Duloxetine Krka - Duloxetine uses, dose and side effects

Depression
generalized anxiety disorder (constant feeling of anxiety or worry)
painful diabetic neuropathy (usually described as burning, stinging, stinging, stabbing, or aching pain or as an electric shock . The affected area may be completely numb, or cause pain from touch, heat, cold, or pressure).

In most people with depression or anxiety, Duloxetine Krka starts working within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Talk to your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine Krka even when you are feeling better to prevent relapse into depression or anxiety.

For most people who have painful diabetic neuropathy, it can take a few weeks before they feel better. Talk to your doctor if you do not feel better after 2 months.

Duloxetine contained in Duloxetine Krka may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Duloxetine Krka

Do not use Duloxetine Krka

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 medicine in the last 14 days that belong to the group of monoamine oxidase inhibitors ( MAOIs ) (see “Other medicines and Duloxetine Krka”)
if you are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections you
if you are taking other medicines containing duloxetine (see “Other medicines and Duloxetine Krka”)

Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take Duloxetine Krka.

Warnings and cautions

If you suffer from any of the following, Duloxetine Krka may not be right for you. Talk to your doctor before taking Duloxetine Krka if you:

taking other antidepressants (see “Other medicines and Duloxetine Krka”)
takes St. John’s wort, an herbal medicine ( Hypericum perforatum )
have kidney disease
have had seizures (seizures)
have had mania
have bipolar disorder
have eye problems, such as a certain type of glaucoma (increased pressure in the eye)
have previously had bleeding disorders (tendency to get bruises), especially if you are pregnant (see “Pregnancy and breast-feeding”)
is at risk for low sodium levels (for example, if you are taking diuretics, especially if you are older)
while being treated with another medicine that may cause liver damage
taking other medicines containing duloxetine (see “Other medicines and Duloxetine Krka”)

Drugs such as Duloxetine Krka (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Duloxetine Krka may cause a feeling of restlessness and difficulty sitting or standing still. If this happens, tell your doctor.

Suicidal ideation and worsening of your depression or anxiety

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer. These thoughts may be common if you:

have previously had thoughts of harming yourself or committing suicide
is younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and young people under 18 years of age

Duloxetine Krka should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know the risk of side effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, defiance, and anger) are greater in patients under 18 years of age when taking this type of drug. Despite this, Duloxetine Krka can be prescribed by your doctor to patients under 18 years of age if the doctor deems it appropriate. If your doctor has prescribed Duloxetine Krka to a patient under the age of 18 and you want to discuss this, you should contact your doctor again. You should also inform your doctor if you notice any of the above symptoms or if they worsen when patients under 18 take Duloxetine Krka. Also, the long-term effects on growth, maturity, and development of intellect and behavior have not yet been determined for this age group.

Other medicines and Duloxetine Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The active ingredient in Duloxetine Krka, duloxetine, is used in other medicines for other conditions:

painful diabetic neuropathy, depression, anxiety, and urine leakage.

The use of more than one of these medicines at the same time should be avoided. Contact your doctor if you are already taking other medicines that contain duloxetine.

Your doctor will decide if you can take Duloxetine Krka with other medicines. Check with your doctor before starting or stopping any medications, including over-the-counter and herbal remedies.

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

Monoamine oxidase inhibitors ( MAOIs ): Duloxetine Krka should not be taken if you are taking or have taken another antidepressant medicine calledMAOIsfor the last 14 days. Examples ofMAO inhibitors are moclobemide (an antidepressant drug) and linezolid (an antibiotic). Many prescription drugs, including Duloxetine Krka, can, if taken together with an MAOI, cause serious or even life-threatening side effects. Before you can take Duloxetine Krka at least 14 days have passed since treatment with anMAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Krka before you can start taking an MAOI.

Drugs that can cause drowsiness: Such drugs include prescription drugs such as benzodiazepines, strong painkillers, drugs for psychosis, phenobarbital, and antihistamine s.

Drugs that increase the levels of serotonin: Triptans, tramadol, tryptophan, SSRIs-läkemedel (e.g. paroxetine and fluoxetine ), SNRIs -läkemedel (e.g. venlafaxine ), tricyclic antidepressants (e.g. clomipramine, amitriptyline), pethidine, wort and MAOIs (eg moclobemide and linezolid). These drugs increase the risk of side effects. Contact your doctor if you experience any unusual symptoms while taking any of these medicines with Duloxetine Krka.

Oral anticoagulants or antiplatelet agents: Blood thinners or agents that prevent blood clots from forming. These agents may increase the risk of bleeding.

Duloxetine Krka with food, drink, and alcohol

Duloxetine Krka can be taken with or without food. You should be careful with alcohol during treatment with Duloxetine Krka.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, 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 during treatment with Duloxetine Krka. You should only use Duloxetine Krka after consulting your doctor regarding the possible benefits of the treatment and any risks to the fetus.
Tell your midwife or doctor that you are using Duloxetine Krka. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) may increase. This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
If you take Duloxetine Krka at the end of your pregnancy, your baby may experience some symptoms after birth. These symptoms usually occur at birth or within a few days after your baby is born. Symptoms may include weak muscles, tremors, tremors, difficulty feeding, breathing problems, and seizures. If your newborn baby has any of these symptoms, or if you are concerned about your baby’s health, you should contact your doctor or midwife for advice.
If you take Duloxetine Krka at the end of your pregnancy, there is an increased risk of severe vaginal bleeding shortly after delivery, especially if you have previously had bleeding disorders. Your doctor or midwife should tell you to take duloxetine so that they can give you advice.
Tell your doctor if you are breast-feeding. The use of Duloxetine Krka during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

Duloxetine Krka may make you feel drowsy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine Krka affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Duloxetine Krka contains sucrose

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

How to use Duloxetine Krka

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Duloxetine Krka should be swallowed. Swallow the capsule whole with water.

For depression and painful diabetic neuropathy:

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

For generalized anxiety disorder:

The most common starting dose is Duloxetine Krka 30 mg once a day, after which most patients switch to 60 mg once a day, but your doctor will prescribe the dose that is right for you. Dose one may need to be adjusted up to 120 mg, depending on how you respond to Duloxetine Krka.

It is easier to remember to take Duloxetine Krka if you take it at the same time each day.

Ask your doctor how long to take Duloxetine Krka. Do not stop taking Duloxetine Krka, or change the dose, without first discussing this with your doctor. For you to feel better, it is important to treat your illness in the right way. If left untreated, it can persist and become more severe and difficult to treat.

If you use more Duloxetine Krka then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Symptoms of overdose include drowsiness, coma, serotonergic syndrome (a rare reaction that can cause severe feelings of happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating, or stiff muscles), seizures, vomiting, and rapid heartbeat.

If you forget to use Duloxetine Krka

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more Duloxetine Krka per day than your doctor prescribed.

If you stop using Duloxetine Krka

DO NOT STOP taking Duloxetine Krka, even if you feel better, without talking to your doctor first. If your doctor thinks you no longer need Duloxetine Krka, he/she will reduce your dose for at least two weeks before stopping treatment completely.

Some patients who abruptly stop taking Duloxetine Krka may experience symptoms such as:

dizziness, tingling and numbness or sensations of electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, feeling of restlessness or worry, anxiety, nausea / vomiting (feeling sick), tremors, headache , muscle pain, irritation, diarrhea, heavy sweating or dizziness.

These problems are usually mild and disappear within a few days. Ask your doctor if the reactions are bothersome.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

headache, drowsiness
nausea, dry mouth

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

loss of appetite
difficulty sleeping, feelings of upset, decreased sex drive, anxiety, difficulty getting or not having an orgasm, strange dreams
dizziness, feeling sluggish, tremors, numbness including numbness or tingling in the skin
dimsyn
tinnitus (sensation of sound in the ear without external sound source)
palpitation
high blood pressure , hemorrhage
yawning
constipation, diarrhea, abdominal pain, nausea and vomiting, heartburn or indigestion, flatulence
increased sweating, (itchy) rash
muscle pain, muscle spasm
painful urination, frequent bladder emptying
erection problems, ejaculation disorders
fall accidents (mostly in the elderly), fatigue
weight loss

Children and adolescents under the age of 18 treated with this antidepressant experienced some weight loss when starting treatment. However, the weight increased after 6 months of treatment so that it corresponded to other children and adolescents of the same age and the same sex.

Uncommon side effects (may affect up to 1 in 100 people)

pharyngitis causing a hoarse voice
suicidal thoughts, difficulty sleeping, gnashing of teeth, feeling disoriented, lack of motivation
sudden involuntary twitches or twitches in the muscles, a feeling of restlessness and difficulty sitting or standing still, feeling nervous, difficulty concentrating, taste changes, difficulty controlling movements such as lack of coordination or involuntary movements in the muscles, restless legs (numbness and stinging feeling in the legs), poor sleep
large pupil er (the dark field in the middle of the eye), visual disturbances
the feeling of dizziness (dizziness), sore ears
fast or irregular heartbeat
fainting and dizziness when getting up, cold fingers and/or toes
feel thick in the throat, nosebleeds
bloody vomiting or black tarry stools, gastrointestinal inflammation, belching, difficulty swallowing
inflammation of the liver that can cause abdominal pain and yellowing of the skin and whites of the eyes
night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
muscle tension, muscle twitching
difficulty or inability to urinate, difficulty urinating, need to empty the bladder at night, need to empty the bladder more often than usual, decreased urine flow
abnormal vaginal bleeding, abnormal menstruation, including heavy, painful, irregular or prolonged menstruation, unusually short or absent menstruation, pain in the testicles or scrotum
chest pain, feeling cold, thirst, shaking, feeling hot, abnormal gait
weight gain
Duloxetine Krka can cause effects that you do not notice, such as an increase in liver enzymes or the level of potassium, creatine phosphokinase, sugar, or cholesterol in the blood.

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

severe allergic reactions that cause difficulty breathing or dizziness, with swollen tongue or swollen lips, allergic reactions
impaired thyroid function, which can cause fatigue or weight gain
dehydration, low sodium levels in the blood (affects the elderly the most; symptoms may be dizzy, weak, confused, sleepy or very tired, nausea or vomiting, more severe symptoms are fainting, seizures or falls), the syndrome of insufficient secretion of antidiuretic hormone ( SIADH)
suicidal behavior, mania (overactivity, a flight of thought, and reduced need for sleep), hallucinations, aggression, and anger
“Serotonergic syndrome” (a rare reaction that can cause feelings of happiness, drowsiness, clumsiness, restlessness, feelings of intoxication, fever, sweating, or stiff muscles), seizures
increased pressure in the eye ( glaucoma )
cough, wheezing, and shortness of breath that may be accompanied by high body temperature
inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the colon (causes diarrhea)
liver problems, yellowing of the skin and whites of the eyes (jaundice)
Stevens-Johnson syndrome (a severe disease with blisters on the skin, mouth, eyes, and genitals), severe allergic reactions that cause swelling of the face and throat ( angioedema ).
cramps in the jaw muscles
abnormal odor on the urine
menopausal symptoms, abnormal production of breast milk in men and women
severe vaginal bleeding shortly after delivery ( postpartum haemorrhage )

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

inflammation of the blood vessels of the skin ( cutaneous vasculitis )

5. How to store Duloxetine Krka

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 after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is duloxetine. Each capsule contains 30 or 60 mg of duloxetine (as duloxetine hydrochloride).
Other ingredients are:
- Capsule contents: Sugar spheres (sucrose, maize starch), hypromellose 6 cp, sucrose, hypromellose phthalate, talc, and triethyl citrate.
- Capsule shell: Gelatin, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) – only in 60 mg capsules, ink (shellac, black iron oxide (E172)). See section 2 “Duloxetine Krka contains sucrose”

What the medicine looks like and contents of the pack

30 mg hard enteric capsule: White to off-white pellets in a size 3 hard gelatin capsule (mean length: 15.9 mm). The body of the capsule is white and the lid is dark blue. The body of the capsule is marked with “30” in black.

60 mg hard enteric capsule: White to off-white pellets in a size 1 hard gelatin capsule (medium length: 19.4 mm). The body of the capsule is yellowish green and the lid is dark blue. The body of the capsule is marked with “60” in black.

Duloxetine Krka is available in packs containing 7, 10, 14, 28, 30, 56, 60, 90, and 100 hard enteric capsules in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer