30 mg and 60 mg hard enteric 
capsules duloxetine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Duloxetine Accord is and what it is used for 
2. What you need to know before you use Duloxetine Accord 
3. How to use Duloxetine Accord 
4. Possible side effects 
5. How to store Duloxetine Accord 
6. Contents of the packaging and other information 

1. What Duloxetine Accord is and what it is used for

Duloxetine Accord contains the active substance duloxetine. Duloxetine Accord increases the amount of serotonin and norepinephrine in the nervous system.

Duloxetine Accord is used in adults to treat:

  • Depression
  • generalized anxiety disorder (constant feeling of anxiety or worry)
  • painful diabetic neuropathy (usually described as burning, stinging, stinging, stabbing, or aching pain or as an electric shock. Pain can be caused by touch, heat, cold, or pressure but the affected area can also be completely numb).

In most people with depression or anxiety, Duloxetine Accord starts working within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Talk to your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine Accord even when you are feeling better to prevent relapse into depression or anxiety.

For most people who have painful diabetic neuropathy, it can take a few weeks before they feel better. Talk to your doctor if you do not feel better after 2 months.

Duloxetine contained in Duloxetine Accord may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Duloxetine Accord

Do not take Duloxetine Accord if you:

  • is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
  • have liver disease
  • have severe kidney disease
  • taking or during the last 14 days taking medicine that belongs to the group monoamine oxidase inhibitors ( MAO inhibitors, see “Other medicines and Duloxetine Accord”)
  • taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections you
  • taking other medicines containing duloxetine (see “Other medicines and Duloxetine Accord”)

Talk to your doctor if you have high blood pressure or heart disease. Your doctor

will tell you if you should take Duloxetine Accord.

Warnings and cautions

If you suffer from any of the following, Duloxetine Accord may not be for you. Talk to your doctor before taking Duloxetine Accord if you:

  • taking other medicines for depression (see “Other medicines and Duloxetine Accord”)
  • takes St. John’s wort, a herbal medicine ( Hypericum perforatum )
  • have kidney disease
  • have had seizures (seizures)
  • have had mania
  • have bipolar disorder
  • have eye problems, such as a certain type of glaucoma (increased pressure in the eye)
  • have previously had bleeding disorders (tendency to get bruises), especially if you are pregnant (see “Pregnancy and breast-feeding”)
  • is at risk for low sodium levels (for example, if you are taking diuretics, especially if you are older)
  • while being treated with another medicine that may cause liver damage
  • taking other medicines containing duloxetine (see “Other medicines and Duloxetine Accord”)

Duloxetine Accord may cause a feeling of restlessness and difficulty sitting or standing still. If this happens, tell your doctor.

Drugs such as Duloxetine Accord (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common if you:

  • have previously had thoughts of harming yourself or committing suicide
  • is younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact your doctor or go to a hospital if you have thoughts of harming yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and young people under 18 years of age

Duloxetine Accord should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking this type of drug. Despite this, Duloxetine Accord can be prescribed by a doctor to patients under the age of 18 if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse. Also, the long-term effects on growth, maturity, and development of intellect and behavior have not yet been determined for this age group.

Other medicines and Duloxetine Accord

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

The active ingredient in Duloxetine Accord, duloxetine, is used in other medicines for other conditions:

  • painful diabetic neuropathy, depression, anxiety, and urine leakage.

The use of more than one of these medicines at the same time should be avoided. Contact your doctor if you are already taking other medicines that contain duloxetine.

Your doctor will decide if you can take Duloxetine Accord with other medicines. Check with your doctor before starting or stopping any medications, including over-the-counter and herbal remedies.

Tell your doctor if you are taking any of the following:

Monoamine oxidase inhibitors ( MAOIs ): Duloxetine Accord should not be taken if you are taking or have taken another antidepressant calledMAOIsin the last 14 days. Examples ofMAO inhibitorsare moclobemide (an antidepressant drug) and linezolid (an antibiotic). Many prescription drugs, including Duloxetine Accord, when taken with an MAOI, can cause serious or even life-threatening side effects. Before you can take Duloxetine Accord, at least 14 days must have elapsed since treatment with anMAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Accord before you can start taking an MAOI.

Drugs that can cause drowsiness: Such drugs include prescription drugs such as benzodiazepines, strong painkillers, drugs for psychosis, phenobarbital, and antihistamine s.

Drugs that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs -läkemedel (e.g. paroxetine and fluoxetine ), SNRIs -läkemedel (e.g. venlafaxine ), tricyclic antidepressants (e.g. clomipramine, amitriptyline), pethidine, wort and MAOIs (eg moclobemide and linezolid). These drugs increase the risk of side effects. Contact your doctor if you experience any unusual symptoms while taking any of these medicines with Duloxetine Accord.

Oral anticoagulants or antiplatelet agents: Blood thinners or agents that prevent blood clots from forming. These agents may increase the risk of bleeding.

Duloxetine Accord with food, drink, and alcohol

Duloxetine Accord can be taken with or without food. You should be careful with alcohol during treatment with Duloxetine Accord.

Pregnancy and breastfeeding

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 are planning to become pregnant during treatment with Duloxetine Accord. You should only use Duloxetine Accord after consulting your doctor regarding the possible benefits of the treatment and any risks to the fetus.
  • Tell your midwife or doctor that you are using Duloxetine Accord. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) may increase. This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
  • If you take Duloxetine Accord at the end of your pregnancy, your baby may experience some postpartum symptoms. These symptoms usually occur at birth or within a few days after your baby is born. Symptoms may include weak muscles, tremors, tremors, difficulty feeding, breathing problems, and seizures. If your newborn baby has any of these symptoms, or if you are concerned about your baby’s health, you should contact your doctor or midwife for advice.
  • If you take Duloxetine Accord at the end of your pregnancy, there is an increased risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should tell you to take duloxetine so that they can give you advice.
  • Tell your doctor if you are breast-feeding. The use of Duloxetine Accord during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Duloxetine Accord contains sucrose

Duloxetine Accord contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Duloxetine Accord

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Duloxetine Accord is taken by mouth. Swallow the capsule whole with water. Do not crush or chew.

For depression and painful diabetic neuropathy:

The usual dose is Duloxetine Accord 60 mg once a day, but your doctor will prescribe the dose that is right for you.

For generalized anxiety disorder:

The most common starting dose is Duloxetine Accord 30 mg once a day, and most patients then switch to 60 mg once a day, but your doctor will prescribe the dose that is right for you. Dose one may need to be adjusted up to 120 mg, depending on how you respond to Duloxetine Accord.

It is easier to remember to take Duloxetine Accord if you take it at the same time each day.

Ask your doctor how long to take Duloxetine Accord. Do not stop taking Duloxetine Accord, or change the dose, without first discussing it with your doctor. For you to feel better, it is important to treat your illness in the right way. If left untreated, it can persist and become more severe and difficult to treat.

If you take more Duloxetine Accord than you should:

Contact your doctor or pharmacist immediately if you have taken more Duloxetine Accord than your doctor prescribed. Symptoms of overdose include drowsiness, coma, serotonergic syndrome (a rare reaction that can cause severe feelings of happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating, or stiff muscles), seizures, vomiting, and rapid heartbeat.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Duloxetine Accord

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 one dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more Duloxetine Accord per day than prescribed by your doctor

If you stop taking Duloxetine Accord

DO NOT STOP taking Duloxetine Accord, even if you feel better, without talking to your doctor first. If your doctor thinks you no longer need Duloxetine Accord, he/she will reduce the dose for at least two weeks before stopping treatment completely.

Some patients who abruptly stop taking Duloxetine Accord may experience symptoms such as:

  • dizziness, tingling and numbness or sensations of electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, feeling of restlessness or worry, anxiety, nausea/vomiting (feeling sick), tremors, headache, muscle pain, irritation, diarrhea, heavy sweating or dizziness.

These problems are usually mild and disappear within a few days. Ask your doctor if the reactions are bothersome.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are usually mild to moderate and usually disappear after a few weeks.

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

  • headache, drowsiness
  • nausea, dry mouth

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

  • loss of appetite
  • difficulty sleeping, feelings of upset, decreased sex drive, anxiety, difficulty getting or not having an orgasm, strange dreams
  • dizziness, feeling sluggish, tremors, numbness, which include numbness or tingling in the skin
  • dimsyn
  • tinnitus (sensation of sound in the ear without external sound source)
  • palpitation
  • high blood pressure, hemorrhage
  • yawning
  • constipation, diarrhea, abdominal pain, nausea and vomiting, heartburn or indigestion, flatulence
  • increased sweating, (itchy) rash
  • muscle pain, muscle spasm
  • painful urination, frequent bladder emptying
  • erection problems, ejaculation disorders
  • fall accidents (mostly in the elderly), fatigue
  • weight loss

Children and adolescents under the age of 18 treated with this antidepressant experienced some weight loss when starting treatment. However, the weight increased after 6 months of treatment so that it corresponded to other children and adolescents of the same age and the same sex.

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

  • pharyngitis causing a hoarse voice
  • suicidal thoughts, difficulty sleeping, gnashing of teeth, feeling disoriented, lack of motivation
  • sudden involuntary twitching or twitching of the muscles, a feeling of restlessness and difficulty sitting or standing still, feeling nervous, difficulty concentrating, changes in taste, difficulty controlling movements, e.g. lack of coordination or involuntary movements in the muscles, restless legs (numbness and tingling sensation in the legs), poor sleep
  • large pupil er (the dark field in the middle of the eye), visual disturbances
  • (dizziness and sore ears)
  • fast or irregular heartbeat
  • fainting and dizziness when getting up, cold fingers and/or toes
  • feel thick in the throat, nosebleeds
  • bloody vomiting or black tarry stools, gastrointestinal inflammation, belching, difficulty swallowing
  • inflammation of the liver that can cause abdominal pain and yellowing of the skin and whites of the eyes
  • night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
  • muscle tension, muscle twitching
  • difficulty or inability to urinate, difficulty urinating, need to empty the bladder at night, need to empty the bladder more often than usual, decreased urine flow
  • abnormal vaginal bleeding, abnormal menstruation, including heavy, painful, irregular or prolonged menstruation, unusually short or absent menstruation, pain in the testicles or scrotum
  • chest pain, feeling cold, thirst, shaking, feeling hot, abnormal gait
  • weight gain
  • Duloxetine Accord can cause effects that you do not notice, such as an increase in liver enzymes or the level of potassium, creatine phosphokinase, sugar, or cholesterol in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

  • severe allergic reactions that cause difficulty breathing or dizziness, with swollen tongue or swollen lips, allergic reactions
  • impaired thyroid function, which can cause fatigue or weight gain
  • dehydration, low sodium levels in the blood (mostly affects the elderly); the symptoms may be feeling dizzy, weak, confused, sleepy or very tired, nausea or vomiting, more serious symptoms are fainting, seizures or falls, insufficient secretion of antidiuretic hormone (SIADH)
  • suicidal behavior, mania (overactivity, thoughtlessness, and decreased need for sleep), feelings of aggression and anger
  • “Serotonergic syndrome” (a rare reaction that can cause feelings of happiness, drowsiness, clumsiness, restlessness, feelings of intoxication, fever, sweating, or stiff muscles), seizures
  • increased pressure in the eye ( glaucoma )
  • cough, wheezing, and shortness of breath that may be accompanied by high body temperature
  • inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the colon (causes diarrhea)
  • liver problems, yellowing of the skin, and whites of the eyes (jaundice)
  • Stevens-Johnson syndrome (a severe disease with blisters on the skin, mouth, ey, es, and genitals), severe allergic reactions that cause swelling of the face and throat ( angioedema )
  • cramps in the jaw muscles
  • abnormal odor on the urine
  • menopausal symptoms, abnormal production of breast milk in men and women
  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage). 

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

  • inflammation of the blood vessels of the skin ( cutaneous vasculitis )

5. How to store Duloxetine Accord

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 and blister.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is duloxetine.

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

Other ingredients are:

Capsule contents: Sugar spheres (containing maize starch and sucrose), hypromellose 2910 (E464), crospovidone (type B), talc, sucrose, carboxymethyl ethylcellulose, povidone, titanium dioxide (E171), macrogol (E1521), polysorbate 80 (E4). (See the end of section 2 for more information on sucrose.)

Capsule 30 mg: gelatin, titanium dioxide (E171), sodium laurilsulfate, indigo carmine (E132).

Capsule cover 60 mg: gelatin, titanium dioxide (E171), sodium lauryl sulfate, indigo carmine (E132), yellow iron oxide (E172).

Food color, gold ink (30 mg): shellac (E904), propylene glycol, yellow iron oxide (E172).

Food color, gold ink (60 mg): shellac (E904), propylene glycol, potassium hydroxide, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Duloxetine Accord is a hard enteric capsule.

Each capsule Duloxetine Accord contains pellets of duloxetine hydrochloride with a shell that resists the acidic gastric juice.

Duloxetine Accord is available in strengths of 30 mg and 60 mg.

30 mg hard enteric capsule: White to off-white pellets in a size 3 hard gelatin capsule (15.80 ± 0.40 mm) with an opaque blue top labeled “H” and an opaque white cap labeled “191”.

60 mg hard enteric capsule: White to off-white pellets in a size 1 hard gelatin capsule (19.30 ± 0.40 mm) with an opaque blue body marked with “H” and an opaque green body marked with “192”.

Doluxetine Accord is provided in:

30 mg: blister packs of 7, 10, 14, 28, 28×1, 30, 90, 98, 98×1 and 100 capsules.

60 mg: blister packs of 10, 14, 28, 28×1, 30, 90, 98, 98×1 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer:

Paradox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola

PLA 3000, Malta

Muhammad Nadeem

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