20 mg and 40 mg enteric capsules, hard
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.
This leaflet contains information about:
1. What Duloxetine Actavis is and what it is used for
2. What you need to know before you use Duloxetine Actavis
3. How to use Duloxetine Actavis
4. Possible side effects
5. How to store Duloxetine Actavis
6. Contents of the packaging and other information
What Duloxetine Actavis is and what it is used for
Duloxetine Actavis contains the active substance duloxetine. Duloxetine Actavis increases the amount of serotonin and norepinephrine in the nervous system.
Duloxetine Actavis is a drug that is to be taken orally and is used to treat stress incontinence in women.
Exercise incontinence is a medical problem that causes urine leakage in connection with physical exertion or activities such as laughter, coughing, sneezing, heavy lifting, or exercise.
Duloxetine Actavis is believed to work by strengthening the muscles that hold back urine when laughing, sneezing, or exercising.
The effect of Duloxetine Actavis is enhanced when combined with an exercise program that strengthens the muscles of the pelvic floor.
Duloxetine contained in Duloxetine Actavis 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.
What you need to know before you use Duloxetine Actavis
Do not use Duloxetine Actavis 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 Duloxetine Actavis”)
- Take fluvoxamine which is commonly used to treat depression, ciprofloxacin or enoxacin which is used to treat certain infections.
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take Duloxetine Actavis.
Warnings and cautions
If you suffer from any of the following, Duloxetine Actavis may not be for you. Talk to your doctor before taking Duloxetine Actavis if you:
- taking antidepressants (see “Other medicines and Duloxetine Actavis”)
- 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
- take other medicines containing duloxetine (see “Other medicines and Duloxetine Actavis”).
Duloxetine Actavis may cause a feeling of restlessness and difficulty sitting or standing still. If this happens, tell your doctor.
Drugs such as Duloxetine Actavis ( SSRIs / SNRIs) may 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
Although Duloxetine Actavis is not indicated for the treatment of depression, the active substance (duloxetine) is also used in antidepressants. 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:
- 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 Actavis should not 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. 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 Actavis
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 Actavis, duloxetine, is also used in other medicines for other diseases:
- 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 Actavis 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 Actavis should not be taken if you are taking or have taken (in the last 14 days) an antidepressant called an MAOI. Examples ofMAO inhibitorsare moclobemide (an antidepressant drug) and linezolid (an antibiotic). Many of the prescription drugs, including Duloxetine Actavis, if taken with an MAOI, can cause serious or even life-threatening side effects. Before you can take Duloxetine Actavis, at least 14 days must have passed since treatment with anMAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Actavis before you can start taking an MAOI.
Drugs that can cause drowsiness: This includes prescription drugs such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and sedative antihistamines.
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 unexpected symptoms while taking these medicines with Duloxetine Actavis.
Oral anticoagulants or antiplatelet drugs: Blood thinners or blockers that prevent blood clots from forming. These agents may increase the risk of bleeding.
Duloxetine Actavis with alcohol
You should be careful with alcohol while taking Duloxetine Actavis.
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 Duloxetine Actavis. You should only use Duloxetine Actavis after consulting your doctor regarding the possible benefits of the treatment and any possible risks to the fetus.
- Tell your midwife or doctor that you are using Duloxetine Actavis. 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 Actavis 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 Actavis 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 Actavis during breast-feeding is not recommended. Consult your doctor or pharmacist.
Driving and using machines
Duloxetine Actavis may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine Actavis 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 Actavis 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.
How to use Duloxetine Actavis
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one 40 mg capsule of Duloxetine Actavis twice daily (morning and late afternoon/evening). However, your doctor may choose to start your treatment with a 20 mg capsule twice daily for two weeks and then increase the dose one to 40 mg twice daily.
Duloxetine Actavis is taken orally. Swallow the capsule whole with a glass of water.
Duloxetine Actavis can be taken with or without food.
It is easier to remember to take Duloxetine Actavis if you take it at the same time each day.
Do not stop taking Duloxetine Actavis, 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 Actavis then you should
Contact your doctor or pharmacist immediately if you have taken more Duloxetine Actavis than your doctor advised. 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, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Duloxetine Actavis
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 the forgotten dose. Do not take more Duloxetine Actavis per day than prescribed by your doctor.
If you stop taking Duloxetine Actavis
DO NOT STOP taking Duloxetine Actavis, even if you feel better, without talking to your doctor first. If your doctor thinks you no longer need Duloxetine Actavis, he/she will reduce your dose for two weeks.
Some patients who abruptly stop taking Duloxetine Actavis after more than a week of treatment may experience symptoms such as:
- dizziness, tingling of needles or sensations of electric shock (especially in the head), sleep disturbances (vivid dreams, nightmares, insomnia), fatigue, drowsiness, feeling of restlessness or anxiety, anxiety, nausea/vomiting, tremors, headache, muscle aches, 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 short time.
Very common (may affect more than 1 user in 10):
- nausea, dry mouth, constipation
Common (may affect up to 1 in 10 people):
- loss of appetite
- difficulty falling asleep, feeling upset, decreased sexual desire, anxiety, poor sleep
- headache, dizziness, feeling sluggish, feeling drowsy, tremors, and numbness, which include numbness or tingling in the skin
- high blood pressure, redness
- diarrhea, stomach pain, nausea and vomiting, heartburn or indigestion
- increased sweating
- weakness chills.
Uncommon (may affect up to 1 in 100 people):
- pharyngitis causing a hoarse voice
- allergic reactions
- impaired thyroid function, which can cause fatigue or weight gain
- gnashing of teeth, feeling disoriented, lack of motivation, difficulty getting or not having an orgasm, strange dreams
- feeling nervous, difficulty concentrating, taste changes, poor sleep
- large pupil er (the dark field in the middle of the eye), visual disturbances, the eyes feel dry
- tinnitus (sensation of sound in the ear without external sound source), pain in the ears
- palpitations, rapid and/or irregular heartbeat
- bloody vomiting or black tarry stools, gastrointestinal inflammation, inflammation of the mouth, belching, difficulty swallowing, flatulence, bad breath
- inflammation of the liver that can cause abdominal pain and yellowing of the skin and whites of the eyes
- (itchy) rash, night sweats, hives, cold sweats, increased tendency to bruise
- muscle pain, muscle tension, muscle twitching, cramping in the jaw muscles
- difficulty urinating, painful urination, need to empty the bladder during the night, frequent bladder emptying, abnormal odor on the urine
- abnormal vaginal bleeding, menopausal symptoms
- chest pain, feeling cold, thirsty, feeling hot
- weight loss, weight gain
- Duloxetine Actavis 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 (may affect up to 1 in 1,000 people):
- severe allergic reactions that cause difficulty breathing or dizziness, with swollen tongue or swollen lips
- 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, suicidal ideation, mania (overactivity, thoughtlessness, and decreased need for sleep), feelings of aggression and anger
- “Serotonergic syndrome” (a rare reaction that may cause feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or stiff muscles), seizures, sudden involuntary twitching or twitching of the muscles, a feeling of restlessness, and difficulty sitting or standing still, difficulty controlling movements e.g. lack of coordination or involuntary movements in the muscles, restless legs (numbness and tingling sensation in the legs)
- increased pressure in the eye ( glaucoma )
- fainting and dizziness when getting up, cold fingers and/or toes
- feel thick in the throat, nosebleeds
- cough, wheezing, and shortness of breath that may be accompanied by high body temperature
- bright red blood in the stool, 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 ), sensitivity to sunlight
- muscle twitching
- difficulty or inability to urinate, need to empty the bladder more often than usual, decreased urine flow
- abnormal menstruation, including heavy, painful, irregular or prolonged menstruation, unusually short or absent menstruation, abnormal production of breast milk
- severe vaginal bleeding shortly after delivery ( postpartum hemorrhage)
- fall accidents (mostly in the elderly), abnormal gait.
Very rare (may affect up to 1 in 10,000 people):
- inflammation of the blood vessels of the skin ( cutaneous vasculitis ).
5. How to store Duloxetine Actavis
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 after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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
What Duloxetine Actavis contains
The active substance is duloxetine
One capsule contains 20 mg or 40 mg of duloxetine (as hydrochloride).
Capsule contents: Sugar spheres (sucrose, maize starch), hypromellose phthalate, hypromellose (E15 LV), triethyl citrate, hydroxypropyl cellulose, talc.
Capsule cover 20 mg: Brilliant blue FCF (E133), titanium dioxide (E171), hypromellose (E464).
Capsule cover 40 mg: Titanium dioxide (E171), yellow iron oxide (E172), hypromellose (E464).
Printing inks: shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.
What Duloxetine Actavis looks like and the contents of the pack
Duloxetine Actavis is a hard, gastric juice-resistant capsule. Each capsule contains fine grains of duloxetine hydrochloride with a coating that resists the acidic gastric juice.
Duloxetine Actavis is available in 2 strengths: 20 and 40 mg.
The 20 mg capsule has an opaque blue lower part marked ‘DLX 20’, and an opaque blue upper part marked ‘DLX 20’, length 15.9 mm.
The 40 mg capsule has an opaque yellow lower part marked with ‘DLX 40, and an opaque yellow upper part marked with’ DLX 40, length 19.4 mm.
Duloxetine Actavis is available in:
- Plastic cans (HDPE) with a screw cap with silica gel desiccant in pack sizes 28, 30, 56, 60, 84, 90, 98, and 100 capsules.
- Blisters (AL / AL) in pack sizes of 7, 10, 28, 30, 56, and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf