DULOXETINA 30 mg Enteric-Coated Hard Capsule

Содержание инструкции

1. Duloxetina Zentiva 30 mg hard gastro-resistant capsules, 60 mg hard gastro-resistant capsules
   1. What is Duloxetina Zentiva and what is it used for
   2. What you need to know before taking Duloxetina Zentiva
   3. How to take Duloxetina Zentiva
   4. Possible side effects
   5. How to store Duloxetina Zentiva
   6. Package contents and other information

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

duloxetina

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Duloxetina Zentiva contains the active substance duloxetine. Duloxetina Zentiva increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetina Zentiva 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 oppressive, or as an electric shock. In the affected area, there may be loss of sensation, or sensations in which contact, heat, cold or pressure can cause pain).

Duloxetina Zentiva 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. Talk to your doctor if you do not start to feel better after this time. Your
doctor may continue to give you Duloxetina Zentiva when 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. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Zentiva

Do not take Duloxetina Zentiva if you:

• are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6);
• have a liver disease;
• have a severe kidney disease;
• are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see “Other medicines and Duloxetina Zentiva”);
• are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections.
• are taking other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Zentiva’).

Tell your doctor if you have high blood pressure or a heart condition. Your doctor will tell you if you can
take Duloxetina Zentiva.

Warnings and precautions
The reasons why Duloxetina Zentiva may not be suitable for you are as follows. Talk to your doctor
before taking Duloxetina Zentiva if:

• you are taking other medicines to treat depression (see “Other medicines and Duloxetina Zentiva”);
• you are taking St. John's wort (Hypericum perforatum), a herbal medicinal product;
• you have a kidney disease;
• you have had seizures (convulsions);
• you have had a manic episode;
• you suffer from bipolar disorder;
• you have problems with your eyes, such as certain types of glaucoma (increased pressure inside the eye);
• you have a history of blood clotting disorders (tendency to bruise easily), especially if you are pregnant (see “Pregnancy and breastfeeding”);
• you are at risk of having low sodium levels in your blood (for example if you are taking diuretics, especially if you are an elderly person);
• you are being treated with another medicine that can cause liver damage;
• you are taking opioid medicines such as medicines that contain buprenorphine, tramadol and pethidine. The use of these medicines together with Duloxetina Zentiva can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Duloxetina Zentiva”);
• you are taking other medicines that contain duloxetine (see “Other medicines and Duloxetina Zentiva”).

Duloxetina Zentiva may cause a feeling of restlessness or an inability to sit still or
remain motionless. If this happens to you, you must tell your doctor.
Medicines such as Duloxetina Zentiva (so-called selective serotonin reuptake inhibitors
(SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs) can cause symptoms of sexual dysfunction
(see section 4). In some cases, these symptoms have been observed to persist after stopping
treatment.

Thoughts of suicide and worsening of depression and anxiety
If you are depressed and/or anxious sometimes you may have thoughts of harming yourself or of
killing yourself. These thoughts may be increased when you first start taking
antidepressants, as these medicines take time to work, usually about 2 weeks but sometimes even longer.
You may be more likely to have these thoughts if you:

• have had thoughts of killing yourself or harming yourself in the past;
• are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years old with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or of killing yourself, contact your doctor or go
immediately to hospital.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think that
your depression or anxiety is getting worse, or if they are worried about changes in your
behaviour.

Children and adolescents under 18 years of age
Normally Duloxetina Zentiva should not be used in children and adolescents under 18 years
of age. Also, you should know that patients under 18 years of age, when taking this type of
medicines, have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostile behaviour (especially aggressive behaviour, oppositional behaviour and anger).
However, the doctor may prescribe Duloxetina Zentiva to patients under 18 years of age if he/she
believes that this is the best solution for them. If the doctor has prescribed Duloxetina Zentiva to a
patient under 18 years of age and you want clarification, return to the doctor. You must tell the doctor if
any of the symptoms mentioned above appear or worsen when patients under 18 years of age are
taking Duloxetina Zentiva. Also, long-term safety effects relating to growth, maturity and cognitive and behavioural development have not yet been demonstrated in this age group.

Other medicines and Duloxetina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The main component of Duloxetina Zentiva, duloxetine, is found in other medicines for other
conditions: diabetic neuropathic pain, depression, anxiety and urinary incontinence. The simultaneous use of more than one of these medicines should be avoided. Check with your doctor if you are already
taking medicines that contain duloxetine.
The doctor must decide whether you can take Duloxetina Zentiva with other medicines. Do not start or
stop taking any medicine, including those bought without a prescription
and herbal medicinal products, before consulting your doctor.
Also tell your doctor if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAOIs):You must not take Duloxetina Zentiva if you are taking, or have recently taken (within the last 14 days) another antidepressant 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 Zentiva, can cause serious or even life-threatening side effects. You must wait at least 14 days after stopping taking an MAOI before you can take Duloxetina Zentiva. Also, you must wait at least 5 days after stopping taking Duloxetina Zentiva 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, tryptophan, selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine), selective serotonin-noradrenaline reuptake inhibitors (SNRIs) (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St. John's wort, MAOIs (such as moclobemide and linezolid) and opioid medicines such as medicines that contain buprenorphine, tramadol and pethidine. These medicines increase the risk of side effects such as serotonin syndrome (see section “Warnings and precautions”); if you experience any unusual symptoms while taking one of these medicines together with Duloxetina Zentiva, you should consult your doctor.
• Oral anticoagulants and antiplatelet agents:Medicines that thin the blood or prevent blood clots from forming. These medicines may increase the risk of bleeding.

Duloxetina Zentiva with food, drinks and alcohol
Duloxetina Zentiva can be taken independently of meals. You should be careful if you drink alcohol
while being treated with Duloxetina Zentiva.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you are pregnant, or planning a pregnancy, while taking Duloxetina Zentiva. You should only use Duloxetina Zentiva after discussing the potential benefits and any potential risk to the unborn child with your doctor.
• Make sure your midwife and/or doctor knows that you are being treated with Duloxetina Zentiva. 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 means that the newborn has fast breathing and a bluish skin colour. These symptoms usually appear during the first 24 hours after birth. If this happens to the newborn, contact your midwife or doctor immediately.
• If you take Duloxetina Zentiva near the end of your pregnancy, your newborn may experience some symptoms just after being born. These usually appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, nervousness, difficulty feeding, a breathing disorder and seizures. If the newborn presents any of these symptoms after birth, or you are worried about the health of the baby, contact your doctor or midwife who will be able to advise you.
• If you take Duloxetina Zentiva near the end of your pregnancy there is an increased risk of excessive vaginal bleeding immediately after delivery, particularly if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking duloxetine so that they can advise you.
• Available data on the use of duloxetine during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If duloxetine is taken during the second half of pregnancy there may be an increased risk that the newborn may be born prematurely (6 more newborns born prematurely per 100 women taking duloxetine in the second part of pregnancy), mostly between weeks 35 and 36 of pregnancy.
• Tell your doctor if you are breastfeeding. The use of Duloxetina Zentiva during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

Driving and using machines
Duloxetina Zentiva may cause drowsiness or dizziness. Do not drive or do not use
tools or machines until you know how Duloxetina Zentiva affects you.

Duloxetina Zentiva contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Duloxetina Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Duloxetina Zentiva is taken orally. Swallow the capsule without chewing, with the help of a glass of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Zentiva is 60 mg once a day, but your doctor will prescribe the dose that he/she considers right for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Zentiva is 30 mg once a day, after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that he/she considers right for you. The dose may be adjusted up to 120 mg per day, based on your response to Duloxetina Zentiva.
To help you remember to take Duloxetina Zentiva, it may be easier for you to take it every day at the same time.
Talk to your doctor about how long you should continue to take Duloxetina Zentiva. Do not stop taking Duloxetina Zentiva, or change the dose, without talking to your doctor. Appropriate treatment of the disorder is important to help you feel better. If left untreated, the disorder may not improve and may become more serious and difficult to treat.

If you take more Duloxetina Zentiva than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina Zentiva greater than what your doctor has prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and increased heart rate.

If you forget to take Duloxetina Zentiva
If you forget a dose, take it as soon as you remember. However, if this is the time to take the next dose, skip the forgotten dose and take only one single dose as usual. Do not take a double dose to make up for the forgotten dose. Do not take more of Duloxetina Zentiva than has been prescribed for you for one day.

If you stop taking Duloxetina Zentiva
Even if you feel better, DO NOT stop taking the capsules without consulting your doctor. If your doctor believes you no longer need Duloxetina Zentiva, he/she will ask you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.
Some patients who suddenly stop taking Duloxetina Zentiva have experienced symptoms such as:

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

If you have any further questions on 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 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, feeling sleepy;
• feeling unwell (nausea), dry mouth.

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

• loss of appetite;
• difficulty sleeping, feeling agitated, decreased sexual desire, anxiety, difficulty or inability to reach orgasm, unusual dreams;
• dizziness, feeling lazy, tremor, numbness, including a sensation of tingling or pins and needles in the skin;
• blurred vision;
• tinnitus (perception of a sound in the ear in the absence of an external sound stimulus);
• feeling your heart beating in your chest;
• increased blood pressure, hot flush;
• increased yawning;
• constipation, diarrhea, stomach pain, feeling unwell (vomiting), heartburn, indigestion, accumulation of gas in the intestine;
• increased sweating, rash (itchy);
• muscle pain, muscle spasm;
• painful urination, frequent urination;
• difficulty getting 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 had
some weight loss when they first started taking this medicine. After
6 months of treatment the weight increased to be equal to that of other children and adolescents
of the same age and sex.

Uncommon side effects(may affect up to 1 in 100 people):

• inflammation of the throat causing a hoarse voice;
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, feeling disoriented, lack of motivation;
• sudden and involuntary spasms or contractions of the muscles, feeling restless or inability to sit still or remain quiet, feeling nervous, difficulty concentrating, changes in taste, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality;
• dilated pupils (the dark center of the eye), vision disturbances;
• feeling dizzy or “lightheaded” (vertigo), ear pain;
• increased and/or irregular heartbeat;
• fainting, dizziness, feeling empty-headed or about to faint when standing up, feeling cold in the fingers of the hands and/or feet;
• feeling of constriction in the throat, nosebleeds;
• vomiting blood or presence of black, tarry stools, gastroenteritis, belching, difficulty swallowing;
• liver inflammation that can 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, needing to urinate during the night, needing 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, pain in the testicles or scrotum;
• chest pain, feeling cold, thirst, tremor, feeling hot, abnormal gait;
• weight gain;
• Duloxetina Zentiva may cause effects of which you may not be aware, such as increases in liver enzymes, or levels in the blood of potassium, creatine phosphokinase, sugars or cholesterol.

Rare side effects(may affect up to 1 in 1,000 people):

• severe allergic reaction causing difficulty breathing or dizziness with swelling of the tongue and lips, allergic reactions;
• decreased activity of the thyroid gland which can cause fatigue or weight gain;
• dehydration, low levels of sodium in the blood (especially in elderly people; symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling sick or being sick, more serious symptoms are loss of consciousness, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH);
• suicidal behavior, mania (hyperactivity, racing thoughts and decreased need for sleep), hallucinations, aggressive behavior and anger;
• “Serotonin syndrome” (a rare reaction that can cause feelings of great happiness, sleepiness, 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;
• inflammation of the mouth, presence of bright red blood in the stool, bad breath, inflammation of the large intestine (colon) (causing diarrhea);
• 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 smell of urine;
• symptoms of menopause, abnormal production of breast milk in men and women.
• excessive bleeding from the vagina immediately after childbirth (postpartum hemorrhage)

Very rare side effects(may affect up to 1 in 10,000 people):

• Inflammation of the blood vessels in the skin (cutaneous vasculitis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system indicated in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Duloxetina Zentiva

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 package/ blister after SCAD.
The expiry date refers to the last day of that month.
Store below 30°C. Store in the original package to protect the medicine
from humidity.
Do not dispose of any medicine in 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 Zentiva contains
The active ingredient is duloxetine. Each capsule contains duloxetine hydrochloride equivalent to 30 or 60 mg
of duloxetine.
The other ingredients are:
Capsule contents: sucrose, corn starch, hypromellose, talc, hypromellose acetate succinate,
triethyl citrate.
Capsule shell:

Duloxetina Zentiva 30 mg
Capsule cap: indigo carmine (E132), titanium dioxide (E171), gelatin.
Capsule body: titanium dioxide (E171), gelatin.

Duloxetina Zentiva 60 mg:
Capsule cap: indigo carmine (E132), titanium dioxide (E171), gelatin.
Capsule body: yellow iron oxide (E172), titanium dioxide (E171), gelatin.

Description of the appearance of Duloxetina Zentiva and package contents
Duloxetina Zentiva is a hard, gastro-resistant capsule. Each Duloxetina Zentiva capsule contains
duloxetine hydrochloride granules with a coating to protect them from stomach acid.
Duloxetina Zentiva is available in 2 dosages: 30 mg and 60 mg.
The 30 mg capsules are opaque, hard gelatin capsules approximately 15.9 mm long with an opaque
white body and an opaque blue cap containing spherical granules of color ranging from almost white to
light brown – yellow.
The 60 mg capsules are opaque, hard gelatin capsules approximately 19.4 mm long with an opaque
ivory body and an opaque blue cap containing spherical granules of color ranging from almost white to
light brown – yellow.
Duloxetina Zentiva 30 mg is available in packs of 7, 28, 56, 84 and 98 capsules.
Duloxetina Zentiva 60 mg is available in packs of 14, 28, 56, 84 and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
S.C. Zentiva S.A
Theodor Pallady Nr 50
032266 Bucharest
Romania
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2778 0890
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .