SONGAR 0.25 MG Hard capsule

Содержание инструкции

1. SONGAR 0.125 mg hard capsules
   1. What is Songar and what is it used for
   2. What you need to know before taking Songar
2. Songar together with efavirenz may cause profound drowsiness and severe
   1. How to take Songar
   2. Possible side effects
   3. How to store Songar
   4. Contents of the pack and other information
3. SONGAR 0.25 mg hard capsules, 0.375 mg/ml oral drops, solution
   1. What is Songar and what is it used for
   2. What you need to know before taking Songar
   3. How to take Songar
   4. Possible side effects
   5. How to store Songar
   6. Contents of the pack and other information

SONGAR 0.125 mg hard capsules

Triazolam
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. Do not pass it on to others, even if they have the same symptoms as you, 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 Songar is and what it is used for
• 2. What you need to know before you take Songar
• 3. How to take Songar
• 4. Possible side effects
• 5. How to store Songar
• 6. Contents of the pack and other information

1. What is Songar and what is it used for

Songar contains the active substance triazolam. Triazolam belongs to a group of
medicines called benzodiazepines and acts on the central nervous system by reducing anxiety
(anxiolytic effect), agitation and reactions to emotions (sedative effect) and facilitating
sleep (hypnotic effect). Songar also produces muscle relaxation and calms
convulsions.
Songar is used for the short-term treatment of insomnia(difficulty
falling asleep or sleeping properly), when the disorder is severe and causes discomfort
in normal daily life.

2. What you need to know before taking Songar

Do not take Songar:

• if you are allergic to triazolam or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease that causes severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have severe breathing problems (severe respiratory failure);
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
• if you have severe liver problems (severe hepatic failure);
• if you are taking ketoconazole and itraconazole (medicines against fungal infections), nefazodone (a medicine against depression), efavirenz and other medicines used against HIV infection (see section “Other medicines and Songar”);
• children and adolescents under the age of 18;
• pregnancy and breastfeeding.

Warnings and precautions
The duration of treatment with Songar should be as short as possible. It is recommended not to exceed 4 weeks.See section 3 “How to take Songar”.
Consult your doctor or pharmacist beforetaking Songar if you think that any of the following conditions apply to you (see also section 4 “Possible side effects”):

• you have mild or moderate liver problems (mild or moderate hepatic insufficiency);
• you have breathing problems because this medicine can decrease your spontaneous breathing capacity or can cause a temporary interruption of breathing (apnea);
• you have or have had problems with alcohol or drug abuse, because Songar can also cause dependence (see section “Development of dependence”);
• you are taking other medicines that cause drowsiness or decrease mental functions (see section “Other medicines and Songar”);
• you suffer or have ever suffered from depression, because Songar can worsen your condition and the tendency to suicide;

Consult your doctor or pharmacist if duringthe administration of Songar the following conditions occur (see also section 4 “Possible side effects”):

• severe and rapid allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with inability to swallow and breathe (angioedema). Sometimes, these reactions can be fatal. Stop taking this medicine immediatelyand go to the nearest emergency room. You should no longer take medicines based on triazolam and your doctor will advise you on other medicines to take to continue the treatment of your illness;
• behavioral disorders related to sleep, such as “drowsiness while driving” (see section “Driving and using machines”). These disorders may occur more frequently if you take Songar together with alcohol or other medicines that decrease mental functions, or if you take Songar at doses higher than those recommended. If you experience these side effects, you should inform your doctor who will likely advise you to stop treatment with this medicine.

Memory disorders
After taking Songar you may have difficulty remembering what happened aftertaking the medicine. Therefore, it is advisable that you can sleep for 7-8 hours after taking this medicine.
Paradoxical reactions
Songar can cause mental reactions and effects opposite to those expected (paradoxical effects) such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, altered behavior (see section 4 “Possible side effects”). These effects are more common in children and the elderly.
If you experience these effects, consult your doctor who will advise you on the correct way to stop taking this medicine.
Development of tolerance
Following repeated use of this medicine for several weeks, a decrease in its effectiveness (tolerance) may occur. Songar is recommended for short-term treatments.
Development of dependence
The use of benzodiazepines, including Songar, can cause dependence, which can manifest as increasing need, desire or exaggerated search for taking the medicine (psychic dependence) or development of physical disorders that decrease or disappear only after taking the medicine (physical dependence). The probability of developing psychic and physical dependence on this medicine increases with increasing dose and duration of treatment.
You are more likely to develop dependence on Songar if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or currently drink alcohol frequently and/or in large quantities. In case of abrupt discontinuation of treatment with Songar after the development of dependence, you may experience symptoms of withdrawalsuch as:
• severesymptoms: muscle and abdominal cramps, vomiting, sweating, tremors, feeling of detachment or estrangement from oneself or from the outside world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise and physical contact, hallucinations, seizures;
• other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability;
• rebound insomnia. If you stop treatment abruptly, you may temporarily develop insomnia that is worse than what you had before starting treatment with this medicine. In addition, you may experience mood changes, restlessness, anxiety and sleep disturbances.

Do not stop taking Songar suddenly. Consult your doctor or pharmacist who will advise you on the correct way to stop treatment with this medicine.See section 3 “If you stop taking Songar”.
If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very poor, you are more sensitive to the effect of Songar. Therefore, in these cases, your doctor will advise you to reduce the dosage of this medicine to avoid excessive sedation, dizziness and reduced ability to coordinate movements (see section 3 “How to take Songar”).

Children and adolescents
Do not give Songar to children and adolescents under the age of 18.

Other medicines and Songar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines because they must notbe taken at the same time as Songar:

• ketoconazole, itraconazole (medicines against fungal infections);
• nefazodone (a medicine against depression);
• efavirenz (a medicine used to fight HIV infection). The administration of

Songar together with efavirenz may cause profound drowsiness and severe

inability to breathe normally, which can sometimes lead to death;

• protease inhibitors (other medicines used against HIV infection), such as ritonavir, because these medicines can increase the effects of Songar.

Tell your doctor if you are taking any of the following medicines with Songar because caution is required:

• other medicines against fungal infections. Their administration together with Songar is not recommended;
• cimetidine (a medicine to reduce stomach acidity);
• antibiotics such as erythromycin, clarithromycin and troleandomycin. Your doctor may advise you to reduce the dose of Songar you are taking;
• isoniazid (an antibiotic);
• fluvoxamine, sertraline and paroxetine (medicines against depression);
• diltiazem and verapamil (medicines against high blood pressure);
• oral contraceptives, imatinib (a medicine against some types of cancer) and aprepitant (a medicine against nausea and vomiting). These medicines can increase the effects of Songar. Therefore your doctor may advise you to reduce the dose of Songar you are taking;
• medicines that cause a strong reduction of all brain functions, such as:
• medicines for the treatment of some mental illnesses (antipsychotics)
• calmants and sleep inducers (hypnotics, sedatives)
• medicines for the treatment of anxiety (anxiolytics)
• medicines for the treatment of depression (antidepressants)
• medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics)
• medicines for the treatment of epileptic seizures (antiepileptics)
• anaesthetics
• medicines to counteract allergic reactions (sedative antihistamines). Songar taken together with these medicines can cause an excessive decrease in all mental functions. Furthermore, Songar administered together with narcotic analgesic medicines can cause euphoria, with an increased likelihood of developing psychic dependence;

The association of Songar and 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. Because of this,
concomitant use should only be considered when alternative therapeutic options are not possible.
However, if your doctor prescribes Songar in conjunction with opioids, the dose and
duration of concomitant treatment must be limited by your doctor.
Tell your doctor if you are taking opioids and carefully follow the dose that has been
recommended to you.
It may be helpful to inform friends and family to observe the possible appearance of
signs and symptoms as described above.
If these symptoms appear, contact your doctor.

• rifampicin (an antibiotic) and carbamazepine (an antiepileptic medicine and used against convulsions) because they can reduce the effect of Songar.

Songar with food and alcohol
Do not drink alcohol while taking Songar because alcohol increases the effects of the
medicine.
Do not drink grapefruit juice while taking Songar because the effects of the medicine
may increase.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
Do not use Songar during pregnancy.
Breastfeeding
Do not breastfeed while taking Songar because this medicine can pass into
breast milk. Consult your doctor if you have any doubts.

Driving and using machines
Donot drive or use machines if you experience drowsiness or
dizziness during treatment with Songar. Songar can also cause a condition called “sleepiness while driving”, i.e.
you may drive without being fully aware of it and without remembering having done so.
Your vigilance may be altered especially if you have not slept for a sufficient time
after taking Songar.

3. How to take Songar

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

Capsules
The recommended dose is 1 capsule equivalent to 0.125 mg – 2 capsules equivalent to 0.25 mg
Take Songar once a day just beforegoing to bed. The doctor will advise you on the lowest possible dose.
It is recommended not to exceed the maximum daily dose.

Instructions for use

Using the capsules
For the administration of 0.0625 mg, open the hard capsule by slightly rotating one end and take one of the two tablets contained therein.
Store the other tablet in the closed capsule and swallow it, including the shell, next time.

If you are elderly and/or suffer from liver or kidney problems
The recommended dose is 1 capsule equivalent to 0.125 mg to be taken once a day just beforegoing to bed.

Duration of treatment
The doctor will advise you on the shortest possible treatment duration. The average treatment duration is 7-10 days. The maximum recommended duration of therapy should not exceed 4 weeks. This period also includes the time required to gradually reduce the dose of Songar until discontinuation.
The doctor will decide based on your condition whether you can take this medicine for a longer period.

If you take more Songar than you should
It is important that you never take more medicine than prescribed. Generally, there are no life-threatening dangers if you accidentally take a dose of medicine higher than prescribed, unless you are also taking alcohol or other medicines.
Symptoms
Symptoms may include:

• disorders of motor coordination;
• speech articulation disorder;
• drowsiness;
• loss of ability to coordinate movements;
• poor muscle tone;
• low blood pressure;
• reduced breathing;
• coma;
• death.

The most serious, rare cases can occur when large amounts 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
Contact your doctor immediately or go to the nearest emergency room if you take more Songar than prescribed by your doctor. If you are conscious, you will be induced to vomit within one hour of taking the medicine; if you are unconscious, you will undergo gastric lavage. If these procedures are not sufficient, you may be given activated charcoal to reduce the absorption of Songar, or flumazenil, a medicine that counteracts the effects of Songar.

If you forget to take Songar
If you forget to take a dose, take it as soon as you remember, but make sure you can rest immediately afterwards and for long enough. Do not take a double dose to make up for a missed dose. If you think you have forgotten more than one dose, consult your doctor.

If you stop taking Songar
Do not stop taking Songar suddenly, unless you experience severe allergic reactions or swelling of the face, tongue and throat (see section 2 “Warnings and precautions”). The doses must be reduced gradually. The doctor will advise you on how to stop treatment.
If you stop taking Songar or reduce the dose suddenly, you may temporarily develop withdrawal symptoms or rebound symptoms (see section 2 “Development of dependence”).
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.

STOPtaking this medicine immediately and contact your doctor if you experience any of the following side effects because they are serious(see section 2 “Warnings and precautions”):

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat with resulting inability to swallow and breathe

Contact your doctor immediatelyif you experience any of the following side effects because the use of Songar must be stopped:

• effects opposite to those expected (paradoxical effects) (see section 2 Paradoxical disorders) such as:
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delirium
• anger
• nightmares
• impaired ability to examine reality normally
• behavioral disorders

Contact your doctor immediatelyif you experience any of the following side effects because they can be serious:

• physical dependence on the medicine (see section Development of dependence)
• psychic dependence on the medicine (see section Development of dependence)
• withdrawal symptoms (see section Development of dependence)
• rebound symptoms (see section Development of dependence)
• sleep-related behavioral disorders, such as “drowsiness while driving”
• difficulty remembering what happened after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see section 2 Memory disorders)
• excessive slowing of the rate and depth of breathing

Contact your doctor if you experience any of the following side effects:

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

• drowsiness
• dizziness
• headache
• loss of coordination

Uncommon side effects(may affect up to 1 in 100 people):

• confusion
• insomnia
• memory loss
• visual disturbances

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

• skin rash
• severe muscle weakness

Frequency not known(the frequency cannot be estimated from available data):

• allergic reactions
• swelling of body parts due to allergy
• hypersensitivity
• sleepwalking
• sudden and transient loss of consciousness
• excessive reduction of activity and response to stimuli (sedation)
• decreased level of consciousness
• disorders of the ability to speak normally
• reduced attention
• distortion or decrease of the sense of taste
• changes in sexual desire
• falling to the ground
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delirium
• anger
• nightmares
• in patients with compromised respiratory function: respiratory depression

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: www.aifa.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 Songar

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 package and on the blister
after “Expiry”. The expiry date refers to the last day of that month.
Store at a temperature below 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. Contents of the pack and other information

What Songar contains
The active ingredient is triazolam.
Capsules
One Songar 0.125 mg hard capsule contains 0.125 mg of triazolam (in two tablets
of 0.0625mg of triazolam each).
The other ingredients are: microcrystalline cellulose, dibasic calcium phosphate, talc, precipitated silica, magnesium stearate, erythrosine E127, sodium carboxymethylcellulose and gelatin.

Description of the appearance of Songar and contents of the pack
Songar 0.125 mg hard capsules are transparent hard capsules containing 2
round pink tablets. The hard capsules are available in opaque blisters in
packs of 10 hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milano

Manufacturer
Valeas SpA - Industria Chimica e Farmaceutica
Via Vallisneri, 10
20133 Milano

SONGAR 0.25 mg hard capsules, 0.375 mg/ml oral drops, solution

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

1. What is Songar and what is it used for

Songar contains the active substance triazolam. Triazolam belongs to a group of
medicines called benzodiazepines and acts on the central nervous system reducing anxiety
(anxiolytic effect), agitation and reactions to emotions (sedative effect) and facilitating
sleep (hypnotic effect). Songar also produces muscle relaxation and calms
convulsions.
Songar is used for the short-term treatment of insomnia(difficulty
falling asleep or sleeping properly), when the disorder is severe and causes discomfort
in normal daily life.

2. What you need to know before taking Songar

Do not take Songar:

• if you are allergic to triazolam or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease that causes severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have severe breathing problems (severe respiratory failure);
• if you suffer from episodes of interrupted breathing for several seconds during sleep (sleep apnea);
• if you have severe liver problems (severe hepatic failure);
• if you are taking ketoconazole and itraconazole (medicines against fungal infections), nefazodone (a medicine against depression), efavirenz and other medicines used against HIV infection (see section “Other medicines and Songar”);
• children and adolescents under 18 years of age;
• pregnancy and breastfeeding.

Warnings and precautions
The duration of treatment with Songar should be as short as possible. It is recommended not to exceed 4 weeks.See section 3 “How to take Songar”.
Consult your doctor or pharmacist beforetaking Songar if you think that any of the following conditions apply to you (see also section 4 “Possible side effects”):

• you have mild or moderate liver problems (mild or moderate hepatic insufficiency);
• you have breathing problems because this medicine can decrease your spontaneous breathing capacity or can cause a temporary interruption of breathing (apnea);
• you have or have had problems with alcohol or drug abuse, because Songar can also cause dependence (see section “Development of dependence”);
• you are taking other medicines that cause drowsiness or decrease mental functions (see section “Other medicines and Songar”);
• you suffer from or have ever suffered from depression, because Songar can worsen your condition and the tendency to suicide;

Consult your doctor or pharmacist if duringthe administration of Songar the following conditions occur (see also section 4 “Possible side effects”):

• severe and rapid allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with inability to swallow and breathe (angioedema). Sometimes, these reactions can be fatal. Stop taking this medicine immediatelyand go to the nearest emergency room. You should no longer take medicines containing triazolam and your doctor will advise you on other medicines to take to continue treating your condition;
• behavioral disorders related to sleep, such as “drowsiness while driving” (see section “Driving and operating machinery”). These disorders may occur more frequently if you take Songar together with alcohol or other medicines that decrease mental functions, or if you take Songar at doses higher than those recommended. If you experience these side effects, you should inform your doctor who will likely advise you to stop treatment with this medicine.

Memory disorders
After taking Songar you may have difficulty remembering what happened aftertaking the medicine. Therefore, it is advisable that you can sleep for 7-8 hours after taking this medicine.
Paradoxical reactions
Songar can cause mental reactions and effects opposite to those expected (paradoxical effects) such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, behavioral changes (see section 4 “Possible side effects”). These effects are more common in children and the elderly.
If you experience these effects, consult your doctor who will advise you on the correct way to stop taking this medicine.
Development of tolerance
Following repeated use of this medicine for several weeks, a decrease in its effectiveness (tolerance) may occur. Songar is recommended for short-term treatments.
Development of dependence
The use of benzodiazepines, including Songar, can cause dependence, which can manifest as increasing need, desire or exaggerated search for taking the medicine (psychic dependence) or development of physical disorders that decrease or disappear only after taking the medicine (physical dependence). The probability of developing psychic and physical dependence on this medicine increases with increasing dose and duration of treatment.
You are more likely to develop dependence on Songar if:

• you have taken drugs in the past or are currently taking drugs;
• you have drunk alcohol in the past or drink alcohol frequently and/or in large quantities. In case of abrupt discontinuation of treatment with Songar after the development of dependence, you may experience symptoms of withdrawalsuch as:
• severesymptoms: muscle and abdominal cramps, vomiting, sweating, tremors, feeling of detachment or estrangement from oneself or from the external world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise and physical contact, hallucinations, seizures;
• other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability;
• rebound insomnia. If you stop treatment abruptly, you may temporarily develop insomnia that is worse than what you had before starting treatment with this medicine. You may also experience mood changes, restlessness, anxiety and sleep disturbances.

Do not stop taking Songar suddenly. Consult your doctor or pharmacist who will advise you on the correct way to stop treatment with this medicine.See section 3 “If you stop taking Songar.”
If you are elderly and/or suffer from particular health conditions
If you are elderly and/or your general health conditions are very weak, you are more sensitive to the effect of Songar. Therefore, in these cases your doctor will advise you to reduce the dosage of this medicine to avoid excessive sedation, dizziness and reduced ability to coordinate movements (see section 3 “How to take Songar”).

Children and adolescents
Do not give Songar to children and adolescents under 18 years of age.

Other medicines and Songar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following medicines because they must notbe taken at the same time as Songar:

• ketoconazole, itraconazole (medicines against fungal infections);
• nefazodone (a medicine against depression);
• efavirenz (a medicine used to fight HIV infection). Taking Songar together with efavirenz can cause deep sleepiness and a severe inability to breathe normally, which can sometimes lead to death;
• protease inhibitors (other medicines used against HIV infection), such as ritonavir, because these medicines can increase the effects of Songar.

Tell your doctor if you are taking any of the following medicines together with Songar because caution is necessary:

• other medicines against fungal infections. Their administration together with Songar is not recommended;
• cimetidine (a medicine to reduce stomach acidity);
• antibiotics such as erythromycin, clarithromycin and troleandomycin. Your doctor may advise you to reduce the dose of Songar you are taking;
• isoniazid (an antibiotic);
• fluvoxamine, sertraline and paroxetine (medicines against depression);
• diltiazem and verapamil (medicines against high blood pressure);
• oral contraceptives, imatinib (a medicine against some types of tumors) and aprepitant (a medicine against nausea and vomiting). These medicines can increase the effects of Songar. Therefore, your doctor may advise you to reduce the dose of Songar you are taking;
• medicines that cause a strong reduction of all brain functions, such as:
• medicines for the treatment of some mental illnesses (antipsychotics)
• calming and sleep-inducing agents (hypnotics, sedatives)
• medicines for the treatment of anxiety (anxiolytics)
• medicines for the treatment of depression (antidepressants)
• medicines for the treatment of acute or chronic severe pain (narcotic analgesics)
• medicines for the treatment of epilepsy (antiepileptics)
• anesthetics
• medicines to counteract allergic reactions (sedative antihistamines).

Songar taken together with these medicines can cause an excessive decrease in all mental functions.
Furthermore, Songar administered together with narcotic analgesic medicines can cause euphoria, with an increased likelihood of developing psychic dependence;
The concomitant use of Songar and opioids (potent analgesics, medicines for substitution therapy and some medicines for cough) increases the risk of drowsiness, respiratory depression, coma and can be life-threatening. For this reason, concomitant use should only be considered when alternative therapeutic options are not possible.
However, if your doctor prescribes Songar 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 as described above.
If these symptoms occur, contact your doctor.

• rifampicin (an antibiotic) and carbamazepine (an antiepileptic medicine and used against convulsions) because they can reduce the effect of Songar.

Songar with drinks and alcohol
Do not drink alcohol while taking Songar because alcohol increases the effects of the medicine.
Do not drink grapefruit juice while taking Songar because the effects of the medicine may increase.

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 use Songar during pregnancy.
Breastfeeding
Do not breastfeed while taking Songar because this medicine can pass into breast milk. Consult your doctor if you have any doubts.

Driving and operating machinery
Do notdrive or operate machinery if you experience drowsiness or dizziness while taking Songar. Songar can also cause a disorder called “drowsiness while driving”, i.e. you may drive without being fully aware and without remembering having done so.
Your vigilance may be altered especially if you have not slept for enough time after taking Songar.

Songar 0.375 mg/ml oral drops contains alcohol and propylene glycol
This medicine contains 113 mg of alcohol (ethanol) per dose of 20 drops. This amount is equivalent to 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 466.66 mg of propylene glycol per dose of 20 drops equivalent to 6.66 mg/Kg/day in adults (70kg)

Songar 0.375 mg/ml oral drops and sodium
Songar 0.375 mg/ml oral drops contains less than 1 mmol (23 mg) of sodium per dose of 20 drops (0.25 mg) i.e. essentially “sodium-free”.

Songar 0.25 mg hard capsules and sodium
Songar 0.25 mg hard capsules contains less than 1 mmol (23 mg) of sodium per dose of 0.25 mg (1 capsule) i.e. essentially “sodium-free”.
For those who engage in sports, the use of medicines containing ethyl alcohol may determine positivity to doping tests in relation to the concentration limits of alcohol indicated by some sports federations.

3. How to take Songar

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults

Capsules
The recommended dose is ½ capsule (i.e. 1 tablet contained in the capsule equal to 0.125
mg) – 1 capsule (i.e. 2 tablets of 0.125 mg each, equal to 0.25 mg contained in the
capsule).

Oral drops, solution
10-20 drops (corresponding to 0.125 mg - 0.25 mg)
Take Songar once a day just beforegoing to bed. The doctor will advise you on the
lowest possible dose.
It is recommended not to exceed the maximum daily dose.

Instructions for use

Using the capsules
For the administration of 0.125 mg, open the hard capsule by slightly rotating
one end and take one of the two tablets contained therein.
Keep the other tablet in the closed capsule and swallow it, including the shell, next
time.

Using the drop bottle
One drop of Songar oral drops, solution corresponds to 0.0125 mg of triazolam.
Take Songar oral drops diluted with water.

If you are elderly and/or suffer from liver or kidney problems
The recommended dose is ½ capsule (i.e. 1 tablet contained in the capsule equal to 0.125 mg
) or 10 drops of solution (corresponding to 0.125 mg) to be taken once a day

just beforegoing to bed.

Duration of treatment
The doctor will advise you on the shortest possible treatment duration. The average duration of
treatment is 7-10 days. The recommended maximum duration of therapy should not exceed
4 weeks. This period also includes the time needed to gradually reduce the dose of Songar until discontinuation.
The doctor will decide based on your condition whether you can take this medicine for a
longer period.

If you take more Songar than you should
It is important that you never take more medicine than prescribed. Generally, there are
no life-threatening risks if you accidentally take a dose of medicine higher than
prescribed, unless you are also taking alcohol or other
medicines.
Symptoms
The symptoms may be:

• disturbances of motor coordination;
• difficulty in articulating speech;
• drowsiness;
• loss of coordination ability;
• poor muscle tone;
• low blood pressure;
• reduced breathing;
• coma;
• death.

The most serious, rare cases can occur when large amounts 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
Contact your doctor immediately or go to the nearest emergency room if you take more
Songar than prescribed by your doctor. If you are conscious, you will be induced to vomit within
one hour of taking the medicine; if you are unconscious, you will undergo gastric lavage. If these procedures are not sufficient, you may be given activated charcoal,
to reduce the absorption of Songar, or flumazenil, a medicine that counteracts the effects of
Songar.

If you forget to take Songar
If you forget to take a dose, take it as soon as you remember, but make sure you can
rest immediately afterwards and for long enough. Do not take a double dose to make up for the
missed dose. If you think you have missed more than one dose, consult your doctor.

If you stop taking Songar
Do not stop taking Songar suddenly, unless you experience
severe allergic reactions or swelling of the face, tongue and throat (see paragraph 2
“Warnings and precautions”). The doses must be reduced gradually. The doctor will advise you on how to stop the treatment.
If you stop taking Songar or reduce the dose suddenly, you may temporarily develop
withdrawal symptoms or rebound symptoms (see paragraph 2
“Development of dependence”).
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.

STOPtaking this medicine immediately and contact your doctor if you experience any of the following side effects because they are serious(see section 2 “Warnings and precautions”):

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat with resulting inability to swallow and breathe

Contact your doctor immediatelyif you experience any of the following side effects because the use of Songar must be stopped:

• effects opposite to those expected (paradoxical effects) (see section 2 Paradoxical disorders) such as:
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delirium
• anger
• nightmares
• impaired ability to examine reality normally
• behavioral disorders

Contact your doctor immediatelyif you experience any of the following side effects because they can be serious:

• physical dependence on the medicine (see section Development of dependence)
• psychic dependence on the medicine (see section Development of dependence)
• withdrawal symptoms (see section Development of dependence)
• rebound symptoms (see section Development of dependence)
• sleep-related behavioral disorders, such as “drowsiness while driving”
• difficulty remembering what happened after taking the medicine (anterograde amnesia). This may also be accompanied by behavioral changes (see section 2 Memory disorders)
• excessive slowing of the rate and depth of breathing

Contact your doctor if you experience any of the following side effects:

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

• drowsiness
• dizziness
• headache
• loss of coordination of movements

Uncommon side effects(may affect up to 1 in 100 people):

• confusional state
• insomnia
• memory loss
• vision disorders

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

• skin rash
• severe muscle weakness

Frequency not known(the frequency cannot be estimated from available data):

• allergic reactions
• swelling of body parts due to allergy
• hypersensitivity
• sleepwalking
• sudden and transient loss of consciousness
• excessive reduction of activity and response to stimuli (sedation)
• reduced level of consciousness
• speech disorders
• reduced attention
• distortion or decrease of the sense of taste
• changes in sexual desire
• falling to the ground
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delirium
• anger
• nightmares
• in patients with impaired respiratory function: respiratory depression

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 www.aifa.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 Songar

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 package and on the blister
after “Expiry”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Drops
Validity after first opening: 30 days.
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 Songar contains
The active ingredient is triazolam.
Capsules
One Songar 0.25 mg hard capsule contains 0.25 mg of triazolam (in two tablets of
0.125 mg of triazolam each).
The other ingredients are: microcrystalline cellulose, dibasic calcium phosphate dihydrate, talc,
silica, magnesium stearate, indigotine lake (E 132), sodium starch glycolate type A, gelatin.
Drops
1 ml of Songar oral drops, solution (equivalent to 30 drops) contains 0.375 mg of triazolam.
The other ingredients are: sodium saccharin, lemon flavour, orange flavour, propylene
glycol, ethanol,purified water.

Description of the appearance of Songar and contents of the pack
Songar 0.25 mg hard capsules are transparent hard capsules containing 2
round, blue-coloured tablets. The hard capsules are available in opaque blisters in
packs of 10, 20 hard capsules.
Songar oral drops solution is a clear solution. The oral drops are available in
19 ml polyethylene bottle with dropper and child-resistant closure.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan

Manufacturer
Valeas SpA - Industria Chimica e Farmaceutica
Via Vallisneri, 10
20133 Milan