DULOXETINA 30 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. DULOXETINA DOC Generici 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules
   1. What is DULOXETINA DOC Generici and what it is used for
   2. What you need to know before taking DULOXETINA DOC Generici
   3. How to take DULOXETINA DOC Generici
   4. Possible side effects
   5. How to store DULOXETINA DOC Generici
   6. Contents of the pack and other information

DULOXETINA DOC Generici 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules

Generic medicine

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

1. What is DULOXETINA DOC Generici and what it is used for

DULOXETINA DOC Generici contains the active ingredient duloxetine. DULOXETINA DOC Generici
increases the levels of serotonin and noradrenaline in the nervous system.
DULOXETINA DOC Generici is used in adults to treat:

• depression
• generalised anxiety disorder (a chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, sharp, stabbing, shooting, or oppressive, or as an electric shock. You may have a loss of sensation in the affected area, or sensations where contact, heat, cold or pressure can cause pain).

DULOXETINA DOC Generici starts to be effective in most people with
depression or anxiety within two weeks of starting treatment, but it may take
2-4 weeks before you feel better. Contact your doctor if you do not start to feel better after
this time. Your doctor may continue to give you DULOXETINA DOC Generici when you feel better
to prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before you
feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking DULOXETINA DOC Generici

Do not take DULOXETINA DOC Generici if:

• you are allergic to duloxetine or any of the other ingredients of this medicine

(listed in section 6)

• you have a liver disease
• you have a severe kidney disease
• you are taking or have taken in the last 14 days another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see “Other medicines and DULOXETINA DOC Generici”)
• you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
• you are taking other medicines that contain duloxetine (see “Other medicines and DULOXETINA DOC Generici”) Tell your doctor if you have high blood pressure or a heart condition. The doctor will tell you if you can take DULOXETINA DOC Generici.

Warnings and precautions
The reasons why DULOXETINA DOC Generici may not be suitable for you are as follows. Talk to
your doctor before taking DULOXETINA DOC Generici if:

• you are taking other medicines to treat depression (see “Other medicines and DULOXETINA DOC Generici”)
• you are taking St. John's Wort (Hypericum perforatum), a herbal medicinal product
• you have a kidney disease
• you have had convulsions (seizures)
• you have had a manic episode
• you suffer from bipolar disorder
• you have problems with your eyes, such as certain types of glaucoma (increased pressure inside the eye)
• you have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see “Pregnancy and breastfeeding”)
• you are at risk of having low sodium levels in your blood (for example if you are taking diuretics, especially if you are an elderly person)
• you are being treated with another medicine that can cause liver damage
• you are taking other medicines that contain duloxetine (see “Other medicines and DULOXETINA DOC Generici”).

DULOXETINA DOC Generici may cause a feeling of restlessness or an inability to sit still or
remain immobile. If this happens to you, you must tell your doctor.
Medicines such as DULOXETINA DOC Generici (so-called selective serotonin reuptake inhibitors (SSRIs)
and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual
dysfunction (see section 4). In some cases, persistence of these symptoms has been observed after
discontinuation of treatment.

Thoughts of suicide and worsening of depression and anxiety
If you are depressed and/or anxious, sometimes you may have thoughts of harming yourself or of
killing yourself. These thoughts may increase when you first start taking antidepressants, as these
medicines take time to work, usually about 2 weeks, but sometimes longer.
You may be more likely to have these thoughts if you:

• have had thoughts of killing yourself or harming yourself in the past
• are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who are

being treated with an antidepressant.

If at any time you have thoughts of harming yourself or of killing yourself, contact your doctor or go
to hospital immediately.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried about changes in your
behaviour.

Children and adolescents
Normally DULOXETINA DOC Generici should not be used in children and adolescents
under 18 years of age. Also, you should know that patients under 18 years of age, when taking this
type of medicine, have an increased risk of undesirable effects such as suicide attempt, suicidal
thoughts and hostile behaviour (especially aggressive behaviour, oppositional behaviour and anger).
Despite this, the doctor may prescribe DULOXETINA DOC Generici to patients under 18 years of age if
he/she believes that this is the best solution for them. If the doctor has prescribed DULOXETINA DOC
Generici to a patient under 18 years of age and you would like clarification, return to the doctor.
You must tell the doctor if any of the symptoms mentioned above appear or worsen when patients
under 18 years of age are taking DULOXETINA DOC Generici. Furthermore, long-term safety effects
regarding growth, maturity and cognitive and behavioural development have not yet been demonstrated
in this age group.

Other medicines and DULOXETINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
The main component of DULOXETINA DOC Generici, duloxetine, is found in other medicines
for other conditions:

• diabetic neuropathic pain, depression, anxiety and urinary incontinence. The simultaneous use of more than one of these medicines must be avoided. Check with your doctor if you are already taking medicines that contain duloxetine.

The doctor must decide if you can take DULOXETINA DOC Generici with other medicines.

Do not start or stop taking any medicine, including those bought without
prescription and herbal medicinal products, before consulting your
doctor.
Also tell your doctor if you are taking any of the following medicines:

Monoamine Oxidase Inhibitors (MAOIs): You must not take DULOXETINA DOC Generici if
you are taking, or have recently taken (within the last 14 days) another antidepressant called a
monoamine oxidase inhibitor (MAOI). Examples of MAOI medicines include moclobemide (an
antidepressant) and linezolid (an antibiotic). Taking an MAOI together with many prescription
medicines, including DULOXETINA DOC Generici, can cause serious or even life-threatening side
effects. You must wait at least 14 days after stopping taking an MAOI before you can take
DULOXETINA DOC Generici. Also, you must wait at least 5 days after stopping taking
DULOXETINA DOC Generici before taking an MAOI.

Medicines that cause drowsiness: These include medicines prescribed by your doctor, such as
benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.

Medicines that increase serotonin levels: Triptans, tramadol, tryptophan, Selective Serotonin
Reuptake Inhibitors (SSRIs) (such as paroxetine and fluoxetine), Serotonin-Noradrenaline Reuptake
Inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine,
amitriptyline), pethidine, St. John's Wort (hypericum) and MAOIs (such as moclobemide and
linezolid). These medicines increase the risk of side effects; if you experience any unusual
symptoms while taking one of these medicines together with DULOXETINA DOC Generici, you
should consult your doctor.

Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent blood
clotting. These medicines may increase the risk of bleeding.

DULOXETINA DOC Generici with food, beverages and alcohol
DULOXETINA DOC Generici can be taken independently of meals. You should be careful
if you drink alcohol while being treated with DULOXETINA DOC Generici.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant, or are planning to become pregnant, while

discussing with your doctor the potential benefits and any potential risk to the unborn child.

• Make sure your midwife and/or doctor know that you are being treated with DULOXETINA DOC Generici. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves the newborn having a fast breathing rate and a bluish skin colour. These symptoms usually appear during the first 24 hours after birth. If this happens to the newborn, contact your midwife or doctor immediately.
• If you take DULOXETINA DOC Generici near the end of your pregnancy, the newborn may experience some symptoms just after being born. Generally these appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, nervousness, difficulty feeding, a breathing disorder and convulsions. If the newborn presents any of these symptoms after birth, or you are worried about the health of the baby, contact your doctor or midwife who will be able to advise you.
• If you take DULOXETINA DOC Generici near the end of your pregnancy there is an increased risk of excessive vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking duloxetine so that they can advise you.
• Available data on the use of DULOXETINA DOC Generici during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If DULOXETINA DOC Generici is taken during the second half of pregnancy there may be

an increased risk that the newborn may be born prematurely (6 more newborns born
prematurely per 100 women taking DULOXETINA DOC Generici in the second
part of pregnancy), mostly between weeks 35 and 36 of pregnancy.

• Tell your doctor if you are breastfeeding. The use of DULOXETINA DOC Generici during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

Driving and using machines
DULOXETINA DOC Generici may cause drowsiness or dizziness. Do not drive or
use tools or machines until you know how DULOXETINA DOC Generici
affects you.

DULOXETINA DOC Generici contains sucrose
DULOXETINA DOC Generici contains sucrose. If you have been diagnosed with an intolerance to
certain sugars, contact your doctor before taking this medicine.

DULOXETINA DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium
free’.

3. How to take DULOXETINA DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
DULOXETINA DOC Generici is taken orally. Swallow the capsule without chewing, with
the help of a glass of water.

For depression and diabetic neuropathic pain
The usual dose of DULOXETINA DOC Generici is 60 mg once a day, but your doctor will
prescribe the dose that he/she deems right for you.

For generalized anxiety disorder
The usual starting dose of DULOXETINA DOC Generici is 30 mg once a day, after which
most patients will receive 60 mg once a day, but your doctor will prescribe the dose
that he/she deems right for you. The dose may be adjusted up to 120 mg per day, based on your
response to DULOXETINA DOC Generici.
To help you remember to take DULOXETINA DOC Generici, it may be easier for you to take it
every day at the same time.
Talk to your doctor about how long you should continue to take DULOXETINA DOC Generici. Do not
stop taking DULOXETINA DOC Generici, or change the dose, without talking to
your doctor. Appropriate treatment of the disorder is important to help you feel better. If
untreated, the disorder may not improve and may become more serious and difficult to treat.

If you take more DULOXETINA DOC Generici than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of DULOXETINA
DOC Generici greater than what your doctor has prescribed. Symptoms of overdose
include drowsiness, coma, serotonin syndrome (a rare reaction that can cause
feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk,
fever, sweating, or muscle rigidity), seizures, vomiting, and increased heart rate.

If you forget to take DULOXETINA DOC Generici
If you forget a dose, take it as soon as you remember. However, if this is the time to
take the next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a missed dose. Do not take more than
the quantity of DULOXETINA DOC Generici that has been prescribed for you for one day.

If you stop taking DULOXETINA DOC Generici
Even if you feel better, DO NOT stop taking the capsules without consulting your
doctor. If your doctor believes you no longer need DULOXETINA DOC Generici, he/she will ask you to
gradually reduce the dose over a period of at least 2 weeks before stopping treatment
completely.
Some patients who suddenly stop taking duloxetine have experienced symptoms
such as:

• dizziness, sensations of tingling like pinpricks and needles or electric shock-like sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or unwellness (vomiting), tremor, headache, muscle pain, feeling irritable, diarrhea, excessive sweating, or dizziness.

Usually these symptoms are not serious and disappear within a few days, but if you experience symptoms
that are bothersome, you should consult your doctor.
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. Normally these effects are mild to moderate and often disappear after a few weeks.

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

• headache, feeling of drowsiness
• feeling unwell (nausea), dry mouth.

Common side effects (may affect up to 1 in 10 people)

• loss of appetite
• difficulty falling asleep (insomnia), feeling of agitation, decreased sexual desire, anxiety, difficulty or inability to reach orgasm, unusual dreams
• dizziness, feeling of sluggishness, tremor, numbness, including a sensation of tingling or pins and needles in the skin
• blurred vision
• tinnitus (perception of a sound in the ear in the absence of an external sound stimulus)
• feeling the heart beating in the chest
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhea, stomach pain, retching (vomiting), heartburn, indigestion, accumulation of gas in the intestine
• increased sweating, rash (itchy)
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss.

Children and adolescents under 18 years of age with depression treated with this medicine have experienced some weight loss when they first started taking this medicine. After 6 months of treatment the weight increased to be equal to that of other children and adolescents of the same age and sex.

Uncommon side effects (may affect up to 1 in 100 people)

• inflammation of the throat causing a hoarse voice
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling of disorientation, lack of motivation
• sudden and involuntary spasms or contractions of the muscles, feeling of restlessness or inability to sit still or remain quiet, feeling of nervousness, difficulty concentrating, changes in the sense of taste, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the dark center of the eye), visual disturbances
• feeling of dizziness or “spinning” (vertigo), ear pain
• acceleration or irregularity of the heartbeat
• fainting, dizziness, feeling of emptiness or impending fainting while standing, feeling of coldness in the fingers of the hands and/or feet
• feeling of constriction in the throat, nosebleeds
• vomiting blood or presence of black, tarry stools, gastroenteritis, belching, difficulty swallowing
• inflammation of the liver which can cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, urticaria, cold sweats, sensitivity to sunlight, increased tendency to develop bruises
• muscle stiffness, muscle contraction
• difficulty or inability to urinate, difficulty starting urination, need to urinate during the night, need to urinate more than usual, reduced urine flow
• abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged cycles, unusually light or absent cycles, pain in the testicles or scrotum
• chest pain, feeling of cold, thirst, tremor, feeling of warmth, abnormal gait
• weight gain
• DULOXETINA DOC Generici may cause effects of which you may not be aware, such as increases in liver enzymes, or levels in the blood of potassium, creatine phosphokinase, sugars or cholesterol.

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

• severe allergic reaction causing difficulty breathing or dizziness with swelling of the tongue and lips, allergic reactions
• decreased activity of the thyroid gland which can cause fatigue or weight gain
• dehydration, low levels of sodium in the blood (especially in elderly people; symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling nauseous or vomiting, more serious symptoms are loss of consciousness, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, mania (hyperactivity, racing thoughts and decreased need for sleep), hallucinations, aggressive behavior and anger
• “Serotonin Syndrome” (a rare reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• cough, wheezing and shortness of breath possibly accompanied by fever.
• inflammation of the mouth, presence of bright red blood in the stool, bad breath, inflammation of the large intestine (colon) (which causes diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with the appearance of blisters on the skin, mouth, eyes and genitals), severe allergic reaction causing swelling of the face or throat (angioedema)
• contraction of the muscles of the mouth
• altered smell of urine
• menopausal symptoms, abnormal production of breast milk in men and women
• excessive vaginal bleeding immediately after childbirth (postpartum hemorrhage)
• Inflammation of the blood vessels of the skin (cutaneous vasculitis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 DULOXETINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
30 mg: store at a temperature below 30°C. Store in the original packaging
to protect the medicine from light.
60 mg: store at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DULOXETINA DOC Generici contains
The active ingredient is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other ingredients are:

Capsule contents: hypromellose, talc, titanium dioxide, methacrylic acid copolymer with
methyl methacrylate, sodium lauryl sulfate, polysorbate 80, triethyl citrate, sugar granules (corn starch and
sucrose), sucrose.

Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132). The 60 mg capsule
also contains yellow iron oxide (E172).

Printing ink:shellac, black iron oxide (E172), potassium hydroxide.

Description of DULOXETINA DOC Generici and contents of the pack
DULOXETINA DOC Generici is a hard gastro-resistant capsule. Each capsule of DULOXETINA
DOC Generici contains granules of duloxetine hydrochloride with a coating to protect them
from stomach acidity.
DULOXETINA DOC Generici is available in 2 dosages: 30 mg and 60 mg.
The 30 mg capsules are opaque blue and opaque white (approximately 15 mm in size), with
the inscription “E” in black on the cap and the inscription “127” on the body of the
capsule.
The 60 mg capsules are opaque blue and opaque green (approximately 19 mm in size), with
the inscription “E” in black on the cap and the inscription “129” on the body of the
capsule.
DULOXETINA DOC Generici 30 mg is available in blisters in packs of 7 and 28 capsules.
DULOXETINA DOC Generici 60 mg is available in blisters in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l - Via Turati 40 - 20121 Milano – Italy.

Manufacturer
Towa Pharmaceutical Europe S.L., C/San Martí, 75-97, Martorelles, 08107 Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations
Italy: DULOXETINA DOC Generici