Package leaflet: Information for the patient

TIENOR 10 mg/ml oral drops solution

Clotiazepam
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, 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What TIENOR is and what it is used for
What you need to know before taking TIENOR
How to take TIENOR
Possible side effects
How to store TIENOR
Contents of the pack and other information

1. What TIENOR is and what it is used for

TIENOR contains the active substance clotiazepam, which belongs to a group of medicines called benzodiazepines.
TIENOR is used for the treatment of:

Anxiety, tension and related disorders;
Insomnia.

Clotiazepam is indicated only when the condition is severe, disabling or causes severe distress.

2. What you should know before taking TIENOR

Do not take TIENOR

if you are allergic to clotiazepam or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from severe myasthenia gravis, a condition in which muscles are very weak
if you have severe respiratory difficulties
if you have severe liver problems
if you have a sleep disorder caused by partial or complete blockage of the airways during sleep (sleep apnoea syndrome)
if you have a condition of the eye called narrow-angle glaucoma, characterized by high pressure inside the eye.

Do not give TIENOR to children under 6 years of age.

The symptoms listed above may be worsened by the so-called anticholinergic effect, i.e. the inhibitory effect on a substance called acetylcholine, produced by the body, which is responsible for transmitting nerve impulses in the nervous system.

Warnings and precautions

Talk to your doctor or pharmacist before taking TIENOR.

Be especially careful:

if you have been using TIENOR for several weeks, as repeated use may lead to a certain loss of effectiveness of the hypnotic effects of benzodiazepines;
if you have a history of alcohol or drug abuse, as the use of this class of medicines may lead to dependence, and the risk of this occurring is higher if you have previously abused drugs or alcohol. If this happens, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms: loss of sense of reality (derealization), feeling detached from one's body (depersonalization), hypersensitivity to sounds (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures;
if you suffer from insomnia and rebound anxiety. Rebound effect refers to the return of symptoms for which you are taking this medicine, and may occur when treatment is stopped. These symptoms may reappear in a worsened form and may be accompanied by other reactions such as mood changes, anxiety, restlessness or sleep disturbances. Since the risk of such withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you must gradually reduce the dosage;
if you experience intolerance, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, psychosis, behavioural changes or other unwanted behavioural effects. If this occurs, stop using the medicine. These reactions are more frequent in children and elderly patients;
if you suffer from epilepsy: in this case, treatment should be started cautiously;
if you are an elderly patient, if you have cerebral disorders, or if you have respiratory insufficiency: in these cases, you should take a reduced dose;
if you are an elderly patient, if you are over 65 years old, talk to your doctor or pharmacist before taking TIENOR. This is because elderly patients are more sensitive to adverse reactions such as drowsiness, dizziness and muscle weakness. There is also an increased risk of falls, which can cause serious injuries;
if you suffer from renal insufficiency: if you have severe renal insufficiency, you should take a reduced dose;
if you suffer from hepatic insufficiency: benzodiazepines are not recommended in patients with severe liver impairment, as they may precipitate hepatic encephalopathy. In cases of moderate or mild liver impairment, the dose of clotiazepam should be reduced. If liver disorders occur, appropriate measures should be taken, such as discontinuation of treatment, monitoring of blood tests, and particularly liver function tests;
if you suffer from cardiac insufficiency: use this medicine with caution.

You may experience amnesia (total or partial memory loss) during treatment with TIENOR. To avoid this, it is important that you have an uninterrupted sleep of 7–8 hours (see section 4 “Possible side effects”).

If you abuse alcohol or drugs, you should be particularly cautious when using this medicine.

Children and adolescents

TIENOR may be administered to children only after careful evaluation by your doctor regarding the actual need for treatment. The duration of treatment should be as short as possible.

Do not administer TIENOR to children under 6 years of age. The use of benzodiazepines—the class to which this medicine belongs—in children under 6 years of age is reserved for rare and specific indications, decided and monitored by a specialist (neuropaediatrician, psychiatrist). Children are highly sensitive to the effects of benzodiazepines on the central nervous system. In addition, children may not fully metabolize this medicine.

Other medicines and TIENOR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking:

Opioids (strong painkillers, medicines for substitution therapy and some cough medicines). Concomitant use increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes TIENOR with opioids, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about which opioids you are taking and strictly follow the recommended dose. It may be helpful to inform friends or family members so they are aware of the symptoms listed above. If you experience these symptoms, contact your doctor.
Narcotic analgesics. If you are taking these medicines, you may experience increased euphoria, leading to an increased risk of psychological dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450), as they may alter the activity of benzodiazepines.
Theophylline, a medicine used to treat asthma and lung problems. This may affect the efficacy of TIENOR.
Antipsychotics, tranquilizers, antidepressants, hypnotics, anxiolytics/sedatives, narcotic analgesics, antiepileptics, anaesthetics and sedative antihistamines. If you are taking these medicines, TIENOR may enhance their sedative effect.

TIENOR and alcohol

Avoid drinking alcoholic beverages while taking TIENOR, as alcohol may increase the sedative effect of TIENOR.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You should avoid taking TIENOR during the first trimester of pregnancy. After this period, you may take the medicine only with caution and only if the expected benefits outweigh the risks.

If you are a woman of childbearing age, contact your doctor regarding discontinuation of the medicine, both if you plan to become pregnant and if you suspect you are pregnant.

If, for serious medical reasons, you need to take high doses of clotiazepam at the end of pregnancy or during labour, effects on the newborn may occur, such as hypothermia (lowered body temperature), hypotonia (reduced muscle tone) and moderate breathing difficulties. In addition, if you have taken benzodiazepines during the later stages of pregnancy, your newborn may develop physical dependence and may experience withdrawal symptoms in the postnatal period.

Breastfeeding

Benzodiazepines pass into breast milk. You should not take this medicine if you are breastfeeding.

Driving and using machines

TIENOR may cause sedation, amnesia, altered concentration and impaired muscle function, which may negatively affect your ability to drive or operate machinery. If your sleep duration has been insufficient, the likelihood of impaired alertness may be increased.

Do not drive or operate machinery if you are affected by these symptoms.

TIENOR oral drops contain ethanol.

This medicine contains 27.5% vol ethanol (alcohol), equivalent to 22 g of ethanol in 100 ml of product.

Each dose (15 drops) contains 132 mg of ethanol, equivalent to 3.3 ml of beer and 1.32 ml of wine per dose.

The amount of alcohol in this medicine does not appear to have an effect in adults and adolescents, and its effects in children are not evident. However, some effects may occur in young children, for example drowsiness.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.

If you are alcohol-dependent, talk to your doctor before taking this medicine.

TIENOR oral drops contain sodium (sodium saccharin)

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take TIENOR

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 12–15 drops, 1 to 3 times daily.
Children from 6 years of age:
The recommended dose is 0.2–0.6 mg/kg/day, i.e. 5 to 15 drops per day, divided into 2–3 doses (5 drops = 2 mg of clotiazepam).
The drops make water slightly opalescent.
The dose should always be individually adjusted for each patient according to medical advice.
Elderly
If you are elderly, your dosage must be carefully determined by your doctor, who will consider whether a reduction of the doses indicated above is necessary.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be exceeded.
Severe hepatic impairment, impaired renal function, or presence of debilitating organic diseases
If you have severe hepatic impairment, impaired renal function, or debilitating organic diseases, your doctor will adjust your dose accordingly.
Anxiety, tension, and other somatic or psychiatric manifestations associated with anxiety syndrome
You should be regularly reassessed, and the need for continued treatment should be carefully evaluated, particularly if you are asymptomatic.
The total duration of treatment should generally not exceed 8–12 weeks, including a gradual withdrawal period. In certain cases, extension beyond this maximum treatment period may be necessary; however, this should not occur without re-evaluation of your condition by the doctor.
Insomnia
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four weeks. In certain cases, extension beyond this maximum treatment period may be necessary; if so, this must not occur without re-evaluation of your condition by the doctor.
If you take more TIENOR than you should
If you or someone else has taken more drops of TIENOR than prescribed, contact your doctor or go to the nearest hospital immediately.
Symptoms of overdose vary depending on the amount taken and whether other central nervous system depressants (including alcohol) have been taken concomitantly. Mild symptoms include dysarthria, urinary retention, tremor, mental clouding, confusion, lethargy, and dizziness. In more severe cases, loss of muscle coordination (ataxia), decreased muscle tone (hypotonia), drop in blood pressure (hypotension), respiratory difficulty, rarely coma, and very rarely death may occur.
If you are conscious, induce vomiting within one hour of ingestion. If unconscious, gastric lavage with airway protection and/or administration of activated charcoal will be performed to reduce gastric absorption (if no improvement is observed with stomach emptying).
The antidote for this medicine is flumazenil, which is indicated in cases of severe intoxication with coma and/or respiratory failure, and will be administered by qualified healthcare personnel.
If you forget to take TIENOR
Do not take a double dose to make up for the missed dose.
If you stop taking TIENOR
Do not stop treatment with TIENOR without consulting your doctor. Treatment should be gradually reduced.
If you stop treatment abruptly, you may experience withdrawal symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
In severe cases, the following symptoms may occur: loss of sense of reality (derealization), feeling detached from one's body (depersonalization), hypersensitivity to sound (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise, and physical touch, hallucinations, or epileptic seizures.
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 gets them.
The frequency of side effects with benzodiazepines increases with age and depends on both the dose and duration of treatment.
If you experience any of the side effects listed below, stop taking TIENOR and contact your doctor.

Anaphylactic reactions (very rare frequency)
Allergic skin reactions, erythema, urticaria
Restlessness
Irritability
Aggressiveness
Delirium
Nightmares
Hallucinations
Psychosis
Behavioural changes. These reactions may be quite severe and are more likely in children and elderly patients.

More frequent side effects at the beginning of treatment

Headache, drowsiness and drowsiness upon waking (when the medicine is taken late in the evening), confusion, lethargy (a state of deep pathological sleep), loss of muscle coordination (ataxia)
Dizziness
Dry mouth (xerostomia)
Joint pain (arthralgia)
Emotional numbness
Fatigue.

Other possible side effects

Decrease in white blood cells in the blood (leucopenia)
Confusion in elderly patients, memory disturbances, behavioural changes and paranoid symptoms
Double vision (diplopia) and visual disturbances
Drop in blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
Respiratory depression in patients with chronic respiratory insufficiency, edema
Nausea, vomiting, increased appetite, constipation
Alterations in liver function, visible as yellowish discoloration of the skin and mucous membranes (jaundice) and increased transaminase levels (see section "Warnings and precautions")
Decreased muscle tone, fatigue, malaise, weakness, myalgia
Changes in sexual desire, menstrual disorders and ovulation disturbances, enlargement of male breast tissue (gynaecomastia)
Tinnitus
Amnesia: Anterograde amnesia may occur, i.e. impairment of long-term memory. To reduce the risk of this side effect, ensure an uninterrupted sleep of 7–8 hours. The risk increases with higher doses. Amnesic effects may be associated with behavioural changes
Depression: During treatment with benzodiazepines, an underlying depressive state may be unmasked
Dependence: The use of benzodiazepines, even at therapeutic doses, may lead to physical dependence; stopping treatment may result in a more pronounced rebound of symptoms or withdrawal symptoms. Psychological dependence may also occur
Sedation: This may occasionally occur on an individual and unpredictable basis. This effect is, however, uncommon and generally transient. If necessary, a dose reduction may be considered.

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: 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 TIENOR

Keep this medicine out of the sight and reach of children.
This medicine must be used within 6 months after first opening the bottle.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Store below 25°C.
The bottle is sealed with a child-resistant safety cap.
To open, press down and at the same time unscrew the safety cap.
To close again: press the safety cap down and at the same time screw it tightly back on.
Do not dispose of any medicine 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 TIENOR contains

The active substance is clotiazepam. 100 ml of solution contain 1.0 g of clotiazepam.
The other components are: sodium saccharin, cherry flavour, raspberry flavour, quinoline yellow E104, anhydrous alcohol, polyethylene glycol 400, purified water.

Description of the appearance of TIENOR and contents of the pack
Oral drops, solution – 20 ml bottle
Marketing Authorization Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milan
Italy
Manufacturer
Doppel Farmaceutici Srl
Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)
Italy
Farmaceutici Formenti S.p.A.
Via Giuseppe Di Vittorio, 2 – 21040 Origgio (VA)
Italy
Package leaflet: information for the patient

TIENOR 5 mg tablets

Clotiazepam
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 pass it on to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, please contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What TIENOR is and what it is used for
What you need to know before taking TIENOR
How to take TIENOR
Possible side effects
How to store TIENOR
Contents of the pack and other information

7. What TIENOR is and what it is used for

TIENOR contains the active substance clotiazepam, which belongs to a group of medicines called benzodiazepines.
TIENOR is used for the treatment of:

Anxiety, tension, and related disorders;
Insomnia.

Clotiazepam is indicated only when your condition is severe, disabling, or causing you severe distress.

8. What you should know before taking TIENOR

Do not take TIENOR

if you are allergic to clotiazepam or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from severe myasthenia gravis, a condition in which muscles are very weak
if you have severe respiratory difficulties
if you have severe liver problems
if you suffer from a sleep disorder caused by partial or complete blockage of the airways during sleep (sleep apnea syndrome)
if you have a condition of the eye called narrow-angle glaucoma, characterized by high pressure inside the eye.

Do not give TIENOR to children under 6 years of age.
The symptoms listed above may be worsened by the so-called anticholinergic effect, that is, the inhibitory
effect on a substance called acetylcholine, produced by our body and necessary for transmitting
nerve impulses in the nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking TIENOR.
Be especially careful:

if you have been using TIENOR for several weeks, as repeated use may lead to a certain loss of effectiveness of the hypnotic effects of benzodiazepines;
if you have a history of alcohol or drug abuse, as the use of this class of medicines may lead to dependence, and the risk of this occurring is higher if you have previously abused drugs or alcohol. If this happens, once dependence has developed, abruptly stopping treatment will be accompanied by withdrawal symptoms: loss of sense of reality (derealization), feeling detached from your body (depersonalization), hypersensitivity to sounds (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures;
if you suffer from insomnia and rebound anxiety. Rebound effect refers to the return of symptoms for which you are taking this medicine, and may occur when treatment is stopped. These symptoms may reappear in a worsened form and may be accompanied by other reactions such as mood changes, anxiety, restlessness or sleep disturbances. Since the risk of such withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you must gradually reduce the dosage;
if you experience intolerance, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, psychosis, behavioral changes or other undesirable behavioral effects. If this occurs, stop using the medicine. These reactions are more frequent in children and elderly patients;
if you suffer from epilepsy: in this case you must start treatment cautiously;
if you are an elderly patient, if you have cerebral disorders, or if you have respiratory insufficiency: in these cases, you must take a reduced dose;
if you are an elderly patient, if you are over 65 years old, consult your doctor or pharmacist before taking TIENOR. This is because elderly patients are more sensitive to adverse reactions such as drowsiness, dizziness and muscle weakness. There is also an increased risk of falls, which can cause serious injuries.
if you suffer from renal insufficiency: if you have severe renal insufficiency, you must take a reduced dose;
if you suffer from hepatic insufficiency: benzodiazepines are not recommended in patients with severe liver impairment as they may precipitate hepatic encephalopathy. In moderate or mild liver impairment, the dose of clotiazepam must be reduced. If liver disorders occur, appropriate measures must be taken, such as discontinuation of treatment, blood tests and particularly monitoring of liver function;
if you suffer from cardiac insufficiency: use this medicine with caution.

Children and adolescents
You may administer TIENOR to children only after careful evaluation by your doctor regarding the actual need for treatment. The treatment period should be as short as possible.
Do not administer TIENOR to children under 6 years of age. The use of benzodiazepines—the class to which this medicine belongs—in children under 6 years of age is reserved for rare and specific indications, decided and monitored by a specialist (neuropediatrician, psychiatrist). Children are highly sensitive to the effects of benzodiazepines on the central nervous system. Moreover, children may not fully metabolize this medicine.

Other medicines and TIENOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, tell your doctor if you are taking:

Opioids (strong painkillers, medicines for substitution therapy, and some cough medicines). Concomitant use increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes TIENOR with opioids, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about which opioids you are taking and strictly follow the recommended dose. It may be helpful to inform friends or relatives so they are aware of the symptoms listed above. If you experience these symptoms, contact your doctor.
Narcotic analgesics. If you are taking these medicines, you may experience increased euphoria, leading to increased psychological dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450), as they may alter the activity of benzodiazepines.
Theophylline, a medicine used to treat asthma and lung problems. It may affect the efficacy of TIENOR.
Antipsychotics, tranquilizers, antidepressants, hypnotics, anxiolytics/sedatives, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines. If you are taking these medicines, TIENOR may enhance their sedative effect.

TIENOR and alcohol
Avoid drinking alcoholic beverages while taking TIENOR, as alcohol may increase the sedative effect of TIENOR.

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
You should avoid taking TIENOR during the first trimester of pregnancy. After this period, you may take the medicine only with caution and only if the expected benefits outweigh the risks.
If you are a woman of childbearing age, contact your doctor regarding discontinuation of the medicine, both if you plan to become pregnant and if you suspect you are pregnant.
If, for serious medical reasons, you need to take high doses of clotiazepam at the end of pregnancy or during labor, effects on the newborn may occur, such as hypothermia (lowered body temperature), hypotonia (reduced muscle tone), and moderate breathing difficulties. In addition, if you have taken benzodiazepines during the late stages of pregnancy, your newborn may develop physical dependence and may experience withdrawal symptoms in the postnatal period.

Breastfeeding
Benzodiazepines pass into breast milk. You must not take this medicine if you are breastfeeding.

Driving and using machines
TIENOR may cause sedation, amnesia, impaired concentration and impaired muscle function, which may negatively affect your ability to drive and use machinery. If your sleep duration has been insufficient, the likelihood that your alertness is impaired may be increased.
Do not drive or operate machinery if you are affected by these effects.

TIENOR contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

TIENOR contains Sunset Yellow FCF (E110)
It may cause allergic reactions.

9. How to take TIENOR

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet 1 to 3 times daily.
However, the dosage must be individually tailored for each patient according to medical advice.
Elderly
If you are elderly, your doctor must carefully determine your dosage and may consider reducing the
doses indicated above.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be
exceeded.
Severe hepatic impairment, impaired renal function, or presence of debilitating organic diseases
If you have severe liver disease, impaired kidney function, or debilitating organic diseases, your doctor
will adjust your dose accordingly.
Anxiety, tension, and other somatic or psychiatric manifestations associated with anxiety syndrome
You should be regularly reassessed, and the need for continued treatment should be carefully evaluated,
particularly if you are asymptomatic.
The total duration of treatment should generally not exceed 8–12 weeks, including a gradual tapering
period. In certain cases, extension beyond the maximum treatment period may be necessary; however,
this should not occur without re-evaluation of your condition by the doctor.
Insomnia
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four
weeks. In certain cases, extension beyond the maximum treatment period may be necessary; if so, this
must not occur without re-evaluation of your condition by the doctor.
If you take more TIENOR than you should
If you or someone else has taken more TIENOR tablets than prescribed, contact your doctor or go to
the nearest hospital immediately.
Symptoms of overdose vary depending on the amount taken and possible concomitant intake of other
central nervous system depressants, including alcohol, and may include in mild cases: dysarthria,
urinary retention, tremor, mental clouding, confusion, lethargy, and dizziness. In more severe cases: loss
of muscle coordination (ataxia), decreased muscle tone (hypotonia), low blood pressure (hypotension),
respiratory difficulty, rarely coma, and very rarely death.
If you are conscious, induce vomiting within one hour of ingestion. If you are unconscious, gastric
lavage with airway protection and/or administration of activated charcoal will be performed to reduce
gastrointestinal absorption (if no improvement is observed after stomach emptying).
The antidote for this medicine is flumazenil, which is indicated in cases of severe intoxication with
coma and/or respiratory failure, and will be administered by qualified healthcare personnel.
If you forget to take TIENOR
Do not take a double dose to make up for the missed tablet.
If you stop taking TIENOR
Do not stop treatment with TIENOR without consulting your doctor. Treatment must be gradually
tapered off.
If you stop treatment abruptly, you may experience withdrawal symptoms such as headache, muscle
pains, extreme anxiety, tension, restlessness, confusion, and irritability.
In severe cases, the following symptoms may occur: loss of sense of reality (derealization), feeling
detached from one's body (depersonalization), hypersensitivity to sound (hyperacusis), numbness and
tingling in the extremities, hypersensitivity to light, noise, and physical touch, hallucinations, or
seizures.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The frequency of benzodiazepine-related side effects increases with age and depends on both the dose and duration of treatment.
If you experience any of the side effects listed below, stop taking TIENOR and contact your doctor immediately.

Anaphylactic reactions (very rare frequency)
Allergic skin reactions, erythema, urticaria
Restlessness
Irritability
Aggressiveness
Delirium
Nightmares
Hallucinations
Psychosis
Behavioral changes

These reactions can be quite severe and are more likely in children and elderly patients.

More frequent side effects at the beginning of treatment

Headache, drowsiness, and drowsiness upon waking (when the medicine is taken late in the evening), confusion, lethargy (a state of deep pathological sleep), loss of muscle coordination (ataxia)
Dizziness
Dry mouth (xerostomia)
Joint pain (arthralgia)
Emotional blunting
Fatigue

Other possible side effects

Decrease in white blood cells in the blood (leucopenia)
Confusion in elderly patients, memory disturbances, behavioral changes, and paranoid symptoms
Double vision (diplopia) and visual disturbances
Drop in blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
Respiratory depression in patients with chronic respiratory insufficiency, edema
Nausea, vomiting, increased appetite, constipation
Alterations in liver function, visible as yellowish discoloration of the skin and mucous membranes (jaundice), and increased transaminase levels (see section "Warnings and precautions")
Decreased muscle tone, fatigue, malaise, weakness, myalgia
Changes in sexual desire, menstrual disorders and ovulation disturbances, enlargement of male breast tissue (gynecomastia)
Tinnitus
Amnesia: anterograde amnesia may occur, i.e. impairment of long-term memory. To reduce the risk of this side effect, ensure an uninterrupted sleep of 7–8 hours. The risk increases with higher doses. Amnesic effects may be associated with behavioral changes
Depression: benzodiazepine use may unmask an underlying depressive state
Dependence: the use of benzodiazepines, even at therapeutic doses, may lead to physical dependence. Discontinuation of treatment may result in a more intense rebound of symptoms or withdrawal symptoms. Psychological dependence may also occur
Sedation: this may occasionally occur on an individual basis and is unpredictable. This effect is uncommon and generally transient. If necessary, dose reduction may be considered

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system: http://www.agenziafarmaco.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.

11. How to store TIENOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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.

12. Package contents and other information

What TIENOR contains

The active substance is clotiazepam. One tablet contains 5 mg of clotiazepam.
The other components are: lactose, maize starch, microcrystalline cellulose, povidone, magnesium stearate, quinoline yellow E104, sunset yellow FCF E110.

Description of the appearance of TIENOR and contents of the pack
40 tablets
Marketing Authorization Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milan
Italy
Manufacturer
Farmaceutici Formenti S.p.A.
Via Giuseppe di Vittorio 2
21040 Origgio (Varese)
Italy

Patient information leaflet

TIENOR 10 mg tablets

Clotiazepam
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What TIENOR is and what it is used for
What you need to know before taking TIENOR
How to take TIENOR
Possible side effects
How to store TIENOR
Contents of the pack and other information

13. What TIENOR is and what it is used for

TIENOR contains the active substance clotiazepam, which belongs to a group of medicines called benzodiazepines.
TIENOR is used for the treatment of:

Anxiety, tension, and related disorders;
Insomnia. Clotiazepam is indicated only when the condition is severe, disabling, or causing severe distress.

14. What you need to know before taking TIENOR

Do not take TIENOR

if you are allergic to clotiazepam or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from severe myasthenia gravis, a condition in which muscles are very weak
if you have severe breathing difficulties
if you have severe liver problems
if you suffer from a sleep disorder caused by partial or complete blockage of the airways during sleep (sleep apnea syndrome)
if you have a condition of the eye called narrow-angle glaucoma, characterized by high pressure inside the eye.

Do not give TIENOR to children under 6 years of age.
The symptoms listed above may be worsened by the so-called anticholinergic effect, i.e. the inhibitory
effect on a substance called acetylcholine, produced by our body and responsible for transmitting
nerve impulses in the nervous system.
Warnings and precautions
Talk to your doctor or pharmacist before taking TIENOR.
Be especially careful:

if you have been using TIENOR for several weeks, as repeated use may lead to a certain loss of effectiveness of the hypnotic effects of benzodiazepines;
if you have a history of alcohol or drug abuse, since the use of this class of medicines may lead to dependence, and the risk of this occurring is higher if you have previously abused drugs or alcohol. If this happens, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms: loss of sense of reality (derealization), feeling detached from one's body (depersonalization), hypersensitivity to sounds (hyperacusis), numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures;
if you suffer from insomnia and rebound anxiety. Rebound effect refers to the return of symptoms for which you are taking this medicine, and may occur when treatment is stopped. These symptoms may reappear in a worsened form and may be accompanied by other reactions such as mood changes, anxiety, restlessness or sleep disturbances. Since the risk of such withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you must gradually reduce the dosage;
if you experience intolerance, agitation, irritability, aggressiveness, delusions, anger, nightmares, hallucinations, psychosis, behavioral changes or other undesirable behavioral effects. If this occurs, discontinue use of the medicine. Such reactions are more frequent in children and elderly patients;
if you suffer from epilepsy: in this case, treatment should be started with caution;
if you are an elderly patient, if you have brain disorders, or if you have respiratory insufficiency: in these cases, you should take a reduced dose;
if you are an elderly patient, if you are over 65 years old, talk to your doctor or pharmacist before taking TIENOR. This is because elderly patients show increased sensitivity to adverse reactions such as drowsiness, dizziness and muscle weakness. There is also an increased risk of falls, which can cause serious injuries.
if you suffer from renal insufficiency: if you have severe renal insufficiency, you should take a reduced dose;
if you suffer from hepatic insufficiency: benzodiazepines are not indicated in patients with severe liver failure as they may precipitate encephalopathy. In cases of moderate or mild hepatic insufficiency, the dose of clotiazepam should be reduced. If liver disorders occur, appropriate measures should be taken, such as discontinuation of treatment, monitoring of blood tests and particularly liver function tests;
if you suffer from cardiac insufficiency: use this medicine with caution.

Please note that benzodiazepines are not recommended as first-line treatment for psychotic disorders and should not be used alone to treat depression or anxiety associated with depression, as suicidal thoughts may occur.
You may experience amnesia (total or partial memory loss) during treatment with TIENOR.
To avoid this, it is important that you have an uninterrupted sleep of 7-8 hours (see section 4 "Possible side effects").
If you abuse alcohol or drugs, you should pay particular attention when using this medicine.
Children and adolescents
You may administer TIENOR to children only after careful evaluation by your doctor regarding the actual need for treatment. The duration of treatment should be as short as possible.
Do not administer TIENOR to children under 6 years of age. The use of benzodiazepines, the class to which this medicine belongs, in children under 6 years of age is reserved for rare and specific indications, decided and monitored by a specialist (neuropediatrician, psychiatrist). Children are highly sensitive to the effects of benzodiazepines on the central nervous system. In addition, children may not fully metabolize this medicine.
Other medicines and TIENOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
In particular, tell your doctor if you are taking:

Opioids (strong painkillers, medicines for substitution therapy, and some cough medicines). Concomitant use increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes TIENOR with opioids, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about which opioids you are taking and strictly follow the recommended dose. It may be helpful to inform friends or family members so they are aware of the symptoms listed above. If you experience these symptoms, contact your doctor.
Narcotic analgesics. If you are taking these medicines, you may experience increased euphoria leading to increased psychological dependence.
Compounds that inhibit certain liver enzymes (especially cytochrome P450), as they may alter the activity of benzodiazepines.
Theophylline, a medicine used to treat asthma and lung problems. This may affect the effectiveness of TIENOR.
Antipsychotics, tranquilizers, antidepressants, hypnotics, anxiolytics/sedatives, narcotic analgesics, antiepileptics, anesthetics and sedative antihistamines. If you are taking these medicines, TIENOR may enhance their sedative effect.

TIENOR with alcohol
Avoid drinking alcoholic beverages while taking TIENOR, as alcohol may increase the sedative effect of TIENOR.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should avoid taking TIENOR during the first trimester of pregnancy. After this period, you may take the medicine only with caution and only if the expected benefits outweigh the risks.
If you are a woman of childbearing age, contact your doctor regarding discontinuation of the medicine, both if you plan to become pregnant and if you suspect you are pregnant.
If, for serious medical reasons, you need to take high doses of clotiazepam at the end of pregnancy or during labor, effects on the newborn may occur, such as hypothermia (lowered body temperature), hypotonia (reduced muscle tone), and moderate breathing difficulties. In addition, if you have taken benzodiazepines during the later stages of pregnancy, your newborn may develop physical dependence and may experience withdrawal symptoms in the postnatal period.
Breastfeeding
Benzodiazepines pass into breast milk. You must not take this medicine if you are breastfeeding.
Driving and using machines
TIENOR may cause sedation, amnesia, altered concentration and impaired muscle function, which may negatively affect your ability to drive and use machinery. If the duration of sleep has been insufficient, the likelihood that your alertness is impaired may be increased.
Do not drive or operate machinery if you are affected by these effects.
TIENOR contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

15. How to take TIENOR

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet taken 1 to 3 times daily.
The recommended dose for sleep induction is 1 or 2 tablets taken in the evening before bedtime.
However, the dose must always be individually adjusted for each patient according to medical advice.
Elderly
If you are elderly, your doctor must carefully determine the dosage and may consider reducing the
doses indicated above.
Treatment should be initiated with the lowest recommended dose. The maximum dose must not be
exceeded.
Severe hepatic impairment, impaired renal function, or presence of debilitating organic diseases
If you have severe liver disease, impaired kidney function, or debilitating organic diseases, your doctor
will adjust your dose accordingly.
Anxiety, tension, and other somatic or psychiatric manifestations associated with anxiety syndrome
You should be regularly reassessed, and the need for continued treatment should be carefully evaluated,
especially if you are asymptomatic.
The total duration of treatment should generally not exceed 8–12 weeks, including a gradual tapering
period. In certain cases, extension beyond the maximum treatment period may be necessary; however,
this must not occur without re-evaluation of your condition by the doctor.
Insomnia
The duration of treatment generally ranges from a few days to two weeks, up to a maximum of four
weeks. In certain cases, extension beyond the maximum treatment period may be necessary; if so, this
must not occur without re-evaluation of your condition by the doctor.
If you take more TIENOR than you should
If you or someone else has taken more TIENOR tablets than prescribed, contact your doctor or go to the
nearest hospital immediately.
Symptoms of overdose vary depending on the amount ingested and whether other central nervous
system depressants (including alcohol) have been taken concomitantly. Mild symptoms include:
dysarthria, urinary retention, tremor, mental clouding, confusion, lethargy, and dizziness. In more
severe cases: loss of muscle coordination (ataxia), decreased muscle tone (hypotonia), low blood
pressure (hypotension), respiratory difficulty, rarely coma, and very rarely death.
If you are conscious, induce vomiting within one hour of ingestion. If unconscious, gastric lavage will
be performed with airway protection and/or administration of activated charcoal to reduce gastric
absorption (if no improvement is observed with gastric emptying).
The antidote for this medicine is flumazenil, which is indicated in cases of severe poisoning with coma
and/or respiratory failure, and will be administered by qualified medical personnel.
If you forget to take TIENOR
Do not take a double dose to make up for the forgotten tablet.
If you stop taking TIENOR
Do not stop treatment with TIENOR without consulting your doctor. The treatment must be gradually
tapered off.
If you abruptly discontinue treatment, you may experience withdrawal symptoms such as headache,
muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
In severe cases, the following symptoms may occur: loss of sense of reality (derealization), feeling of
detachment from one's body (depersonalization), hypersensitivity to sound (hyperacusis), numbness
and tingling in the extremities, hypersensitivity to light, noise, and physical touch, hallucinations, or
seizures.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

16. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The frequency of benzodiazepine-related side effects increases with age and depends on both the dosage and duration of treatment.
If you experience any of the side effects listed below, stop taking TIENOR and contact your doctor immediately:

anaphylactic reactions (very rare)
allergic skin reactions, erythema, urticaria
restlessness
irritability
aggression
delirium
nightmares
hallucinations
psychosis
behavioural changes

These reactions can be quite serious and are more likely to occur in children and elderly patients.
More frequent side effects at the beginning of treatment

headache, drowsiness, and drowsiness upon waking (when the medicine is taken late in the evening), confusion, lethargy (a state of deep pathological sleep), loss of muscle coordination (ataxia)
dizziness
dry mouth (xerostomia)
joint pain (arthralgia)
emotional blunting
fatigue

Other possible side effects

decrease in white blood cells in the blood (leucopenia)
confusion in elderly patients, memory disturbances, behavioural changes, and paranoid symptoms
double vision (diplopia) and visual disturbances
drop in blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
respiratory depression in patients with chronic respiratory insufficiency, oedema
nausea, vomiting, increased appetite, constipation
liver function abnormalities, visible as yellowing of the skin and mucous membranes (jaundice) and increased transaminase levels (see section “Warnings and precautions”)
decreased muscle tone, fatigue, malaise, weakness, myalgia
changes in sexual desire, menstrual and ovulation disorders, enlargement of male breast tissue (gynaecomastia)
tinnitus
amnesia: anterograde amnesia may occur, i.e. impairment of long-term memory. To reduce the risk of this side effect, ensure an uninterrupted sleep of 7–8 hours. The risk increases at higher doses. Amnesic effects may be associated with behavioural changes
depression: during the use of benzodiazepines, an underlying depressive state may be unmasked
dependence: the use of benzodiazepines, even at therapeutic doses, may lead to the development of physical dependence; discontinuation of treatment may result in rebound symptoms or withdrawal symptoms. Psychological dependence may also occur
sedation: this may occasionally occur on an individual and unpredictable basis. This effect is, however, uncommon and generally transient. If necessary, a dose reduction may be considered.

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: http://www.agenziafarmaco.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.

17. How to store TIENOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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.

18. Package contents and other information

What TIENOR contains

The active substance is clotiazepam. One tablet contains 10.0 mg of clotiazepam.
The other components are: lactose, maize starch, microcrystalline cellulose, povidone, magnesium stearate, indigotine E132.

Description of the appearance of TIENOR and contents of the pack
30 tablets
Marketing Authorization Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milan
Italy
Manufacturer
Farmaceutici Formenti S.p.A.
Via Giuseppe di Vittorio 2
21040 Origgio (Varese)

Tienor

Package leaflet: Information for the patient

TIENOR 10 mg/ml oral drops solution

1. What TIENOR is and what it is used for

2. What you should know before taking TIENOR

3. How to take TIENOR

4. Possible side effects

5. How to store TIENOR

6. Package contents and other information

TIENOR 5 mg tablets

7. What TIENOR is and what it is used for

8. What you should know before taking TIENOR

9. How to take TIENOR

10. Possible side effects

11. How to store TIENOR

12. Package contents and other information

Patient information leaflet

TIENOR 10 mg tablets

13. What TIENOR is and what it is used for

14. What you need to know before taking TIENOR

15. How to take TIENOR

16. Possible side effects

17. How to store TIENOR

18. Package contents and other information