DULOFOR 60 mg Capsules

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. DULOFOR, 30 mg, gastro-resistant hard capsules
3. DULOFOR, 60 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Leaflet
4. What is Dulofor and what is it used for
5. Important information before taking Dulofor
   1. When not to take Dulofor:
   2. Warnings and precautions
   3. Suicidal thoughts and worsening depression or anxiety
   4. If you experience suicidal thoughts or self-harm, contact your doctor or go to the hospital immediately.
   5. Children and adolescents under 18 years of age
   6. Dulofor and other medicines
   7. Taking Dulofor with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Dulofor contains lactose, Allura Red (E 129), orange yellow S (E 110), and sodium
6. How to take Dulofor
   1. Treatment of depression and diabetic neuropathic pain:
   2. Treatment of generalized anxiety disorder:
   3. Taking more Dulofor than prescribed
   4. Missing a dose of Dulofor
   5. Stopping treatment with Dulofor
7. Possible side effects
   1. Very common side effects (may affect more than 1 in 10 people)
   2. Common side effects (may affect up to 1 in 10 people)
   3. Uncommon side effects (may affect up to 1 in 100 people)
   4. Rare side effects (may affect up to 1 in 1,000 people)
   5. Very rare side effects (may affect up to 1 in 10,000 people)
   6. Frequency not known (frequency cannot be estimated from the available data)
   7. Reporting side effects
8. How to store Dulofor
9. Contents of the pack and other information
   1. What Dulofor contains
   2. What Dulofor looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Patient Information Leaflet: User Information

DULOFOR, 30 mg, gastro-resistant hard capsules

DULOFOR, 60 mg, gastro-resistant hard capsules

Duloxetine

Read the leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dulofor and what is it 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 is Dulofor and what is it used for

Dulofor contains the active substance duloxetine. Dulofor increases the levels of serotonin and noradrenaline in the nervous system.
Dulofor is used in adults to treat:

• depression,
• generalized anxiety disorder (persistent feeling of anxiety or nervousness),
• diabetic neuropathic pain (usually described as burning, shooting, stabbing, or like an electric shock; there may be loss of sensation or altered sensation in a particular area of the body, and pressure may cause pain).

In most people with depression or anxiety, Dulofor starts working within 2 weeks of starting treatment, but improvement in mood may take up to 2 to 4 weeks. If you do not feel better after this time, you should see your doctor. Even if you feel better, your doctor may recommend continuing to take Dulofor to prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain, improvement in pain may take several weeks. You should see your doctor if you do not feel any improvement after 2 months.

2. Important information before taking Dulofor

When not to take Dulofor:

• if you are allergic to duloxetine or 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 antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see "Dulofor and other medicines"),
• if you are taking fluvoxamine, which is usually used to treat depression, ciprofloxacin, or enoxacin (antibiotics used to treat certain infections).

Tell your doctor if you have high blood pressure or heart disease. Your doctor will decide whether you should take Dulofor.

Warnings and precautions

The following are reasons why Dulofor may not be suitable for you. Before taking Dulofor, tell your doctor if:

• you are taking other antidepressant medicines (see "Dulofor and other medicines"),
• you are taking herbal medicines containing St. John's Wort (Hypericum perforatum),
• you have kidney disease,
• you have had fits (seizures) in the past,
• you have had manic episodes in the past,
• you have bipolar disorder,
• you have eye problems, such as certain types of glaucoma (increased pressure in the eye),
• you have had bleeding disorders (a tendency to bruise) or have had bleeding from the stomach or intestines, especially if you are taking blood-thinning medicines (see "Dulofor and other medicines"),
• you have a risk of low sodium levels in the blood (for example, if you are taking diuretics, especially if you are elderly),
• you are taking other medicines that may cause liver damage.

Duloxetine, the active ingredient in Dulofor, is also used in other medicines to treat other conditions:

• diabetic neuropathic pain,
• depression,
• anxiety,
• urinary incontinence. You should not take more than one of these medicines at the same time. If you are taking another medicine containing duloxetine, you should discuss this with your doctor.

Dulofor may cause feelings of restlessness or an inability to sit or stand still. If you experience these symptoms, you should tell your doctor.
You should also contact your doctor if:

• you experience objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting, as these may indicate serotonin syndrome.

Suicidal thoughts and worsening depression or anxiety

Depression and/or anxiety can lead to suicidal thoughts or self-harm. These thoughts can worsen when you first start taking antidepressant medicines, as it can take 2 weeks or more for the medicine to start working.
These thoughts can worsen in:

• patients who have had suicidal thoughts or self-harm in the past.
• young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with mental health conditions who were treated with antidepressant medicines.

Suicidal thoughts or self-harm are more likely to occur if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult - clinical trial data indicate an increased risk of suicidal behavior in people under 25 years of age with mental health conditions who are taking antidepressant medicines.

If you experience suicidal thoughts or self-harm, contact your doctor or go to the hospital immediately.

It may be 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 may want to ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years of age

Dulofor should not normally be used for children and adolescents under 18 years of age. In children and adolescents under 18 years of age, who are treated with this class of medicines, there is an increased risk of side effects, such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger). However, your doctor may prescribe Dulofor for a patient under 18 years of age if they decide that it is in the patient's best interests. If your doctor has prescribed Dulofor for a patient under 18 years of age and you are concerned, you should discuss this with your doctor. You should tell your doctor if a patient under 18 years of age who is taking Dulofor experiences any of the above side effects. Additionally, there is a lack of long-term safety data on the use of Dulofor in this age group regarding growth, maturation, and cognitive and behavioral development.

Dulofor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Your doctor will decide whether you can take Dulofor with other medicines. Do not start or stop taking other medicines, including those bought without a prescription, herbal products, or dietary supplements, without talking to your doctor.
Tell your doctor if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAOIs):Do not take Dulofor with another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI. MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Dulofor, can cause serious or life-threatening side effects. After stopping an MAOI, you must wait at least 14 days before starting Dulofor. Before starting an MAOI, you must wait at least 5 days after stopping Dulofor.
• Sedatives:These include prescription medicines, such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
• Medicines that increase 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 and amitriptyline), pethidine, St. John's Wort (Hypericum perforatum), and MAOIs (e.g., moclobemide and linezolid). These medicines increase the risk of side effects.
• Oral anticoagulants or antiplatelet agents: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 with or without food. Be careful when drinking alcohol while taking Dulofor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should tell your doctor if you become pregnant or plan to become pregnant while taking Dulofor. You can take Dulofor only after discussing the benefits and risks of treatment with your doctor. You should tell your midwife and/or doctor that you are taking Dulofor. Taking similar medicines during pregnancy (selective serotonin reuptake inhibitors) may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn, which causes rapid breathing and bluish skin. These symptoms usually occur within the first 24 hours after birth. If you notice any of these symptoms in your baby, you should contact your midwife and/or doctor immediately.
If you take Dulofor near the end of your pregnancy, your baby may experience certain symptoms after birth, usually within the first few days. These symptoms include floppiness, trembling, difficulty feeding, breathing difficulties, and seizures. If you notice any of these symptoms in your baby, you should contact your doctor or midwife for help.
If you take Dulofor near the end of your pregnancy, there is an increased risk of heavy bleeding from the vagina after delivery, especially if you have a history of bleeding disorders. You should tell your doctor or midwife that you are taking duloxetine so that they can recommend appropriate care.
Available data on the use of duloxetine in early pregnancy (first three months) do not indicate an increased risk of birth defects in the baby. However, if you take Dulofor in the second half of your pregnancy, there may be an increased risk of premature birth, mainly between 35 and 36 weeks of pregnancy (6 additional premature births per 100 women treated with duloxetine in the second half of pregnancy).
You should tell your doctor if you are breastfeeding. It is not recommended to take Dulofor while breastfeeding. Breastfeeding women should ask their doctor or pharmacist for advice.

Driving and using machines

Dulofor may cause drowsiness or dizziness. You should not drive or operate machinery until you know how Dulofor affects you.

Dulofor contains lactose, Allura Red (E 129), orange yellow S (E 110), and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking Dulofor.
Allura Red (E 129) may cause allergic reactions.
Orange yellow S (E 110) may cause allergic reactions (only for Dulofor 60 mg).
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Dulofor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dulofor is taken by mouth, with or without food. Swallow the capsule whole with water.

Treatment of depression and diabetic neuropathic pain:

The usual dose of Dulofor is 60 mg once a day. However, your doctor will prescribe the dose that is right for you.

Treatment of generalized anxiety disorder:

The usual starting dose of Dulofor is 30 mg once a day. For most patients, the dose is then increased to 60 mg once a day. However, your doctor will prescribe the dose that is right for you. The dose may be increased up to 120 mg, depending on your response to treatment.
Taking Dulofor at the same time each day will help you remember to take it.
Your doctor will tell you how long to take Dulofor. Do not stop taking Dulofor or change your dose without talking to your doctor. It is important to treat your condition effectively to help you feel better. If you do not treat your condition, it may continue or get worse, and become difficult to treat.

Taking more Dulofor than prescribed

If you take more Dulofor than you should, contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, anxiety, restlessness, confusion, agitation, hallucinations, fever, sweating, stiffness, and tremors), seizures, vomiting, and rapid heartbeat.

Missing a dose of Dulofor

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take your next dose as usual. Do not take a double dose to make up for a missed dose. Do not take more than the prescribed daily dose of Dulofor.

Stopping treatment with Dulofor

Even if you feel better, do not stop taking the capsules without talking to your doctor. If your doctor decides that you no longer need to take Dulofor, your doctor will gradually reduce your dose over at least 2 weeks.
Some patients who stop taking Dulofor may experience side effects, such as:

• dizziness,
• a sensation of pins and needles or electric shock-like sensations (especially in the head),
• sleep disturbances (vivid dreams, nightmares, insomnia),
• fatigue, drowsiness,
• restlessness or agitation,
• anxiety,
• nausea (feeling sick) or vomiting,
• tremors (shaking),
• headache,
• muscle pain,
• irritability,
• diarrhea,
• excessive sweating.

These side effects are usually not serious and go away within a few days. However, if they are troublesome, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dulofor can cause side effects, although not everybody gets them.
These effects are usually mild or moderate and often disappear after a few weeks.

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

• headache
• drowsiness
• nausea
• dry mouth

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

• loss of appetite
• sleep disturbances
• agitation
• decreased libido
• difficulty achieving orgasm
• anxiety
• abnormal dreams
• dizziness
• feeling sluggish
• tremors
• numbness, including numbness, tingling, or prickling of the skin
• blurred vision
• ringing in the ears (hearing a sound in the ears when there is no external source of the sound)
• palpitations (feeling of rapid or forceful heartbeat)
• increased blood pressure, flushing
• yawning
• constipation
• diarrhea
• abdominal pain
• vomiting
• heartburn
• flatulence
• increased sweating, rash (itching)
• muscle pain, muscle spasms
• painful urination, frequent urination
• problems with erection, changes in ejaculation
• falls (especially in the elderly), fatigue
• weight loss

In children and adolescents under 18 years of age with depression, treated with this medicine, there was a decrease in weight after starting treatment. After 6 months of treatment, body weight increased and was 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)

• sore throat, which can cause hoarseness
• suicidal thoughts
• difficulty sleeping, poor quality sleep
• teeth grinding
• disorientation
• lack of motivation
• sudden involuntary movements or muscle twitching
• feeling restless or unable to sit or stand still
• irritability
• difficulty concentrating
• taste disturbances, difficulty controlling movements, such as lack of coordination or involuntary movements, restless legs syndrome
• pupil dilation (the black center of the eye becomes larger), vision problems
• dizziness, dizziness caused by problems with the inner ear
• ear pain
• rapid or irregular heartbeat
• fainting, dizziness
• feeling of emptiness in the head or fainting when standing up
• feeling cold in the fingers or toes
• pressure in the throat
• nosebleeds
• vomiting blood or black, tarry stools
• inflammation of the stomach and intestines, acid reflux
• difficulty swallowing
• liver inflammation, which can cause stomach pain and yellowing of the skin or whites of the eyes
• night sweats, hives (itching)
• increased tendency to bruise
• muscle stiffness and twitching
• difficulty or inability to urinate
• difficulty starting to urinate
• need to urinate at night
• need to urinate more often than usual
• decreased amount of urine
• abnormal vaginal bleeding
• menstrual disorders, including heavy, painful, irregular, or prolonged menstrual periods
• infrequent or absent menstrual periods
• testicular or scrotal pain
• chest pain
• feeling cold or hot
• gait disturbances
• thirst
• chills
• weight gain

Dulofor may cause side effects that you are not aware of, such as increased liver enzyme activity or potassium levels in the blood, increased creatine phosphokinase activity, glucose or cholesterol levels in the blood.

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

• severe allergic reaction causing difficulty breathing, dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid function, which can cause fatigue or weight gain
• dehydration
• low sodium levels in the blood (especially in the elderly; symptoms may include dizziness, weakness, confusion, drowsiness, excessive tiredness, or nausea, or vomiting; more severe symptoms include fainting, seizures, and falls)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior
• manic episodes (excessive activity, racing thoughts, and decreased need for sleep)
• hallucinations, aggression, and anger
• serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, anxiety, restlessness, confusion, agitation, hallucinations, fever, sweating, stiffness, and tremors)
• seizures
• increased eye pressure (glaucoma)
• cough, wheezing, and shortness of breath, which may be accompanied by fever
• mouth inflammation, bad breath
• red blood in the stool, inflammation of the large intestine (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition with blisters on the skin, mouth, eyes, and genitals)
• severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasms
• abnormal urine odor
• menopausal symptoms
• abnormal breast milk production in men or women
• excessive bleeding from the vagina shortly after delivery (postpartum hemorrhage)

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

• inflammation of blood vessels in the skin

Frequency not known (frequency cannot be estimated from the 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 side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dulofor

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 blister and carton after EXP. The expiry date refers to the last day of that month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater 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 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 content: maize starch, corn starch, microcrystalline cellulose, povidone K30, talc, magnesium stearate, sodium stearyl fumarate, hypromellose acetate succinate, titanium dioxide (E 171), lactose monohydrate, hypromellose, macrogol 4000 Capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), Allura Red (E 129), yellow orange S (E 110) (only 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: capsule size 2 with a white opaque body with "30" printed on it and a dark blue opaque cap, containing 4 white or almost white, round, biconvex tablets.
Dulofor, 60 mg: capsule size 0E with a yellow-green opaque body with "60" printed on it and a dark blue opaque cap, containing 8 white or almost white, round, biconvex tablets.
Dulofor, gastro-resistant hard capsules, is available in blisters (PVC/PE/PCTFE/Aluminum or PA/Aluminum/PVC/Aluminum) in a cardboard box.
Package 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 authorization holder and manufacturer

Marketing authorization 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
Date of last revision of the leaflet:September 2024