Package leaflet: Information for the user Duloxetine 30mg gastro-resistant capsules, hard Duloxetine 60mg 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 Duloxetine Gastro-resistant Capsules are and what they are use for

2. What you need to know before you take Duloxetine Gastro-resistant Capsules

3.    How to take Duloxetine Gastro-resistant Capsules

4.    Possible side effects

5.    How to store Duloxetine Gastro-resistant Capsules

6.    Contents of the pack and other information

1.    What Duloxetine Gastro-resistant Capsules are and what they are used for

Duloxetine Gastro-resistant Capsules contain the active substance duloxetine. Duloxetine increases the level of serotonin and noradrenaline in the nervous system.

Duloxetine is used to treat the following conditions in adults:

•    depression

•    diabetic neuropathic pain

•    generalised anxiety disorder

2.    What you need to know before you take Duloxetine Gastro-resistant Capsule

Do not take Duloxetine Gastro-resistant Capsule 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

Taking any of the following medicines:

-    Monoamine oxidase inhibitor (MAOI) in the last 2 weeks

-    containing duloxetine

-    which is used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections (eg. fluvoxamine)

Warnings and precautions

Talk to your doctor or pharmacist before taking Duloxetine Gastro-resistant Capsule. The following are reasons why Duloxetine Gastro-resistant Capsule may not be suitable for you. If you:

-    are taking other medicines to treat depression

-    have had mania

-    have had seizures

-    suffer from bipolar disorder

-    have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)

-    have high blood pressure

-    ifyou are already taking St. John's Wort, a herbal medicine fordepression

-    have liver or kidney disease

-    have a history of bleeding disorders (such as gastrointestinal haemorrhage)

-    are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) are taking other medicines containing duloxetine

If you have suicidal thoughts or want to harm yourself, you must contact to your doctor immediately. It can take few weeks before your illness improves so you may still he at risk.

Children and adolescents under 18years of age

Duloxetine Gastro-resistant Capsule should normally not be used for children and adolescents under 18 years as increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger). Your doctor may prescribe for patients under 18 because he/she decides that this is in their best interests.

Other medicines and Duloxetine Gastro-resistant Capsule

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Check with your doctor if you are already taking other medicines containing duloxetine.

Your doctor should decide whether you can take Duloxetine Gastro-resistant Capsule 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:

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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 Gastro-resistant Capsule that has been prescribed for you in one day.

If you stop taking Duloxetine Gastro-resistant Capsule

DO NOT stop taking Duloxetine Gastro-resistant Capsule without consulting your doctor first. When stopping taking Duloxetine Gastro-resistant Capsule, your doctor will help you to gradually take less of the medicine. This might be done by slowly reducing the amount of medicine you take each day, week by week.

As you take less Duloxetine Gastro-resistant Capsule you may notice some side-effects such as:

•    feelings pin or electric shock-like (particularly in the head), inability to sleep, feeling restless or agitated, feeling anxious, dizziness, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, diarrhoea, excessive sweating

Most people find that any effects are mild and go away in few days. If you notice any effects when you are reducing Duloxetine Gastro-resistant Capsule, your doctor may decide that you should come off it more slowly. If you notice any severe side-effects, talk to your doctor.

The doctor may ask you to start taking a slightly higher dose again and then reduce it more slowly.

If you have any further questions on the use of this medicine, ask your doctor. 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 few weeks.

Very common side effects (may affect more than 1 in 10 people)

•    feeling sick (nausea), dry mouth

•    headache, feeling sleepy

Common side effects (may affect up to 1 in 10 people)

•    decrease sense of appetite

•    anxiety, trouble sleeping, feeling agitated, less sex drive, difficulty or failure to experience orgasm, unusual dreams

•    feeling sluggish, dizziness, tremor, including numbness, pricking or tingling of the skin

•    eyesight blurred

•    hearing sound in the ear when there is no external sound

•    feeling the heart pumping in the chest,

•    increased in blood pressure, flushing

•    yawning increased

•    increased sweating, (itchy) rash

•    constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking wind

•    pain in muscle or muscle spasm

•    frequent urination, pain during urination,

•    problems in erection, changes in ejaculation

•    falls (mostly in elderly people), fatigue

•    loss in body weight

Uncommon side effects (may affect up to 1 in 100 people)

•    inflammation in the throat that causes a hoarse voice

•    inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the eyes

•    weight gain

•    suicidal thoughts, difficulty in sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation

•    sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality

•    large pupils, problems with eyesight

•    feeling of dizziness or “spinning” (vertigo), pain in ear

•    fast and/or irregular heartbeat

•    fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes

•    abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, pain in the testicles or scrotum

•    throat tightness, nose bleeds

•    vomiting blood, orblacktarry stools (faeces), gastroenteritis, burping, difficulty swallowing

•    night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise

•    difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow

•    chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait

•    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)

•    serious allergic reaction such as difficulty in breathing or dizziness with swollen tongue or lips

•    decreased thyroid gland activity which can cause tiredness or weight gain

•    increased pressure in the eye (glaucoma)

•    abnormal urine odour

•    dehydration, feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls),

•    suicidal behaviour, 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 ofbeing drunk, fever, sweating or rigid muscles), fits

•    inflammation ofthemouth, passing bright red blood in your stools,bad breath

•    yellowing of the skin or whites of the eyes (jaundice), liver failure

•    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)

•    menopausal symptoms, abnormal production of breast milk in men or women

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 at: www.mhra.gnv.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine

5. How to store Duloxetine Gastro-resistant Capsule

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 as EXP or EXP date.

Store in the original package to protect from moisture. Store below 25°C.

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 Gastro-resistant Capsule contains The active substance is duloxetine.

Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content: Sugar sphere, hypromellose, purified talc, sucrose, hypromellose phthalate, triethyl citrate (See end of section 2 for further information on sucrose).

Capsule shell:

30mg: Gelatin, titanium dioxide (E171), edible grey and black ink 60mg: Gelatin, titanium dioxide (E171), FD & C Blue 2 (E132), edible grey and black ink

Edible grey ink: titanium dioxide (E171), black iron oxide (E172), propylene glycol, shellac.

Edible black ink: black iron oxide (E172), propylene glycol, shellac.

What Duloxetine Gastro-resistant Capsule looks like and contents of the pack

Duloxetine Gastro-resistant Capsule is a hard gastro-resistant capsule. Each capsule contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.

Duloxetine Gastro-resistant Capsule is available in 2 strengths: 30 mg and 60 mg.

The 30 mg capsules are white and clear and are printed with “1L” and "085". The 60 mg capsules are blue and clear and are printed with “1L” and "086”.

Duloxetine Gastro-resistant Capsule 30 mg and 60mg is available in packs of

7.    14, 28, 56, 84, 98, 100 and 500 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Wave Pharma Limited.,

4th floor, Cavendish House,

369 Burnt Oak, Broadway, Edgware,

Middlesex HA8 5 AW, United Kingdom.

If you would like this leaflet in a different format or register a complaint, please contact the Marketing Authorisation holder listed above.

This leaflet was last revised in September 2015    S

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