Document: Duloxetin Actavis gastro-resistant capsule, hard ENG PL change

• Duloxetin Actavis gastro-resistant capsule, hard PL
• Duloxetin Actavis gastro-resistant capsule, hard ENG PL

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Package leaflet: Information for the user

Duloxetin Actavis 20 mg hard gastro-resistant capsules

Duloxetin Actavis 40 mg hard gastro-resistant capsules

duloxetine (as hydrochloride)

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 Duloxetin Actavis is and what it is used for

2. What you need to know before you take Duloxetin Actavis

3. How to take Duloxetin Actavis

4. Possible side effects

5. How to store Duloxetin Actavis

6. Contents of the pack and other information

1. What Duloxetin Actavis is and what it is used for

Duloxetin Actavis contains the active substance duloxetine. Duloxetin Actavis increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetin Actavis 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.

Duloxetin Actavis 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 Duloxetin Actavis is reinforced when combined with a training program called Pelvic Floor Muscle Training (PFMT).

2. What you need to know before you take Duloxetin Actavis

Do not take Duloxetin Actavis 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 Duloxetin Actavis’)

- 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 Duloxetin Actavis.

Warnings and precautions

The following are reasons why Duloxetin Actavis may not be suitable for you.Talk to your doctor before you take Duloxetin Actavis if you:

- are taking medicines to treat depression (see ‘Other medicines and Duloxetin Actavis’)

- 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 Duloxetin Actavis’)

Duloxetin Actavis 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 Duloxetin Actavis 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

Duloxetin Actavis 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 Duloxetin Actavis in this age group have not yet been demonstrated.

Other medicines and Duloxetin Actavis

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

The main ingredient of Duloxetin Actavis, 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 Duloxetin Actavis 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 Duloxetin Actavis if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examplesof MAOIsincludemoclobemide(an antidepressant)and linezolid(an antibiotic)Taking a MAOI together with many prescription medicines, including Duloxetin Actavis, 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 Duloxetin Actavis. Also, you need to wait at least 5 days after you stop taking Duloxetin Actavis 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 asvenlafaxine), tricyclicantidepressants(such as clomipramine, amitriptyline), pethidine, St John’s Wort and MAOIs(such asmoclobemideand linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetin Actavis, 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.

Duloxetin Actavis with food, drink and alcohol

Duloxetin Actavis may be taken with or without food. You should take extra care if you drink alcohol while taking Duloxetin Actavis.

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.

Driving and using machines

Duloxetin Actavis may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Duloxetin Actavis affects you.

Duloxetin Actavis contains sucrose

Duloxetin Actavis 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.

Duloxetin Actavis 40mg capsules contain Sunset Yellow FCF (E110): May cause allergic reactions.

3. How to take Duloxetin Actavis

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Duloxetin Actavis is for oral use. You should swallow your capsule whole with a drink of water.

The recommended dose 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.

To help you remember to take Duloxetin Actavis, you may find it easier to take it at the same times every day.

Do not stop taking Duloxetin Actavis, 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 Duloxetin Actavis than you should

Call your doctor or pharmacist immediately if you take more than the amount of Duloxetin Actavis 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 Duloxetin Actavis

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 Duloxetin Actavis that has been prescribed for you in one day.

If you stop taking Duloxetin Actavis

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 Duloxetin Actavis he or she will ask you to reduce your dose over 2 weeks.

Some patients, who suddenly stop taking Duloxetin Actavis after more than 1 week of therapy, have had symptoms such as:

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.

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

• vomiting blood, or black tarry stools (faeces), 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

• Duloxetin Actavis 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)

• 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, inflammation of the large intestine (leading to diarrhoea)

• 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

Very rare side effects (may affect up to 1 in 10,000 people)

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 system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Duloxetin Actavis

Keep this medicine out of the sight and reach of children.

Do not store above 25°C

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiry date refers to the last day of that month.

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 protect the environment.

6. Contents of the pack and other information

What Duloxetin Actavis contains

The active substance is duloxetine:

Each capsule contains 20 or 40 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content: sugar spheres (sucrose, maize starch), hypromellose phthalate (HP-55), hypromellose (E15 LV), triethyl citrate, hydroxypropyl cellulose, talc

Capsule shell 20mg: Brilliant Blue FCF (E133), titanium dioxide (E171), Hypromellose (E464), printing ink

Capsule shell 40mg: titanium dioxide (E171), Sunset Yellow FCF (E110), Quinoline Yellow (E104), Hypromellose (E464), printing ink

Printing ink contains: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What Duloxetin Actavis looks like and contents of the pack

Duloxetin Actavis is a hard gastro‑resistant capsule. Each capsule of Duloxetin Actavis contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.

Duloxetin Actavis is available in 2 strengths: 20 and 40 mg.

The 20 mg capsules have an opaque blue body imprinted with ‘DLX 20’ and an opaque blue cap imprinted with ‘DLX 20’, length 15.9 mm.

The 40 mg capsules have an opaque yellow body imprinted with ‘DLX 40’ and an opaque yellow cap imprinted with ‘DLX 40’, length 19.4 mm.

Duloxetin Actavis is available in:

• Plastic (HDPE) containers with twist-off cap with integrated silica gel desiccant in pack sizes of 28, 30, 56, 60, 84, 90, 98 and 100 capsules.

• Blister (AL/AL) in pack sizes of 7, 10, 28, 30, 56 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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Manufacturer

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Str.,

Dupnitsa 2600,

Bulgaria

This medicinal product is authorised in the Member States of the EEA under the following names:

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This leaflet was last revised in 2016-05-23

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