Duloxetine EG: detailed information

Package leaflet: Information for the patient

DULOXETINE EG 30 mg gastro-resistant hard capsules, 60 mg gastro-resistant hard capsules

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

Contents of this leaflet

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

1. What DULOXETINA EG is and what it is used for

DULOXETINA EG contains the active substance duloxetine. DULOXETINA EG increases the levels of serotonin and
noradrenaline in the nervous system.
DULOXETINA EG 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 crushing, or as an electric shock. In the affected area, there may be loss of sensation, or sensations where touch, heat, cold, or pressure can cause pain)

DULOXETINA EG 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 begin to feel better after this time. Your doctor may continue your treatment with DULOXETINA EG after you feel better to prevent depression or anxiety from returning.
In people with diabetic neuropathic pain, it may take several weeks before you feel better. Inform your doctor if you do not feel better after 2 months.

2. What you should know before taking DULOXETINE EG

DO NOT take DULOXETINE EG if:

you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6); DE/H/4171/01-02/DC 1/8
you have liver disease;
you have severe kidney disease;
you are taking or have taken within the last 14 days another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see "Other medicines and DULOXETINE EG");
you are taking fluvoxamine, which is commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections.

Tell your doctor if you have high blood pressure or heart disease. Your doctor will determine whether you can
take DULOXETINE EG.
Warnings and precautions
Reasons why DULOXETINE EG may not be suitable for you include the following. Consult your doctor before
taking DULOXETINE EG if:

you are taking other medicines to treat depression (see "Other medicines and DULOXETINE EG");
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 in the eye);
you have a history of coagulation disorders (tendency to bruise easily);
you are at risk of low sodium levels (e.g. if you are taking diuretics, especially if you are elderly);
you are being treated with another medicine that may cause liver damage.

The active substance of DULOXETINE EG, duloxetine, is used in other medicines to treat other conditions:

diabetic neuropathic pain, depression, anxiety, and urinary incontinence.

Avoid using multiple medicines containing duloxetine simultaneously. Check with your doctor if you are already taking other medicines containing duloxetine.
DULOXETINE EG may cause a feeling of restlessness or inability to sit or stand 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 self-harming or suicidal thoughts. These
effects may worsen when starting antidepressants for the first time, as all medicines of this type require time to take effect, usually about two weeks but sometimes longer. You are more likely to experience such thoughts:

if you have previously had suicidal or self-harming thoughts;
if you 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 antidepressants.

If at any time you experience self-harming or suicidal thoughts, contact your doctor immediately or go to hospital.
It may be helpful to inform a friend or relative that you are depressed or suffer from anxiety disorders and ask them to read this leaflet. You may ask them to observe whether your depression or anxiety worsens or whether they notice any concerning changes in your behaviour.
DE/H/4171/01-02/DC 2/8
Children and adolescents under 18 years of age
DULOXETINE EG should not normally be used to treat children and adolescents under 18 years of age. You should be aware that, when taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger).
Nevertheless, your doctor may prescribe DULOXETINE EG to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed DULOXETINE EG to a patient under 18 years of age and you wish to obtain further information, consult them again. You should inform the doctor if any of the above symptoms appear or worsen during treatment with DULOXETINE EG in a patient under 18 years of age. In addition, the long-term safety effects of DULOXETINE EG on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.
Other medicines and DULOXETINE EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Your doctor will assess whether you can take DULOXETINE EG with other medicines. Do not start or stop
taking any medicine, including over-the-counter medicines and herbal remedies, without first consulting your
doctor.
Inform your doctor if you are taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs): you must not take DULOXETINE EG if you are currently 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 DULOXETINE EG may cause serious or even life-threatening adverse effects. Wait at least 14 days after stopping an MAOI before taking DULOXETINE EG. Additionally, you must wait at least 5 days after stopping DULOXETINE EG 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), meperidine, St. John’s Wort (Hypericum), 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 DULOXETINE EG, consult your doctor.
Oral anticoagulants and antiplatelet agents: medicines that thin the blood or prevent clot formation. These medicines may increase the risk of bleeding.
DULOXETINE EG with alcohol
Exercise caution if you drink alcohol while being treated with DULOXETINE EG.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
DE/H/4171/01-02/DC 3/8

Inform your doctor if you become pregnant or are planning a pregnancy while taking DULOXETINE EG. You should use DULOXETINE EG only after discussing with your doctor the potential benefits and potential risks to the baby.

Make sure to inform your midwife and/or doctor that you are taking DULOXETINE EG. 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 blue. These symptoms usually occur within the first 24 hours after birth. If your baby shows these symptoms, contact your midwife and/or doctor immediately.
If you take DULOXETINE EG near the end of pregnancy, the newborn may show certain symptoms at 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.

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

Driving and using machines
DULOXETINE EG may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how DULOXETINE EG affects you.
DULOXETINE EG contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DULOXETINA EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For depression and diabetic neuropathic pain:
The recommended dose of DULOXETINA EG is 60 mg once daily, but your doctor will prescribe the dose
they consider appropriate for you.
For generalized anxiety disorder:
The recommended starting dose of DULOXETINA EG is 30 mg once daily. Most patients will then be given
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 EG.
DULOXETINA EG is for oral use. Swallow the capsule whole, without chewing, with a glass of water.
DULOXETINA EG can be taken regardless of food intake.
To help you remember to take DULOXETINA EG, it may be helpful to take it at the same time each day.
Talk to your doctor about how long you should continue taking DULOXETINA EG. Do not stop taking
DULOXETINA EG or change the dose without first consulting your doctor. Appropriate treatment of the
condition is important to help you feel better. If left untreated, your condition might never improve and
could become more severe and harder to treat.
If you take more DULOXETINA EG than you should
Contact your doctor or pharmacist immediately if you have taken more DULOXETINA EG than prescribed.
Symptoms of overdose may 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 EG
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 continue with your regular dosing schedule. Do not take a double dose to make up for a
forgotten dose. Do not take more DULOXETINA EG in a day than prescribed by your doctor.
If you stop taking DULOXETINA EG
DO NOT stop taking your capsules without first consulting your doctor, even if you feel better. If your doctor
decides you no longer need DULOXETINA EG, they will instruct you to gradually reduce the dose over a
period of at least 2 weeks before stopping treatment completely.
Some patients who have stopped taking duloxetine suddenly have experienced symptoms such as:

dizziness, tingling sensations like pins and needles or electric shock sensations (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or malaise (vomiting), tremor, headache, muscle pain, feeling irritable, diarrhoea, excessive sweating or dizziness. Usually these symptoms are not severe and disappear within a few days, but if you experience bothersome symptoms, consult your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, drowsiness;
feeling unwell (nausea), dry mouth.

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

loss of appetite;
difficulty sleeping, feeling restless, reduced sexual desire, anxiety, difficulty or inability to achieve orgasm, unusual dreams;
dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or pins and needles in the skin;
blurred vision;
tinnitus (perception of sound in the ear in the absence of external auditory stimulus);
awareness of heartbeat (palpitations);
increased blood pressure, hot flushes;
increased yawning;
constipation, diarrhoea, stomach ache, retching (vomiting), heartburn or indigestion, gas accumulation in the intestine;
increased sweating, skin rash (itchy);
muscle pain, muscle spasm;
painful urination, frequent urination;
difficulty achieving 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 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 quality of sleep;
pupil dilation (the dark centre of the eye), visual disturbances;
feeling of dizziness or "spinning" (vertigo), ear pain;
rapid and/or irregular heartbeat;
fainting, dizziness, feeling of emptiness in the head or fainting upon standing up, cold sensation in fingers of hands and/or feet;
feeling of tightness in the throat, nosebleeds;
vomiting blood or presence of 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 normal, 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, feeling cold, thirst, trembling, feeling hot, abnormal gait;
weight gain;
DULOXETINE EG may cause effects you may not be aware of, such as increases in liver enzymes, or blood levels of potassium, creatine phosphokinase, blood sugar, or cholesterol.

Rare side effects (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;
decreased activity of the thyroid gland 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 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 drunk, fever, sweating or muscle rigidity), seizures;
increased pressure inside the eye (glaucoma);
mouth inflammation, presence of bright red blood in stools, bad breath;
liver failure, yellowing of the skin or whites of the eyes (jaundice);
Stevens-Johnson syndrome (a serious illness 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 smell of urine;
menopausal symptoms, 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 experience any side effects, 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.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DULOXETINE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Store the medicine in the
original packaging to protect it from moisture.
Do not dispose of medicines 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 EG contains
The active substance is duloxetine.
Each gastro-resistant hard capsule contains 30 mg of duloxetine (as hydrochloride).
Each gastro-resistant hard capsule contains 60 mg of duloxetine (as hydrochloride).
The other components are:
Capsule contents: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc,
titanium dioxide (E171), hydroxypropylcellulose.
Capsule shell: gelatin, titanium dioxide (E 171), indigo carmine (E132), iron oxide yellow (E 172) (only
for the 60 mg capsules).
DE/H/4171/01-02/DC 7/8

Description of the appearance of DULOXETINA EG and package contents
DULOXETINA EG consists of gastro-resistant hard capsules. Each DULOXETINA EG capsule contains granules of duloxetine hydrochloride coated with a protective layer that shields them from gastric acid.
DULOXETINA EG is available in two formulations: 30 mg and 60 mg.
The 30 mg capsules have a white body and a blue cap and are filled with white gastro-resistant granules.
The 60 mg capsules have a green body and a blue cap and are filled with white gastro-resistant granules.
DULOXETINA EG 30 mg is available in packs of 7, 28 and 98 capsules.
DULOXETINA EG 60 mg is available in packs of 28 and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

This medicinal product is authorised in the European Economic Area Member States under the following
names:
DE Duloxetin AL 30, 60 mg magensaftresistente Hartkapseln
IT DULOXETINA EG
DE/H/4171/01-02/DC 8/8