Serpax

Package leaflet: Information for the patient

Serpax 15 mg tablets, 30 mg tablets

oxazepam
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, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 Serpax is and what it is used for

Serpax contains the active substance oxazepam, which belongs to a class of medicines called "benzodiazepines", which act on anxiety states and have calming properties.
Serpax is used in adults for the treatment of anxiety and the associated physical and mental symptoms of anxiety (e.g. tension).
Medicines of the same class as Serpax (benzodiazepines) are indicated only when the disorder is severe, disabling, or causes severe distress.
Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Serpax

Do not take Serpax

• if you are allergic to oxazepam or to 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 apnoea syndrome (temporary cessation of breathing during sleep);
• if you suffer from severe respiratory insufficiency or severe pulmonary insufficiency (serious breathing problems);
• if you suffer from severe myasthenia gravis (an autoimmune disease affecting the muscles, causing weakness and fatigue);
• if you suffer from severe hepatic insufficiency (serious liver problems);
• if you suffer from spinal or cerebral ataxia;
• if you are pregnant or think you may be pregnant, or if you are breastfeeding (see section "Pregnancy and breastfeeding").

Do not give this medicine to children and adolescents (0–18 years).
Warnings and precautions
Talk to your doctor or pharmacist before taking Serpax.
In particular, talk to your doctor or pharmacist before taking Serpax if you think any of the following conditions apply to you:

• you have breathing disorders, for example chronic obstructive pulmonary disease;
• you suffer from depression;
• you have a psychiatric illness;
• you have reduced liver function;
• you have a thyroid disease;
• you are not taking medication for a diagnosed thyroid disorder;
• you have narrow-angle glaucoma (an eye disease caused by increased pressure of the fluid inside the eye);
• you have previously experienced angioedema reactions while taking medicines of the benzodiazepine class;
• you have conditions in which a drop in blood pressure could lead to cardiovascular or cerebrovascular complications.

If you are to take Serpax for a long time (chronic therapy), your doctor will prescribe blood tests to monitor possible changes in blood cells and to check liver function.
Development of tolerance
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance).
Development of dependence
The use of oxazepam may lead to physical and psychological dependence, as occurs with other medicines similar to oxazepam. The risk of dependence is higher 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 disturbances (amnesia)
The use of oxazepam may cause memory disturbances or inability to retain new information (anterograde amnesia). This effect is more likely to occur several hours after taking the medicine. Therefore, to reduce the risk, you must ensure you can have an uninterrupted sleep period of 7–8 hours after taking this medicine (see section "How to take Serpax").
Paradoxical psychiatric reactions
When benzodiazepines are used, paradoxical reactions may occur, such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, behavioural changes, anxiety states, hostility, excitement, sleep disturbances or insomnia, sexual excitement, sedation, fatigue, drowsiness, ataxia, confusion, depression, unmasking of depression with suicidal tendencies, dizziness, changes in libido, impotence, reduced orgasm. If this occurs, your doctor will discontinue treatment.
Elderly patients
Due to age-related changes in the brain and associated diseases, Serpax may increase the risk of developing adverse effects of the following types:

• neurological (e.g. confusion and general impairment of mental functions),
• psychiatric (e.g. increased anxiety and delirium),
• respiratory (difficulty in breathing),
• musculoskeletal (falls and fractures due to muscle relaxation effects).

Children and adolescents
Do not give this 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 medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines that reduce or block the activity of the central nervous system:
• medicines used to treat anxiety and insomnia (barbiturates)
• medicines used for certain mental illnesses (antipsychotics/neuroleptics)
• sedative and sleep-inducing medicines (hypnotics/sedatives)
• anxiolytic medicines used to reduce anxiety and treat anxiety disorders
• medicines used to treat depression (antidepressants)
• medicines used to treat severe acute or chronic pain (narcotic analgesics)
• medicines used to treat epilepsy (antiepileptics)
• medicines used to suppress seizures (anticonvulsants)
• anaesthetics
• antiallergic medicines that have a sedative effect (sedative antihistamines)
  These medicines, when used together with Serpax, may increase the central nervous system depressant effects of Serpax.
• sodium oxybate (a medicine used for narcolepsy);
• theophylline or aminophylline (medicines used for bronchial asthma), as they may reduce the effects of Serpax;
• medicines that affect how the liver works, as they may increase the activity of this medicine.

Opioids
Concomitant use of Serpax and opioids (strong analgesics, medicines for addiction therapy, 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 Serpax 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 dosing 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 any of these symptoms.
Laboratory tests
If you are taking Serpax and are due to undergo the dexamethasone suppression test (a test performed to assess cortisol levels in the blood), inform your doctor, as results may be altered by this medicine.
Serpax and alcohol
Do not drink alcohol while taking Serpax, as the simultaneous intake of alcohol and Serpax may increase the sedative effect (physical and mental relaxation) of this medicine.
If you have previously abused alcohol, your doctor will monitor you closely during treatment with Serpax, as you are more likely to develop dependence on this medicine.
Taking alcohol with Serpax may also severely impair your ability to drive or operate machinery (see section "Driving and use of machines").
Pregnancy, breastfeeding and fertility
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 Serpax during pregnancy.
If you plan to become pregnant or suspect you are pregnant, contact your doctor, who will evaluate whether to discontinue treatment with this medicine.
If the medicine is taken during the last three months of pregnancy or during labour at high doses, the newborn may experience adverse effects, including serious ones such as reduced activity, decreased muscle tone (hypotonia), lowered body temperature (hypothermia), breathing problems, and feeding difficulties. Chronic use of benzodiazepines during the late stages of pregnancy may cause physical dependence or withdrawal symptoms in newborns after birth.
Breastfeeding
Do not take Serpax if you are breastfeeding, as benzodiazepines such as Serpax pass into breast milk.
Fertility
The effects of oxazepam on human fertility are unknown.
Driving and use of machines
Do not drive or operate machinery if, during treatment with Serpax, you experience adverse effects such as sedation (physical and mental relaxation), amnesia (memory disturbances), impaired concentration, or altered muscle function. Your alertness may be impaired, especially if you have not had sufficient sleep after taking Serpax or if you have consumed alcohol.
Serpax contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Serpax

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate dose and duration of treatment for you, after evaluating your health condition.

How much to take:

• Treatment of mild to moderate anxiety
  The usual recommended dose is: 1 tablet of 15 mg, 3 or 4 times daily.
• Treatment of severe anxiety or anxiety associated with depression
  The usual recommended dose is: 1 tablet of 15 mg or 1 tablet of 30 mg, three or four times daily.

Do not exceed the maximum dose of 120 mg (4 tablets of 30 mg).
After taking this medicine, you should allow for a period of approximately 7–8 hours for sleep.

If you are elderly or debilitated
If you are elderly or debilitated, your doctor will initially prescribe 1 tablet of 15 mg once or twice daily and will subsequently evaluate whether to increase the dose.

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

Duration of treatment
Your doctor will prescribe the shortest possible treatment duration.
Generally, treatment should not exceed 8–12 weeks, including a period of gradual withdrawal.
At the beginning of Serpax treatment, your doctor will explain how to gradually reduce the dose of this medicine in order to minimize the risk of withdrawal and rebound symptoms (see sections “If you stop taking Serpax” and “Possible side effects”).
In certain cases, your doctor may decide to extend the duration of treatment mentioned above, after re-evaluating your health condition.

If you take more Serpax than you should
In case of accidental ingestion/overdose of Serpax, contact your doctor immediately or go to the nearest hospital.

Symptoms
Taking an excessive dose of Serpax together with alcohol or medicines that depress the central nervous system can be life-threatening. Overdose with benzodiazepines may cause central nervous system depression of varying severity.

In mild cases, symptoms of accidental overdose with Serpax may include:

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

In more severe cases, symptoms may include:

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

Treatment
After assessing the symptoms, your doctor will monitor respiratory and circulatory function parameters and provide appropriate supportive therapy (e.g., with activated charcoal and/or gastric lavage).
Your doctor may consider using flumazenil (a medicine that acts by blocking the effects of benzodiazepines). If you are taking medicines for depression or suffer from epilepsy, inform your doctor, as flumazenil should not be used in these cases.

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

If you stop taking Serpax

• Do not stop treatment with Serpax without first consulting your doctor.
• Your doctor will gradually reduce your dose during the discontinuation phase.
• Abruptly stopping this medicine may cause:
  • rebound symptoms (when symptoms that led to oxazepam treatment reappear in a more severe form after stopping treatment), such as mood changes, anxiety, restlessness, or sleep disturbances;
  • withdrawal symptoms, such as rebound symptoms, headache, muscle pain, extreme anxiety, tension, depression, restlessness, confusion, irritability, sweating, dizziness, dysphoria;
  • severe symptoms such 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 arms or legs, hypersensitivity to light, noise, or physical touch, involuntary movements, vomiting, nausea, diarrhea, loss of appetite, perception of non-existent things (hallucinations/delirium), tremor, abdominal cramps, muscle pain (myalgia), agitation, sensation of increased heartbeat (palpitations), increased heart rate (tachycardia), panic attacks, vertigo, increased reflexes (hyperreflexia), short-term memory loss, increased body temperature (hyperthermia), epileptic 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 everyone experiences them.
Immediately contact your doctor if, during treatment with Serpax, you experience any of the following serious side effects:

• severe allergic reaction
• swelling of the tongue and throat (angioedema) which may cause airway obstruction, potentially leading to death
• restlessness
• agitation
• irritability
• aggression
• delusion
• anger
• nightmares
• hallucinations
• psychosis
• behavioural changes
• onset of depression with suicidal tendencies. These reactions are more frequent if you suffer from personality disorders or if you are elderly.

During treatment with Serpax, the following side effects have been observed and reported with the frequencies listed below:
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, erection problems (erectile dysfunction), orgasm disorders
• nausea

Not known (frequency cannot be estimated from available data)

• reduction in blood cell counts and other blood disorders (thrombocytopenia, agranulocytosis, pancytopenia, blood dyscrasias)
• allergic reactions, skin reactions (e.g. rash)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• low sodium levels in the blood (hyponatraemia)
• disinhibition
• euphoria, hostility
• sexual arousal disorders
• sleep disturbances, insomnia
• coma
• extrapyramidal symptoms (e.g. rigidity, resting tremor, reduced movement/absence of spontaneous movements, slow and clumsy movements)
• seizures, epileptic fits, tremor
• long-term memory disorders (amnesia), transient inability to memorize new information (anterograde amnesia)
• dizziness
• difficulty articulating words (dysarthria)
• headache
• sensation of instability, reduced alertness
• dulling of senses and orientation (sensorial clouding)
• other memory disorders
• emotional blunting (emotional numbing)
• changes in appetite
• visual disturbances (including double vision and blurred vision)
• low blood pressure
• reduced breathing (respiratory depression), cessation of breathing (apnoea), worsening of nocturnal apnoea
• worsening of lung obstruction disease
• constipation
• yellowish discoloration 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
• lowered body temperature (hypothermia)
• paradoxical reaction (such as anxiety states)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You may 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 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 which is stated on the packaging after "Exp". 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Serpax contains
Serpax 15 mg tablets

• The active substance is oxazepam 15 mg
• The other ingredients are lactose (see section "Serpax tablets contain lactose"), magnesium stearate, maize starch, pregelatinized starch.

Serpax 30 mg tablets

• The active substance is oxazepam 30 mg
• The other ingredients are lactose (see section "Serpax tablets contain lactose"), microcrystalline cellulose, polacriline potassium, magnesium stearate.

Description of the appearance of Serpax and contents of the pack
Serpax 15 mg tablets
White, flat, round tablets with bevelled edges for oral use. The number “15” and a score line are imprinted on one side.
Packed in blisters containing 20 tablets.

Serpax 30 mg tablets
White, flat, round tablets with bevelled edges for oral use. The number “30” is imprinted on one side and a double score line on the other side.
Packed in blisters containing 20 tablets.

Not all pack sizes may be marketed.

Marketing Authorization 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