DULOXETINA 90 mg Enteric-Coated Hard Capsules

Зміст інструкції

1. Duloxetina Liconsa 90 mg hard gastro-resistant capsules, 120 mg hard gastro-resistant capsules
   1. What is Duloxetina Liconsa and what it is used for
   2. What you need to know before taking Duloxetina Liconsa
   3. How to take Duloxetina Liconsa
   4. Possible side effects
   5. How to store Duloxetina Liconsa
   6. Package contents and other information

Duloxetina Liconsa 90 mg hard gastro-resistant capsules, 120 mg hard gastro-resistant capsules

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 Liconsa is and what it is used for
• 2. What you need to know before you take Duloxetina Liconsa
• 3. How to take Duloxetina Liconsa
• 4. Possible side effects
• 5. How to store Duloxetina Liconsa
• 6. Contents of the pack and other information

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

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

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)

Duloxetina Liconsa 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 feel better. Contact your doctor if you do not begin to feel better after this period. Your doctor
may continue to give you Duloxetina Liconsa when you feel better to prevent both depression and
the return of anxiety.

2. What you need to know before taking Duloxetina Liconsa

Do not take Duloxetina Liconsa:

• If you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• If you have a liver disease
• If you have a severe kidney disease
• If 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 Liconsa’)
• If you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
• If you are taking other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Liconsa’)

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

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

• you are taking other medicines to treat depression (see ‘Other medicines and Duloxetina Liconsa’)
• you are taking St. John’s Wort (Hypericum perforatum), a herbal medicinal product
• you have a kidney disease
• you have had convulsions (seizures)
• 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 bleeding 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 other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Liconsa’)

Duloxetina Liconsa may cause a feeling of restlessness or inability to sit still or
remain immobile. If this happens to you, you should tell your doctor.
Also, tell your doctor if:
You experience signs and symptoms of restlessness, hallucinations, loss of coordination, rapid heartbeat,
increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting, you may be suffering from serotonin syndrome.
In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome
(NMS). The signs and symptoms of NMS can include a combination of fever, rapid heartbeat,
sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Medicines such as Duloxetina Liconsa (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, persistence of these symptoms has been observed after discontinuation
of treatment.

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

• have had thoughts of self-harm or suicide in the past
• are young. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 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.
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 your depression or
anxiety is getting worse, or if they are worried about changes in your
behavior.

Children and adolescents under 18 years of age
Normally Duloxetina Liconsa 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 medicine,
have an increased risk of undesirable effects such as suicide attempt, suicidal thoughts
and hostile behavior (especially aggressive behavior, oppositional behavior and anger). Despite this, the
doctor may prescribe Duloxetina Liconsa 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 Liconsa to a patient under 18 years of age and
you would like clarification, talk to the doctor. Tell the doctor if any of the above symptoms
appear or worsen when a patient under 18 years of age is taking Duloxetina Liconsa.
In addition, the effects on long-term safety regarding growth, maturation and cognitive and behavioral
development of Duloxetina Liconsa in this age group have not yet been
demonstrated.

Other medicines and Duloxetina Liconsa
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription.
The main component of Duloxetina Liconsa, 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 if you can take Duloxetina Liconsa 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 Liconsa 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 Liconsa, 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 Liconsa. Also, you must wait at least 5 days after stopping
taking Duloxetina Liconsa 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), 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 one of these medicines together with Duloxetina Liconsa, you should consult
your doctor.

Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent
the formation of blood clots. These medicines may increase the risk of bleeding.

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

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 are planning a pregnancy, while taking Duloxetina Liconsa. You should only use Duloxetina Liconsa after discussing with your doctor the potential benefits and any potential risk to the unborn child.
• Make sure your midwife and/or doctor knows that you are being treated with Duloxetina Liconsa. When taken during pregnancy, similar medicines (SSRIs) can increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves the newborn having a fast breathing rate and a bluish skin color. These symptoms usually appear within the first 24 hours after birth. If this happens to the newborn, contact your midwife or doctor immediately.
• If you take Duloxetina Liconsa near the end of your pregnancy, the newborn may experience some symptoms shortly after birth. Generally, these appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremor, nervousness, difficulty feeding, a breathing disorder and convulsions. If the newborn experiences any of these symptoms after birth, or you are concerned about the baby's health, contact your doctor or midwife who will be able to advise you.
• If you take Duloxetina Liconsa 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 if you are taking duloxetine so that they can advise you.
• Available data on the use of Duloxetina Liconsa during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If Duloxetina Liconsa is taken during the second half of pregnancy there may be an increased risk that the baby may be born prematurely (6 more babies born prematurely per 100 women taking Duloxetina Liconsa 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 Liconsa during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

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

Duloxetina Liconsa contains sucrose
Duloxetina Liconsa contains sucrose. If you have been diagnosed with an intolerance to certain
sugars, contact your doctor before taking this medicine.

Duloxetina Liconsa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say essentially ‘sodium-free’.

3. How to take Duloxetina Liconsa

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Duloxetina Liconsa is taken orally. Swallow the capsule whole, with the help of a glass
of water. Alternatively, you can carefully open the capsule and sprinkle the contents onto a little
apple sauce. Immediately ingest without chewing

For depression:
The usual dose of Duloxetina Liconsa is 60 mg once a day, but your doctor will prescribe the dose
that he/she deems right for you.

For generalized anxiety disorder:
The usual starting dose of Duloxetina Liconsa 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 deems right
for you. The dose may be adjusted up to 120 mg per day, based on your response to Duloxetina
Liconsa.
To help you remember to take Duloxetina Liconsa, 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 Liconsa. Do not stop
taking Duloxetina Liconsa, 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 severe and difficult to treat.
For doses not obtainable with this dosage, other dosages of this medicine and other
products containing duloxetine are available.

If you take more Duloxetina Liconsa than you should
Contact your doctor or pharmacist immediately if you have taken a quantity of Duloxetina Liconsa
greater than what your doctor 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 rigidity),
seizures, vomiting and accelerated heartbeat.

If you forget to take Duloxetina Liconsa
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 missed dose and take only a single dose as usual. Do not take
a double dose to make up for a missed dose. Do not take more than the amount of
Duloxetina Liconsa that has been prescribed for you for one day.

If you stop taking Duloxetina Liconsa
Even if you feel better, DO NOT stop taking the capsules without consulting
your doctor. If your doctor believes you no longer need Duloxetina Liconsa, he/she will tell you to reduce
the dose gradually over a period of at least 2 weeks before stopping treatment completely.
Some patients who abruptly stop taking Duloxetina Liconsa 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 doubts 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 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 drive, 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, retching (vomiting), heartburn, indigestion, accumulation of gas in the intestine
• increased sweating, itchy rash
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty getting an erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss

In children and adolescents under 18 years of age with depression treated with this medicine, weight loss has been observed
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
• thoughts of suicide, 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 the sense of taste, difficulty controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the central and dark part of the eye), visual disturbances
• feeling dizzy or “lightheaded” (vertigo), ear pain
• increased or irregular heartbeat
• fainting, dizziness, feeling lightheaded or about to faint when standing up, feeling cold in the hands and/or feet
• feeling of constriction in the throat, nosebleeds
• vomiting blood or having black, tarry stools, gastroenteritis, belching, difficulty swallowing
• inflammation of the liver which 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, chills, feeling hot, abnormal gait
• weight gain
• Duloxetina Liconsa 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, convulsions or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, mania (hyperactivity, racing thoughts and reduced 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 rigidity), convulsions
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the large intestine (causing diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with the appearance of blisters on 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
• excessive bleeding from the vagina immediately after childbirth (postpartum hemorrhage)
• cough, wheezing and shortness of breath possibly accompanied by fever

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

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

Frequency not known (cannot be estimated from the available data)

• Signs and symptoms of a condition called "stress cardiomyopathy" which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

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 at: https://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 Duloxetina Liconsa

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 box and on the blister after EXP.
The expiry date refers to the last day of that month.
Aluminum/Aluminum Blister
Do not store at a temperature above 30°C.
Transparent PVC/PCTFE blister sealed with Aluminum foil
Do not store at a temperature above 30°C.
Store in the original blister pack to protect it from moisture.
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 Liconsa contains
The active ingredientis duloxetine
Each capsule contains duloxetine hydrochloride equivalent to 90 mg of duloxetine.
Each capsule contains duloxetina hydrochloride equivalent to 120 mg of duloxetine.
The other ingredientsare:
o Capsule content: sugar spheres (sugar syrup, corn starch, sucrose),
acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, hypromellose, sucrose,
anhydrous colloidal silica, talc, triethyl citrate, glyceryl monostearate, triethyl citrate, polysorbate 80,
water
o Capsule shell:

• 90 mg capsules:titanium dioxide (E171), gelatin, FCF-FD&C Blue1 (brilliant blue FCF) (E133), FD&C Blue 2 (indigo carmine) (E132),
• 120 mg capsules:titanium dioxide (E171), gelatin, FD&C Blue 2 (indigo carmine) (E132), yellow iron oxide (E172),

Description of the appearance of Duloxetina Liconsa and package contents
Duloxetina Liconsa is a hard, gastro-resistant capsule. Each Duloxetina Liconsa capsule
contains granules of duloxetine hydrochloride with a coating to protect them from stomach acidity.
Duloxetina Liconsa 90 mg are hard gelatin capsules of approximately 21.4-22.0 mm, dark blue
opaque cap and light blue opaque body.
Duloxetina Liconsa 120 mg are hard gelatin capsules of approximately 23.0-23.6 mm, dark blue
opaque cap and light blue opaque body.
Aluminum/Aluminum Blisters
Duloxetina Liconsa 90 mg is available in packs of 28 and 98 capsules.
Duloxetina Liconsa 120 mg is available in packs of 28 and 98 capsules.
Transparent PVC/PCTFE blister sealed with aluminum foil
Duloxetina Liconsa 90 mg is available in packs of 28 and 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LABORATORIOS LICONSA, S.A.
Calle Dulcinea S/n
Alcalá De Henares, Madrid 28805
Spain

Manufacturer
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara),
Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: