20 mg and 40 mg hard enteric 
capsules duloxetine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Duloxetine STADA is and what it is used for 
2. What you need to know before you use Duloxetine STADA 
3. How to use Duloxetine STADA 
4. Possible side effects 
5. How to store Duloxetine STADA 6. Contents of the pack 
and other information 

1. What Duloxetine STADA is and what it is used for

Duloxetine Stada contains the active substance duloxetine. Duloxetine Stada increases the amount of serotonin and norepinephrine in the nervous system.

Duloxetine Stada is a medicine that is taken orally and is used to treat stress incontinence in women.

Exercise incontinence is a medical problem that causes urine leakage in connection with physical exertion or activities such as laughter, coughing, sneezing, heavy lifting, or exercise.

Duloxetine Stada is believed to work by strengthening the muscles that hold back urine when laughing, sneezing, or exercising.

The effect of Duloxetine Stada is enhanced when combined with an exercise program that strengthens the muscles in the pelvic floor.

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

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

Do not take Duloxetine STADA if you:

  • is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6).
  • have liver disease
  • have severe kidney disease
  • or has taken a medicine belonging to the group monoamine oxidase inhibitors ( MAOIs ) for the last 14 days (see “Other medicines and Duloxetine Stada”)
  • Take fluvoxamine which is commonly used to treat depression, ciprofloxacin or enoxacin which is used to treat certain infections.

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

Warnings and cautions

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

  • taking antidepressants (see “Other medicines and Duloxetine Stada”)
  • takes St. John’s wort, a 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
  • take other medicines that contain duloxetine (see “Other medicines and Duloxetine Stada”).

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

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

If you start to feel worse and have thoughts of harming yourself

Although Duloxetine Stada is not indicated for the treatment of depression, the active substance (duloxetine) is also used in antidepressants. 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 using 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 Stada should not be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking this type of drug. 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 STADA

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

The main ingredient of Duloxetine Stada, duloxetine, is also used in other medicines for other diseases:

  • 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 Stada 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 Stada should not be taken if you are taking or have been taking (for the past 14 days) an antidepressant called an MAOI. Examples ofMAO inhibitorsare moclobemide (an antidepressant drug) and linezolid (an antibiotic). Many of the prescription drugs, including Duloxetine Stada, can, if taken with an MAOI, cause serious or even life-threateningside effects. Before you can take Duloxetine Stada, at least 14 days must have passed since treatment with anMAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Stada before you can start taking an MAOI.

Drugs that can cause drowsiness: This includes prescription drugs such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

Drugs that increase serotonin levels: Triptans, tramadol, tryptophan, SSRIs (eg paroxetine and fluoxetine ), SNRIs (eg venlafaxine ), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John’s wort, and MAO inhibitors (eg moclobemide and linezolid). These drugs increase the risk of side effects. Contact your doctor if you experience unexpected symptoms while taking these medicines with Duloxetine Stada.

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

Duloxetine STADA with food, drink, and alcohol

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

Pregnancy and breastfeeding

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 Stada. You should only use Duloxetine Stada after consulting your doctor regarding the possible benefits of the treatment and any possible risks to the fetus.
  • Tell your midwife or doctor that you are using Duloxetine Stada. 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 Stada 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 are taking Duloxetine Stada at the end of your pregnancy, there is an increased risk of severe vaginal bleeding shortly after delivery, especially if you have a history of 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 Stada during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 STADA 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 STADA

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

Dosage

The recommended dose is a 40 mg capsule of Duloxetine Stada twice daily (in the morning and late afternoon/evening). However, your doctor may choose to start your treatment with a 20 mg capsule twice daily for two weeks and then increase the dose one to 40 mg twice daily.

Method of administration

Duloxetine Stada is taken orally. Swallow the capsule whole with a glass of water.

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

Do not stop taking Duloxetine Stada, or change the dose, without first discussing it 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 take more Duloxetine STADA then you should

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center immediately 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 take Duloxetine STADA

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 Stada per day than prescribed by your doctor.

If you stop taking Duloxetine STADA

DO NOT STOP taking Duloxetine Stada, even if you feel better, without talking to your doctor first. If your doctor thinks you no longer need Duloxetine Stada, he / she will reduce the dose one to two weeks.

Some patients who stop taking Duloxetine Stada abruptly after more than a week of treatment may experience symptoms such as:

  • dizziness, tingling of needles or sensations of electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, feeling of restlessness or anxiety, anxiety, nausea / vomiting, tremors, headache, muscle aches, 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. These are usually mild to moderate and usually disappear after a short time.

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

  • nausea, dry mouth , constipation
  • fatigue.

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

  • loss of appetite
  • difficulty falling asleep, feeling upset, decreased sexual desire, anxiety, difficulty sleeping
  • headache, dizziness, feeling sluggish, feeling drowsy, tremors and numbness, which include numbness or tingling in the skin
  • imsyn
  • vertigo ( vertigo )
  • high blood pressure , redness
  • diarrhea, stomach pain, nausea (vomiting), heartburn or indigestion
  • increased sweating
  • weakness, chills.

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

  • pharyngitis causing hoarse voice
  • allergic reactions
  • impaired thyroid function, which can cause fatigue or weight gain
  • dehydration
  • gnashing of teeth, feeling disoriented, lack of motivation, difficulty getting or not having an orgasm, strange dreams
  • feeling nervous, difficulty concentrating, taste changes, poor sleep
  • large pupil er (the dark field in the middle of the eye), visual disturbances, the eyes feel dry
  • tinnitus (sensation of sound in the ear without external sound source), pain in the ears
  • palpitations, rapid and / or irregular heartbeat
  • fainting
  • yawning
  • bloody vomiting or black tarry stools, gastrointestinal inflammation, inflammationof the mouth, belching, difficulty swallowing, flatulence, bad breath
  • inflammation of the liver that can cause abdominal pain and yellowing of the skin and whites of the eyes
  • (itchy) rash, night sweats, hives, cold sweats, increased tendency to bruise
  • muscle pain, muscle tension, muscle twitching, cramping in the jaw muscles
  • difficulty urinating, painful urination, need to empty the bladder during the night, frequent bladder emptying, abnormal odor on the urine
  • abnormal vaginal bleeding, menopausal symptoms
  • chest pain, feeling cold, thirsty, feeling hot
  • weight loss, weight gain
  • Duloxetine can cause effects that you do not notice, such as an increase in liver enzymes or the level of potassium , creatine phosphokinase, sugar or cholesterolin 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
  • low sodium levels in the blood (mostly affects the elderly); the symptoms may be feeling dizzy, weak, confused, sleepy or very tired, nausea or vomiting, more serious symptoms are fainting, seizures or falls, insufficient secretion of antidiuretic hormone (SIADH)
  • suicidal behavior, suicidal ideation, mania (overactivity, thoughtlessness and decreased need for sleep), feelings of aggression and anger
  • “Serotonergic syndrome” (a rare reaction that may cause feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or stiff muscles), seizures, sudden involuntary twitching or twitching of the muscles, a feeling of restlessness and difficulty sitting or stand still, difficulty controlling movements e.g. lack of coordination or involuntary movements in the muscles, restless legs (numbness and tingling sensation in the legs)
  • increased pressure in the eye ( glaucoma )
  • fainting and dizziness when getting up, cold fingers and / or toes
  • feel thick in the throat, nosebleeds
  • bright red blood in the stool, inflammation of the colon (causes diarrhea)
  • liver problems, yellowing of the skin and whites of the eyes (jaundice)
  • Stevens-Johnson syndrome (severe disease with blisters on the skin, mouth, eyes and genitals), severe allergic reactions that cause swelling of the face and throat ( angioedema ), sensitivity to sunlight
  • muscle twitching
  • difficulty or inability to urinate, need to empty bladder more often than usual, decreased urine flow
  • abnormal menstruation, including heavy, painful, irregular or prolonged menstruation, unusually short or absent menstruation, abnormal production of breast milk
  • severe vaginal bleeding shortly after delivery ( postpartum haemorrhage )
  • fall accidents (mostly in the elderly), abnormal gait
  • cough, wheezing and shortness of breath that may be accompanied by high body temperature.

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

  • inflammation of the blood vessels in the skin ( cutaneous vasculitis ).

5. How to store Duloxetine STADA

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

This medicine does not require any special temperature storage instructions. 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 20 mg of duloxetine (as hydrochloride).

Each capsule contains 40 mg of duloxetine (as hydrochloride).

Other ingredients are:

Capsule contents: hypromellose, hypromellose acetate succinate , sucrose, sugar spheres (sucrose, maize starch), talc, titanium dioxide (E171), hydroxypropylcellulose

Capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172) ( only 40 mg capsule )

What the medicine looks like and contents of the pack

Duloxetine Stada is a hard, gastric juice-resistant capsule. Each capsule contains fine grains of duloxetine hydrochloride with a coating that resists the acidic gastric juice.

Duloxetine Stada is available in 2 strengths:

20 mg enteric capsules have a blue body and a blue cap, filled with off-white enteropellets.

40 mg enteric capsules have an orange body and a blue cap, filled with off-white enteropellets.

The capsules for all strengths are supplied in PVC / PCTFE / PVC / Al blister.

Pack sizes

20 mg: Packs of 28, 56 and 98 capsules.

40 mg: Packs of 28, 56, 98 and 140 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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