Ansaren

Package leaflet: Information for the patient

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

ketazolam
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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 Anseren is and what it is used for

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

• anxiety, tension, and other somatic or psychiatric conditions characterised by an anxious state
• insomnia.

Your doctor will prescribe Anseren only if your condition is severe, negatively affects your daily life, and causes you significant distress.

2. What you need to know before taking Anseren

Do not take Anseren

• if you are allergic to ketazolam, other benzodiazepines, or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from severe myasthenia gravis, a disease causing muscle weakness
• if you have severe respiratory problems (severe respiratory insufficiency)
• if you have severe liver problems (severe hepatic insufficiency)
• if you have a condition that impairs your breathing during sleep (sleep apnea)
• if you have a form of glaucoma, a disease causing increased pressure inside the eye, known as acute angle-closure glaucoma
• if you have acute poisoning from alcohol, analgesics (medicines to reduce pain), hypnotics (medicines that induce sleep), neuroleptics (psychiatric drugs), antidepressants (medicines for depression), or lithium (a medicine for mood disorders).

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

• if you have previously abused drugs or alcohol
• if you are elderly or debilitated, as a lower dose may be required (see section 3 "How to take Anseren")
• if you have brain damage (particularly due to 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 liver failure (hepatic encephalopathy)
• if you notice that after a few weeks the medicine is not working as well as it did initially (tolerance)

Dependence: When taking this medicine, there is a risk of dependence, meaning a need to continue taking the medicine. The risk increases with higher doses and longer duration of treatment. The risk is greater if you have previously abused drugs or alcohol. Drug dependence may occur even at therapeutic doses and even in the absence of risk factors.

Withdrawal: If you abruptly 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 may also occur when switching from a long-acting benzodiazepine to a short-acting one. Therefore, such substitution is not recommended.
After stopping treatment, you may also experience so-called "rebound phenomena," meaning a more intense return of the symptoms that led you to take this medicine (rebound insomnia and rebound anxiety) (see section 3 "If you stop taking Anseren").
The risk of withdrawal and rebound symptoms is higher when stopping Anseren abruptly; therefore, it is recommended to gradually reduce the dose.

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

Amnesia: Memory loss (amnesia) may occur. This is more likely several hours after taking the medicine. To reduce the risk of amnesia, ensure an uninterrupted sleep of 7–8 hours.

Behavioural reactions: You may experience behavioural disturbances (paradoxical psychiatric reactions). If you experience behavioural disturbances, 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 disorders 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 must not be administered to patients under 18 years of age.

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

• medicines that reduce the activity of the central nervous system: such as antipsychotics (medicines used in psychiatric disorders), hypnotics (medicines that induce sleep), anxiolytics/sedatives (medicines to reduce anxiety and promote relaxation), antidepressants (medicines for depression)
• narcotic analgesics (medicines used to relieve pain)
• antiepileptics (medicines for epilepsy)
• anaesthetics
• sedative antihistamines (medicines for allergies that cause drowsiness)
• muscle relaxants (medicines that relax muscles)
• medicines that increase ketazolam levels 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 and alcohol
Do not take Anseren with alcohol, as alcohol increases its sedative effect. This may negatively affect your ability to drive or operate machinery.

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.
You must not take Anseren during the first trimester of pregnancy. After the first trimester, your doctor will only prescribe Anseren if the benefits to you clearly outweigh the risks to the fetus.
You must not take Anseren while breastfeeding, as benzodiazepines, including ketazolam, pass into breast milk.

Driving and using machines
Anseren may impair your ability to drive or operate machinery, as it may cause sedation, memory loss (amnesia), difficulty concentrating, and impaired muscle function. These effects may be worsened if you have had insufficient sleep or have consumed alcohol.

3. How to take Anseren

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is 30 mg daily. Take the capsules with some liquid, preferably in the evening before going to bed.
Depending on your individual response, the dose may range from 15 mg to 75 mg daily.
Your doctor will start your treatment with the lowest possible dose. Additionally, your doctor will monitor you regularly at the beginning of treatment to assess whether the dose or frequency of administration can be reduced. Be careful not to exceed the maximum dose.
Your doctor will prescribe Anseren for the shortest possible duration. In some cases, after careful evaluation, your doctor may decide to continue your treatment beyond the maximum recommended duration, but only after carefully reassessing 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.
Your doctor will periodically evaluate your condition and the need for continued regular treatment with Anseren, especially if your anxiety symptoms are no longer present.

Treatment of insomnia
The duration of treatment generally ranges 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 or debilitated patients, or in patients with liver or kidney problems, your doctor will carefully evaluate whether to reduce the dose of Anseren.

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

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

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

Overdose with benzodiazepines, including Anseren, should not be life-threatening unless taken together with alcohol or other medicines that depress the central nervous system (see section “Other medicines and Anseren”).

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

If you stop taking Anseren
Do not stop treatment with Anseren abruptly.
Anseren may cause dependence; if this occurs, when you stop treatment suddenly, the symptoms that led you to take this medicine (anxiety and insomnia) may return more intensely, and you may experience additional symptoms such as mood changes and restlessness.
Withdrawal symptoms may occur, 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 sound (hyperacusis), numbness and tingling in hands and feet, sensitivity to light, noise and physical touch, hallucinations (seeing or hearing things that do not exist), or epileptic seizures may occur.
This is more likely to occur if treatment is stopped abruptly. If your doctor decides to discontinue treatment, the dose will be gradually reduced to minimize withdrawal symptoms.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately and stop treatment if you experience:

• restlessness
• agitation
• irritability
• aggression
• delirium
• anger
• nightmares
• hallucinations (seeing or hearing things that are not real)
• psychosis
• behavioural changes. These effects are symptoms of a "paradoxical psychiatric reaction" and may be quite severe. They are more likely in elderly patients.

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 possible side effects with Anseren administration

• stomach or intestinal disturbances
• changes in sexual desire
• skin reactions
• visual disturbances
• speech disorders in which words are spoken slowly and incorrectly (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)
• changes in menstrual cycle
• muscle pain
• memory loss (amnesia) (see section “Warnings and precautions”)
• worsening of pre-existing depression
• dependence (see section “Warnings and precautions”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 above 25°C.
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.
Do not dispose of any medicine via 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 Anseren contains

• The active substance is ketazolam. Each hard capsule contains 15 mg, 30 mg or 45 mg of ketazolam.
• The other components are: calcium carmellose, hydrogenated vegetable oil.
• The capsule components are: gelatin, titanium dioxide (E171) and (only for the 30 mg and 45 mg capsules) indigo carmine (E132).

Description of the appearance of Anseren and package contents
Each pack of Anseren 15 mg hard capsules contains 30 oral capsules of 15 mg.
Each pack of Anseren 30 mg hard capsules contains 15 oral capsules of 30 mg.
Each pack of Anseren 45 mg hard capsules contains 10 oral capsules of 45 mg.
Marketing Authorization 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