SONIREM 10 мг/мл Капли для приема внутрь, раствор

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

SONIREM 10 mg/ml oral drops, solution

Zolpidem tartrate
For Adults
Generic medicine

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. Never give it to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Sonirem and what is it used for

Sonirem contains zolpidem tartrate as its active ingredient. Zolpidem tartrate belongs to the group of
medicines called hypnotics. This medicine acts on your brain helping you to sleep.
Sonirem is used in adult patients for the short-term treatment of severe sleep disorders that cause
significant distress.
Sonirem should not be used every day for long periods of time. Ask your doctor for advice
if you have any doubts about why this medicine has been prescribed to you.

2. What you need to know before taking Sonirem

Do not takeSonirem

• If you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can include skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• If you have severe liver problems.
• If you suffer from brief pauses in breathing during sleep (sleep apnea syndrome).
• If you suffer from severe muscle weakness (myasthenia gravis).
• If you suffer from severe and/or acute breathing problems.
• If you are under the age of 18 years.
• If you are pregnant or breastfeeding.

Warnings and precautions
Consult your doctor or pharmacist before taking Sonirem if:

• You are elderly or frail. If you get up during the night, be careful because there is an increased risk of falling and consequently of a hip fracture due to the muscle-relaxing effect of the oral drops.
• You have kidney problems, caution is required although a dose adjustment is not necessary.
• You have a history of breathing difficulties. During the intake of Sonirem your breathing may become more difficult.
• You have or have had a history of alcohol abuse or substance abuse, extreme caution is necessary. You must be carefully monitored during treatment with Sonirem as you are at risk of physical and psychological dependence.
• You have liver problems as you may be at risk of brain damage (encephalopathy).
• You have a history of psychosis, depression or anxiety accompanied by depression. Sonirem may mask or worsen the symptoms (risk of suicide).

Other considerations
General
Before taking Sonirem

• The cause of sleep disorders must be identified by your doctor.
• Any other pre-existing illness must be treated before starting treatment with Sonirem.
• If the treatment of sleep disorders is unsuccessful after 7-14 days, this may indicate the presence of a psychiatric or physical illness that needs to be diagnosed.

Tolerance
After repeated use for a few weeks, a certain reduction in the sleep-inducing effect
of benzodiazepines or other substances similar to benzodiazepines with a short duration of action may occur.

Dependence
Physical and psychological dependence can develop as a result of treatment with Sonirem.
The risk increases with the dose and duration of treatment and is greater in patients with a history of abuse
of alcohol and drugs. If physical dependence develops, abrupt discontinuation of treatment may
cause withdrawal syndrome.

Withdrawal syndrome (Rebound insomnia)
Sonirem should be gradually reduced as you approach the end of your treatment. At the end of
treatment, for a short period of time, the original symptoms may reappear and be worse.
They may be accompanied by other reactions such as mood changes, anxiety and restlessness.

Memory impairment
Sonirem can cause memory loss (amnesia) in some patients.
Generally this condition occurs a few hours after taking the drops. To minimize
this risk, you should ensure that uninterrupted sleep of 7 – 8 hours is possible (see section 4.
“Possible side effects”).

Psychiatric and paradoxical reactions
Sonirem can cause undesirable behavioral effects such as restlessness, agitation, irritability,
aggression, delirium (false beliefs), outbursts of anger, nightmares, and other unconscious nocturnal behaviors such as
eating and driving, hallucinations, psychosis, sleepwalking, inappropriate behavior,
increased insomnia and other adverse behavioral effects. If these undesirable effects occur, you should
stop taking Sonirem and contact your doctor or go to the hospital immediately .The risk of these undesirable effects may be greater in the elderly.
If you are not sure whether the above applies to you, talk to your doctor or pharmacist before taking Sonirem.

Psychomotor impairment the next day (see also Driving and operating machinery)
The day after taking Sonirem, the risk of psychomotor impairment, including impairment of the ability to drive vehicles, may increase if you:

• take this medicine less than 8 hours before performing activities that require mental alertness
• take a higher dose than recommended
• take zolpidem while already taking other medicines with a depressant effect on the central nervous system or other medicines that increase the levels of zolpidem in the blood, or while drinking alcohol, or while taking illicit substances.

Sleepwalking and associated behaviors
Sleepwalking and other associated behaviors such as driving while asleep, preparing and eating food,
making phone calls, having sexual intercourse, with amnesia for the event have been reported in patients who were taking zolpidem and were not fully awake.
It appears that the use of alcohol and other
CNS depressants together with zolpidem, as well as the use of zolpidem at doses exceeding the
recommended maximum dose, increases the risk of these behaviors.

Serious injuries
Zolpidem can cause drowsiness and reduced consciousness, which can lead to falls and
consequently serious injuries.
Take the single dose immediately when going to bed.
Do not take another dose during the same night.

Special patients

• If you are elderly or debilitated, you should take a lower dose of zolpidem (See section 3). Zolpidem has a muscle-relaxing effect. For this reason, especially elderly patients are at risk of falls, and consequently of hip fractures, when getting out of bed during the night.
• If your kidney function is impaired, the elimination of the drug may be reduced. Although a dose reduction is not necessary, caution is required. Consult your doctor about this.
• If you have breathing problems, they may worsen with zolpidem.
• If you have previously abused drugs or alcohol, you should be carefully monitored by your doctor during treatment with zolpidem, because you are at risk of habituation and psychological dependence on this drug.
• If you have severe liver disease, you should not take zolpidem, because you are at risk of brain damage (encephalopathy). Consult your doctor about this.
• If you suffer from delirium (psychosis), depression or anxiety related to depression, zolpidem tartrate 10 mg should not be the only treatment you receive.

Other medicines and Sonirem
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines or herbal medicines. This is because Sonirem
can affect the action of other medicines. Other medicines can also affect the action of Sonirem.

Tell your doctor if you are taking any of the following medicines:
Sonirem can increase the effect of the following medicines:

• Medicines for the treatment of mental disorders (antipsychotics)
• Medicines for depression (antidepressants)
• Medicines for epilepsy (anticonvulsants)
• Medicines used during surgical operations (anaesthetics)
• Medicines to calm or reduce anxiety or for sleep disorders (anxiolytics/sedatives)
• Medicines for hay fever, rash or other allergies that can cause drowsiness (sedating antihistamines)
• Some Medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol.

The concomitant use of Sonirem and opioids (strong painkillers, drugs 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 Sonirem together with opioids, the dose and duration of concomitant therapy
must be limited by the doctor. Tell your doctor all the opioid medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform
friends or family to pay attention to the signs and symptoms above. See your doctor if
these symptoms occur.
While you are taking zolpidem with the following medicines, drowsiness and
psychomotor impairment the next day, including impairment of the ability to
drive vehicles, may increase.

• medicines for some mental health problems (antipsychotics)
• medicines for insomnia (hypnotics)
• medicines to calm or reduce anxiety
• medicines for depression
• medicines for moderate to severe pain (narcotic analgesics)
• medicines for epilepsy
• medicines used for anesthesia
• medicines for hay fever, rashes (rash) or other allergies, which can cause drowsiness (sedating antihistamines).

While you are taking zolpidem with antidepressants, including bupropion, desipramine, fluoxetine,
sertraline and venlafaxine, you may see things that are not there (hallucinations).

It is recommended not to take zolpidem with fluvoxamine or ciprofloxacin.

The following medicines may increase the possibility of experiencing side effects when
you take Sonirem.
To make this less likely, your doctor may decide to reduce your dose of
Sonirem:
Some antibiotics such as clarithromycin or erythromycin.
Some medicines for fungal infections such as ketoconazole and itraconazole.
Ritonavir (a protease inhibitor) – for HIV infections.

The following medicines may reduce the effect of Sonirem:

• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin.
• Rifampicin (an antibiotic) - for infections.
• St John's Wort (a herbal medicine) - for mood changes and depression.

Sonirem with food, drinks and alcohol
Do not drink alcoholic beverages while taking Sonirem as alcohol increases the effects of
this medicine and will make you sleep very deeply, causing you breathing problems or difficulty
waking up.

Pregnancy, breastfeeding and fertility
Pregnancy

• If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
• Tell your doctor if you want to plan a pregnancy during treatment with Sonirem, or if you think you are pregnant, so that the doctor can decide whether to change or continue treatment.
• Sonirem should not be taken during pregnancy, as there is insufficient data to assess the safety of administering Sonirem during pregnancy and breastfeeding.
• If Sonirem is taken for a long period during the last months of pregnancy, the newborn may have withdrawal syndrome after birth.
• Taking Sonirem for medical reasons near the end of pregnancy or during childbirth may harm your baby.

Breastfeeding

• As zolpidem passes into breast milk in small amounts, Sonirem should not be taken during breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Sonirem significantly impairs the ability to drive vehicles and use machinery, for example with
the risk of "falling asleep at the wheel".
The day after taking Sonirem (as happens with other hypnotic medicines), you should be
aware that:

• you may feel drowsy, sleepy, dizzy or confused
• it may take you longer to make decisions
• your vision may be blurred or double
• you may feel less alert.

To minimize the above effects, a period of at least 8 hours between taking
zolpidem and driving vehicles, using machinery and working at height is recommended.
Do not drink alcohol or take other psychoactive substances while taking Sonirem, as these substances
can increase the effects of this medicine listed above.
Sonirem contains Sodium Benzoate
This medicine contains 0.25mg of Sodium Benzoate in each ml.
This medicine contains less than 1 mmol of sodium (23 mg) per ml, that is to say essentially “sodium-free”.

3. How to take Sonirem

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
To deliver the prescribed dose of medicine, it is necessary to hold the bottle in an upright position with the
opening facing downwards.
After dispensing the number of drops corresponding to the prescribed dose, stop dispensing the medicine
by returning the bottle with the opening facing upwards. If the liquid does not come out of the bottle (it is possible
that small air or liquid bubbles obstruct the passage through the dropper), wait a few
moments without shaking the bottle. To facilitate the flow of liquid, close the bottle,turn it
over several times or gently tap it with a finger and repeat the dispensing as described above.

The recommended dose is
Adults
The recommended dose within 24 hours is 10 mg (25 drops) of Sonirem. A lower dose may be prescribed to
certain patients. Sonirem should be taken:

• in a single administration,
• immediately before bedtime.

Make sure that at least 8 hours have passed after taking this medicine before performing activities that
require your attention.
Do not exceed 10 mg within 24 hours.

Elderly, debilitated patients or patients with liver problems
A lower dose of 12 drops per night may be used. This dose may be increased to 25
drops by your doctor.

Maximum dose
The daily dose of 25 drops of Sonirem must not be exceeded.

Use in children and adolescents:
Sonirem should not be administered to patients under the age of 18 years.
25 drops contain 10 mg of zolpidem tartrate and correspond to 1 ml of solution.
Dilute the required number of drops in a glass of water and drink.
It is recommended to take Sonirem immediately before bedtime.

Duration of treatment with Sonirem
The duration of treatment with Sonirem should be as short as possible. In general, it can be a few days
up to 2 weeks and should not exceed 4 weeks, including the withdrawal period. Your doctor
will decide the withdrawal period based on your individual needs.
Some situations may require a longer treatment period. Your doctor will decide on the
best treatment cycle for your symptoms.

If you take more Sonirem than you should
It is important that you do not take more drops of Sonirem than prescribed. If you accidentally take too
many drops, contact the nearest Emergency Room or your doctor immediately. Be accompanied by
someone as an overdose can cause you to become very sleepy quickly, high doses can lead
to coma.

If you forget to take Sonirem
If you forget to take a dose immediately before going to bed but remember during the
night, take the forgotten dose if you still have 7-8 hours of uninterrupted sleep available. If this is not
possible, take the next dose before going to bed the next night.
Do not take a double dose to make up for the missed dose. If you are worried, ask
advice from your pharmacist or your doctor.

If you stop taking Sonirem
Always contact your doctor before stopping treatment with Sonirem because the dose must be
reduced gradually. This is because a sudden interruption of treatment increases the risk of
withdrawal syndrome.

• The treatment must be gradually discontinued as the symptoms for which you are being treated will reappear and be worse than before (worsening of insomnia), as well as anxiety, restlessness and mood changes may also occur. These effects will disappear over time.
• If you have become physically dependent on Sonirem, a sudden interruption of treatment could lead to the appearance of undesirable effects such as headache, muscle pain, anxiety, tension, restlessness, confusion, irritability and insomnia. In severe cases, other effects may appear such as hypersensitivity to light, noise and physical contact, abnormal hearing acuity and painful sensitivity to sound, hallucinations, numbness and tingling of the extremities, detachment from reality (feeling that the world around is not real), depersonalization (feeling the mind separate from the body) or epileptic seizures (violent attacks or shaking). These symptoms may also appear between doses, especially if the dose is high.

If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Sonirem and go to your doctor or hospital immediately if:

• You have an allergic reaction. Symptoms can include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• You see or hear things that are not real (hallucinations). If you experience any of these symptoms, you should stop taking Sonirem and go to your doctor or hospital immediately.

Contact your doctor as soon as possible if you experience any of the following side effects:
Common(present in 1 in 10 people)

• Memory loss while taking Sonirem (amnesia) and inappropriate behaviour during this period. This is more likely to occur in the first few hours after taking the medicine. If you get 7-8 hours of sleep after taking Sonirem, it is less likely to cause you problems.
• Worsening of insomnia after taking the medicine.
• Drowsiness during the day.

Uncommon(present in 1 in 100 people)
Blurred or double vision.

Other effects that have been reported include

• Decreased attention to the surrounding environment.
• Falls, especially in the elderly.

Sleep-driving and other abnormal behaviours
There have been reports of people doing things while asleep that they do not remember when they wake up after taking a sleeping medicine.
This includes sleep-driving, sleep-walking and having sexual intercourse. Alcohol and some medicines for depression or anxiety can increase the likelihood of these serious effects.

Contact your doctor or pharmacist if any of the following side effects gets worse or lasts longer
than a few days:
Common (present in 1 in 10 people)
Dizziness, headache, worsening of insomnia, recent memory loss, which may be associated with
inappropriate behaviour.
Diarrhoea, nausea, vomiting, abdominal pain.
Fatigue or agitation.
Back pain.
Hallucinations, nightmares.
Respiratory tract infections.

Uncommonpresent in 1 in 100 people

• Re-emergence of a pre-existing depression.
• Confusion or irritability.
• Dependence.

Other effects that have been reported,the frequency of which cannot be defined based on available data,
include:

• Itchy skin or rash, excessive sweating.
• Decreased level of consciousness.
• Muscle weakness.
• Difficulty breathing.
• Feeling restless, aggressive, angry or showing inappropriate behaviour.
• Believing things that are not true (delusions).
• Changes in sexual behaviour (libido).
• Changes in liver enzyme levels - highlighted in blood test results.
• Changes in gait.
• Sonirem may be less effective than usual. If any of the side effects worsen or if you notice any other side effect

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 Sonirem

• 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 bottle and the cardboard packaging after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage temperature.
• Store in the original packaging to protect the medicine from light.
• Dispose of the bottle 60 days after its opening, even if some solution remains.

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 Sonirem contains
The active ingredient is zolpidem tartrate. Each ml (25 drops) contains 10 mg of zolpidem tartrate equivalent to
8.03 mg of zolpidem.
The excipients are:
Citric acid monohydrate, sodium benzoate E211, purified water, sodium hydroxide (for pH adjustment) and concentrated hydrochloric acid 37% (for pH adjustment).

Description of the appearance of Sonirem and contents of the pack
Sonirem 10 mg/ml oral drops, solution, is a clear, colorless or slightly yellowish solution.
It is supplied in a bottle containing 30 ml of solution with a dropper for administering the
medicine.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milano
Italy
Tel: +39 02 64431
Fax: +39 02 66102753
e-mail: [email protected]
Manufacturer
Italfarmaco S.A.,
San Rafael, 3 Polig. Industrial Alcobendas
28108 Alcobendas (Madrid)
Spain

This medicinal product is authorised in the Member States of the EEA under the following denominations:
Italy: Sonirem 10 mg/ml oral drops, solution
Greece: Oniria 10 mg/ml, πόσιμες σταγόνες διάλυμα