Songar

Package leaflet: Information for the user

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

Triazolam
Generic medicine
Read this entire 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, consult 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 effects, including those not listed in this leaflet, consult 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 taking 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 Songar is and what it is 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 emotional reactions (sedative effect), and by facilitating sleep (hypnotic effect). Songar also produces muscle relaxation and helps control seizures.
Songar is used for the short-term treatment of insomnia (difficulty falling asleep or sleeping properly) when the condition is severe and causes distress in normal daily life.

2. What you should know before taking Songar

Do not take Songar:

• if you are allergic to triazolam or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have serious breathing problems (severe respiratory insufficiency);
• if you suffer from episodes of breathing interruption lasting several seconds during sleep (sleep apnea);
• if you have serious liver problems (severe hepatic insufficiency);
• if you are taking ketoconazole or itraconazole (medicines for fungal infections), nefazodone (a medicine for depression), efavirenz or other medicines used against HIV infection (see section “Other medicines and Songar”);
• in children and adolescents under 18 years of age;
• during pregnancy or 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”.
Talk to your doctor or pharmacist before taking Songar if you think any of the following conditions apply to you (also see section 4 “Possible side effects”):

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

Talk to your doctor or pharmacist if any of the following conditions occur during treatment with Songar (also see section 4 “Possible side effects”):

• severe and rapidly occurring allergic reactions (anaphylactic reactions) or swelling of the face, tongue and throat with difficulty swallowing and breathing (angioedema). Sometimes these reactions can be fatal. Immediately stop taking this medicine and go to the nearest emergency room. You must never take triazolam-containing medicines again, and your doctor will recommend alternative medicines for continuing your treatment;
• sleep-related behavioral disturbances, such as “sleep-driving” (see section “Driving and use of machines”). These disturbances are more likely to occur if you take Songar together with alcohol or other medicines that reduce mental functions, or if you take Songar at doses higher than recommended. If you experience these side effects, inform your doctor, who will likely advise you to stop treatment with this medicine.

Memory disturbances
After taking Songar, you may have difficulty remembering events that occurred after taking the medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Songar may cause mental reactions and effects opposite to those expected (paradoxical effects), such as restlessness, agitation, irritability, aggression, delirium, anger, nightmares, hallucinations, psychosis, and behavioral changes (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, contact your doctor, who will advise you on the correct way to discontinue this medicine.
Development of tolerance
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance). Songar is recommended for short-term treatment only.
Development of dependence
The use of benzodiazepines, including Songar, may lead to dependence, which may manifest as an increasing need, excessive desire or craving to take the medicine (psychological dependence), or the development of physical symptoms that decrease or disappear only after taking the medicine again (physical dependence). The likelihood of developing psychological and physical dependence increases with higher doses and longer duration of treatment.
You are more likely to develop dependence on Songar if:

• you have previously or currently used drugs;
• you have previously or currently consumed alcohol frequently and/or in large quantities.
  If treatment with Songar is abruptly stopped after dependence has developed, you may experience withdrawal symptoms such as:
  • severe symptoms: muscle and abdominal cramps, vomiting, sweating, tremors, feelings of detachment or estrangement from oneself or the external world, increased sensitivity to sound, numbness and tingling in arms or legs, hypersensitivity to light, noise and physical contact, hallucinations, epileptic seizures;
  • other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability;
  • rebound insomnia. If treatment is abruptly stopped, you may temporarily develop insomnia worse than that which you had before starting treatment with this medicine. Additionally, 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 discontinue treatment with this medicine.
See section 3 “If you stop taking Songar.”
If you are elderly and/or have specific health conditions
If you are elderly and/or your general health condition is very weak, you are more sensitive to the effects of Songar. Therefore, in such cases your doctor may advise reducing the dose 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 or adolescents under 18 years of age.
Other medicines and Songar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking any of the following medicines, as they must not be taken together with Songar:

• ketoconazole, itraconazole (medicines for fungal infections);
• nefazodone (a medicine for depression);
• efavirenz (a medicine used to treat HIV infection). Taking Songar together with efavirenz may cause profound drowsiness and severe difficulty breathing, which can sometimes lead to death;
• protease inhibitors (other medicines used against HIV infection), such as ritonavir, because these medicines may increase the effects of Songar.

Inform your doctor if you are taking any of the following medicines together with Songar, as caution is required:

• other antifungal medicines. Their concomitant use with Songar is not recommended;
• cimetidine (a medicine to reduce stomach acidity);
• antibiotics such as erythromycin, clarithromycin, and troleandomycin. Your doctor may advise reducing your dose of Songar;
• isoniazid (an antibiotic);
• fluvoxamine, sertraline, and paroxetine (medicines for depression);
• diltiazem and verapamil (medicines for high blood pressure);
• oral contraceptives, imatinib (a medicine for certain types of cancer), and aprepitant (a medicine for nausea and vomiting). These medicines may increase the effects of Songar. Therefore, your doctor may advise reducing your dose of Songar;
• medicines that strongly reduce all brain functions, such as:
  • medicines for certain mental illnesses (antipsychotics)
  • sedatives and sleep-inducing medicines (hypnotics, sedatives)
  • medicines for anxiety (anxiolytics)
  • medicines for depression (antidepressants)
  • medicines for severe acute or chronic pain (narcotic analgesics)
  • medicines for epileptic seizures (antiepileptics)
  • anesthetics
  • medicines for allergic reactions (sedating antihistamines).

Taking Songar together with these medicines may cause excessive reduction of all mental functions.
Additionally, Songar taken together with narcotic analgesics may cause euphoria, increasing the risk of developing psychological dependence.
The concomitant use of Songar and opioids (strong 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 Songar 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 prescribed dose.
It may be helpful to inform friends and family to watch for signs and symptoms such as those listed above.
If these symptoms occur, contact your doctor.

• rifampicin (an antibiotic) and carbamazepine (an antiepileptic medicine used for seizures), as they may reduce the effect of Songar.

Songar with beverages and alcohol
Do not drink alcohol while taking Songar, as alcohol increases the effects of the medicine.
Do not drink grapefruit juice while taking Songar, as it may increase the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Songar during pregnancy.
Breastfeeding
Do not breastfeed while taking Songar, as this medicine may pass into breast milk. Consult your doctor if you have any doubts.
Driving and use of machinery
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Songar. Songar may also cause a condition called “sleep-driving”, meaning you may drive without being fully aware and without remembering having done so.
Your alertness may be impaired especially if you have not slept long enough after taking Songar.
Songar 0.375 mg/ml oral drops contains alcohol and propylene glycol
This medicine contains 113 mg of alcohol (ethanol) per 20-drop dose. 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 20-drop dose, equivalent to 6.66 mg/kg/day in an adult (70 kg).
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 20-drop dose (0.25 mg), i.e., essentially “sodium-free”.
Songar 0.25 mg hard capsules and sodium
Songar 0.25 mg hard capsules contain less than 1 mmol (23 mg) of sodium per 0.25 mg dose (1 capsule), i.e., essentially “sodium-free”.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may result in positive anti-doping tests according to the blood alcohol concentration limits set by certain sports federations.

3. How to take Songar

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult 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 (equivalent to 0.125 mg – 0.25 mg)

Take Songar once daily just before going to bed. Your doctor will advise you on the lowest possible dose.
It is recommended not to exceed the maximum daily dose.

Instructions for use
Use of capsules
To administer 0.125 mg, open the hard capsule by gently twisting one end and take one of the two tablets contained inside.
Store the remaining tablet in the closed capsule and swallow it, including the shell, the next time.

Use of the dropper 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 have 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 (equivalent to 0.125 mg), taken once daily just before going to bed.

Duration of treatment
Your doctor will advise you on the shortest possible treatment duration. The average treatment duration is 7–10 days. The recommended maximum treatment duration should not exceed 4 weeks. This period includes the time needed to gradually reduce the dose of Songar before stopping.
Your doctor will decide, based on your condition, whether you may 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 is no life-threatening risk if you accidentally take a higher dose than prescribed, unless you also consume alcohol or other medicines at the same time.

Symptoms
Symptoms may include:

• motor coordination disturbances;
• slurred speech;
• drowsiness;
• loss of ability to coordinate movements;
• reduced muscle tone;
• low blood pressure;
• reduced breathing;
• coma;
• death.

More severe, although 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 reduce consciousness and major brain functions.

Treatment
Contact your doctor immediately or go to the nearest emergency department if you take more Songar than prescribed. If you are conscious, vomiting will be induced within one hour of taking the medicine; if you are unconscious, gastric lavage will be performed.
If these measures are not sufficient, activated charcoal may be administered 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 ensure you can rest immediately afterwards for a sufficient length of time. Do not take a double dose to make up for a 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, or throat (see section 2 “Warnings and precautions”). Doses must be gradually reduced. Your doctor will advise you on how to discontinue 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
STOP taking this medicine immediately and contact your doctor if you experience any of the following side effects, as they are serious (see section 2 “Warnings and precautions”):

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue, and throat leading to difficulty swallowing and breathing

Contact your doctor immediately if you experience any of the following side effects, as treatment with Songar must be discontinued:

• effects opposite to those expected (paradoxical effects) (see section 2, Paradoxical reactions), such as:
  • aggression
  • hallucinations
  • restlessness
  • agitation
  • irritability
  • delirium
  • anger
  • nightmares
  • impaired ability to normally assess reality
  • behavioural disturbances

Contact your doctor immediately if you experience any of the following side effects, as they may be serious:

• physical dependence on the medicine (see section Development of dependence)
• psychological 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 behavioural disorders, such as “drowsiness while driving”
• difficulty remembering events after taking the medicine (anterograde amnesia). This may also be accompanied by behavioural 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 ability to coordinate movements

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 (frequency cannot be estimated from the available data):

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

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.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 stated on the carton and blister pack after "Expiry". The expiry date refers to the last day of that month.
Store below 25°C.
Drops
Usable for: 30 days after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Songar contains
The active substance is triazolam.
Capsules
One Songar 0.25 mg hard capsule contains 0.25 mg of triazolam (in two tablets of
0.125 mg triazolam each).
The other components are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, talc,
silica, magnesium stearate, indigo carmine lake (E 132), sodium starch glycolate type A, gelatin.
Oral drops
1 ml of Songar oral drops solution (equivalent to 30 drops) contains 0.375 mg of triazolam.
The other components 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 tablets.
The hard capsules are available in opaque blisters packed in packs of 10 or 20 hard capsules.
Songar oral drops solution is a clear solution. The oral drops are supplied in a 19 ml polyethylene bottle with dropper and child-resistant cap.
It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan
Manufacturer
SONGAR 0.25 mg hard capsules
ICE S.p.A.
Via Cantone Moretti 29
Località San Bernardo
10015 Ivrea (Turin)
SONGAR 0.375 mg/ml oral drops, solution
VAMFARMA S.r.l.
Via Kennedy, 5
26833 Comazzo (Lodi)

Package leaflet: information for the user

SONGAR 0.125 mg hard capsules

Triazolam
Equivalent medicine
Please 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Songar is and what it is 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 emotional reactions (sedative effect), and by facilitating sleep (hypnotic effect). Songar also produces muscle relaxation and helps control seizures.
Songar is used for the short-term treatment of insomnia (difficulty falling asleep or sleeping properly) when the condition is severe and causes distress in normal daily life.

2. What you should know before taking Songar

Do not take Songar:

• if you are allergic to triazolam or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a disease causing severe muscle weakness and easy fatigue (myasthenia gravis);
• if you have serious breathing problems (severe respiratory insufficiency);
• if you experience episodes of breathing interruption lasting several seconds during sleep (sleep apnea);
• if you have severe liver problems (severe hepatic insufficiency);
• if you are taking ketoconazole or itraconazole (medicines for fungal infections), nefazodone (a medicine for depression), efavirenz or other medicines used against HIV infection (see section “Other medicines and Songar”);
• in children and adolescents under 18 years of age;
• during 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”.
Talk to your doctor or pharmacist before taking Songar if you think any of the following conditions apply to you (also see section 4 “Possible side effects”):

• you have mild or moderate liver problems (mild or moderate hepatic insufficiency);
• you have breathing difficulties, as this medicine may reduce your natural ability to breathe or may cause temporary interruption of breathing (apnea);
• you have or have had problems with alcohol or drug abuse and dependence, because Songar may also cause dependence (see section “Development of dependence”);
• you are taking other medicines that cause drowsiness or reduce mental functions (see section “Other medicines and Songar”);
• you suffer or have ever suffered from depression, as Songar may worsen your condition and increase suicidal tendencies.

Talk to your doctor or pharmacist if the following conditions occur during treatment with Songar (also see section 4 “Possible side effects”):

• severe and rapidly occurring allergic reactions (anaphylactic reactions) or swelling of the face, tongue, and throat with difficulty swallowing and breathing (angioedema). These reactions may sometimes be fatal. Immediately stop taking this medicine and go to the nearest emergency room. You must never again take medicines containing triazolam, and your doctor will advise alternative medicines for continuing your treatment;
• sleep-related behavioral disorders, such as “driving while not fully awake” (see section “Driving and use of machines”). These disorders are more likely to occur if you take Songar together with alcohol or other medicines that reduce mental functions, or if you take Songar at doses higher than recommended. If you experience these side effects, inform your doctor, who will likely advise you to discontinue treatment with this medicine.

Memory disturbances
After taking Songar, you may have difficulty remembering events that occurred after taking the medicine. Therefore, it is advisable that you are able to sleep for 7–8 hours after taking this medicine.
Paradoxical reactions
Songar may cause mental reactions and effects opposite to those expected (paradoxical effects), such as restlessness, agitation, irritability, aggression, delirium, rage, nightmares, hallucinations, psychosis, and behavioral changes (see section 4 “Possible side effects”). These effects are more common in children and elderly people.
If you experience these effects, consult your doctor, who will advise you on the proper way to discontinue this medicine.
Development of tolerance
After repeated use of this medicine for several weeks, its effectiveness may decrease (tolerance). Songar is recommended for short-term treatment only.
Development of dependence
The use of benzodiazepines, including Songar, may lead to dependence, which may manifest as an increasing need, desire, or excessive urge to take the medicine (psychological dependence), or the development of physical symptoms that diminish or disappear only after taking the medicine (physical dependence). The likelihood of developing psychological and physical dependence on this medicine increases with higher doses and longer treatment duration.
You are more likely to develop dependence on Songar if:

• you have previously or currently used drugs;
• you have previously or currently consumed alcohol frequently and/or in large quantities.
  If treatment with Songar is abruptly stopped after dependence has developed, you may experience withdrawal symptoms such as:
  • severe symptoms: muscle cramps and abdominal cramps, vomiting, sweating, tremors, feelings of detachment or estrangement from oneself or the external world, increased sensitivity to sound, numbness and tingling in the arms or legs, light sensitivity, hypersensitivity to noise and physical contact, hallucinations, epileptic seizures;
  • other symptoms: headache, muscle pain, extreme anxiety, emotional tension, restlessness, confusion, irritability;
  • rebound insomnia. If treatment is abruptly stopped, you may temporarily develop insomnia that is worse than the one you had before starting treatment with this medicine. Additionally, you may experience mood changes, restlessness, anxiety, and sleep disturbances.

Do not stop taking Songar suddenly. Talk to your doctor or pharmacist, who will advise you on the proper way to discontinue treatment with this medicine. See section 3 “If you stop taking Songar”.
If you are elderly and/or have specific health conditions
If you are elderly and/or your general health condition is very weak, you are more sensitive to the effects of Songar. In such cases, your doctor may advise reducing the dose of this medicine to avoid excessive sedation, dizziness, and reduced coordination (see section 3 “How to take Songar”).
Children and adolescents
Do not give Songar to children or adolescents under 18 years of age.
Other medicines and Songar
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking any of the following medicines, as they must not be taken together with Songar:

• ketoconazole, itraconazolo (medicines for fungal infections);
• nefazodone (a medicine for depression);
• efavirenz (a medicine used to treat HIV infection). Taking Songar together with efavirenz may cause profound drowsiness and severe difficulty breathing, which may sometimes lead to death;
• protease inhibitors (other medicines used against HIV infection), such as ritonavir, because these medicines may increase the effects of Songar.

Inform your doctor if you are taking any of the following medicines together with Songar, as caution is required:

• other medicines for fungal infections. Their concomitant use with Songar is not recommended;
• cimetidine (a medicine to reduce stomach acidity);
• antibiotics such as erythromycin, clarithromycin, and troleandomycin. Your doctor may advise reducing your dose of Songar;
• isoniazid (an antibiotic);
• fluvoxamine, sertraline, and paroxetine (medicines for depression);
• diltiazem and verapamil (medicines for high blood pressure);
• oral contraceptives, imatinib (a medicine for certain types of cancer), and aprepitant (a medicine for nausea and vomiting). These medicines may increase the effects of Songar. Therefore, your doctor may advise reducing your dose of Songar;
• medicines that strongly reduce all brain functions, such as:
  • medicines for certain mental illnesses (antipsychotics)
  • sedatives and sleep-inducing medicines (hypnotics, sedatives)
  • medicines for anxiety (anxiolytics)
  • medicines for depression (antidepressants)
  • medicines for severe acute or chronic pain (narcotic analgesics)
  • medicines for epileptic seizures (antiepileptics)
  • anesthetics
  • medicines to counteract allergic reactions (sedative antihistamines).
    Taking Songar together with these medicines may cause excessive reduction of all mental functions. Additionally, Songar taken together with narcotic analgesics may cause euphoria, increasing the risk of developing psychological dependence.

The combination of Songar and opioids (strong analgesics, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when no alternative treatment options are available.
However, if your doctor prescribes Songar 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 members to watch for signs and symptoms such as those listed above.
If you experience any of these symptoms, contact your doctor.

• rifampicin (an antibiotic) and carbamazepine (an antiepileptic medicine used for seizures), as they may reduce the effect of Songar.

Songar with food and alcohol
Do not drink alcohol while taking Songar, as alcohol increases the effects of the medicine.
Do not drink grapefruit juice while taking Songar, as it may increase the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not use Songar during pregnancy.
Breastfeeding
Do not breastfeed while taking Songar, as this medicine may pass into breast milk. Consult your doctor if you have any doubts.
Driving and use of machines
Do not drive or operate machinery if you experience drowsiness or dizziness during treatment with Songar. Songar may also cause a disorder called “driving while not fully awake,” meaning you may drive without being fully aware and may not remember having done so.
Your alertness may be particularly impaired if you have not slept long enough after taking Songar.

3. How to take Songar

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
Capsules
The recommended dose is 1 capsule containing 0.125 mg – 2 capsules containing 0.25 mg.
Take Songar once daily just before going to bed. Your doctor will advise you on the lowest effective dose.
It is recommended not to exceed the maximum daily dose.
Instructions for use
Use of capsules
For administration of 0.0625 mg, open the hard capsule by gently twisting one end and take one of the two tablets contained inside.
Keep the other tablet in the re-closed capsule and swallow it, including the shell, the next time.
If you are elderly and/or have liver or kidney problems
The recommended dose is 1 capsule containing 0.125 mg to be taken once daily just before
going to bed.
Duration of treatment
Your doctor will recommend the shortest possible duration of treatment. The average duration of treatment is 7–10 days. The maximum recommended duration of therapy should not exceed 4 weeks. This period includes also the time needed to gradually reduce the dose of Songar before stopping.
Your 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. In general, there is no life-threatening risk if you accidentally take a higher dose than prescribed, unless you also consume alcohol or other medicines at the same time.
Symptoms
Symptoms may include:

• impaired motor coordination;
• slurred speech;
• drowsiness;
• loss of ability to coordinate movements;
• reduced muscle tone;
• low blood pressure;
• slowed breathing;
• coma;
• death.

The most severe, rare cases may occur when large amounts 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
Contact your doctor immediately or go to the nearest emergency department if you take more Songar than prescribed. If you are conscious, vomiting will be induced within one hour after taking the medicine; if you are unconscious, gastric lavage will be performed. If these procedures are not sufficient, activated charcoal may be administered to reduce 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 for a sufficiently long period. Do not take a double dose to make up for a 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, or throat (see section 2 “Warnings and precautions”). Doses should be gradually reduced. Your doctor will advise you on how to discontinue 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 questions 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 everybody gets them.
STOP taking this medicine immediately and contact your doctor
if you experience any of the following side effects, as they are serious (see section 2
"Warnings and precautions"):

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat, leading to difficulty swallowing and breathing

Contact your doctor immediately if you experience any of the following side effects, as
treatment with Songar must be discontinued:

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

Contact your doctor immediately if you experience any of the following side effects, as
they may be serious:

• physical dependence on the medicine (see section Development of dependence)
• psychological 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 behavioural disturbances, such as "drowsiness while driving"
• difficulty remembering events occurring after taking the medicine (anterograde amnesia). This may also be accompanied by behavioural changes (see section 2 Memory disturbances)
• 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 ability to coordinate movements

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 (frequency cannot be estimated from the available data):

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

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.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 stated on the carton and blister after "Expiry". The expiry date refers to the last day of that month.
Store below 25°C.
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 Songar contains
The active substance is triazolam.
Capsules
One Songar hard capsule of 0.125 mg contains 0.125 mg of triazolam (in two tablets of 0.0625 mg triazolam each).
The other components are: microcrystalline cellulose, dibasic calcium phosphate, talc, precipitated silica, magnesium stearate, erythrosine colour E127, sodium carboxymethyl starch, and gelatin.

Description of the appearance of Songar and contents of the pack
The Songar hard capsules 0.125 mg are transparent hard capsules containing two 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 Milan

Manufacturer
Valeas SpA - Chemical and Pharmaceutical Industry
Via Vallisneri, 10
20133 Milan