Duloxetine +pharma: detailed information

Package leaflet: Information for the user

Duloxetine +pharma, 30 mg, hard enteric-coated capsules
Duloxetine +pharma, 60 mg, hard enteric-coated capsules
Duloxetinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

What Duloxetine +pharma is and what it is used for
Important information before taking Duloxetine +pharma
How to take Duloxetine +pharma
Possible side effects
How to store Duloxetine +pharma
Contents of the pack and other information

1. What Duloxetine +pharma is and what it is used for

Duloxetine +pharma contains the active substance duloxetine. Duloxetine +pharma increases the concentration of serotonin and noradrenaline in the nervous system.
Duloxetine +pharma is indicated in adults for the treatment of:

depression
generalized anxiety disorder (persistent feelings of anxiety or nervousness)
diabetic neuropathic pain (usually described as burning, shooting, stabbing, aching, or electric-shock-like sensations. In certain areas of the body, loss of sensation may occur, or sensations such as touch, heat, cold, or pressure may cause pain).

In most people with depression or anxiety, Duloxetine +pharma begins to work within two weeks of starting treatment, but it may take 2 to 4 weeks before an improvement in well-being is noticed. You should consult your doctor if you do not feel better after this time. Even if your condition improves, your doctor may recommend continuing to take Duloxetine +pharma to prevent recurrence of depression or anxiety.
In people with diabetic neuropathic pain, improvement may occur after several weeks. You should consult your doctor if no improvement occurs after 2 months.

2. Important information before using Duloxetine +pharma

When not to use Duloxetine +pharma

if the patient is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
if the patient has liver disease
if the patient has severe kidney disease
if the patient is taking or has taken within the last 14 days another medicine which is a monoamine oxidase inhibitor (MAOI) (see "Duloxetine +pharma with other medicines")
if the patient is taking fluvoxamine, which is mainly used in the treatment of depression, or ciprofloxacin or enoxacin – medicines used to treat certain infections
if the patient is taking other medicines containing duloxetine (see "Duloxetine +pharma with other medicines").

Tell your doctor if the patient has high blood pressure or heart disease.
Your doctor will decide whether the patient should take Duloxetine +pharma.
Warnings and precautions
Below is a list of reasons why Duloxetine +pharma may not be suitable for the patient. Before starting treatment with Duloxetine +pharma, discuss with your doctor if:

the patient is taking other antidepressant medicines (see "Duloxetine +pharma with other medicines");
the patient is taking herbal medicines containing St. John's wort (Hypericum perforatum);
the patient has kidney disease;
the patient has had seizures (fits) in the past;
the patient has had episodes of mania in the past;
the patient has bipolar affective disorder;
the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eye);
the patient has had bleeding problems (tendency to bruise), especially if the patient is pregnant (see "Pregnancy and breastfeeding");
the patient is at risk of low sodium levels (for example, when taking diuretics, especially in elderly patients);
the patient is currently taking other medicines that may cause liver damage;
the patient is taking other medicines containing duloxetine (see "Duloxetine +pharma with other medicines").

Duloxetine +pharma may cause feelings of restlessness or inability to sit still or remain motionless. If such symptoms occur, inform your doctor.
You should also contact your doctor:
If the patient develops objective and subjective symptoms such as agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhoea, drowsiness, nausea, vomiting, as these may indicate serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome.
Objective and subjective symptoms of neuroleptic malignant syndrome may include:
fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected by blood tests).
Medicines such as Duloxetine +pharma (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening depression or anxiety
People with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines take some time to work, usually about 2 weeks, but sometimes longer.
The risk of suicidal thoughts, thoughts of self-harm or suicide is higher if:

the patient has previously had suicidal thoughts or a desire to self-harm;
the patient is a young adult – clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders taking antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going to a hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. You may also ask them for their opinion on whether the patient's depression or anxiety has worsened or whether behavioural changes are causing concern. The patient may ask them to inform him or her if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Children and adolescents under 18 years of age
Duloxetine +pharma is generally not recommended for use in children and adolescents under 18 years of age. In patients under 18 years of age taking medicines of this class, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviours, and manifestations of anger). Nevertheless, your doctor may decide to prescribe Duloxetine +pharma to patients under 18 years of age if he or she considers it beneficial. If you have any doubts regarding the recommendation to use Duloxetine +pharma in a patient under 18 years of age, contact your doctor again. Inform your doctor immediately if any of the adverse reactions listed above occur or worsen in a patient under 18 years of age taking Duloxetine +pharma.
In addition, there are no long-term safety data on the use of Duloxetine +pharma in this age group regarding growth, maturation, cognitive development, and behavioural development.
Duloxetine +pharma with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Duloxetine, the main ingredient in Duloxetine +pharma, may also be present in medicines used to treat other conditions:

diabetic neuropathic pain
depression
anxiety
urinary incontinence.

Avoid taking more than one of these medicines simultaneously. The patient should consult their doctor if taking other medicines containing duloxetine.
Your doctor will decide whether it is safe to take Duloxetine +pharma together with other medicines.
Do not start or stop taking any other medicines, including those available without a prescription and herbal supplements, without first consulting your doctor.
You should also inform your doctor if the patient is taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs)
Do not take Duloxetine +pharma together with another antidepressant medicine called a monoamine oxidase inhibitor (MAOI), or within a short time interval (within 14 days) after stopping an MAOI.
Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs together with many prescription medicines, including Duloxetine +pharma, may cause serious or even life-threatening adverse reactions.
At least 14 days must pass after stopping an MAOI before starting Duloxetine +pharma. Similarly, at least 5 days must pass after stopping Duloxetine +pharma before starting an MAOI.
Medicines causing drowsiness
These include prescription medicines such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Medicines increasing serotonin levels
Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), selective norepinephrine reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, buprenorphine, St. John's wort (Hypericum perforatum), and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of adverse reactions.
If any unusual symptoms occur while taking these medicines together with Duloxetine +pharma, contact your doctor.
Oral anticoagulants or antiplatelet medicines
Medicines that thin the blood or prevent blood clotting may increase the risk of bleeding.
Duloxetine +pharma with food, drink and alcohol
Duloxetine +pharma can be taken during or between meals.
Exercise caution when consuming alcohol while taking Duloxetine +pharma.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The patient should inform her doctor if she becomes pregnant while taking Duloxetine +pharma or if she is trying to become pregnant. The patient may take Duloxetine +pharma only after discussing with her doctor the potential benefits of treatment and the risks to the unborn child.
The patient should inform her midwife and (or) doctor that she is taking Duloxetine +pharma. Use during pregnancy of similar medicines (selective serotonin reuptake inhibitors) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, causing rapid breathing and cyanosis in the baby. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her baby, she should contact her midwife and (or) doctor immediately.
If the patient takes Duloxetine +pharma towards the end of pregnancy, certain symptoms may occur in the newborn. These usually appear at birth or within the next few days. Symptoms may include: muscle weakness, tremor, jitteriness, feeding difficulties, breathing problems, and seizures. If the patient notices any of these symptoms, or is concerned about the baby's health, she should contact her doctor or midwife for help.
If the patient takes Duloxetine +pharma towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if she has a history of bleeding disorders. Inform your doctor or midwife about taking duloxetine so they can recommend appropriate management.
Available data on the use of duloxetine during the first three months of pregnancy generally do not show an increased risk of congenital malformations in the child. If the patient takes Duloxetine +pharma during the second half of pregnancy, there may be an increased risk of premature birth, mainly between weeks 35 and 36 (6 additional premature births per 100 women taking duloxetine in the second half of pregnancy).
The patient should inform her doctor if she is breastfeeding. Use of Duloxetine +pharma during breastfeeding is not recommended. Breastfeeding women should consult their doctor or pharmacist for advice.

Driving and operating machinery
Duloxetine +pharma may cause drowsiness or dizziness. The patient should not drive or operate machinery until they know how they react to Duloxetine +pharma.
Duloxetine +pharma contains sucrose
Duloxetine +pharma contains sucrose. If the doctor has previously diagnosed the patient with an intolerance to certain sugars, contact the doctor before starting treatment.

3. How to take Duloxetine +pharma

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Duloxetine +pharma is taken orally. The capsule should be swallowed whole with water.

Treatment of depression and diabetic neuropathic pain
The usual dose of Duloxetine +pharma is 60 mg taken once daily. However, your doctor will
determine the dose appropriate for you.

Treatment of generalized anxiety disorder
The usual initial dose of Duloxetine +pharma is 30 mg once daily. In most patients, the dose is
subsequently increased to 60 mg once daily. However, your doctor will determine the appropriate
dose for you. The dose may be increased up to 120 mg daily, depending on your response to
treatment.

Taking Duloxetine +pharma at the same time each day will help you remember to take it.

Your doctor will inform you how long you should take Duloxetine +pharma. Do not stop taking
Duloxetine +pharma or change the dose without consulting your doctor. Proper treatment of the
condition is important so that you feel better. If left untreated, your condition may not improve, may
worsen, and become more difficult to treat.

Taking more Duloxetine +pharma than recommended
If you take more Duloxetine +pharma than recommended, contact your doctor or pharmacist
immediately. Symptoms of overdose may include: drowsiness, coma, serotonin syndrome (a rare
reaction which may cause excessive feelings of well-being, drowsiness, lack of coordination,
restlessness, sensation of alcohol intoxication, fever, sweating, or muscle stiffness), seizures,
vomiting, and rapid heartbeat.

Missing a dose of Duloxetine +pharma
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip
the missed dose and take the next dose at the usual time. Do not take a double dose to make up for
a missed dose. Do not take more than the daily dose of Duloxetine +pharma prescribed by your
doctor.

Stopping Duloxetine +pharma
DO NOT stop taking Duloxetine +pharma without consulting your doctor, even if you feel better. If
your doctor decides that you no longer need to take Duloxetine +pharma, they will recommend
gradually reducing the dose over at least 2 weeks.

Some patients who stop taking Duloxetine +pharma abruptly may experience symptoms such as:

dizziness, tingling sensations like being pricked by pins or needles or feeling of electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, difficulty falling asleep), fatigue, drowsiness, restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhoea, excessive sweating, or vertigo.

These symptoms are usually not serious and resolve within a few days. However, if they are
bothersome, contact your doctor.

If you have any further 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 usually resolve within a few weeks.
Very common (may affect more than 1 in 10 people)

headache, drowsiness
nausea, dry mouth

Common (may affect up to 1 in 10 people)

loss of appetite
sleep disturbances, restlessness, reduced libido, anxiety, difficulty or inability to achieve orgasm, unusual dreams
dizziness, feeling slowed down, muscle tremors, numbness affecting: numbness, tingling or prickling sensation of the skin
blurred vision
tinnitus (hearing sounds in the ears with no external source)
palpitations
increased blood pressure, sudden flushing of the face
excessive yawning
constipation, diarrhoea, abdominal pain, vomiting, heartburn or indigestion, passing wind
increased sweating
(itchy) rash
muscle pain, muscle cramps
painful urination, frequent urination
difficulty achieving 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 after starting treatment. After 6 months of treatment, body weight
increased and equalized with that observed in other children and adolescents of the same age
and sex.
Uncommon (may affect up to 1 in 100 people)

sore throat causing hoarseness
suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, disorientation, lack of motivation
sudden involuntary movements or muscle twitching, feeling of restlessness or inability to sit still or stand still, irritability, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g. lack of coordination or unintended muscle movements, restless legs syndrome
worsened quality of sleep
dilated pupils (dark central point of the eye), vision disturbances
feeling of dizziness or "spinning" (vertigo), ear pain
rapid and (or) irregular heartbeat
fainting, dizziness, feeling of emptiness in the head or fainting upon standing
cold sensation in fingers of hands and (or) feet
tightness in the throat, nosebleeds
vomiting blood or black, tarry stools, inflammation of the stomach and intestines, regurgitation of stomach contents, difficulty swallowing
inflammation of the liver, which may cause abdominal pain and yellowing of the skin or whites of the eyes
night sweats, urticaria, cold sweats, photosensitivity, increased tendency to bruising
muscle stiffness and tremors
difficulty or inability to urinate, difficulty initiating urination, need to urinate at night, need to urinate more than usual, decreased urine output
abnormal vaginal bleeding, menstrual disorders, including heavy, painful, irregular or prolonged periods, abnormally light periods or absence of periods
testicular or scrotal pain
chest pain, cold sensation, thirst, chills, feeling of heat, gait disturbances
weight gain
Duloxetine +pharma may cause side effects that may not be noticeable, such as increased liver enzyme activity or blood potassium levels, increased creatine phosphokinase activity, blood glucose or cholesterol levels.

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

severe allergic reaction causing difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
reduced thyroid function, which may cause fatigue or weight gain
dehydration, low blood sodium levels (especially in elderly people; symptoms may include: dizziness, weakness, confusion, drowsiness, excessive fatigue, nausea or vomiting; more severe symptoms include: fainting, seizures and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
suicidal behaviour, manic state (excessive activity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger outbursts
serotonin syndrome (a rare reaction which may cause feelings of excessive well-being, drowsiness, lack of motor coordination, restlessness, especially motor restlessness, feeling of alcohol intoxication, fever, sweating or muscle stiffness), seizures
increased eye pressure (glaucoma)
inflammation of the mouth
bright red blood in stool, bad breath, inflammation of the large intestine (leading to diarrhoea)
liver failure, yellow discoloration of the skin or whites of the eyes (jaundice)
Stevens-Johnson syndrome (a serious condition with ulceration of the skin, mouth, eyes and genital organs)
severe allergic reaction causing swelling of the face or throat (angioedema)
jaw muscle spasm
unusual urine odour
menopausal symptoms, abnormal milk production in men or women
cough, wheezing and shortness of breath, possibly accompanied by fever
excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage)

Very rare (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 available data)

objective and subjective symptoms of a condition called stress cardiomyopathy, which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Duloxetine +pharma

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 pack after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Duloxetine +pharma contains

The active substance is duloxetine.

Duloxetine +pharma, 30 mg, hard enteric capsules
Each capsule contains 30 mg of duloxetine (as hydrochloride).
Duloxetine +pharma, 60 mg, hard enteric capsules
Each capsule contains 60 mg of duloxetine (as hydrochloride).

Other ingredients are:
- capsule contents: sucrose, pellets (containing maize starch), methacrylic acid and ethyl acrylate copolymer 1:1 dispersion 30% (Eudragit L30D55), hypromellose, sucrose, anhydrous colloidal silica, talc, triethyl citrate, Plasacryl T20 (glyceryl stearate, triethyl citrate, polysorbate 80, water).
- capsule shell Duloxetine +pharma, 30 mg: titanium dioxide (E 171), gelatin, indigo carmine (E 132), water. Duloxetine +pharma, 60 mg: titanium dioxide (E 171), gelatin, indigo carmine (E 132), yellow iron oxide (E 172), water.
- green ink (only Duloxetine +pharma, 30 mg): shellac, propylene glycol, potassium hydroxide, black iron oxide (E 172), yellow iron oxide (E 172).
- white ink (only Duloxetine +pharma, 60 mg): shellac, propylene glycol, povidone, titanium dioxide (E 171).

What Duloxetine +pharma looks like and contents of the pack
Duloxetine +pharma is available as hard enteric capsules. Each capsule contains duloxetine hydrochloride pellets coated with a layer protecting them from gastric juice.
Duloxetine +pharma, 30 mg, hard enteric capsules
White opaque size 3 hard gelatin capsules with a yellow print "30 mg" on the body and blue opaque cap with a yellow print "DLX".
Duloxetine +pharma, 60 mg, hard enteric capsules
Green opaque size 1 hard gelatin capsules with a white print "60 mg" on the body and blue opaque cap with a white print "DLX".
Duloxetine +pharma is available in packs containing 10, 28 and 30 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz
Austria
Manufacturer
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria