Duloxetine 40 Mg Gastro-Resistant Capsules
Package leaflet: information for the user
Duloxetine 40mg gastro-resistant capsules, hard
Duloxetine 20mg gastro-resistant capsules, hard
duloxetine
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 of the 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 Duloxetine Capsules are and what they are used for
2. What you need to know before you take Duloxetine Capsules
3. How to take Duloxetine Capsules
4. Possible side effects
5. How to store Duloxetine Capsules
6. Contents of the pack and other information
1. What Duloxetine Capsules are and what they are used for
Duloxetine Capsules contain the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system.
Duloxetine Capsules 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.
Duloxetine 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 Duloxetine Capsules is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
2. What you need to know before you take Duloxetine Capsules
DO NOT take Duloxetine Capsules if you:
- 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 have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see 'Other medicines and Duloxetine Capsules')
- are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking duloxetine.
Warnings and Precautions
The following are reasons why duloxetine may not be suitable for you. Talk to your doctor before you take Duloxetine Capsules if you:
- are taking medicines to treat depression (see 'Other medicines and Duloxetine Capsules)
- are taking St. John's Wort, a herbal treatment (Hypericum perforatum)
- have kidney disease
- have had seizures (fits)
- have had mania
- suffer from bipolar disorder
- have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
- have a history of bleeding disorders (tendency to develop bruises)
- are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly)
- are currently being treated with another medicine which may cause liver damage
- are taking other medicines containing duloxetine (see 'Other medicines and Duloxetine Capsules')
Duloxetine Capsules may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
Thoughts of suicide and worsening of depression or anxiety disorder
Although Duloxetine Capsules 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:
- have previously had thoughts about killing or harming yourself
- are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
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.
Children and adolescents under 18 years of age
Duloxetine Capsules 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 duloxetine in this age group have not yet been demonstrated.
Other medicines and Duloxetine Capsules
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The main ingredient of Duloxetine Capsules, duloxetine, is used in other medicines for other conditions:
• diabetic neuropathic pain, depression, anxiety and urinary incontinence
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 Duloxetine Capsules 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 Duloxetine Capsules 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 duloxetine, 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 Duloxetine Capsules. Also, you need to wait at least 5 days after you stop taking Duloxetine Capsules 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 duloxetine, 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.
Duloxetine Capsules with food, drink and alcohol
Duloxetine Capsules may be taken with or without food. You should take extra care if you drink alcohol while taking Duloxetine Capsules.
Pregnancy and breast-feeding
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 you are trying to become pregnant, while you are taking Duloxetine Capsules. You should use duloxetine only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Duloxetine Capsules. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you take Duloxetine Capsules near the end of your pregnancy, your baby might have some symptoms when it is born. These usually begin at birth or within a few days of your baby being born. These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits. If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
• Tell your doctor if you are breast-feeding. The use of Duloxetine Capsules while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.
Driving and using machines
Duloxetine Capsules may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine Capsules affects you.
Duloxetine Capsules contains sucrose
Duloxetine Capsules 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.
3. How to take Duloxetine Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Duloxetine Capsules is for oral use. You should swallow your capsule whole with a drink of water. Do not crush or chew.
The recommended dose of Duloxetine Capsules is 40mg twice a day (in the morning and late afternoon/evening). Your doctor may decide to start your treatment with 20mg twice a day for two weeks before increasing the dose to 40mg twice a day.
To help you remember to take Duloxetine Capsules, you may find it easier to take it at the same times every day.
Do not stop taking Duloxetine Capsules, 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.
If you take more Duloxetine Capsules than you should
Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Capsules 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.
Duloxetine 20mg gastro-resistant capsules, hard
PL 29831/0649
Duloxetine 40mg gastro-resistant capsules, hard
PL 29831/0651
Duloxetine 20mg gastro-resistant capsules, hard
PL 29831/0649
Duloxetine 40mg gastro-resistant capsules, hard
PL 29831/0651
Duloxetine 20mg gastro-resistant capsules, hard
PA1339/61/1
Duloxetine 40mg gastro-resistant capsules, hard
PA1339/61/3
107500/1
If you forget to take Duloxetine Capsules
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 Duloxetine Capsules that has been prescribed for you in one day.
If you stop taking Duloxetine Capsules
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 Duloxetine Capsules he or she will ask you to reduce your dose over 2 weeks.
Some patients, who suddenly stop taking Duloxetine Capsules after more than 1 week of therapy, have had symptoms such as:
• dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.
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.
4. Possible side effects
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.
If you suffer from any of the following at any time during your treatment stop taking the medicine and seek immediate medical help:
• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or lips
• low levels of sodium in the blood (mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls), syndrome of inappropriate secretion of anti-diuretic hormone (SIADH)
• suicidal behaviour, suicidal thoughts
• "Serotonin syndrome" (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling of the face or throat (angioedema)
• vomiting blood, or black tarry stools (faeces)
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
Very common side effects (may affect more than 1 in 10 people)
• feeling sick (nausea), dry mouth, constipation
• fatigue
Common side effects (may affect up to 1 in 10 people)
lack of appetite
trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty sleeping headache, dizziness, feeling sluggish, feeling sleepy, tremor, numbness, including numbness, pricking or tingling of the skin blurred eyesight
feeling of dizziness or "spinning" (vertigo) increased blood pressure, flushing diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion increased sweating weakness, shivering
Uncommon side effects (may affect up to 1 in 100 people)
throat inflammation that causes a hoarse voice
allergic reactions
decreased thyroid gland activity which can cause tiredness or weight gain dehydration
grinding or clenching the teeth, feeling disorientated, lack of motivation, difficulty or failure to experience orgasm, unusual dreams
• feeling nervous, difficulty concentrating, changes in sense of taste, poor sleep quality
• large pupils (the dark centre of the eye), problems with eyesight, eyes feel dry
• tinnitus (hearing sound in the ear when there is no external sound), ear pain
• feeling the heart pumping in the chest, fast and/or irregular heart beat
• fainting
• increased yawning
• gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, breaking wind, bad breath
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes
• (itchy) rash, night sweats, hives, cold sweats, increased tendency to bruise
• muscle pain, muscle tightness, muscle spasm, contraction of the jaw muscle
• difficulty to start urinating, painful urination needing to pass urine during the night, frequent urination, abnormal urine odour
• abnormal vaginal bleeding, menopausal symptoms
• chest pain, feeling cold, thirst, feeling hot
• weight loss, weight gain
• Duloxetine Capsules may cause effects that you may not be aware of, such as increases in liver enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol
Rare side effects (may affect up to 1 in 1000 people)
• mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
• fits, sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome
• increased pressure in the eye (glaucoma)
• dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
• throat tightness, nose bleeds
• passing bright red blood in your stools, inflammation of the large intestine (leading to diarrhoea)
• sensitivity to sunlight
• muscle twitching
• difficulty or inability to pass urine, needing to pass more urine than normal, having a decreased urine flow
• abnormal periods, including heavy, painful,
irregular or prolonged periods, unusually light or missed periods, abnormal production of breast milk
• falls (mostly in elderly people), abnormal gait
Very rare side effects (may affect up to 1 in 10,000 people)
• inflammation of the blood vessels in the skin (cutaneous vasculitis)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;
Fax: +353 1 6762517; Website: www.hpra.ie; email: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Duloxetine Capsules
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 and blister.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Duloxetine Capsules contain
The active substance is duloxetine.
Each capsule contains 20mg or 40mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: sugar spheres (containing maize starch and sucrose), hypromellose 2910 (E464), crospovidone (type B), talc, sucrose, carboxy methyl ethyl cellulose, povidone, titanium dioxide (E171), Macrogol (E1521), Polysorbate 80 (E433) (See end of section 2 for further information on sucrose). Capsule shell (for 20mg strength): gelatin, titanium dioxide (E171), sodium laurilsulfate, iron oxide yellow (E172), indigo carmine (E132). Capsule shell (for 40mg strength): gelatin, titanium dioxide (E171), sodium laurilsulfate, indigo carmine (E132), iron oxide yellow (E172), iron oxide red (E172).
Edible black ink (for 20mg and 40mg strengths): shellac (E904), propylene glycol, black iron oxide (E172), potassium hydroxide.
What Duloxetine Capsules looks like and contents of the pack
Duloxetine Capsules is a gastro-resistant capsule, hard. Each capsule of Duloxetine Capsules contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
Duloxetine Capsules is available in 20mg and 40mg strengths.
The 20mg capsules are opaque green cap and opaque green body size "4" (14.40 ± 0.40 mm), imprinted with "H" on cap and "190" on body, filled with white to off white coloured pellets.
The 40mg capsules are opaque blue cap and opaque orange body size "2" (17.80 ± 0.40 mm), imprinted with "H" on cap and "D3" on body, filled with white to off white coloured pellets.
Duloxetine Capsules is available in:
20mg: blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 and 500 capsules.
40mg: blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, 100 and 500 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK
Manufacturer
CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information:
This is a service provided by the Royal National Institute of Blind People.
For patients in the Republic of Ireland please call +44 1978 661261.
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom
Republic of Ireland
This leaflet was last revised in 07/2016.
Detailed information on this medicine is available on the website of MHRA, UK or HPRA, Republic of Ireland.