30 mg, 60 mg hard enteric 
capsules duloxetine (as hydrochloride)

Read all of this leaflet carefully before you start using 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.

In this leaflet you will find information about: 
1. What Aritavi is and what it is used for 
2. What you need to know before you use Aritavi 
3. How to use Aritavi 
4. Possible side effects 
5. How to store Aritavi 
6. Contents of the packaging and other information 

1. What Aritavi is and what it is used for

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

Aritavi 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, Aritavi 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 Aritavi 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 found in Aritavi 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 Aritavi

Do not take Aritavi if you:

  • is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6).
  • have a liver disease
  • have a serious kidney disease
  • or has taken a medicine belonging to the group monoamine oxidase inhibitors ( MAOIs ) for the last 14 days, see “Other medicines and Aritavi”)
  • taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections you
  • take other medicines containing duloxetine (see “Other medicines and Aritavi”).

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

Warnings and cautions

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

  • taking other medicines for depression (see “Other medicines and Aritavi”)
  • 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)
  • 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 containing duloxetine (see “Other medicines and Aritavi”).

Aritavi can cause a feeling of restlessness and difficulty sitting or standing still. If this happens, tell your doctor.

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

Suicidal ideation and worsening of depression or anxiety

Patients who are depressed and/or anxious can sometimes have thoughts of harming themselves or thinking about committing suicide. These thoughts can be reinforced when starting antidepressant treatment, as it takes time for such drugs to take effect – usually about two weeks, but sometimes longer. You are more likely to get these types of thoughts:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are a young adult. 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.

If you have thoughts of harming yourself or are considering suicide: contact your doctor or nearest hospital immediately.

It may be helpful to talk to a relative or close friend about your depression or anxiety, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety seems to be getting worse, or if they are worried that your behavior is changing.

Children and young people under 18 years of age

Aritavi 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, Aritavi 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. In addition, 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 Aritavi

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 Aritavi, 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 Aritavi 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: Aritavi should not be taken if you are taking or have taken another antidepressant called MAO inhibitors in the last 14 days. Examples of MAO inhibitors are moclobemide (an antidepressant drug) and linezolid (an antibiotic). Many prescription drugs, including Aritavi, if taken with an MAOI, can cause serious or even life-threatening side effects. Before you can take Aritavi, 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 Aritavi 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 Aritavi.

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

Aritavi with food, drink, and alcohol

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

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 plan to become pregnant during treatment with Aritavi. You should only use Aritavi 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 Aritavi. 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. These symptoms usually appear within 24 hours after the baby is born. If this affects your baby, contact a midwife or doctor immediately.
  • If you take Aritavi 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.
  • Tell your doctor if you are breast-feeding. The use of Aritavi during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

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

Aritavi contains sucrose

Aritavi 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 Aritavi

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

Aritavi is taken by mouth. Swallow the capsule whole with water.

For depression and painful diabetic neuropathy:

The usual dose is Aritavi 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 Aritavi 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 Aritavi.

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

Ask your doctor how long to take Aritavi. Do not stop taking Aritavi, or change the dose, without first discussing this with your doctor. In order 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 forget to use Aritavi

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 Aritavi per day than prescribed by your doctor.

If you stop using Aritavi

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

Some patients who abruptly stop taking Aritavi 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 (affects more than 1 user in 10)

  • headache, drowsiness
  • nausea, dry mouth

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

  • decreased appetite
  • difficulty sleeping, feelings of upset, decreased sex drive, anxiety, difficulty having 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 of 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 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, feeling cold, thirst, shaking, feeling hot, abnormal gait
  • weight gain
  • Aritavi 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 the blood.

Rare side effects (affects 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), 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 )
  • 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.

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Aritavi

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiration date is the last day of the specified month.

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 core: sugar spheres (sucrose, maize starch) hypromellose phthalate (HP 55), hypromellose (E15 LV), triethyl citrate, hydroxypropyl cellulose, talc

Capsule cover 30 mg: Hypromellose (E464), titanium dioxide (E171), brilliant blue FCF (E133), black iron oxide (E172), printing ink.

Capsule cover 60 mg: Hypromellose (E464), titanium dioxide (E171), black iron oxide (E172), printing ink.

The printing ink contains shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What the medicine looks like and the contents of the pack

Aritavi is a hard, enteric-resistant capsule. Each capsule of Aritavi contains granules of duloxetine hydrochloride with a coating that resists the acidic gastric juice.

Aritavi is available in 2 strengths: 30 mg and 60 mg.

The 30 mg capsule has an opaque lower gray part marked with “DLX 30” and an opaque upper blue part marked with “DLX 30”, length 18 mm.

The 60 mg capsule has an opaque lower gray part marked “DLX 60” and an opaque upper white part marked “DLX 60”, length 20.4 mm.

Aritavi 30 mg is available in:

  • Plastic jar (HDPE) with a screw cap with integrated silica gel desiccant, pack sizes 28, 30, 56, 60, 84, 90, 98, or 100 capsules.
  • Blister (AL / AL), pack sizes of 7, 10, 14, 28, 30 and 100 capsules.

Aritavi 60 mg is available in:

  • Plastic jar (HDPE) with a screw cap with integrated silica gel desiccant, pack sizes 28, 30, 56, 60, 84, or 90 capsules.
  • Blister (AL / AL), pack sizes of 7, 10, 14, 28, 30, 56 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Local representative:

Muhammad Nadeem

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