30 mg, 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 can harm them, even if they show signs of illness 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 Orion is and what it is used for 
2. What you need to know before you use Duloxetine Orion 
3. How to take Duloxetine Orion 
4. Possible side effects 
5. How to store Duloxetine Orion 
6. Contents of the packaging and other information 

What Duloxetine Orion is and what it is used for

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

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

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

Do not take Duloxetine Orion, 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
  • take or have taken a medicine belonging to the group monoamine oxidase inhibitors ( MAOIs ) in the last 14 days (see “Other medicines and Duloxetine Orion”)
  • taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections you
  • take other medicines that contain duloxetine (see “Other medicines and Duloxetine Orion”).

Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take Duloxetine Orion.

Warnings and cautions

  • If you suffer from any of the following, Duloxetine Orion may not be right for you. Talk to your doctor before taking Duloxetine Orion if you:
  • taking other medicines for depression (see “Other medicines and Duloxetine Orion”)
  • takes St. John’s wort, a herbal medicine (Hypericum perforatum)
  • have kidney disease
  • have had epileptic 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
  • take other medicines that contain duloxetine (see “Other medicines and Duloxetine Orion”).

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

Medicines such as Duloxetine Orion ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Suicidal ideation and worsening of your depression or anxiety

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 using 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 a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring 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 Orion 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. Nevertheless, Duloxetine Orion may be prescribed by a doctor to patients under 18 years of age 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 Orion

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 in Duloxetine Orion, 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. Check with your doctor if you are already taking other medicines that contain duloxetine.

Your doctor will decide if you can take Duloxetine Orion 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 Orion should not be taken if you are taking or have taken another antidepressant called MAO inhibitor in the last 14 days. Examples of MAO inhibitorsare moclobemide (an antidepressant drug) and linezolid (an antibiotic ). Many prescription drugs, including Duloxetine Orion, can, if taken with an MAOI, cause serious or even life-threatening side effects. Before you can take Duloxetine Orion, at least 14 days must have passed since stopping treatment with an MAOI. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Orion before you can start taking an MAOI 

Medicines 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 (eg paroxetine and fluoxetine ), SNRIs (eg venlafaxine ), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John’s 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 Orion.

Oral anticoagulants or antiplatelet agents

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

Duloxetine Orion with food, drink, and alcohol

Duloxetine Orion can be taken with or without food. You should be careful with alcohol while taking Duloxetine Orion.

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.

Pregnancy

Tell your doctor if you become pregnant or plan to become pregnant during treatment with Duloxetine Orion. You should only use Duloxetine Orion after consulting your doctor about the possible benefits of treatment and any possible risks to the fetus.

Tell your midwife or doctor that you are using Duloxetine Orion. 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 Orion 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 Orion 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.

Breast-feeding

Tell your doctor if you are breast-feeding. The use of Duloxetine Orion during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

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

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 Orion 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.

Other excipients

This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

How to take Duloxetine Orion

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

For depression and painful diabetic neuropathy

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

For generalized anxiety disorder

The recommended starting dose is Duloxetine Orion 30 mg once daily, and most patients then switch to 60 mg once daily, 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 Orion.

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

Ask your doctor how long to take Duloxetine Orion. Do not stop taking Duloxetine Orion, 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.

Duloxetine Orion is taken by mouth. Swallow the capsule whole with water.

If you take more Duloxetine Orion then you should

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.

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 forget to take Duloxetine Orion

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 Orion per day than prescribed by your doctor.

If you stop taking Duloxetine Orion

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

Some patients who abruptly stop taking Duloxetine Orion 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 ( may affect more than 1 user in 10  ):

  • headache, drowsiness
  • nausea, dry mouth.

Common  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 18 years of age treated with duloxetine for depression 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  ( 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 twitches or twitches in 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, abnormal feeling, feeling cold, thirst, shaking, feeling hot, abnormal gait
  • weight gain
  • Duloxetine Orion can cause effects that you do not notice, such as an increase in liver enzymes or the level of potassium, creatine phosphokinase, or blood sugar.

Rare  ( may affect up to 1 in 1000 users ):

  • 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), hallucinations, 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 )
  • sudden dangerously high blood pressure (hypertensive crisis)
  • 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, eyes, 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
  • Duloxetine Orion can cause effects that you do not notice, such as an increase in blood cholesterol
  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage).

Very rare  ( may affect up to 1 in 10 000 users ):

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

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Duloxetine Orion

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, label, and blister after EXP. The expiration date is the last day of the specified month.

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. One capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).
  • The other ingredients are:

Capsule contents: Sugar spheres (sucrose, maize starch, purified water), hypromellose, hydroxypropyl cellulose, crospovidone, talc, purified water

Capsule coatinghypromellose, hypromellose phthalate, triethyl citrate, titanium dioxide, talc, purified water.

Capsule shell 30 mg: gelatin, titanium dioxide, indigo carmine, sodium laurilsulfate, water

Capsule cover 60 mg: gelatin, titanium dioxide, indigo carmine, sodium lauryl sulfate, water, yellow iron oxide

Black ink: shellac, black iron oxide.

What the medicine looks like and the contents of the pack

Duloxetine Orion is a hard enteric capsule. A Duloxetine Orion capsule contains white to off-white pellets of duloxetine hydrochloride with a coating that resists acidic gastric juice.

30 mg: Blue and white capsules, length 16 mm and marked with “DLX” and “30”.

60 mg: Blue and green capsules, length 19 mm and marked with “DLX” and “60”.

Pack sizes :

7, 28, 56, and 98 capsules in aluminum blister packaging.

30 and 1000 capsules in a plastic jar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

Leave a Reply