Dulofor

DULOFOR, 30 mg, hard enteric capsules
DULOFOR, 60 mg, hard enteric capsules
Duloxetine
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents

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

1. What Dulofor is and what it is used for

Dulofor contains the active substance duloxetine. Dulofor increases the levels of serotonin and norepinephrine in the nervous system.
Dulofor is indicated in adults for the treatment of:

• depression,
• generalized anxiety disorder (chronic feelings of anxiety or nervousness),
• diabetic neuropathic pain (typically described as burning, shooting, stabbing, aching, or like electric shocks. In certain areas of the body, there may be loss of sensation or abnormal sensitivity to touch, heat, or cold, and pressure may cause pain).

In most people with depression or anxiety, Dulofor begins to work within two weeks of starting treatment, although improvement in well-being may take 2 to 4 weeks. If the patient does not feel better after this time, they should consult their doctor. Even if the patient's condition improves, the doctor may recommend continuing treatment with Dulofor to prevent recurrence of depression or anxiety.
In patients with diabetic neuropathic pain, improvement may occur after several weeks. Consult your doctor if no improvement occurs after 2 months.

2. Important information before using Dulofor

When not to use Dulofor:

• 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 "Dulofor with other medicines"),
• if the patient is taking fluvoxamine, which is mainly used in the treatment of depression, ciprofloxacin or enoxacin (medicines used to treat certain infections).

Tell the doctor if the patient has high blood pressure or heart disease.
The doctor will decide whether the patient should take Dulofor.
Warnings and precautions
Below are reasons why Dulofor may not be suitable for the patient.
Before taking Dulofor, the patient should inform the doctor if:

• the patient is taking other antidepressants (see "Dulofor with other medicines"),
• the patient is taking herbal medicines containing St. John's wort ( Hypericum perforatum ),
• the patient has kidney disease,
• the patient has previously had seizures,
• the patient has previously had episodes of mania,
• the patient has bipolar affective disorder,
• the patient has eye diseases, such as a specific type of glaucoma (increased pressure in the eye),
• the patient has ever had bleeding disorders (tendency to bruise), especially if the patient is pregnant (see "Pregnancy and breastfeeding"),
• the patient is at risk of developing low sodium levels (e.g. when taking diuretics, particularly in elderly patients),
• the patient is currently taking other medicines that may cause liver damage.

Duloxetine, the main component of Dulofor, is also present in various medicines used
in the treatment of other conditions:

• diabetic neuropathic pain,
• depression,
• anxiety,
• urinary incontinence.
  Concomitant use of more than one of these medicines should be avoided. The patient should consult the doctor if taking other medicines containing duloxetine.

Dulofor may cause restlessness or an inability to sit still or remain motionless. If such symptoms occur, inform the doctor.
The patient should also contact the doctor:
If symptoms occur, such as agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhoea, drowsiness, nausea, vomiting, as this may indicate serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome.
Symptoms of neuroleptic malignant syndrome may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected through blood tests).
Medicines such as Dulofor (so-called SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening depression or anxiety
Depression and (or) anxiety may contribute to thoughts of self-harm or suicide. These may worsen after starting antidepressants, as it takes some time, usually two weeks or longer, before the medicines begin to work.
These thoughts may worsen:

• in patients who previously experienced suicidal or self-harming thoughts.
• in young adults. 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 antidepressants. People with depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressants, as the medicines only start working after some time, usually after

2 weeks, but sometimes later.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely 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 thoughts of self-harm or suicide, contact the doctor immediately
or go directly to hospital.
It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety or concerning changes in behaviour.
Children and adolescents under 18 years of age
Dulofor should generally not be used in children and adolescents under 18 years of age.
Patients under 18 years of age taking medicines from this group have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and manifestations of anger). Nevertheless, the doctor may prescribe Dulofor to a patient under 18 years of age if he/she decides it is beneficial. If Dulofor has been prescribed to a patient under 18 years of age and this raises concerns, contact the doctor again. Inform the doctor if any of the adverse effects listed above occur or worsen in a patient under 18 years of age taking Dulofor. Furthermore, there is a lack of long-term safety data on the use of Dulofor in this age group regarding growth, maturation, and cognitive and behavioural development.
Dulofor with other medicines
Tell the 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.
The doctor will decide whether Dulofor can be taken together with other medicines. Do not
start or stop taking other medicines, including over-the-counter medicines and herbal
preparations, without consulting the doctor.
Inform the doctor if taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs) : Do not take Dulofor together with another antidepressant called a monoamine oxidase inhibitor (MAOI) or within a short time interval (within 14 days) after stopping an MAOI. MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Concomitant use of MAOIs with many prescription medicines, including Dulofor, may cause severe or even life-threatening adverse effects. At least 14 days must pass after stopping an MAOI before starting Dulofor. At least 5 days must pass after stopping Dulofor before starting an MAOI.
Medicines causing drowsiness : These may include prescription medicines such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Medicines increasing serotonin levels : Triptans, buprenorphine, tramadol, tryptophan, selective serotonin reuptake inhibitors (e.g. paroxetine and fluoxetine), selective norepinephrine reuptake inhibitors (e.g. venlafaxine), tricyclic antidepressants (e.g. clomipramine, amitriptyline), pethidine, St. John's wort ( Hypericum perforatum ), and MAOIs (e.g. moclobemide and linezolid). These medicines increase the risk of adverse effects.
If any symptoms occur while taking these medicines together with Dulofor, contact the doctor.
Oral anticoagulants or antiplatelet medicines : Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.
Taking Dulofor with food, drink and alcohol
Dulofor can be taken during or between meals. Exercise caution when consuming alcohol while taking Dulofor.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult the doctor or pharmacist before using this medicine.
The patient should inform the doctor if she becomes pregnant while taking Dulofor or plans to become pregnant. The patient may take Dulofor only after discussing with the doctor the expected benefits of treatment and the possible risks to the unborn child.
The patient should inform the midwife and (or) doctor about taking Dulofor. 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 infant. Such symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her child, she should contact the midwife and (or) doctor immediately.
If the patient takes Dulofor towards the end of pregnancy, certain symptoms may occur in the newborn. These usually occur at birth or within a few days after birth. 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 child's health, she should contact the doctor or midwife for help.
If the patient takes Dulofor towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. Inform the doctor or midwife about taking duloxetine so they can recommend appropriate management.
Available data on the use of duloxetine during the first trimester of pregnancy generally do not show an increased risk of congenital malformations in the child. If the patient takes Dulofor during the second half of pregnancy, there may be an increased risk of preterm birth, mainly between the 35th and 36th week of pregnancy (6 additional premature infants per 100 women taking duloxetine in the second half of pregnancy).
The patient should inform the doctor if she is breastfeeding. Use of Dulofor during breastfeeding is not recommended. Breastfeeding women should consult the doctor or pharmacist for advice.
Driving and using machines
Dulofor may cause drowsiness or dizziness. The patient should not drive or operate machinery until he/she knows how he/she reacts to Dulofor.
Dulofor contains lactose, Allura Red (E 129), Sunset Yellow FCF (E 110) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.
Allura Red (E 129) may cause allergic reactions.
Sunset Yellow FCF (E 110) may cause allergic reactions (only for Dulofor 60 mg).
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Dulofor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Dulofor is taken orally. The capsule should be swallowed whole with water.
Treatment of depression and diabetic neuropathic pain:
The usual dose of Dulofor is 60 mg taken once daily. However, your doctor will determine the
appropriate dose for the individual patient.
Treatment of generalized anxiety disorders:
The usual initial dose of Dulofor 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 the
individual patient. The dose may be increased up to 120 mg, depending on the patient's response
to treatment.
Taking Dulofor at the same time each day will help you remember to take it.
Your doctor will inform you how long you should continue taking Dulofor. Do not stop taking Dulofor
or change the dose without consulting your doctor. Proper treatment of the condition is important
for your improvement. Without treatment, your condition may persist, worsen, and become more
difficult to treat.
Taking more Dulofor than prescribed
If you take more Dulofor than prescribed, contact your doctor or pharmacist immediately.
Symptoms of overdose include: drowsiness, coma, serotonin syndrome (a rare reaction which may
cause excessive feelings of well-being, drowsiness, lack of coordination, restlessness, sensation
of drunkenness, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.
If you miss a dose of Dulofor
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 your next dose at the regular time. Do not take a double dose to
make up for a missed dose. Do not exceed the daily dose of Dulofor prescribed by your doctor.
Stopping Dulofor treatment
Even if you feel better, do not stop taking Dulofor capsules without consulting your doctor. If your
doctor decides that you no longer need to take Dulofor, they will recommend gradually reducing
the dose over at least 2 weeks.
In some patients who abruptly stop taking Dulofor, the following symptoms may occur:

• dizziness,
• tingling sensations like pins and needles or electric shocks (especially in the head),
• sleep disturbances (vivid dreams, nightmares, difficulty falling asleep),
• fatigue, drowsiness,
• restlessness or agitation,
• anxiety,
• nausea or vomiting,
• tremor (shaking),
• headache,
• muscle pain,
• irritability,
• diarrhea,
• excessive sweating.

These symptoms are usually mild and resolve within a few days. However, if they are troublesome,
you should contact your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate and generally resolve within a few weeks.

Very common adverse effects (may affect more than 1 in 10 people)

• headache
• drowsiness
• nausea
• dry mouth

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

• loss of appetite
• sleep disturbances
• restlessness
• reduced sexual drive
• difficulty or inability to achieve orgasm
• anxiety
• unusual dreams
• dizziness
• feeling slowed down
• muscle tremors
• numbness, including loss of sensation, tingling or prickling of the skin
• blurred vision
• tinnitus (ringing in the ears in the absence of an external sound source)
• palpitations
• increased blood pressure, sudden flushing of the face
• excessive yawning
• constipation
• diarrhoea
• abdominal pain
• vomiting
• heartburn
• indigestion, flatulence
• increased sweating, rash (itchy)
• muscle pain, muscle cramps
• painful urination, frequent urination
• difficulty in 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 became comparable to that observed in other children and adolescents of the same age and sex.

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

• sore throat causing hoarseness
• suicidal thoughts
• difficulty falling asleep, worsened sleep quality
• teeth grinding
• disorientation
• lack of motivation
• sudden involuntary movements or muscle twitching
• restlessness or inability to remain still
• irritability
• difficulty concentrating
• taste disturbances, difficulty controlling movements, e.g. lack of coordination or involuntary muscle movements, restless legs syndrome
• dilated pupils (dark central spot of the eye), vision problems
• dizziness, vertigo due to vestibular disturbances
• ear pain
• fast 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
• hepatitis, which may cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, urticaria, cold sweats
• photosensitivity
• increased tendency to bruise
• muscle stiffness and tremors
• difficulty or inability to urinate
• difficulty initiating urination
• need to urinate at night
• need to urinate more than usual
• reduced urine output
• abnormal vaginal bleeding
• menstrual disorders, including heavy, painful, irregular or prolonged periods
• rarely, scanty periods or absence of periods
• testicular or scrotal pain
• chest pain
• cold sensation, hot sensation
• gait disturbances
• thirst
• chills
• weight gain

Dulofor may cause adverse effects that are not apparent, such as increased liver enzyme activity or blood potassium levels, increased creatine phosphokinase activity, or increased blood glucose or cholesterol levels.

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

• severe allergic reaction causing breathing difficulties, dizziness with swelling of the tongue or lips, allergic reactions
• decreased 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 or 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)
• cough, wheezing and shortness of breath, possibly accompanied by fever
• inflammation of the oral cavity, bad breath
• bright red blood in stool, inflammation of the large intestine (leading to diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with blisters on the skin, in the mouth, eyes and on the genitals)
• severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasm
• abnormal urine odour
• menopausal symptoms
• abnormal milky discharge from the breast in men or women
• excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage)

Very rare adverse effects (may affect up to 1 in 10,000 people)

• cutaneous vasculitis (inflammation of blood vessels in the skin)

Frequency not known (frequency cannot be estimated from available data)

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dulofor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the carton after EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dulofor contains

• The active substance is duloxetine.
• Each 30 mg capsule contains 30 mg of duloxetine (as hydrochloride).
• Each 60 mg capsule contains 60 mg of duloxetine (as hydrochloride).
• The other ingredients are:
  Capsule contents: pregelatinized starch, corn starch, microcrystalline cellulose, povidone K30, talc, magnesium stearate, sodium stearyl fumarate, hypromellose acetate succinate, titanium dioxide (E 171), monohydrate lactose, hypromellose, polyethylene glycol 4000.
  Capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), Allura red (E 129), quinoline yellow (E 104) (only in 60 mg), orange yellow (E 110) (only in 60 mg).
  Edible green ink contains: shellac, indigo carmine (E 132), titanium dioxide (E 171), propylene glycol (E 1520).

What Dulofor looks like and contents of the pack
Dulofor 30 mg: size 2 capsule with an opaque white body printed with “30” and an opaque dark blue cap, containing 4 white or almost white, round, biconvex tablets.
Dulofor 60 mg: size 0E capsule with a yellowish-green body printed with “60” and an opaque dark blue cap, containing 8 white or almost white, round, biconvex tablets.
Dulofor enteric hard capsules are available in blister packs (PVC/PE/PCTFE/Aluminium or PA/Aluminium/PVC/Aluminium) contained in a cardboard box.
Pack sizes:
Dulofor 30 mg: 7, 28 and 98 capsules
Dulofor 60 mg: 28, 56, 84, 98, 100 and 500 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
69300 Rodopi
Greece
Pharmathen S.A.
6 Dervenakion Str.
153 51 Pallini, Attiki
Greece