Duloxetine Liconsa

Package leaflet: Information for the user

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

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Duloxetina Liconsa contains the active substance 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 feelings 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 to 4 weeks before you start feeling better. Contact your doctor if you do not begin to feel better after this time. Your doctor may continue your treatment with Duloxetina Liconsa after you feel better to prevent both depression and recurrence of anxiety.

2. What you should know before taking Duloxetina Liconsa

Do not take Duloxetina Liconsa:

• If you are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)
• If you have liver disease
• If you have 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 commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• If you are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Liconsa')

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise you whether you can take Duloxetina Liconsa.
Warnings and precautions
Reasons why Duloxetina Liconsa may not be suitable for you include the following. 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 preparation
• You have kidney disease
• You have had seizures (epileptic fits)
• You have experienced a manic episode
• You suffer from bipolar disorder
• You have eye problems, including certain types of glaucoma (increased pressure inside the eye)
• You have a history of coagulation disorders (tendency to bruise easily), especially if you are pregnant (see "Pregnancy and breastfeeding")
• You are at risk of low sodium levels (e.g. if you are taking diuretics, particularly if you are elderly)
• You are being treated with another medicine that may cause liver damage
• You are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Liconsa')

Duloxetina Liconsa may cause a feeling of restlessness or inability to sit still. If this happens to you, inform your doctor.
You should also contact your doctor if:
You experience signs and symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, or vomiting, as you may be suffering from serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).
Medicines such as Duloxetina Liconsa (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression and anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may occasionally 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 such thoughts if you:

• Have previously had thoughts of suicide or self-harm
• 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 have thoughts of harming yourself or committing 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 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 Liconsa 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 who take this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggressive, oppositional, and angry behaviour). Nevertheless, your doctor may prescribe Duloxetina Liconsa to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed Duloxetina Liconsa to a patient under 18 years of age and you would like further clarification, discuss it again with your doctor. Inform your doctor if any of the symptoms listed above appear or worsen while a patient under 18 years of age is taking Duloxetina Liconsa.
Furthermore, the long-term safety effects of Duloxetina Liconsa on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.
Other medicines and Duloxetina Liconsa
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 Liconsa, duloxetine, is found in other medicines used for other conditions:

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

Concurrent use of more than one of these medicines should be avoided. Check with your doctor if you are already taking medicines containing duloxetine.
Your doctor must decide whether you can take Duloxetina Liconsa 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 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, may cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Liconsa. In addition, you must wait at least 5 days after stopping Duloxetina Liconsa 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), meperidine, St. John’s wort (hypericum), 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 Liconsa, consult your doctor.
Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent clot formation. These medicines may increase the risk of bleeding.
Duloxetina Liconsa with food, drinks and alcohol
Duloxetina Liconsa can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with Duloxetina Liconsa.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Inform your doctor if you become pregnant or are planning a pregnancy while taking Duloxetina Liconsa. You should use Duloxetina Liconsa only after discussing with your doctor the potential benefits and any possible risks to the unborn child.
• Make sure your midwife and/or doctor knows that you are taking Duloxetina Liconsa. 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 newborn, contact your midwife or doctor immediately.
• If you take Duloxetina Liconsa near the end of pregnancy, the newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days. These symptoms may include weak muscles, tremors, nervousness, feeding difficulties, breathing problems, and seizures. If your newborn shows any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife for advice.
• If you take Duloxetina 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 they can provide appropriate advice.
• Available data on the use of Duloxetina Liconsa during the first three months of pregnancy do not show an overall increased risk of birth defects in the child. If Duloxetina Liconsa is taken during the second half of pregnancy, there may be an increased risk of premature birth (6 additional premature births per 100 women taking Duloxetina Liconsa in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.
• Inform your doctor if you are breastfeeding. The use of Duloxetina Liconsa during breastfeeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines
Duloxetina Liconsa may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Liconsa affects you.
Duloxetina Liconsa contains sucrose
Duloxetina Liconsa contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
Duloxetina Liconsa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially 'sodium-free'.

3. How to take Duloxetina Liconsa

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, consult your doctor or pharmacist.
Duloxetina Liconsa is taken by mouth. Swallow the capsule whole with a glass
of water. Alternatively, you may carefully open the capsule and sprinkle the contents onto a small amount
of apple sauce. Swallow immediately without chewing.
For depression:
The usual dose of Duloxetina Liconsa 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 Liconsa is 30 mg once daily, after which most patients will receive
60 mg once daily. However, your doctor will prescribe the dose they consider appropriate
for you. The dose may be adjusted up to 120 mg daily, depending on your response to Duloxetina
Liconsa.
To help you remember to take Duloxetina Liconsa, it may be easier to take it at the same time each day.
Talk to your doctor about how long you should continue taking Duloxetina Liconsa. Do not stop
taking Duloxetina Liconsa, 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.
For doses not achievable with this strength, other strengths 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 more Duloxetina Liconsa 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, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.
If you forget to take Duloxetina Liconsa
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 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 Liconsa than prescribed 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 decides that you no longer need Duloxetina Liconsa, 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 Liconsa abruptly 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, feelings of restlessness or agitation, anxiety, feeling unwell (nausea) or actual illness (vomiting), tremor, headache, muscle pain, irritability, diarrhoea, excessive sweating, or dizziness.

These symptoms are usually not severe and disappear within a few days. However, if you experience bothersome symptoms, consult your doctor.
If you have any questions about 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 everybody gets them. Usually, 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, feeling drowsy
• 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 sex drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or skin tingling
• blurred vision
• tinnitus (perception of ringing or noise in the ear in the absence of external sound stimulus)
• awareness of heartbeat (palpitations)
• increased blood pressure, hot flush
• increased yawning
• constipation, diarrhoea, stomach ache, retching (vomiting), heartburn, indigestion, gas accumulation in the intestine
• increased sweating, skin rash (pruritic)
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty achieving an erection, ejaculation disorders
• falls (especially in elderly people), fatigue
• weight loss

In children and adolescents under 18 years of age with depression treated with this medicine, weight loss has occurred when they first started taking the medicine. After 6 months of treatment, weight increased to match that of other children and adolescents of the same age and sex.

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

• throat inflammation causing hoarseness

• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, 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 sleep quality

• pupil dilation (the central dark part of the eye), visual disturbances

• feeling of dizziness or spinning (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

• sensation of throat tightness, nosebleeds

• vomiting blood or presence of black, tarry stools, gastroenteritis, belching, difficulty swallowing

• liver inflammation which may cause abdominal pain and yellowing of the skin or whites of the eyes (jaundice)

• 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 normal, 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, chills, feeling hot, abnormal gait

• weight gain

• Duloxetina Liconsa may cause side effects you may not be aware of, such as increased liver enzymes, or increased blood levels of potassium, creatine phosphokinase, blood sugar, or cholesterol.

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

• severe allergic reaction causing breathing difficulties or dizziness with swelling of the tongue and lips, allergic reactions
• reduced activity of the thyroid gland which may cause tiredness or weight gain
• dehydration, low sodium levels in the blood (especially in elderly people; symptoms may include dizziness, feeling weak, confused, drowsy or very tired, 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 rigidity), 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 illness with blistering of the skin, mouth, eyes and genitals), severe allergic reaction causing swelling of the face or throat (angioedema)
• contraction of the muscles of the mouth
• altered odour of urine
• menopausal symptoms, abnormal production of breast milk in men and women
• excessive vaginal bleeding immediately after childbirth (postpartum haemorrhage)
• 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 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 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: 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 carton and on the blister after EXP.
The expiry date refers to the last day of that month.
Aluminium/Aluminium blisters
Do not store above 30°C.
Clear PVC/PCTFE blisters sealed with an aluminium foil
Do not store above 30°C.
Store in the original blister packaging to protect from moisture.
Do not dispose of any medicine 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 Liconsa contains
The active substance is duloxetine.
Each capsule contains duloxetine hydrochloride equivalent to 90 mg of duloxetine.
Each capsule contains duloxetine hydrochloride equivalent to 120 mg of duloxetine.
The other components are:
o Capsule contents: sugar spheres (sugar syrup, corn starch, sucrose),
methacrylic 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 Blue No. 1 (Brilliant Blue FCF) (E133), FD&C Blue No. 2 (Indigo Carmine) (E132),
• 120 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue No. 2 (Indigo Carmine) (E132), yellow iron oxide (E172),

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

Marketing Authorization 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 authorized in the European Economic Area Member States under the following names: