DEPALTA 30 MG GASTRO-RESISTANT CAPSULES HARD - patient leaflet, side effects, dosage

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 Depalta Gastro resistant Capsules are and what they are used for

• 2. What you need to know before you take Depalta Gastro resistant Capsules

• 3. How to take Depalta Gastro resistant Capsules

• 4. Possible side effects

• 5. How to store Depalta Gastro resistant Capsules

• 6. Contents of the pack and other information

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

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

Depalta is used to treat the following conditions in adults:

• depression
• 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)
• generalised anxiety disorder (chronic feeling of anxiety or nervousness)

Depalta Gastro resistant Capsule 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 Depalta Gastro resistant Capsule 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.

2. what you need to know before you take depalta gastro-resistant capsuleare allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)

have liver disease

have severe kidney disease

have taken a monoamine oxidase inhibitor (MAOI) in the last 2 weeks are taking

• Other medicines containing duloxetine
• which is used to treat depression(eg. fluvoxamine),
• 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 Depalta Gastro resistant Capsule.

Warnings and precautions

Talk to your doctor or pharmacist before taking Depalta Gastro resistant Capsule. The following are reasons why Depalta 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

are already taking St. John's Wort (a herbal medicine for depression)

have 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 currently being treated with another medicine which may cause liver damage are taking other medicines containing duloxetine

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

Depalta Gastro resistant Capsule 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.

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

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

Depalta Gastro resistant Capsule should normally not be used for children and adolescents under 18 years as there is a risk of side effects such as attempted suicide, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger). However, your doctor may still prescribe for under 18 because he/she decides that this is in their best interests.Discuss with your doctor If your are concerned. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Depalta Gastro resistant Capsule. Also, the long term effects of Depalta Gastro resistant Capsule have not been demonstrated.

Other medicines and Depalta 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.

The main ingredient of Depalta Gastro resistant Capsule ( duloxetine) is used in other medicines for other 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 Depalta 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:

monoamine oxidase inhibitors (MAOIs): You should not use Depalta in combination with MAOIs (such as moclobemide or linezolid) or within at least 2 weeks of discontinuing treatment with an MAOI. Also, you should wait at least 5 days after you stop taking Depalta before you take a MAOI. Taking MAOI together with many prescription medicines including Depalta Gastro resistant Capsule can cause serious and even life threatening side effects.

Fluvoxamine, since it is likely to result in higher concentrations of duloxetine. Medicines that increase the level of serotonin such as triptans, tramadol, tryptophan SSRIs (such as paroxetineand fluoxetine) SNRIs (such as venlafaxine), These medicines increase the risk of side effects; if you get any unusual symptoms taking any of these medicines together with Depalta Gastro resistant Capsule, you should see your doctor.

medicines that cause sleepiness such as benzodiazepines, strong painkillers or phenobarbital and anti histamines medicines which thin the blood or prevent the blood from clotting (oral anticoagulants or antiplatelet agents. These medicines might increase the risk of bleeding.

Depalta Gastro-resistant Capsule with food, drink and alcohol

You can take Depalta Gastro resistant Capsules with or without food, Care should be taken if you drink alcohol while you are being treated with Depalta Gastro resistant Capsule.

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. You should use Depalta Gastro resistant Capsule only after discussing the potential benefits and any potential risks to your unborn child with your doctor.

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 Depalta Gastro resistant Capsule 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 Depalta Gastro resistant Capsule 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.

Available data from the use of Depalta Gastro resistant Capsule during the first three months of pregnancy do not show an increased risk of overall birth defects in general in the child. If Depalta Gastro resistant Capsule is taken during the second half of pregnancy, there may be an increased risk that the infant will be born early (6 additional premature infants for every 100 women who take Depalta Gastro resistant Capsule in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.

Tell your doctor if you are breast feeding. The use of Depalta Gastro resistant Capsule while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

Depalta Gastro resistant Capsule may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Depalta Gastro resistant Capsule affects you.

Depalta Gastro-resistant Capsule contains sucrose

Depalta Gastro resistant Capsule 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.

3. how to take depalta gastro-resistant capsule

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

Depalta Gastro resistant Capsule is for oral use. You should swallow your capsule whole with a drink of water.

Dosage in Adults:

The recommended dose of Depalta Gastro resistant Capsule is given below:

Condition	Dosage
Depression	The usual dose is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Diabetic neuropathic pain	The usual dose is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Generalised anxiety disorder	The usual starting dose 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 Depalta Gastro resistant Capsule

Talk with your doctor about how long you should keep taking Depalta Gastro resistant Capsule. Do not stop taking Depalta Gastro resistant Capsule, 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 Depalta Gastro-resistant Capsule than you should

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

amount of Depalta Gastro resistant Capsule prescribed by your doctor.Symptoms of overdose include sleepiness, coma, feelings of great happiness, drowsiness, fever, sweating, rigid muscles, vomiting' and fast heart rate.

If you forget to take Depalta Gastro-resistant Capsule

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

If you stop taking Depalta Gastro-resistant Capsule

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

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

• Tingling feelings like Pins and needles or electric shock like feelings (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 may go away in few days. If you notice any effects when you are reducing Depalta 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. Your 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/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 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, numbness, pricking or tingling ofthe skin
• eyesight blurred
• hearing sound in the ear when there is no external sound(tinnitus)
• feeling the heart pumping in the chest,
• increased in blood pressure, flushing
• increased yawning
• 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 with erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• loss in body weight

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. However, their weight increased to match other children and adolescents of their age and sex after 6 months oftreatment.

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

• inflammation in the throat that causes a hoarse voice
• inflammation ofthe liver that may cause abdominal pain and yellowing of the skin or whites ofthe 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 oftaste, difficulty controlling movement e.g. lack of coordination or involuntary movements ofthe muscles, restless leg syndrome, poor sleep quality
• problems with eyesight , large pupils
• feeling of dizziness or “spinning” (vertigo), pain in ear
• fast and/or irregular heart beat
• 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, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
• night sweats, cold sweats, hives, sensitivity to sunlight, increased tendency to bruise
• difficulty or inability to pass urine, difficulty in starting to pass urine, 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 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 of the mouth, passing bright red blood in your stools, bad breath, inflammation ofthe large intestine (leading to diarrhoea)
• yellowing ofthe skin or whites ofthe eyes (jaundice), liver failure
• Stevens Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals), serious allergic reaction which causes swelling ofthe face or throat
• menopausal symptoms, abnormal production ofbreast milk in men or women
• contraction ofjaw muscle
• Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage)

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

• Inflammation ofthe blood vessels in the skin (Cutaneous vasculitis)

5. how to store depalta gastro-resistant capsuledo 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 250C.

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 informationthe 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 Depalta Gastro-resistant Capsule looks like and contents of the pack

Depalta 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.

Depalta 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 “ „IL ”and “085".

The 60 mg capsules are blue and clear and are printed with “ H_”and "086”.

Depalta 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.

Distributed By:

Unit 4 6, Wintonlea, Monument Way West,

Woking, GU21 5EN, United Kingdom

Marketing Authorisation Holder and Manufacturer

4th floor, Cavendish House,

369 Burnt Oak Broadway, Edgware,

Middlesex HA8 5AW, United Kingdom.

Ifyou 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 April 2021.

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