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Urbanol: Embrace Inner Peace – Conquer Anxiety Effortlessly!

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URBANOL – your ultimate solution for anxiety and stress relief. Unwind and regain your inner balance with URBANOL’s calming effects. Embrace a life free from anxiety and worries. Try URBANOL now for a serene and harmonious tomorrow!

Therapeutic indications

URBANOL is used in the treatment of anxiety in neurotic patients and for pre-operative
medication. It may be effective in relieving the acute symptoms of alcohol withdrawal syndrome but has not specific usefulness in the treatment of psychotic patients.

URBANOL is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

Urbanol: Embrace Inner Peace - Conquer Anxiety Effortlessly!
Urbanol: Embrace Inner Peace – Conquer Anxiety Effortlessly!

Urbanol used for

URBANOL contains a medicine called clobazam. This belongs to a group of medicines called benzodiazepines. It works by having a calming effect on the brain.

URBANOL can be used for:

  • Severe anxiety, over a short period of time
  • Relieving the short-term (acute) symptoms of alcohol withdrawal syndrome (effects experienced when a person stops consuming alcohol).

How to take Urbanol

Do not share medicines prescribed for you with any other person.
Always take URBANOL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Your doctor will tell you how long your treatment with URBANOL will last. Do not stop treatment
early or abruptly because you may experience serious side effects.
If you have the impression that the effect of URBANOL is too strong or too weak for you, tell your
doctor or pharmacist.

Taking URBANOL:

  • Each capsule should be swallowed whole, and without chewing; with a glass of water
  • URBANOL can be taken with or without food.
  • Keep taking URBANOL until your doctor tells you to stop.
  • URBANOL is usually given for 2 to 4 weeks. After that, your doctor will decide whether you should continue your treatment.

How much to take:

Adults:

  •  Your doctor will decide on the dose you should take.
  • The usual dose is 10 mg to 30 mg each day. This can be taken as two separate doses or as a single dose at night.
  • Your doctor may lower the dose to suit you.

Children (over 3 years old) and the elderly:
The daily dose will be half of the adult dose.

In people with kidney or liver problems:
The dosage will be determined by the prescribing doctor, as adjustments might be necessary.

If you take more URBANOL than you should:
If you take more URBANOL than you should or in the event of overdosage, tell your doctor/pharmacist or go to the casualty department at your nearest hospital straight away. Do not drive yourself, because you may start to feel sleepy. Remember to take the pack and any tablets that are left, with you. This is so the doctor knows what you have taken.

If you forget to take/miss a dose of URBANOL:

  • If you miss a dose of URBANOL, take it as soon as you remember.
  • However, if it is nearly time for the next dose, skip the missed dose.
  • Do not take a double dose to make up for any forgotten dose.

Posology and method of administration

The normal adult dose ranges between 10 – 30 mg daily: doses of 20 mg and above should preferably be given at bedtime or in divided doses.

For elderly and debilitated patients as well as in children and light-weight patients, the daily dose should be halved.

Increased responsiveness and higher susceptibility to adverse effects may be present in these patients and low initial doses and gradual dose increments, under careful observation, are required.

Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.

Dosage and duration of treatment must be adjusted to the indication, the severity of the condition and the individual clinical response. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.

Patients with renal or hepatic impairment:

Increased responsiveness and higher susceptibility to adverse effects may be present in these
patients and require low initial doses and gradual dose increments under careful observation.

Secondary dose adjustment:
After improvement of symptoms, the dose may be reduced.

Duration of treatment:

The duration of treatment should be as short as possible. The patient should be reassessed
after a period, not exceeding 4 weeks, and regularly thereafter in order to evaluate the need for
continued treatment, especially where the patient is free of symptoms. The overall duration of
treatment generally should not be more than 8-12 weeks, including a tapering off process. In
certain cases, extension beyond the maximum treatment period may be necessary. If so, it should
not take place without re-evaluation of the patient’s status, using special expertise. It is strongly
recommended that prolonged periods of uninterrupted treatment be avoided, since it may lead to
dependence.

Discontinuation of treatment:

It is strongly recommended that after prolonged treatment, URBANOL is not withdrawn suddenly,
but rather that the dose is reduced gradually under medical supervision; otherwise, withdrawal symptoms may occur.

ADMINISTRATION:

The 10 mg tablets can be divided into equal halves of 5 mg.
The capsules are to be swallowed without chewing with a generous amount of liquid (approximately 1 glass).

URBANOL can be given with or without food.

Contraindications

  • Known hypersensitivity to benzodiazepines, or hypersensitivity to clobazam or any of the
    excipients of URBANOL.
  • Patients with any history of drug or alcohol dependence (increased risk of development of dependence)
  • Myasthenia gravis (risk of aggravation of muscle weakness)
  • Severe respiratory insufficiency (risk of deterioration)
  • Sleep apnoea syndrome (risk of deterioration)
  • Severe impairment of liver function (risk of precipitating encephalopathy)
  • During the first trimester of pregnancy (see section 4.6, for use during second and third trimester)
  • Breastfeeding women
  • Benzodiazepines must not be given to children without careful assessment of the need for their use. URBANOL must not be used in children of age 3 years and younger.

What you need to know before take Urbanol

Do not take URBANOL if:

  • You are hypersensitive (allergic) to benzodiazepines, or clobazam or any of the other
    ingredients of URBANOL.
  • You have ever had problems with drugs or alcohol dependence in the past
  • You have a long-term (chronic) condition in which the muscles become weak and tire easily (myasthenia gravis).
  • You have serious breathing problems (severe respiratory insufficiency).
  • You stop breathing for short periods during sleep (sleep apnoea syndrome).
  • You have serious liver problems.
  • You are in the first three months of pregnancy or think you might be pregnant (see below, under PREGNANCY, BREASTFEEDING AND FERTILITY for more information).
  • You are breastfeeding.
  • The patient or your child is 3 years old or younger.

Do not take URBANOL if any of the above applies to you. If you are not sure, talk to your doctor
or pharmacist before taking URBANOL.

Take special care with URBANOL:

Check with your doctor or pharmacist before taking URBANOL:

  • You should avoid drinking alcohol during treatment with URBANOL, as this could increase the risk of the side effects of URBANOL.
  • ou may experience anterograde amnesia (loss of memory of events following trauma) if you are taking high doses of URBANOL.
  • If you have ever become dependent upon another drug or alcohol.
  • URBANOL can be addictive and cause withdrawal effects if treatment is stopped abruptly.
    Your doctor will prescribe URBANOL for a limited duration and decrease your dosage gradually to prevent these withdrawal effects from happening.
  • If you have shallow breathing (respiratory depression).
  • If you have problems controlling your movements (spinal or cerebellar ataxia).
  • If you have liver or kidney problems.
  • If you are an elderly person (the side effects of URBANOL may be stronger).
  • If you have depression, irrational fears and obsessions.
  • If you have delusions (believing things which are not true) or hallucinations (sensing thingswhich are not there).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before
taking URBANOL.

Special warnings and precautions for use

Amnesia:

Anterograde amnesia may occur even if benzodiazepines are used in normal dose range, but especially at higher dose levels. In case of loss or bereavement psychological adjustment may be inhibited by benzodiazepines.

Muscle weakness:

Clobazam can cause muscle weakness. Therefore, in patients with pre-existing muscle weakness or spinal or cerebellar ataxia or sleep apnoea, special observation is required, and a dose reduction may be necessary. Clobazam is contraindicated in patients with myasthenia gravis.

Depression and personality disorders:

Disinhibiting effects may be manifested in various ways. Suicide may be precipitated in patients
who are depressed and aggressive behaviour towards self and others may be precipitated.
Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.

Dependence:

Benzodiazepines, including URBANOL, may lead to physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment.

However, this risk is present even with daily intake of URBANOL over periods of only a few weeks and applies not
only to possible abuse with particularly high doses but also to the therapeutic dose range. The risk of dependence is increased in patients with a history of alcohol or drug abuse.

Therefore, the duration of treatment should be as short as possible. The therapeutic benefit must be balanced against the risk of dependence during prolonged use.
Rebound phenomena are characterised by a recurrence in enhanced form of the symptoms which originally led to URBANOL treatment. This may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness

Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage be decreased gradually.
Once physical dependence has developed, abrupt termination of URBANOL treatment will lead to withdrawal symptoms.

These may include headaches, sleep disturbances, extreme anxiety, tension, restlessness, confusion, excitability and irritability.

In severe cases the following symptoms may occur:
derealisation, depersonalisation, hallucinations and symptomatic psychoses (e.g. withdrawal
delirium), numbness and tingling sensations in the extremities, muscle pain, tremor, sweating,
nausea, hyperacusis, hypersensitivity to light, noise and physical contact, as well as epileptic seizures.

A withdrawal syndrome may also occur when abruptly changing over from a benzodiazepine with a long duration of action (for example URBANOL) to one with a short duration of action.

Pregnancy:

Clobazam is not recommended during the first trimester of pregnancy and in women of
childbearing potential not using contraception.

Serious skin reaction:

Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults during the postmarketing experience. A majority of the reported cases involved the concomitant use of other medicines, including anti-epileptic medicines that are associated with serious skin reactions.
SJS/TEN could be associated with a fatal outcome. Patients should be closely monitored for
signs or symptoms of SJS/TEN, especially during the first 8 weeks of treatment. Clobazam should be immediately discontinued when SJS/TEN is suspected. If signs or symptoms suggest SJS/TEN, use of this medicine should not be resumed and alternative therapy should be considered.

Respiratory depression:

Respiratory function should be monitored in patients with chronic or acute severe respiratory
insufficiency and a dose reduction of clobazam may be necessary. Clobazam is contraindicated
in patients with severe respiratory insufficiency.

Renal and hepatic impairment:

In patients with impairment of renal or hepatic function, responsiveness to clobazam and susceptibility to adverse effects are increased, and a dose reduction may be necessary. In longterm treatment renal and hepatic function must be checked regularly.

Elderly patients:

In the elderly, due to the increased sensitivity to adverse reactions such as drowsiness, dizziness and muscle weakness, there is an increased risk of fall that may result in serious injury. A dose reduction is recommended.

Tolerance in epilepsy:

In the treatment of epilepsy with benzodiazepines – including clobazam – consideration must be
given to the possibility of a decrease in anti-convulsant efficacy (development of tolerance) during
the course of treatment.

CYP2C19 poor metabolisers:

In patients who are CYP2C19 poor metabolisers, levels of the active metabolite Ndesmethylclobazam are expected to be increased as compared to extensive metabolisers. As this may lead to increased side effects, dosage adjustment of clobazam may be necessary (e.g. low starting dose with careful dose titration).

Alcohol:

It is recommended that patients abstain from drinking alcohol during treatment with URBANOL, as there is an increased risk of sedation and other adverse effects.

Concomitant use of opioids and benzodiazepines

Concomitant use of opioids and benzodiazepines, including clobazam, may result in sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate.

If a decision is made to prescribe clobazam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.

URBANOL is not recommended for the primary treatment of psychotic illness. In patients with depression or anxiety associated with depression, URBANOL must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepines (such as URBANOL) alone, can precipitate suicide in such patients.

Before treatment of anxiety states associated with emotional instability it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment.

In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive treatment, i.e. not for primary treatment.

Patients receiving barbiturates, antihistamines, narcotics or other central nervous system depressants. There is an additive risk of central nervous system depression when these medicines are taken together. Large doses may produce syncope.

Duration of treatment:

The duration of treatment should be as short as possible but should not exceed 8 – 12 weeks in case of anxiety, including the tapering-off process. Extension beyond these periods should not take place without re-evaluation of the situation.

It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.

Interaction with other medicines and other forms of interaction

  • Alcohol

Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50 % and therefore lead to increased clobazam effects.

  • Central nervous system (CNS) depressant medication

Especially when URBANOL is administered in higher doses, a mutually potentiating effect is to be expected if other CNS depressant medicines (such as antipsychotics, anxiolytics, certain antidepressant agents, anticonvulsant medicines, sedative antihistamines, anaesthetics, hypnotics or narcotic analgesics, or other sedatives) are taken at the same time. Special caution is also necessary when URBANOL is administered in cases of intoxication with such substances or with lithium.

  • Anticonvulsants

If URBANOL is administered simultaneously with anticonvulsants, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient’s anticonvulsant medication.

In patients receiving concomitant treatment with valproic acid, there may be a slight to moderate rise in plasma valproic acid concentration.

Phenytoin plasma levels may rise if patients receive concomitant treatment with URBANOL.

Where possible, it is recommended that blood levels of concomitantly administered valproic acid
or phenytoin be monitored.

Carbamazepine and phenytoin may increase the metabolic conversion of clobazam to the active
metabolite N-desmethylclobazam.

Stiripentol increases plasma levels of clobazam and its active metabolite, N-desmethylclobazam, through inhibition of CYP3A and CYP2C19. Monitoring of blood levels is recommended, prior to initiation of stiripentol and then once new steady-state concentration has been reached, i.e. after approximately 2 weeks.

  • Narcotic analgesics

If URBANOL is used concomitantly with narcotic analgesics, possible euphoria may be enhanced; this may lead to increased psychological dependence.

  • Muscle relaxants

The effects of muscle relaxants and nitrous oxide may be enhanced.

  • CYP2C19 inhibitors

Strong and moderate inhibitors of CYP2C19 may result in increased exposure to Ndesmethylclobazam (N-CLB), the active metabolite of clobazam. Dosage adjustment of URBANOL may be necessary when co-administered with strong (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate (e.g. omeprazole) CYP2C19 inhibitors.

  • CYP2D6 substrates

Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of medicines metabolised by CYP2D6 (e.g. dextromethorphan, pimozide, paroxetine, nebivolol) may be necessary.

Fertility, pregnancy and lactation

Pregnancy:

URBANOL should be used judiciously during pregnancy and preferably avoided. Administration of URBANOL before or during childbirth can result in the occurrence of respiratory depression (including respiratory distress and apnoea), which may be associated with other disorders such as signs of sedation, hypothermia, hypotonia, feeding difficulties in the new-born and an increase in fetal heart rate (signs and symptoms of the so-called “floppy infant
syndrome“).

Moreover, infants born to mothers who have taken benzodiazepines over longer periods during the later stages of pregnancy may have developed physical dependence and may be at risk of developing a withdrawal syndrome in the postnatal period. Appropriate monitoring of the new-born in the postnatal period is recommended.

Generally, URBANOL must not be used in the first trimester of pregnancy. In the later stages of pregnancy, it must only be used if there are compelling indications

Lactation:

URBANOL must not be used in breastfeeding women, since it passes into breast milk.

Effects on ability to drive and use machines

Some adverse effects (e.g., sedation, muscle weakness) may impair the patient’s ability to concentrate and react, and, therefore constitute a risk in situations where these abilities are of special importance (e.g., climbing dangerous heights, operating a vehicle or machinery).

Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥ 1/10); common
(≥ 1/100 to ≤ 1/10); uncommon (≥ 1/1 000 to ≤ 1/100); rare (≥ 1/10 000 to ≤ 1/1 000); very rare (≤
1/10 000); not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Not known: blood dyscrasias have been reported.

Metabolism and nutrition disorders:

Common: decreased appetite

Psychiatric disorders:

Common: irritability, aggressiveness, restlessness, depression (pre-existing depression may be unmasked), drug tolerance (especially during prolonged use), acute agitation

Uncommon: abnormal behaviour, confusional state, anxiety, delusion, nightmare, loss of libido
(particularly with high doses or in long-term treatment, and is reversible)

Not known: dependence (especially during prolonged use), initial insomnia, anger, fits of rage, nightmares, hallucination, psychotic disorder, poor sleep quality, difficulty in falling asleep or sleeping through suicidal ideation or tendencies. In the event of such reactions, treatment with URBANOL must be discontinued.

Pre-existing depression may be unmasked during benzodiazepine use.
Tolerance and dependence may develop, especially during prolonged use.

Nervous system disorders:

Very common: tiredness and sleepiness (somnolence), especially at the beginning of treatment
and when higher doses are used

Common: sedation, dizziness, disturbance in attention, slowed or indistinct speech (disorders of
articulation), (particularly with high doses or in long-term treatment, and is reversible), headache,
tremor, ataxia or a fine tremor of the fingers may occur

Uncommon: numbed emotions, emotional poverty, anterograde amnesia may occur even if benzodiazepines are used in the normal dose range, but especially at higher dose levels, amnesia effects may be associated with inappropriate behaviour, memory impairment,

Not known: Slowed reaction time, drowsiness*, disorientation and confusion, muscle weakness, lethargy, cognitive disorder, impairment of consciousness (sometimes combined with respiratory disorders, may occur in very rare cases, particularly in elderly patients; these effects sometimes persist for a considerable length of time), nystagmus (particularly with high doses or in long-term treatment), unsteadiness of gait and other motor functions (such reactions occur particularly with high doses or in long-term treatment, and are
reversible).

*drowsiness is more common in elderly and debilitated patients and in patients receiving high
doses.

Eye disorders:

Uncommon: visual disorders (diplopia). Such reactions occur particularly with high doses or in long-term treatment and are reversible.

Respiratory, thoracic and mediastinal disorders:

Not known: URBANOL may cause respiratory depression, especially if administered in high doses. Therefore, particularly in patients with pre-existing compromised respiratory function (e.g. in patients with bronchial asthma) or brain damage, respiratory insufficiency may occur or deteriorate.

Gastrointestinal disorders:

Common: dry mouth, constipation, decreased appetite, nausea/vomiting

Hepato-biliary disorders:

Unknown: hepatic dysfunction has been reported

Skin and subcutaneous tissue disorders:

Uncommon: cutaneous reactions, such as rash may develop in very rare cases

Not known: photosensitivity reactions, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (including some cases with fatal outcome)

Musculoskeletal and connective tissue disorders:

Not known: muscle spasms, muscle weakness

General disorders and administration site disorders:

Very common: fatigue, especially at the beginning of treatment and when higher doses are used
Not known: slow response to stimuli, hypothermia

 

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Overdose

Signs and symptoms:

Overdose and intoxication with benzodiazepines, including URBANOL, may lead to central nervous system depression, associated with drowsiness, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension and, rarely, coma. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including alcohol.

Management:

In treatment for intoxication, it is recommended that the possible involvement of multiple agents be taken into consideration.

Gastric lavage, intravenous fluid replenishment and general supportive measures may be indicated in addition to monitoring of consciousness, respiration, pulse rate and blood pressure.
Secondary elimination of URBANOL (by forced diuresis or haemodialysis) is ineffective.

 

Frequent Asked Questions about Urbanol:

What is Urbanol, and how does it work?

Urbanol is a medication used to treat anxiety and related conditions. Its active ingredient, clobazam, acts on the central nervous system to reduce anxiety and promote relaxation.

Is Urbanol safe to use?

Urbanol is generally safe when taken as prescribed by a healthcare professional. However, like all medications, it may have potential side effects. It’s essential to follow the recommended dosage and consult your doctor if you have any concerns.

Who can take Urbanol?

Urbanol is typically prescribed to individuals suffering from anxiety disorders, panic attacks, and other anxiety-related conditions. It is not recommended for children or pregnant women without proper medical supervision.

Can Urbanol be addictive?

Urbanol belongs to the benzodiazepine class of drugs, which can be habit-forming if misused or taken for an extended period. It’s crucial to take Urbanol only as prescribed by your healthcare provider.

How quickly does Urbanol start working?

Urbanol’s effects may vary from person to person. Some individuals may experience relief within a short time, while others may need a few weeks of consistent use for the full benefits to manifest.

Can I drive or operate machinery while taking Urbanol?

Urbanol may cause drowsiness and impair your ability to perform tasks that require focus and alertness. Avoid driving or operating machinery until you know how the medication affects you.

What should I do if I miss a dose of Urbanol?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Avoid taking double doses to make up for the missed one.

Are there any specific drug interactions with Urbanol?

Urbanol may interact with certain medications, including other benzodiazepines, antidepressants, and anticonvulsants. Inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.

Can I drink alcohol while taking Urbanol?

Alcohol may intensify the sedative effects of Urbanol, leading to increased drowsiness and impaired coordination. It’s best to avoid alcohol while using this medication.

Can I stop taking Urbanol abruptly?

Abruptly stopping Urbanol may lead to withdrawal symptoms, including rebound anxiety. Consult your healthcare provider to develop a tapering plan if you need to discontinue the medication.

 

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