What is Yentreve used for?

• Moderate to severe stress urinary incontinence (SUI) in women.
• Duloxetine has been shown to reduce the frequency of episodes of leakage. It may be more effective if combined with a pelvic floor muscle re-training programme, and you should discuss this with your doctor. Duloxetine has not been shown to benefit mild SUI (less than 14 episodes of leakage per week).

How does Yentreve work?

• Yentreve capsules contain the active ingredient duloxetine hydrochloride, which is a type of medicine called a combined serotonin and noradrenaline reuptake inhibitor.
• Duloxetine is used to treat stress urinary incontinence (SUI) in women. SUI is the accidental leakage of urine when pressure in the bladder is increased suddenly, for example by coughing, sneezing, laughing, lifting or exercise.
• The urethral sphincter is the muscle at the exit to the bladder that holds back urine. We normally relax it voluntarily when we want to urinate. However, there are various factors, for example pregnancy, childbirth and obesity, that can weaken the tone of the urethral sphincter, allowing it to leak out urine involuntarily when the pressure in the bladder increases.
• Duloxetine is thought to work by increasing the tone of the urethral sphincter. It does this by its action on serotonin and noradrenaline in the spinal cord.
• Serotonin and noradrenaline are compounds called neurotransmitters. They are stored in nerve cells and are involved in transmitting messages between the nerve cells. Neurotransmitters are released from nerve cells as a message is transmitted. Once the message has been transmitted, the nerve cells then reabsorb the neurotransmitter.
• Duloxetine prevents serotonin and noradrenaline from being reabsorbed back into nerve cells in the spinal cord. This enhances the nerve messages that are sent to the urethral sphincter. These messages increase the tone of the urethral sphincter during the time that urine is being stored in the bladder. This makes it less likely to open slightly under stress such as coughing and allow urine to leak out. The sphincter can still be relaxed voluntarily when you want to pass urine.

How do I take Yentreve?

Your doctor may ask you to start treatment by taking one 20mg capsule twice a day. Your dose will then be increased after a couple of weeks. The usual dose is one 40mg capsule taken twice a day, morning and evening. Try and take your capsules at the same times each day.

The capsules should be swallowed whole with a drink. They can be taken either with or without food.

If you forget to take a dose at your usual time, take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the missed dose and take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.

You should continue taking this medicine twice every day until your doctor tells you to stop. When you stop treatment this should be done gradually over two weeks, following the instructions given by your doctor.

Important information about Yentreve

• Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance. This medicine may make you feel sleepy or dizzy and so may reduce your ability to drive or operate hazardous machinery safely. If you do experience drowsiness this may be made worse by alcohol.
• This medicine may cause a drop in blood pressure when moving from a lying or sitting position to sitting or standing, which may cause dizziness, light-headedness or fainting, particularly when you first start treatment. For this reason you should take care when moving from lying down to sitting or standing, particularly if you wake up in the night, until you know how this medicine affects you. If you feel dizzy or light-headed at any time during treatment, sit or lie down until the symptoms pass.
• This medicine can cause some people's blood pressure to increase. It is recommended that that your blood pressure is monitored while you are taking this medicine if you suffer from heart disease or high blood pressure, especially during the first month of treatment.

Although this medicine is not used to treat depression, the active ingredient (duloxetine) also exists as an antidepressant, called Cymbalta. As with other antidepressant medicines, there have been isolated cases of people experiencing suicidal thoughts during or shortly after stopping treatment with duloxetine. For this reason, you should let your doctor know if you have any distressing thoughts or feelings, including depressive feelings or agitation, at any time while taking this medicine or after stopping treatment.

Medicines of this type have been associated with the development of unpleasant or distressing restlessness and the need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. If you experience these symptoms you should consult your doctor.

Yentreve should be used with caution by

• Elderly people.
• Women with decreased kidney function.
• Women with bipolar affective disorder (manic depression).
• Women with a history of mania.
• Women with a history of seizures, eg epilepsy.
• Women with raised pressure in the eyeball, eg glaucoma or a risk of developing glaucoma.
• Women with high blood pressure.
• Women with heart disease.
• Women with bleeding tendencies.
• Women taking medicines to reduce blood clotting.

Yentreve should not be used by

• Children and adolescents under 18 years of age.
• Women with liver disease resulting in decreased liver function.
• Women with severely decreased kidney function.
• Women with uncontrolled high blood pressure.
• Women who have taken a monoamine oxidase inhibitor (MAOI) antidepressant medicine in the last 14 days.
• Women taking the medicines fluvoxamine, ciprofloxacin or enoxacin.
• Women with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (Yentreve capsules contain sucrose).
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• It should not be used during pregnancy unless considered essential by your doctor and only if the expected benefits outweigh any potential risks to the developing baby.
• This medicine passes into breast milk in small amounts, so this medicine is not recommended for women who are breastfeeding. 

Side effects of Yentreve

• Feeling sick.
• Constipation.
• Dry mouth.
• Fatigue.
• Headache.
• Dizziness or spinning sensation.
• Feeling sleepy, weak or lethargic.
• Blurred vision.
• Tremor.
• Pins and needles sensations.
• Decreased appetite.
• Disturbances of the gut such as diarrhoea, abdominal pain, vomiting or indigestion.
• Difficulty sleeping (insomnia).
• Anxiety, agitation.

How can Yentreve affect other medicines?

The following medicines may increase the blood level of duloxetine and so should not be taken in combination with this medicine:

• ciprofloxacin
• enoxacin
• fluvoxamine.

Yentreve must not be taken at the same time as, or within 14 days of taking a monoamine oxidase inhibitor, for example the MAOI antidepressants phenelzine, tranylcypromine or isocarboxacid and the antibiotic linezolid. In addition, this type of medicine should not be started until at least five days after stopping Yentreve.

This medicine should not be used at the same time as a medicine called Cymbalta, which also contains duloxetine, but is used for depression.

There may be an increased risk of a rare side effect called the serotonin syndrome if Yentreve is taken with any of the following medicines, which also enhance the activity of serotonin in the central nervous system. These medicines are not recommended for use in combination with Yentreve:

• dapoxetine
• fentanyl
• pethidine
• SSRI antidepressants, eg fluoxetine, paroxetine
• tricyclic antidepressants such as clomipramine or amitriptyline
• tramadol
• triptans for migraine, eg sumatriptan
• tryptophan
• venlafaxine.

The use of Yentreve in combination with antidepressant medicines, particularly any of those those mentioned above, is not recommended. If your doctor wants you to start taking an antidepressant, it is recommended that Yentreve is stopped gradually first.

There may be an increased risk of drowsiness or sedation if this medicine is taken with any of the following medicines (which can also cause drowsiness):

• antipsychotics, eg haloperidol
• barbiturates, eg phenobarbital
• benzodiazepines, eg diazepam, lorazepam
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• strong opioid painkillers, eg morphine, codeine
• sleeping tablets, eg zopiclone.

There may be an increased risk of bleeding if duloxetine is taken by people who are taking any of the following medicines, which are known to affect the ability of the blood to clot:

• anticoagulants (to prevent and treat blood clots) such as warfarin or dabigatran
• antiplatelet medicines (to "thin the blood") such as aspirin, dipyridamole or clopidogrel
• non-steroidal anti-inflammatory drugs (NSAIDs) eg ibuprofen, diclofenac, naproxen.
• There may be an increased risk of side effects on the liver if this medicine is taken in combination with medicines that can affect the liver.

Duloxetine may increase the blood levels of the following medicines:

• flecainide
• metoprolol
• propafenone
• risperidone
• tricyclic antidepressants such as nortriptyline, amitriptyline or imipramine.

References:

https://www.gov.uk/drug-safety-update/duloxetine-marketed-as-cymbalta-and-yentreve-for-different-disorders

https://www.netdoctor.co.uk/medicines/liver-kidney-urinary-system/a8597/yentreve-duloxetine/

https://www.medicines.org.uk/emc/product/5561/smpc

https://www.drugs.com/uk/yentreve.html

https://www.ema.europa.eu/en/documents/product-information/yentreve-epar-product-information_en.pdf

https://www.medicines.ie/medicines/yentreve-34277/patient-info