The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL08553/0531.
Duloxetine 30mg & 60mg Gastro-Resistant Capsules, Hard
Duloxetine 30 mg Gastro-Resistant Capsules, Hard
Duloxetine 60 mg Gastro-Resistant Capsules, Hard
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
Duloxetine capsules contain the active substance duloxetine. Duloxetine increases the levels of serotonin and noradrenaline in the nervous system.
Duloxetine is used in adults to treat:
Duloxetine starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine when you are feeling better to prevent your depression or anxiety from returning.
In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months.
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking Duloxetine.
The following are reasons why Duloxetine may not be suitable for you. Talk to your doctor before you take Duloxetine if you:
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.
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:
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.
Duloxetine 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 for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Duloxetine 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. 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.
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 active substance of Duloxetine capsules, duloxetine, is used in other medicines for other conditions:
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, buprenorphine, 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 may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with Duloxetine.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Make sure your midwife and/or doctor knows you are on Duloxetine. 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 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.
If you take Duloxetine near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
Duloxetine may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine affects you.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Duloxetine is for oral use. You should swallow your capsule whole with a drink of water.
The usual dose of duloxetine is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
The usual starting dose of duloxetine is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you. The dose may be adjusted up to 120 mg a day based on your response to duloxetine.
To help you remember to take Duloxetine, you may find it easier to take it at the same time every day. Talk with your doctor about how long you should keep taking Duloxetine. Do not stop taking Duloxetine, 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.
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 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.
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 at least 2 weeks before stopping treatment altogether.
Some patients who stop taking Duloxetine suddenly 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 any further questions on the use of this medicine, ask your doctor or pharmacist.
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)
Common side effects (may affect up to 1 in 10 people)
Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine. Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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.
Do not store above 30°C. Store in the original package to protect from moisture.
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.
The active substance is duloxetine.
Each 30 mg gastro-resistant capsule, hard contains 30 mg of duloxetine (as hydrochloride).
Each 60 mg gastro-resistant capsule, hard contains 60 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres (containing: sucrose, maize starch), glycine talc, titanium dioxide (E171), triethyl citrate.
Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only)
Printing ink: propylene glycol, shellac, yellow iron oxide (E172) (30 mg only), titanium dioxide (E171) (60 mg only), potassium hydroxide (60 mg only).
Duloxetine is a gastro-resistant capsule, hard. Each capsule of Duloxetine contains pellets of duloxetine with a covering to protect them from stomach acid.
Duloxetine 30 mg capsules are white to off white spherical pellets filled in size ‘3’ hard gelatin capsules with opaque blue coloured cap and opaque white coloured body, imprinted ‘RDY609’ on cap and ‘30mg’ on body with golden yellow ink.
Duloxetine 60 mg capsules are white to off white spherical pellets filled in size ‘1’ hard gelatin capsules with opaque blue coloured cap and opaque green coloured body, imprinted ‘RDY610’ on cap and ‘60mg’ on body with white ink.
Pack sizes of 28, 42, 56, 84 and 98 capsules.
Not all pack sizes may be marketed.
This leaflet was last revised in 06/2022