DULOXETINA 30 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

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

1. What Duloxetina Pensa is and what it is used for

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

• depression
• generalised 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)

Duloxetina Pensa 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 start to feel better. Talk to your doctor if you do not start to feel better after
this time. Your doctor may continue to give you Duloxetina Pensa when you feel better to
prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before
you start to feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Pensa

Do not take Duloxetina Pensa 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 Duloxetina Pensa’)
• are taking fluvoxamine which is commonly 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 Duloxetina Pensa’)

Tell your doctor if you have high blood pressure or a heart condition. Your doctor will need to decide if you can take Duloxetina Pensa.

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

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

Duloxetina Pensa may cause a feeling of restlessness or an inability to sit still or
remain immobile. If this happens to you, you should tell your doctor.
Medicines such as Duloxetina Pensa (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 or anxiety
If you are depressed and/or anxious sometimes you may have thoughts of harming yourself or of
killing yourself. These thoughts may be increased when you first start taking
antidepressants, as these medicines take time to work, usually about 2 weeks but sometimes even 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 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 harming yourself or of killing yourself, contact your doctor or go
immediately to hospital.
You may find it helpful to tell a relative or close friend that you are depressed or anxious, and ask them to read this leaflet. You can ask them to watch out for any changes in your
depression or anxiety, or if they are worried about your behaviour.

Children and adolescents under the age of 18 years
Normally Duloxetina Pensa should not be used in children and adolescents under the
age of 18 years.
Also, you should know that patients under the age of 18 years, when taking this type of
medicines, 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 Pensa to patients under the age of 18 years if
he/she believes that this is the best solution for them. If the doctor has prescribed Duloxetina
Pensa to a patient under the age of 18 years and you would like clarification, return to the doctor. You should
tell the doctor if any of the symptoms mentioned above occur or worsen when patients
under the age of 18 years are taking Duloxetina Pensa. 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 Pensa
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 Pensa, 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 Duloxetina Pensa with other medicines. Do not start or
stop taking any medicine, including those bought without a prescription
or 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 Duloxetina Pensa 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 Pensa, 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 Pensa. Also, you must
wait at least 5 days after stopping taking Duloxetina Pensa 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
Pensa, you should consult your doctor.

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

Duloxetina Pensa with food, drink and alcohol
Duloxetina Pensa can be taken with or without food. You should be careful if you drink alcohol
while being treated with Duloxetina Pensa.

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

• Tell your doctor if you are pregnant, or planning a pregnancy, while taking Duloxetina Pensa. You should only use Duloxetina Pensa after discussing the potential benefits and any potential risk to the unborn child with your doctor.

Make sure your midwife and/or doctor knows that you are being treated with Duloxetina Pensa.
When taken during pregnancy, similar medicines (SSRIs) may increase the risk of
developing 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 tone. 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 Pensa near the end of your pregnancy, your newborn
may develop some symptoms soon after birth. 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
your newborn develops any of these symptoms after birth, or you are concerned about the
health of the baby, contact your doctor or midwife who will be able to advise you.
If you take Duloxetina Pensa 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.
The available data on the use of Duloxetina Pensa during the first 3 months of pregnancy
do not show an increased risk of overall birth defects in the baby. However, if
Duloxetina Pensa 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 Pensa 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 Pensa during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

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

Duloxetina Pensa contains sucrose
Duloxetina Pensacontains sucrose. If you have been diagnosed with an intolerance to
certain sugars, contact your doctor before taking this medicine

Duloxetina Pensa 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 Pensa

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Duloxetina Pensais taken orally. Swallow the capsule whole with water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Pensa is 60 mg once a day, but your doctor will prescribe the dose that he/she considers right for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Pensa 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 considers right for you.
The dose may be adjusted up to 120 mg per day, depending on your response to Duloxetina Pensa.
To help you remember to take Duloxetina Pensa, 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 Pensa. Do not stop taking Duloxetina Pensa, 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 may not improve and may become more serious and difficult to treat.

If you take more Duloxetina Pensa than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina Pensa 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 Pensa
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 of Duloxetina Pensa than has been prescribed for you for one day.

If you stop taking Duloxetina Pensa
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If your doctor believes you no longer need Duloxetina Pensa, 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 Duloxetina Pensa 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 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 further questions on 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 everybody gets 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 sleepiness
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty falling asleep, 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 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, itchy rash
• 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
• increased or irregular 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
• liver inflammation 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 of cold, thirst, tremor, feeling of warmth, abnormal gait
• weight gain
• Duloxetina Pensa 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, sleepiness, 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 stools, bad breath, inflammation of the large intestine (causing diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious illness 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 bleeding from the vagina immediately after childbirth (postpartum hemorrhage)

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

• inflammation of the 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 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 Duloxetina Pensa

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. The expiry date refers to the last day of that month.
30 mg:

Alu/Alu Blisters:This medicine does not require any special storage conditions.
Store in the original package to protect the medicine from light.

PVC/PVDC-Alu Blisters:Do not store above 25°C. Store in the original package
to protect the medicine from light.
PE bottle: This medicine does not require any special storage conditions.
Store in the original package to protect the medicine from light.
60 mg:

Alu/Alu Blisters:This medicine does not require any special storage conditions.

PVC/PVDC-Alu Blisters:Do not store above 25°C.
PE bottle: This medicine does not require any special storage conditions.
Store in the original package to protect the medicine from light.
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. Package contents and other information

What Duloxetina Pensa 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, ethyl acrylate-methyl methacrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate, sugar spheres (corn starch and sucrose) and sucrose.

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

Printing ink:

Description of the appearance of Duloxetina Pensa and package contents
Duloxetina Pensa is a hard gastro-resistant capsule. Each Duloxetina Pensa capsule contains
granules of duloxetine hydrochloride with a coating to protect them from stomach acid.
Duloxetina Pensa is available in 2 dosages: 30 mg and 60 mg.
The 30 mg capsules are opaque blue and white (approximately 15 mm in size) marked
with the code " E127 " printed in black.
The 60 mg capsules are opaque blue and green (approximately 19 mm in size) marked
with the code " E129 " printed in black.
Duloxetina Pensa 30 mg is available in blister packs of 7, 28 and 98 capsules and bottles
containing 500 capsules.
Duloxetina Pensa 60 mg is available in blister packs of 28 and 98 capsules and bottles
containing 500 capsules.
Not all pack sizes may be marketed.

MARKETING AUTHORISATION HOLDER AND
MANUFACTURER
MARKETING AUTHORISATION HOLDER:
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milan

MANUFACTURER:
Towa Pharmaceutical Europe, S.L., C/ de Sant Martí, 75-97, 08107 Martorelles, Barcelona, Spain.

This medicinal product is authorised in the Member States of the European Economic Area
under the following designations:
Italy: Duloxetina pensa 30 mg gastro-resistant hard capsules
Duloxetina pensa 60 mg gastro-resistant hard capsules
Denmark: Duloxetin Pensa 30 mg enterokapsler, hårde
Duloxetin Pensa 60 mg enterokapsler, hårde
Finland: Duloxetin Pensa 30 mg enterokapseli, kova
Duloxetin Pensa 60 mg enterokapseli, kova
Germany: Duloxetin Pensa 30 mg magensaftresistente Hartkapseln
Duloxetin Pensa 60 mg magensaftresistente Hartkapseln
Norway: Duloxetin Pensa 30 mg enterokapsler, harde
Duloxetin Pensa 60 mg enterokapsler, harde
Netherlands: Duloxetine Pensa 30 mg maagsapresistente capsules, hard
Duloxetine Pensa 60 mg maagsapresistente capsules, hard
Sweden: Duloxetin Pensa 30 mg enterokapslar, hårda
Duloxetin Pensa 60 mg enterokapslar, hårda