Duloxetine +pharma

Package Leaflet: Information for the User

Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard

Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard

Duloxetine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, as You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has Been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Them, Even if Their Symptoms are the Same as Yours.
• If the Patient Experiences Any Undesirable Effects, Including Those Not Mentioned in this Package Leaflet, They Should Inform Their Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Duloxetine +pharma and What is it Used for
• 2. Important Information Before Taking Duloxetine +pharma
• 3. How to Take Duloxetine +pharma
• 4. Possible Undesirable Effects
• 5. How to Store Duloxetine +pharma
• 6. Package Contents and Other Information

1. What is Duloxetine +pharma and What is it 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 for Use in Adults for the Treatment of:

• Depression
• Generalized Anxiety Disorders (Persistent Feeling of Anxiety or Nervousness)
• Pain in Diabetic Neuropathy (Usually Described as Burning, Piercing, Pricking, or Shooting, or a Feeling of Electric Shock. In a Specific Part of the Body, There may be a Loss of Sensation, or Sensations such as Touch, Heat, Cold, or Pressure may Cause Pain).

In Most Patients 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 Mood is Noticed. 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 Advise Continuing to Take Duloxetine +pharma to Prevent a Relapse of Depression or Anxiety.
In Patients with Pain in Diabetic Neuropathy, an Improvement in Condition may Occur After Several Weeks.
If an Improvement is Not Noted After 2 Months, the Patient Should Consult Their Doctor.

2. Important Information Before Taking Duloxetine +pharma

When Not to Take Duloxetine +pharma

• If the Patient is Allergic to Duloxetine or Any of the Other Ingredients of this Medication (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 Another Medication that is a Monoamine Oxidase Inhibitor (MAOI) (See "Duloxetine +pharma and Other Medications") Within the Last 14 Days
• If the Patient is Taking Fluvoxamine, Which is Mainly Used to Treat Depression, Ciprofloxacin, or Enoxacin - Medications Used to Treat Certain Infections
• If the Patient is Taking Other Medications Containing Duloxetine (See "Duloxetine +pharma and Other Medications").

The Patient Should Inform Their Doctor if They Have High Blood Pressure or Heart Disease. The Doctor will Decide if the Patient Should Take Duloxetine +pharma.

Warnings and Precautions

The Following are Reasons Why Duloxetine +pharma may Not be Suitable for the Patient. Before Starting to Take Duloxetine +pharma, the Patient Should Discuss the Following with Their Doctor:

• If the Patient is Taking Other Antidepressant Medications (See "Duloxetine +pharma and Other Medications");
• If the Patient is Taking Herbal Medications Containing St. John's Wort (Hypericum perforatum);
• If the Patient has Kidney Disease;
• If the Patient has Had Seizures in the Past;
• If the Patient has Had Episodes of Mania in the Past;
• If the Patient has Bipolar Affective Disorder;
• If the Patient has Eye Diseases, Such as Certain Types of Glaucoma (Increased Pressure in the Eye);
• If the Patient has Had Bleeding Disorders in the Past (Tendency to Bruise), Especially if the Patient is Pregnant (See "Pregnancy and Breastfeeding");
• If the Patient is at Risk of Decreased Sodium Levels (e.g., When Taking Diuretics, Especially in the Elderly);
• If the Patient is Currently Taking Other Medications that may Cause Liver Damage;
• If the Patient is Taking Other Medications Containing Duloxetine (See "Duloxetine +pharma and Other Medications").

Duloxetine +pharma may Cause Restlessness or an Inability to Sit Still or Stay in One Place. If Such Symptoms Occur, the Patient Should Inform Their Doctor.
The Patient Should Also Contact Their Doctor:
If the Patient Experiences Objective and Subjective Symptoms Such as Restlessness, Hallucinations, Loss of Coordination, Rapid Heartbeat, Increased Blood Pressure, Exaggerated Reflexes, Diarrhea, Coma, Nausea, Vomiting, as These may Indicate Serotonin Syndrome.
In its Most Severe Form, Serotonin Syndrome can Resemble Neuroleptic Malignant Syndrome.
Objective and Subjective Symptoms of Neuroleptic Malignant Syndrome may Include: a Combination of Fever, Rapid Heartbeat, Sweating, Severe Muscle Stiffness, Confusion, Increased Muscle Enzyme Activity (Determined by Blood Tests).
Medications Such as Duloxetine +pharma (So-Called SNRIs) may Cause Symptoms of Sexual Dysfunction (See Section 4). In Some Cases, These Symptoms have Persisted After Discontinuation of Treatment.
Suicidal Thoughts and Worsening Depression or Anxiety
Patients with Depression and/or Anxiety Disorders may Sometimes have Thoughts of Self-Harm or Suicide. These Thoughts may Intensify at the Beginning of Treatment with Antidepressant Medications, as these Medications may Take Some Time to Start Working, Usually Within 2 Weeks, but Sometimes Later.
The Occurrence of Suicidal Thoughts, Self-Harm, or Suicide is More Likely if:

• The Patient has Had Suicidal Thoughts or Self-Harm in the Past;
• The Patient is a Young Adult - Clinical Trial Data Indicate an Increased Risk of Suicidal Behavior in People Under 25 with Mental Disorders Taking Antidepressant Medications.

If the Patient Experiences Suicidal Thoughts or Self-Harm, They Should Immediately Contact Their Doctor or Go to the Hospital.

It may be Helpful to Inform Relatives or Friends About the Depression or Anxiety Disorder and Ask Them to Read this Package Leaflet. The Patient may Also Ask for Their Opinion on Whether the Depressive or Anxious Condition has Worsened or if There are Any Concerning Changes in Behavior. The Patient may Ask to be Informed if They Notice Any Worsening of Depression or Anxiety or Concerning Changes in Behavior.

Children and Adolescents Under 18 Years of Age

Duloxetine +pharma Should Not be Used in Children and Adolescents Under 18 Years of Age. In Patients Under 18 Years of Age Taking Medications in this Class, There is a Greater Risk of Undesirable Effects, Such as Suicide Attempts, Suicidal Thoughts, and Hostility (Mainly Aggression, Rebellious Behavior, and Expressions of Anger). However, the Doctor may Recommend the Use of Duloxetine +pharma in Patients Under 18 Years of Age if They Decide it is Beneficial for Them. If There are Any Doubts About the Recommendation to Use Duloxetine +pharma in a Patient Under 18 Years of Age, the Doctor Should be Consulted Again. The Doctor Should be Informed if Any of the Above Undesirable Effects Occur or Worsen in a Patient Under 18 Years of Age Taking Duloxetine +pharma.
Additionally, There is a Lack of Long-Term Safety Data on the Use of Duloxetine +pharma in this Age Group Regarding Growth, Maturation, and Cognitive and Behavioral Development.

Duloxetine +pharma and Other Medications

The Patient Should Inform Their Doctor or Pharmacist About All Medications They are Currently Taking or Have Recently Taken, as Well as Any Medications They Plan to Take, Including Those Available Without a Prescription.
Duloxetine, the Main Ingredient in Duloxetine +pharma, may Also be Found in Medications Used to Treat Other Conditions:

• Pain in Diabetic Neuropathy
• Depression
• Anxiety
• Urinary Incontinence.

The Patient Should Avoid Taking More than One of these Medications at the Same Time. The Patient Should Consult Their Doctor if They are Taking Other Medications Containing Duloxetine.
The Doctor will Decide if the Patient can Take Duloxetine +pharma at the Same Time as Other Medications.

The Patient Should Not Start or Stop Taking Other Medications, Including Those Available Without a Prescription and Herbal Preparations, Without Consulting Their Doctor.

The Patient Should Also Inform Their Doctor if They are Taking Any of the Following Medications:
Monoamine Oxidase Inhibitors (MAOIs)
The Patient Should Not Take Duloxetine +pharma at the Same Time as Another Antidepressant Medication Called a Monoamine Oxidase Inhibitor (MAOI) or Within a Short Period of Time (Within 14 Days) After Stopping the MAOI.
Examples of MAOIs Include Moclobemide (an Antidepressant Medication) and Linezolid (an Antibiotic). Taking MAOIs at the Same Time as Many Prescription Medications, Including Duloxetine +pharma, can Cause Serious or Life-Threatening Undesirable Effects.
After Stopping the MAOI, at Least 14 Days Should Pass Before Starting to Take Duloxetine +pharma. Similarly, at Least 5 Days Should Pass After Stopping Duloxetine +pharma Before Starting to Take an MAOI.
Sedative Medications
These Include Prescription Medications, Such as Benzodiazepines, Strong Painkillers, Antipsychotic Medications, Phenobarbital, and Antihistamine Medications.
Medications that Increase Serotonin Levels
Tryptans, Tramadol, Tryptophan, Selective Serotonin Reuptake Inhibitors (Such as Paroxetine and Fluoxetine), Selective Noradrenaline Reuptake Inhibitors (Such as Venlafaxine), Tricyclic Antidepressant Medications (Such as Clomipramine, Amitriptyline), Pethidine, Buprenorphine, St. John's Wort (Hypericum perforatum), and MAOIs (Such as Moclobemide and Linezolid). These Medications Increase the Risk of Undesirable Effects.
If Any Unusual Symptoms Occur While Taking these Medications at the Same Time as Duloxetine +pharma, the Patient Should Consult Their Doctor.
Oral Anticoagulants or Antiplatelet Medications
Medications 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 with or Without Food.
The Patient Should be Cautious When Consuming Alcohol While Taking Duloxetine +pharma.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks They may be Pregnant, or Plans to Have a Child, They Should Consult Their Doctor or Pharmacist Before Taking this Medication.

• The Patient Should Inform Their Doctor if They Become Pregnant or Plan to Become Pregnant While Taking Duloxetine +pharma. The Patient may Only Take Duloxetine +pharma After Consulting with Their Doctor and Weighing the Potential Benefits of Treatment Against the Risks to the Unborn Child.
• The Patient Should Inform Their Midwife and/or Doctor that They are Taking Duloxetine +pharma. The Use of Similar Medications (Selective Serotonin Reuptake Inhibitors) During Pregnancy may Increase the Risk of a Serious Condition in Newborns Called Persistent Pulmonary Hypertension, Which can Cause Rapid Breathing and Bluish Skin. Such Symptoms Usually Occur Within the First 24 Hours After Birth. If the Patient Notices These Symptoms in Their Child, They Should Immediately Contact Their Midwife and/or Doctor.
• If the Patient Takes Duloxetine +pharma at the End of Pregnancy, the Newborn may Experience Certain Symptoms. These Symptoms Usually Occur at Birth or Within a Few Days. The Symptoms may Include: Muscle Weakness, Tremors, Jitters, Difficulty Feeding, Difficulty Breathing, and Seizures. If the Patient Notices Any of These Symptoms or is Concerned About Their Child's Health, They Should Consult Their Doctor or Midwife for Help.
• If the Patient Takes Duloxetine +pharma at the End of Pregnancy, There is an Increased Risk of Excessive Bleeding from the Uterus Shortly After Delivery, Especially if the Patient has Had Bleeding Disorders in the Past. The Patient Should Inform Their Doctor or Midwife About Taking Duloxetine +pharma so They can Recommend Appropriate Action.

Available Data on the Use of Duloxetine in the First Three Months of Pregnancy do Not Show an Increased Risk of Congenital Malformations in the Child. If the Patient Takes Duloxetine +pharma in the Second Half of 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 Taking Duloxetine in the Second Half of Pregnancy).

• The Patient Should Inform Their Doctor if They are Breastfeeding. The Use of Duloxetine +pharma is Not Recommended During Breastfeeding. Breastfeeding Women Should Consult Their Doctor or Pharmacist for Advice.

Driving and Operating Machines

Duloxetine +pharma may Cause Drowsiness or Dizziness. The Patient Should Not Drive or Operate Machines Until They are Familiar with the Effects of Duloxetine +pharma.

Duloxetine +pharma Contains Sucrose

Duloxetine +pharma Contains Sucrose. If the Doctor has Previously Determined that the Patient has an Intolerance to Some Sugars, the Patient Should Consult Their Doctor Before Taking this Medication.

3. How to Take Duloxetine +pharma

This Medication Should Always be Taken as Directed by the Doctor or Pharmacist. If the Patient has Any Doubts, They Should Consult Their Doctor or Pharmacist.
Duloxetine +pharma is Taken Orally. The Capsule Should be Swallowed Whole with Water.
Treatment of Depression and Pain in Diabetic Neuropathy
The Usual Dose of Duloxetine +pharma is 60 mg Taken Once a Day, but the Doctor will Prescribe the Dose Suitable for the Patient.
Treatment of Generalized Anxiety Disorders
The Usual Initial Dose of Duloxetine +pharma is 30 mg Once a Day. In Most Patients, the Dose is Then Increased to 60 mg Once a Day, but the Doctor will Prescribe the Suitable Dose for the Patient. The Dose may be Increased up to 120 mg per Day, Depending on the Patient's Response to Treatment.
Taking Duloxetine +pharma at the Same Time Every Day will Help the Patient Remember to Take it.
The Doctor will Inform the Patient How Long to Take Duloxetine +pharma. The Patient Should Not Stop Taking Duloxetine +pharma or Change the Dose Without Consulting Their Doctor. Proper Treatment of the Condition is Essential for the Patient to Feel Better. If the Condition is Not Treated, the Patient's Condition may Not Improve, may Become More Severe, and may be More Difficult to Treat.

Taking a Higher Dose of Duloxetine +pharma than Recommended

If the Patient Takes a Higher Dose of Duloxetine +pharma than Recommended, They Should Immediately Contact Their Doctor or Pharmacist. Symptoms of Overdose Include: Drowsiness, Coma, Serotonin Syndrome (a Rare Reaction that may Cause Excessive Happiness, Drowsiness, Coordination Disorders, Restlessness, Especially Motor, Feeling of Intoxication, Fever, Sweating, or Muscle Stiffness), Seizures, Vomiting, and Rapid Heartbeat.

Missing a Dose of Duloxetine +pharma

If the Patient Misses a Dose, They Should Take it as Soon as Possible. However, if it is Almost Time for the Next Dose, the Patient Should Skip the Missed Dose and Take the Next Dose as Usual. The Patient Should Not Take a Double Dose to Make up for the Missed Dose. The Patient Should Not Take a Higher Daily Dose of Duloxetine +pharma than Prescribed by Their Doctor.

Stopping Treatment with Duloxetine +pharma

The Patient Should NotStop Taking Duloxetine +pharma Without Consulting Their Doctor, Even if They Feel Better. If the Doctor Decides that the Patient No Longer Needs to Take Duloxetine +pharma, They will Recommend Gradually Reducing the Dose Over at Least 2 Weeks.
In Some Patients Who Suddenly Stop Taking Duloxetine +pharma, the Following Symptoms may Occur:

• Dizziness, Feeling of Pins and Needles or Electric Shock, Especially in the Head, Sleep Disturbances (Vivid Dreams, Nightmares, Difficulty Falling Asleep), Fatigue, Drowsiness, Restlessness or Agitation, Anxiety, Nausea or Vomiting, Tremors, Headaches, Muscle Pain, Irritability, Diarrhea, Excessive Sweating, or Dizziness of Vestibular Origin.

These Symptoms are Usually Not Serious and Disappear Within a Few Days. However, if They are Troublesome, the Patient Should Consult Their Doctor.
If the Patient has Any Further Doubts About Taking this Medication, They Should Consult Their Doctor or Pharmacist.

4. Possible Undesirable Effects

Like All Medications, Duloxetine +pharma can Cause Undesirable Effects, Although Not Everyone Will Experience Them.
These Effects are Usually Mild to Moderate and Usually Disappear Within a Few Weeks.
Very Common(May Occur in More than 1 in 10 Patients)

• Headache, Drowsiness
• Nausea, Dry Mouth

Common(May Occur in Up to 1 in 10 Patients)

• Lack of Appetite
• Sleep Disturbances, Agitation, Decreased Libido, Anxiety, Difficulty or Inability to Achieve Orgasm, Unusual Dreams
• Dizziness, Feeling of Slowing Down, Tremors, Numbness Including: Numbness, Tingling, or Prickling of the Skin
• Blurred Vision
• Tinnitus (Hearing a Sound in the Ears Without an External Source)
• Palpitations
• Increased Blood Pressure, Sudden Redness of the Face
• Increased Yawning
• Constipation, Diarrhea, Abdominal Pain, Vomiting, Heartburn or Indigestion, Flatulence
• Increased Sweating
• (Itchy) Rash
• Muscle Pain, Muscle Cramps
• Painful Urination, Frequent Urination
• Difficulty or Inability to Achieve an 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 Medication, a Decrease in Weight has been Observed After Starting Treatment. After 6 Months of Treatment, Weight Increased and Became Comparable to that of Other Children and Adolescents of the Same Age and Sex.
Uncommon(May Occur in Up to 1 in 100 Patients)

• Sore Throat Causing Hoarseness
• Suicidal Thoughts, Difficulty Falling Asleep, Grinding of the Teeth or Clenching of the Jaw, Disorientation, Lack of Motivation
• Sudden Involuntary Movements or Muscle Twitching, Feeling of Restlessness or Inability to Sit Still or Stay in One Place, Irritability, Difficulty Concentrating, Taste Disorders, Difficulty Controlling Movements, e.g., Lack of Coordination or Involuntary Muscle Movements, Restless Legs Syndrome
• Poor Sleep Quality
• Pupil Dilation (Dark Center of the Eye), Vision Disturbances
• Feeling of Dizziness or "Spinning" (Vestibular Dizziness), Ear Pain
• Rapid and/or Irregular Heartbeat
• Fainting, Dizziness, Feeling of Emptiness in the Head or Fainting When Standing Up
• Feeling of Cold in the Fingers of the Hands and/or Feet
• Constriction in the Throat, Nosebleeds
• Vomiting Blood or Black, Tarry Stools, Inflammation of the Stomach and Intestines, Reflux of Stomach Contents, 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 and Twitching
• Difficulty or Inability to Urinate, Frequent Urination, Need to Urinate at Night, Need to Urinate in Larger Quantities than Usual, Decreased Amount of Urine
• Abnormal Vaginal Bleeding, Menstrual Disorders, Including Heavy, Painful, Irregular, or Prolonged Menstruation, or Absence of Menstruation
• Pain in the Testicles or Scrotum
• Chest Pain, Feeling of Cold, Thirst, Chills, Fever, Difficulty Walking
• Weight Gain

Duloxetine +pharma may Cause Undesirable Effects that the Patient may Not be Aware of, Such as Increased Liver Enzyme Activity or Potassium Levels in the Blood, Increased Creatine Phosphokinase Activity, Blood Glucose or Cholesterol Levels.

Rare(May Occur in Up to 1 in 1,000 Patients)

• Severe Allergic Reaction Causing Difficulty Breathing or Dizziness with Swelling of the Tongue or Lips
• Decreased Thyroid Function, Which may 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, 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 Expressions of Anger
• Serotonin Syndrome (a Rare Reaction that may Cause Excessive Happiness, Drowsiness, Coordination Disorders, Restlessness, Especially Motor, Feeling of Intoxication, Fever, Sweating, or Muscle Stiffness), Seizures
• Increased Eye Pressure (Glaucoma)
• Oral Inflammation
• Bright Red Blood in the Stool, Unpleasant Breath, Inflammation of the Colon (Leading to Diarrhea)
• Liver Failure, Yellowing of the Skin or Whites of the Eyes (Jaundice)
• Stevens-Johnson Syndrome (a Serious Disease with Ulcers of the Skin, Mouth, Eyes, and Genital Organs)
• Severe Allergic Reaction Causing Swelling of the Face or Throat (Angioedema)
• Jaw Muscle Spasm
• Unusual Urine Odor
• Menopausal Symptoms, Abnormal Milk Production in Men or Women
• Cough, Wheezing, Shortness of Breath, and Possibly Accompanied by Fever
• Excessive Uterine Bleeding Shortly After Delivery (Postpartum Hemorrhage)

Very Rare(May Occur in Up to 1 in 10,000 Patients)

• Inflammation of the Blood Vessels in the Skin

Frequency Not Known(Cannot be Determined from Available Data)

• Objective and Subjective Symptoms of a Condition Called Stress-Induced Cardiomyopathy, Which may Include: Chest Pain, Shortness of Breath, Dizziness, Fainting, Irregular Heartbeat.

Reporting Undesirable Effects

If the Patient Experiences Any Undesirable Effects, Including Those Not Mentioned in this Package Leaflet, They Should Inform Their Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Medicinal Product 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.
Undesirable Effects can Also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Duloxetine +pharma

The Medication Should be Stored in a Place that is Not Visible and Not Accessible to Children.
The Medication Should Not be Used After the Expiration Date Stated on the Package and Blister After: "EXP". The Expiration Date Refers to the Last Day of the Specified Month.
There are No Special Storage Instructions for this Medication.
Medications Should Not be Disposed of in the Drain or Household Waste. The Patient Should Ask Their Pharmacist How to Dispose of Unused Medications. This will Help to Protect the Environment.

6. Package Contents and Other Information

What Duloxetine +pharma Contains

• The Active Substance of the Medication is Duloxetine.

Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard
Each Capsule Contains 30 mg of Duloxetine (as Hydrochloride).
Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard
Each Capsule Contains 60 mg of Duloxetine (as Hydrochloride).

• Other Ingredients are:
• Capsule Contents: Sucrose, Spheres (Containing Corn Starch), Methacrylic Acid and Ethyl Acrylate Copolymer 1:1, 30% Dispersion (Eudragit L30D55), Hypromellose, Sucrose, Silica, Colloidal, Anhydrous, Talc, Triethyl Citrate, Plasacryl T20 (Glycerol 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), Iron Oxide Yellow (E 172), Water.
• Green Ink (Only Duloxetine +pharma, 30 mg): Shellac, Propylene Glycol, Potassium Hydroxide, Iron Oxide Black (E 172), Iron Oxide Yellow (E 172).
• White Ink (Only Duloxetine +pharma, 60 mg): Shellac, Propylene Glycol, Povidone, Titanium Dioxide (E 171).

What Duloxetine +pharma Looks Like and What the Package Contains

Duloxetine +pharma is Available in the Form of Gastro-Resistant Capsules, Hard. Each Capsule Contains Pellets of Duloxetine Hydrochloride Coated with a Layer that Protects Them from the Action of Stomach Acid.
Duloxetine +pharma, 30 mg, Gastro-Resistant Capsules, Hard
The Capsules are Hard, Size 3, Consisting of a Non-Transparent White Body with a Yellow Print "30 mg" and a Non-Transparent Blue Cap with a Yellow Print "DLX".
Duloxetine +pharma, 60 mg, Gastro-Resistant Capsules, Hard
The Capsules are Hard, Size 1, Consisting of a Non-Transparent Green Body with a White Print "60 mg" and a Non-Transparent Blue Cap with a White Print "DLX".
Duloxetine +pharma is Available in Packages of 10, 28, and 30 Capsules.
Not All Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

+pharma Arzneimittel GmbH
Hafnerstraße 211
8054 Graz
Austria

Manufacturer

Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
8054 Graz
Austria
Date of Last Update of the Package Leaflet:August 2024