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

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important for 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.

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

1. What Cymbalta is and what it is used for

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

Cymbalta 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, Cymbalta 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 Cymbalta even when you are feeling better to prevent recurrence of 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.

What you need to know before you take Cymbalta

DO NOT TAKE Cymbalta 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
  • takes or has taken during the last 14 days a medicine belonging to the group monoamine oxidase inhibitors ( MAOIs ) (see “Other medicines and Cymbalta”)
  • 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 Cymbalta”).

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

Warnings and cautions

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

  • taking other medicines for depression (see “Other medicines and CymbaltaALTA”)
  • 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 that contain duloxetine (see “Other medicines and Cymbalta”).

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

Drugs such as Cymbalta (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 are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

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

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

Cymbalta 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, Cymbalta can 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.

Cymbalta with food, drink, and alcohol

Cymbalta can be taken regardless of the meal. You should be careful with alcohol during treatment with Cymbalta.

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 Cymbalta. You should only use Cymbalta 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 taking Cymbalta. 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 Cymbalta 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 Cymbalta 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 Cymbalta during the first three months of pregnancy do not indicate a generally increased risk of birth defects in the baby. If Cymbalta 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 Cymbalta 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 Cymbalta during breast-feeding is not recommended. Consult your doctor or pharmacist.

Driving and using machines

Cymbalta can make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Cymbalta affects you.

Cymbalta contains sucrose

Cymbalta 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.

Cymbalta contains sodium

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

How to take Cymbalta

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

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

For depression and painful diabetic neuropathy:

The usual dose is Cymbalta 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 Cymbalta 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 Cymbalta.

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

Ask your doctor how long to take Cymbalta. Do not stop taking Cymbalta, 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 take more Cymbalta then you should

Contact your doctor or pharmacist immediately if you have taken more Cymbalta than your doctor prescribed. 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 Cymbalta

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 Cymbalta per day than prescribed by your doctor.

If you stop taking Cymbalta

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

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

  • headache, drowsiness
  • nausea, dry mouth

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

  • 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
  • Tamsyn
  • 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 user in 100)

  • 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
  • Cymbalta 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 user in 1000)

  • 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); symptoms may include dizziness, weakness, confusion, sleepiness or tiredness, 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), 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
  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage)

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

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

5. How to store Cymbalta

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.

Store in the original package. Moisture sensitive. Do not store above 30 ° 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

Content declaration

The active substance is duloxetine. Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).

Other ingredients are:

Capsule contents: Hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide E171, triethyl citrate.

(See the end of section 2 for more information on sucrose)

Capsule shell: Gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only), and green food color (30 mg) or white food color (60 mg).

Green food color: Synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.

White food color: Titanium dioxide (E171), propylene glycol, shellac, povidone.

What the medicine looks like and the contents of the pack

Cymbalta is a hard, gastric juice-resistant capsule. Each capsule of CYMBALTA contains granules of duloxetine hydrochloride with a shell that resists the acidic gastric juice.

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

The 30 mg capsule is blue and white, marked “30 mg” and the code “9543”.

The 60 mg capsule is blue and green, marked “60 mg” and the code “9542”.

Cymbalta 30 mg is supplied in packs containing 7, 28, or 98 hard capsules.

Cymbalta 60 mg is supplied in packs containing 28, 56, 84, or 98 hard enteric capsules and in multipacks containing 100 (5 cartons of 20) or 500 (25 cartons of 20) hard enteric capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer: Lilly SA, Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain.

Further information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Muhammad Nadeem

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