Duloxetine Krka

Package leaflet: Information for the patient

Duloxetina Krka 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Duloxetina Krka contains the active substance duloxetine. Duloxetina Krka increases levels of serotonin and noradrenaline in the nervous system.
Duloxetina Krka 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, pressing, or like 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 Krka 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 feeling better. If you do not begin to feel better after this time, speak to your doctor. Your doctor may continue to prescribe Duloxetina Krka 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 feeling better. Inform your doctor if you do not feel better after 2 months.

2. What you should know before taking Duloxetina Krka

Do NOT take Duloxetina Krka 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 Krka')
• 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 Krka')

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

• you are taking other medicines to treat depression (see 'Other medicines and Duloxetina Krka')
• you are taking St John's Wort ( Hypericum perforatum ), a herbal preparation
• you have kidney disease
• you have had seizures (epileptic fits)
• 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 bruise easily)
• you are at risk of having 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
• you are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Krka')

Duloxetina Krka may cause a feeling of restlessness or inability to sit still.
If this happens to you, tell your doctor.
Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or have anxiety disorders, you may sometimes 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 have these thoughts if you:

• have previously had thoughts of suicide or self-harm
• 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 an antidepressant.

If at any time you have thoughts of harming yourself or committing suicide, contact your doctor or go
to hospital immediately .
It may be helpful to inform a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think 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 Krka 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 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 Krka to patients under 18 years of age if he/she considers it the best option for them. If your doctor has prescribed Duloxetina Krka 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 above symptoms appear or worsen while patients under 18 years of age are taking Duloxetina Krka. In addition, long-term effects on growth, maturation, and cognitive and behavioural development have not yet been established for Duloxetina Krka in this age group.
Other medicines and Duloxetina Krka
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 Krka, duloxetine, is found in other medicines for different conditions:

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

Concomitant use of more than one of these medicines should be avoided. Check with your doctor if you are already taking medicines containing duloxetine.
Your doctor must decide whether you can take Duloxetina Krka 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 Krka 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 Krka, may cause serious, even life-threatening, side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Krka. In addition, you must wait at least 5 days after stopping Duloxetina Krka 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 (hypericum), and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you experience any unusual symptoms while taking any of these medicines together with Duloxetina Krka, 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 Krka with food, drink and alcohol
Duloxetina Krka can be taken regardless of meals. You should be cautious if you drink alcohol while being treated with Duloxetina Krka.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, 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 to become pregnant while taking Duloxetina Krka. You should use Duloxetina Krka only after discussing with your doctor the potential benefits and any potential risks for the unborn child .
Ensure that your midwife and/or doctor knows you are taking Duloxetina Krka. 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 this happens to your baby, contact your midwife or doctor immediately.
If you take Duloxetina Krka near the end of pregnancy, the newborn may experience certain symptoms shortly after 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 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 Krka during breastfeeding is not recommended. Consult your doctor or pharmacist for advice .
Driving and using machines
Duloxetina Krka may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Krka affects you.
Duloxetina Krka contains sucrose
Duloxetina Krka contains sucrose . If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Duloxetina Krka

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Duloxetina Krka 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 Krka is 60 mg once daily. However, your doctor will prescribe the dose that is right for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Krka is 30 mg once daily. Most patients are then increased to 60 mg once daily. Your doctor will determine the dose that is right for you. The dose may be adjusted up to a maximum of 120 mg daily, depending on your response to Duloxetina Krka.

To help you remember to take Duloxetina Krka, 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 Krka. Do not stop taking Duloxetina Krka 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 worse and more difficult to treat.

If you take more Duloxetina Krka than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Krka 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, sensations of drunkenness, fever, sweating, or muscle rigidity), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetina Krka
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 at the usual time. Do not take a double dose to make up for the missed one. Do not take more Duloxetina Krka than the amount prescribed for one day.

If you stop taking Duloxetina Krka
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If your doctor decides that you no longer need Duloxetina Krka, they will ask you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.

Some patients who stop taking Duloxetina Krka abruptly have experienced symptoms such as:

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

These symptoms are usually not severe and will resolve within a few days. However, if you experience bothersome symptoms, consult your doctor.

If you have any questions about how to use 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. 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, 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 an external auditory stimulus);
• awareness of your heartbeat;
• increased blood pressure, hot flushes;
• increased yawning;
• constipation, diarrhoea, stomach ache, retching (vomiting), heartburn, indigestion, gas accumulation in the intestine;
• increased sweating, skin rash (itchy);
• 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 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, disorientation, lack of motivation;
• sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still or remain motionless, feeling nervous, difficulty concentrating, altered sense of taste, movement control problems 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, cold sensation in fingers and/or toes;
• 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 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 Krka 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 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, 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);
• 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 facial or throat swelling (angioedema);
• contraction of the muscles of the mouth;
• altered odour 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 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 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 Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original packaging to protect the medicine 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 Krka contains

• The active substance is duloxetine. Each gastro-resistant hard capsule contains 30 mg or 60 mg of duloxetine (as duloxetine hydrochloride).
• The other ingredients are: Capsule contents: sugar spheres (sucrose, maize starch), hypromellose 6 cP, sucrose, hypromellose phthalate, talc (E553b) and triethyl citrate (E1505). Capsule shell: gelatin (E441), titanium dioxide (E171), indigotine (E132), iron oxide yellow (E172) – only in 60 mg capsules, printing ink (shellac (E904), iron oxide black (E172)). See section 2 "Duloxetina Krka contains sucrose".

Description of the appearance of Duloxetina Krka and pack sizes
Gastro-resistant hard capsules 30 mg: white to off-white spherical microgranules in a hard gelatin capsule of size 3. The body of the capsule is white and the cap is dark blue. The number "30" is printed in black on the body of the capsule.
Gastro-resistant hard capsules 60 mg: white to off-white spherical microgranules in a hard gelatin capsule of size 1. The body of the capsule is yellowish-green and the cap is dark blue. The number "60" is printed in black on the body of the capsule.
Duloxetina Krka is available in packs of 7 and 28 gastro-resistant hard capsules in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano (Italy)

This medicinal product is authorised in the Member States of the European Economic Area under the following names: