its effectiveness (tolerance) may occur.

Development of dependence
The use of oxazepam can cause physical and psychological dependence, as can happen with other medicines similar to
oxazepam. The risk of dependence is greater with increasing dose and duration of treatment or if you
have previously abused drugs and/or alcohol, or if you suffer from significant personality disorders.

Memory disorders (amnesia)
The use of oxazepam can cause memory disorders or inability to memorize new information (anterograde amnesia). This effect occurs more often several hours after taking the medicine. Therefore, to
reduce the risk, before taking this medicine you must ensure that you can have a sufficient period of
uninterrupted sleep of 7-8 hours (see section “How to take Serpax”).

Psychiatric and paradoxical reactions
When using benzodiazepines, paradoxical reactions such as restlessness, agitation,
irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, behavioral changes, states
of anxiety, hostility, excitement, sleep disorders or insomnia, sexual excitement, sedation, fatigue,
drowsiness, ataxia, confusion, depression, unmasking of depression with suicidal tendencies, dizziness,
changes in libido, impotence, decreased orgasm can occur. If this should happen, your doctor will
discontinue the treatment.

Elderly
With brain aging and in association with age-related diseases, Serpax can
increase the risk of developing adverse effects of type:

• neurological (e.g. confusion and in general alteration of mental functions),
• psychiatric (e.g. increased anxiety and delusions),
• respiratory (difficulty in breathing),
• musculoskeletal (falls and fractures due to the relaxing effect on muscles).

Children and adolescents
Do not givethis medicine to children and adolescents (0-18 years) (see section “Do not take Serpax”).

Other medicines and Serpax
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines that reduce and block the activity of the central nervous system:
• medicines used for the treatment of anxiety and insomnia (barbiturates)
• medicines used for some mental illnesses (antipsychotics)
• calming and sleep-inducing medicines (hypnotics/sedatives)
• mental medicines used to reduce states of anxiety and cure anxiety disorders (anxiolytics)
• medicines used for the treatment of pain acute or chronic of high intensity (narcotic analgesics).
• medicines used for the treatment of epilepsy (antiepileptics)
• medicines used to sedate convulsions (anticonvulsants)
• anesthetics
• medicines used to counteract allergic manifestations that have a sedative effect (sedative antihistamines) These medicines, when used together with Serpax, can increase the depressive effects on the central nervous system of Serpax.
• sodium oxybate(medicine used for narcolepsy);
• theophylline or aminophylline(medicines used against bronchial asthma), because they can reduce the effects of Serpax;
• medicines that act on how the liver works,because they can increase the activity of this medicine.

Opioids
The concomitant use of Serpax and opioids (strong painkillers, medicines for the treatment of dependence and some
medicines for cough) increases the risk of drowsiness, difficulty in 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 Serpax together with opioids, the dose and duration of treatment
concomitantly must be limited by the doctor.
Tell your doctor about all the opioid medicines you are taking and carefully follow the
recommendation on the dose of the doctor. It may be helpful to inform friends or relatives to pay attention to
the signs and symptoms listed above. Consult your doctor if you experience these symptoms.

Laboratory tests
If you are taking Serpax and have to undergo the dexamethasone suppression test (a test performed to
assess the amount of cortisol in the blood), tell your doctor because the results may be altered by
this medicine.

Serpax and alcohol
Do notdrink alcohol while taking Serpax because the simultaneous intake of alcohol and Serpax can
increase the sedative effect (physical and mental relaxation) of this medicine.
If you have previously abused alcohol, your doctor will monitor you during treatment with Serpax, as
you are more likely to develop dependence on this medicine.
The intake of alcohol with Serpax can also lead to a serious impairment of the ability to drive
vehicles and operate machinery (see section “Driving and using machines”).

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

Pregnancy

Do not takeSerpax during pregnancy.
If you intend to become pregnant or suspect you are pregnant, you should contact your doctor who will assess the
suspension of treatment with this medicine.
If the medicine is taken during the last 3 months of pregnancy or during labor at high doses, the
newborn may experience adverse effects, even serious, such as reduced activity, reduced muscle tone
(hypotonia), lowering of body temperature (hypothermia), breathing problems and nutritional problems. Chronic use of benzodiazepines during the last stages of pregnancy can cause newborns
symptoms of physical dependence or withdrawal symptoms after birth.

Breastfeeding

Do not takeSerpax if you are breastfeeding with breast milk, as benzodiazepines such as Serpax pass into
breast milk.

Fertility
The effects of oxazepam on human fertility are unknown.

Driving and using machines
Do not drive or operate machinery if you experience adverse effects such as
sedation (physical and mental relaxation), amnesia (memory disorders), alteration of concentration and
muscle function during treatment with Serpax. Your vigilance may be altered especially if you have not slept for a sufficient time after taking Serpax or if you have taken alcohol.

Serpax contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to take Serpax

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the dose and duration of treatment most suitable for you, after evaluating your state of
health.

How much to take:

• Treatment of mild to moderate anxietyThe recommended dose is generally: 1 tablet of 15 mg 3 or 4 times a day.
• Treatment of severe anxiety or anxiety associated with depressionThe recommended dose is generally: 1 tablet of 15 mg or 1 tablet of 30 mg, three or four times a day.

Do not exceedthe maximum dose, equal to 120 mg (4 tablets of 30 mg).
After taking this medicine, you should allow for a period of about 7-8 hours for sleep.

If you are elderly or debilitated
If you are elderly or debilitated, the doctor will initially prescribe 1 tablet of 15 mg, one or two times a
day and will subsequently assess whether to increase the dose.

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

Duration of treatment
The doctor will prescribe the shortest possible duration of treatment.
Generally the duration of treatment should not exceed 8-12 weeks, including a period of gradual withdrawal.
At the beginning of treatment with Serpax, 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 paragraphs
“If you stop taking Serpax” and “Possible side effects”).
In certain cases the doctor may decide to extend the duration of treatment above, after
re-evaluating your state of health.

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

Symptoms
Taking an excessive dose of Serpax together with alcohol or drugs that depress the central nervous
system can be life-threatening. Taking an excessive dose of benzodiazepines can cause a
depression of the central nervous system of varying degrees.
In mild cases, the symptoms in case of accidental ingestion/intake of an excessive dose of Serpax may
be:

• drowsiness;
• mental confusion;
• continuous sleep and reduced response to normal stimuli (lethargy).

In more severe cases, the symptoms may be:

• reduced motor and gait coordination (ataxia);
• reduced muscle tone (hypotonia);
• low blood pressure (hypotension);
• reduced breathing (respiratory depression);
• coma;
• death.

Treatment
The doctor, after evaluating the symptoms, will monitor the parameters of respiratory and
circulatory function and 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 works 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 should not be used.

If you forget to take Serpax
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you stop taking Serpax

• Do notstop treatment with Serpax without first consulting your doctor.
• The doctor will gradually reduce the dose during the phase of suspension of therapy.
• Abrupt discontinuation of this medicine can cause:
• rebound symptoms(when the symptoms that led to treatment with oxazepam reappear in a more severe form after discontinuation of treatment) such as mood changes, anxiety, restlessness or sleep disturbances;
• withdrawal symptomssuch as rebound symptoms, headache, muscle pain, extreme anxiety, tension, depression, restlessness, confusion, irritability, sweating, dizziness, dysphoria;
• serious symptomssuch as: feeling detached or estranged from oneself (depersonalization) or from the external world (derealization), increased sensitivity to sounds (hyperacusis), ringing in the ears (tinnitus), numbness and tingling in the legs or arms, hypersensitivity to light or noise or physical contact, involuntary movements, vomiting, nausea, diarrhea, loss of appetite, perceiving things that do not exist in reality (hallucinations/delirium), tremor, abdominal cramps, muscle pain (myalgia), agitation, feeling of increased heartbeats (palpitations), increased heart rate (tachycardia), panic attacks, dizziness, increased reflexes (hyper-reflexia), short-term memory loss, increased body temperature (hyperthermia), seizures;

If you have any doubts about the use of Serpax, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediatelyif you experience any of the following seriousside effects during treatment with Serpax:

• severe allergic reaction
• swelling of the tongue and throat (angioedema) which can cause obstruction of the airways, which can also lead to death
• restlessness
• agitation
• irritability
• aggression
• delusion
• rage
• nightmares
• hallucinations
• psychosis
• behavioral changes
• development of depression with suicidal tendencies. These reactions are more frequent if you suffer from personality disorders and if you are elderly.

The following side effects have been observed and reported during treatment with Serpax with the following
frequencies:

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

• sedation
• drowsiness
• fatigue

Common (may affect up to 1 in 10 people)

• depression
• movement disorder with loss of coordination of muscles and joints (ataxia)
• confusion, dizziness
• tiredness, muscle weakness

Uncommon (may affect up to 1 in 100 people)

• changes in sexual desire, problems with erection (erectile dysfunction), disorders of orgasm
• nausea

Not known (frequency cannot be estimated from available data)

• reduction in the number of blood cells and other blood diseases (thrombocytopenia, agranulocytosis, pancytopenia, blood dyscrasias)
• allergic reactions, skin reactions (e.g. rash)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• decrease in sodium in the blood (hyponatremia)
• disinhibition
• euphoria, hostility
• sexual arousal disorders
• sleep disorders, insomnia
• coma
• extrapyramidal symptoms (e.g. rigidity, resting tremor, few/absence of spontaneous movements, slow and clumsy movements)
• convulsions, seizures, tremor
• long-term memory disorders (amnesia), transient inability to memorize new information (anterograde amnesia)
• vertigo
• difficulty articulating words (dysarthria)
• headache
• sense of instability, reduced alertness
• weakening of senses and orientation (obnubilation of consciousness)
• other memory disorders
• lack of emotional sensitivity (blunting of emotions)
• changes in appetite
• visual disturbances (including diplopia and blurred vision)
• lowering of blood pressure
• reduction in breathing (respiratory depression), cessation of breathing (apnea), worsening of sleep apnea
• worsening of a disease with obstruction of the lungs
• constipation
• yellowing of the skin and whites of the eyes (jaundice)
• increase in certain substances produced by the liver (liver enzymes, alkaline phosphatase and bilirubin)
• hair loss
• lowering of body temperature (hypothermia)
• paradoxical reaction (such as anxiety states)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 help provide more information on the safety of this
medicine.

5. How to store Serpax

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Serpax contains

Serpax 15 mg tablets

• the active ingredient is oxazepam 15 mg
• the other ingredients are lactose(see section Serpax tablets contains lactose), magnesium stearate, corn starch, pregelatinized starch.

Serpax 30 mg tablets

• the active ingredient is oxazepam 30 mg
• the other ingredients are lactose(see section Serpax tablets contains lactose), microcrystalline cellulose, potassium polacrilin, magnesium stearate.

Description of the appearance of Serpax and contents of the packs

Serpax 15 mg tablets
It is presented as white, flat and round tablets for oral use with beveled edges. The number “15” and the fracture line are
imprinted on one side.
Packaged in blisters of 20 tablets.

Serpax 30 mg tablets
It is presented as white, flat and round tablets for oral use with beveled edges. The number “30” is
imprinted on one side and a double fracture line on the other side.
Packaged in blisters of 20 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Italia S.r.l., Via Vittor Pisani, 20 - 20124 Milano - Italy

Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
D-48159 Münster
Germany
Meda Pharma GmbH & Co. KG
Benzstrasse 1
D-61352 Bad Homburg
Germany