Duloxetine 20mg gastro-resistant capsules, hard

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 is and what it is used for
2. What you need to know before you take Duloxetine
3. How to take Duloxetine
4. Possible side effects
5. How to store Duloxetine
6. Contents of the pack and other information

DO NOT take Duloxetine 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’)
• 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 if you:

• are taking medicines to treat depression (see ‘Other medicines and Duloxetine’)
• 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’)

Duloxetine may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.

Medicines like Duloxetine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder

Although Duloxetine 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 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

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The main ingredient of this medicine, 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 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 if you are taking or have recently taken (within the last 14 days) another 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. Also, you need to wait at least 5 days after you stop taking Duloxetine before you take a MAOI.

Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and 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 symptoms 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 with food, drink and alcohol

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

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. 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.
  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 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 while breast-feeding is not recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine contains sucrose

Duloxetine 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.

If you take more Duloxetine than you should

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

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 that has been prescribed for you in one day.

If you stop taking Duloxetine

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

Some patients, who suddenly stop taking Duloxetine 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.

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 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.

What Duloxetine contains

The active substance is duloxetine.

Each capsule contains 20 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, carboxymethyl 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 lauryl sulfate, iron oxide yellow (E172), indigo carmine (E132).

Capsule shell (for 40mg strength): gelatin, titanium dioxide (E171), sodium lauryl sulfate, indigo carmine (E132) iron oxide yellow (E172), iron oxide red (E172).

Edible black ink (for 20 and 40mg strengths): shellac (E904), propylene glycol, black iron oxide (E172), potassium hydroxide.

What Duloxetine looks like and contents of the pack

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

Duloxetine 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 is available in 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 and Manufacturer

Marketing Authorisation Holder:

Manufacturer: