Yentreve 20 mg, 40 mg hard gastro-resistant capsules

XPIL (Text-only Patient Information Leaflet)

Source: Yentreve_PIL_YEN030_Jun24_IE-NI.pdf

Note: This XPIL text version is intended for accessibility (screen readers / large print).

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Package leaflet: Information for the user

YENTREVE® 40 mg hard gastro-resistant capsules

YENTREVE® 20 mg hard gastro-resistant capsules

duloxetine (as hydrochloride)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What YENTREVE is and what it is used for

2. What you need to know before you take YENTREVE

3. How to take YENTREVE

4. Possible side effects

5. How to store YENTREVE

6. Contents of the pack and other information

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1. What YENTREVE is and what it is used for

YENTREVE contains the active substance duloxetine. YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.

YENTREVE is a medicine taken by mouth to treat Stress Urinary Incontinence (SUI) in women.

Stress urinary incontinence is a condition where urine leaks accidentally during exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.

YENTREVE is believed to work by strengthening the muscle that holds back urine during such activities.

The effectiveness of YENTREVE is improved when combined with Pelvic Floor Muscle Training (PFMT).

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2. What you need to know before you take YENTREVE

Do NOT take YENTREVE if you:

- are allergic to duloxetine or any of the other ingredients (see section 6)

- have liver disease

- have severe kidney disease

- are taking, or have taken within the last 14 days, monoamine oxidase inhibitors (MAOIs)

- are taking fluvoxamine (for depression), ciprofloxacin or enoxacin (for infections)

Talk to your doctor if you have high blood pressure or heart disease.

Warnings and precautions

Talk to your doctor before taking YENTREVE if you:

- take medicines for depression

- take St. John’s Wort

- have kidney disease

- have seizures or a history of seizures

- have mania or bipolar disorder

- have certain eye problems (glaucoma)

- have bleeding disorders, especially if pregnant

- are at risk of low sodium levels (e.g., using diuretics)

- take medicines that can damage the liver

- take other medicines containing duloxetine

Possible conditions:

- YENTREVE may cause restlessness or inability to sit still. Tell your doctor if this happens.

- YENTREVE may cause serotonin syndrome (restlessness, hallucinations, fast heartbeat, diarrhoea, nausea, coma). Severe cases resemble Neuroleptic Malignant Syndrome (NMS) with fever, sweating, stiffness, confusion.

- Medicines like YENTREVE (SSRIs/SNRIs) may cause sexual dysfunction, sometimes continuing after stopping treatment.

Thoughts of suicide and worsening depression/anxiety

Although YENTREVE is not indicated for depression, duloxetine is an antidepressant. Patients with depression or anxiety may have suicidal thoughts, especially under 25. Contact your doctor if you experience such thoughts.

Children and adolescents under 18 years

Do not use YENTREVE in this age group due to increased risk of side effects such as suicide attempt, suicidal thoughts, aggression, anger, and unknown long-term safety.

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3. Other medicines and YENTREVE

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

Duloxetine is used in other medicines (for depression, anxiety, neuropathic pain, incontinence). Avoid combining with these.

Do not start or stop any medicines without checking with your doctor.

Do not take YENTREVE if:

- you are taking or recently took (within 14 days) MAOIs. Wait 14 days after stopping an MAOI before starting YENTREVE, and wait 5 days after stopping YENTREVE before starting an MAOI.

Other medicines that may interact:

- Medicines causing sleepiness (benzodiazepines, strong painkillers, antipsychotics, phenobarbital, sedating antihistamines)

- Medicines increasing serotonin (triptans, tramadol, tryptophan, SSRIs, SNRIs, tricyclic antidepressants, pethidine, St John’s Wort, MAOIs)

- Blood thinners (anticoagulants, antiplatelets)

YENTREVE with food, drink and alcohol

- May be taken with or without food

- Use caution with alcohol

Pregnancy and breast-feeding

- Tell your doctor if you are pregnant, planning pregnancy, or breastfeeding

- Use only if benefits outweigh risks

- SSRIs in pregnancy may cause persistent pulmonary hypertension of the newborn (PPHN)

- Newborns may have symptoms if exposed near birth (floppy muscles, jitteriness, poor feeding, breathing issues, fits)

- May increase risk of excessive vaginal bleeding after birth

- May cause preterm birth if taken in second half of pregnancy

- Do not breastfeed while taking YENTREVE

Driving and using machines

- May cause sleepiness or dizziness. Do not drive or operate machines until you know how it affects you.

YENTREVE contains:

- Sucrose: tell your doctor if intolerant to sugars

- Sodium: less than 23 mg per capsule (sodium-free)

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4. How to take YENTREVE

Always take as prescribed. Swallow whole with water.

Recommended dose: 40 mg twice daily (morning and evening). Doctor may start with 20 mg twice daily for 2 weeks.

Take at the same times daily to help remember.

Do not stop or change dose without doctor’s advice.

If you take more YENTREVE than you should

- Contact your doctor immediately. Symptoms: sleepiness, coma, serotonin syndrome, fits, vomiting, fast heart rate.

If you forget a dose

- Take it when you remember unless near next dose. Do not double dose.

If you stop taking YENTREVE

- Do not stop suddenly. Doctor will reduce dose gradually over 2 weeks.

- Stopping suddenly may cause: dizziness, tingling, vivid dreams, fatigue, anxiety, nausea, vomiting, tremor, sweating, diarrhoea.

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5. Possible side effects

Like all medicines, this medicine can cause side effects.

Very common (≥1/10):

- Nausea, dry mouth, constipation

- Fatigue

Common (≤1/10):

- Loss of appetite

- Sleep problems, agitation, low sex drive, anxiety

- Headache, dizziness, sluggishness, tremor, tingling

- Blurred vision

- Vertigo

- High blood pressure, flushing

- Diarrhoea, stomach pain, vomiting, indigestion

- Sweating

- Weakness, shivering

Uncommon (≤1/100):

- Throat inflammation

- Allergic reactions

- Low thyroid activity

- Dehydration

- Teeth grinding, disorientation, lack of motivation, unusual dreams

- Nervousness, poor concentration, taste changes

- Eye problems, dry eyes

- Tinnitus, ear pain

- Palpitations, irregular heartbeat

- Fainting, yawning

- Vomiting blood, black stools, gastroenteritis, indigestion, burping, wind, bad breath

- Liver inflammation, yellow skin/eyes

- Rash, hives, bruising, sweating at night

- Muscle pain, spasms, jaw tightness

- Urinary issues

- Vaginal bleeding, menopausal symptoms

- Weight loss/gain

- Abnormal blood test results (liver enzymes, potassium, cholesterol)

Rare (≤1/1000):

- Serious allergic reaction

- Low sodium (especially elderly)

- Suicidal behaviour or thoughts, mania, hallucinations, aggression

- Serotonin syndrome

- Eye pressure (glaucoma)

- Dizziness or fainting on standing

- Nosebleeds, throat tightness

- Breathing problems with fever

- Blood in stools, colitis

- Liver failure, jaundice

- Stevens-Johnson syndrome, angioedema, sunlight sensitivity

- Muscle twitching

- Abnormal menstruation, postpartum haemorrhage

- Falls, abnormal gait

Very rare (≤1/10,000):

- Vasculitis (inflammation of blood vessels)

Not known:

- Stress cardiomyopathy (chest pain, shortness of breath, dizziness, irregular heartbeat)

Reporting side effects

Talk to your doctor or pharmacist. Report via:

- Ireland: HPRA Pharmacovigilance (www.hpra.ie)

- UK (NI): Yellow Card Scheme (www.mhra.gov.uk/yellowcard)

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6. How to store YENTREVE

- Keep out of sight and reach of children.

- Do not use after expiry date on carton.

- Store in original package to protect from moisture.

- Do not store above 30 °C.

- Do not dispose via wastewater or household waste. Ask pharmacist for disposal advice.

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7. Contents of the pack and other information

What YENTREVE contains

- Active substance: duloxetine hydrochloride (20 or 40 mg)

- Other ingredients:

 - Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate

 - Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide, yellow iron oxide, edible black ink

 - Ink: black iron oxide (E172), propylene glycol, shellac

What YENTREVE looks like

- Gastro-resistant capsules with duloxetine pellets

- 40 mg: orange and blue, printed “40 mg” and “9545”

- 20 mg: blue, printed “20 mg” and “9544”

Pack sizes

- 40 mg: 28, 56, 98, 140, 196

- 20 mg: 28, 56, 98

- Not all pack sizes marketed

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

Local contact

Ireland & UK (NI): Eli Lilly and Company (Ireland) Limited

Tel: +353 (0)1 661 4377

This leaflet was last revised in June 2024.

Other sources of information

Detailed information is available at: www.ema.europa.eu

Code: YEN030