Duloxetine Teva

Package leaflet: Information for the user

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

Generic medicine
Please read 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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• depression
• generalised anxiety disorder (a 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 in which touch, heat, cold, or pressure can cause pain)

Duloxetina Teva 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 to prescribe
Duloxetina Teva once you start feeling 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 two months.

2. What you should know before taking Duloxetina Teva

DO NOT take Duloxetina Teva 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 a medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see "Other medicines and Duloxetina Teva")
• 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 Teva”)

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise you whether you
can take Duloxetina Teva.
Warnings and precautions
Reasons why Duloxetina Teva may not be suitable for you are listed below. Please consult your doctor before
taking Duloxetina Teva if:

• you are taking other medicines to treat depression (see "Other medicines and Duloxetina Teva")
• you are taking St. John’s wort, a herbal preparation (Hypericum perforatum)
• 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)
• you are at risk of low sodium levels (for example, if you are taking diuretics, particularly if you are elderly)
• you are currently being treated with another medicine that may cause liver damage
• you are taking other medicines containing duloxetine (see “Other medicines and Duloxetina Teva”)

Duloxetina Teva may cause a feeling of restlessness or inability to sit still. If this occurs, inform your doctor.
Medicines such as Duloxetina Teva [so-called selective serotonin reuptake inhibitors (SSRIs) and
serotonin-norepinephrine 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 suffer from anxiety, you may sometimes experience suicidal thoughts or self-harm
ideation. These thoughts may increase when you first start treatment with antidepressants, as these medicines
may take some time to become effective—usually about two weeks, but sometimes longer.
You may be more likely to have such thoughts if you:

• have previously had suicidal thoughts or self-harmed
• 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 experience suicidal thoughts or self-harm ideation, contact your doctor or go
immediately to hospital.
You may find it 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 under 18 years of age
Duloxetina Teva is generally NOT recommended for use in children and adolescents under 18 years of age.
Furthermore, you should be aware that patients under 18 years of age taking this type of medicine 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 Teva to
patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed Duloxetina Teva to a patient under 18 years of age and you have any questions, please 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 Teva. In addition, long-term effects on growth, puberty, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Duloxetina Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those without a prescription.
The active ingredient in Duloxetina Teva, duloxetine, is used in other medicines for the following conditions:

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

Concomitant use of more than one of these medicines should be avoided. If you are already taking other
medicines containing duloxetine, discuss this with your doctor.
Your doctor will decide whether you can take Duloxetina Teva with other medicines. DO NOT start or stop
taking any medicine, including over-the-counter medicines and herbal preparations, without first 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 Teva 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 Duloxetina Teva may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Teva. Additionally, you must wait at least 5 days after stopping Duloxetina Teva 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, SSRIs (selective serotonin reuptake inhibitors, such as paroxetine and fluoxetine), SNRIs (serotonin-norepinephrine reuptake inhibitors such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), meperidine, 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 Teva, 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 Teva with food, drinks and alcohol
Be cautious if you drink alcohol while being treated with Duloxetina Teva.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 Teva. You should use Duloxetina Teva only after discussing with your doctor the potential benefits and any possible risks to the unborn child.

Ensure that your midwife and/or doctor know that you are taking Duloxetina Teva. Similar medicines (SSRIs) taken during pregnancy 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 this occurs in your newborn, contact your midwife and/or doctor immediately.
If you take Duloxetina Teva 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 Teva during breastfeeding is NOT recommended. Seek advice from your doctor or pharmacist.
  Driving and using machines
  Duloxetina Teva may cause drowsiness or dizziness. DO NOT drive or operate tools or machinery until you know how Duloxetina Teva affects you.
  Duloxetina Teva 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 Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Duloxetina Teva is for oral use. Swallow the capsule whole with water.
For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Teva 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 Teva is 30 mg once daily. Most patients will then be increased to 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 Teva.
To help you remember to take Duloxetina Teva, it may be easier to take it at the same time each day.
Ask your doctor how long you should continue taking Duloxetina Teva. DO NOT stop
taking Duloxetina Teva 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 more severe and harder to treat.
If you take more Duloxetina Teva than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Teva than prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that may cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.
If you forget to take Duloxetina Teva
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 dose as usual. DO NOT take a double dose to make up for the forgotten dose. DO NOT take more Duloxetina Teva than the amount prescribed for one day.
If you stop taking Duloxetina Teva
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor first.
If your doctor decides you no longer need Duloxetina Teva, they will instruct you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.
Some patients who stop taking Duloxetina Teva 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, anxiety, feeling unwell (nausea) or vomiting, agitation (tremor), headache, muscle pain, irritability, diarrhoea, excessive sweating, or vertigo.

These symptoms are usually not severe and resolve within a few days. However, if you experience bothersome symptoms, consult your doctor.
If you have any questions about using 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. These effects are usually 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, feeling restless, reduced sexual desire, anxiety, difficulty or inability to reach 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 ringing or other sound in the ear in the absence of external sound)
• awareness of heartbeat (palpitations)
• increased blood pressure, hot flushes
• increased yawning
• constipation, diarrhoea, stomach ache, 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 central part 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 the fingers of the hands and/or feet
• tightness in the throat, 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 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, tremor, feeling hot, abnormal gait
• weight gain
• duloxetine may cause effects you may not be aware of, such as increases in liver enzymes or 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 breathing difficulties or dizziness with swelling of the tongue or 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, weakness, confusion, drowsiness or extreme fatigue, 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, 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 and 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 urine odour
• menopausal symptoms, abnormal production of breast milk in men or 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 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/web/guest/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 Teva

Keep this medicine out of the sight and reach of children.
Do not store above 25 °C.
Do not use this medicine after the expiry date stated on the carton/blister container/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 no longer used. This will help protect the environment.

6. Package contents and other information

What Duloxetina Teva contains

• The active substance is duloxetine. Each hard capsule contains duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine.
• The other components are:

Capsule contents: Sugar spheres (sucrose, maize starch), hypromellose phthalate,
hypromellose, triethyl citrate, hydroxypropylcellulose, talc.
Capsule shell 30 mg: hypromellose (E464), titanium dioxide (E171), Brilliant Blue FCF (E133), iron oxide black (E172), printing ink.
Capsule shell 60 mg: hypromellose (E464), titanium dioxide (E171), iron oxide black (E172), printing ink.
The printing ink contains: shellac, propylene glycol, strong ammonia solution, iron oxide black (E172), potassium hydroxide.

Description of the appearance of Duloxetina Teva and package contents

Duloxetina Teva is a hard, gastro-resistant capsule. Each Duloxetina Teva capsule contains granules of duloxetine hydrochloride with a coating to protect them from the acidity of the stomach.

Duloxetina Teva is available in two strengths: 30 mg and 60 mg.

The 30 mg capsules are 18 mm long and have an opaque grey body printed with the marking 'DLX 30' and an opaque blue cap printed with 'DLX 30'.

The 60 mg capsules are 20 mm long and have an opaque grey body printed with the marking 'DLX 60' and an opaque white cap printed with 'DLX 60'.

Duloxetina Teva 30 mg is available in:

• Plastic bottles (HDPE) with screw cap and integrated silica gel box as desiccant containing 100 capsules.
• OPA/Al/PVC-Al blisters containing 7, 14, 28, 30, 56, 98, and 100 capsules.

Duloxetina Teva 60 mg is available in:

• HDPE bottles with screw cap and integrated silica gel box as desiccant containing 100 capsules.
• OPA/Al/PVC-Al blisters containing 14, 28, 30, 56, 98, and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands

Manufacturer
Balkanpharma - Dupnitsa AD, Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:

Austria: Duloxetin ratiopharm GmbH 30 mg, 60 mg magensaftresistente Hartkapseln
Belgium: Duloxetine Teva Generics 30 mg, 60 mg harde maagsapresistente capsules / gélules gastro-résistantes / magensafresistente Hartkapseln
Germany: Duloxetin-ratiopharm 30 mg, 60 mg magensaftresistente Hartkapseln
Spain: Duloxetina Tevagen 30 mg, 60 mg cápsulas duras gastrorresistentes EFG
France: DULOXETINE TEVA Santé 30 mg, 60 mg gélule gastro-résistante
Croatia: Duloksetin Pliva 30 mg, 60 mg želučanootporne tvrde kapsule
Hungary: Duloxetin ratiopharm 30 mg, 60 mg gyomornedv-ellenálló kemény kapszula
Italy: Duloxetina Teva
Netherlands: Duloxetine Teva 30 mg, 60 mg harde maagsapresistente capsules
Portugal: Duloxetina Mepha
Slovenia: Duloksetin Teva B.V. 30, 60 mg mg trde gastrorezistentne capsule
Sweden: Duloxetin Tvea