Duloxetine PensA: detailed information

Package leaflet: Information for the user

Duloxetina Pensa 30 mg gastro-resistant hard capsules, 60 mg gastro-resistant hard capsules

Equivalent medicine
Please read all of this leaflet carefully before taking 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Duloxetina Pensa is and what it is used for
What you need to know before taking Duloxetina Pensa
How to take Duloxetina Pensa
Possible side effects
How to store Duloxetina Pensa
Contents of the pack and other information

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

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

depression
generalized anxiety disorder (chronic feelings of anxiety or nervousness)
diabetic neuropathic pain (often described as burning, sharp, stabbing, shooting, or crushing, or like an electric shock. The affected area may have reduced sensation, or sensations where touch, heat, cold, or pressure may cause pain)

Duloxetina Pensa begins 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 feeling better. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue to prescribe Duloxetina Pensa once you are feeling better to prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before you start feeling better. Inform your doctor if you do not feel better after 2 months.

2. What you should know before taking Duloxetina Pensa

Do not take Duloxetina Pensa if you:

are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
have liver disease
have 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, or ciprofloxacin or enoxacin, which are used to treat certain infections
are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Pensa')

Tell your doctor if you have high blood pressure or heart disease. Your doctor will decide whether
you can take Duloxetina Pensa.
Warnings and precautions
Reasons why Duloxetina Pensa may not be suitable for you include the following. Talk to your doctor
before taking Duloxetina Pensa if:

you are taking other medicines to treat depression (see 'Other medicines and Duloxetina Pensa')
you are taking St. John’s Wort (Hypericum perforatum), a herbal preparation
you have kidney disease
you have had seizures (epileptic fits)
you have experienced a manic episode
you suffer from bipolar disorder
you have eye problems, such as certain types of glaucoma (increased pressure inside the eye)
you have a history of bleeding disorders (tendency to bruise easily), especially if you are pregnant (see "Pregnancy and breastfeeding")
you are at risk of low sodium levels (e.g. if you are taking diuretics, particularly if you are elderly)
you are being treated with another medicine that may cause liver damage
you are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Pensa')

Duloxetina Pensa may cause a feeling of restlessness or inability to sit still. If this happens, tell your doctor.
Medicines such as Duloxetina Pensa (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts may increase when you first start treatment with antidepressants, because these medicines usually take about 2 weeks, and sometimes longer, to become effective.
You may be more likely to have these thoughts if you:

have previously had thoughts of suicide or self-harm
are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts about harming yourself or committing suicide, contact your doctor or go
immediately to hospital.
You may find it helpful to tell a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Children and adolescents under 18 years of age
Duloxetina Pensa is generally not recommended for use in children and adolescents under 18 years of age.
Furthermore, patients under 18 years of age who take this type of medicine may have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour and anger).
Nevertheless, your doctor may prescribe Duloxetina Pensa to patients under 18 years if he/she considers it the best treatment option. If your doctor has prescribed Duloxetina Pensa to a patient under 18 years and you would like further clarification, consult your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years are taking Duloxetina Pensa. In addition, in this age group, the long-term effects of Duloxetina Pensa on growth, maturation, and cognitive and behavioural development have not yet been established.
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 not requiring a prescription.
The main active ingredient in Duloxetina Pensa, duloxetine, is also 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 containing duloxetine.

Your doctor must decide whether you can take Duloxetina Pensa with other medicines. Do not start or
stop taking any medicine, including those purchased without a prescription and herbal preparations,
before consulting your doctor.
Also inform 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 medicine 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, may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Pensa. Also, you must wait at least 5 days after stopping Duloxetina Pensa before starting 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), meperidine, 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 any of these medicines together with Duloxetina Pensa, you must consult your doctor.
Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent blood clots. These medicines may increase the risk of bleeding.
Duloxetina Pensa with food, drinks and alcohol
Duloxetina Pensa can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with Duloxetina Pensa.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Inform your doctor if you become pregnant or are planning a pregnancy while taking Duloxetina Pensa. You should use Duloxetina Pensa only after discussing with your doctor the potential benefits and any possible risks to the unborn child.

Ensure that your midwife and/or doctor knows that you are taking Duloxetina Pensa.
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 causes the baby to breathe faster and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this happens to your newborn, contact your midwife or doctor immediately.
If you take Duloxetina Pensa near the end of pregnancy, the newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days after birth. These symptoms may include floppy muscles, tremors, irritability, feeding difficulties, breathing problems and seizures. If the newborn shows any of these symptoms after birth, or if you are concerned about the baby’s health, 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 they can advise you appropriately.
Available data on the use of Duloxetina Pensa during the first three months of pregnancy do not show an overall increased risk of birth defects in the baby. If Duloxetina Pensa is taken during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature births per 100 women taking Duloxetina Pensa in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.

Inform your doctor if you are breastfeeding. The use of Duloxetina Pensa during breastfeeding is not recommended. Consult your doctor or pharmacist for advice.

Driving and using machines
Duloxetina Pensa may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Pensa affects you.
Duloxetina Pensa contains sucrose
Duloxetina Pensa contains sucrose. If you have been diagnosed by your doctor with an intolerance to certain sugars, consult him 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 exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Duloxetina Pensa is taken orally. Swallow the capsule whole with water.
For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Pensa is 60 mg once daily, but your doctor will prescribe the dose they consider appropriate for you.
For generalized anxiety disorder:
The usual starting dose of Duloxetina Pensa is 30 mg once daily; thereafter, most patients will receive 60 mg once daily, but your doctor will prescribe the dose they consider appropriate for you.
The dose may be adjusted up to 120 mg daily, depending on your response to Duloxetina Pensa.
To help you remember to take Duloxetina Pensa, it may be easier to take it at the same time each day.
Talk to your doctor about how long you should continue taking Duloxetina Pensa. Do not stop taking Duloxetina Pensa, or change the dose, without first discussing it with your doctor. Appropriate treatment of the condition is important to help you feel better. If left untreated, the condition may not improve and may become worse and more difficult to treat.
If you take more Duloxetina Pensa than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Pensa than prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.
If you forget to take Duloxetina Pensa
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next 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 Duloxetina Pensa prescribed 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 decides you no longer need Duloxetina Pensa, they will ask you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.
Some patients who stop taking Duloxetina Pensa abruptly have experienced symptoms such as:

dizziness, tingling sensations like pins and needles or electric shock sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feelings of restlessness or agitation, anxiety, nausea or malaise (vomiting), tremor, headache, muscle pain, irritability, diarrhoea, excessive sweating, or vertigo.

These symptoms are usually not severe and disappear within a few days, but if you experience bothersome symptoms, you should consult your doctor.
If you have any questions 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 everybody will experience them. Usually 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, feeling restless, reduced sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams
dizziness, feeling of sluggishness, tremor, numbness, including a sensation of tingling, prickling or skin tingling
blurred vision
tinnitus (perception of sound in the ear in the absence of external auditory stimuli)
awareness of heartbeat (palpitations)
increased blood pressure, hot flush
increased yawning
constipation, diarrhoea, stomach ache, retching (vomiting), heartburn, indigestion, gas accumulation in the intestine
increased sweating, skin rash (pruritic)
muscle pain, muscle spasm
painful urination, frequent urination
difficulty achieving an erection, ejaculation disorders
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 first starting treatment. After 6 months of treatment, weight increased to be comparable to that of other children and adolescents of the same age and sex.

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

throat inflammation causing hoarseness
suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling disoriented, lack of motivation
sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still or remain motionless, feeling nervous, difficulty concentrating, changes in taste sensation, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
pupil dilation (the dark centre of the eye), visual disturbances
feeling of dizziness or "spinning" (vertigo), ear pain
accelerated or irregular heartbeat
fainting, dizziness, feeling of emptiness in the head or impending faint when standing, cold sensation in fingers and/or toes
sensation of throat tightness, nosebleeds
vomiting blood or presence of black, tar-like stools, gastroenteritis, belching, difficulty swallowing
liver inflammation which may cause abdominal pain and yellowing of the skin or whites of the eyes (jaundice)
night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to develop bruises
muscle stiffness, muscle contraction
difficulty or inability to urinate, difficulty initiating urination, need to urinate during the night, need to urinate more than usual, reduced urinary flow
abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged periods, unusually light or absent periods, testicular or scrotal pain
chest pain, cold sensation, thirst, trembling, feeling of warmth, abnormal gait
weight gain
Duloxetina Pensa may cause effects you may not be aware of, such as increases in liver enzymes, blood potassium levels, creatine phosphokinase, blood sugar, or cholesterol levels

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
reduced thyroid gland activity which may cause fatigue or weight gain
dehydration, low sodium levels in the blood (especially in elderly people; symptoms may include dizziness, weakness, confusion, drowsiness or extreme tiredness, nausea or feeling like vomiting; more severe symptoms include loss of consciousness, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
suicidal behaviour, mania (hyperactivity, racing thoughts and reduced need for sleep), hallucinations, aggressive behaviour and anger
"Serotonin syndrome" (a rare reaction which may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feeling intoxicated, fever, sweating or muscle rigidity), seizures
increased pressure inside the eye (glaucoma)
cough, wheezing and shortness of breath possibly accompanied by fever
mouth inflammation, presence of bright red blood in stools, bad breath, inflammation of the large intestine (causing diarrhoea)
liver failure, yellowing of the skin or whites of the eyes (jaundice)
Stevens-Johnson syndrome (a serious condition with blistering of 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 odour of urine
menopausal symptoms, abnormal production of breast milk in men and women
excessive vaginal bleeding immediately after childbirth (postpartum haemorrhage)

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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the packaging. 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.
Keep in the original packaging to protect the medicine from light.
PVC/PVDC-Alu blisters: Do not store above 25°C. Keep in the original packaging to protect the medicine from light.
PE bottle: This medicine does not require any special storage conditions.
Keep in the original packaging 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.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via 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 substance is duloxetine. Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other components are: Capsule contents: hypromellose, talc, titanium dioxide, methacrylic acid-ethyl acrylate 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 gastro-resistant hard capsule. Each Duloxetina Pensa capsule contains granules of duloxetine hydrochloride with a coating designed to protect them from stomach acid.
Duloxetina Pensa is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules are opaque, blue and white in color (approximately 15 mm in size), marked with the code " E127 " printed in black.
The 60 mg capsules are opaque, blue and green in color (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 in bottles containing 500 capsules.
Duloxetina Pensa 60 mg is available in blister packs of 28 and 98 capsules, and in 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 Milano, Italy

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

This medicinal product is authorised in the European Economic Area Member States under the following names:

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