YENTREVE – Duloxetine uses, dose and side effects


20 mg/40 mg gastro-resistant capsules, hard Duloxetine (as hydrochloride)

What YENTREVE is and what it is used for

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

YENTREVE is a medicine to be taken by mouth and is used to treat stress incontinence in women.

Stress incontinence is a medical problem that causes you to leak urine during physical exertion or activities such as laughing, coughing, sneezing, heavy lifting, or exercise.

YENTREVE is thought to work by strengthening the muscles that hold back urine when you laugh, sneeze or exercise.

The effect of YENTREVE is enhanced when it is combined with an exercise program that strengthens the pelvic floor muscles.

What you need to know before you take YENTREVE

Do not use YENTREVE


  • are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
  • have liver disease
  • have severe kidney disease
  • are taking or in the last 14 days have taken a medicine that belongs to the group of monoamine oxidase inhibitors ( MAO inhibitors ) (see “Other medicines and YENTREVE”)
  • are taking 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 YENTREVE.

Warnings and precautions

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

  • taking medicines for depression (see “Other medicines and YENTREVE”)
  • taking St. John’s wort, a natural remedy ( Hypericum perforatum )
  • have kidney disease
  • have had convulsions (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 bruise), especially if you are pregnant (see “Pregnancy and breast-feeding”)
  • are at risk of low sodium levels (for example, if you take diuretics, especially if you are older)
  • at the same time being treated with another drug that can cause liver damage
  • are taking other medicines containing duloxetine (see “Other medicines and YENTREVE”).

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

Medicines such as Cymbalta (so-called SSRIs /SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

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

Although YENTREVE is not intended for the treatment of depression, the active substance (duloxetine) is also used in medicines against depression. 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 anti-depressant drugs, as it takes time for drugs of this type 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 antidepressants have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor or the nearest hospital immediately if you have thoughts of harming yourself or committing suicide.

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

Children and young people under the age of 18

YENTREVE 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 the age of 18 when taking medicines of this type. Furthermore, the long-term effects on growth, maturation, and development of intellect and behavior have not yet been established for this age group.

Other medicines and YENTREVE

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. The main ingredient in YENTREVE, duloxetine, is also used in other medicines for other diseases

  • painful diabetic neuropathy, depression, anxiety, and urinary leakage

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 containing duloxetine.

Your doctor will decide whether you can take YENTREVE together with other medicines. Check with your doctor before you start or stop taking any medicines, including over-the-counter medicines and natural remedies.

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

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

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

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

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

YENTREVE with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

  • Tell your doctor if you become pregnant or plan to become pregnant while taking YENTREVE. You should only use YENTREVE after consulting your doctor about the possible benefits of the treatment and possible risks to the fetus.
  • Tell your midwife or doctor that you are using YENTREVE. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a severe condition called persistent pulmonary hypertension of the newborn (PPHN) may increase. This condition causes the child to breathe faster and appear bluish. The symptoms usually appear within 24 hours of the baby being born. If this affects your child, contact your midwife or doctor immediately.
  • If you take YENTREVE at the end of pregnancy, your baby may have some symptoms after birth. These symptoms usually appear at the time of delivery or within a few days after your baby is born. Symptoms can include weak muscles, tremors, tremors, feeding difficulties, 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 YENTREVE 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 be told that you are taking duloxetine so that they can advise you.
  • Available data from the use of YENTREVE during the first three months of pregnancy do not show an overall increased risk of birth defects in the baby. If YENTREVE is taken during the second half of pregnancy, there may be an increased risk of the baby being born early (6 extra premature babies per 100 women taking YENTREVE during the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.
  • Tell your doctor if you are breastfeeding. Use of YENTREVE during breastfeeding is not recommended. Consult your doctor or pharmacist.

Driving ability and use of machinery

YENTREVE may make you feel sleepy or dizzy. Do not drive or use tools or machines until you know how YENTREVE affects you.

YENTREVE contains sucrose

YENTREVE contains sucrose . If you have an intolerance to some sugars, consult your doctor before using this medicine.

YENTREVE contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.

How to take YENTREVE

Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

YENTREVE is taken by mouth. Swallow the capsule whole with a glass of water.

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

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

Do not stop taking YENTREVE, 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 serious and difficult to treat.

If you take more YENTREVE than you should

If you have taken more YENTREVE than your doctor prescribed, contact your doctor or pharmacist immediately. Symptoms of overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause intense feelings of happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating, or stiff muscles), seizures, vomiting, and rapid heartbeat.

If you forget to take YENTREVE

If you have forgotten 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 double doses to make up for missed doses. Do not take more YENTREVE per day than prescribed by your doctor.

If you stop taking YENTREVE

DO NOT STOP taking YENTREVE, even if you feel better, without first talking to your doctor. If your doctor thinks you no longer need YENTREVE, she/he will reduce the dose once every two weeks. Some patients, who after longer than one week of treatment abruptly stop taking YENTREVE, may experience symptoms such as:

  • dizziness, pins, and needles or electric shock sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), tiredness, sleepiness, feeling restless or restless, anxiety, nausea/vomiting, tremors, headache, muscle pain, irritability, diarrhea, heavy sweating or dizziness. These symptoms are usually mild and disappear within a few days. Consult your doctor if the reactions are bothersome.

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

Possible side effects

Like all medicines, this medicine can cause side effects. 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 user in 10)

  • loss of appetite
  • difficulty falling asleep, feeling agitated, decreased sex drive, anxiety, poor sleep
  • headache, dizziness, feeling sluggish, feeling sleepy, tremors, and numbness, which includes numbness or tingling of the skin
  • blurred vision
  • dizziness
  • increased blood pressure, flushing
  • diarrhea, stomach ache, nausea, and vomiting, heartburn, or indigestion
  • increased sweating
  • powerlessness, frostbite.

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

  • inflammation of the throat that causes a hoarse voice
  • allergic reactions
  • reduced thyroid function, which can cause fatigue or weight gain
  • dehydration
  • teeth grinding, feeling disoriented, lack of motivation, difficulty or lack of orgasm, strange dreams
  • feeling nervous, difficulty concentrating, taste changes, poor sleep
  • large pupils (the dark field in the middle of the eye), visual disturbances, the eyes feeling dry
  • tinnitus (sensation of sound in the ear without an external sound source), pain in the ears
  • palpitations, fast and/or irregular heartbeats
  • fainting
  • yawns
  • vomiting blood or black tarry stools, inflammation of the gastrointestinal tract, inflammation of the mouth, belching, difficulty swallowing, tension, bad breath
  • inflammation of the liver which can cause pain in the abdomen 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, jaw muscle spasm
  • difficulty starting to urinate, painful urination, need to empty the bladder during the night, frequent bladder emptying, the unusual smell of urine
  • abnormal vaginal bleeding, menopause symptoms
  • chest pain, feeling cold, thirsty, feeling hot
  • weight loss, weight gain
  • Center may cause effects that you do not notice, such as increases in liver enzymes or levels of potassium, creatine phosphokinase, sugar, or cholesterol in the blood.

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

  • severe allergic reactions causing difficulty breathing or dizziness, with swollen tongue or swollen lips
  • the low sodium level in the blood (mostly affects the elderly); symptoms may include 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 thoughts, mania (overactivity, flight of mind, and reduced need for sleep), feelings of aggression and anger
  • “serotonergic syndrome” (a rare reaction that may cause euphoria, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or stiff muscles), fits, sudden involuntary jerks or twitches in the muscles, a feeling of restlessness and difficulty sitting or standing 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 )
  • Coughing, wheezing, and shortness of breath which may be accompanied by a high body temperature
  • fainting and dizziness when standing up, cold fingers and/or toes
  • feeling 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 (a severe disease with blistering of the skin, mouth, eyes, and genitals), severe allergic reactions causing swelling of the face and throat ( angioedema ), sensitivity to sunlight
  • muscle twitching
  • difficulty or inability to pass water, need to empty the bladder more often than usual, decreased urine flow
  • abnormal periods, including heavy, painful, irregular or prolonged periods, unusually short or absent periods, abnormal production of breast milk
  • heavy vaginal bleeding shortly after childbirth ( postpartum hemorrhage)
  • falls (mostly in the elderly), abnormal gait.

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

  • Inflammation in the blood vessels of the skin ( cutaneous vasculitis)

How to store YENTREVE

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the carton.

Store in the original packaging. Store at a maximum of 30°C. Moisture sensitive.

Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Packaging contents and other information

Contents declaration

The active substance is duloxetine. One capsule contains 20 or 40 mg of duloxetine (as duloxetine hydrochloride).

Other ingredients:

Capsule contents: Hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate.

(see the end of section 2 for more information on sucrose)

Capsule shell: Gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide (E172), yellow iron oxide (E172), and black food coloring.

Food coloring: Synthetic, black iron oxide (E172), propylene glycol, shellac.

Appearance and package sizes of the medicine

YENTREVE is a hard, enteric-resistant capsule.

Each capsule contains fine grains of duloxetine hydrochloride with a coating that resists the acidic gastric juice.

YENTREVE is provided in 2 strengths: 20 and 40 mg.

Orange and blue capsules, marked “40 mg” and “9545”.

Blue capsule, marked “20 mg” and “9544”.

YENTREVE 40 mg is supplied in packs of 28, 56, 98, 140, or 196 (2×98) capsules.

YENTREVE 20 mg is supplied in packs of 28, 56, or 98 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing Authorization Holder: Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.

Manufacturer: Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

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