ADEPRIL 10 mg Sugar-Coated Tablet

Содержание инструкции

1. Adepril 10 mg coated tablets, 25 mg coated tablets
   1. What is Adepril and what is it used for
   2. What you need to know before taking Adepril
   3. How to take Adepril
   4. Possible side effects
   5. How to store Adepril
   6. Contents of the pack and other information

Adepril 10 mg coated tablets, 25 mg coated tablets

Amitriptyline

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

1. What is Adepril and what is it used for

Adepril 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 Adepril

Do not take Adepril:

• 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 suffer from a severe liver disease.

If you are being treated with Adepril, 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 Adepril.
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.
QT interval prolongation
With ADEPRIL, a heart problem called "QT interval prolongation" (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 problems with low levels of potassium or magnesium, or high levels of potassium in the blood;
• you are awaiting surgery, as it may be necessary to stop treatment with amitriptyline before you are given anesthetics. In the event of emergency surgery, the anesthesiologist should be informed of the treatment with amitriptyline;
• you have an overactive thyroid or are taking medicines for the thyroid.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes 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
if your anxiety is getting worse or if they are worried 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 abnormally high 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) and paralytic ileus (intestinal blockage)
• diabetes, as it may be necessary to adjust treatment with antidiabetic medicines.

If you are using antidepressants such as selective serotonin reuptake inhibitors (SSRIs), your doctor
may consider adjusting the dose of the medicine (see also section 2
Other medicines and Adepril and section 3).
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 conditions 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 long QT syndrome
• This medicine should not be taken at the same time as an anticholinergic (see also section 2 Other medicines and Adepril)
• Suicidal thoughts and behaviors may occur at the beginning of treatment with antidepressants even in patients suffering from conditions other than depression; in the treatment

of patients with enuresis, the same precautions used in the
treatment of patients with depression should therefore be taken

Other medicines and Adepril
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 Adepril (see section 2 Do not take Adepril)
• 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 thioridazine (used to treat schizophrenia)
• tramadol (pain reliever)
• 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 conditions (e.g. beta-blockers and antiarrhythmics)
• cimetidine (anti-ulcer drug, 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)
• St. John's Wort (Hypericum perforatum), a herbal product used for depression
• thyroid medicines
• valproic acid.

Tell your doctor also 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 the
doctor that you are taking this medicine.
Similarly, tell the dentist that you are taking this medicine if you are to receive a
local anesthetic.

ADEPRIL AND ALCOHOL
It is not advisable to drink alcohol during treatment with this medicine,
as it may increase the sedative effect.

PREGNANCY AND BREASTFEEDING
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 essential 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, tremors, 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 MACHINERY
Adepril can cause drowsiness and dizziness, especially at the beginning of treatment. Do not drive and
do not use tools or machinery if you experience these symptoms.

ADEPRIL CONTAINS SUCROSE.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”.

3. How to take Adepril

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 starting doses and for subsequent dose increments.

Depression

Adults
The recommended starting 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 starting 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 starting 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 higher 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 starting 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 higher 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 treatment
of neuropathic pain, chronic tension headache prophylaxis 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 Adepril.
• 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 to 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 risks
Patients 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 Adepril
This medicine can be taken with or without food.
Swallow the tablets with a sip of water. Do not chew them.

Duration of treatment
Do not change the dose of the medicine and do not stop treatment without consulting
your doctor.

Depression
As with other medicines for the treatment of depression, it may take several
weeks before an improvement is noticed.
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 entire 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 several weeks before an improvement in pain is noticed.
Consult your doctor regarding the duration of treatment and continue to take this medicine
for the entire 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 ADEPRIL THAN YOU SHOULD:
Contact your doctor or the nearest hospital emergency room immediately, even if there are no
disorders or signs of poisoning. If you go to the doctor or hospital, bring the
medicine container with you.
Symptoms of overdose include:

• dilated pupils,
• rapid or irregular heartbeat,
• difficulty urinating,
• dry mouth and tongue,
• intestinal blockage,
• convulsions,
• fever
• agitation,
• confusion,
• hallucinations,
• involuntary 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, vomiting and
high blood sugar levels.

IF YOU FORGET TO USE ADEPRIL
Take the next dose at the usual time. Do not take a double dose to make up for the
forgotten dose.

IF YOU STOP TAKING ADEPRIL
The doctor will decide when and how to stop treatment to avoid unpleasant symptoms that
may occur in case of abrupt discontinuation (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, Adepril can cause side effects, although not everybody gets them.
Seek immediate medical attention if you notice any of the following symptoms:

• Transient blurred vision, seeing rainbows 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 in 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 help with blood clotting). 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 following side effects 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
• aggressiveness
• nasal congestion.

Common: may affect up to 1 in 10 people

• confusion
• sexual dysfunction (reduced sexual desire, erectile dysfunction)
• attention disorder
• altered taste
• numbness or tingling in the arms or legs
• coordination disorder
• 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

• loss of 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
• particular forms of abnormal heart rhythm (called torsades 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

An increased risk of bone fractures has been observed in patients taking medicines of this type.

REPORTING OF SIDE EFFECTS
If you get any side effects, even those not listed in this leaflet, tell your doctor. 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 Adepril

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
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 ADEPRIL CONTAINS
ADEPRIL 10 mg coated tablets
The active ingredient is amitriptyline hydrochloride. Each tablet contains 11.4 mg of amitriptyline
hydrochloride (equivalent to 10 mg amitriptyline).
The other ingredients are: tribasic calcium phosphate; microcrystalline cellulose; corn starch;
povidone; magnesium stearate; colophony; sandarac gum; shellac; turpentine; sodium
dioctylsulfosuccinate; talc; light magnesium carbonate; titanium dioxide (E 171); kaolin; gelatine;
sucrose.

ADEPRIL 25 mg coated tablets
The active ingredient is amitriptyline hydrochloride. Each tablet contains 28.5 mg (equivalent to
25 mg amitriptyline).
The other ingredients are: tribasic calcium phosphate; microcrystalline cellulose; corn starch;
povidone; magnesium stearate; colophony; sandarac gum; shellac; turpentine; sodium
dioctylsulfosuccinate; talc; light magnesium carbonate; titanium dioxide (E 171); kaolin; gelatine;
sucrose.

Description of the appearance of Adepril and contents of the pack
Coated tablets 10 mg - Pack of 30 coated tablets in blisters.
Coated tablets 25 mg - Pack of 30 coated tablets in blisters.

MARKETING AUTHORISATION HOLDER AND MANUFACTURER
TEOFARMA S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Fax 0382/525845
e-mail: [email protected]

Manufacturer
TEOFARMA S.r.l.
Viale Certosa 8/A - 27100 Pavia