TIENOR 5 mg Таблетки

Содержание инструкции

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

TIENOR 10 mg/ml oral drops solution

Clotiazepam
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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is TIENOR and what is it used for

TIENOR contains the active ingredient 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 causes you significant
distress.

2. What you need to know before you take TIENOR

Do not take TIENOR

• if you are allergic to clotiazepam or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from myasthenia gravis, a condition in which the muscles are very weak
• if you suffer from severe breathing difficulties
• if you suffer from 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 suffer from a condition of the eye called narrow-angle glaucoma, characterized by high pressure inside the eye. Do not give TIENOR to children under the age of 6 years.

The above symptoms may be aggravated by the so-called anticholinergic effect, i.e. the inhibitory effect on a
substance, called acetylcholine, produced by our body which serves to transfer nerve impulses in the
nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking TIENOR.
Pay particular attention:

• if you have been taking TIENOR for several weeks, as repeated use may cause some 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 can lead to dependence and the risk of this happening is higher if you have previously abused drugs or alcohol. If this should occur, once dependence has developed, abrupt discontinuation of 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 of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures;
• if you suffer from insomnia and rebound anxiety. The rebound effect consists of the reappearance of the symptoms for which you are taking this medicine and may occur when it 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. Because the risk of these withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you should gradually reduce the dosage;
• if you experience intolerance, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, psychosis, behavioral changes and other undesirable behavioral effects. If this should happen, stop using the medicine. These reactions are more common in children and the elderly;
• if you suffer from epilepsy: in this case you should start treatment with caution;
• if you are an elderly patient, if you have brain disorders, or if you have respiratory failure: in these cases, you should take a reduced dose;
• if you are an elderly patient, if you are over 65 years of age, consult your doctor or pharmacist before taking TIENOR. This is because the elderly experience greater sensitivity to adverse reactions such as drowsiness, dizziness and muscle weakness. There is also an increased risk of falls which can cause serious injury.
• if you suffer from kidney failure: if you have severe kidney failure you should take a reduced dose;
• if you suffer from liver failure: benzodiazepines are not indicated in patients with severe liver failure as they may precipitate encephalopathy. In moderate or mild liver failure, 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 in particular liver function;
• if you suffer from heart failure: use this medicine with caution.

Keep in mind that benzodiazepines are not recommended as primary treatment for psychotic disorders and
should not be used alone to treat depression or anxiety associated with depression as you may experience
suicidal thoughts.
You may experience amnesia (total or partial memory loss) during treatment with TIENOR.
To avoid this, it is important that you have 7-8 hours of uninterrupted sleep (see section 4 “Possible
side effects”).
If you abuse alcohol or drugs, you should be particularly careful when using this medicine.

Children and adolescents
You can give TIENOR to children only after careful evaluation by your doctor of the actual need for
treatment. The duration of treatment should be as short as possible.
Do not give TIENOR to children under the age of 6 years. 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 very 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 medicines for cough). Concurrent use increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes 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 follow your doctor's recommended dose strictly. It may be helpful to inform friends or relatives so that 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 an increase in euphoria leading to an increase in psychological dependence.
• Compounds that inhibit certain liver enzymes (especially cytochrome P450) because they can alter the activity of benzodiazepines.
• Theophylline, a medicine used to treat asthma and lung problems. It may have an effect on 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 the sedative action.

TIENOR with alcohol
Avoid drinking alcoholic beverages while taking TIENOR because alcohol can increase the sedative effect
of TIENOR.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are 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 can 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 stopping the medicine, whether you
intend to become pregnant or suspect you are pregnant.
If, for serious medical reasons, you have to take high doses of clotiazepam at the end of pregnancy or during
labor, effects on the newborn such as hypothermia (lowering of body temperature), hypotonia (reduction of
muscle tone) and moderate difficulty breathing may occur. 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 can cause sedation, amnesia, impaired concentration and muscle function that can negatively
affect your ability to drive and operate 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 these effects affect you.
TIENOR oral drops contains ethanol.
This medicine contains 27.5% vol of 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 is unlikely to have an effect on adults and adolescents and its
effects in children are not evident. Some effects may occur in young children, for example feeling sleepy.
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 have an alcohol dependence, talk to your doctor before taking this medicine.

TIENOR oral drops contains 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 following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults
The recommended dose is 12-15 drops 1 to 3 times a day.

Children 6 years and older:
The recommended dose is 0.2-0.6 mg/kg/day, i.e. 5 to 15 drops per day divided into 2-3
administrations (5 drops = 2mg of clotiazepam).
The drops in water give a slight opalescence.
The dose must however be personalized for each patient according to medical advice.

Elderly
If you are elderly, the dosage must be carefully established by your doctor who will have to assess a
possible reduction of the dosages indicated above.
Treatment should be started with the lowest recommended dose. The maximum dose must not be
exceeded.

Severe liver disease or impaired renal function or presence of organic diseases
If you experience severe liver disease or impaired renal function or debilitating organic diseases, your
doctor will adjust your dose.

Anxiety, tension and other somatic or psychiatric manifestations associated with anxious syndrome
You must be regularly re-evaluated and the need for continued treatment must be carefully assessed,
particularly if you are symptom-free.
The overall duration of treatment should generally not exceed 8-12 weeks, including a period of
gradual discontinuation. In certain cases, extension beyond the maximum treatment period may be
necessary; in such cases, this should not occur without re-evaluation of your condition by the doctor.

Insomnia
The duration of treatment generally varies 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,
it should 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 you should, contact your doctor or go to the
nearest hospital.
The symptoms of overdose vary depending on the amount taken, and any concomitant intake
of other depressants of the Central Nervous System, including alcohol, and include in mild cases:
dysarthria, urinary retention, tremor, clouding of consciousness, mental confusion, lethargy and a feeling
of dizziness. In more severe cases, loss of muscle coordination (ataxia), decreased
muscle tone (hypotonia), decreased blood pressure (hypotension), difficulty breathing,
rarely coma and very rarely death.
If you are conscious, induce vomiting within one hour of taking the medication. If you are unconscious,
gastric lavage will be performed with protection of the airways and/or administration of activated charcoal
to reduce gastric absorption (if no improvement is observed with stomach emptying).
The antidote to this medicine is flumazenil, which is indicated in case of severe poisoning 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 a missed dose.

If you stop taking TIENOR
Do not stop treatment with TIENOR without consulting your doctor. Treatment must be
reduced gradually.
If you suddenly stop treatment, you will 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 sounds
(hyperacusis), numbness and tingling of the extremities, hypersensitivity to light, noise and
physical contact, hallucinations or seizures.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The frequency of side effects of benzodiazepines increases with age and depends on both the
dosage and the duration of treatment.
If you experience any of the side effects described below, stop taking TIENOR and
consult your doctor.

• anaphylactic reactions (very rare frequency)
• allergic skin reactions, erythema, urticaria
• restlessness
• irritability
• aggression
• delirium
• nightmares
• hallucinations
• psychosis
• behavioral changes. These reactions can be quite serious. They are more likely in children and the elderly.

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 (pathological deep sleep state), loss of muscle coordination (ataxia)
• dizziness
• dry mouth (xerostomia)
• joint pain (arthralgia)
• emotional numbness
• fatigue.

Other possible side effects

• decreased white blood cells in the blood (leukopenia)
• confusion in the elderly, memory disorders, behavioral changes and paranoid symptoms
• double vision (diplopia) and visual disturbances
• low blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
• respiratory depression in patients with chronic respiratory failure, edema
• nausea, vomiting, increased appetite, constipation
• alterations in liver function, visible with yellowish discoloration of the skin and mucous membranes (jaundice) and increased transaminase values (see paragraph “Warnings and precautions”)
• decreased muscle tone, fatigue, malaise, weakness, myalgia
• changes in sexual desire, menstrual disorders and ovulation disorders, increased breast volume in men (gynecomastia)
• tinnitus
• amnesia: anterograde amnesia, i.e. long-term memory impairment, may occur. To reduce the risk of this side effect, you should have 7-8 hours of uninterrupted sleep. The risk increases at higher doses. Amnestic effects may be associated with behavioral changes
• depression: a pre-existing depressive state may be unmasked during the use of benzodiazepines
• dependence: the use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause a resurgence of symptoms in a more pronounced manner or withdrawal. Psychological dependence can occur
• sedation: it may sometimes occur on an individual and unpredictable basis. This effect, however, is 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, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system
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 of first opening the bottle.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Store at a temperature below 25°C.
The bottle is sealed with a child-resistant cap.
To open, press and simultaneously unscrew the cap.
To close: press the cap and simultaneously screw it on tightly.
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 TIENOR contains

• The active ingredient is clotiazepam. 100 ml of solution contains 1.0 g of clotiazepam.
• The other ingredients 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 – bottle of 20 ml

Marketing Authorisation Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milano
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

TIENOR 5 mg tablets

Clotiazepam
Read this leaflet carefully before you start 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

• 7. What TIENOR is and what it is used for
• 8. What you need to know before you take TIENOR
• 9. How to take TIENOR
• 10. Possible side effects
• 11. How to store TIENOR
• 12. Contents of the pack and other information

7. What is TIENOR and what is it used for

TIENOR contains the active ingredient 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 causes you significant
distress.

8. What you need to know before you take TIENOR

Do not take TIENOR

• if you are allergic to clotiazepam or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from myasthenia gravis, a condition in which the muscles are very weak
• if you suffer from severe breathing difficulties
• if you suffer from 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 suffer from a condition of the eye called narrow-angle glaucoma, characterized by high pressure inside the eye.

Do not give TIENOR to children under the age of 6 years.
The symptoms listed above may be aggravated by the so-called anticholinergic effect, i.e. the inhibitory
effect on a substance, called acetylcholine, produced by our body which serves to transmit
nerve impulses in the nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking TIENOR.
Pay particular attention:

• if you are using TIENOR for several weeks, as repeated use may cause some 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 can lead to dependence and the risk of this happening is higher if you have previously abused drugs or alcohol. If this should occur, once dependence has developed, abrupt discontinuation of 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 of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures;
• if you suffer from insomnia and rebound anxiety. The rebound effect consists of the reappearance of the symptoms for which you are taking this medicine and may occur when it 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. Because the risk of these withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you should gradually reduce the dosage;
• if you experience intolerance, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes and other undesirable behavioral effects. If this should happen, stop using the medicine. These reactions are more common in children and the elderly;
• if you suffer from epilepsy: in this case you should start treatment with caution;
• if you are an elderly patient, if you have brain disorders, or if you have respiratory failure: in these cases, you should take a reduced dose;
• if you are an elderly patient, if you are over 65 years of age, consult your doctor or pharmacist beforetaking TIENOR. This is because the elderly are more sensitiveto adverse reactions such as drowsiness, dizziness and muscle weakness. There is also agreater risk offalls which can cause serious injury.
• if you suffer from kidney failure: if you have severe kidney failure you should take a reduced dose;
• if you suffer from liver failure: benzodiazepines are not indicated in patients with severe liver failure as they may precipitate encephalopathy. In mild or moderate liver failure it is necessary to reduce the dose of clotiazepam. In case of onset of liver disorders, appropriate measures should be taken such as discontinuation of treatment, monitoring of blood tests and in particular liver function;

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 medicines for cough). Concomitant use increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes 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 follow the doctor's recommended dose strictly. It may be helpful to inform friends or relatives so that 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 an increase in euphoria leading to an increase in psychological dependence.
• Compounds that inhibit certain liver enzymes (especially cytochrome P450) because they can alter the activity of benzodiazepines.
• Theophylline, a medicine used to treat asthma and lung problems. It may have an effect on 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 strengthen the sedative action.

TIENOR with alcohol
Avoid drinking alcoholic beverages while taking TIENOR because alcohol can increase the
sedative effect of TIENOR.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
You should avoid taking TIENOR during the first period of pregnancy. After this period,
you can only take the medicine with caution and only if the expected benefits outweigh the risks.
If you are a woman of childbearing potential, contact your doctor regarding discontinuation of the medicine,
whether you intend to start a pregnancy or suspect you are pregnant.
If, for serious medical reasons, you have to take high doses of clotiazepam at the end of pregnancy or during
labor, effects on the newborn such as hypothermia (lowering of body temperature), hypotonia (reduction of
muscle tone) and moderate difficulty in breathing may occur. In addition, if you have taken benzodiazepines
during the advanced stages of pregnancy, your newborn baby 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 can cause sedation, amnesia, impaired concentration and muscle function
which can negatively affect your ability to drive and operate machinery. If your sleep duration has been insufficient, the likelihood that your alertness is altered may be increased.

Do not drive or use machines if these effects affect you.
TIENOR contains lactose
If your doctor has diagnosed you with lactose intolerance, contact him before taking
this medicine.

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

9. How to take TIENOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet 1 to 3 times a day.
However, the dose should be personalized for each patient according to medical advice.

Elderly
If you are elderly, the dosage must be carefully established by your doctor, who will need to assess a
possible reduction of the dosages indicated above.
Treatment should be started with the lowest recommended dose. The maximum dose must not be
exceeded.

Severe hepatic impairment or altered renal function or presence of organic diseases
If you experience severe hepatic impairment or altered renal function or debilitating organic diseases, your
doctor will adjust your dose.

Anxiety, tension and other somatic or psychiatric manifestations associated with anxiety syndrome
You must be regularly re-evaluated and the need for continued treatment must be carefully assessed,
particularly if you are symptom-free.
The overall duration of treatment should generally not exceed 8-12 weeks, including a
period of gradual discontinuation. In certain cases, extension beyond the maximum treatment period may be necessary; in such cases, 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, it should 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 you should, contact your doctor or go to the
nearest hospital.
The symptoms of overdose vary depending on the amount taken and any concomitant intake
of other central nervous system depressants, including alcohol, and include in mild cases: dysarthria, urinary retention, tremor, clouding of consciousness, mental confusion, lethargy and a feeling
of dizziness. In more severe cases, loss of muscle coordination (ataxia), decreased
muscle tone (hypotonia), low blood pressure (hypotension), difficulty breathing,
rarely coma and very rarely death.
If you are conscious, induce vomiting within one hour of taking the medication. If you are 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 to this medicine is flumazenil, which is indicated in case of severe poisoning with
coma and/or respiratory failure and will be administered by competent healthcare personnel.

If you forget to take TIENOR
Do not take a double dose to make up for a missed tablet.

If you stop taking TIENOR
Do not stop taking TIENOR without consulting your doctor. Treatment must be
reduced gradually.
If you suddenly stop treatment, you will 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 sounds
(hyperacusis), numbness and tingling of the extremities, hypersensitivity to light, noise and
physical contact, hallucinations or seizures.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

10. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects of benzodiazepines increases with age and depends on both the
dosage and the duration of treatment.
If any of the side effects described below occur, stop taking TIENOR and
consult your doctor

• anaphylactic reactions (very rare frequency)
• allergic skin reactions, erythema, urticaria
• restlessness
• irritability
• aggression
• delirium
• nightmares
• hallucinations
• psychosis
• behavioral changes.

Such reactions can be quite serious. They are more likely in children and the elderly.

More common side effects at the beginning of treatment

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

Other possible side effects

• decreased white blood cells in the blood (leukopenia)
• confusion in the elderly, memory disorders, behavioral changes and paranoid symptoms
• double vision (diplopia) and visual disturbances
• low blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
• respiratory depression in patients with chronic respiratory failure, edema
• nausea, vomiting, increased appetite, constipation
• alterations in liver function, visible with a yellowish discoloration of the skin and mucous membranes (jaundice) and increased levels of transaminases (see paragraph “Warnings and precautions”)
• decreased muscle tone, fatigue, malaise, weakness, myalgia
• changes in sexual desire, menstrual disorders and ovulation, increased breast volume in males (gynecomastia)
• tinnitus
• amnesia: anterograde amnesia, i.e. long-term memory disorder, may occur. To reduce the risk of this side effect, you should have 7-8 hours of uninterrupted sleep. The risk increases at higher doses. Amnesic effects may be associated with behavioral changes
• depression: a pre-existing depressive state may be unmasked during the use of benzodiazepines
• dependence: the use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause a resurgence of symptoms in a more pronounced manner or withdrawal. Psychological dependence may occur
• sedation: may sometimes occur on an individual and unpredictable basis. This effect, however, is uncommon and generally transient. If necessary, a dose reduction may be considered.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system 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 which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in waste water 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 ingredient is clotiazepam. One tablet contains 5 mg of clotiazepam.
• The other ingredients are: lactose, corn starch, microcrystalline cellulose, povidone, magnesium stearate, quinoline yellow E104, sunset yellow FCF E110.

Description of the appearance of TIENOR and package contents
40 tablets

Marketing Authorisation Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milano
Italy

Manufacturer
Farmaceutici Formenti SPA
Via Giuseppe di Vittorio 2
21040 Origgio (Varese)

TIENOR 10 mg tablets

Clotiazepam
Read this leaflet carefully before you start 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 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

• 13. What TIENOR is and what it is used for
• 14. What you need to know before you take TIENOR
• 15. How to take TIENOR
• 16. Possible side effects
• 17. How to store TIENOR
• 18. Contents of the pack and other information

13. What is TIENOR and what is it used for

TIENOR contains the active ingredient 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 causes you significant distress.

14. What you need to know before you take TIENOR

Do not take TIENOR

• if you are allergic to clotiazepam or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from myasthenia gravis, a condition in which the muscles are very weak
• if you suffer from severe breathing difficulties
• if you suffer from 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 suffer from 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 above symptoms may be aggravated by the so-called anticholinergic effect, i.e. the inhibitory effect on a substance, called acetylcholine, produced by our body which serves to transfer
nerve impulses in the nervous system.

Warnings and precautions
Talk to your doctor or pharmacist before taking TIENOR.
Pay particular attention:

• if you have been taking TIENOR for several weeks, as repeated use may cause some loss of efficacy of the hypnotic effects of benzodiazepines;
• if you have a history of alcohol or drug abuse, as the use of this class of medicines can lead to dependence and the risk of this happening is higher if you have previously abused drugs or alcohol. If this should occur, once dependence has developed, abrupt discontinuation of 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 of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or seizures;
• if you suffer from insomnia and rebound anxiety. The rebound effect consists of the reappearance of the symptoms for which you are taking this medicine and can occur when it 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. Because the risk of these withdrawal or rebound symptoms is greater after abrupt discontinuation of treatment, you should gradually reduce the dosage;
• if you experience intolerance, agitation, irritability, aggression, disappointment, anger, nightmares, hallucinations, psychosis, behavioral changes and other undesirable behavioral effects. If this happens, stop using the medicine. These reactions are more common in children and the elderly;
• if you suffer from epilepsy: in this case you should start treatment with caution;
• if you are an elderly patient, if you have brain disorders, or if you have respiratory failure: in these cases, you should take a reduced dose;
• if you are an elderly patient, if you are over 65 years of age, consult your doctor or pharmacist beforetaking TIENOR. This is because the elderly are more sensitive toadverse reactions such as drowsiness, dizziness and muscle weakness. There is also agreater risk offalls which can cause serious injury.
• if you suffer from kidney failure: if you have severe kidney failure you should take a reduced dose;
• if you suffer from liver failure: benzodiazepines are not indicated in patients with severe liver failure as they can precipitate encephalopathy. In moderate or mild liver failure it is necessary to reduce the dose of clotiazepam. If liver disorders occur, appropriate measures should be taken such as discontinuation of treatment, control of blood tests and in particular liver function;
• if you suffer from heart failure: use this medicine with caution.

Keep in mind that benzodiazepines are not recommended as primary treatment for psychotic disorders and should not be used alone to treat depression or anxiety associated with
depression as you may experience suicidal thoughts.
You may experience amnesia (total or partial memory loss) during treatment with TIENOR.
To avoid this, it is important that you have 7-8 hours of uninterrupted sleep (see section 4 “Possible
side effects”).
If you abuse alcohol or drugs, you should be particularly careful when using this medicine.

Children and adolescents
You can give TIENOR to children only after careful evaluation by your doctor
of the actual need for treatment. The duration of treatment should be as short as possible.
Do not give 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 very sensitive to the effects of benzodiazepines on the central nervous system. Furthermore, 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 medicines for cough). Concomitant use increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should be considered only when other treatment options are not 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 follow your doctor's recommended dose strictly. 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 an increase in euphoria leading to an increased psychic dependence.
• Compounds that inhibit certain liver enzymes (especially cytochrome P450) because they can alter the activity of benzodiazepines.
• Theophylline, a medicine used to treat asthma and lung problems. It may have an effect on 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 strengthen the sedative action.

TIENOR with alcohol
Avoid drinking alcoholic beverages while taking TIENOR because alcohol can increase the sedative
effect of TIENOR.

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
You should avoid taking TIENOR during the first trimester of pregnancy. After this period,
you can only take the medicine with caution and only if the expected benefits outweigh the risks.
If you are a woman of childbearing potential, contact your doctor regarding stopping the medicine,
whether you intend to become pregnant or suspect you are pregnant.
If, for serious medical reasons, you have to take high doses of clotiazepam at the end of pregnancy or during labor, effects on the newborn such as hypothermia (lowering of
body temperature), hypotonia (reduction of muscle tone) and moderate difficulty in
breathing may occur. In addition, if you have taken benzodiazepines during the advanced stages of pregnancy, your
newborn baby 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 can cause sedation, amnesia, impaired concentration and muscle function
which can negatively affect your ability to drive and operate machinery. If your sleep duration has been insufficient, the likelihood that your alertness is altered may be increased.

Do not drive or operate machinery if these effects affect you.
TIENOR contains lactose.
If your doctor has diagnosed you with lactose intolerance, contact him before taking
this medicine.

15. How to take TIENOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet 1 to 3 times a day.
The recommended dose as a sleep inducer is 1 or 2 tablets in the evening before bedtime.
The dose must, however, be personalized for each patient according to medical advice.

Elderly
If you are elderly, the dosage must be carefully established by your doctor who will need to assess a
possible reduction of the dosages indicated above.
Treatment should be started with the lowest recommended dose. The maximum dose must not be
exceeded.

Severe hepatic impairment or altered renal function or presence of organic diseases
If you experience severe hepatic impairment or altered renal function or debilitating organic diseases, your
doctor will adjust your dose.

Anxiety, tension and other somatic or psychiatric manifestations associated with anxiety syndrome
You must be regularly re-evaluated and the need for continued treatment must be carefully assessed,
particularly if you are symptom-free.
The overall duration of treatment should generally not exceed 8-12 weeks, including a
period of gradual discontinuation. In certain cases, extension beyond the maximum treatment period may be necessary; in such cases, 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, it should 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 you should, contact your doctor or go to the
nearest hospital.
The symptoms of overdose vary depending on the amount taken, and any concomitant intake
of other central nervous system depressants, including alcohol, and include in mild cases: dysarthria, urinary retention, tremor, clouding of consciousness, mental confusion, lethargy and a feeling
of dizziness. In more severe cases, loss of muscle coordination (ataxia), decreased
muscle tone (hypotonia), decreased blood pressure (hypotension), difficulty breathing,
rarely coma and very rarely death.
If you are conscious, induce vomiting within one hour of taking the medicine. If, however, you are unconscious,
gastric lavage will be performed with protection of the airways and/or administration of activated charcoal to reduce gastric absorption (if no improvement is observed with stomach emptying).
The antidote to this medicine is flumazenil, which is indicated in case of severe poisoning with
coma and/or respiratory failure and will be administered by competent healthcare personnel.

If you forget to take TIENOR
Do not take a double dose to make up for a missed tablet.

If you stop taking TIENOR
Do not stop taking TIENOR without consulting your doctor. Treatment must be
reduced gradually.
If you suddenly stop treatment, you will 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 sounds
(hyperacusis), numbness and tingling of the extremities, hypersensitivity to light, noise and
physical contact, hallucinations or seizures.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

16. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the side effects of benzodiazepines increases with age and depends on both
If any of the side effects described below occur, stop taking TIENOR and
consult your doctor:

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

Such reactions can be quite serious. They are more likely in children and the elderly.

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 (pathological deep sleep state), loss of muscle coordination (ataxia)
• dizziness
• dry mouth (xerostomia)
• joint pain (arthralgia)
• emotional numbness
• fatigue.

Other possible side effects

• decreased white blood cells in the blood (leukopenia)
• confusion in the elderly, memory disorders, behavioural changes and paranoid symptoms
• double vision (diplopia) and visual disturbances
• low blood pressure (hypotension), fainting (syncope), tachycardia, postural hypotension
• respiratory depression in patients with chronic respiratory failure, edema
• nausea, vomiting, increased appetite, constipation
• alterations in liver function, visible with yellowish discoloration of the skin and mucous membranes (jaundice) and increased transaminase values (see paragraph “Warnings and precautions”)
• decreased muscle tone, fatigue, malaise, weakness, myalgia
• changes in sexual desire, menstrual disorders and ovulation disorders, increased breast volume in males (gynecomastia)
• tinnitus
• amnesia: anterograde amnesia, i.e. long-term memory disorder, may occur. To reduce the risk of this side effect occurring, you should have uninterrupted sleep of 7-8 hours. The risk increases at higher doses. Amnesic effects may be associated with behavioural changes
• depression: a pre-existing depressive state may be unmasked during the use of benzodiazepines
• dependence: the use of benzodiazepines, even at therapeutic doses, can lead to the development of physical dependence: discontinuation of therapy can cause a resurgence of symptoms in a more pronounced manner or withdrawal. Psychological dependence can occur
• sedation: may sometimes occur on an individual and unpredictable basis. This effect, however, is uncommon and generally transient. If necessary, a dose reduction may be considered.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell
your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
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.

18. Package Contents and Other Information

What TIENOR contains

• The active ingredient is clotiazepam. One tablet contains 10.0 mg of clotiazepam.
• The other ingredients are: lactose, corn starch, microcrystalline cellulose, povidone, magnesium stearate, indigotine E132.

Description of the appearance of TIENOR and package contents
30 tablets

Marketing Authorisation Holder
FARMAKA S.r.l.
Via Villapizzone, 26 – 20156 Milano
Italy

Manufacturer
Farmaceutici Formenti SPA
Via Giuseppe di Vittorio 2
21040 Origgio (Varese)