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The product code(s) for this leaflet is: PLGB 14895/0267.
Yentreve 20mg and 40mg hard gastro-resistant capsules
YENTREVE® 40 mg hard gastro-resistant capsules
YENTREVE® 20 mg hard gastro-resistant capsules
Duloxetine (as hydrochloride)
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
YENTREVE contains the active substance duloxetine. YENTREVE increases the levels of serotonin and noradrenaline in the nervous system.
YENTREVE is a medicine to be taken by mouth to treat Stress Urinary Incontinence (SUI) in women.
Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise.
YENTREVE is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities.
The efficacy of YENTREVE is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking YENTREVE.
The following are reasons why YENTREVE may not be suitable for you. Talk to your doctor before you take Yentreve if you:
YENTREVE may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
Medicines like Yentreve (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine. If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this if you:
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
YENTREVE should not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of YENTREVE in this age group have not yet been demonstrated.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions:
Using more than one of these medicines at the same time should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine.
Your doctor should decide whether you can take YENTREVE with other medicines. Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
You should also tell your doctor if you are taking any of the following:
Monoamine oxidase inhibitors (MAOIs): You should not take YENTREVE if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking a MAOI together with many prescription medicines, including YENTREVE, can cause serious or even life-threatening side effects. You must wait at least 14 days after you have stopped taking an MAOI before you can take YENTREVE. Also, you need to wait at least 5 days after you stop taking YENTREVE before you take a MAOI.
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and sedative antihistamines.
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John’s Wort and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with YENTREVE, you should see your doctor.
Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting. These medicines might increase the risk of bleeding.
YENTREVE may be taken with or without food. You should take extra care if you drink alcohol while taking YENTREVE.
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.
YENTREVE may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how YENTREVE affects you.
YENTREVE contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
YENTREVE is for oral use. You should swallow your capsule whole with a drink of water.
The recommended dose of YENTREVE is 40 mg twice a day (in the morning and late afternoon/evening). Your doctor may decide to start your treatment with 20 mg twice a day for two weeks before increasing the dose to 40 mg twice a day.
To help you remember to take YENTREVE, you may find it easier to take it at the same times every day.
Do not stop taking YENTREVE, or change your dose, without talking to your doctor. Treating your disorder properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and difficult to treat.
Call your doctor or pharmacist immediately if you take more than the amount of YENTREVE prescribed by your doctor. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.
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 a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of YENTREVE that has been prescribed for you in one day.
DO NOT stop taking your capsules without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need YENTREVE he or she will ask you to reduce your dose over 2 weeks.
Some patients, who suddenly stop taking YENTREVE after more than 1 week of therapy, have had symptoms such as:
These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate and often disappear after a short time.
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Store in the original package to protect from moisture. Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
The active substance is duloxetine.
Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose).
Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), red iron oxide and yellow iron oxide, edible black ink.
Edible ink: synthetic black iron oxide (E172), propylene glycol, shellac.
YENTREVE is a hard gastro-resistant capsule. Each capsule of YENTREVE contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
YENTREVE is available in 2 strengths: 20 and 40 mg.
The 40 mg capsules are orange and blue and are printed with ’40 mg’ and the code ‘9545’.
The 20 mg capsules are blue and are printed with ’20 mg’ and the code ‘9544’.
YENTREVE 40 mg is available in packs of 28, 56, 98, 140 and 196 (2 x 98) capsules.
YENTREVE 20 mg is available in packs of 28, 56 and 98 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2021.
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