DULOXETINA 30 mg Hard Gastro-Resistant Capsule

Содержание инструкции

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

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

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

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

Duloxetina Almus contains the active ingredient duloxetine. Duloxetina Almus increases the levels of
serotonin and noradrenaline in the nervous system.
Duloxetina Almus 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 touch, heat, cold, or pressure can cause pain) Duloxetina Almus 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 feel better. Contact your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetina Almus when you feel better to prevent depression or anxiety from returning.

In people with diabetic neuropathic pain, it may take several weeks before
you feel better. Tell your doctor if you do not feel better after 2 months.

2. What you need to know before taking Duloxetina Almus

Do not take Duloxetina Almus:

• 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 Almus’)
• 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 Almus’)

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

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

• you are taking other medicines to treat depression (see ‘Other medicines and Duloxetina Almus’)
• 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 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 other medicines that contain duloxetine (see ‘Other medicines and Duloxetina Almus’)

Duloxetina Almus may cause a feeling of restlessness or an inability to sit still or remain
motionless. If this happens to you, you should tell your doctor.
Medicines such as Duloxetina Almus (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 increase 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 of age 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
to hospital immediately.
You may find it helpful to tell a relative or close friend that you are depressed or anxious, 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 Almus 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 undesirable effects such as suicide attempt, suicidal thoughts and hostile behaviour (especially aggressive behaviour, oppositional behaviour and anger).
However, the doctor may prescribe Duloxetina Almus 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 Almus to a
patient under 18 years of age and you would like clarification, return to the doctor. You should tell the doctor if
any of the above symptoms appear or worsen when patients under 18 years of age are
taking Duloxetina Almus. Furthermore, long-term safety effects of Duloxetina Almus relating to growth, maturity and cognitive and behavioural development have not yet been demonstrated in this age group.

Other medicines and Duloxetina Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
The main component of Duloxetina Almus, 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 Almus 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 Almus 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 Almus, 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 Almus. Also, you must
wait at least 5 days after stopping taking Duloxetina Almus 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, SSRIs (such as
paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine,
amitriptyline), pethidine, St. John's Wort 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 Almus, 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 Almus with food, drink and alcohol
Duloxetina Almus can be taken independently of meals. You should be careful if you drink alcohol
while being treated with Duloxetina Almus.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, 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 Almus. You should only use Duloxetina Almus 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 Almus. When taken during pregnancy, similar medicines (SSRIs) can increase the risk of a serious condition occurring in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which involves the newborn having a fast breathing rate 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 Almus 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 presents any of these symptoms after birth, or you are worried about the baby’s health, contact your doctor or midwife who will be able to advise you.
• If you take Duloxetina Almus 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 that you are taking duloxetine so that they can advise you.
• Available data on the use of Duloxetina Almus during the first 3 months of pregnancy do not show an increased risk of overall birth defects in the baby. If Duloxetina Almus 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 Duloxetina Almus 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 Almus during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

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

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

Duloxetina Almus 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 Almus

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Duloxetina Almus is taken orally. Swallow the capsule whole, with the help of a glass
of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Almus 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 Almus 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, depending on your response to
Duloxetina Almus.
To help you remember to take Duloxetina Almus, 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 Almus. Do not stop
taking Duloxetina Almus, 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.

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

If you forget to take Duloxetina Almus
If you forget a dose, take it as soon as you remember. However, if it is 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 of Duloxetina Almus than
has been prescribed for you for one day.

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

• dizziness, sensations of tingling like pins and needles or electric shock-like sensations (especially in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling of restlessness or agitation, feeling of anxiety, feeling unwell (nausea) or sickness (vomiting), tremor, headache, muscle pain, feeling of irritability, 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 questions 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 everyone will experience 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 of drowsiness
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty falling asleep, feeling of agitation, decreased sexual desire, anxiety, difficulty or inability to reach orgasm, unusual dreams
• dizziness, feeling of sluggishness, tremor, numbness, including a sensation of tingling or pins and needles in the skin
• blurred vision
• tinnitus (perception of a sound in the ear when there is no external sound stimulus)
• feeling your heart beating in your chest
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, stomach pain, retching (vomiting), heartburn, indigestion, accumulation of gas in the intestines
• increased sweating, rash (itchy)
• muscle pain, muscle spasm
• painful urination, frequent urination
• difficulty having an erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine have experienced
some weight loss when 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 the sense of taste, difficulty controlling movements such as, for example, lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the dark center of the eye), visual disturbances
• feeling of dizziness or “spinning” (vertigo), ear pain
• increased or irregular heartbeat
• fainting, dizziness, feeling lightheaded or about to faint while 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 cycles, unusually light or absent, pain in the testicles or scrotum
• chest pain, feeling cold, thirst, trembling, feeling hot, abnormal gait
• weight gain
• Duloxetina Almus 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, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• inflammation of the mouth, presence of 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 vaginal bleeding 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)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. 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 Almus

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 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.
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. Contents of the pack and other information

What Duloxetina Almus contains
The active substanceis duloxetine as hydrochloride.
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Each capsule contains 60 mg of duloxetine (as hydrochloride).
The other ingredientsare:
o Capsule content: sugar granules, methacrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30% (Eudragit L30D55), hypromellose, sucrose, anhydrous colloidal silica, talc,
triethyl citrate, plasacryl T20 (glycerol monostearate, triethyl citrate, polysorbate 80, water).
o Capsule shell:

• 30 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue 2, water.
• 60 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue 2, yellow iron oxide (E172), water.

Description of the appearance of Duloxetina Almus and contents of the pack
Duloxetina Almus is a hard, gastro-resistant capsule. Each Duloxetina Almus capsule
contains granules of duloxetine hydrochloride with a coating to protect them from stomach acid.
Duloxetina Almus 30 mg capsules are hard gelatin capsules with an opaque blue cap and an opaque white body.
Duloxetina Almus 60 mg capsules are hard gelatin capsules with an opaque blue cap and an opaque green body.
Transparent PVC/PCTFE blister sealed with aluminum foil and Aluminum/Aluminum blister
Duloxetina Almus 30 mg is available in packs of 7 and 28 capsules.
Duloxetina Almus 60 mg is available in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genova
Italy

Manufacturers
Laboratorios Liconsa, S.A.
Avda. Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Pharmascience International Limited
Julia House, Themistokli Dervi 3
P.C. 1066, Nicosia
Cyprus

This medicinal product is authorised in the other Member States of the European Economic Area under the
following denominations:
Netherlands Duloxetine Laboratorios Liconsa30 mg hard gastro-resistant capsules
Duloxetine Laboratorios Liconsa60 mg hard gastro-resistant capsules
France Duloxetine Almus 30 mg, gastro-resistant capsule
Duloxetine Almus 60 mg, gastro-resistant capsule
Ireland Duloxetine Pinewood 30 mg hard gastro-resistant capsules
Duloxetine Pinewood 60 mg hard gastro-resistant capsules
Italy Duloxetina Almus
Poland Duloxetine Medical Valley
Spain Duloxetina Almus 30 mg hard gastro-resistant capsules EFG
Duloxetina Almus 60 mg hard gastro-resistant capsules EFG