20 mg and 40 mg enteric
capsule duloxetine
What Loxentia is and what it is used for
Loxentia contains the active substance duloxetine. Loxentia increases the amount of serotonin and norepinephrine in the nervous system.
Loxentia is a medicine 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.
Loxentia is believed to work by strengthening the muscles that hold back urine when laughing, sneezing, or exercising.
The effect of Loxentia is enhanced when combined with an exercise program that strengthens the muscles in the pelvic floor.
Duloxetine contained in Loxentia may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Loxentia
Do not use Loxentia
- is allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
- have liver disease
- have severe kidney disease
- has or during the last 14 days has taken a medicine that belongs to the group monoamine oxidase inhibitors ( MAOIs ) (see “Other medicines and Loxentia”)
- taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat certain infections you
Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should take Loxentia.
Warnings and cautions
If you suffer from any of the following, Loxentia may not be right for you. Talk to your doctor before using Loxentia if you:
- taking antidepressants (see “Other medicines and Loxentia”)
- takes St. John’s wort , an 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 Loxentia”)
Medicines such as Loxentia ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Loxentia can cause a feeling of restlessness and difficulty sitting or standing still. If this happens, tell your doctor.
If you start to feel worse and have thoughts of harming yourself
Although Loxentia 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 can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for a drug of this type 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 go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It can 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
Loxentia 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. 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 Loxentia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The most important ingredient in Loxentia, 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 Loxentia with other medicines. Check with your doctor before you start or stop taking any medicines, including over-the-counter and herbal remedies.
Tell your doctor if you are taking any of the following:
Monoamine oxidase inhibitors ( MAOIs ): Loxentia should not be taken if you are taking or have taken (during the last 14 days) another antidepressant medicine called MAO inhibitors. Examples of MAO inhibitors are moclobemide (an antidepressant drug) and linezolid (an antibiotic ). Many of the prescription drugs, including Loxentia, if taken with an MAOI, can cause serious or even life-threatening side effects. Before you can take Loxentia at least 14 days have passed since treatment with a MAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Loxentia before you can start taking an MAOI.
Drugs that can cause drowsiness: This includes prescription drugs such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.
Drugs that increase serotonin levels: Triptans, tramadol, tryptophan, SSRIs (eg paroxetine and fluoxetine ), SNRIs (eg venlafaxine ), tricyclic antidepressants (eg clomipramine, amitriptyline), pethidine, St. John’s wort, and MAO inhibitors (eg moclobemide and linezolid). These drugs increase the risk of side effects. Contact your doctor if you get any unexpected symptoms while taking these medicines with Loxentia.
Oral anticoagulants or thrombocyte aggregation inhibitors: Blood thinners or blockers that prevent blood clots from forming. These agents may increase the risk of bleeding.
Loxentia with food, drink and alcohol
Loxentia can be taken with or without food. You should be careful with alcohol during treatment with Loxentia.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, 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 Loxentia. You should only use Loxentia after consulting your doctor about the possible benefits of the treatment and any possible risks to the fetus.
- Tell your midwife or doctor that you are taking Loxentia. 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 your midwife or doctor immediately.
- If you take Loxentia at the end of your pregnancy, your baby may experience some postpartum symptoms. These symptoms usually appear 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 Loxentia at the end of your pregnancy, there is an increased risk of severe vaginal bleeding shortly after delivery, especially if you have previously had bleeding disorders. Your doctor or midwife should tell you to take duloxetine so that they can give you advice.
- Available data from the use of duloxetine during the first three months of pregnancy do not indicate a general increased risk of birth defects in the baby. If Loxentia is taken during the second half of pregnancy, there may be an increased risk of the baby being born prematurely (6 extra premature babies per 100 women taking Loxentia during the second half of pregnancy), usually between weeks 35 and 36 of the pregnancy.
- Tell your doctor if you are breast-feeding. The use of Loxentia during breast-feeding is not recommended. Consult your doctor or pharmacist.
Driving and using machines
Loxentia may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Loxentia affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Loxentia 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 Loxentia
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Loxentia is taken by mouth. Swallow the capsule whole with a glass of water.
The usual dose is a 40 mg Loxentia capsule twice daily (in the 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.
It is easier to remember to take Loxentia if you take it at the same time each day.
Do not stop taking Loxentia, or change the dose, without first discussing this 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 use more Loxentia than you should
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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 user in 10)
- nausea, dry mouth , constipation
- fatigue
Common side effects (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
- dimsyn
- dizziness
- high blood pressure , redness
- diarrhea, stomach pain, nausea and vomiting, heartburn or indigestion
- increased sweating
- weakness, chills
Uncommon side effects (may affect up to 1 in 100 people)
- pharyngitis causing hoarse voice
- allergic reactions
- impaired thyroid function, which can cause fatigue or weight gain
- dehydration
- gnashing of teeth, feeling disoriented, lack of motivation, difficulty getting or not having an orgasm, strange dreams
- feeling nervous, difficulty concentrating, changes in taste, 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
- fainting
- yawning
- 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
- Loxentia 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
- low sodium level 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 intoxicated, fever, sweating or stiff muscles), seizures, sudden involuntary twitching or twitching of the muscles, a feeling of restlessness and difficulty sitting or stand 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 (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 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 haemorrhage )
- fall accidents (mostly in the elderly), abnormal gait
Very rare side effects (may affect up to 1 in 10,000 people)
- inflammation of the blood vessels of the skin ( cutaneous vasculitis )
How to store Loxentia
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.
Store in the original package. Moisture sensitive.
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.
Contents of the package and other information
Content declaration
The active substance is duloxetine. Each capsule contains 20 mg or 40 mg of duloxetine (as duloxetine hydrochloride).
Other ingredients are:
Capsule contents: Sugar spheres (sucrose, maize starch), hypromellose 6 cp, sucrose, hypromellose phthalate, talc, and triethyl citrate.
Capsule shell: Gelatin, titanium dioxide (E171), indigotin (E132), yellow iron oxide (E172) – only in 40 mg capsules, red iron oxide (E172) – only in 40 mg capsules, ink (shellac, black iron oxide (E172)).
See section 2 “Loxentia contains sucrose”
What the medicine looks like and contents of the pack
20 mg enteric capsule: White to off-white pellets in a size 4 hard gelatin capsule (mean length 14.4 mm). The body and lid of the capsule are light blues. The capsule body is marked with “20” in black.
40 mg enteric capsule: White to off-white pellets in a size 2 hard gelatin capsule (mean length 17.9 mm). The body of the capsule is light orange and the lid is light blue. The capsule body is marked with “40” in black.
Loxentia is available in packs containing 7, 10, 14, 28, 30, 56, 60, 90, and 100 hard enteric capsules in blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia