Duloxetine Medical Vallei

Leaflet accompanying the packaging: patient information

Duloxetine Medical Valley, 30 mg, gastro-resistant hard capsules

Duloxetine Medical Valley, 60 mg, gastro-resistant hard capsules

Duloxetine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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, stabbing, stinging, shooting, or like an electric shock. In a specific area of the body, there may be a loss of sensation or sensations of touch, heat, or cold, and pressure may be painful). In most people 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 after this time the patient does not feel better, 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. You should consult your doctor if improvement does not occur after 2 months.

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

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

Warnings and precautions

Below are listed some reasons why Duloxetine Medical Valley may not be suitable for you. Before taking Duloxetine Medical Valley, you should inform your doctor if:

• you are taking other antidepressant medicines (see "Duloxetine Medical Valley and other medicines")
• 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 manic episodes in the past
• you have bipolar affective disorder
• you have eye diseases, such as a certain type 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 diagnosed with a risk of decreased sodium levels (e.g., when taking diuretics, especially in the elderly)
• you are currently taking other medicines that may cause liver damage
• you are taking other medicines containing duloxetine (see "Duloxetine Medical Valley and other medicines")

Duloxetine Medical Valley may cause a feeling of restlessness or an inability to sit or stand still. If such symptoms occur, you should inform 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 body temperature, rapid changes in 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). Objective and subjective symptoms of NMS may include: a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzyme activity (determined by blood tests). Medicines such as Duloxetine Medical Valley (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Suicidal thoughts and worsening depression or anxiety

People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen when starting antidepressant medicines, as these medicines start working only after some time, usually after 2 weeks, but sometimes later.

Such thoughts are more likely to occur if:

• the patient has had suicidal thoughts or self-harm thoughts in the past
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, you should contact your doctor or go directly to the hospital immediately.

It may be helpful to inform relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety has worsened or if you have any worrying changes in your 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 taking medicines of this class, 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, your 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 your doctor recommends the use of Duloxetine Medical Valley in a patient under 18 years of age, you should contact your doctor again. You should inform your doctor if any of the above side effects occur or worsen 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 medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.

Duloxetine, the active ingredient of Duloxetine Medical Valley, is also found in other medicines used to treat other diseases:

• diabetic neuropathic pain, depression, anxiety, and urinary incontinence.

You should avoid taking more than one of these medicines at the same time. You should consult your doctor if you are taking other medicines containing duloxetine. Your doctor will decide whether you can take Duloxetine Medical Valley with other medicines. Do not start or stop taking other medicines, including those available without a prescription and herbal preparations, without consulting your doctor.

You should inform 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 another antidepressant medicine called an MAOI within the last 14 days. MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs with many prescription medicines, including Duloxetine Medical Valley, can cause serious or even life-threatening side effects. After stopping an MAOI, at least 14 days must pass before starting Duloxetine Medical Valley. After stopping Duloxetine Medical Valley, at least 5 days must pass before taking an MAOI.

Sedative medicines:These include prescription medicines, such as benzodiazepines, strong painkillers, antipsychotic medicines, phenobarbital, and antihistamines.

Medicines that increase serotonin levels:Triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (e.g., paroxetine and fluoxetine), selective noradrenaline reuptake inhibitors (e.g., venlafaxine), tricyclic antidepressants (e.g., clomipramine and amitriptyline), pethidine, St. John's Wort (Hypericum perforatum), and MAOIs (e.g., moclobemide and linezolid). These medicines increase the risk of side effects.

If you experience any unusual symptoms while taking any of these medicines with Duloxetine Medical Valley, you should contact your doctor.

Oral anticoagulants or antiplatelet agents:Medicines that thin the blood or prevent blood clotting. These medicines may increase the risk of bleeding.

Duloxetine Medical Valley with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

• You should tell your doctor if you become pregnant or plan to become pregnant while taking Duloxetine Medical Valley. Duloxetine Medical Valley can be taken only after discussing the expected benefits and possible risks to the unborn child with your doctor.
• You should ensure that your midwife and/or doctor know that you are taking Duloxetine Medical Valley. Similar medicines (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 in the baby. These symptoms usually occur within the first 24 hours after birth. If you notice them in your baby, you should contact your midwife and/or doctor immediately.
• If you take Duloxetine Medical Valley towards the end of your pregnancy, your newborn baby might have some symptoms. These symptoms usually occur soon after birth or within a few days. They include: floppiness, trembling, jitteriness, difficulty feeding, difficulty breathing, and seizures. If your baby experiences any of these symptoms or if you are concerned about your baby's health, you should contact your doctor or midwife, who will provide you with appropriate explanations.
• If you take Duloxetine Medical Valley towards the end of your pregnancy, there is an increased risk of excessive bleeding from the vagina shortly after delivery, especially if you have had bleeding disorders in the past. You should inform your doctor or midwife about taking duloxetine so they can recommend appropriate action.
• 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 in the baby. If you take Duloxetine Medical Valley in the second half of your pregnancy, there may be an increased risk of premature birth, mainly between the 35th and 36th week of pregnancy (6 additional premature births per 100 women taking Duloxetine Medical Valley in the second half of pregnancy).
• You should inform your doctor if you are breastfeeding. The use of Duloxetine Medical Valley during breastfeeding is not recommended. You should consult your doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine Medical Valley contains sucrose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Duloxetine Medical Valley contains sodium

This medicine 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 medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, you should consult your 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 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. In most patients, the dose is then 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, depending on your response to Duloxetine Medical Valley.

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

Your doctor will discuss with you how long you should take Duloxetine Medical Valley. You should not stop taking Duloxetine Medical Valley or change your dose without consulting your doctor. Proper treatment of your condition is important for you to feel better. Without treatment, your condition may persist and become difficult to treat.

Taking a higher dose of Duloxetine Medical Valley than prescribed

If you take more Duloxetine Medical Valley than you should, you should contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause excessive happiness, drowsiness, coordination disorders, restlessness, especially motor restlessness, a feeling of intoxication, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heartbeat.

Missing a dose of Duloxetine Medical Valley

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

Stopping treatment with Duloxetine Medical Valley

DO NOT STOP TAKING THE CAPSULES WITHOUT YOUR DOCTOR'S ADVICE, EVEN IF YOU FEEL BETTER.If your doctor decides that you no longer need to take Duloxetine Medical Valley, they will tell you how to reduce your dose gradually over at least 2 weeks to prevent side effects. Some patients who stop taking duloxetine abruptly may experience side effects such as:

• dizziness, tingling sensation similar to pins and needles or electric shock (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 disorders.

These symptoms are usually not severe and go away within a few days. However, if they are bothersome, you should consult your doctor for advice.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

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, decreased libido, 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)
• palpitations (feeling of fluttering or pounding heart)
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhea, abdominal pain, vomiting, heartburn or indigestion, gas
• increased sweating, rash (itching)
• muscle aches, muscle spasms
• painful urination, frequent urination
• difficulty or inability to achieve 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 became 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):

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty sleeping, teeth grinding or clenching, disorientation, lack of motivation
• sudden involuntary movements or tremors, feeling of restlessness or an inability to sit or stand still, agitation, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g., lack of coordination or involuntary movements, restless legs syndrome, poor sleep quality
• pupil dilation (the black center of the eye), vision disturbances
• dizziness, dizziness due to balance disorders, ear pain
• rapid or irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or fainting when standing up, feeling of coldness in the fingers of the hands and/or feet
• throat tightness, nosebleeds
• vomiting blood or black, tarry stools, stomach and intestinal inflammation, reflux of stomach contents, difficulty swallowing
• liver inflammation, which can cause abdominal 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 often than usual, weaker urine flow
• abnormal vaginal bleeding, menstrual disturbances, including heavy, painful, irregular, or prolonged menstrual periods, abnormally light or absent menstrual periods
• chest pain, feeling of coldness, thirst, chills, feeling of heat, difficulty walking
• weight gain
• Duloxetine Medical Valley may cause side effects that you are not aware of, such as increased liver enzyme activity or potassium levels in the blood, increased creatine phosphokinase activity, 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, nausea or vomiting, 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 disorders, restlessness, especially motor restlessness, a feeling of intoxication, fever, sweating, or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• mouth inflammation, red blood in the 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 disease called stress cardiomyopathy, which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Reporting side effects

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

5. How to store Duloxetine Medical Valley

The medicine should be kept out of the sight and reach of children.

Do not use this medicine 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 transparent PVC/PCTFE/Aluminum foil and blisters from Aluminum/Aluminum foil

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Duloxetine Medical Valley contains

• The active substance of Duloxetine Medical Valley 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).
• -The other ingredients are:

o

capsule contents: sucrose, maize starch, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion (Eudragit L30D55), hypromellose, sucrose, colloidal anhydrous silica, 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 gastro-resistant hard capsule. Each capsule contains duloxetine hydrochloride pellets coated with a protective layer to prevent them from coming into contact with 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 medicine 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