Duloxetine Boehringer Ingelheim
duloxetine
Medicinal product no longer authorised
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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for
Before you take DULOXETINE BOEHRINGER INGELHEIM
How to take DULOXETINE BOEHRINGER INGELHEIM
Possible side effects
5 How to store DULOXETINE BOEHRINGER INGELHEIM
6. Further information
DULOXETINE BOEHRINGER INGELHEIM increases the levels of serotonin and noradrenaline in the nervous system.
DULOXETINE BOEHRINGER INGELHEIM is used in adults to treat a condition called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain).
The effect of DULOXETINE BOEHRINGER INGELHEIM may be noticeable in many patients with diabetic neuropathic pain within 1 week of treatment.
are allergic (hypersensitive) to duloxetine or any of the other ingredients of DULOXETINE BOEHRINGER INGELHEIM
have liver disease
have severe kidney disease are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘Taking other medicines’)
−
are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections
Talk to your doctor if you have high blood pressure. Your doctor will tell you if you should be taking DULOXETINE BOEHRINGER INGELHEIM.
The following are reasons why DULOXETINE BOEHRINGER INGELHEIM may not be suitable for you. Talk to your doctor before you take the medicine if you:
are taking other medicines to treat depression(see ‘Taking other medicines’)
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
Medicinal product no longer authorised
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
are currently being treated with another medicine which may cause liver damage
are taking other medicines containing duloxetine
have intolerance to some sugars (see end of Section 2)
are considering stopping DULOXETINE BOEHRINGER INGELHEIM (see section 3)
DULOXETINE BOEHRINGER INGELHEIM 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 your depression or anxiety disorder
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.
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.
Use in children and adolescents under 18 years of age
DULOXETINE BOEHRINGER INGELHEIM 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. Despite this, your doctor may prescribe DULOXETINE BOEHRINGER INGELHEIM for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed DULOXETINE BOEHRINGER INGELHEIM for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking DULOXETINE BOEHRINGER INGELHEIM. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of DULOXETINE BOEHRINGER INGELHEIM in this age group have not yet been demonstrated.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The main ingredient of DULOXETINE BOEHRINGER INGELHEIM, duloxetine, is used in other medicines for other conditions:
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 BOEHRINGER INGELHEIM 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:
Medicinal product no longer authorised
Monoamine Oxidase Inhibitors (MAOIs): You should not take DULOXETINE BOEHRINGER INGELHEIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Taking a MAOI together with many prescription medicines, including DULOXETINE BOEHRINGER INGELHEIM, 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 BOEHRINGER INGELHEIM. Also, you need to wait at least 5 days after you stop taking DULOXETINE BOEHRINGER INGELHEIM before you take a MAOI.
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital, antihistamines.
Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with DULOXETINE BOEHRINGER INGELHEIM, you should see your doctor.
Oral anticoagulants: medicines which thin the blood. These medicines might increase the risk of bleeding.
DULOXETINE BOEHRINGER INGELHEIM may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with DULOXETINE BOEHRINGER INGELHEIM.
Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you
become pregnant, or you are trying to become pregnant, while you are taking DULOXETINE BOEHRINGER INGELHEIM. You should use DULOXETINE BOEHRINGER
INGELHEIM only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
are breast-feeding. The use of DULOXETINE BOEHRINGER INGELHEIM while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.
DULOXETINE BOEHRINGER INGELHEIM may make you feel sleepy of dizzy. Do not drive or use any tools or machines until you know how DULOXETINE BOEHRINGER INGELHEIM affects you.
DULOXETINE BOEHRINGER INGELHEIM 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.
Always take DULOXETINE BOEHRINGER INGELHEIM exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Medicinal product no longer authorised
DULOXETINE BOEHRINGER INGELHEIM is for oral use. You should swallow your capsule whole with a drink of water.
To help you remember to take DULOXETINE BOEHRINGER INGELHEIM, you may find it easier to take it at the same times every day.
Talk with your doctor about how long you should keep taking DULOXETINE BOEHRINGER INGELHEIM. Do not stop taking DULOXETINE BOEHRINGER INGELHEIM without talking to your doctor.
Call your doctor or pharmacist immediately if you take more than the amount of DULOXETINE BOEHRINGER INGELHEIM prescribed by your doctor.
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 BOEHRINGER INGELHEIM 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 DULOXETINE BOEHRINGER INGELHEIM he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.
Some patients who stop taking DULOXETINE BOEHRINGER INGELHEIM suddenly have had symptoms such as :
dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, 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 product, ask your doctor or pharmacist.
Like all medicines, DULOXETINE BOEHRINGER INGELHEIM can cause side effects, although not everybody gets them. These effects are normally mild to moderate and often disappear after a few weeks.
feeling sick (nausea), somnolence, headache, dizziness and dry mouth
tiredness, trouble sleeping, anxiety, feeling agitated or having abnormal dreams
tremor or numbness, including numbness or tingling of the skin
diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain
tinnitus (perception of sound in the ear when there is no external sound)
blurred eyesight
feeling the heart pumping in the chest, flushing, increased sweating, night sweats
problems getting an erection, less sex drive
(itchy) rash
muscle pain, muscle tightness, muscle spasm
increased yawning
lack of appetite, weight loss
Medicinal product no longer authorised
throat inflammation
feeling disorientated, feeling sleepy, lack of motivation
tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking
poor sleep quality
restless legs syndrome
burping, indigestion, gastroenteritis
vertigo, ear pain
inflammation of the liver that may cause abdominal pain
large pupils (the dark centre of the eye), visual disturbance
fast or irregular heart beat
sexual problems, including changes in ejaculation and abnormal orgasm
abnormal periods, including heavy or prolonged periods
allergic reactions, increased tendency to bruise, blisters or sensitivity to sunlight
increase in blood pressure, feeling cold in your fingers and/or toes, feeling dizzy (particularly when standing up too quickly), cold sweats, shivering or fainting
an increased level of sugar in the blood
need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased
grinding of teeth, feeling hot/cold, thirst, throat tightness, nose bleeds
weight gain
decreased thyroid gland activity
dehydration
mania (over activity, racing thoughts and decrease need for sleep)
bad breath
increased pressure in the eye (glaucoma)
menopausal symptoms
contraction of the jaw muscle
increased level of cholesterol in the blood, low levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused),
serious allergic reaction which causes difficulty in breathing or dizziness or hives
fits
hallucinations, suicidal thoughts, behaviour aggression and anger
a sensation of restlessness or an inability to sit or stand still or “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces)
having abnormal urine odour
syndrome of inadequate secretion of anti-diuretic hormone (SIADH)
chest pain
yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema)
Medicinal product no longer authorised
Do not use DULOXETINE BOEHRINGER INGELHEIM after the expiry date which is stated on the carton.
Store in the original package. Do not store above 30°C.
The active substance is duloxetine.
Each capsule contains 30 or 60 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 sulphate, titanium dioxide (E171), indigo carmine (E132), iron oxide yellow (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
Edible White Ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule
Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
DULOXETINE BOEHRINGER INGELHEIM is available in two strengths: 30 and 60 mg.
The 30 mg capsules has an opaque white body, imprinted with ‘30 mg’ and an opaque blue cap, imprinted with ‘9543’.
The 60 mg capsules has an opaque green body, imprinted with ‘60 mg’ and an opaque blue cap, imprinted with ‘9542’.
DULOXETINE BOEHRINGER INGELHEIM 30 mg is available in packs of 7, 28 and 98 capsules. DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Manufacturer: Lilly S.A., Avda. De la Industria, 30,28108 Alcobendas, Madrid, Spain.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
S.C.S. Boehringer Ingelheim Comm.V. Tél/Tel: +32 27 73 33 11
S.C.S. Boehringer Ingelheim Comm.V. Tél/Tel: +32 2 773 33 11
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
Boehringer Ingelheim Pharma Tel.: +36 1 224 7120
Boehringer Ingelheim spol. s r.o. Tel.: + 42 02 34 65 51 11
Medicinal product no longer authorised
Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88
Boehringer Ingelheim b.v. Tel: +31 30 6 02 59 14
Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 69 50 50 83 09
Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Boehringer Ingelheim Pharma GmbH Tel: + 37 2 60 80 940
Boehringer Ingelheim Austria GmbH Tel: +43 1 80 105 0
Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Eli Lilly Polska Sp. z o.o. Tel. + 48 22 4403300
Boehringer Ingelheim España S.A. Tel: +34 93 404 58 00
Boehringer Ingelheim, Lda Tel: +351 21 313 53 00
Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33
Eli Lilly România S.R.L. Tel: + 40 21 4023000
Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Boehringer Ingelheim Pharma Tel.: +386 1 586 40 00
Vistor hf.
Tel: +354 535 7000
Boehringer Ingelheim Italia S.p.A. Tel: +39 02 535 51
Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 310 2800
Boehringer Ingelheim Ellas A.E. Tηλ: +30 2 10 89 06 300
Boehringer Ingelheim AB Tel: +46 8 721 21 00
Boehringer Ingelheim Pharma GmbH Tel: +37 167 24 00 68
Boehringer Ingelheim Pharma Ges mbH Tel.: +370 37 47 39 22
Medicinal product no longer authorised