TRIPTIZOL 25 mg Coated Tablet

Зміст інструкції

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

TRIPTIZOL 10 mg coated tablets
TRIPTIZOL 25 mg coated tablets
amitriptyline hydrochloride

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:

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

1. What is TRIPTIZOL and what is it used for

TRIPTIZOL belongs to a group of medicines called tricyclic antidepressants.
This medicine is used to treat:

• Depression in adults (major depressive episodes)
• Neuropathic pain in adults
• Prophylaxis of chronic tension headache in adults
• Prophylaxis of migraine in adults
• Involuntary loss of urine during the night in children aged 6 years and over only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been obtained to all other non-pharmacological and pharmacological treatments, including muscle relaxants and desmopressin. This medicine must be prescribed exclusively by a healthcare professional experienced in the treatment of persistent enuresis.

2. What you need to know before taking TRIPTIZOL

Do not take TRIPTIZOL

• if you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6)
• if you have recently had a heart attack (myocardial infarction)
• if you have heart problems, such as abnormal heart rhythm evident on an electrocardiogram (ECG), heart block or coronary artery disease
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• if you have taken MAOIs in the last 14 days
• if you have taken moclobemide the day before
• if you have a severe liver disease. If you are being treated with TRIPTIZOL, you must stop taking this medicine and wait 14 days before starting treatment with an MAOI. This medicine should not be used in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIPTIZOL.
If you receive a high dose of amitriptyline, heart rhythm disturbances and
hypotension may occur. These can also occur with the usual doses in patients with pre-existing
heart disease.
Prolongation of the QT interval
With TRIPTIZOL, a heart problem called "prolongation
of the QT interval" (evident on an electrocardiogram, ECG) and heart rhythm disturbances
(fast or irregular heartbeat) have been reported. Tell your doctor if:

• you have a slow heartbeat
• you have or have had a problem with the heart's inability to pump blood around the body as it should (a condition called heart failure)
• you are taking any other medicine that can cause heart problems, or
• you have low levels of potassium or magnesium or high levels of potassium in your blood
• you are about to have surgery, as it may be necessary to stop treatment with amitriptyline before you are given anesthetics. In case of emergency surgery, the anesthesiologist should be informed of the treatment with amitriptyline
• you have an overactive thyroid or are receiving medicines for the thyroid.

Suicidal thoughts and worsening of depression
If you are depressed, you sometimes may have the idea of harming yourself or committing suicide. These thoughts may
increase at the beginning of treatment with antidepressants, because the effect of these medicines
does not appear immediately, but after two weeks or even more.
You are more likely to have these kinds of thoughts:

• If you have previously thought about suicide or self-harm
• If you are a young adult. Information obtained from clinical studies has highlighted an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric illnesses who were being treated with an antidepressant. If at any time you think about harming yourself or committing suicide, contact your doctor immediately or go to hospital. If you are depressed, it may be helpful to tell a family member or friend and ask them to read

depression or anxiety is getting worse or if they are concerned about changes in your
behavior.
Manic episodes
Some patients with manic-depressive illness may enter a manic phase.
This is characterized by a variety of rapidly changing ideas, exaggerated cheerfulness and
excessive physical activity. In these cases it is important to contact your doctor,
who will probably modify the treatment.
Tell your doctor if you have or have had in the past any medical problem, in particular:

• narrow-angle glaucoma (loss of vision due to an abnormal increase in pressure inside the eye)
• epilepsy, a history of seizures or convulsions
• difficulty urinating
• enlarged prostate
• thyroid disease
• bipolar disorder
• schizophrenia
• severe liver disease
• severe heart disease
• pyloric stenosis (narrowing of the stomach outlet valve) and paralytic ileus (intestinal blockage)
• diabetes, because it may be necessary to adjust the treatment with antidiabetic medicines.

If you are using antidepressants such as SSRIs, your doctor may consider adjusting the
dose of the medicine (see also section 2 Other medicines and TRIPTIZOL and section 3).
Tell your doctor if you are taking medicines containing buprenorphine. The use of TRIPTIZOL together
with medicines containing buprenorphine may lead to serotonin syndrome, a
condition that can be fatal (see “Other medicines and TRIPTIZOL”).
Elderly people are more likely to experience certain side effects, such as
dizziness when getting up, due to low blood pressure (see also
section 4 Possible side effects).

Children and adolescents

Depression, neuropathic pain, chronic tension headache and migraine prophylaxis
Do not give this medicine to children and adolescents under 18 years of age for the
treatment of these diseases as the long-term safety and efficacy have not been
established in this age group.

Involuntary loss of urine during the night

• Before starting therapy with amitriptyline, an ECG should be performed to rule out a long QT syndrome
• This medicine should not be taken at the same time as an anticholinergic (see also section 2 Other medicines and TRIPTIZOL)
• Suicidal thoughts and behaviors may occur at the beginning of treatment with antidepressants even in patients suffering from disorders other than depression; the same precautions used in the treatment of patients with depression should therefore be taken in the treatment of patients with enuresis.

Other medicines and TRIPTIZOL
Some medicines can alter the effect of other medicines and this can sometimes cause
serious side effects.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicine, such as:

• monoamine oxidase inhibitors (MAOIs) such as phenelzine, iproniazide, isocarboxazide, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's disease). These medicines should not be taken at the same time as TRIPTIZOL (see section 2 Do not take TRIPTIZOL)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (may be present in cough or cold medicines and some anesthetics)
• medicines for the treatment of high blood pressure, such as calcium channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine and methyldopa
• anticholinergics, such as certain medicines for the treatment of Parkinson's disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)
• thioridazine (used to treat schizophrenia) tramadol (painkiller) medicines containing buprenorphine. These medicines may interact with Triptizol and may manifest symptoms such as involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38 °C. Contact your doctor if you experience these symptoms
• medicines for the treatment of fungal infections (e.g. fluconazole, terbinafine, ketoconazole and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressants (e.g. SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion)
• medicines for certain heart diseases (e.g. beta-blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir (used to treat HIV)
• oral contraceptives
• rifampicin (for the treatment of infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• valproic acid
• St. John's Wort (Hypericum perforatum), a herbal product used for depression
• thyroid medicines.

Also tell your doctor if you are taking or have recently taken medicines that
can alter the heart rhythm, such as:

• medicines for the treatment of irregular heartbeat (e.g. quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hay fever)
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• cisapride (used to treat certain digestive disorders)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and detoxification)
• diuretics (medicines that increase urine production, e.g. furosemide).

If you are to undergo surgery and receive general or local anesthetics, tell your
doctor that you are taking this medicine.
Similarly, tell your dentist that you are taking this medicine if you are to receive
a local anesthetic.

TRIPTIZOL with alcohol
It is not advisable to drink alcohol while being treated with this
medicine, as it may increase the sedative effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become
pregnant, ask your doctor for advice before taking this
medicine.
Amitriptyline is not recommended during pregnancy unless your doctor considers it
clearly necessary and only after a careful assessment of the benefit and risk. If you
have taken this medicine in the last months of pregnancy, the newborn may experience
withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing,
feeding disorders, loud crying, urinary retention and constipation.
Your doctor will tell you whether to start/continue/stop breastfeeding or stop using
this medicine taking into account the benefit of breastfeeding for the baby and
the benefit of therapy for you.

Driving and using machines
This medicine can cause drowsiness and dizziness, especially at the
beginning of
treatment. Do not drive and do not use tools or machines if you experience these symptoms.

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

3. How to take TRIPTIZOL

Take this medicine following exactly the instructions of your doctor. If you have
doubts consult your doctor.
Not all dosage schemes can be achieved with all pharmaceutical forms/dosages. The appropriate formulation/dosage must be defined for the
starting doses and for subsequent dose increments.

Depression

Adults
The recommended initial dose is 25 mg twice a day.
Based on your response to the medicine, your doctor may gradually increase the dose up to
150 mg per day divided into two doses.

Elderly (over 65 years of age) and patients with cardiovascular disease
The recommended initial dose is 10 mg – 25 mg per day.
Based on your response to the medicine, your doctor may gradually increase the dose up to
a total daily dose of 100 mg, divided into two doses. If you receive doses of 100 mg - 150 mg, your
doctor may perform more frequent checks.

Use in children and adolescents
This medicine should not be given to children or adolescents for the
treatment of depression. For further information see paragraph 2.

Neuropathic pain, chronic tension headache and migraine prophylaxis
The doctor will modify the treatment based on symptoms and response to therapy.

Adults
The recommended initial dose is 10 mg - 25 mg in the evening.
The recommended daily dose is 25 mg - 75 mg.
Based on your response to the medicine, your doctor may gradually increase the dose. If
you receive doses greater than 100 mg per day, your doctor may perform more
frequent checks. Your doctor will tell you whether to take the dose once a day or divided into two doses.

Elderly (over 65 years of age) and patients with cardiovascular disease
The recommended initial dose is 10 mg – 25 mg in the evening.
Based on your response to the medicine, your doctor may gradually increase the dose.
If you receive doses greater than 75 mg per day, your doctor may perform more
frequent checks.

Use in children and adolescents
This medicine should not be given to children or adolescents for the
treatments of neuropathic pain, prophylaxis of chronic tension headache and migraine prophylaxis.
For further information see paragraph 2.

Involuntary loss of urine during the night

Use in children and adolescents
Recommended doses for children:

• under 6 years of age: see paragraph 2 Do not take TRIPTIZOL
• between 6 and 10 years of age: 10 mg - 20 mg per day. A more suitable dosage form should be used for this group of patients
• 11 years of age or older: 25 mg - 50 mg. Increase the dose gradually. Take this medicine 1 - 1.5 hours before bedtime. Before starting treatment, the doctor will perform an ECG of the heart to look for any signs of abnormal heartbeat. The doctor will re-evaluate the treatment after 3 months and, if necessary, perform an ECG. Do not stop treatment without consulting your doctor. Patients with particular risksPatients with liver disease or people who are “slow metabolizers” generally receive lower doses. The doctor may take blood samples to determine the level of amitriptyline in the blood (see also paragraph 2). How and when to take TRIPTIZOLThis medicine can be taken with or without food. Swallow the tablets with a glass of water. Do not chew them. Duration of treatmentDo not change the dose of the medicine and do not stop treatment without consulting your doctor. DepressionAs with other medicines for the treatment of depression, it may take a few weeks before you notice an improvement. The duration of treatment for depression varies on an individual basis and is generally at least 6 months. The doctor will determine the duration of treatment.

Continue to take this medicine for the time recommended by your doctor.
The underlying disease may persist for a long time. If you stop treatment too early, the
symptoms may recur.

Neuropathic pain, chronic tension headache and migraine prophylaxis
It may take a few weeks before you notice an improvement in pain.
Consult your doctor regarding the duration of treatment and continue to take this
medicine for the time recommended by your doctor.

Involuntary loss of urine during the night
After 3 months, the doctor will decide whether to continue treatment.

If you take more TRIPTIZOL than you should
Contact your doctor or the nearest hospital emergency room immediately, even
if you have no symptoms or signs of poisoning. If you go to the doctor or hospital, bring with
you the container of the medicine.
Symptoms of overdose include:

• dilated pupils
• rapid or irregular heartbeat
• difficulty urinating
• dry mouth and tongue
• intestinal blockage
• convulsions
• fever
• agitation
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• difficulty breathing
• bluish discoloration of the skin
• reduced heart rate
• numbness
• loss of consciousness
• coma
• various symptoms to the heart such as cardiac block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.

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

If you forget to take TRIPTIZOL
Take the next dose at the usual time. Do not take a double dose to make up for the
missed dose.

If you stop taking TRIPTIZOL
The doctor will decide when and how to stop treatment to avoid unpleasant symptoms
that may occur when treatment is stopped abruptly (e.g. headache, malaise,
insomnia and irritability).
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Seek immediate medical attention if you notice any of the following symptoms:

• Transient blurred vision, seeing rainbows around lights and eye pain. See an eye doctor immediately before continuing treatment with this medicine. These disturbances may be signs of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people.
• A heart problem called “prolonged QT interval” (evident on an electrocardiogram, ECG). Common side effect, may affect up to 1 in 10 people.
• Troublesome constipation, stomach bloating, fever and vomiting. These symptoms may be due to paralysis of parts of the intestine. Rare side effect, may affect up to 1 in 1,000 people.
• Yellowing of the skin and whites of the eyes (jaundice). May have problems with the liver. Rare side effect, may affect up to 1 in 1,000 people.
• Bruising, bleeding, paleness or persistent sore throat and fever. These symptoms may be early signs of problems with the blood or bone marrow. Effects on the blood include a reduction in the number of red blood cells (which carry oxygen throughout the body), white blood cells (which help fight infections) and platelets (which promote coagulation). Rare side effect, may affect up to 1 in 1,000 people.
• Suicidal behavior or thoughts. Rare side effect, may affect up to 1 in 1,000 people.

The side effects listed below have been reported with the following frequencies:
Very common: may affect more than 1 in 10 people

• drowsiness/torpor
• tremor in the hands or other parts of the body
• dizziness
• headache
• irregular, strong or fast heartbeat
• dizziness upon standing up, due to low blood pressure (orthostatic hypotension)
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• slurred or slowed speech
• aggression
• nasal congestion. Common: may affect up to 1 in 10 people
• confusion
• sexual disorders (decreased sexual desire, erectile dysfunction)
• attention deficit
• altered taste
• numbness or tingling in the arms or legs
• loss of coordination
• dilated pupils
• heart block
• fatigue
• low sodium levels in the blood
• agitation
• urination disorders
• feeling of thirst. Uncommon: may affect up to 1 in 100 people
• excitement, anxiety, difficulty sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhea, vomiting
• skin rash, hives, swelling of the face and tongue
• difficulty urinating
• increased milk production or milk flow from the breasts in people who are not breastfeeding
• increased pressure inside the eye
• collapse conditions
• worsening of heart failure
• worsening of liver function (e.g., cholestatic hepatopathy). Rare: may affect up to 1 in 1,000 people
• decreased appetite
• delirium (especially in elderly patients), hallucinations
• abnormal heart rhythm or sequence of heartbeat
• swelling of the salivary glands
• hair loss
• increased sensitivity to sunlight
• breast enlargement in men
• fever
• weight loss
• changes in liver function test results Very rare: may affect up to 1 in 10,000 people
• heart muscle disease
• feeling of inner restlessness and an urgent need to be constantly moving
• peripheral nerve disorders
• acute increase in pressure inside the eye
• specific forms of abnormal heart rhythm (called torsade de pointes)
• allergic inflammation of the alveoli of the lungs and lung tissue. Not known: frequency cannot be estimated based on available data
• feeling of absent appetite
• increase or decrease in blood sugar levels
• paranoia
• movement disorders (involuntary movements or decreased movements)
• hypersensitivity inflammation of the heart muscle
• hepatitis
• hot flashes
• dry eye In patients taking medicines of this type, an increased risk of bone fractures has been observed.

Reporting of side effects
If you experience any side effects, including 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 contribute to providing more information on the safety of this
medicine.

5. How to store TRIPTIZOL

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 label after
“Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.

6. Contents of the pack and other information

What TRIPTIZOL contains
TRIPTIZOL 10 mg coated tablets

• The active ingredient is amitriptyline hydrochloride. Each tablet contains 10 mg of amitriptyline hydrochloride.
• The other ingredients are lactose monohydrate; dibasic calcium phosphate dihydrate; powdered cellulose; corn starch; indigotine (E 132); hydrated colloidal silica; stearic acid; magnesium stearate; hypromellose; hydroxypropylcellulose; indigotine on hydrated aluminum (E 132); titanium dioxide; talc; carnauba wax.

TRIPTIZOL 25 mg coated tablets

• The active ingredient is amitriptyline hydrochloride. Each tablet contains 25 mg of amitriptyline hydrochloride.
• The other ingredients are lactose monohydrate; dibasic calcium phosphate dihydrate; powdered cellulose; corn starch; quinoline yellow on hydrated aluminum (E 104); hydrated colloidal silica; stearic acid; magnesium stearate; hypromellose; hydroxypropylcellulose; titanium dioxide; talc; carnauba wax; yellow iron oxide.

Description of the appearance of TRIPTIZOL and contents of the pack
Coated tablets.
TRIPTIZOL 10 mg coated tablets are presented in packs of 30 tablets in
blisters.
TRIPTIZOL 25 mg coated tablets are presented in packs of 25 tablets in
blisters.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT Specialità Igienico Terapeutiche S.r.l. - Via Cavour, 70 - 27035
Mede (PV)