DULOFOR 30 mg Capsules

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. DULOFOR, 30 mg, hard gastro-resistant capsules
3. DULOFOR, 60 mg, hard gastro-resistant capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
4. What Dulofor is and what it is used for
5. Before you take Dulofor
   1. Do not take Dulofor:
   2. Warnings and precautions
   3. Suicidal thoughts and worsening depression or anxiety
   4. If you experience suicidal thoughts or self-harm, you should contact your doctor or go to the hospital immediately.
   5. Children and adolescents under 18 years
   6. Other medicines and Dulofor
   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 FCF (E 110), and sodium
6. How to take Dulofor
   1. Treatment of depression and diabetic neuropathic pain:
   2. Treatment of generalised anxiety disorder:
   3. If you take more Dulofor than you should
   4. If you forget to take Dulofor
   5. If you stop taking 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 of 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 authorisation holder and manufacturer
   4. Marketing authorisation holder
   5. Manufacturer

Patient Information Leaflet: User Information

DULOFOR, 30 mg, hard gastro-resistant capsules

DULOFOR, 60 mg, hard gastro-resistant capsules

Duloxetine

Read all of this leaflet carefully before taking this medicine because 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Dulofor is and what it is used for
• 2. Before you take 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 noradrenaline in the nervous system.
Dulofor is used in adults to treat:

• depression,
• generalised anxiety disorder (excessive worry, nervousness, anxiety, fear that is persistent and overwhelming),
• diabetic neuropathic pain (described as burning, shooting, stabbing, or like an electric shock, or allodynia, hyperaesthesia, or hypoaesthesia in a body part).

In most people with depression or anxiety, Dulofor starts to work within 2 weeks of starting treatment, but it may take 2 to 4 weeks for you to start feeling better. If you do not feel better after this time, you should see your doctor. Even if you feel better, your doctor may recommend that you continue taking Dulofor to keep the symptoms of depression or anxiety from returning.
In people with diabetic neuropathic pain, the improvement in symptoms may take longer to develop.

2. Before you take Dulofor

Do not 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 medicine called a monoamine oxidase inhibitor (MAOI) (see "Taking 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 can 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 antidepressants (see "Taking other medicines"),
• are taking herbal supplements containing St. John's Wort (Hypericum perforatum),
• have kidney disease,
• have had seizures in the past,
• have had manic episodes in the past,
• have bipolar disorder,
• have eye problems, such as certain types of glaucoma (increased pressure in the eye),
• have had bleeding disorders (a tendency to bruise) or are taking medicines that affect blood clotting, especially if you are taking medicines to prevent blood clots (anticoagulants),
• have a risk of low sodium levels (e.g., if you are taking diuretics, especially if you are elderly),
• are taking other medicines that may harm your liver.

Duloxetine, the active ingredient in Dulofor, is also available in other medicines used 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 dizziness or drowsiness. If you experience these symptoms, you should tell your doctor.
You should also tell your doctor if you experience:

• objective and subjective symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, sweating, or nausea and 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 start taking antidepressants, as it may take 2 weeks or more for the medicine to start working.

• in patients who have had suicidal thoughts or self-harm in the past.
• in young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

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

• if you have had suicidal thoughts or self-harm in the past;
• if you are a young adult - clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should 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 anxious 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 behaviour.

Children and adolescents under 18 years

Dulofor should not normally be used for children and adolescents under 18 years. Also, you should be aware that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger) when they take this class of medicines.

Other medicines and Dulofor

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will decide whether you can take Dulofor with other medicines.
Do not
start or stop taking any 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 if you are taking or have taken an MAOI within the past 14 days. 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.

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.
Tell your doctor if you become pregnant while taking Dulofor. You should only take Dulofor during pregnancy if your doctor considers it necessary.

Driving and using machines

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

Dulofor contains lactose, Allura red (E 129), orange yellow FCF (E 110), and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Allura red (E 129) may cause allergic reactions.
Orange yellow FCF (E 110) may cause allergic reactions (only for Dulofor 60 mg).
This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially 'sodium-free'.

3. How to take Dulofor

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take Dulofor by mouth, with or without food, and swallow the capsules 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 generalised anxiety disorder:

The usual starting dose of Dulofor is 30 mg once a day, and your doctor may increase this to 60 mg once a day. However, your doctor will prescribe the dose that is right for you. The dose may be increased to a maximum of 120 mg a day, depending on your response to the medicine.
Taking Dulofor at the same time each day will help you remember to take it.
Your doctor will tell you how long you should keep taking Dulofor. Do not stop taking Dulofor without talking to your doctor. It is important to continue the treatment for as long as your doctor recommends.

If you take more Dulofor than you should

If you take more Dulofor than you should, contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, sleepiness, serotonin syndrome (a rare reaction that may cause feelings of agitation, confusion, rapid heart rate, changes in blood pressure, fever, sweating, or rigidity), seizures, vomiting, and rapid heartbeat.

If you forget to take 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 only the next dose. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily dose of Dulofor prescribed by your doctor.

If you stop taking Dulofor

Do not stop taking Dulofor without talking to your doctor. If your doctor decides that you can stop taking Dulofor, your doctor will gradually reduce your dose over a period of at least 2 weeks.
Some patients who stop taking Dulofor may experience side effects such as:

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

These side effects are usually not serious and disappear within a few days. However, if you experience any of these side effects, you should contact your doctor.

4. Possible side effects

Like all medicines, Dulofor can cause side effects, although not everybody gets them.

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
• tremor
• numbness, including numbness, tingling, or prickling sensation 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 a rapid or forceful heartbeat)
• increased blood pressure, flushing
• yawning
• constipation
• diarrhea
• abdominal pain
• vomiting
• indigestion, flatulence
• increased sweating, rash (itching)
• muscle pain, muscle spasms
• difficult or painful urination, frequent urination
• erectile dysfunction, 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 class of medicines, weight loss was observed.

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

• sore throat, which can lead to a hoarse voice
• suicidal thoughts
• difficulty sleeping, poor quality sleep
• grinding of the teeth
• disorientation
• lack of motivation
• involuntary movements or muscle twitching
• feeling restless or unable to sit still
• irritability
• difficulty concentrating
• taste disturbances, difficulty controlling movements, lack of coordination, or involuntary movements
• pupil dilation, vision problems
• dizziness, dizziness caused by disorders of 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 and toes
• constriction in the throat
• nosebleeds
• vomiting blood or black, tarry stools
• inflammation of the stomach and intestines, reflux of stomach contents
• difficulty swallowing
• inflammation of the liver, which can cause stomach pain and yellowing of the skin or whites of the eyes
• night sweats, hives, cold sweats
• sensitivity to sunlight
• increased tendency to bruise
• stiffness and muscle twitching
• difficulty or inability to urinate
• difficulty starting urination
• need to urinate at night
• need to urinate more often than usual
• decreased amount of urine
• abnormal vaginal bleeding, changes in menstrual cycle, 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 enzymes or potassium 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, feeling tired or sleepy, or nausea and vomiting, or more severe symptoms such as 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 may cause feelings of agitation, confusion, rapid heart rate, changes in blood pressure, fever, sweating, or rigidity)
• seizures
• increased pressure in the eye (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 milk secretion from the breasts in men or women
• excessive bleeding from the vagina shortly after childbirth (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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system listed in the "Further information" section.

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.
Store in a cool, dry place, below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 duloxetine (as hydrochloride).
• Each 60 mg capsule contains 60 mg duloxetine (as hydrochloride).
• The other ingredients are: Capsule contents: maize starch, maize-based cellulose, 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), quinoline yellow (E 104) (only 60 mg), orange yellow FCF (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, hard gastro-resistant capsules, is available in blisters (PVC/PE/PCTFE/Aluminium or PA/Aluminium/PVC/Aluminium) in a carton 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
Date of last revision of the leaflet:September 2024