Duloxetine Alter

Package leaflet: Information for the user

Duloxetina Alter 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Duloxetina Alter contains the active substance duloxetina. Duloxetina Alter increases the levels of serotonin and noradrenaline in the nervous system.
Duloxetina Alter 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 crushing pain, or as an electric shock. The affected area may have reduced sensation, or sensations in which touch, heat, cold, or pressure may cause pain)

Duloxetina Alter 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 Alter once you are feeling better to prevent depression or anxiety from returning.
In patients 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.
AIC in GU 275 of 25/11/2015

2. What you need to know before taking Duloxetina Alter

Do NOT take Duloxetina Alter if you:

• are allergic to duloxetine or to any of the other ingredients of this medicine (listed in section 6)

ES-H-0297-001-002-DC

• have liver disease
• have severe kidney disease
• are taking or have taken within the last 14 days another medicine known as a Monoamine Oxidase Inhibitor (MAOI) (see 'Other medicines and Duloxetina Alter')
• are taking fluvoxamine, which is commonly used to treat depression, or ciprofloxacin or enoxacin, which are used to treat certain infections
• are taking other medicines containing duloxetine (see 'Other medicines and Duloxetina Alter')
  Tell your doctor if you have high blood pressure or a heart condition. Your doctor will advise you whether you can take Duloxetina Alter.

Warnings and precautions
Reasons why Duloxetina Alter may not be suitable for you include the following.
Medicines such as Duloxetina Alter (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.
Talk to your doctor before taking Duloxetina Alter if:

• you are taking other medicines to treat depression (see 'Other medicines and Duloxetina Alter')

• 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, such as certain types of glaucoma (increased pressure inside the eye)

• you have a history of coagulation disorders (tendency to bruise easily)

• you are at risk of low sodium levels (e.g. if you are taking diuretics, especially 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
  Alter')
  Duloxetine may cause a feeling of restlessness or inability to sit still. If this happens to you, inform your doctor.
  Suicidal thoughts and worsening of depression and anxiety disorders
  If you are depressed and/or have anxiety disorders, you may occasionally have thoughts of harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as these medicines require 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 killing yourself or harming yourself

• 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 to hospital immediately.
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
Duloxetine 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 taking this type of medicine have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviour and anger). Nevertheless, your doctor may prescribe duloxetine to patients under 18 years of age if he/she considers it the best option for them. If your doctor has prescribed duloxetine to a patient under 18 years of age and you require clarification, consult your doctor again. You must inform the doctor if any of the symptoms listed above appear or worsen while patients under 18 years of age are taking duloxetine. Furthermore, long-term effects on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and Duloxetina Alter
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 Alter, duloxetine, is present in other medicines for different conditions:

• diabetic neuropathic pain, depression, anxiety and urinary incontinence
  Concomitant use of more than one of these medicines must be avoided. Check with your doctor if you are already taking medicines containing duloxetine.

AIC in GU 275 del 25/11/2015
Your doctor must decide whether you can take Duloxetina Alter with other medicines. Do not start or stop taking any medicine, including those purchased 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 Alter 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 Alter, can cause serious or even life-threatening side effects. You must wait at least 14 days after stopping an MAOI before starting Duloxetina Alter. Additionally, you must wait at least 5 days after stopping Duloxetina Alter before starting 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 adverse effects; if you experience any unusual symptoms while taking any of these medicines together with Duloxetina Alter, 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 Alter with food, drinks and alcohol
Duloxetina Alter can be taken regardless of meals. You should be cautious about drinking alcohol while being treated with Duloxetina Alter.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• Inform your doctor if you become pregnant or are planning a pregnancy while taking Duloxetina Alter. You should use Duloxetina Alter only after discussing with your doctor the potential benefits and any possible risks to the unborn child.

Ensure that your midwife and/or doctor knows that you are being treated with Duloxetina Alter.
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 the newborn, contact your midwife or doctor immediately.
If you take Duloxetina Alter near the end of pregnancy, the newborn may show some symptoms shortly after birth. These usually appear at birth or within a few days of birth. These symptoms may include floppy muscles, tremors, irritability, feeding difficulties, breathing problems and seizures. If the newborn shows any of these symptoms after birth, or if you are concerned about the baby’s health, contact your doctor or midwife, who will be able to advise you.

• Inform your doctor if you are breastfeeding. The use of Duloxetina Alter during breastfeeding is not recommended. Ask your doctor or pharmacist for advice.

Driving and using machines
Duloxetina Alter may cause drowsiness or dizziness. Do not drive or operate tools or machinery until you know how Duloxetina Alter affects you.
Duloxetina Alter contains sucrose
Duloxetina Alter contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Duloxetina Alter

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Duloxetina Alter is taken orally. Swallow the capsule whole, without chewing, with a glass of water.

For depression and diabetic neuropathic pain:
The usual dose of Duloxetina Alter 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 Alter is 30 mg once daily. Most patients will then be increased to 60 mg once daily, but your doctor will determine the dose appropriate for you. The dose may be adjusted up to 120 mg daily, depending on your response to Duloxetina Alter.

To help you remember to take Duloxetina Alter, it may be helpful to take it at the same time each day.

Talk to your doctor about how long you should continue taking Duloxetina Alter. Do not stop taking Duloxetina Alter 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.

If you take more Duloxetina Alter than you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetina Alter 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 rigidity), seizures, vomiting, and rapid heartbeat.

If you forget to take Duloxetina Alter
If you miss 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 only your next scheduled dose as usual. Do not take a double dose to make up for a missed one. Do not take more Duloxetina Alter than the amount prescribed for one day.

If you stop taking Duloxetina Alter
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 Alter, they will ask you to gradually reduce the dose over a period of at least two weeks before stopping treatment completely.

Some patients who stop taking Duloxetina Alter 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, feelings of restlessness or agitation, anxiety, nausea or malaise (vomiting), tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness. These symptoms are usually not severe and resolve within a few days. However, if you experience bothersome symptoms, consult your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually 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, feeling restless, reduced sex drive, anxiety, difficulty or inability to reach orgasm, unusual dreams
• dizziness, feeling sluggish, tremor, numbness, including a sensation of tingling, prickling or pins and needles in the skin
• blurred vision
• tinnitus (perception of sound in the ear in the absence of external sound stimuli)
• 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, 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 first starting treatment. After 6 months of treatment, weight increased to levels comparable to 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 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, feeling nervous, difficulty concentrating, altered sense of taste, problems controlling movements such as lack of coordination or involuntary muscle movements, restless legs syndrome, poor quality of sleep
• pupil dilation (the dark centre of the eye), visual disturbances
• feeling dizzy or lightheaded (vertigo), ear pain
• rapid or irregular heartbeat
• fainting, dizziness, mental fogginess or near-fainting when standing up, cold sensation in fingers and/or toes
• throat tightness, nosebleeds
• vomiting blood or passing black, tar-like stools, gastroenteritis, belching, difficulty swallowing
• liver inflammation which may cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• muscle stiffness, muscle contraction
• difficulty or inability to urinate, difficulty starting urination, need to urinate during the night, need 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, testicular or scrotal pain
• chest pain, feeling cold, thirst, tremor, feeling hot, abnormal gait
• weight gain
• Duloxetina Alter may cause effects you may not be aware of, such as increases in liver enzymes, blood potassium levels, creatine phosphokinase, blood sugar or cholesterol levels

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 fatigue, 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, drunken sensation, fever, sweating or muscle stiffness), seizures
• increased pressure inside the eye (glaucoma)
• mouth inflammation, presence of bright red blood in stools, bad breath
• 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
  • cough, wheezing and shortness of breath, possibly accompanied by fever

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 Duloxetine Alter

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 packaging after
EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. 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 Alter contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other components are:
Capsule contents: hypromellose, sugar spheres (sucrose and maize starch), talc,
sucrose, hypromellose phthalate, triethyl citrate
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigotine
Cap of the capsule: gelatin, titanium dioxide (E171), indigotine

Description of the appearance of Duloxetina Alter and package contents
Duloxetina Alter is a hard gastro-resistant capsule. Each Duloxetina Alter capsule contains duloxetine hydrochloride granules with a coating to protect them from stomach acid.
Duloxetina Alter is available in 2 strengths: 30 mg and 60 mg.
The 30 mg capsules are blue and white in color.
The 60 mg capsules are blue and green in color.
Duloxetina Alter 30 mg is available in blisters made of polyamide/aluminum/polyvinyl chloride – aluminum, in packs of 7 and 28 capsules.
Duloxetina Alter 60 mg is available in blisters made of polyamide/aluminum/polyvinyl chloride – aluminum, in packs of 28 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorization in the Official Journal 275 of 25/11/2015

Marketing Authorization Holder and Manufacturer
Laboratori Alter srl
Via Egadi, 7
20144 Milano
Italy

Manufacturer
Laboratorios Lesvi, S.L.
Avda. Barcelona, 69, 08970, Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorized in the European Economic Area Member States under the following names

AIC in GU 275 of 25/11/2015