DULOXETINE 90 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Duloxetine Medical Valley, 90 mg, Gastro-Resistant Hard Capsules
3. Duloxetine Medical Valley, 120 mg, Gastro-Resistant Hard Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Contents of the Package Leaflet
4. What Duloxetine Medical Valley is and what it is used for
5. Important information before taking Duloxetine Medical Valley
   1. When not to take Duloxetine Medical Valley
   2. Warnings and precautions
   3. Children and adolescents under 18 years of age
   4. Duloxetine Medical Valley with other medicines
   5. Duloxetine Medical Valley with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Duloxetine Medical Valley contains sucrose
   9. Duloxetine Medical Valley contains sodium
6. How to take Duloxetine Medical Valley
   1. What to do if you take more Duloxetine Medical Valley than you should
   2. What to do if you forget to take Duloxetine Medical Valley
   3. What to do if you stop taking Duloxetine Medical Valley
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. Frequency not known (cannot be estimated from the available data)
   4. Reporting of side effects
8. How to store Duloxetine Medical Valley
9. Contents of the pack and other information
   1. What Duloxetine Medical Valley contains
   2. What Duloxetine Medical Valley looks like and contents of the pack
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the Patient

Duloxetine Medical Valley, 90 mg, Gastro-Resistant Hard Capsules

Duloxetine Medical Valley, 120 mg, Gastro-Resistant Hard Capsules

Duloxetine

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

• Keep this package 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 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 Package Leaflet

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

1. What Duloxetine Medical Valley is and what it is used for

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

• depression
• generalized anxiety disorder (long-standing feelings of anxiety or nervousness) In most people with depression or anxiety, Duloxetine Medical Valley starts to work within 2 weeks of starting treatment, but it may take 2 to 4 weeks for the improvement to occur. If after this time the patient does not feel better, they should see their doctor. Even if the patient's condition improves, the doctor may recommend continuing to take Duloxetine Medical Valley to prevent the depression or anxiety from coming back.

2. Important information before taking Duloxetine Medical Valley

When not to take Duloxetine Medical Valley

• 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 with Duloxetine Medical Valley")
• If you are taking fluvoxamine, a medicine used to treat depression, ciprofloxacin or enoxacin, medicines used to treat some infections
• If you are taking other medicines containing duloxetine (see "Taking other medicines with Duloxetine Medical Valley")

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

Warnings and precautions

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

• you are taking other antidepressant medicines (see "Taking other medicines with Duloxetine Medical Valley")
• you are taking herbal medicines containing St. John's Wort (Hypericum perforatum)
• you have kidney disease
• you have had seizures in the past
• you have had episodes of mania 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 in the past (tendency to bruise), especially if you are pregnant (see "Pregnancy and breastfeeding")
• you have been told that you have an increased risk of developing low sodium levels in your blood (for example, if you are taking diuretics, especially if you are elderly)
• you are currently taking other medicines that may harm your liver
• you are taking other medicines containing duloxetine (see "Taking other medicines with Duloxetine Medical Valley")

Duloxetine Medical Valley may cause feelings of restlessness or an inability to sit 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 this may indicate serotonin syndrome.

In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). The symptoms of NMS can include:

• a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzyme activity (measured by a blood test)

Medicines like Duloxetine Medical Valley (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
Suicidal thoughts and worsening depression or anxiety
People with depression or anxiety may sometimes have thoughts of harming themselves or of suicide. These thoughts may be more frequent when first taking antidepressants, as these medicines take time to start working, usually about 2 weeks, but sometimes longer.

• it is more likely if you have had thoughts of harming yourself or suicide in the past
• it is more likely if you are a young adult

If you experience thoughts of harming yourself or suicide, you should contact your doctor or go to 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

Duloxetine Medical Valley should not normally be used for children and adolescents under 18 years. Duloxetine Medical Valley should only be used in children and adolescents under 18 years for the treatment of major depressive episodes, when other treatments have failed. The doctor should carefully consider the potential benefits and risks before prescribing this medicine for a child or adolescent.

Duloxetine Medical Valley with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• Duloxetine, the active ingredient in Duloxetine Medical Valley, is also available in other medicines used to treat other conditions, such as diabetic neuropathic pain, depression, anxiety, and stress urinary incontinence.

Do not take more than one of these medicines at the same time. If you are already taking another medicine containing duloxetine, you should discuss this with your doctor.

Your doctor will decide whether you can take Duloxetine Medical Valley with other medicines.

Do not start or stop taking any other medicines, including those obtained without a prescription, herbal products, or dietary supplements, without talking to your doctor first.

Tell your doctor if you are taking any of the following medicines:

• Monoamine oxidase inhibitors (MAOIs):Do not take Duloxetine Medical Valley if you are taking or have taken an MAOI within the past 14 days. MAOIs include medicines such as moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including Duloxetine Medical Valley, can cause serious or life-threatening side effects.

Duloxetine Medical Valley with food, drink, and alcohol

Duloxetine Medical Valley can be taken with or without food.

Be careful when drinking alcohol while taking Duloxetine Medical Valley.

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 or plan to become pregnant while taking Duloxetine Medical Valley. Duloxetine Medical Valley should only be used during pregnancy if the potential benefits outweigh the potential risks.
• Make sure that your midwife and/or doctor know that you are taking Duloxetine Medical Valley. If you are taking Duloxetine Medical Valley during pregnancy, your newborn baby might have some symptoms when it is born. These symptoms are:

Urgent medical attention is required if your baby experiences:

• muscle weakness, trembling, or jitteriness
• difficulty feeding
• difficulty breathing
• seizures

If you are taking Duloxetine Medical Valley at the end of your pregnancy, your baby might have some other symptoms, such as:

• being floppy
• trembling
• being restless
• having difficulty sleeping
• having difficulty feeding
• having breathing difficulties
• having seizures

Tell your doctor or midwife if your baby experiences any of these symptoms.

If you are taking Duloxetine Medical Valley at the end of your pregnancy, there is a risk that you may experience bleeding from the vagina after giving birth, especially if you had bleeding disorders in the past.

Tell your doctor or midwife that you are taking Duloxetine Medical Valley so that they can recommend the best course of action.

There is not enough data on the use of Duloxetine Medical Valley during the first three months of pregnancy to assess the risk of birth defects. If you are taking Duloxetine Medical Valley in the second half of your pregnancy, there is a risk that your baby may be born prematurely, mainly between 35 and 36 weeks of pregnancy.

• Tell your doctor if you are breastfeeding. It is not recommended to take Duloxetine Medical Valley while breastfeeding. Ask your doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine Medical Valley contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Duloxetine Medical Valley contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Duloxetine Medical Valley

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 Duloxetine Medical Valley by mouth, with or without food.

Swallow the capsule whole with water.

Alternatively, you can open the capsule and sprinkle the contents onto a small amount of apple sauce.

Swallow the mixture immediately without chewing.

Treatment of depression:

The usual dose of Duloxetine Medical Valley is 60 mg once a day, but your doctor will prescribe the dose that is right for you.

Treatment of generalized anxiety disorder:

The usual starting dose of Duloxetine Medical Valley is 30 mg once a day.

For most patients, the dose will be increased to 60 mg once a day, but your doctor will prescribe the dose that is right for you. The dose can be increased up to 120 mg per day, depending on your response to Duloxetine Medical Valley.

Taking Duloxetine Medical Valley at the same time each day may help you remember to take it.

Your doctor will discuss with you how long you should take Duloxetine Medical Valley.

Do not stop taking Duloxetine Medical Valley or reduce your dose without the advice of your doctor. It is important to continue the treatment for as long as your doctor tells you to.

For doses that cannot be achieved with these strengths, other strengths of this medicine or other duloxetine-containing medicines are available.

What to do if you take more Duloxetine Medical Valley than you should

If you take more Duloxetine Medical Valley 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 extreme happiness, sleepiness, coordination problems, restlessness, confusion, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting), seizures, and rapid heartbeat.

What to do if you forget to take Duloxetine Medical Valley

If you forget to take a dose, take it as soon as you remember.

However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Do not take a double dose to make up for a forgotten dose.

Do not take more than the prescribed dose of Duloxetine Medical Valley per day.

What to do if you stop taking Duloxetine Medical Valley

Do not stop taking the capsules without talking to your doctor first.

If your doctor decides that you should stop taking Duloxetine Medical Valley, they will tell you how to gradually reduce your dose over at least 2 weeks.

Some patients who stop taking duloxetine may experience side effects, such as:

• dizziness, tingling sensations like pins and needles or electric shock-like feelings (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, sleepiness, restlessness, anxiety, nausea (feeling sick) or vomiting, tremors, headaches, muscle aches, irritability, diarrhea, excessive sweating, or dizziness due to problems with your balance

These symptoms are usually not severe and disappear within a few days. However, if they are troublesome, you should contact your doctor for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Duloxetine Medical Valley can cause side effects, although not everybody gets them.

These effects are usually mild or moderate and often disappear within 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, restlessness, decreased libido, anxiety, difficulty achieving orgasm, abnormal dreams
• dizziness, feeling sluggish, tremors, numbness, including numbness, tingling, or prickling sensations 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 having a fast or irregular heartbeat)
• increased blood pressure, flushing
• yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or acid reflux, gas
• increased sweating, rash (itching)
• muscle pain, muscle spasms
• 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 duloxetine, weight decreased after starting treatment. After 6 months of treatment, 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, teeth grinding or jaw clenching, disorientation, lack of motivation
• sudden involuntary movements or muscle twitching, feeling restless or an inability to sit still, agitation, difficulty concentrating, changes in taste, difficulty controlling movements, such as lack of coordination or involuntary movements, restless legs syndrome, poor quality sleep
• pupil dilation (the black center of the eye becomes larger), vision disturbances
• dizziness, dizziness due to problems with your balance, ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling lightheaded or fainting when standing up, feeling cold in the fingers and toes
• throat tightness, 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, cold sweats, increased 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 more often than usual, weaker than usual urine flow
• abnormal vaginal bleeding, changes in menstrual periods, including heavy, painful, irregular, or prolonged periods, or absence of periods
• chest pain, feeling cold, thirst, chills, fever, difficulty walking
• weight gain

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

• severe allergic reaction, which can cause difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• decreased thyroid function, which can cause tiredness or weight gain
• dehydration, low sodium levels in the blood (mainly in the elderly; symptoms may include dizziness, weakness, confusion, sleepiness, tiredness, nausea, or vomiting; more severe symptoms include fainting, seizures, and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behavior, mania (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and anger
• serotonin syndrome (a rare reaction that may cause feelings of extreme happiness, sleepiness, coordination problems, restlessness, confusion, rapid heartbeat, increased blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting), seizures
• increased pressure in the eye (glaucoma)
• mouth inflammation, red blood in the stool, bad breath, inflammation of the large intestine (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a severe skin condition with blisters, mouth sores, and eye problems), severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasm
• abnormal urine odor

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

• inflammation of blood vessels in the skin

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

• symptoms of a condition called "stress cardiomyopathy", which can include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported to the national reporting system listed below.

You can also report side effects directly via the national reporting system.

5. How to store Duloxetine Medical Valley

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 carton and blister after "EXP". The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package to protect from moisture.

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 Duloxetine Medical Valley contains

• The active substance is duloxetine. Each capsule contains duloxetine hydrochloride equivalent to 90 mg or 120 mg of duloxetine.
• The other ingredients are:

Capsule contents:

• sucrose, sugar spheres (sucrose, corn starch, sucrose), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, hypromellose, sucrose, colloidal anhydrous silica, talc, triethyl citrate, glycerol monostearate, triethyl citrate, polysorbate 80

Capsule shell:

• 90 mg capsules: titanium dioxide (E 171), gelatin, FCF - FD&C Blue 1 (brilliant blue FCF) (E 133), FD&C Blue 2 (indigo carmine) (E 132)
• 120 mg capsules: titanium dioxide (E 171), gelatin, FD&C Blue 2 (indigo carmine) (E 132), yellow iron oxide (E 172)

What Duloxetine Medical Valley looks like and contents of the pack

Duloxetine Medical Valley is a gastro-resistant hard capsule.

Each capsule contains duloxetine hydrochloride pellets, which are coated with a protective layer to prevent them from being affected by stomach acid.

Duloxetine Medical Valley 90 mg is a hard, gelatin capsule, approximately 21.4-22 mm in length, with a dark blue cap and a light blue body.

Duloxetine Medical Valley 120 mg is a hard, gelatin capsule, approximately 23-23.6 mm in length, with a dark blue cap and a blue body.

Aluminum/Aluminum blisters

Duloxetine Medical Valley 90 mg is available in packs of 28 and 98 capsules.

Duloxetine Medical Valley 120 mg is available in packs of 28 and 98 capsules.

PVC/PCTFE/Aluminum blisters

Duloxetine Medical Valley 90 mg is available in packs of 28 and 98 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer

Laboratorios Liconsa S.A
Avda. Miralcampo 7
Polígono Industrial Miralcampo
Azuqueca de Henares
19200 Guadalajara
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Duloxetine Liconsa 90 mg gastro-resistant hard capsules
Duloxetine Liconsa 120 mg gastro-resistant hard capsules
Duloxetine Liconsa 90 mg harde maagsapresistente capsules
Duloxetine Liconsa 120 mg harde maagsapresistente capsules
Duloxetin Liconsa 90 mg magensaftresistente Hartkapseln
Duloxetin Liconsa 120 mg magensaftresistente Hartkapseln
Finland:
Duloxetine Liconsa 90 mg enteric-coated hard capsules
Duloxetine Liconsa 120 mg enteric-coated hard capsules
Greece:
Duloxetine Liconsa 90 mg Γαστροανθεκτικό καψάκιο, σκληρό
Duloxetine Liconsa 120 mg Γαστροανθεκτικό καψάκιο, σκληρό
Spain:
Duloxetina Liconsa 90 mg cápsulas duras gastrorresistentes
Duloxetina Liconsa 120 mg cápsulas duras gastrorresistentes
Netherlands:
Duloxetine Liconsa 90 mg harde maagsapresistente capsules
Duloxetine Liconsa 120 mg harde maagsapresistente capsules
Luxembourg:
Duloxetine Liconsa 90 mg gélules gastro-résistantes
Duloxetine Liconsa 120 mg gélules gastro-résistantes
Duloxetine Liconsa 90 mg magensaftresistente Hartkapseln
Duloxetine Liconsa 120 mg magensaftresistente Hartkapseln
Germany:
Duloxetin AXiromed 90 mg magensaftresistente Hartkapseln
Duloxetin AXiromed 120 mg magensaftresistente Hartkapseln
Norway:
Duloxetine Liconsa
Duloxetine Liconsa
Poland
Duloxetine Medical Valley
Portugal:
Duloxetina Liconsa 90 mg
Duloxetina Liconsa 120 mg
Sweden:
Duloxetine Medical Valley 90 mg hårda enterokapslar
Duloxetine Medical Valley 120 mg hårda enterokapslar
Hungary:
Duloxetine Liconsa 90 mg
Duloxetine Liconsa 120 mg
Italy:
Duloxetina Liconsa 90 mg
Duloxetina Liconsa 120 mg
Date of last revision of the package leaflet: 07/2024