Duloxetine Doc Generici

Package leaflet: Information for the user

DULOXETINE DOC Generics 30 mg gastro-resistant hard capsules, 60 mg gastro-resistant hard capsules

Generic medicine
Please read all of this leaflet carefully before you start 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DULOXETINE DOC Generics is and what it is used for
2. What you need to know before taking DULOXETINE DOC Generics
3. How to take DULOXETINE DOC Generics
4. Possible side effects
5. How to store DULOXETINE DOC Generics
6. Contents of the pack and other information

1. What DULOXETINA DOC Generici is and what it is used for

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

DULOXETINA DOC Generici 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 DOC Generici 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 should know before taking DULOXETINA DOC Generici

Do not take DULOXETINA DOC Generici if:

• you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• 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 DULOXETINA DOC Generici")
• you are taking fluvoxamine, which is commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• you are taking other medicines containing duloxetine (see "Other medicines and DULOXETINA DOC Generici")

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise whether you can take DULOXETINA DOC Generici.

Warnings and precautions
Reasons why DULOXETINA DOC Generici may not be suitable for you include the following. Talk to your doctor before taking DULOXETINA DOC Generici if:

• you are taking other medicines to treat depression (see "Other medicines and DULOXETINA DOC Generici")
• 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, including 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 (for example, 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 DOC Generici").

DULOXETINA DOC Generici may cause a feeling of restlessness or inability to sit still. If this occurs, inform your doctor.
Medicines such as DULOXETINA DOC Generici (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.

Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or have anxiety disorders, you may sometimes experience thoughts of harming yourself or of suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines require time to become effective, usually about 2 weeks, but sometimes longer.
You may be more likely to have such thoughts if:

• you have previously had thoughts of suicide or self-harm
• 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 who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital.
It may be helpful to inform a relative 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
DULOXETINA DOC Generici is generally not recommended for use in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this type of medicine may have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggressive, oppositional, and angry behaviour). Nevertheless, your doctor may prescribe DULOXETINA DOC Generici to patients under 18 years of age if he/she considers it the best option for them. If your doctor has prescribed DULOXETINA DOC Generici to a patient under 18 years of age and you require 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 of age are taking DULOXETINA DOC Generici. Furthermore, in this age group, the long-term safety of DULOXETINA DOC Generici with regard to growth, maturation, and cognitive and behavioural development has not yet been established.

Other medicines and DULOXETINA DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

The main active ingredient in DULOXETINA DOC Generici, duloxetine, is also found in other medicines used for other 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 DOC Generici together 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 DOC Generici 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 many prescription medicines, including DULOXETINA DOC Generici, may cause serious or even life-threatening adverse effects. You must wait at least 14 days after stopping an MAOI before starting DULOXETINA DOC Generici. In addition, you must wait at least 5 days after stopping DULOXETINA DOC Generici before starting an MAOI.

Medicines causing 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, amitriptiline), meperidine, St. John’s Wort (hypericum), and MAOIs (such as moclobemide and linezolid). These medicines may increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with DULOXETINA DOC Generici, 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 DOC Generici with food, drinks and alcohol
DULOXETINA DOC Generici can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with DULOXETINA DOC Generici.

Pregnancy and breastfeeding
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.

• Inform your doctor if you become pregnant or are planning a pregnancy while taking DULOXETINA DOC Generici. You should use DULOXETINA DOC Generici only after discussing with your doctor the potential benefits and any possible risks for the unborn child.

• Ensure that your midwife and/or doctor knows you are being treated with DULOXETINA DOC Generici. 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 DOC Generici near the end of pregnancy, the newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days. These symptoms may include weak 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 for advice.

• If you take DULOXETINA DOC Generici 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 accordingly.

• Available data on the use of DULOXETINA DOC Generici during the first three months of pregnancy do not show an overall increased risk of birth defects in the child. If DULOXETINA DOC Generici is taken during the second half of pregnancy, there may be an increased risk that the baby will be born prematurely (6 additional premature births per 100 women taking DULOXETINA DOC Generici 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 DOC Generici during breastfeeding is not recommended. Seek advice from your doctor or pharmacist.

Driving and using machines
DULOXETINA DOC Generici may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how this medicine affects you.

DULOXETINA DOC Generici contains sucrose
DULOXETINA DOC Generici contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

DULOXETINA DOC Generici 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 DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
DULOXETINA DOC Generici is taken orally. Swallow the capsule whole, without chewing, with a glass of water.

For depression and diabetic neuropathic pain
The usual dose of DULOXETINA DOC Generici 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 DOC Generici is 30 mg once daily. Most patients will then be given 60 mg once daily, but your doctor will determine the dose they consider appropriate for you. The dose may be adjusted up to 120 mg daily, depending on your response to DULOXETINA DOC Generici.

To help you remember to take DULOXETINA DOC Generici, 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 DOC Generici. Do not stop taking or change the dose of DULOXETINA DOC Generici 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 DOC Generici than you should
Contact your doctor or pharmacist immediately if you have taken more DULOXETINA DOC Generici than prescribed. Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction that may cause feelings of intense well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

If you forget to take DULOXETINA DOC Generici
If you forget 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 scheduled dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the amount of DULOXETINA DOC Generici prescribed for one day.

If you stop taking DULOXETINA DOC Generici
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If your doctor decides you no longer need DULOXETINA DOC Generici, 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 duloxetine suddenly have experienced symptoms such as:

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

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 everybody gets them. Normally these side 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 falling asleep (insomnia), restlessness, reduced sexual desire, anxiety, difficulty or inability to reach 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 external sound stimuli)
• awareness of your 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 match 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, disorientation, lack of motivation
• sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still, 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 dizzy or lightheaded (vertigo), ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or impending faint when standing up, cold sensation in fingers and/or toes
• sensation of throat tightness, nosebleeds
• vomiting blood or passing 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
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• 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, tremor, feeling hot, abnormal gait
• weight gain
• DULOXETINE DOC Generici may cause effects you may not be aware of, such as increased liver enzymes, or increased 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
• reduced 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 stiffness), 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 (colon) (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 (post-partum 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 effects, including those not listed in this leaflet, please 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 DULOXETINE DOC Generics

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 carton after Exp. The expiry
date refers to the last day of that month.
30 mg: store below 30°C. Keep in the original packaging to protect the medicine from light.
60 mg: store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What DULOXETINA DOC Generici 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, copolymer of methacrylic acid with methyl methacrylate, sodium lauryl sulfate, polysorbate 80, triethyl citrate, sugar granules (corn starch and sucrose), sucrose.
Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132). The 60 mg capsule also contains yellow iron oxide (E172).
Printing ink: shellac, black iron oxide (E172), potassium hydroxide.

Description of the appearance of DULOXETINA DOC Generici and package contents
DULOXETINA DOC Generici is a hard gastro-resistant capsule. Each capsule of DULOXETINA DOC Generici contains duloxetine hydrochloride granules coated to protect them from stomach acid.
DULOXETINA DOC Generici is available in two strengths: 30 mg and 60 mg.
The 30 mg capsules are opaque blue and opaque white (approximately 15 mm in size), with the black printed characters “E” on the cap and “127” on the body of the capsule.
The 60 mg capsules are opaque blue and opaque green (approximately 19 mm in size), with the black printed characters “E” on the cap and “129” on the body of the capsule.
DULOXETINA DOC Generici 30 mg is available in blister packs containing 7 and 28 capsules.
DULOXETINA DOC Generici 60 mg is available in blister packs containing 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l - Via Turati 40 - 20121 Milano – Italy.
Manufacturer
Towa Pharmaceutical Europe S.L., C/San Martí, 75-97, Martorelles, 08107 Barcelona, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names
Italy: DULOXETINA DOC Generici