VALDORM 15 mg Hard Capsule

Зміст інструкції

1. Valdorm 15 mg capsule, 30 mg capsule
   1. What is Valdorm and what is it used for
   2. What you need to know before you take Valdorm
   3. How to take Valdorm
   4. Possible side effects
   5. How to store Valdorm
   6. Package contents and other information

Valdorm 15 mg capsule, 30 mg capsule

Flurazepam
Generic medicine

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

1. What is Valdorm and what is it used for

Valdorm is a hypnotic medicine that contains the active ingredient flurazepam and
belongs to a class of psychotropic drugs called “benzodiazepines”.
This medicine is used for the short-term treatment of insomnia, particularly
when insomnia is severe, disabling and causes significant discomfort.

2. What you need to know before you take Valdorm

Do not take Valdorm

• if you are allergic to flurazepam or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to benzodiazepines (a group of medicines to which Valdorm belongs);
• if you suffer from a disease that causes severe muscle weakness (myasthenia gravis);
• if you suffer from severe respiratory problems such as severe respiratory failure, severe lung failure and respiratory depression (severe reduction of breathing);
• if you suffer from severe liver problems (severe hepatic insufficiency);
• if you suffer from sleep apnea (temporary cessation of breathing during sleep);
• If you suffer from mental illnesses such as obsessive or phobic states, or chronic psychosis (mental disorders that cause you to have recurring thoughts against your will or fears);

Warnings and precautions
Talk to your doctor or pharmacist before taking Valdorm.
The duration of Valdorm treatment should be as short as possible. It is recommended not to
exceed 4 weeks including a period of gradual withdrawal (see section 3 “how to
take Valdorm”). Any extension of therapy beyond this period should not occur
without re-evaluation of the clinical situation.
In case of prolonged treatment, it is advisable to have blood tests and check the values of the
liver.
Talk to your doctor or pharmacist before taking Valdorm if any of the following conditions
apply to you (see section 4 “possible side effects”):

• If you are an elderly and/or debilitated person. Your doctor will prescribe a reduced dose
• If you are an elderly person and are taking medicines for the treatment of epilepsy (in particular hydantoins or barbiturates or combinations containing them). In this case, the association with Valdorm increases the risk of side effects and toxicity.
• If you suffer from chronic respiratory failure. Your doctor will prescribe a reduced dose.
• If you suffer from a liver disease (hepatic insufficiency). Your doctor will prescribe a reduced dose.
• If you suffer from or have ever suffered from depression or anxiety related to depression because Valdorm may worsen your condition and the tendency to suicide.
• If you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis);
• If you have problems with coordination of movements caused by a condition called ataxia (spinal or cerebellar). Valdorm is not indicated in this case.
• If you have or have had problems with drug or alcohol abuse because the development of dependence is greater (see “Development of dependence”).
• If you are taking medicines that decrease the activity of the central nervous system, that cause drowsiness or decrease mental functions (psychotropic drugs) due to the risk of unexpected adverse interaction effects (see “Other medicines and Valdorm”).

Development of tolerance
After prolonged use of the medicine for several weeks, a decrease in
effectiveness (tolerance) may occur. Valdorm is recommended for short-term treatments.

Development of dependence
The use of Valdorm, like that of other benzodiazepines, can lead to the development of 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 probability that
psychic and physical dependence develops from this medicine increases with increasing dose and
duration of treatment. Furthermore, this probability is greater in people who have abused or
are abusing drugs or alcohol, or in patients with severe personality disorders. In this case, it will
be necessary to regularly monitor by your doctor and the suspension of treatment
must occur gradually.
Once dependence has developed, abrupt cessationof treatment will be
accompanied by withdrawal criseswhich can manifest even in patients who have taken
normal therapeutic doses and for short periods with symptoms such as:

• Depression, nervousness, mood changes, rebound insomnia, sweating, diarrhea, headache, muscle pain, severe anxiety, tension, restlessness, confusion and irritability.
• In severe cases, distorted perception of the outside world (derealization), a feeling of detachment from reality (depersonalization), tingling of

hands and feet, excessive sensitivity to light, noise, sounds and physical contact,
hallucinations or seizures.

• In rare cases, discontinuation of treatment following an excessive dosage can cause confusion, mental disorders and convulsions.

Rebound insomnia and anxiety
If you suddenly stop treatment, you may temporarily develop insomnia
worse than before you started treatment with this medicine.
Other reactions may also occur, such as mood changes, anxiety, restlessness or sleep disturbances.
Do not stop taking Valdorm suddenly. Talk to your doctor who will advise you on the correct way
to interrupt treatment with this medicine (See section 3 “If you stop taking Valdorm”).
Abuse of benzodiazepines has been reported.

Memory disorders
Benzodiazepines can limit a person's ability to remember recent information
(anterograde amnesia). This usually happens several hours after taking the medicine and,
therefore, to reduce the risk, you should make sure you have uninterrupted sleep for at least 7-8
hours (see “Possible side effects”).
If you wake up during the period of maximum activity of the medicine, your memory may be
compromised.

Paradoxical reactions
Benzodiazepines such as Valdorm can cause effects opposite to those expected (paradoxical effects)
such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares,
hallucinations, psychosis, altered behavior, onset of depression with suicidal tendencies (see section 4 “Possible side effects”). If this should happen, consult your
doctor because treatment should be discontinued. These reactions are more frequent in children and
the elderly.

If you are elderly
If you are elderly, take Valdorm as prescribed by your doctor.
This medicine may increase the risk of falls and fractures due to a relaxing effect on the muscles.

Children and adolescents
Vadorm should not be used in children and adolescents under the age of 18.

Other medicines and Valdorm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Pay particular attention and talk to your doctor or pharmacist if you have taken or
are taking one or more of the following medicines:

• Barbiturates (medicines used to reduce anxiety and/or induce sleep or treat epilepsy)
• antipsychotics (medicines used to treat mental disorders or some forms of depression);
• hypnotics (medicines for treating insomnia)
• anxiolytics/sedatives (medicines used to treat anxiety states);
• antidepressants (medicines used to treat depression);
• narcotic analgesics (medicines for treating severe pain). In this case, an increase in euphoria may occur, which causes an increase in psychic dependence.
• antiepileptics (medicines for treating epilepsy, a disease caused by uncontrolled movements of the body and loss of consciousness) such as, for example, hydantoin;
• anesthetics (medicines used during surgical operations);
• sedating antihistamines (medicines for treating allergies);
• medicines used to sedate convulsions (anticonvulsants)
• medicines used to treat high blood pressure (antihypertensives)
• beta-blockers (medicines used to treat high blood pressure and other heart problems)
• theophylline or aminophylline (medicines used mainly for the treatment of asthma)
• muscle relaxants (medicines that relax muscles)
• medicines that act on certain liver enzymes, because they can modify the activity of Valdorm, for example: cimetidine and omeprazole (used for the treatment of gastric disorders), disulfiram (used in the treatment of alcoholism) or rifampicin (an antibiotic)
• The concomitant use of Valdorm with opioids (potent analgesics, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, causes difficulty in breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when no therapeutic alternatives are possible. However, if your doctor prescribes Valdorm in conjunction with opioids, the dose and duration of concomitant treatment must be limited by your doctor. It may be helpful to inform friends and family to observe the possible appearance of signs and symptoms such as those listed above. If these symptoms occur, contact your doctor.

Valdorm with alcohol
Do not drink alcoholic beverages while taking Valdorm as the calming effect of the
medicine may be increased.
This can lead to a serious impairment of the ability to drive vehicles or operate
machinery (see “Driving and using machines”).
If you have abused alcohol in the past, your doctor will monitor you during treatment with
Valdorm, as you are more likely to develop dependence on this medicine.

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 take this medicine during pregnancy, especially during the first three months and the last
three months, unless your doctor considers it strictly necessary. During pregnancy
Valdorm should only be taken if absolutely necessary and under the direct supervision of
your doctor.
If you take this medicine for serious medical reasons, during the last period of pregnancy
or during labor at high doses, the newborn may manifest the following symptoms:

• irregular heartbeat
• reduction of body temperature below 35°C (hypothermia);
• poor muscle tone (hypotonia);
• difficulty breathing.

Furthermore, if you take benzodiazepines (a group of medicines to which Valdorm belongs) for a long
time during the advanced stages of pregnancy, the newborn may develop physical dependence on
the medicine and present a certain risk of developing withdrawal symptoms in the period
after birth.
Breastfeeding
Do not take Valdorm if you are breastfeeding as this medicine passes into breast milk.
If it is necessary to take Valdorm regularly, stop breastfeeding.

Fertility
If you are a woman of childbearing age, if you intend to become pregnant or if you suspect you are
pregnant, consult your doctor who will assess the suspension of treatment with this medicine.
The administration of Valdorm must be discontinued gradually and according to the instructions
given by the doctor.

Driving and using machines
Valdorm has a sedative effect, can cause a temporary loss of memory (amnesia),
can affect concentration and alter muscle function. Therefore, taking
this medicine can have negative effects on the ability to drive vehicles and operate
machinery. If you haven't slept enough, the threshold of attention is more likely to be
altered, so do not drive on the days you take Valdorm.

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

3. How to take Valdorm

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have doubts, consult your doctor or pharmacist.
The dose and duration of treatment with Valdorm will be established by your doctor according to the type and
severity of insomnia based on your response to treatment and age. Do not change the prescribed dose
without consulting your doctor. If you think that the effect of the medicine is too weak or too strong
talk to your doctor.
During therapy with Valdorm you must be regularly monitored to decrease if
necessary the dose in order to prevent an accumulation of the medicine in the body.

The recommended doses are:
Adults:1 capsule of 15 mg or 1 capsule of 30 mg in the evening, before bedtime.
The doctor may prescribe an initial dose of 15 mg (1 capsule) and subsequently increase it,
if necessary, to 30 mg (1 capsule of 30 mg or 2 capsules of 15 mg).
Do not exceed the maximum dose of 60 mg (2 capsules of 30 mg) per day.
Undergo regular checks, especially at the beginning of treatment, to decrease, if
necessary, the dose or frequency of taking the medicine in order to avoid accumulations of
excessive doses of the medicine in the body.

Use in children and adolescents:Do not administer this medicine to children and
adolescents under 18 years of age as Valdorm is not for pediatric use.

Use in particular categories of patients
Elderly or debilitated patients:the recommended dose is 1 capsule of 15 mg. If you belong to
this category, consider that you may be particularly susceptible to adverse effects
and therefore the dose of 15 mg should not be exceeded.

Patients with kidney or liver problems:the initial dose is 1 capsule of 15 mg and in general
should not be exceeded. The doctor may further reduce your dosage.

Patients with chronic pulmonary insufficiency:the doctor may consider it necessary
to reduce the dosage.

Duration of treatment
The doctor will advise you on the duration of treatment, which should be as short as possible. The duration
of treatment generally varies from a few days to 2 weeks, up to a maximum of 4
weeks, including a period of gradual discontinuation.
In certain cases, it may be necessary to use the medicine beyond the maximum treatment period (4 weeks) but only after the doctor has reassessed your health conditions.
Chronic long-term treatment is not recommended.
If you have taken benzodiazepines for a prolonged time, you may need a longer period during which to gradually reduce the doses (see section “If you stop taking Valdorm”).

If you take more Valdorm than you should
It is important that you never take more medicine than prescribed.
In case of accidental ingestion/taking of an excessive dose of Valdorm, immediately inform
your doctor or go to the nearest hospital.
Symptoms
Generally there are no life-threatening dangers if you accidentally take a dose of medicine
higher than prescribed unless you also take alcohol or other medicines.
In less severe cases, the symptoms in case of accidental ingestion/taking of an excessive dose
of Valdorm may be: loss of sensory and intellectual abilities, mental confusion,
continuous sleep and reduced response to normal stimuli (lethargy in more severe cases, may include
speech, vision or movement disorders, loss of coordination and muscle tone, low blood pressure, breathing problems, in rare cases coma and, very
rarely, death.
The most serious, rare cases can manifest when large quantities of medicine are taken
or when this medicine is taken together with alcoholic beverages or other medicines
that reduce consciousness and the main brain functions.
Treatment
The doctor, after evaluating the symptoms, will perform 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.

If you forget to take Valdorm
Do not take a double dose to make up for a missed dose.

If you stop taking Valdorm
Do not stop treatment with Valdorm without first consulting your doctor.
The doctor will advise you on how to stop treatment by gradually reducing the dose. The
abrupt interruption of this medicine may temporarily cause withdrawal
or rebound symptoms (the symptoms that led to treatment with flurazepam reappear in a more severe form after discontinuation of treatment) (see section 2 “Development of dependence”).
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 everybody gets them.
The following side effects have been reported:

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

• drowsiness, even during the day;
• headache;
• dizziness caused by problems with the nervous system;
• reduced level of attention;
• loss of muscle coordination (ataxia);
• altered taste;
• loss of emotions;
• muscle weakness;
• fatigue.

Rare side effects(may affect up to 1 in 1,000 people)

• visual disturbances, for example double vision;
• stomach and intestinal disorders;
• abdominal pain;
• nausea;
• changes in sexual desire (libido);
• skin reactions (e.g. rash);
• reduction in blood pressure (hypotension);
• hypersensitivity, for example rapid swelling of the skin and mucous membranes (angioedema);
• difficulty breathing, especially at night (respiratory depression);
• inability to empty the bladder (urinary retention).
• dizziness caused by balance problems due to ear or labyrinth diseases

Very rare side effects(may affect up to 1 in 10,000 people)

• yellowing of the skin (jaundice);
• increased liver enzymes.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• extrapyramidal disorders (e.g. rigidity, resting tremor, few/absence of spontaneous movements, slow and clumsy movements)
• confusion;
• limited ability to memorize new information (anterograde amnesia) also associated with changes in behavior (see section 2 “Memory disorders”);
• dependence (see section 2 “Development of dependence”)
• withdrawal syndrome, rebound effects (see section 2 “Development of rebound phenomena/Withdrawal phenomena”)
• depression
• paradoxical reactions (e.g. anxiety, sleep disorders, insomnia, nightmares, restlessness, agitation, irritability, aggression, delirium, mental disorders, behavioral changes, emotional disturbances, suicide attempts, suicidal ideation) (see section 2 “Paradoxical disorders”)
• hallucinations;
• Blood disorders, for example reduction in the number of platelets (thrombocytopenia), reduction in the number of white blood cells (leukopenia, agranulocytosis), reduction in the number of all cells present in the blood (pancytopenia);
• Falls and fractures. The risk of falls and fractures increases if you are of Asian origin

Furthermore, the use of Benzodiazepines, a class of drugs such as Valdorm, can bring to light a
pre-existing depression and can cause reactions such as restlessness, agitation, irritability,
aggression, delusion, anger, nightmares, hallucinations, psychosis, behavioral changes. These
side effects are more likely if you are elderly.
The use of benzodiazepines (even at recommended doses) can cause physical or psychological dependence.
Discontinuation of therapy may cause undesirable effects (rebound phenomena) or withdrawal crises (see “Warnings and precautions” and “If you stop taking Valdorm”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Valdorm

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXPIRY
DATE”. The expiry date refers to the last day of that month.
The stated expiry date refers to the product in intact packaging, correctly
stored.
Store at a temperature not exceeding 25°C.
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. Package contents and other information

What Valdorm contains

• The active ingredient is flurazepam. Each Valdorm 15 mg capsule contains 12.62 mg of flurazepam (equivalent to 13.81 mg of flurazepam hydrochloride); each Valdorm 30 mg capsule contains 25.25 mg of flurazepam (equivalent to 27.62 mg of flurazepam hydrochloride).
• The other ingredients are: lactose, talc, magnesium stearate; capsule constituents: titanium dioxide (E 171), iron oxide (E 172), erythrosine (E 127), indigotine (E 132), gelatin.

Description of the appearance of Valdorm and package contents
Valdorm is presented in capsule form
The package of Valdorm 15 mg contains 30 capsules
The package of Valdorm 30 mg contains 30 capsules

Marketing authorization holder and manufacturer
Marketing authorization holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milano

Manufacturer
VAMFARMA S.r.l. - Via Kennedy, 5 - Comazzo (Lodi)