PRAZENE 10 mg Tabletki

Treść ulotki

1. PRAZENE 10 mg tablets, 20 mg tablets, 15 mg/ml oral drops, solution
   1. What is Prazene and what is it used for
   2. What you need to know before taking Prazene
   3. How to take Prazene
   4. Possible side effects
   5. How to store Prazene
   6. Contents of the pack and other information

PRAZENE 10 mg tablets, 20 mg tablets, 15 mg/ml oral drops, solution

Prazepam

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

1. What is Prazene and what is it used for

Prazene contains the active ingredient prazepam. Prazepam belongs to a group of medicines called
benzodiazepines and acts on the central nervous system by reducing anxiety (anxiolytic effect),
improving mood and decreasing the intensity of emotional reactions to mental stress (tranquilizing effect)
and allowing muscle relaxation (muscle relaxant effect).
Prazene is used for the treatment of the following conditions when they are severe and cause discomfort
in normal daily life:

• anxiety, states of emotional tension and other physical and psychological symptoms associated with anxiety.

2. What you need to know before taking Prazene

Do not take Prazene:

• if you are allergic to prazepam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you have a disease that causes severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have severe breathing problems (severe respiratory failure);
• if you have severe liver problems (severe hepatic insufficiency). Prazene causes a worsening of cerebral symptoms that may be associated with severe liver problems, such as mental confusion, altered level of consciousness or coma;
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
• if you are in the first 3 months of pregnancy or breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
The duration of treatment with Prazene should be as short as possible. It is recommended not to
exceed 8-12 weeks of treatment, including the period necessary for the gradual reduction of the
dosage.
Consult your doctor or pharmacist beforetaking Prazene if you think that any of the
following conditions apply to you (see also section 4 Possible side effects):

• suffer from or have ever suffered from breathing problems, because this medicine can decrease the spontaneous breathing capacity. The doctor may give you a lower dose;
• suffer from or have ever suffered from depression, anxiety associated with depression or suicidal thoughts. Prazene, like other benzodiazepines, should not be used alone to treat depression or anxiety related to depression because it can worsen the tendency to suicide;
• suffer from or have ever suffered from problems with the ability to correctly interpret reality associated with thought disorders. Prazene is not the right medicine for the specific treatment of these disorders;
• have or have had problems with alcohol or drug abuse and dependence, because Prazene can also cause dependence (see section Development of dependence);
• have or have ever had significant brain diseases, especially cerebral arteriosclerosis. The doctor will advise you on the most suitable dosage for your condition;
• have or have ever had heart problems (heart failure). The doctor will advise you on the most suitable dosage for your condition.

Memory disorders
After taking Prazene you may have difficulty remembering what happened aftertaking the
medicine. Therefore, it is advisable that you can sleep for 7-8 hours after taking this
medicine.
Paradoxical reactions
Prazene can cause mental reactions and effects opposite to those expected (paradoxical effects)
(see section 4 Possible side effects), such as restlessness, agitation, irritability,
aggressiveness, delusion, anger, nightmares, hallucinations, psychosis, changes in behavior. These
effects are more common in children and the elderly. If you experience these effects, consult your
doctor who will advise you on the correct way to stop taking this medicine.
Development of tolerance
Following repeated use of this medicine for several weeks, a
decrease in its effectiveness (tolerance) may occur. Prazene is recommended for short-term treatments.
Development of dependence
The use of benzodiazepines, including Prazene, can cause dependence, which can manifest as a
growing need, desire or exaggerated search for wanting to take the medicine (psychic dependence)
or the development of physical disorders that decrease or disappear only after taking the medicine
(physical dependence). The likelihood of developing psychic and physical dependence on this medicine
increases with increasing dose and duration of treatment.
You are more likely to develop a dependence on Prazene if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or currently drink alcohol frequently and/or in large quantities;
• you have recently taken or are taking medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics). If you suddenly stop treatment with Prazene after the development of dependence, you may experience withdrawalsymptoms such as:
• severesymptoms: 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, hallucinations and seizures;
• other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion and irritability;
• rebound symptoms: insomnia and anxiety. These symptoms are the same for which you were advised to take treatment with Prazene but, in case of abrupt interruption of the treatment, they may transiently reappear in a more severe form than before starting treatment with this medicine. In addition, you may experience mood changes, anxiety, restlessness or sleep disturbances.

Do not stop taking Prazene suddenly. Consult your doctor or pharmacist who will
advise you on the correct way to stop treatment with this medicine.See
section 3 If you stop taking Prazene.
If you suffer from particular health conditions
If you are elderly and/or debilitated, or suffer from liver or kidney problems, you are more sensitive to the effect of
Prazene. Therefore, in these cases the doctor will advise you on the lowest possible dosage.

Children
The efficacy and safety of Prazene in children have not been established. The doctor will decide whether this medicine
can be given to children based on their condition. The duration of treatment should be
as short as possible.

Other medicines and Prazene
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The concomitant use of Prazene and opioids (strong painkillers, medicines for substitution therapy and
some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening.
For this reason, concomitant use should only be considered when other treatment options are not
possible.
However, if your doctor prescribes Prazene together with opioids, the dose and duration of concomitant therapy
must be limited by the doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow your
doctor's recommendations on dosage. It may be helpful to inform friends or relatives to
make them aware of the above signs and symptoms. Contact your doctor if these symptoms occur.
Tell your doctor or pharmacist if you are taking any of the following medicines together with Prazene
because caution is required:

• medicines that cause a strong reduction of all brain functions, such as:
• sedatives and sleep aids (hypnotics/sedatives)
• for the treatment of the inability to correctly interpret reality associated with thought disorders (neuroleptics)
• for the treatment of anxiety (anxiolytics)
• for the treatment of depression (antidepressants)
• for the treatment of acute or chronic pain of high intensity (narcotic analgesics, opioids)
• for the treatment of epileptic seizures (antiepileptics)
• anaesthetics
• to counteract allergic reactions (sedative antihistamines). Prazene, administered together with narcotic anesthetic medicines, can cause euphoria, with an increased probability of developing psychic dependence;
• oral contraceptives, because they can increase the effects of Prazene;
• clozapine (medicine used against thought disorders), because taking it together with Prazene can cause a severe state of confusion, lowering of blood pressure and

reduction of spontaneous breathing capacity. The doctor may decide to reduce the dosage of
Prazene.

Prazene with alcohol
Donot drink alcohol while taking Prazene because alcohol increases the effects of this medicine.
This can also lead to a serious impairment of the ability to drive vehicles and operate
machinery (see section Driving and using machines).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

This medicine should not be taken during pregnancy, especially during the first and third
trimesters, because it can cause congenital malformations in the fetus.
If you take this medicine during the last 3 months of pregnancy, the newborn may experience:

• severe lung damage with resulting inability to breathe, poor oxygen content in the blood that does not respond to external oxygen administration (respiratory distress syndrome)
• poor muscle tone, continuous sleep, poor emotional interactions with external stimuli, difficulty breastfeeding (floppy infant syndrome)
• tremor, irritability, increased muscle tone, diarrhea, vomiting, vigorous sucking of milk (withdrawal syndrome) Breastfeeding Donot breastfeed while taking Prazene because this medicine can pass into breast milk. Consult your doctor if you have any concerns.

Driving and using machines
Donot drive or operate machinery if you experience any of these side effects: drowsiness, amnesia
(memory disorders), impairment of concentration and muscle function. Your
vigilance may be altered especially if you have not slept enough after
taking Prazene.

Prazene 10 mg and 20 mg tablets contain lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Prazene 15 mg/ml oral drops contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per millilitre of oral solution, i.e.
essentially ‘sodium-free’.

Prazene 15 mg/ml oral drops contain propylene glycol
This medicine contains approximately 497 mg of propylene glycol in 20 drops, equivalent to 746 mg of
propylene glycol per millilitre.
If your child is under 5 years of age, talk to your doctor or pharmacist before giving
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.
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.

3. How to take Prazene

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
Prazene tablets should be taken by mouth, with a little water. The tablets should not
be chewed.
Prazene drops should be diluted with a little water or another beverage.

Adults
In case of repeated administration, the recommended averagedose is 30 mg per day, equivalent to 1
10 mg tablet 3 times a day or 20 drops (considering that 20 drops contain 10
mg of active ingredient) 3 times a day.
The doctor may decide to vary the dose between 20 mg and 60 mg of prazepam per day, depending on how
you respond to treatment. The doctor will advise you on how to take Prazene throughout the day.
In case of single administration, you should take Prazene before going to bed. The recommended initial dose is 20 mg, equivalent to 1 20 mg tablet or 40 drops.
The optimal dosage is usually between 20 and 40 mg per day. The doctor may decide to
vary the dose depending on how you respond to treatment.
The doctor will advise you on how to take Prazene in single administration.

If you are elderly, debilitated, or suffer from liver or kidney problems
It is sufficient to halve the recommended doses for adults.

Children
The doctor will assess the actual need for treatment in children. The dose used must be the
lowest possible and the duration of treatment the shortest possible.
Duration of treatment
The duration of treatment with Prazene must be as short as possible. It is recommended not to exceed
8-12 weeks of treatment, including the time necessary for the gradual reduction of the
dosage. The need to extend the treatment will be carefully evaluated by the doctor.

If you take more Prazene than you should
It is important that you never take more medicine than prescribed. In general, there are no dangers
to life if you accidentally take a dose of medicine higher than the prescribed one, unless you also take alcohol or other medicines.
Symptoms
In mild cases, the symptoms may be:

• blurred vision, drowsiness, disorientation and weakening of sensory functions;
• mental confusion;
• continuous sleep and reduced response to normal stimuli. In more serious cases, when large amounts of medicine are taken with suicidal intent or when this medicine is taken together with alcoholic beverages or other medicines that reduce consciousness and major brain functions, the symptoms may be:
• loss of coordination;
• poor muscle tone;
• low blood pressure;
• reduced spontaneous breathing capacity;
• coma;
• death. Treatment Immediately contact your doctor or go to the nearest emergency room if you take more Prazene than prescribed by your doctor. If you are conscious, you will be induced to vomit within one hour of taking the medicine; if you are unconscious, you will undergo gastric lavage. If these procedures are not sufficient, you may be given activated charcoal to reduce the absorption of Prazene, or flumazenil, a medicine that counteracts the effects of Prazene.

If you forget to take Prazene
If you forget to take a dose, take it as soon as you remember, but make sure you can rest
immediately afterwards and for long enough (7-8 hours). Do not take a double dose to make up for the
forgotten dose. If you think you have forgotten more than one dose, consult your doctor.

If you stop taking Prazene
Do not stop taking Prazene suddenly because the doses must be reduced
gradually. The doctor will advise you on how to stop the treatment.
If you stop taking Prazene or reduce the dose suddenly, you may temporarily develop
withdrawal symptoms or rebound symptoms (see section 2 Development of
dependence).
If, for any reason, you would like to stop taking this medicine to take another medicine of the same type, ask your doctor for advice. He will know how to advise you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Normally, side effects are observed at the beginning of treatment and generally
disappear with continued treatment.
Contact your doctor immediatelyif you experience any of the following side effects because
the intake of Prazene must be stopped:

• opposite effects to those expected (paradoxical effects) (see paragraph 2 Paradoxical disorders) such as:
• restlessness
• agitation
• irritability
• aggressiveness
• feeling of frustration
• anger
• nightmares
• hallucinations
• difficulty in correctly interpreting reality and thought disorders
• behavioral changes Contact your doctor immediatelyif you experience any of the following side effects because they can be serious:
• difficulty remembering what happened after taking the medicine (anterograde amnesia). See paragraph 2 Memory disorders.
• depression or unmasking of pre-existing depression before taking the medicine
• physical dependence on the medicine (see paragraph Development of dependence)
• psychological dependence on the medicine (see paragraph Development of dependence)
• withdrawal symptoms (see paragraph Development of dependence)
• rebound symptoms (see paragraph Development of dependence)

Contact your doctor if you experience any of the following side effects:

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

• drowsiness during the day

Common side effects(may affect up to 1 in 10 people):

• confusion
• particularly intense dreams with significant emotional involvement
• loss of coordination of movements
• dizziness
• headache
• hyperactivity (excitability)
• feeling of emptiness in the head
• slurred and difficult speech
• tremors
• blurred vision
• perception of heartbeats (palpitations)
• dry mouth
• stomach and intestinal disorders
• excessive sweating beyond normal
• skin rashes
• joint pain
• kidney problems
• genital problems
• fatigue
• general weakness

Uncommon side effects(may affect up to 1 in 100 people):

• transient loss of consciousness (syncope)
• itching
• swelling of the feet

Side effects with frequency Not known(frequency cannot be estimated on the basis of available data):

• vertigo
• liver problems
• muscle weakness
• reduction of blood pressure
• alteration of laboratory test values for liver function
• increase in body weight

Other adverse effects reported are:

• decreased ability to experience emotions
• reduction of the state of consciousness
• double vision

These phenomena mainly occur at the beginning of therapy and usually disappear with
subsequent administrations.
Other adverse reactions have been reported occasionally, including:

• changes in sexual desire
• excessive dilation of the pupil
• reduction of white blood cells in the blood.

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 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 Prazene

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 package and blister after
“Expiry”. The expiry date refers to the last day of that month.
This medicine 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 Prazene contains
The active ingredient is prazepam.
Prazene tablets
One Prazene 10 mg tablet contains 10 mg of prazepam.
The other ingredients are: lactose(see section 2 Prazene 10 mg and 20 mg tablets contains
lactose), microcrystalline cellulose, corn starch, magnesium stearate, anhydrous colloidal silica.
One Prazene 20 mg tablet contains 20 mg of prazepam.
The other ingredients are: lactose(see section 2 Prazene 10 mg and 20 mg tablets contains
lactose), microcrystalline cellulose, corn starch, magnesium stearate, anhydrous colloidal silica.
Prazene 15 mg/ml oral drops, solution
1 ml of solution contains 15 mg of prazepam.
The other ingredients are: propylene glycol or (E1520), ethylenediol glycol, polysorbate 80, sodium
saccharinate, levomenthol, anethole, patent blue V (see Section 2 “Prazene 15 mg/ml oral drops
contains “propylene glycol” and “Prazene 15 mg/ml oral drops contains “sodium”)
.

Description of the appearance of Prazene and contents of the packs
Prazene 10 mg tablets are convex tablets, white in colour, with a breaking line on one side. The tablets are available in blisters in packs of 30 tablets.
Prazene 20 mg tablets are flat, round tablets, white in colour, with a breaking line on one side. The tablets are available in blisters in packs of 20 tablets.
Prazene 15 mg/ml oral drops, solution is a blue coloured solution available in a 20 ml glass bottle with a dropper.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Prazene 10 mg and 20 mg tablets
Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg
Mooswaldallee, 1
D-79090 Freiburg
Germany
Prazene 15 mg/ml oral drops, solution
Delpharm Orléans
5 Avenue de Concyr
45071 Orléans Cedex 2
France