Duloxetine Almus

Patient Information Leaflet

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

Generic medicine
Please 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform 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 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

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

Duloxetina Almus contains the active substance 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 feelings of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, sharp, stabbing, shooting, or crushing pain, or as an electric shock. The affected area may experience loss of sensation, or sensations in which touch, heat, cold, or pressure may cause pain)

Duloxetina Almus begins to be effective in most people with depression or anxiety within two weeks of starting treatment, but it may take 2–4 weeks before you start feeling better. If you do not begin to feel better after this time, consult your doctor. Your doctor may continue to prescribe Duloxetina Almus once you start feeling better in order to prevent depression or anxiety from returning.

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

2. What you need to know before taking Duloxetina Almus

Do not take Duloxetina Almus:

• 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 Almus')
• 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 Almus')

Tell your doctor if you have high blood pressure or heart disease. Your doctor will advise you whether
you can take Duloxetina Almus.
Warnings and precautions
Reasons why Duloxetina Almus may not be suitable for you include the following. 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 preparation
• you have kidney disease
• you have had seizures (epileptic fits)
• you have had a manic episode
• you suffer from bipolar disorder
• you have eye problems, such as certain types of glaucoma (increased pressure inside the eye)
• you have a history of blood clotting 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 Almus')

Duloxetina Almus may cause a feeling of restlessness or inability to sit still. If this happens to you, tell
your doctor.
Medicines such as Duloxetina Almus (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 persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression and anxiety disorder
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase when you first start treatment with antidepressants, as these medicines take time to become effective, usually about 2 weeks but sometimes longer.
You may be more likely to have these thoughts if you:

• have previously had thoughts of suicide or self-harm
• are a young adult. Clinical trial data 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 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 could ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Children and adolescents under 18 years of age
Duloxetina Almus is normally not to be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age taking this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggressive behaviour, oppositional behaviour, and anger).
Nevertheless, your doctor may prescribe Duloxetina Almus to patients under 18 years of age if he/she considers it the best option for them. If your doctor has prescribed Duloxetina Almus to a patient under 18 years of age and you would like clarification, speak to your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking Duloxetina Almus. In addition, long-term safety effects of Duloxetina Almus on growth, maturation, and cognitive and behavioural development have not yet been established 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 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

Concurrent use of more than one of these medicines must be avoided. Check with your doctor if you are already taking medicines containing duloxetine.
Your 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 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 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 an MAOI before you can take Duloxetina Almus. Also, you must wait at least 5 days after stopping 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), meperidine, 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 any of these medicines together with Duloxetina Almus, consult your doctor.
Oral anticoagulants and antiplatelet agents: Medicines that thin the blood or prevent blood clots. These medicines may increase the risk of bleeding.
Duloxetina Almus with food, drinks and alcohol
Duloxetina Almus can be taken regardless of meals. You should be cautious if you drink alcohol while being treated with Duloxetina Almus.
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 Almus. You should use Duloxetina Almus 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 Almus. 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 faster and appear bluish. 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 Almus near the end of pregnancy, the newborn may experience certain symptoms shortly after birth. These usually appear at birth or within a few days after birth. These symptoms may include floppy muscles, tremors, irritability, feeding difficulties, breathing problems, and seizures. If your newborn shows any of these symptoms after birth, or if you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.
• 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 they can advise you.
• Available data on the use of Duloxetina Almus during the first three months of pregnancy do not show an overall increased risk of birth defects in the child. If Duloxetina Almus is taken during the second half of pregnancy, there may be an increased risk that the baby will be born prematurely (6 additional premature births per 100 women taking Duloxetina Almus 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 Almus during breastfeeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines
Duloxetina Almus may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Almus affects you.
Duloxetina Almus contains sucrose
Duloxetina Almus contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Duloxetina Almus is taken orally. Swallow the capsule whole with a glass of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Almus is 60 mg once daily, but your doctor will prescribe the dose that is right for you.

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

To help you remember to take Duloxetina Almus, 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 Almus. Do not stop taking Duloxetina Almus or change the dose without discussing it with your doctor. Appropriate treatment of the condition is important to help you feel better. If left untreated, the condition may not improve and may become worse and more difficult to treat.

If you take more Duloxetina Almus than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Almus than prescribed. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures, vomiting and rapid heartbeat.

If you forget to take Duloxetina Almus
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 a forgotten dose. Do not take more Duloxetina Almus than the amount prescribed 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 decides you no longer need Duloxetina Almus, they will ask you to gradually reduce the dose over a period of at least 2 weeks before stopping treatment completely.

Some patients who stop taking Duloxetina Almus suddenly have experienced symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shock sensations (particularly in the head), sleep disturbances (intense dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, feeling unwell (nausea) or being unwell (vomiting), tremor, headache, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.

Usually these symptoms are not severe and disappear within a few days. However, if you experience bothersome symptoms, 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 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, drowsiness
• feeling unwell (nausea), dry mouth

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

• loss of appetite
• difficulty sleeping, restlessness, reduced sexual desire, anxiety, difficulty or inability to reach orgasm, unusual dreams
• dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or skin tingling
• blurred vision
• tinnitus (perception of sound in the ear in the absence of external auditory 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

Children and adolescents under 18 years of age with depression treated with this medicine have experienced some weight loss when first starting treatment. After 6 months of treatment, weight increased to be comparable to that of other children and adolescents of the same age and sex.

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

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, disorientation, lack of motivation
• sudden and involuntary muscle spasms or contractions, feeling restless or unable to sit still, feeling nervous, difficulty concentrating, changes in taste sensation, impaired motor control such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor sleep quality
• pupil dilation (the dark centre of the eye), visual disturbances
• feeling dizzy or lightheaded (vertigo), ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or impending faint when standing up, cold sensation in the fingers and/or toes
• sensation of throat tightness, nosebleeds
• vomiting blood or passing 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, photosensitivity, increased tendency to bruise
• muscle stiffness, muscle contraction
• difficulty or inability to urinate, difficulty initiating urination, need to urinate during the night, need to urinate more than usual, reduced urinary flow
• abnormal vaginal bleeding, abnormal menstrual cycles, including heavy, painful, irregular or prolonged periods, unusually light or absent periods, testicular or scrotal pain
• chest pain, feeling cold, thirst, trembling, feeling hot, abnormal gait
• weight gain

Duloxetina Almus may cause effects you may not be aware of, such as increases in liver enzymes, or 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, weakness, confusion, drowsiness or extreme tiredness, nausea or feeling like vomiting; more severe symptoms include loss of consciousness, seizures or falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, mania (hyperactivity, racing thoughts and reduced need for sleep), hallucinations, aggressive behaviour and anger
• "Serotonin syndrome" (a rare reaction which may cause feelings of extreme well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• mouth inflammation, presence of bright red blood in stools, bad breath, inflammation of the large intestine (causing diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with blistering of the skin, mouth, eyes and genitals), severe allergic reaction causing facial or throat swelling (angioedema)
• contraction of the muscles of the mouth
• altered odour of urine
• menopausal symptoms, abnormal production of breast milk in men and women
• 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)

Reporting of side effects

If you experience any side effects, 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 Almus

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after
“Exp.”. The expiry date refers to the last day of that month.
Aluminum/Aluminum blister
Do not store above 30°C.
Transparent PVC/PCTFE blister sealed with an aluminum foil
Do not store above 30°C.
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 Almus contains
The active substance is duloxetine as hydrochloride.
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Each capsule contains 60 mg of duloxetine (as hydrochloride).
The other components are:
o Capsule contents: sugar granules, methacrylic acid-ethyl acrylate copolymer (1:1)
dispersion 30% (Eudragit L30D55), hypromellose, sucrose, anhydrous colloidal silica, talc,
triethyl citrate, Plasacryl T20 (glyceryl monostearate, triethyl citrate, polysorbate 80, water).
o Capsule shell:

• 30 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue No. 2, water.
• 60 mg capsules: titanium dioxide (E171), gelatin, FD&C Blue No. 2, yellow iron oxide (E172), water.

Description of the appearance of Duloxetina Almus and contents of the package
Duloxetina Almus is a hard gastro-resistant capsule. Each Duloxetina Almus capsule
contains granules of duloxetine hydrochloride with a coating designed to protect them from stomach acidity.
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 blisters sealed with aluminum foil and aluminum/aluminum blisters.
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 Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
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 authorized in other European Economic Area (EEA) Member States under the
following names:
Netherlands Duloxetine Laboratorios Liconsa 30 mg hard gastro-resistant capsules
Duloxetine Laboratorios Liconsa 60 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 gastro-resistant hard capsules EFG
Duloxetina Almus 60 mg gastro-resistant hard capsules EFG