Dutor 40 Mg Gastro-Resistant Capsules Hard
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dutor 20 mg gastro-resistant capsules, hard Dutor 40 mg 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Dutoris and what it is used for
2. What you need to know before you take Dutor
3. How to take Dutor
4. Possible side effects
5. How to store Dutor
6. Contents of the pack and other information
1. WHAT DUTOR IS AND WHAT IT IS USED FOR
Dutor contains the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system.
Dutor is a medicine 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.
Dutor 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 Dutor is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUTOR Do not take Dutor 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 Dutor’).
• 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 Dutor.
Warnings and precautions
The following are reasons why Dutor may not be suitable for you. Talk to your doctor before you take Dutor if you:
• are taking medicines to treat depression (see ‘Other medicines and Dutor’).
• 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.
The active substance of Dutor, 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.
Dutor 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 Dutor is not indicated for the treatment of depression, its active substance (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
Dutor should normally 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 Dutor in this age group have not yet been demonstrated.
Other medicines and Dutor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Your doctor should decide whether you can take Dutor 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 Dutor 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 Dutor, 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 Dutor. Also, you need to wait at least 5 days after you stop taking Dutor 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 Dutor, you should see your doctor.
Oral anticoagulants or antiplatelet medicines:
Medicines which thin the blood or prevent the blood from clotting. These medicines might increase the risk of bleeding.
Dutor with food, drink and alcohol
Care should be taken if you drink alcohol while you are being treated with Dutor.
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 Dutor. You should use Dutor 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 Dutor. When taken during pregnancy, similar medicines (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 Dutor 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 Dutor while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.
Driving and using machines
Dutor may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Dutor affects you.
Dutor contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE DUTOR
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Dutor 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.
Dutor is for oral use. You should swallow your capsule whole with a drink of water. Dutor may be taken with or without food.
To help you remember to take Dutor, you may find it easier to take it at the same times every day.
Do not stop taking Dutor, 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 Dutor than you should
Call your doctor or pharmacist immediately if you take more than the amount of Dutor 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 forget to take Dutor
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 Dutor that has been prescribed for you in one day.
If you stop taking Dutor
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 Dutor he or she will ask you to reduce your dose over 2 weeks.
Some patients who suddenly stop taking Dutor 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 any 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.
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, including 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
• vomiting blood, or black tarry stools (faeces), gastroenteritis, inflammation of the mouth, burping, difficulty swallowing, 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
• Dutor 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 1,000 people)
• 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, mania (over activity, racing thoughts and decreased need for sleep), hallucinations, aggression and anger
• “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, 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
• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• 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), 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
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DUTOR
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/bottle pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Shelf life after first opening of the HDPE bottle:
28’s container: 30 days
98’s and 100’s container: 100 days
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dutor contains
The active substance is duloxetine.
Dutor20 mg:
Each gastro-resistant capsule, hard contains 20 mg of duloxetine (as hydrochloride).
Dutor40 mg:
Each gastro-resistant capsule, hard contains 40 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: Hypromellose 2910, hypromellose acetate succinate, sucrose, sugar spheres (consisting of sucrose, maize starch, (liquid) glucose, purified water), talc, titanium dioxide (E 171), triethyl citrate, macrogol 400
Dutor20 mg:
Capsule shell: gelatine, sodium lauryl sulphate, titanium dioxide (E 171), indigo carmine (E 132) Dutor40 mg:
Capsule shell: gelatine, sodium lauryl sulphate, titanium dioxide (E 171), Indigo carmine (E 132), iron oxide yellow (E 172), iron oxide red (E 172)
Printing ink: shellac, black iron oxide (E 172), potassium hydroxide
What Dutor looks like and contents of the pack
Dutor is a gastro-resistant capsule, hard. Each capsule of Dutor contains pellets of duloxetine with a covering to protect them from stomach acid.
Dutor20 mg: Size ‘4’ hard gelatin capsule having light blue cap and body, imprinted with ’20 mg’ on the body and ‘1109’ on the cap with black ink, containing off white to reddish brown coloured pellets.
Dutor40 mg: Size ‘2’ hard gelatin capsule having light blue cap and orange body, imprinted with ’40 mg’ on the body and ‘1112’ on the cap with black ink, containing off white to reddish brown coloured pellets.
Pack sizes:
Dutor20 mg is available in blister packs of 7, 28, 56, 98 capsules.
Dutor40 mg is available in blister packs of 7, 28, 56, 98, 140 and 196 (2 x 98) capsules.
Dutor20 mg/40 mg is available in HDPE bottles with PP screw cap of 28, 98 and 100 capsules
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Torrent Pharma (UK) Ltd
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex
RH11 7XA
United Kingdom