Duloxetine medical valley

Package leaflet: Information for the patient

Duloxetine Medical Valley, 30 mg, hard enteric capsules
Duloxetine Medical Valley, 60 mg, hard enteric capsules
Duloxetinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Duloxetine Medical Valley is and what it is used for
2. What you need to know 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 indicated in adults for the treatment of:

• depression
• generalized anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (usually described as burning, stabbing, piercing, shooting, or electric-shock-like pain. In a specific part of the body, loss of sensation may occur or touch, heat, or cold may be perceived abnormally, and pressure may cause pain). In most patients with depression or anxiety, Duloxetine Medical Valley begins to work within two weeks of starting treatment, although improvement in well-being may take 2 to 4 weeks. 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 recommend continuing treatment with Duloxetine Medical Valley to prevent recurrence of depression or anxiety.

In patients with diabetic neuropathic pain, improvement may occur after several weeks.
Please consult your doctor if no improvement is observed after 2 months.

2. Important information before using Duloxetine Medical Valley

When not to use Duloxetine Medical Valley

• If the patient is allergic to duloxetine or any of the other ingredients of this medicine (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 medicine called a monoamine oxidase inhibitor (MAOI) (see "Duloxetine Medical Valley and other medicines")
• If the patient is taking fluvoxamine, a medicine usually used to treat depression, or ciprofloxacin or enoxacin, medicines used to treat certain infections
• If the patient is taking other medicines containing duloxetine (see "Duloxetine Medical Valley and other medicines").

Tell the doctor if the patient has high blood pressure or heart disease.
The doctor will decide whether the patient should take Duloxetine Medical Valley.
Warnings and precautions
Below are several reasons why Duloxetine Medical Valley may not be suitable for the patient. Before taking Duloxetine Medical Valley, inform the doctor if:

• the patient is taking other antidepressant medicines (see "Duloxetine Medical Valley and other medicines")
• the patient is taking herbal medicines containing St John’s wort (Hypericum perforatum)
• the patient has kidney disease
• the patient has had seizures in the past
• the patient has had episodes of mania in the past
• the patient has bipolar affective disorder
• the patient has eye diseases, such as a specific type of glaucoma (increased pressure in the eye)
• the patient has had bleeding disorders (tendency to bruise easily), particularly if the patient is pregnant (see "Pregnancy and breastfeeding")
• the patient has been identified as being at risk of developing low sodium levels (for example, when taking diuretics, especially in elderly people)
• the patient is currently taking other medicines that may cause liver damage
• the patient is taking other medicines containing duloxetine (see "Duloxetine Medical Valley and other medicines")

Duloxetine Medical Valley may cause feelings of restlessness or an inability to sit still or remain motionless. If such symptoms occur, inform the doctor.
Also contact the doctor:
If the patient experiences objective and subjective symptoms such as agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, increased reflexes, diarrhoea, drowsiness, nausea, vomiting, as these may indicate serotonin syndrome.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Objective and subjective symptoms of neuroleptic malignant syndrome may include: a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased activity of muscle enzymes (detected 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 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 increase at the beginning of treatment with antidepressants, as these medicines take some time to work, usually about 2 weeks, but sometimes longer.
The occurrence of such thoughts is more likely if:

• the patient has previously had suicidal thoughts or thoughts of self-harm
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders taking antidepressants.

If the patient experiences thoughts of self-harm or suicide, contact the doctor immediately
or go directly to hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behaviour.
Children and adolescents under 18 years of age
Generally, Duloxetine Medical Valley should not 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 an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger). However, the doctor may prescribe Duloxetine Medical Valley for patients under 18 years of age if he or she decides it is beneficial for them. If in doubt, and if the doctor prescribes Duloxetine Medical Valley for a patient under 18 years of age, contact the doctor again. Inform the doctor if any of the adverse reactions listed above occur or worsen in a patient under 18 years of age taking Duloxetine Medical Valley. In addition, there is a lack of long-term safety data on the use of duloxetine in this age group regarding growth, puberty, and cognitive and behavioural development.
Duloxetine Medical Valley and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Duloxetine, the main ingredient of Duloxetine Medical Valley, is also present in other medicines used to treat other conditions:

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

Avoid taking more than one of these medicines simultaneously. The patient should consult the doctor if taking other medicines containing duloxetine.
The doctor will decide whether Duloxetine Medical Valley can be taken together with other medicines. Do not start or stop taking any other medicines, including those available without a prescription and herbal preparations, without first contacting the doctor.
Inform the doctor if the patient is taking any of the following medicines:
Monoamine oxidase inhibitors (MAOIs): Do not take Duloxetine Medical Valley if the patient is taking or has recently taken (within the last 14 days) another antidepressant medicine known as a monoamine oxidase inhibitor (MAOI). MAOI medicines include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking MAOIs together with many prescription medicines, including Duloxetine Medical Valley, may cause severe or even life-threatening adverse reactions. At least 14 days must pass after stopping an MAOI before starting Duloxetine Medical Valley. After stopping Duloxetine Medical Valley, wait at least 5 days before starting an MAOI.
Medicines causing drowsiness: These include medicines prescribed by a doctor, such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Medicines increasing 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, amitriptyline), pethidine, St John’s wort (Hypericum perforatum), and MAOIs (e.g. moclobemide and linezolid). These medicines increase the risk of adverse reactions.
If any unusual symptoms occur while taking any of these medicines together with Duloxetine Medical Valley, contact the doctor.
Oral anticoagulants or antiplatelet medicines: 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 may be taken with or without food. Exercise caution when consuming alcohol while taking Duloxetine Medical Valley.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult the doctor before using this medicine.

• Inform the doctor if the patient becomes pregnant or plans to become pregnant while taking Duloxetine Medical Valley. Duloxetine Medical Valley should only be taken after discussing with the doctor the expected benefits of treatment and the possible risks to the unborn child.
• Ensure that the midwife and (or) doctor are aware that the patient is taking Duloxetine Medical Valley. Similar medicines (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually occur within the first 24 hours after birth. If the patient notices these symptoms in her baby, she should contact the midwife and (or) doctor immediately.
• If the patient takes Duloxetine Medical Valley towards the end of pregnancy, certain symptoms may occur in the newborn. These usually appear shortly after birth or within the following few days. Symptoms include: muscle weakness, tremor, shaking, difficulty sucking, breathing difficulties, and seizures. If any of these symptoms occur in the newborn, or if the patient is concerned about the baby's health, she should contact the doctor or midwife, who will provide appropriate advice.
• If the patient takes Duloxetine Medical Valley towards the end of pregnancy, there is an increased risk of excessive vaginal bleeding shortly after delivery, especially if the patient has previously had bleeding disorders. Inform the doctor or midwife about taking duloxetine so they can recommend appropriate management.
• Available data on the use of Duloxetine Medical Valley during the first three months of pregnancy generally do not show an increased risk of congenital malformations in the child. If the patient takes Duloxetine Medical Valley during the second half of pregnancy, there may be an increased risk of premature birth, mainly between weeks 35 and 36 of pregnancy (6 additional premature births per 100 women taking Duloxetine Medical Valley in the second half of pregnancy).
• Inform the doctor if the patient is breastfeeding. The use of Duloxetine Medical Valley during breastfeeding is not recommended. Consult the doctor or pharmacist for advice.

Driving and operating machinery
Duloxetine Medical Valley may cause drowsiness or dizziness. Do not drive or operate machinery until the patient knows how the medicine affects him or her.
Duloxetine Medical Valley contains sucrose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.
Duloxetine Medical Valley contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Duloxetine Medical Valley

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
please 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 daily, but your doctor will determine
the dose appropriate for each individual patient.
Treatment of generalized anxiety disorders:
The usual initial dose of Duloxetine Medical Valley is 30 mg once daily.
For most patients, the dose is subsequently increased to 60 mg once daily, but your doctor will determine
the appropriate dose for each patient. The dose may be increased up to 120 mg depending on the patient's
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 continue taking Duloxetine Medical Valley. Do not
discontinue treatment or change the dose of Duloxetine Medical Valley without consulting your doctor.
Appropriate treatment of the condition is important for your improvement. Without treatment, the
condition may persist, worsen, and become more difficult to treat.
Taking more Duloxetine Medical Valley than prescribed
If you take more Duloxetine Medical Valley than prescribed, contact your doctor or pharmacist immediately.
Symptoms of overdose may include drowsiness, coma, serotonin syndrome (a rare reaction which may cause
excessive feelings of well-being, drowsiness, motor incoordination, restlessness, sensation of alcohol
intoxication, fever, sweating, or muscle rigidity), seizures, vomiting, and rapid heartbeat.
Missing a dose of Duloxetine Medical Valley
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose,
skip the missed dose and take the next dose at the regular time. 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 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 recommend gradually reducing the dose
over at least 2 weeks until the medicine is completely discontinued. In some patients who abruptly stop
duloxetine, the following symptoms may occur:

• dizziness, tingling sensations like pins and needles or electric shocks (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, motor restlessness or agitation, anxiety, nausea or vomiting, tremor, headache, muscle pain, irritability, diarrhea, excessive sweating, or dizziness due to vestibular disturbances.

These symptoms are usually not severe and resolve within a few days. However, if they are troublesome,
consult your doctor for advice.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
These reactions are usually mild or moderate and generally resolve within a few weeks.

Very common adverse reactions (may occur in more than 1 in 10 patients)

• headache, drowsiness
• nausea, dry mouth

Common adverse reactions (may occur in up to 1 in 10 patients)

• loss of appetite
• sleep disturbances, restlessness, decreased libido, anxiety, difficulty or inability to achieve orgasm, unusual dreams
• dizziness, feeling of sluggishness, muscle tremor, numbness, including tingling, pricking or stinging sensations of the skin
• blurred vision
• tinnitus (hearing sound in the ears in the absence of external sound source)
• palpitations
• increased blood pressure, sudden flushing of the face
• excessive yawning
• constipation, diarrhoea, abdominal pain, vomiting, heartburn or indigestion, flatulence
• increased sweating, rash (itchy)
• muscle pain, muscle cramps
• painful urination, frequent urination
• problems achieving erection, changes in ejaculation
• falls (especially in elderly people), fatigue
• weight loss

In children and adolescents under 18 years of age with depression treated with duloxetine, weight loss has been observed after starting treatment. After 6 months of treatment, body weight increased and became comparable to that observed in other children and adolescents of the same age and sex.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• throat inflammation causing hoarseness
• suicidal thoughts, difficulty falling asleep, teeth grinding or clenching, disorientation, lack of motivation
• sudden involuntary movements or muscle tremor, feeling of restlessness or inability to sit still or remain motionless, irritability, difficulty concentrating, taste disturbances, difficulty controlling movements, e.g. lack of coordination or involuntary muscle movements, restless legs syndrome, worsened sleep quality
• pupil dilation (dark central part of the eye), visual disturbances
• dizziness, dizziness due to vestibular disorders, ear pain
• rapid and (or) irregular heartbeat
• fainting, dizziness, feeling of emptiness in the head or fainting upon standing, cold sensation in fingers and (or) toes
• tightness in the throat, nosebleeds
• vomiting blood or black, tarry stools, inflammation of the stomach and intestines, regurgitation of stomach contents, difficulty swallowing
• hepatitis, which may cause abdominal pain and yellowing of the skin or whites of the eyes
• night sweats, urticaria, cold sweats, photosensitivity, increased tendency to bruising
• muscle stiffness and tremor
• difficulty or inability to urinate, difficulty initiating urination, need to urinate at night, need to pass larger than usual amounts of urine, reduced urine stream
• abnormal vaginal bleeding, menstrual disorders, including heavy, painful, irregular or prolonged periods, unusually light periods or absence of periods, testicular or scrotal pain
• chest pain, cold sensation, thirst, chills, hot flushes, gait disturbances
• weight gain
• Duloxetine Medical Valley may cause adverse reactions that are not apparent, such as increased liver enzyme activity or blood potassium levels, increased creatine phosphokinase activity, or increased blood glucose or cholesterol levels

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• severe allergic reaction causing breathing difficulties or dizziness with swelling of the tongue or lips, allergic reactions
• reduced thyroid function, which may cause fatigue or weight gain
• dehydration, low blood sodium levels (mainly in elderly people; symptoms may include: dizziness, weakness, confusion, drowsiness, severe fatigue, nausea or vomiting; more severe symptoms include fainting, seizures and falls), syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• suicidal behaviour, mania (excessive activity, racing thoughts and reduced need for sleep), hallucinations, aggression and anger outbursts
• "serotonin syndrome" (a rare reaction that may cause feelings of excessive well-being, drowsiness, impaired motor coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness), seizures
• increased eye pressure (glaucoma)
• inflammation of the mouth, bright red blood in stool, bad breath, inflammation of the large intestine (leading to diarrhoea)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious condition involving blistering of the skin, inside the mouth, eyes and genital organs), severe allergic reaction causing swelling of the face or throat (angioedema)
• jaw muscle spasm
• abnormal urine odour
• menopausal symptoms, abnormal milk production in the breasts in men or women
• excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage)
• cough, wheezing and shortness of breath, possibly accompanied by fever

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• inflammation of blood vessels in the skin

Frequency not known (cannot be estimated from available data)

• objective and subjective symptoms of a condition called stress cardiomyopathy, which may include: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Duloxetine Medical Valley

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister. The expiry date is indicated as: EXP. The expiry date refers to the last day of the stated month.
Aluminium/Aluminium foil blisters
Do not store above 30°C.
PVC/PCTFE/Aluminium foil blisters
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Package contents and other information

What Duloxetine Medical Valley contains

• The active substance is duloxetine in the form of 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, beads of methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (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 hard, enteric-coated capsule. Each capsule contains pellets of duloxetine hydrochloride coated with a protective layer to prevent degradation by gastric juice.
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.
Blister packs made of transparent PVC/PCTFE/Aluminum and blister packs made of Aluminum/Aluminum foil.
Duloxetine Medical Valley 30 mg, hard enteric-coated capsules, are available in packs containing 7 and 28 capsules.
Duloxetine Medical Valley 60 mg, hard enteric-coated capsules, are available in packs containing 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
France: Duloxetine Almus 30 mg, gélule gastro-resistante
Duloxetine Almus 60 mg, gélule gastro-resistante
Spain: Duloxetine Almus 30 mg mg cápsulas duras gastrorresistentes EFG
Duloxetine Almus 60 mg mg cápsulas duras gastrorresistentes EFG
Netherlands: Duloxetine Laboratorios Liconsa 30 mg harde maagsapresistente capsules
Duloxetine Laboratorios Liconsa 60 mg harde maagsapresistente capsules
Ireland: Duloxetine Pinewood 30 mg hard gastro-resistant capsules
Duloxetine Pinewood 60 mg hard gastro-resistant capsules
Poland: Duloxetine Medical Valley
Italy: Duloxetina Almus