Patient Information Leaflet: Information for the User

Valdorm 15 mg capsules, 30 mg capsules

Flurazepam
Equivalent medicine
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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valdorm is and what it is used for
What you need to know before taking Valdorm
How to take Valdorm
Possible side effects
How to store Valdorm
Contents of the pack and other information

1. What Valdorm is and what it is used for

Valdorm is a hypnotic medicine containing the active substance flurazepam and belongs to a class of psychotropic drugs known as "benzodiazepines".
This medicine is used for the short-term treatment of insomnia, particularly when insomnia is severe, disabling and causes significant distress.

2. What you should know before taking 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 causing severe muscle weakness (myasthenia gravis);
if you suffer from severe respiratory problems such as severe respiratory insufficiency, severe pulmonary insufficiency, or respiratory depression (severe reduction in breathing);
if you suffer from severe liver problems (severe hepatic insufficiency);
if you suffer from sleep apnoea (temporary cessation of breathing during sleep);
if you suffer from mental disorders such as obsessive or phobic states, or chronic psychosis (mental disorders causing recurrent involuntary thoughts 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 gradual withdrawal period (see section 3 “How to take Valdorm”). Any extension of treatment beyond this period should only occur after reassessment of your clinical condition.
If treatment is prolonged, blood tests and liver function monitoring are advised.
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 elderly and/or debilitated. Your doctor will prescribe a reduced dose.
If you are elderly and taking medicines for epilepsy (particularly hydantoins, barbiturates, or combinations containing them). In this case, combination with Valdorm increases the risk of adverse effects and toxicity.
If you suffer from chronic respiratory insufficiency. Your doctor will prescribe a reduced dose.
If you suffer from liver disease (hepatic insufficiency). Your doctor will prescribe a reduced dose.
If you suffer from or have previously suffered from depression or anxiety associated with depression, as Valdorm may worsen your condition and increase suicidal tendencies.
If you suffer from a mental disorder causing altered perception of reality, thought disturbances, or mental confusion (psychosis).
If you have movement coordination problems caused by a condition called ataxia (spinal or cerebellar). Valdorm is not indicated in this case.
If you have or have previously had problems with drug or alcohol abuse, as the risk of dependence is higher (see “Development of dependence”).
If you are taking medicines that reduce central nervous system activity, cause drowsiness, or impair mental function (psychotropic medicines), due to the risk of unexpected adverse interactions (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 treatment only.
Development of dependence
The use of Valdorm, like other benzodiazepines, may lead to dependence, which may manifest as an increasing need, excessive desire, or urge to take the medicine (psychic dependence), or the development of physical symptoms that decrease or disappear only after taking the medicine (physical dependence). The likelihood of developing psychic and physical dependence increases with higher doses and longer treatment duration. Additionally, this risk is greater in individuals who have abused or currently abuse drugs or alcohol, or in patients with severe personality disorders. In such cases, regular monitoring by your doctor is necessary, and treatment discontinuation should be gradual.
Once dependence has developed, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms, which may occur even in patients who have taken normal therapeutic doses for short periods, with symptoms such as:

Depression, nervousness, mood changes, rebound insomnia, sweating, diarrhoea, headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability.
In severe cases, distorted perception of the external world (derealization), feeling of detachment from reality (depersonalization), tingling in hands and feet, excessive sensitivity to light, noise, sounds, and physical contact, hallucinations, or epileptic seizures.
In rare cases, discontinuation following excessive dosing may cause confusion, psychiatric disturbances, and convulsions.

Rebound insomnia and anxiety
If treatment is abruptly stopped, you may temporarily experience insomnia worse than before starting treatment with this medicine.
Additionally, other reactions may occur, such as mood changes, anxiety, restlessness, or sleep disturbances.
Do not stop taking Valdorm suddenly. Consult your doctor, who will advise you on the correct way to discontinue treatment with this medicine (see section 3 “If you stop taking Valdorm”).
Abuse of benzodiazepines has been reported.
Memory disturbances
Benzodiazepines may impair the ability to retain recent information (anterograde amnesia). This usually occurs several hours after taking the medicine; therefore, to reduce the risk, ensure an uninterrupted sleep of at least 7–8 hours (see “Possible side effects”).
If you wake up during the period of peak medicine activity, memory may be impaired.
Paradoxical reactions
Benzodiazepines such as Valdorm may cause effects opposite to those expected (paradoxical reactions), such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, behavioural changes, or onset of depression with suicidal tendencies (see section 4 “Possible side effects”). If this occurs, consult your doctor, as treatment should be discontinued. These reactions are more frequent in children and elderly patients.
If you are elderly
If you are elderly, take Valdorm exactly as prescribed by your doctor.
This medicine may increase the risk of falls and fractures due to its muscle-relaxing effect.
Children and adolescents
Valdorm must not be used in children and adolescents under 18 years of age.
Other medicines and Valdorm
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
Pay particular attention and consult your doctor or pharmacist if you have taken or are currently 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 certain forms of depression)
hypnotics (medicines used to treat insomnia)
anxiolytics/sedatives (medicines used to treat anxiety)
antidepressants (medicines used to treat depression)
narcotic analgesics (medicines used to treat severe pain). In this case, increased euphoria may occur, increasing the risk of psychic dependence.
antiepileptics (medicines used to treat epilepsy, a disease characterized by uncontrollable body movements and loss of consciousness), such as phenytoin
anaesthetics (medicines used during surgical procedures)
sedating antihistamines (medicines used to treat allergies)
medicines used to suppress seizures (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 mainly used to treat asthma)
muscle relaxants (medicines that relax muscles)
medicines that affect certain liver enzymes, as they may alter Valdorm’s activity, for example: cimetidine and omeprazole (used to treat gastric disorders), disulfiram (used in the treatment of alcoholism), or rifampicin (an antibiotic)
Concomitant use of Valdorm with opioids (potent analgesics, medicines for substitution 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 alternative therapeutic options are available. However, if your doctor prescribes Valdorm together with opioids, the dose and duration of concomitant treatment must be strictly limited by your doctor. Inform your doctor if you are taking opioids and carefully follow the recommended dosage. It may be helpful to inform friends and family to watch for signs and symptoms as described above. If such symptoms occur, contact your doctor immediately.

Valdorm and alcohol
Do not consume alcoholic beverages while taking Valdorm, as the calming effect of the medicine may be enhanced.
This may severely impair your ability to drive or operate machinery (see “Driving and use of machines”).
If you have previously abused alcohol, your doctor will monitor you closely during Valdorm treatment, as you are more likely to develop dependence on this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy, especially during the first and last three months, unless your doctor considers it strictly necessary. During pregnancy, Valdorm should only be taken when clearly needed and under direct medical supervision.
If you take this medicine for serious medical reasons during the late stages of pregnancy or during labour at high doses, the newborn may show the following symptoms:

irregular heartbeat
body temperature below 35°C (hypothermia)
poor muscle tone (hypotonia)
breathing difficulties

Furthermore, if you take benzodiazepines (the group of medicines to which Valdorm belongs) for a prolonged period during advanced pregnancy, the newborn may develop physical dependence on the medicine and be at risk of withdrawal symptoms after birth.
Breastfeeding
Do not take Valdorm if you are breastfeeding, as this medicine passes into breast milk.
If regular use of Valdorm becomes necessary, discontinue breastfeeding.
Fertility
If you are a woman of childbearing age, planning a pregnancy, or suspect you are pregnant, consult your doctor, who will evaluate whether treatment with this medicine should be discontinued.
Valdorm should be discontinued gradually and according to your doctor’s instructions.
Driving and use of machines
Valdorm has a sedative effect, may cause temporary memory loss (amnesia), may affect concentration, and may impair muscle function. Therefore, taking this medicine may negatively affect your ability to drive vehicles or operate machinery. If you have not had sufficient sleep, your attention threshold is more likely to be impaired; therefore, do not drive on days when you take Valdorm.
Valdorm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Valdorm

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment with Valdorm will be determined by your doctor according to the type and severity of your insomnia, your response to treatment, and your 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, discuss it with your doctor.
During treatment with Valdorm, you should be monitored regularly so that, if necessary, the dose can be reduced to prevent accumulation of the medicine in the body.
Recommended doses are:
Adults: 1 capsule of 15 mg or 1 capsule of 30 mg in the evening, before going to bed.
Your doctor may prescribe an initial dose of 15 mg (1 capsule) and subsequently increase it, if needed, to 30 mg (1 capsule of 30 mg or 2 capsules of 15 mg).
Do not exceed the maximum daily dose of 60 mg (2 capsules of 30 mg).
Undergo regular check-ups, especially at the beginning of treatment, to reduce, if necessary, the dose or frequency of administration in order to avoid excessive accumulation of the medicine in the body.
Use in children and adolescents: Do not give this medicine to children and adolescents under 18 years of age, as Valdorm is not intended for pediatric use.
Use in specific patient groups
Elderly or debilitated patients: the recommended dose is 1 capsule of 15 mg. If you belong to this group, note 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 should generally not be exceeded. Your doctor may further reduce your dosage.
Patients with chronic pulmonary insufficiency: your doctor may consider it necessary to reduce the dosage.
Duration of treatment
Your doctor will advise you on the duration of treatment, which should be as short as possible. The treatment duration is generally from a few days up to 2 weeks, and 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 your doctor has reassessed your health condition.
Long-term chronic treatment is not recommended.
If you have taken benzodiazepines for a prolonged period, you may need a longer period during which doses are gradually reduced (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/overdose of Valdorm, contact your doctor immediately or go to the nearest hospital.
Symptoms
Generally, there is no life-threatening risk if you accidentally take more medicine than prescribed, unless you also consume alcohol or other medicines at the same time.
In milder cases, symptoms of accidental overdose may include loss of sensory and intellectual abilities, mental confusion, continuous drowsiness, and reduced response to normal stimuli (lethargy); in more severe cases, symptoms may include speech disturbances, vision or movement problems, loss of coordination and muscle tone, low blood pressure, breathing difficulties, and in rare cases coma, and very rarely, death.
More severe, rare cases may occur when large quantities of the medicine are taken, or when this medicine is taken together with alcoholic beverages or other medicines that depress consciousness and major brain functions.
Treatment
After evaluating the symptoms, the doctor will provide appropriate supportive therapy (e.g., with activated charcoal and/or gastric lavage).
The doctor may consider using flumazenil (a medicine that works by blocking the effects of benzodiazepines). If you are taking medicines for 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 the forgotten dose.
If you stop taking Valdorm
Do not stop treatment with Valdorm without first consulting your doctor.
Your doctor will advise you on how to stop treatment by gradually reducing the dose. Abruptly stopping this medicine may temporarily cause withdrawal or rebound symptoms (the symptoms that led to treatment with flurazepam reappear in a more severe form after stopping treatment) (see section 2 “Development of dependence”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported:
Common adverse effects (may affect up to 1 in 10 people)

drowsiness, including during the day;
headache;
dizziness caused by nervous system disorders;
reduced level of attention;
loss of muscle coordination (ataxia);
altered taste;
emotional blunting;
muscle weakness;
fatigue.

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

visual disturbances, such as double vision;
stomach and intestinal disorders;
abdominal pain;
nausea;
changes in sexual desire (libido);
skin reactions (e.g. rash);
reduced blood pressure (hypotension);
hypersensitivity, such as 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 disorders.

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

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

Adverse effects with unknown frequency (frequency cannot be determined from the available data)

extrapyramidal disorders (e.g. rigidity, resting tremor, reduced movement/absence of spontaneous movements, slow and clumsy movements);
confusion;
limited ability to memorize new information (anterograde amnesia), sometimes associated with behavioural changes (see section 2 “Memory disturbances”);
dependence (see section 2 “Development of dependence”);
withdrawal syndrome, rebound effects (see section 2 “Development of rebound/withdrawal phenomena”);
depression;
paradoxical reactions (e.g. anxiety, sleep disturbances, insomnia, nightmares, restlessness, agitation, irritability, aggression, delirium, mental disorders, behavioural changes, emotional disturbances, suicide attempts, suicidal ideation) (see section 2 “Paradoxical disturbances”);
hallucinations;
blood disorders, such as reduced platelet count (thrombocytopenia), reduced white blood cell count (leucopenia, agranulocytosis), reduced number of all blood cells (pancytopenia);
Falls and fractures. The risk of falls and fractures increases if you are elderly.

In addition, the use of benzodiazepines, a class of medicines including Valdorm, may unmask pre-existing depression and may cause reactions such as restlessness, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, and behavioural disturbances. These adverse effects are more likely in elderly patients.
The use of benzodiazepines (even at recommended doses) may lead to physical or psychological dependence. Discontinuation of treatment may cause adverse effects (rebound phenomena) or withdrawal symptoms (see “Warnings and precautions” and “If you stop taking Valdorm”).
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Valdorm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
The stated expiry date applies to the product if the packaging is intact and the product is stored correctly.
Store below 25°C.
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 Valdorm contains

The active substance is flurazepam. Each capsule of Valdorm 15 mg contains 12.62 mg of flurazepam (equivalent to 13.81 mg of flurazepam monohydrochloride); each capsule of Valdorm 30 mg contains 25.25 mg of flurazepam (equivalent to 27.62 mg of flurazepam monohydrochloride).
The other components 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 the contents of the pack
Valdorm is available in capsule form.
The Valdorm 15 mg pack contains 30 capsules.
The Valdorm 30 mg pack contains 30 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturer
VAMFARMA S.r.l. - Via Kennedy, 5 - Comazzo (Lodi)