DULEX 30 mg Kapsułki Powlekane

Treść ulotki

1. Dulex 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules
   1. What Dulex is and what it is used for
   2. What you need to know before taking Dulex
   3. How to take Dulex
   4. Possible side effects
   5. How to store Dulex
   6. Package Contents and Other Information

Dulex 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules

Duloxetine
Generic medicine

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

1. What Dulex is and what it is used for

Dulex contains the active substance duloxetine. Dulex increases the levels of serotonin and noradrenaline in the nervous system.
Dulex is used in adults to treat:

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

Dulex 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 Dulex when you feel better to prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, several weeks may be needed before you feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Dulex

DO NOT take Dulex if you:

• are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• have a liver disease
• have a severe kidney disease
• are taking or have taken within the last 14 days, another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see ‘Other medicines and Dulex’)
• are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
• are taking other medicines that contain duloxetine (see ‘Other medicines and Dulex’).

Tell your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if
you can take Dulex.

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

• you are taking other medicines to treat depression or if you have other conditions that are treated with antidepressants. The use of these medicines together with Dulex may lead to serotonin syndrome, a condition that can be life-threatening (see ‘Other medicines and Dulex’)
• you are taking St. John's Wort ( Hypericum perforatum), a herbal remedy
• you have a kidney disease
• you have had seizures (convulsions)
• 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 bruise easily)
• you are at risk of having low sodium levels (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 Dulex’)
• if you are taking medicines containing buprenorphine or buprenorphine/naloxone.

Dulex may cause a feeling of restlessness or an inability to sit still or remain calm. If this
happens to you, you must tell your doctor.
Medicines such as Dulex (so-called selective serotonin reuptake inhibitors -
noradrenaline (SNRIs)) can cause symptoms of sexual dysfunction (see section 4).
In some cases, these symptoms have been observed to persist after stopping treatment.

Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or anxious, you may sometimes have thoughts about self-harm or suicide.
These thoughts may be increased 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 previously had thoughts about killing yourself or self-harm
• are 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 were treated with an antidepressant

If at any time you have thoughts of self-harm or suicide, 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 under 18 years of age
Normally Dulex 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 attempts, suicidal thoughts and hostile behaviour (especially aggressive behaviour, opposition and anger).
Despite this, your doctor may prescribe Dulex to patients under 18 years of age if he/she believes that this is the best solution for them. If the doctor has prescribed Dulex to a patient under 18
years of age and you would like clarification, return to the doctor. You must inform the doctor if any of the above symptoms occur or worsen when patients under 18 years of age are taking
Dulex. Furthermore, long-term safety effects of Dulex relating to growth, maturity and cognitive and behavioural development have not yet been demonstrated in this age group.

Other medicines and Dulex
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The main component of Dulex, 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 should be avoided. Check with your doctor
if you are already taking medicines that contain duloxetine.
The doctor must decide if you can take Dulex with other medicines. Do not start or stop
taking any medicine, including those bought without a prescription and herbal remedies, 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 Dulex 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 Dulex, 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 Dulex. Also, you must wait at least 5 days after stopping taking Dulex 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, fluoxetine, fluvoxamine,
sertraline, citalopram and escitalopram), Selective Serotonin/Noradrenaline Reuptake
Inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine,
amitriptyline, trimipramine and doxepin), pethidine, St. John's Wort (hypericum), buprenorphine or
buprenorphine/naloxone and MAOIs (such as moclobemide, tranylcypromine and linezolid). These
medicines may interact with Dulex and symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased
muscle contraction, fever above 38 °C may occur. Contact your doctor if you experience these symptoms.

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

Dulex with food, drinks and alcohol
Dulex can be taken independently of meals. You should be careful if you drink alcohol when
you are being treated with Dulex.

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

• Tell your doctor if you are pregnant, or planning to become pregnant, while taking Dulex. You should only use duloxetine after discussing the potential benefits and any potential risks to the unborn child with your doctor.

Make sure your midwife and/or doctor knows that you are being treated with Dulex. When taken in
pregnancy, similar medicines (SSRIs) may increase the risk of a serious
condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which
means that the newborn has 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 Dulex near the end of your pregnancy, the newborn may experience
some symptoms shortly after birth. Generally, these appear at birth or within a few days of
birth. These symptoms may include flaccid muscles, tremor, nervousness, difficulty
breastfeeding, breathing problems and seizures. If the newborn experiences any
of these symptoms after birth, or you are concerned about the baby's health, contact your
doctor or midwife who will be able to advise you.

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

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

Dulex contains sucrose
Dulex contains sucrose. If you have been diagnosed with an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Dulex

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Dulex 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 Dulex is 60 mg once a day, but your doctor will prescribe the dose that
they consider right for you.

For generalized anxiety disorder:
The usual starting dose of Dulex is 30 mg once a day, after which most
patients will receive 60 mg once a day, but the doctor will prescribe the dose that they consider right for
you.
The dose may be adjusted up to 120 mg per day, based on your response to Dulex.
To help you remember to take Dulex, 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 Dulex. Do not stop
taking Dulex, or change the dose, without talking to your doctor. Appropriate treatment
of the disorder is important to help you feel better. If left untreated, the disorder cannot
improve and may become more serious and difficult to treat.

If you take more Dulex than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Dulex greater
than what your doctor 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 Dulex
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 the missed dose. Do not take more than
the amount of Dulex that has been prescribed for you for one day.

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

• dizziness, sensations of tingling like pins and needles or electric shock sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or unwell (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 sleepy
• feeling unwell (nausea), dry mouth.

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

• loss of appetite
• difficulty falling asleep, feeling restless, decreased sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling sluggish, 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 your heart beating in your chest
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhea, stomach pain, retching (vomiting), heartburn, indigestion, accumulation of gas in the intestines
• 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 disoriented, lack of motivation
• sudden and involuntary spasms or contractions of the muscles, feeling restless or inability to sit still or remain quiet, feeling nervous, 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
• dilated pupils (the dark center of the eye), vision disorders
• feeling dizzy or “lightheaded” (vertigo), ear pain
• accelerated or irregular heartbeat
• fainting, dizziness, feeling empty-headed or about to faint when standing up, feeling cold 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, hives, cold sweats, sensitivity to sunlight, increased tendency to develop bruises
• muscle stiffness, muscle contraction
• difficulty or inability to urinate, difficulty starting urination, needing to urinate during the night, needing to urinate more than usual, reduced urine flow
• abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged periods, unusually light or absent periods, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, tremor, feeling hot, abnormal gait
• weight gain
• Dulex 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 sick or being sick, 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, sleepiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, presence of bright red blood in the stools, bad breath, inflammation of the large intestine (leading to 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 jaw muscles
• altered smell of urine
• symptoms of menopause, abnormal production of breast milk in men and women.

Very rare side effects (may affect up to 1 in 10,000 people)
Inflammation of blood vessels in the skin (cutaneous vasculitis)

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 Dulex

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 package and blister.
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. Package Contents and Other Information

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

Capsule content: sugar granules (containing corn starch and sucrose), hypromellose
2910 (E464), crospovidone (Type B), talc, sucrose, carboxymethyl ethyl cellulose, povidone,
titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E433) (see at the end of the paragraph

2 for further information on sucrose).

Capsule shell (for 30 mg dosage): gelatin, titanium dioxide (E171), sodium lauryl sulfate,
indigo carmine (E132).

Capsule shell (for 60 mg dosage): gelatin titanium dioxide (E171), sodium lauryl sulfate,
indigo carmine (E132), synthetic yellow iron oxide (E172).

Edible gold-colored ink (for 30 mg dosage): shellac (E904), propylene glycol,
yellow iron oxide (E172).

Edible white-colored ink (for 60 mg dosage): shellac (E904), propylene glycol,
potassium hydroxide, titanium dioxide (E171).

Description of the appearance of Dulex and package contents
Dulex is a hard, gastro-resistant capsule. Each Dulex capsule contains duloxetine
hydrochloride granules with a coating to protect them from stomach acidity.
Dulex is available in 30 mg and 60 mg dosages.
The 30 mg capsules have a light blue cap and a light white body, size ‘3’
(15.80 ± 0.40 mm), with ‘H’ printed on the cap and ‘191’ on the body, filled with pellets ranging in color from
white to off-white.
The 60 mg capsules have a light blue cap and a light green body, size ‘1’
(19.30 ± 0.40 mm), with ‘H’ printed on the cap and ‘192’ on the body, filled with pellets ranging in color from
white to off-white.
Dulex 30 mg is available in packs of 7 and 28 capsules.
Dulex 60 mg is available in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ecupharma S.r.l. - Via Mazzini 20 - 20123 Milan (Italy).

Manufacturers:
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park, Paola
PLA 3000
Malta

Hetero Malta Ltd.,
KW20A Corradino Industrial Estate, Paola
PLA 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IT:Dulex