LIMBITRYL 12.5 мг/5 мг Капсулы

Содержание инструкции

1. Limbitryl 12.5 mg/ 5 mg hard capsules
   1. What is Limbitryl and what is it used for
   2. What you need to know before taking Limbitryl
   3. How to take Limbitryl
   4. Possible side effects
   5. How to store Limbitryl
   6. Contents of the pack and other information
2. Limbitryl 25 mg / 10 mg hard capsules
   1. What is Limbitryl and what is it used for
   2. What you need to know before taking Limbitryl
   3. How to take Limbitryl
   4. Possible side effects
   5. How to store Limbitryl
   6. Contents of the pack and other information

Limbitryl 12.5 mg/ 5 mg hard capsules

amitriptyline and chlordiazepoxide

Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Limbitryl and what is it used for

Limbitryl contains the active ingredients amitriptyline, belonging to the class of medicines called “tricyclic
antidepressants”, which has antidepressant activity, and chlordiazepoxide, belonging to the class of medicines called
“benzodiazepines”, substances with anxiolytic activity.
Limbitryl is used in adultsfor the treatment of depression accompanied by anxiety, including the physical
and mental disorders that originate from it.
Consult your doctor if you do not feel better or if you feel worse during treatment.

2. What you need to know before taking Limbitryl

Do not take Limbitryl

• if you are allergic to amitriptyline and/or chlordiazepoxide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to benzodiazepines or tricyclic antidepressants;
• if you suffer from glaucoma, an eye disease caused by an increase in the pressure of the fluid contained within the eye;
• if you suffer from severe hepatic insufficiency (severe reduction of liver function);
• if you have severe kidney damage (severe reduction of kidney function);
• if you suffer from myasthenia gravis (a severe disease that affects the muscles and manifests with weakness and fatigue);
• if you suffer from severe respiratory insufficiency (severe reduction of the activity of the respiratory system);
• if you suffer from sleep apnea syndrome (temporary cessation of breathing during sleep);
• if you suffer from heart failure (impaired heart function);
• if you have recently had a heart attack;
• if you suffer from problems with the conduction of electrical impulses in the heart (heart rhythm disturbances);
• if you suffer from prostatic hypertrophy (enlargement of the prostate) and other conditions that cause narrowing (stenosis) of the gastro-intestinal or genito-urinary tract;
• if you are in the first or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if you have had an intoxication or a history of dependence on substances or medicines that reduce the activity of the nervous system (alcohol, medicines used to relieve pain or other medicines used to treat some disorders of the nervous system);
• if you feel confused and have problems orienting yourself in space and time (delirium);
• if you are unable to coordinate your movements and gait (ataxia);
• if you are already taking drugs called monoamine oxidase inhibitors (MAO) (see sections “Warnings and precautions” and “Other medicines and Limbitryl”).

Do not giveLimbitryl to children and adolescents (0-18 years of age).

Warnings and precautions
Talk to your doctor or pharmacist before taking Limbitryl.
In particular, talk to your doctor or pharmacist before taking Limbitryl if you think that any of the following
conditions apply to you:

• you are taking other medicines similar to Limbitryl, because the undesirable effects may increase (see “Serotonin syndrome” and section “Other medicines and Limbitryl”);
• you are a subject predisposed to the development of changes in the electroencephalogram tracing;
• you suffer from chronic respiratory insufficiency (chronic reduction of respiratory function) as Limbitryl may worsen the functionality of the respiratory system;
• you suffer from hepatic insufficiency (liver disease);
• you suffer from renal insufficiency (kidney disease);
• you suffer from heart failure (a condition in which the supply of oxygen is insufficient to the heart's needs);
• you suffer from heart rate problems;
• you suffer from epilepsy (a disease characterized by uncontrolled body movements and loss of consciousness);
• you suffer from symptoms of urinary retention (inability of the urinary bladder to empty completely);
• you suffer from paralytic ileus (an obstruction of the intestine) or other diseases that cause obstruction of the stomach and intestines;
• you suffer from hyperthyroidism (alteration of the function of the thyroid, a gland in the neck);
• you suffer from mental disorders (psychotic illness);
• you have had problems with drug or alcohol abuse in the past;
• you suffer from ataxia (reduced coordination of movements and gait);
• you have damage to the heart and blood vessels;
• you have damage to the brain;
• you are debilitated (are in poor general health);
• if you suffer from personality disorders (fixed thoughts and a feeling of seeing or hearing things that do not exist or confusion and disorientation);
• you suffer from diabetes (high blood sugar levels);
• you have to undergo surgery, because the treatment with Limbitryl must be stopped several days before;
• you suffer from prostatic hypertrophy (a condition that causes an increase in the volume of the prostate);
• you are taking medicines containing buprenorphine and fentanyl (strong painkillers known as opioids) (see “Serotonin syndrome” and section “Other medicines and Limbitryl”);
• you are taking medicines containing a substance called levodopa, which is used in the treatment of Parkinson's disease (see section “Other medicines and Limbitryl”).

Take special care with Limbitryl:
serious skin reactions have been reported associated with treatment with Limbitryl, including drug
reaction with eosinophilia and systemic symptoms (Drug Reaction with Eosinophilia and Systemic Symptoms,
DRESS). Stop using Limbitryl and contact your doctor immediately if you notice any of the symptoms
related to these serious skin reactions described in section 4.

Serotonin syndrome
The use of this medicine together with others similar to it or with analgesic medicines such as buprenorphine and fentanyl may
lead to serotonin syndrome, a condition that can be fatal and manifests with
symptoms such as involuntary and rhythmic contractions of the muscles, including the muscles that control the movement
of the eyes, agitation, hallucinations, coma, excessive sweating, tremor, accentuated reflexes, increased
muscle contraction, fever higher than 38°C. Contact your doctor if you experience such symptoms.

Suicidal tendency
Like other antidepressant drugs, Limbitryl may increase the tendency to suicide. This risk is higher
if you suffer or have suffered in the past from suicidal behavior or thoughts.
You (or whoever cares for you) should monitor and immediately report to your doctor any
worsening of the illness and the appearance of suicide attempts or thoughts or changes in
behavior.
If you have to take Limbitryl for a long time, your doctor will prescribe blood tests to check if there
are changes in blood cells and check liver function.

Development of tolerance
Following repeated use of this medicine for several weeks, a decrease may occur
in its effectiveness (tolerance).

Development of dependence
The use of high doses and/or for prolonged periods of chlordiazepoxide can lead to physical and psychological dependence, as
happens with other medicines similar to chlordiazepoxide.
This risk is higher if you have abused drugs or alcohol in the past, as you are more likely to develop
habit and dependence on this medicine.

Memory disorders (amnesia)
The use of chlordiazepoxide can cause memory disorders. This effect occurs more often several hours
after taking the medicine. Therefore, to reduce the risk, before taking this medicine you must
make sure you can have a sufficient period of uninterrupted sleep of 7-8 hours (see section “How
to take Limbitryl”).

If you are elderly (over 65 years of age)
If you are elderly, your doctor may decide to reduce your dose.

Children and adolescents
Do not giveLimbitryl to children and adolescents (0-18 years of age).

Other medicines and Limbitryl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of Limbitryl and opioids (strong painkillers, medicines for addiction therapy and
some medicines for cough) 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
Limbitryl together with opioids, the dose and duration of concomitant treatment must be limited by
the doctor. Inform your doctor about all the opioid medicines you are taking and carefully follow
your doctor's dose recommendations. It may be helpful to inform friends or relatives to pay attention to
the above-mentioned signs and symptoms. Contact your doctor if you experience such symptoms.

Avoidtaking other medicines with calming properties if you are taking Limbitryl, as they may interfere
with your ability to drive or operate machinery (see section “Driving and using machines”).
Tell your doctor if you are taking any of the following medicines, because Limbitryl may increase their effect:

• medicines that reduce the activity of the central nervous systemsuch as:
• neuroleptics(medicines used for some mental illnesses). Also, if these medicines are taken together with Limbitryl, it may increase the risk of abnormalities in the electrocardiogram (prolongation of the QT interval) and uncontrolled body movements (convulsions);
• antiepileptics(medicines used for the treatment of epilepsy), particularly barbiturates;
• tranquilizers, anxiolytics/sedatives(medicines that cause physical and mental dullness), may increase the relaxing effects and increase the risk of falls, especially if you are elderly;
• antidepressants(medicines used for the treatment of depression, e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion). Also, antidepressant medicines belonging to the classes of MAO inhibitors, non-selective and selective MAO-A inhibitors (such as moclobemide) and MAO-B (such as selegiline) taken together with Limbitryl may increase the risk of an excessive level of serotonin in the blood ("Serotonin Syndrome", see section “Warnings and precautions”), crises due to high blood pressure and a significant increase in body temperature. If you need to start therapy with Limbitryl and are taking one of these medicines, your doctor will tell you when you should start therapy with Limbitryl;
• hypnotics(medicines that calm and induce sleep);
• narcotic analgesics(medicines for the treatment of acute or chronic severe pain). Also, these medicines taken together with Limbitryl may increase euphoria and physical and psychological dependence;
• anesthetics(medicines for pain relief);
• antihistamines(medicines used to counteract allergic reactions) with a sedative effect;
• anticoagulants(medicines used to thin the blood);
• adrenergic agents, such as norepinephrine (used to treat severe hypotension) and epinephrine (a drug used to treat allergic shock);
• buprenorphine and fentanyl(strong opioid analgesics). Taking Limbitryl in combination with these medicines may increase the risk of an excessive level of serotonin in the blood ("Serotonin Syndrome", see section “Warnings and precautions”).

Tell your doctor or pharmacist if you are taking any of the following medicines, because Limbitryl may decrease
their effect:

• muscle relaxants(medicines used for muscle relaxation);
• ephedrine(a medicine used to counteract some forms of arterial hypotension).

Tell your doctor or pharmacist if you are taking any of the following medicines, because the risk that
side effects occur with the concomitant use of Limbitryl is greater:

• thyroid hormones or thyroid preparations(risk of arrhythmia);
• adrenergic agents, such as isoprenaline and epinephrine (risk of arrhythmia);
• products based on levodopa(medicine used for the treatment of Parkinson's disease);
• valproic acid.

Tell your doctor or pharmacist if you are taking any of the following medicines, because they may decrease the
effects of Limbitryl:

• methylphenidate(medicine used for the treatment of Attention Deficit Hyperactivity Disorder in children);
• barbiturates, carbamazepine, phenytoin(medicines used for the treatment of seizures);
• nicotine.

Tell your doctor or pharmacist if you are taking any of the following medicines, because they may influence the
effects of Limbitryl:

• cimetidine(medicine used in case of stomach ulcer);
• macrolide antibiotics(medicines used for the treatment of some bacterial infections);
• azole antifungal agents(antifungal medicines);
• calcium antagonists(medicines used for high blood pressure and other heart and circulatory disorders);
• protease inhibitors(medicines used to treat viral infections, including those caused by the HIV virus);
• ergot alkaloids(medicines used for the treatment of severe headache);
• antidepressant agents(medicines used for the treatment of depression);
• herbal preparations;
• oral contraceptives(“the pill”);
• disulfiram(medicine used for the treatment of alcoholism).

Tell your doctor or pharmacist if you are taking the following medicines:

• cisapride(medicine used for the treatment of stomach reflux);
• antiarrhythmic agents(medicines used for the treatment of irregular heartbeat, for example, quinidine);
• antihistamine agents(medicines used to counteract allergic reactions);
• antimalarial agents(medicines used for the treatment of malaria), because the use of Limbitryl may increase their effect and the risk of interactions at the heart level;
• anticholinergic agents(medicines that reduce the effects of acetylcholine), because the use of Limbitryl may increase their effect and the side effects of other drugs (such as phenothiazines, anticholinergic agents used for the treatment of Parkinson's disease, antihistamines and haloperidol) may be intensified.

Limbitryl with food, beverages and alcohol
Do notdrink alcohol while taking Limbitryl. If you have abused alcohol in the past, your doctor will monitor you
during treatment with Limbitryl, as you are more likely to develop a dependence on this
medicine.
Drinking alcohol with Limbitryl can also lead to a serious impairment of your ability to drive
vehicles and operate machinery (see section “Driving and using machines”).

Fertility, pregnancy and breastfeeding
Limbitryl may cause congenital malformations (abnormalities, physical defects in newborns from mothers taking this
medicine). If you are of childbearing age, you should use effective contraceptive measures.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your
doctor for advice before taking this medicine; the doctor will assess the suspension of
treatment with this medicine.

Do not takeLimbitryl during pregnancy, especially during the first 3 months and the last 3 months.
The doctor may still prescribe this medicine only if absolutely necessary.
If, for serious health reasons, the doctor decides to prescribe this medicine at high doses during
the last period of pregnancy or during labor, the newborn may experience adverse effects such as
a lowering of body temperature, reduced muscle tone and difficulty breathing. In addition,
newborns born to mothers who have chronically taken benzodiazepines during the advanced stages of
pregnancy may develop physical dependence and may present a certain risk of developing postnatal withdrawal symptoms after birth.

Do not takeLimbitryl if you are breastfeeding, as this medicine passes into breast milk. Limbitryl
is contraindicated during breastfeeding. If the doctor decides to prescribe this medicine, you will
be advised to stop breastfeeding.

Driving and using machines
Do notdrive or operate machinery if you experience side effects such as
drowsiness, sedation (physical and mental relaxation), amnesia (memory disorders), difficulty
concentrating and altered muscle function while taking Limbitryl. Your alertness may be altered especially if you
have not slept for a sufficient time (7-8 hours) or have consumed alcoholic beverages after taking
Limbitryl.
Be particularly careful when driving or using machinery if you are taking Limbitryl together with other
sedative medicines.

Limbitryl contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to take Limbitryl

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the dose and frequency most suitable for you, in order to avoid any possible intake of an
excessive dose of this medicine.

How much to take
The recommended dosage is 2-6 capsules per day, according to the doctor's instructions.
Start treatment with 1 capsule in the morning and 1 in the evening.
Always take the main dose in the evening.

How
Swallow the capsule with a glass of water.
Do not chew.

If you are elderly or debilitated, or if you suffer from kidney or liver disorders
If you are elderly or debilitated, or if you suffer from kidney or liver disorders, the doctor will assess whether to prescribe you doses
lower than those indicated above.

Duration of treatment
The doctor will prescribe the shortest possible duration of treatment.
Generally the duration of treatment should not exceed 8-12 weeks, including a period of
gradual dose reduction until treatment is discontinued.
At the beginning of treatment with Limbitryl, the doctor will explain how to gradually reduce the dose of this
medicine in order to reduce the risk of developing withdrawal and rebound symptoms (see paragraphs
“If you stop taking Limbitryl” and “Possible side effects”).
In certain cases the doctor may decide to extend the duration of treatment above, after
re-evaluating your health status.

If you take more Limbitryl than you should
In case of accidental ingestion/intake of an excessive dose of Limbitryl, immediately inform
your doctor or go to the nearest hospital.

Symptoms
If you accidentally take a dose of medicine higher than that prescribed, you may be in danger
of life, especially if you also take alcohol or other medicines at the same time.
In cases of accidental ingestion/intake of an excessive dose of Limbitryl, the symptoms you may experience
are numerous and include:

• drowsiness,
• confusion,
• excitement,
• restlessness,
• agitation,
• perception of non-existent things (hallucinations),
• dilation of the pupils of the eyes (mydriasis),
• inability of the urinary bladder to empty completely (urinary retention),
• dryness of the mouth, nose and other mucous membranes,
• reduction of intestinal movements,
• uncontrolled body movements (convulsions),
• fever,
• altered heart rhythm (arrhythmia),
• increased heart rate (tachycardia),
• heart failure, a condition in which the supply of oxygen is insufficient to the heart's needs,
• decreased blood pressure,
• severe heart disorder that occurs when blood is not adequately oxygenated (cardiogenic shock),
• levels of acid in the blood higher than normal (metabolic acidosis),
• decreased potassium in the blood (hypokalemia),
• low levels of sodium in the blood (hyponatremia).

In the most severe cases, the symptoms may be:

• movement disorder with loss of coordination of muscles and joints (ataxia),
• absence (atonia) or reduction (hypotonia) of muscle tone,
• low blood pressure (hypotension),
• reduced breathing (respiratory depression),
• prolonged loss of consciousness (coma),
• death.

Amitriptyline overdose in children can have serious consequences. Children are particularly
susceptible to coma, cardiac symptoms, difficulty breathing, seizures, low levels of sodium
in the blood, lethargy, drowsiness, nausea, vomiting, and high blood sugar levels.

Treatment
The doctor, after evaluating the symptoms, will perform the appropriate supportive therapy (for example, performing
gastric lavage, administering activated charcoal and other medicines or using devices for the heart
or to facilitate breathing).

If you forget to take Limbitryl
Do not take a double dose to make up for the missed dose. Take the next dose normally,
as prescribed by your doctor.

If you stop taking Limbitryl

• Do notstop taking Limbitryl without first consulting your doctor.
• The doctor will gradually reduce the dose during the phase of suspension of therapy.
• Abrupt discontinuation of this medicine can cause:
• withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, you may experience a feeling of detachment or estrangement from yourself or from the outside world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise and physical contact, perception of non-existent things, seizures;
• rebound symptoms(when the symptoms that led to treatment with this medicine reappear in a more severe form after discontinuation of treatment) such as mood changes, anxiety, restlessness or sleep disturbances.

If you have any doubts 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.
Contact your doctor immediatelyif you experience any of the following serious side effects during treatment with Limbitryl; your doctor will explain how to stopusing the medicine:

• you develop symptoms such as a significant increase in body temperature, muscle rigidity, changes in mental state, which may be a sign of a condition similar to neuroleptic malignant syndrome
• restlessness, agitation, irritability, aggressiveness, anger
• delusion
• nightmares
• perception of non-existent things (hallucinations)
• manias (psychosis)
• abnormal behaviour
• other behavioural side effects. These reactions are more frequent if you are elderly.

Frequency not known:
Stop using Limbitryl and contact your doctor immediately if you notice any of the following symptoms:
widespread rash, high body temperature and swollen lymph nodes (DRESS or drug reaction with eosinophilia and systemic symptoms).
The following side effects have been observed and reported during treatment with Limbitryl with the following
frequencies:

Very common (may affect more than 1 in 10 people)

• weight gain
• headache
• dizziness
• tremor
• sleepiness
• impaired vision (e.g. difficulty focusing)
• sensation of increased heartbeats (palpitations)
• increased heart rate (tachycardia)
• dry mouth
• constipation
• nausea
• increased sweating (hyperhidrosis).

Common (may affect up to 1 in 10 people)

• reduced level of consciousness
• sedation, fatigue
• movement disorder with loss of coordination of muscles and joints (ataxia)
• balance disorders
• confusional state
• altered sensitivity of the limbs or other parts of the body (paresthesia)
• dilation of the pupil of the eye (mydriasis)
• abnormal electrocardiogram
• problems with the electrical impulses that control the heartbeat (atrioventricular block, conduction disturbances)
• alterations in taste (dysgeusia)
• skin reactions (e.g. skin rash, urticaria)
• erectile dysfunction.

Uncommon (may affect up to 1 in 100 people)

• mood changes (hypomania)
• obsessive thoughts (mania)
• anxiety
• insomnia
• uncontrolled body movements (convulsions)
• increased pressure inside the eye
• ringing or buzzing in the ears (tinnitus)
• high blood pressure (hypertension)
• diarrhea, vomiting
• inability of the urinary bladder to empty completely (urinary retention)
• breast enlargement (gynecomastia).

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

• reduction in the number of blood cells (e.g. thrombocytopenia, leucopenia, agranulocytosis, pancytopenia, eosinophilia)
• weight loss
• loss of appetite (anorexia)
• delirium
• hallucinations
• dizziness
• double vision (diplopia)
• irregular heartbeat (arrhythmia)
• worsening of pre-existing heart failure (condition in which oxygen supply is insufficient to meet the heart's needs)
• low blood pressure (hypotension)
• swelling of the salivary gland
• blockage of the intestine (paralytic ileus)
• yellowing of the skin and whites of the eyes (jaundice)
• increased liver enzymes in the blood (blood bilirubin, transaminases and alkaline phosphatase)
• hair loss (alopecia)
• reactions following exposure of the skin to light (photosensitivity reactions)
• muscle weakness
• decreased sexual desire (libido disorders)
• menstrual problems
• increased body temperature (pyrexia)

Very rare (may affect up to 1 in 10,000 people)

• allergy
• swelling that may involve the tongue and/or throat and that can lead to obstruction of the airways which could be fatal (angioedema).

Not known (frequency cannot be estimated from the available data)

• abnormal secretion of the antidiuretic hormone
• suicide attempt
• suicidal ideation
• memory disorders, including memory loss (amnesia)
• physical and psychological dependence
• depression
• psychotic disorders
• altered behaviour
• emotional disorders
• sleep disorders
• difficulty articulating words (dysarthria)
• walking disorders
• extrapyramidal disorders (e.g. difficulty with movements)
• altered body movements (dystonia)
• depression of breathing
• secretion of milk outside of the breastfeeding period (galactorrhea)
• dry eyes
• low sodium concentration in the blood (hyponatremia).

This medicine can increase the risk of falls and bone fractures, especially if you are elderly.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Limbitryl

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Limbitryl contains

• The active ingredients are:
• amitriptyline hydrochloride 14.15 mg equivalent to amitriptyline 12.5 mg
• chlordiazepoxide 5 mg.
• The other ingredients are: ethylcellulose, corn starch, magnesium stearate, talc, lactose(see section “Limbitryl contains lactose”). Capsule components: gelatin, titanium dioxide, natural type E172 coloring agent.

Description of the appearance of Limbitryl and contents of the pack
It is presented in hard capsules for oral use, packaged in blisters of 20 capsules.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Viatris Italia S.r.l., Via Vittor Pisani, 20 - 20124 Milano – Italy
Manufacturer
Labiana Pharmaceuticals, S.L.U. – Corbera de Llobregat Plant – Barcelona (Spain)

Limbitryl 25 mg / 10 mg hard capsules

amitriptyline and chlordiazepoxide

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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Limbitryl and what is it used for

Limbitryl contains the active ingredients amitriptyline, belonging to the class of medicines called “tricyclic
antidepressants”, which has antidepressant activity, and chlordiazepoxide, belonging to the class of medicines called
“benzodiazepines”, substances with anxiolytic activity.
Limbitryl is used in adultsfor the treatment of depression accompanied by anxiety, including the physical and
mental disorders that originate from it.
Consult your doctor if you do not feel better or if you feel worse during treatment.

2. What you need to know before taking Limbitryl

Do not take Limbitryl

• if you are allergic to amitriptyline and/or chlordiazepoxide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to benzodiazepines or tricyclic antidepressants;
• if you suffer from glaucoma, an eye disease caused by an increase in the pressure of the fluid contained within the eye;
• if you suffer from severe hepatic insufficiency (severe reduction of liver function);
• if you have severe kidney damage (severe reduction of kidney function);
• if you suffer from myasthenia gravis (a severe disease that affects the muscles and manifests with weakness and fatigue);
• if you suffer from severe respiratory failure (severe reduction of the activity of the respiratory system);
• if you suffer from sleep apnea syndrome (temporary cessation of breathing during sleep);
• if you suffer from heart failure (impairment of heart function);
• if you have recently had a heart attack;
• if you suffer from problems with the conduction of electrical impulses in the heart (heart rhythm disturbances);
• if you suffer from prostatic hypertrophy (enlargement of the prostate) and other conditions that cause narrowing (stenosis) of the gastrointestinal or genitourinary tract;
• if you are in the first or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if you are breastfeeding with breast milk (see section “Pregnancy and breastfeeding”);
• if you have had an intoxication or a history of dependence on substances or medicines that reduce the activity of the nervous system (alcohol, medicines used to relieve pain or other medicines used to treat some disorders of the nervous system);
• if you feel confused and have problems orienting yourself in space and time (delirium);
• if you are unable to coordinate your movements and gait (ataxia);
• if you are already taking drugs called monoamine oxidase inhibitors (MAO) (see sections “Warnings and precautions” and “Other medicines and Limbitryl”).

Do not giveLimbitryl to children and adolescents (0-18 years of age).

Warnings and precautions
Talk to your doctor or pharmacist before taking Limbitryl.
In particular, talk to your doctor or pharmacist before taking Limbitryl if you think that any of the following
conditions apply to you:

• you are taking other medicines similar to Limbitryl, because the undesirable effects may increase (see “Serotonin syndrome” and section “Other medicines and Limbitryl”);
• you are a subject predisposed to the development of changes in the electroencephalogram trace;
• you suffer from chronic respiratory failure (chronic reduction of respiratory function) as Limbitryl may worsen the functionality of the respiratory system;
• you suffer from hepatic insufficiency (liver disease);
• you suffer from renal insufficiency (kidney disease);
• you suffer from heart failure (a disease in which the supply of oxygen is insufficient to the needs of the heart);
• you suffer from problems with your heart rate;
• you suffer from epilepsy (a disease characterized by uncontrolled movements of the body and loss of consciousness);
• you suffer from symptoms of urinary retention (inability of the urinary bladder to empty completely);
• you suffer from paralytic ileus (an obstruction of the intestine) or other diseases that cause obstruction of the stomach and intestines;
• you suffer from hyperthyroidism (alteration of the functioning of the thyroid, a gland in the neck);
• you suffer from mental disorders (psychotic illness);
• you have had problems with drug or alcohol abuse in the past;
• you suffer from ataxia (reduced coordination of movements and gait);
• you have damage to the heart and blood vessels;
• you have damage to the brain;
• you are debilitated (are in poor general health);
• if you suffer from personality disorders (fixed thoughts and a feeling of seeing or hearing things that do not exist or confusion and disorientation);
• you suffer from diabetes (high levels of sugar in the blood);
• you have to undergo surgery, because treatment with Limbitryl should be stopped several days before;
• you suffer from prostatic hypertrophy (a condition that causes an increase in the volume of the prostate);
• you are taking medicines containing buprenorphine and fentanyl (strong painkillers known as opioids) (see “Serotonin syndrome” and section “Other medicines and Limbitryl”);
• you are taking medicines containing a substance called levodopa, which is used to treat Parkinson's disease (see section “Other medicines and Limbitryl”).

Take special care with Limbiryl:
serious skin reactions have been reported associated with treatment with Limbitryl, including drug
reaction with eosinophilia and systemic symptoms (Drug Reaction with Eosinophilia and Systemic Symptoms,
DRESS). Stop using Limbitryl and contact your doctor immediately if you notice any of the symptoms
related to these serious skin reactions described in section 4.

Serotonin syndrome
The use of this medicine together with others similar or with analgesic medicines such as buprenorphine and fentanyl can
lead to serotonin syndrome, a condition that can be fatal and manifests with
symptoms such as involuntary and rhythmic contractions of the muscles, including the muscles that control the movement
of the eyes, agitation, hallucinations, coma, excessive sweating, tremor, accentuated reflexes, increased
muscle contraction, fever above 38°C. Contact your doctor if you experience such symptoms.

Suicidal tendency
Like other antidepressant drugs, Limbitryl may increase the tendency to suicide. This risk is greater
if you suffer or have suffered in the past from suicidal behavior or thoughts.
You (or whoever cares for you) should monitor and immediately report to your doctor any
worsening of the illness and the appearance of suicide attempts or thoughts or changes in
behavior.
If you have to take Limbitryl for a long time, your doctor will prescribe blood tests to check if there are alterations of the blood cells and check the functionality of the liver.

Development of tolerance
Following repeated use of this medicine for several weeks, a decrease in its effectiveness (tolerance) may occur.

Development of dependence
The use of high doses and/or for prolonged periods of chlordiazepoxide can lead to physical and psychological dependence, as
happens with other medicines similar to chlordiazepoxide.
This risk is greater if you have previously abused drugs or alcohol, as you are more likely to develop
habit and dependence on this medicine.

Memory disorders (amnesia)
The use of chlordiazepoxide can cause memory disorders. This effect occurs more often several hours
after taking the medicine. Therefore, to reduce the risk, before taking this medicine you must
make sure you can have a sufficient period of uninterrupted sleep of 7-8 hours (see section “How
to take Limbitryl”).

If you are elderly (over 65 years of age)
If you are elderly, your doctor may decide to reduce your dose.

Children and adolescents
Do not giveLimbitryl to children and adolescents (0-18 years of age).

Other medicines and Limbitryl
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of Limbitryl and opioids (strong painkillers, medicines for the treatment of dependence and
some medicines for cough) 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
Limbitryl together with opioids, the dose and duration of concomitant treatment must be limited by
the doctor. Inform your doctor about all opioid medicines you are taking and carefully follow
the doctor's dose recommendation. It may be helpful to inform friends or relatives to pay attention to
the above-mentioned signs and symptoms. Contact your doctor if you experience such symptoms.

Avoidtaking other medicines with calming properties if you are taking Limbitryl, as they may interfere
with your ability to drive or operate machinery (see section “Driving and using machines”).
Tell your doctor if you are taking any of the following medicines, because Limbitryl may increase their effect:

• medicines that reduce the activity of the central nervous systemsuch as:
• neuroleptics(medicines used for some mental illnesses). Also, if these medicines are taken together with Limbitryl, it may increase the risk of abnormalities in the electrocardiogram (prolongation of the QT interval) and uncontrolled body movements (convulsions);
• antiepileptics(medicines used for the treatment of epilepsy), especially barbiturates;
• tranquilizers, anxiolytics/sedatives(medicines that cause physical and mental sluggishness) may increase the relaxing effects and increase the risk of falls, especially if you are elderly;
• antidepressants(medicines used for the treatment of depression, e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion). Also, antidepressant medicines belonging to the classes of MAO inhibitors, non-selective and selective MAO-A inhibitors (such as moclobemide) and MAO-B (such as selegiline) taken together with Limbitryl may increase the risk of an excessive level of serotonin in the blood ("Serotonin Syndrome", see section “Warnings and precautions”), crises due to high blood pressure and a significant increase in body temperature. If you need to start therapy with Limbitryl and are taking one of these medicines, your doctor will tell you when you should start therapy with Limbitryl;
• hypnotics(medicines that calm and promote sleep);
• narcotic analgesics(medicines for the treatment of acute or chronic pain of high intensity). Also, these medicines taken together with Limbitryl may increase euphoria and physical and mental dependence;
• anesthetics(medicines for pain relief);
• antihistamines(medicines used to counteract allergic reactions) with a sedative effect;
• anticoagulants(medicines used to thin the blood);
• adrenergic agents, such as norepinephrine (used to treat severe hypotension) and epinephrine (a drug used to treat allergic shock);
• buprenorphine and fentanyl(strong opioid analgesics). Taking Limbitryl in combination with these medicines may increase the risk of an excessive level of serotonin in the blood ("Serotonin Syndrome", see section “Warnings and precautions”).

Tell your doctor or pharmacist if you are taking any of the following medicines, because Limbitryl may decrease
their effect:

• muscle relaxants(medicines used for muscle relaxation);
• ephedrine(a medicine used to counteract some forms of arterial hypotension).

Tell your doctor or pharmacist if you are taking any of the following medicines, because the risk that
side effects occur with the concomitant use of Limbitryl is greater:

• thyroid hormones or thyroid preparations(risk of arrhythmia);
• adrenergic agents, such as isoprenaline and epinephrine (risk of arrhythmia);
• products based on levodopa(medicine used for the treatment of Parkinson's disease);
• valproic acid.

Tell your doctor or pharmacist if you are taking any of the following medicines, because they may decrease the
effects of Limbitryl:

• methylphenidate(medicine used for the treatment of Attention Deficit Hyperactivity Disorder in children);
• barbiturates, carbamazepine, phenytoin(medicines used for the treatment of seizures);
• nicotine.

Tell your doctor or pharmacist if you are taking any of the following medicines, because they may influence the
effects of Limbitryl:

• cimetidine(medicine used in case of stomach ulcer);
• macrolide antibiotics(medicines used for the treatment of some bacterial infections);
• azole antifungal agents(antifungal medicines);
• calcium antagonists(medicines used for high blood pressure and other heart and circulatory disorders);
• protease inhibitors(medicines used to treat viral infections, including those caused by the HIV virus);
• ergot alkaloids(medicines used for the treatment of severe headaches);
• antidepressant agents(medicines used for the treatment of depression);
• herbal preparations;
• oral contraceptives(“the pill”);
• disulfiram(medicine used for the treatment of alcoholism).

Tell your doctor or pharmacist if you are taking the following medicines:

• cisapride(medicine used for the treatment of stomach reflux);
• antiarrhythmic agents(medicines used for the treatment of irregular heartbeat, for example quinidine);
• antihistamine agents(medicines used to counteract allergic reactions);
• antimalarial agents(medicines used for the treatment of malaria), because the use of Limbitryl may increase their effect and the risk of interactions at the heart level;
• anticholinergic agents(medicines that reduce the effects of acetylcholine),

because the use of Limbitryl may increase their effect and the side effects of
other drugs (such as phenothiazines, anticholinergic agents used for the treatment of Parkinson's disease, antihistamines and haloperidol) may be intensified.

Limbitryl with food, drinks and alcohol
Do not drinkalcohol while taking Limbitryl. If you have abused alcohol in the past, your doctor will monitor you
during treatment with Limbitryl, as you are more likely to develop a dependence on
this medicine.
Drinking alcohol with Limbitryl can also lead to a serious impairment of your ability to drive
vehicles and operate machinery (see section “Driving and using machines”).

Fertility, pregnancy and breastfeeding
Limbitryl may cause congenital malformations (abnormalities, physical defects in infants born to mothers taking this
medicine). If you are of childbearing potential, you should use effective contraceptive measures.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine; the doctor will assess the suspension
of treatment with this medicine.

Do not takeLimbitryl during pregnancy, especially during the first 3 months and the last 3 months. The doctor
may only prescribe this medicine if absolutely necessary.
If, for serious health reasons, the doctor decides to prescribe this medicine at high doses during
the last period of pregnancy or during labor, the newborn may experience undesirable effects such as
a lowering of body temperature, reduced muscle tone and difficulty breathing. In addition,
newborns born to mothers who have been taking benzodiazepines chronically during the advanced stages of
pregnancy may develop physical dependence and may be at certain risk of developing postnatal withdrawal symptoms after birth.

Do not takeLimbitryl if you are breastfeeding, as this medicine passes into breast milk. Limbitryl is
contraindicated during breastfeeding. If the doctor decides to prescribe this medicine, you will
be advised to stop breastfeeding.

Driving and using machines
Do notdrive or operate machinery if you experience side effects such as
drowsiness, sedation (physical and mental relaxation), amnesia (memory disorders), difficulty
concentrating and altered muscle function while taking Limbitryl. Your alertness may be altered especially if you
have not slept for a sufficient time (7-8 hours) or have consumed alcoholic beverages after taking
Limbitryl.
Be particularly careful when driving or using machines if you are taking Limbitryl together with other
sedative medicines.

Limbitryl contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.

3. How to take Limbitryl

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The doctor will establish the dose and frequency most suitable for you, in order to avoid any possible intake of an
excessive dose of this medicine.

How much to take
The recommended dosage is 3 capsules per day, according to your doctor's instructions.

How
Swallow the capsule with a glass of water.
Do not chew.

If you are elderly or debilitated, or if you suffer from kidney or liver disorders
If you are elderly or debilitated, or if you suffer from kidney or liver disorders, your doctor will assess whether to prescribe you doses
lower than those indicated above.

Duration of treatment
The doctor will prescribe you the shortest possible duration of treatment.
Generally the duration of treatment should not exceed 8-12 weeks, including a period of
gradual dose reduction until treatment is discontinued.
At the beginning of treatment with Limbitryl, the doctor will explain how to gradually reduce the dose of this
medicine in order to reduce the risk of developing withdrawal and rebound symptoms (see paragraphs
“If you stop taking Limbitryl” and “Possible side effects”).
In certain cases the doctor may decide to extend the duration of treatment indicated above, after having
re-evaluated your health status.

If you take more Limbitryl than you should
In case of accidental ingestion/intake of an excessive dose of Limbitryl, immediately inform your
doctor or go to the nearest hospital.

Symptoms
If you accidentally take a dose of medicine higher than the prescribed one, you may be in danger
of life, especially if you also take alcohol or other medicines at the same time.
In cases of accidental ingestion/intake of an excessive dose of Limbitryl, the symptoms you may experience
are numerous and include:

• drowsiness,
• confusion,
• excitement,
• restlessness,
• agitation,
• perception of non-existent things (hallucinations),
• dilation of the pupils of the eyes (mydriasis),
• inability of the urinary bladder to empty completely (urinary retention),
• dryness of the mouth, nose and other mucous tissues,
• reduction of intestinal movements,
• uncontrolled body movements (convulsions),
• fever,
• altered heart rhythm (arrhythmia),
• increased heart rate (tachycardia),
• heart failure, a condition in which the supply of oxygen is insufficient to the heart's needs,
• decreased blood pressure,
• severe heart disorder that occurs when blood is not adequately oxygenated (cardiogenic shock),
• levels of acid in the blood higher than normal (metabolic acidosis),
• decreased potassium in the blood (hypokalaemia),
• low levels of sodium in the blood (hyponatraemia).

In the most severe cases, the symptoms may be:

• movement disorder with loss of coordination of muscles and joints (ataxia),
• absence (atonia) or reduction (hypotonia) of muscle tone,
• low blood pressure (hypotension),
• reduced breathing (respiratory depression),
• prolonged loss of consciousness (coma),
• death.

Overdose with amitriptyline in children can have serious consequences. Children are particularly
susceptible to coma, cardiac symptoms, difficulty breathing, seizures, low levels of sodium
in the blood, lethargy, drowsiness, nausea, vomiting and high levels of sugar in the blood.

Treatment
The doctor, after evaluating the symptoms, will carry out the appropriate supportive therapy (for example, performing
gastric lavage, administering activated charcoal and other medicines or using devices for the heart
or to facilitate breathing).

If you forget to take Limbitryl
Do not take a double dose to make up for a missed dose. Take the next dose normally,
as prescribed by your doctor.

If you stop taking Limbitryl

• Do notstop taking Limbitryl without first consulting your doctor.
• The doctor will gradually reduce the dose during the phase of suspension of therapy.
• Abrupt discontinuation of this medicine can cause:
• withdrawal symptomssuch as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, you may experience a feeling of detachment or alienation from yourself or from the outside world, increased sensitivity to sounds, numbness and tingling in the legs or arms, hypersensitivity to light, noise and physical contact, perception of non-existent things, seizures;
• rebound symptoms(when the symptoms that led to treatment with this medicine reappear in a more severe form after stopping treatment) such as mood changes, anxiety, restlessness or sleep disturbances.

If you have any doubts 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 everyone gets them.
Contact your doctor immediatelyif you experience any of the following serious side effects during treatment with Limbitryl; your doctor will explain how to stopusing the medicine:

• you develop symptoms such as a significant increase in body temperature, muscle rigidity, changes in mental status, which may be a sign of a condition similar to neuroleptic malignant syndrome
• restlessness, agitation, irritability, aggressiveness, anger
• delusions
• nightmares
• perception of things that are not real (hallucinations)
• manias (psychosis)
• abnormal behavior
• other behavioral side effects. These reactions are more common if you are elderly.

Frequency not known:
Stop using Limbitryl and contact your doctor immediately if you notice any of the following symptoms:
widespread skin rash, high body temperature and swollen lymph nodes (DRESS or drug reaction with eosinophilia and systemic symptoms).
The following side effects have been observed and reported during treatment with Limbitryl with the following
frequencies:

Very common (may affect more than 1 in 10 people)

• weight gain
• headache
• dizziness
• tremor
• sleepiness
• impaired vision (e.g. difficulty focusing)
• feeling of increased heartbeat (palpitations)
• increased heart rate (tachycardia)
• dry mouth
• constipation
• nausea
• increased sweating (hyperhidrosis).

Common (may affect up to 1 in 10 people)

• reduced level of consciousness
• sedation, fatigue
• movement disorder with loss of coordination of muscles and joints (ataxia)
• balance disorders
• confusional state
• altered sensitivity of the limbs or other parts of the body (paresthesia)
• dilation of the pupil of the eye (mydriasis)
• abnormal electrocardiogram
• problems with the electrical impulses that control the heartbeat (atrioventricular block, conduction disturbances)
• alterations in taste perception (dysgeusia)
• skin reactions (e.g. skin rash, urticaria)
• erectile dysfunction.

Uncommon (may affect up to 1 in 100 people)

• mood changes (hypomania)
• obsessive thoughts (mania)
• anxiety
• insomnia
• uncontrolled body movements (convulsions)
• increased pressure inside the eye
• ringing or buzzing in the ears (tinnitus)
• high blood pressure (hypertension)
• diarrhea, vomiting
• inability of the urinary bladder to empty completely (urinary retention)
• breast enlargement (gynecomastia).

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

• reduction in the number of blood cells (e.g. thrombocytopenia, leucopenia, agranulocytosis, pancytopenia, eosinophilia)
• weight loss
• loss of appetite (anorexia)
• delirium
• hallucinations
• dizziness
• double vision (diplopia)
• irregular heartbeat (arrhythmia)
• worsening of pre-existing heart failure (condition in which oxygen supply is insufficient to meet the heart's needs)
• low blood pressure (hypotension)
• enlargement of the salivary gland
• blockage of the intestine (paralytic ileus)
• yellowing of the skin and whites of the eyes (jaundice)
• increased liver enzymes in the blood (blood bilirubin, transaminases and alkaline phosphatase)
• hair loss (alopecia)
• reactions following exposure of the skin to light (photosensitivity reactions)
• muscle weakness
• decreased sexual desire (libido disorders)
• menstrual problems
• increased body temperature (pyrexia).

Very rare (may affect up to 1 in 10,000 people)

• allergy
• swelling that may affect the tongue and/or throat and may lead to obstruction of the airways which could be fatal (angioedema).

Not known (frequency cannot be estimated from the available data)

• abnormal secretion of the antidiuretic hormone
• suicide attempt
• suicidal ideation
• memory disorders, including memory loss (amnesia)
• physical and psychological dependence
• depression
• psychotic disorders
• altered behavior
• emotional disturbances
• sleep disorders
• difficulty articulating words (dysarthria)
• gait disturbances
• extrapyramidal disorders (e.g. difficulty with movements)
• altered body movements (dystonia)
• depression of breathing
• secretion of milk outside of the breastfeeding period (galactorrhea)
• dry eyes
• low sodium concentration in the blood (hyponatremia).

This medicine can increase the risk of falls and bone fractures, especially if you are elderly.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Limbitryl

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
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 Limbitryl contains

• The active ingredients are:
• amitriptyline hydrochloride 28.3 mg equivalent to amitriptyline 25 mg
• chlordiazepoxide 10 mg.
• The other ingredients are: ethylcellulose, corn starch, magnesium stearate, talc, lactose(see section “Limbitryl contains lactose”). Capsule components: gelatin, titanium dioxide, natural type E172 coloring agent.

Description of the appearance of Limbitryl and contents of the pack
It is presented in hard capsules for oral use, packaged in blister packs of 20 capsules.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Viatris Italia S.r.l., Via Vittor Pisani, 20 - 20124 Milano – Italy
Manufacturer
Labiana Pharmaceuticals, S.L.U. – Corbera de Llobregat Plant – Barcelona (Spain)