Duloxetine Aurobindo: detailed information

Package leaflet: Information for the user

Duloxetine Aurobindo 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

Duloxetina Aurobindo 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. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue your treatment with Duloxetina Aurobindo once 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. Inform your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Aurobindo

Do not take Duloxetina Aurobindo:

if you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6);
if you have liver disease;
if you have severe kidney disease;
if you are taking, or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see also section “Other medicines and Duloxetina Aurobindo”);
if you are taking fluvoxamine, which is commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections;
if you are taking other medicines containing duloxetine (see “Other medicines and Duloxetina Aurobindo”). Inform your doctor if you have high blood pressure or heart disease. Your doctor will determine whether you can take Duloxetina Aurobindo.

Warnings and precautions
Reasons why Duloxetina Aurobindo may not be suitable for you include the following. Please consult your doctor before taking Duloxetina Aurobindo:

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

Medicines such as Duloxetina Aurobindo (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 have persisted after discontinuation of treatment.
Duloxetina Aurobindo may cause a feeling of restlessness or inability to sit still. If this occurs, inform your doctor.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines require some time to become effective, usually about 2 weeks, but sometimes longer.
You may be more likely to experience such thoughts if:

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

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go
immediately to hospital.
It may be 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 wish to ask them to inform you if they believe 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 Aurobindo is normally not intended for use in children and adolescents under 18 years of age. In addition, you should know that 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 (particularly aggressive behaviour, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Duloxetina Aurobindo to patients under 18 years if they consider it the best treatment option. If your doctor has prescribed Duloxetina Aurobindo to a patient under 18 years and you require clarification, consult your doctor again. You must inform the doctor if any of the above symptoms appear or worsen while patients under 18 years are taking Duloxetina Aurobindo. Furthermore, in this age group, the long-term effects of Duloxetina Aurobindo on growth, maturation, and cognitive and behavioural development have not yet been established.
Other medicines and Duloxetina Aurobindo
Inform 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 Aurobindo, duloxetine, is also found in other medicines used for different conditions:

diabetic neuropathic pain, depression, anxiety, and urinary incontinence. Concurrent 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 Aurobindo together with other medicines. Do not start or stop taking any medicine, including those bought 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 Aurobindo 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 Aurobindo, may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Aurobindo. Also, you must wait at least 5 days after stopping Duloxetina Aurobindo before starting an MAOI.
Medicines that cause drowsiness: These include prescription medicines 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, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with Duloxetina Aurobindo, 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 Aurobindo with food, drink and alcohol
Duloxetina Aurobindo can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with Duloxetina Aurobindo.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

You should use Duloxetina Aurobindo 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 being treated with Duloxetina Aurobindo. 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 rapidly and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this occurs in your newborn, contact your midwife or doctor immediately.
If you take Duloxetina Aurobindo near the end of pregnancy, the newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days. Symptoms may include floppy muscles, tremors, irritability, feeding difficulties, breathing problems, and seizures. If your newborn shows any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife, who will be able to advise you.
Inform your doctor if you are breastfeeding. The use of Duloxetina Aurobindo during breastfeeding is not recommended. Consult your doctor or pharmacist for advice.
Driving and using machines
Duloxetina Aurobindo may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Aurobindo affects you.
Duloxetina Aurobindo contains sucrose. If you have been told by your doctor that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Duloxetina Aurobindo

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Duloxetina Aurobindo is taken by mouth. Swallow the capsule whole with a glass
of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Aurobindo is one capsule (60 mg of duloxetine) once daily, but your doctor will prescribe the dose they consider appropriate for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Aurobindo is 30 mg once daily. Most patients will then 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 per day, depending on your response to Duloxetina Aurobindo.

To help you remember to take Duloxetina Aurobindo, it may be easier to take it at the same time each day.
Talk to your doctor to find out how long you should continue taking Duloxetina Aurobindo.
Do not stop taking Duloxetina Aurobindo 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 could become worse and more difficult to treat.

If you take more Duloxetina Aurobindo than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Aurobindo than prescribed. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that may cause feelings of great happiness, drowsiness, clumsiness, restlessness, sensation of drunkenness, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetina Aurobindo
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 dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more Duloxetina Aurobindo than prescribed for one day.

If you stop taking Duloxetina Aurobindo
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If your doctor decides you no longer need Duloxetina Aurobindo, they will ask you to gradually reduce the dose over a period of at least two weeks before stopping treatment completely.

Some patients who stop taking Duloxetina Aurobindo suddenly have experienced symptoms such as:

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

These symptoms are usually not severe and disappear within a few days. However, if you experience bothersome symptoms, 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 everyone experiences them. Usually these effects are mild to moderate and often disappear after a few weeks.

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

headache, drowsiness;
feeling unwell (nausea), dry mouth.

Common (may affect up to 1 in 10 people)

loss of appetite;
difficulty falling asleep, feeling restless, reduced sexual desire, difficulty or inability to achieve orgasm, unusual dreams;
dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or skin tingling;
blurred vision;
tinnitus (perception of sound in the ear in the absence of an external sound stimulus);
awareness of heartbeat (palpitations);
increased blood pressure, flushing;
increased yawning;
constipation, diarrhoea, stomach ache, feeling unwell (vomiting), heartburn or indigestion, gas accumulation in the intestine;
increased sweating, skin rash (causing itching);
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, their weight increased to be comparable to that of other children and adolescents of the same age and sex.

Uncommon (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 quality of sleep;
pupil dilation (the dark centre of the eye), visual disturbances;
feeling dizzy or lightheaded (vertigo), ear pain;
rapid 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 black, tarry stools, gastroenteritis, belching, difficulty swallowing;
liver inflammation which may 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, 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 periods, unusually light or absent periods, testicular or scrotal pain;
chest pain, feeling cold, thirst, trembling, feeling hot, abnormal gait;
weight gain;
Duloxetina Aurobindo 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 (may affect up to 1 in 1,000 people)

severe allergic reaction causing breathing difficulties or dizziness with swelling of the tongue and lips, allergic reactions;
reduced thyroid gland activity which may cause tiredness or weight gain;
dehydration, low sodium levels in the blood (especially in elderly people; symptoms may include dizziness, feeling weak, confused, drowsy or very tired, or having nausea or feeling like vomiting; more severe symptoms include fainting, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH);
suicidal behaviour, mania (hyperactivity, racing thoughts, 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 drunk, fever, sweating or muscle stiffness), seizures;
increased pressure inside the eye (glaucoma);
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;
cough, wheezing and shortness of breath, possibly accompanied by fever.

Very rare (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, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Duloxetina Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Duloxetina Aurobindo after the expiry date stated on the label, carton, and bottle after "EXP.". The expiry date refers to the last day of that month.
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 Aurobindo contains

The active substance is duloxetine. Each capsule contains 30 mg of duloxetine (as hydrochloride). Each capsule contains 60 mg of duloxetine (as hydrochloride).
The other components are:

Capsule contents:
Sugar spheres (sucrose and maize starch), hypromellose Type 2910 (5cP), hydroxypropyl cellulose (low viscosity grade), crospovidone (Type B), talc, triethyl citrate, titanium dioxide (E171), hypromellose phthalate.
Capsule shell:
Cap: titanium dioxide (E171), indigotine (E132), gelatin, sodium lauryl sulfate.
Body: iron oxide yellow (E172) (for 60 mg only), titanium dioxide (E171), indigotine (E132) (for 60 mg only), gelatin, sodium lauryl sulfate.
Printing ink: shellac, propylene glycol, iron oxide black (E172), potassium hydroxide.

Description of the appearance of Duloxetina Aurobindo and package contents
Gastro-resistant hard capsules.
Duloxetina Aurobindo 30 mg gastro-resistant hard capsules
Opaque blue/white opaque hard gelatin capsules, size “3”, containing white to almost white granules, printed with “DLX” in black ink on the opaque blue cap and “30” on the opaque white body.
Duloxetina Aurobindo 60 mg gastro-resistant hard capsules
Opaque blue/dark green opaque hard gelatin capsules, size “1”, containing white to almost white granules, printed with “DLX” in black ink on the opaque blue cap and “60” on the dark green opaque body.
Duloxetina Aurobindo capsules are available in blister packs and in HDPE bottles.
Pack sizes:
Blister pack: 7, 14, 28, 30 and 98 hard capsules.
HDPE bottle: 30, 98, 250 and 1000 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Duloxetin AB 30 mg/60 mg, gastro-resistant capsules, hard
Germany: Duloxetin Aurobindo 30 mg/60 mg magensaftresistente Hartkapseln
Italy: Duloxetina Aurobindo
Luxembourg: Duloxetine AB 60 mg, gélule gastro-résistante / magensaftresistente Hartkapseln
Netherlands: Duloxetine Aurobindo 30 mg/60 mg, maagsapresistente capsules, hard
Portugal: Duloxetina Aurobindo
Romania: Duloxetină Aurobindo 30 mg/60 mg capsule gastrorezistente
Spain: Duloxetina Aurobindo 30 mg/60 mg cápsulas duras gastrorresistentes EFG
United Kingdom: Duloxetine Milpharm 30 mg/60 mg gastro-resistant capsules, hard