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.

In this leaflet: 
1. What Duloxetine Sandoz is and what it is used for 
2. What you need to know before taking Duloxetine Sandoz  
3. How to take Duloxetine Sandoz 
4. Possible side effects 
5. How to store Duloxetine Sandoz 
6. Contents of the packaging and other information 

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

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

Duloxetine Sandoz 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 Sandoz starts working within two weeks of starting treatment, but it may take 2-4 weeks before you feel better. Talk to your doctor about

you do not start to feel better after this time. Your doctor may continue to give you Duloxetine Sandoz 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 Sandoz 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 take Duloxetine Sandoz 

Do not take Duloxetine Sandoz 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, which belongs to the group monoamine oxidase inhibitors ( MAOIs ) (see “Other medicines and Duloxetine Sandoz”)
  • 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 Sandoz”).

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

Warnings and cautions

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

  • taking other medicines for depression (see “Other medicines and Duloxetine Sandoz”)
  • 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
  • taking other medicines containing duloxetine (see “Other medicines and Duloxetine Sandoz”)

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

Drugs such as Duloxetine Sandoz (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 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 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 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 Sandoz 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 Sandoz 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 Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The active ingredient of Duloxetine Sandoz, duloxetine, is used in other medicines for

disease state:

  • 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 Sandoz 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 Sandoz should not be taken if you are taking or have taken another antidepressant called MAOIs for the last 14 days. Examples of MAO inhibitors are moclobemide (an antidepressant drug) and linezolid (an antibiotic ). Many prescription drugs, including Duloxetine Sandoz, if taken with an MAOI, can cause serious or even life-threatening side effects  Before you can take Duloxetine Sandoz at least 14 days have passed since treatment with a MAOIcompleted. Likewise, at least 5 days must have elapsed after stopping treatment with Duloxetine Sandoz 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 Sandoz.
  • Oral anticoagulants or antiplatelet agents: Blood thinners or blockers that prevent blood clots from forming. These agents may increase the risk of bleeding.

Duloxetine Sandoz with food, drink, and alcohol

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

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 Sandoz. You should only use Duloxetine Sandoz after consulting your doctor regarding the possible benefits of treatment and any possible risks to the fetus.

Tell your midwife or doctor that you are using Duloxetine Sandoz. 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 Sandoz 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 Duloxetine Sandoz during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

Duloxetine Sandoz may make you feel drowsy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine Sandoz 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 Sandoz contains lactose, Allura red AC (E 129), sodium, brilliant blue FCF (E 133), and para-orange (E 110)

Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Sodium: Duloxetine Sandoz contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.

Allura Red AC (E129): May cause allergic reactions.

Brilliant blue FCF (E 133): May cause allergic reactions.

Para-orange (E110): May cause allergic reactions (Duloxetine Sandoz 60 mg only).

How to take Duloxetine Sandoz

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

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

For depression and painful diabetic neuropathy:

The usual dose is Duloxetine Sandoz 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 Sandoz 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 Sandoz.

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

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

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 Sandoz per day than prescribed by your doctor.

If you stop taking Duloxetine Sandoz

Do not stop taking Duloxetine Sandoz, even if you feel better, without talking to your doctor first. If your doctor considers that you no longer need Duloxetine Sandoz, he/she will reduce the dose for at least two weeks, before stopping treatment completely.

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

  • dizziness
  • tingling and numbness or sensations of electric shock (especially in the head)
  • sleep disorders (vivid dreams, nightmares, insomnia)
  • fatigue, drowsiness
  • the feeling of restlessness or anxiety
  • anxiety
  • nausea/vomiting (feeling sick)
  • shaking
  • 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 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, dizziness, 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 Sandoz 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 )

  • cough, wheezing, and shortness of breath that may be accompanied by high body temperature
  • 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 (affects the elderly most; symptoms may feel dizzy, weak, confused, sleepy or very tired, nausea or vomiting, more severe 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 )
  • 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 in 10,000 people )

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

5. How to store Duloxetine Sandoz

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 blister/can/carton after EXP. 
The expiration date is the last day of the specified month.

Do not store above 30 ° C.

HDPE cans: After first opening: used within 3 months.

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: pregelatinized maize starch, microcrystalline cellulose, povidone K 30, talc, magnesium stearate, sodium stearyl fumarate, hypromellose acetate succinate, titanium dioxide (E 171), lactose monohydrate, hypromellose, and macrogol 4000.

Capsule shell: titanium dioxide (E 171), gelatin, brilliant blue FCF (E 133), all-red AC (E 129),

quinoline yellow (E 104) (applies to Duloxetine Sandoz 60 mg only), para-orange (E 110) (applies to Duloxetine Sandoz 60 mg only).

Printing ink: shellac, indigo carmine aluminum lacquer (E 132), titanium dioxide (E 171), propylene glycol (E 1520).

What the medicine looks like and the contents of the pack

Duloxetine Sandoz 30 mg are hard enteric capsules with an opaque dark blue upper part and an opaque white lower part marked with “30”. The capsules contain four white to off-white, round, biconvex tablets containing a total of 30 mg of duloxetine as an active substance.

Capsule size: approximately 18 mm.

Duloxetine Sandoz 60 mg are hard enteric capsules with an opaque dark blue upper part and an opaque yellow-green lower part marked with “60”. The capsules contain eight white to off-white, round, biconvex tablets containing a total of 60 mg of duloxetine as an active substance.

Capsule size: approximately 24 mm.

Duloxetine Sandoz hard enteric capsules are supplied in (PVC / PE / PCTFE // Al or PA / Al / PVC // Al) blisters in a carton.

Pack sizes: 
Duloxetine Sandoz 30 mg: 7, 14, 28, 30 and 98 capsules.

Duloxetine Sandoz 60 mg: 14, 28, 30, 56, 84 and 98 capsules.

Duloxetine Sandoz hard enteric capsules are supplied in HPDE jars with a child-resistant PP screw cap in a carton.

Pack sizes: 30, 120, and 200 capsules.

Jar of 120 and 200 capsules are intended for dose dispensing and hospital use only.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Pharmathen SA, Dervenakion str. 6, Pallini, 15351 Attiki, Greece

or

Pharmathen International SA, Industrial Park Sapes, Rodopi Prefecture, Block No 5, 69300 Rodopi, Greece 

Muhammad Nadeem

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