DULOXETINA 30 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

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

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

Duloxetina Alter contains the active ingredient duloxetine. Duloxetina Alter increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetina Alter 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 like 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 Alter 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 to feel better. Contact your doctor if you do not start to feel better after
this time. Your doctor may continue to give you Duloxetina Alter when you feel better to
prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, several weeks may be necessary before
you start to feel better. Tell your doctor if you do not feel better after 2 months.
AIC in GU 275 of 25/11/2015

2. What you need to know before taking Duloxetina Alter

DO NOT take Duloxetina Alter if you:

• are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)

ES-H-0297-001-002-DC

• have a liver disease
• have a severe kidney disease
• are taking or have taken in the last 14 days, another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see ‘Other medicines and Duloxetina Alter’)
• 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 Alter’) Tell your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you can take Duloxetina Alter.

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

• you are taking other medicines to treat depression (see ‘Other medicines and Duloxetina Alter’)
• you are taking St. John's Wort ( Hypericum perforatum), a herbal medicinal product
• you have a kidney disease
• you have had seizures (convulsions)
• you have had 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 develop bruises)
• 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 AIC in GU 275 of 25/11/2015

Duloxetina
Alter’)
Duloxetina can cause a feeling of restlessness or inability to sit still or remain immobile. If this happens to you, you should tell your doctor.

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 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 were treated with an antidepressant

If at any time you have thoughts of harming yourself or 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 anxious, 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 duloxetine 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 side effects such as suicide attempts, suicidal thoughts and hostile behaviour (especially aggressive behaviour, oppositional behaviour and anger). Nevertheless, the doctor may prescribe duloxetine to patients under 18 years of age if he/she believes that this is the best solution for them. If the doctor has prescribed duloxetine to a patient under 18 years of age and you would like clarification, return to the doctor. You should inform the doctor if any of the symptoms above appear or worsen when patients under 18 years of age are taking duloxetine. Furthermore, long-term safety effects of Duloxetina Alter relating to growth, maturity and cognitive and behavioural development have not yet been demonstrated in this age group.

Other medicines and Duloxetina Alter
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 Alter, 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.

AIC in GU 275 of 25/11/2015
The doctor must decide whether you can take Duloxetina Alter with other medicines. Do not start or stop taking any medicine, including those bought without a 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 Alter 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 Alter, 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 Alter. Also, you must wait at least 5 days after stopping taking Duloxetina Alter before taking an MAOI.

Medicines that cause drowsiness: These include medicines prescribed by a 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 Alter, you should consult your doctor.

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

Duloxetina Alter with food, drinks and alcohol
Duloxetina Alter can be taken independently of meals. You should be careful if you drink alcohol while being treated with Duloxetina Alter.

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.

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

Make sure your midwife and/or doctor knows that you are being treated with Duloxetina Alter.
When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves the newborn having accelerated breathing 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 Alter near the end of pregnancy, the newborn may develop 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 seizures. If the 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.

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

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

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

3. How to take Duloxetina Alter

Take this medicine exactly as your doctor or pharmacist has told you. If you have doubts, consult your doctor or pharmacist.
Duloxetina Alter 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 Alter 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 Alter 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 he/she considers right for you. The dose may be adjusted up to 120 mg per day, based on your
response to Duloxetina Alter.
To help you remember to take Duloxetina Alter, 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 Alter. Do not
stop taking Duloxetina Alter, 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 can become more serious and difficult to treat.

If you take more Duloxetina Alter than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina
Alter 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 Alter
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 forgotten dose and take only a single dose as
usual. Do not take a double dose to make up for the forgotten dose. Do not take
more than the amount of Duloxetina Alter that has been prescribed for you for one day.

If you stop taking Duloxetina Alter
Even if you feel better, DO NOT stop taking the capsules without consulting
your doctor. If the doctor believes you no longer need Duloxetina Alter, he/she will ask you to
gradually reduce the dose over a period of at least 2 weeks before stopping
treatment altogether.
Some patients who suddenly stop taking Duloxetina Alter 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 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 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 sleepy
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty sleeping, feeling restless, decreased sexual drive, AIC in GU 275 of 25/11/2015

anxiety, difficulty or inability to reach orgasm, unusual dreams

• dizziness, feeling lazy, 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 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
• pupil dilation (the dark center of the eye), vision disorders
• feeling dizzy or “lightheaded” (vertigo), ear pain
• fast or irregular heartbeat
• fainting, dizziness, lightheadedness or feeling like you might faint while standing up, feeling cold in your hands and/or feet
• feeling of constriction in the throat, nosebleeds
• vomiting blood or having 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 AIC in GU 275 of 25/11/2015
• 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, trembling, feeling hot, abnormal gait
• weight gain
• Duloxetine Alter can 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 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 rigidity), seizures
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, bright red blood in the stool, bad breath
• 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
• symptoms of menopause, abnormal production of breast milk in men and women
• cough, wheezing and shortness of breath possibly accompanied by fever

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly to
AIC in GU 275 of 25/11/2015
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 Duloxetina Alter

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.
Store in the original package to protect the medicine from moisture. Do not store
at a temperature above 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. Package Contents and Other Information

What Duloxetina Alter contains
The active ingredientis duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The otheringredients are:

Capsule contents: hypromellose, sugar granules (sucrose and corn starch), talc,
sucrose, hypromellose phthalate, triethyl citrate

Capsule body: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigotin

Capsule cap: gelatin, titanium dioxide (E171), indigotin

Description of the appearance of Duloxetina Alter and package contents
Duloxetina Alter is a hard, gastro-resistant capsule. Each Duloxetina Alter capsule
contains duloxetine hydrochloride granules with a coating to protect them from stomach acid.
Duloxetina Alter is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white.
The 60 mg capsules are blue and green.
Duloxetina Alter 30 mg is available in polyamide/aluminum/polyvinyl chloride – aluminum
blisters in packs of 7, 28 capsules.
Duloxetina Alter 60 mg is available in polyamide/aluminum/polyvinyl chloride – aluminum
blisters in packs of 28, 56 capsules.
Not all pack sizes may be marketed.
AIC in Official Gazette 275 of 25/11/2015

Marketing Authorisation Holder and Manufacturer
Laboratori Alter srl
Via Egadi, 7
20144 Milan
Italy

Manufacturer
Laboratorios Lesvi, S.L.
Avda. Barcelona, 69, 08970, Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations

AIC in Official Gazette 275 of 25/11/2015