Duloxetine Medical Vallei

Package Leaflet: Information for the Patient

Duloxetine Medical Valley, 30 mg, Gastro-Resistant Hard Capsules

Duloxetine Medical Valley, 60 mg, Gastro-Resistant Hard Capsules

Duloxetine

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

• Keep this 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. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Duloxetine Medical Valley and what is it 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 is Duloxetine Medical Valley and what is it 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 indicated for the treatment of:

• depression
• generalized anxiety disorder (persistent feeling of anxiety or nervousness)
• diabetic neuropathic pain (usually described as burning, shooting, stabbing, or like an electric shock. In a specific area of the body, there may be a loss of sensation or abnormal sensations of touch, heat, or cold, and pressure may be painful). In most patients with depression or anxiety, Duloxetine Medical Valley starts working within two weeks of starting treatment, but improvement in mood may take 2 to 4 weeks. If the patient does not feel better after this time, they should consult their doctor. Even if there is an improvement in the patient's condition, the doctor may recommend continued use of Duloxetine Medical Valley to prevent a relapse of depression or anxiety.

In patients with diabetic neuropathic pain, improvement may occur after several weeks. The patient should consult their doctor if there is no improvement after 2 months.

2. Important information before taking Duloxetine Medical Valley

When not to take Duloxetine Medical Valley

• 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 within the last 14 days another medication called a monoamine oxidase inhibitor (MAOI) (see "Duloxetine Medical Valley and other medications")
• If the patient is taking fluvoxamine, a medication usually used to treat depression, ciprofloxacin, or enoxacin, medications used to treat certain infections
• If the patient is taking other medications containing duloxetine (see "Duloxetine Medical Valley and other medications").

The patient should inform their doctor if they have high blood pressure or heart disease. The doctor will decide whether the patient should take Duloxetine Medical Valley.

Warnings and precautions

The following are some reasons why Duloxetine Medical Valley may not be suitable for the patient. Before taking Duloxetine Medical Valley, the patient should inform their doctor if:

• they are taking other antidepressant medications (see "Duloxetine Medical Valley and other medications")
• they are taking herbal remedies containing St. John's Wort (Hypericum perforatum)
• they have kidney disease
• they have had seizures in the past
• they have had manic episodes in the past
• they have bipolar affective disorder
• they have eye problems, such as a certain type of glaucoma (increased pressure in the eye)
• they have had bleeding disorders in the past (tendency to bruise), especially if they are pregnant (see "Pregnancy and breastfeeding")
• they have been diagnosed with a risk of low sodium levels (e.g., when taking diuretics, especially in the elderly)
• they are currently taking other medications that may cause liver damage
• they are taking other medications containing duloxetine (see "Duloxetine Medical Valley and other medications")

Duloxetine Medical Valley may cause restlessness or an inability to sit or stand still. If such symptoms occur, the patient should inform their doctor. The patient should also contact their doctor if they 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.

If the patient experiences thoughts of self-harm or suicide, they should contact their doctor or go directly to the hospital immediately.

It may be helpful for the patient to inform their relatives or friends about their depression or anxiety and ask them to read this leaflet. The patient may ask them to inform them if they notice that their depression or anxiety has worsened or if there are any worrying changes in their behavior.

Children and adolescents under 18 years of age

Duloxetine Medical Valley should not normally be used in children and adolescents under 18 years of age. It should be noted that in patients under 18 years of age who take medications from this group, there is a greater risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and expressions of anger). However, the doctor may recommend the use of Duloxetine Medical Valley in patients under 18 years of age if they decide it is beneficial for them. If there are any doubts, and the doctor recommends the use of Duloxetine Medical Valley in a patient under 18 years of age, the patient should contact their doctor again. The patient should inform their doctor if they experience any of the above side effects in a patient under 18 years of age taking Duloxetine Medical Valley. Additionally, there is a lack of long-term safety data on the use of duloxetine in this age group regarding growth, maturation, and cognitive and behavioral development.

Duloxetine Medical Valley and other medications

The patient should tell 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 active ingredient in Duloxetine Medical Valley, is also found in other medications used to treat other conditions:

• diabetic neuropathic pain, depression, anxiety, and 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 whether the patient can take Duloxetine Medical Valley with other medications. The patient should not start or stop taking other medications, including those available without a prescription and herbal remedies, without consulting their doctor.The patient should inform their doctor if they are taking any of the following medications:

• Monoamine oxidase inhibitors (MAOIs):The patient should not take Duloxetine Medical Valley if they are taking or have taken another antidepressant medication called an MAOI within the last 14 days. MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medications, including Duloxetine Medical Valley, can cause serious or life-threatening side effects. After stopping an MAOI, the patient must wait at least 14 days before starting Duloxetine Medical Valley. After stopping Duloxetine Medical Valley, the patient must wait at least 5 days before starting an MAOI.
• Sedatives:These include prescription medications, such as benzodiazepines, strong pain medications, antipsychotics, phenobarbital, and antihistamines.
• Medications that increase serotonin levels:Triptans, 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 medications increase the risk of side effects. If the patient experiences any unusual symptoms while taking any of these medications with Duloxetine Medical Valley, they should contact their doctor.
• Oral anticoagulants or antiplatelet agents:Medications that thin the blood or prevent blood clotting. These medications may increase the risk of bleeding.

Duloxetine Medical Valley with food, drink, and alcohol

Duloxetine Medical Valley can be taken with or without food. The patient should be cautious when consuming alcohol while taking Duloxetine Medical Valley.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medication.

• The patient should tell their doctor if they become pregnant or plan to become pregnant while taking Duloxetine Medical Valley. Duloxetine Medical Valley should only be taken after discussing the expected benefits and potential risks with the doctor.
• The patient should ensure that their midwife and/or doctor are aware that they are taking Duloxetine Medical Valley. Similar medications (SSRIs) taken during pregnancy may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn, which causes rapid breathing and bluish discoloration. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in their baby, they should contact their midwife and/or doctor immediately.
• If the patient takes Duloxetine Medical Valley towards the end of their pregnancy, the newborn may experience certain symptoms. These symptoms usually occur soon after birth or within a few days. They include: floppiness, trembling, restlessness, difficulty feeding, difficulty breathing, and seizures. If the newborn experiences any of these symptoms or the patient is concerned about their baby's health, they should contact their doctor or midwife, who will provide them with the necessary explanations.
• If the patient takes Duloxetine Medical Valley towards the end of their pregnancy, there is an increased risk of excessive bleeding from the vagina shortly after delivery, especially if they have had bleeding disorders in the past. The patient should inform their doctor or midwife that they are taking duloxetine so that they can recommend the necessary precautions.
• Available data on the use of Duloxetine Medical Valley during the first three months of pregnancy do not generally indicate an increased risk of birth defects. If the patient takes Duloxetine Medical Valley in the second half of their 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 Medical Valley in the second half of pregnancy).
• The patient should inform their doctor if they are breastfeeding. The use of Duloxetine Medical Valley during breastfeeding is not recommended. The patient should consult their doctor or pharmacist for advice.

Driving and using machines

Duloxetine Medical Valley may cause drowsiness or dizziness. The patient should not drive or operate machinery until they know how Duloxetine Medical Valley affects them.

Duloxetine Medical Valley contains sucrose

If the patient has been told that they have an intolerance to some sugars, they should contact their doctor before taking this medication.

Duloxetine Medical Valley contains sodium

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

3. How to take Duloxetine Medical Valley

This medication should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. Duloxetine Medical Valley is taken orally. The capsule should be swallowed whole with water.

Treatment of depression and diabetic neuropathic pain:The usual dose of Duloxetine Medical Valley is 60 mg taken once daily, but the doctor will prescribe the dose that is right for each patient.

Treatment of generalized anxiety disorder:The usual starting dose of Duloxetine Medical Valley is 30 mg once daily. In most patients, the dose is then increased to 60 mg once daily, but the doctor will prescribe the dose that is right for each patient. The dose can be increased up to 120 mg depending on the patient's response to Duloxetine Medical Valley.

Taking Duloxetine Medical Valley at the same time every day can help the patient remember to take it.

The doctor will discuss with the patient how long they should take Duloxetine Medical Valley. The patient should not stop taking Duloxetine Medical Valley or change their dose without consulting their doctor. Proper treatment of the condition is essential for the patient to feel better. Without treatment, the patient's condition may persist and become more difficult to treat.

Taking a higher dose of Duloxetine Medical Valley than prescribed

If the patient takes more Duloxetine Medical Valley than prescribed, they should contact their doctor or pharmacist immediately. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, restlessness, especially agitation, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Duloxetine Medical Valley

If the patient misses a dose, they should take it as soon as they remember. However, if it is almost time for their next dose, they should skip the missed dose and take their usual dose. The patient should not take a double dose to make up for a missed dose. The patient should not take more than the prescribed daily dose of Duloxetine Medical Valley.

Stopping treatment with Duloxetine Medical Valley

The patient should not stop taking the capsules without their doctor's advice, even if they feel better.If the doctor decides that the patient no longer needs to take Duloxetine Medical Valley, they will recommend a gradual reduction in dose over at least two weeks before stopping the medication completely. In some patients who stop taking duloxetine abruptly, they may experience symptoms such as:

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

These symptoms are usually not severe and go away within a few days. However, if they are troublesome, the patient should consult their doctor for advice. If the patient has any further questions about their medication, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Duloxetine Medical Valley can cause side effects, although not everyone gets them. These effects are usually mild or moderate and usually go away after a few weeks.

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

• headache, drowsiness
• nausea (feeling sick), dry mouth

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

• loss of appetite
• sleep disturbances, restlessness or agitation, decreased sex drive, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling slowed down, tremors, 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)
• rapid or irregular heartbeat
• increased blood pressure, flushing
• yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash (itchy)
• muscle aches, muscle spasms
• painful urination, frequent urination
• problems with getting 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 duloxetine, a decrease in weight has been observed 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 causing hoarseness
• suicidal thoughts, difficulty sleeping, grinding or clenching teeth, disorientation, lack of motivation
• sudden involuntary movements or tremors, feeling restless or an inability to sit or stand still, irritability, difficulty concentrating, changes in taste, difficulty controlling movements, e.g., lack of coordination or involuntary movements, restless legs syndrome, poor quality sleep
• pupil dilation (the black center of the eye), vision disturbances
• dizziness, dizziness due to balance problems, ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling lightheaded or fainting when standing up, feeling cold in the fingers and/or toes
• throat tightness, nosebleeds
• vomiting blood or black, tarry stools, stomach and intestinal inflammation, reflux of stomach contents, 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 tremors
• difficulty or inability to urinate, frequent urination, need to urinate at night, need to urinate more than usual, weaker urine flow
• abnormal vaginal bleeding, menstrual disorders, including heavy, painful, irregular, or prolonged menstrual periods, or absence of menstrual periods
• chest pain, feeling cold, thirst, chills, feeling hot, walking disturbances
• weight gain
• Duloxetine Medical Valley may cause side 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 side effects (may affect up to 1 in 1,000 people):

• severe allergic reaction, causing difficulty breathing or 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 (mainly 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, mania (excessive activity, racing thoughts, and decreased need for sleep), hallucinations, aggression, and expressions of anger
• serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination problems, restlessness, especially agitation, feeling drunk, fever, sweating, or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• mouth inflammation, red blood in stool, unpleasant breath, intestinal inflammation (leading to diarrhea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a severe disease with blistering of the skin, mouth, eyes, and genitals), severe allergic reaction causing swelling of the face or throat (angioedema)

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)

• 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. By reporting side effects, the patient can help provide more information on the safety of this medication.

5. How to store Duloxetine Medical Valley

The medication should be stored out of sight and reach of children. Do not use this medication after the expiry date stated on the carton and blister after the expiry date: EXP. The expiry date refers to the last day of the month stated. Blisters from Aluminum/Aluminum foil. Do not store above 30°C. Blisters from PVC/PCTFE/Aluminum foil. Do not store above 30°C. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Duloxetine Medical Valley contains

• The active substance is duloxetine hydrochloride. 30 mg capsules: Each capsule contains 30 mg of duloxetine (as hydrochloride). 60 mg capsules: Each capsule contains 60 mg of duloxetine (as hydrochloride).
• Other ingredients are:

o
Capsule contents: sucrose, spheres, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30% (Eudragit L30D55), hypromellose, sucrose, colloidal silicon dioxide, anhydrous, talc, triethyl citrate, Plasacryl T20 (glycerol monostearate, triethyl citrate, polysorbate 80, water)
o
Capsule shell:

• 30 mg capsules: titanium dioxide (E 171), gelatin, FD&C Blue 2 (E 132), water
• 60 mg capsules: titanium dioxide (E 171), gelatin, FD&C Blue 2 (E 132), yellow iron oxide (E 172), water

What Duloxetine Medical Valley looks like and contents of the pack

Duloxetine Medical Valley is a hard gastro-resistant 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 30 mg is a hard, gelatin capsule, with an opaque blue cap and an opaque white body. Duloxetine Medical Valley 60 mg is a hard, gelatin capsule, with an opaque blue cap and an opaque green body. Blisters from transparent PVC/PCTFE/Aluminum foil and blisters from Aluminum/Aluminum foil. Duloxetine Medical Valley, 30 mg, gastro-resistant hard capsules, are available in packs of 7 and 28 capsules. Duloxetine Medical Valley, 60 mg, gastro-resistant hard capsules, are available in packs of 28 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: safety@medicalvalley.se

Manufacturer

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

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

France:
Duloxetine Almus 30 mg, gastro-resistant capsule
Duloxetine Almus 60 mg, gastro-resistant capsule
Spain:
Duloxetine Almus 30 mg, hard gastro-resistant capsules EFG
Duloxetine Almus 60 mg, hard gastro-resistant capsules EFG
Netherlands:
Duloxetine Laboratorios Liconsa 30 mg, hard gastro-resistant capsules
Duloxetine Laboratorios Liconsa 60 mg, hard gastro-resistant capsules
Ireland:
Duloxetine Pinewood 30 mg, hard gastro-resistant capsules
Duloxetine Pinewood 60 mg, hard gastro-resistant capsules
Poland
Duloxetine Medical Valley
Italy:
Duloxetine Almus
Date of last revision of the leaflet:07/2024