ANSEREN 45 mg Hard Capsules

Зміст інструкції

1. Anseren 15 mg hard capsules, 30 mg hard capsules, 45 mg hard capsules
   1. What is Anseren and what is it used for
   2. What you need to know before you take Anseren
   3. How to take Anseren
   4. Possible side effects
   5. How to store Anseren
   6. Contents of the pack and other information

Anseren 15 mg hard capsules, 30 mg hard capsules, 45 mg hard capsules

ketazolam

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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Anseren and what is it used for

Anseren contains the active ingredient ketazolam, which belongs to the group of medicines known as benzodiazepines.
Anseren is indicated for the treatment of:

• anxiety, tension and other somatic or psychiatric conditions characterized by a state of anxiety
• insomnia.

The doctor will prescribe Anseren to you only if your disorder is severe, negatively affects your life
and causes you serious discomfort.

2. What you need to know before you take Anseren

Do not take Anseren

• if you are allergic to ketazolam, to other benzodiazepines or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from myasthenia gravis, a disease that causes muscle weakness
• if you have severe breathing problems (severe respiratory failure)
• if you have severe liver problems (severe hepatic insufficiency)
• if you suffer from a condition that prevents you from breathing well at night (sleep apnea)
• if you have a form of glaucoma, a disease that causes increased pressure inside the eye, called acute angle-closure glaucoma
• if you have an acute poisoning from alcohol, analgesics (pain relievers), hypnotics (sleep-inducing medicines), neuroleptics (psychotropic drugs), antidepressants (medicines for depression), lithium (medicine for mood disorders).

Warnings and precautions
Talk to your doctor or pharmacist before taking Anseren.
Tell your doctor:

• if you have previously abused drugs or alcohol
• if you are elderly or debilitated, as a dose reduction may be necessary (see section 3 How to take Anseren)
• if you have brain injuries (in particular from arteriosclerosis)
• if you have kidney problems
• if you suffer from heart failure (cardiac insufficiency)
• if you suffer from respiratory problems (chronic respiratory insufficiency)
• if you have liver problems (hepatic insufficiency) or suffer from mental confusion due to hepatic insufficiency (hepatic encephalopathy);
• if you notice that after a few weeks the medicine does not work as well as it did at the beginning (tolerance)

Dependence:When you take this medicine, there is a risk of developing dependence, i.e. the need to
continue taking the medicine. The risk increases with the dose and duration of treatment. It is
higher if you have previously abused drugs or alcohol. Drug dependence can also occur at
therapeutic doses and if you do not have risk factors.

Withdrawal:When you suddenly stop taking Anseren, you may experience withdrawal symptoms,
such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability (see
section “If you stop taking Anseren”).
Withdrawal symptoms can also occur when switching from a long-acting benzodiazepine to a
short-acting one. Therefore, such a substitution is not recommended.
After stopping treatment, some symptoms called “rebound phenomena” may also occur, i.e. you may
experience, more intensely, the symptoms that led you to take this medicine
(rebound insomnia and anxiety) (see section 3 “If you stop taking Anseren”).
The risk of developing withdrawal and rebound symptoms is greater when you stop taking
Anseren abruptly, therefore it is recommended to gradually reduce the dose.

Duration of treatment:The duration of treatment should be as short as possible and should not exceed
4 weeks for the treatment of insomnia and 8-12 weeks for the treatment of anxiety, including a
period of gradual discontinuation (see section 3 “How to take Anseren”).

Amnesia: Amnesia (memory loss) may occur. This happens more often several hours after
ingestion of the medicine. To reduce the risk of amnesia, make sure you get 7-8 hours of uninterrupted sleep.

Behavioral reactions: You may experience behavioral disorders (paradoxical psychiatric reactions).
If you experience behavioral disorders, stop taking the medicine immediately (see
section 4 “Possible side effects”). These reactions are more common in children and the elderly.
Anseren is not recommended for psychotic illnesses and should not be used alone to treat
depression or anxiety associated with depression, as suicidal thoughts may occur in such patients.

Children and adolescents
Anseren should not be given to patients under the age of 18.

Other medicines and Anseren
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are using:

• medicines that reduce the activity of the central nervous system: or antipsychotics (medicines used in psychiatric disorders) or hypnotics (sleep-inducing medicines) or anxiolytics/sedatives (medicines to reduce anxiety and that relax) or antidepressants (medicines for depression)

or narcotic analgesics (medicines used to reduce pain)
or antiepileptics (medicines for epilepsy)
or anesthetics
or sedative antihistamines (medicines for allergies that cause drowsiness)

• muscle relaxants (medicines that relax muscles)
• medicines that increase the levels of ketazolam in the blood
• beta-blockers (medicines for high blood pressure, heart problems and heart rhythm disorders)
• glycosides (medicines for the heart)
• anticoagulants (medicines that reduce blood clotting)
• medicines for diabetes
• oral contraceptives.

Anseren with alcohol
Do not take Anseren with alcohol, as this increases its sedative effect. This may negatively affect
your ability to drive vehicles or operate machinery.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
You should not take Anseren during the first trimester of pregnancy. After the first trimester of pregnancy,
your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus before prescribing
Anseren.
You should not take Anseren if you are breastfeeding, as benzodiazepines, including ketazolam, pass into
breast milk.

Driving and using machines
Anseren can impair your ability to drive vehicles and operate machinery because it can cause
sedation, memory loss (amnesia), altered concentration and muscle function. If
you have slept little during the night or if you have taken alcohol, these effects may be increased.

3. How to take Anseren

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 30 mg per day. Take the capsules with some
liquid, preferably in the evening before going to bed.
Based on individual response, the dose may vary from 15 mg to 75 mg per day.
The doctor will start the treatment with the lowest possible dose. Furthermore, they will monitor you regularly
at the beginning of treatment to assess the possibility of reducing the dose or the frequency of
administrations. Be careful not to exceed the maximum dose.
The doctor will prescribe Anseren for the shortest possible time. In some cases, the doctor, after careful
evaluation, may decide to continue the treatment beyond the maximum duration, but only after having
carefully assessed your condition.
Treatment of anxiety
The total duration of treatment should not exceed 8-12 weeks, including the period of gradual discontinuation of the medicine.
The doctor will periodically assess your condition and the need for regular treatment with Anseren, in
particular if you no longer experience the symptoms of anxiety.
Treatment of insomnia
The duration of treatment generally varies from a few days to two weeks, up to a maximum of four
weeks, including the period of gradual discontinuation of the medicine.

Use in particular patients
In elderly patients, debilitated patients, or those with liver or kidney problems, the doctor will carefully assess whether to reduce the
dose of Anseren.

Use in children and adolescents
Anseren should not be administered to patients under 18 years of age.

If you take more Anseren than you should
In case of accidental ingestion of an excessive dose of Anseren, immediately inform your doctor or
go to the nearest hospital.
After ingestion of an excessive dose, you may experience the following symptoms:

• dizziness
• mental confusion
• drowsiness
• lethargy
• loss of coordination of movements (ataxia)
• decreased muscle tone (hypotonia)
• reduced blood pressure
• reduced breathing capacity
• rarely coma
• very rarely death.

Ingestion of an excessive dose of benzodiazepines, including Anseren, should not pose a risk to
life, except in case of concomitant use of alcohol or medicines that reduce the activity of the central nervous
system (see section “Other medicines and Anseren”).

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

If you stop taking Anseren
Do not stop treatment with Anseren abruptly.
Anseren can cause dependence; if this occurs, when you abruptly stop treatment with
Anseren, the symptoms that led you to take this medicine (anxiety and insomnia) may manifest
more intensely and you may experience other symptoms such as mood changes and restlessness.
Withdrawal symptoms may appear, such as headache, muscle pain, severe anxiety,
tension, restlessness, confusion, and irritability. In severe cases of withdrawal, derealization
(feeling that things are not real), depersonalization (feeling of detachment from the surrounding
environment), intolerance to sounds (hyperacusis), numbness and tingling of hands and feet, sensitivity to
light, noise and physical contact, hallucinations (seeing and hearing things that do not exist) or seizures can occur.
This is more likely to occur in case of abrupt discontinuation of treatment. If the doctor has decided to
discontinue treatment, they will gradually reduce the dose to minimize withdrawal symptoms.
If you have any doubts about 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.
Contact your doctor immediately and stop treatment if you experience:

• restlessness
• agitation
• irritability
• aggression
• delirium
• rage
• nightmares
• hallucinations (seeing and hearing things that do not exist)
• psychosis
• behavioural changes. These effects are the symptoms of a “paradoxical psychiatric reaction” and can be quite serious. They are more likely in elderly people.

Side effects that occur more frequently at the beginning of treatment

• drowsiness
• reduced emotions
• reduced alertness
• confusion
• fatigue
• headache
• dizziness
• muscle weakness
• loss of coordination of movements (ataxia)
• double vision These side effects usually disappear with continued treatment.

Other side effectsthat may occur with the administration of Anseren

• stomach or intestinal disorders
• changes in sexual desire
• skin reactions
• vision disorders
• speech disorders in which words are pronounced slowly and defectively (dysarthria)
• tremors
• low blood pressure
• yellowing of the skin, mucous membranes and eyes
• weight gain
• increased appetite
• dry mouth or increased salivation
• urinary incontinence or urinary retention
• reduced number of white blood cells in the blood (neutropenia)
• menstrual cycle alterations
• muscle pain
• loss of memory (amnesia) (see section “Warnings and precautions”)
• worsening of pre-existing depression
• dependence (see section “Warnings and precautions”).

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Anseren

Do not store at a temperature above 25°C.
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 packaging after Expires. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Anseren contains

• The active ingredient is ketazolam. Each hard capsule contains 15 mg or 30 mg or 45 mg of ketazolam.
• The other ingredients are: calcium carmellose, hydrogenated vegetable oil.
• The capsule constituents are: gelatin, titanium dioxide (E171) and (only for the 30 mg and 45 mg capsules) indigotin (E 132).

Description of the appearance of Anseren and contents of the pack
Each pack of Anseren 15 mg hard capsules contains 30 capsules for oral use of 15 mg.
Each pack of Anseren 30 mg hard capsules contains 15 capsules for oral use of 30 mg.
Each pack of Anseren 45 mg hard capsules contains 10 capsules for oral use of 45 mg.

Marketing Authorisation Holder and Manufacturer
PHOENIX LABS
Suite 12, Bunkilla Plaza, Bracetown Business Park,
Clonee Co Meath,
Ireland

Manufacturer
Novartis Farmacéutica S.A.
Barberà del Vallès - Spain