LUDOTIM 120 mg GASTRO-RESISTANT HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Ludotim 120 mg hard gastro-resistant capsules

duloxetine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ludotim and what is it used for
2. What you need to know before you take Ludotim
3. How to take Ludotim
4. Possible side effects
5. Storing Ludotim
6. Contents of the pack and other information

1. What is Ludotim and what is it used for

Ludotim contains the active substance duloxetine.

Duloxetine increases the levels of serotonin and noradrenaline in the nervous system.

Ludotim is used in adults to treat:

• depression
• generalized anxiety disorder (a persistent feeling of anxiety or nervousness).

Duloxetine starts to work in most people with depression or anxiety within 2 weeks of starting treatment, but it may take between 2 and 4 weeks before you start to feel better. Tell your doctor if you do not feel better after this time. Your doctor may continue to give you duloxetine when you are feeling better to prevent your depression or anxiety from returning.

2. What you need to know before you take Ludotim

Do not take Ludotim

• if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6),
• if you have liver failure,
• if you have severe kidney disease,
• if you are taking or have taken within the last 14 days another medicine called a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Ludotim’),
• if you are taking fluvoxamine, which is usually used to treat depression, or ciprofloxacin or enoxacin, which are used to treat some infections.

Talk to your doctor if you have high blood pressure or heart disease. Your doctor will decide if you can take Ludotim.

Warnings and precautions

This medicine may not be suitable for you due to the following reasons. Talk to your doctor before taking Ludotim if:

• you are using other medicines to treat depression (see ‘Other medicines and Ludotim’),
• you are taking St. John's Wort (Hypericum perforatum), a herbal remedy,
• you have any kidney disease,
• you have had seizures (fits),
• you have had mania,
• you have bipolar disorder,
• you have eye problems, such as certain types of glaucoma (increased eye pressure),

• you have had bleeding problems (a tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding’)

• you are at risk of having low sodium levels (for example, if you are taking diuretics, especially if you are an elderly person),
• you are being treated with other medicines that may cause liver damage,
• you are taking other medicines that contain duloxetine (see ‘Other medicines and Ludotim’).

Duloxetine may cause a feeling of restlessness or an inability to sit or stand still. If this happens, you should talk to your doctor.

Some medicines of the same group as duloxetine (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts and worsening of your depression or anxiety

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be increased at the start of treatment with antidepressants, as all these medicines take time to work, usually about 2 weeks, but sometimes longer.

You are more likely to have these thoughts if:

• you have previously had thoughts of suicide or self-harm,
• you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

Contact your doctor or go to the hospital immediately if you experience any thoughts of self-harm or suicide.

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years. Also, you should know that patients under 18 years have an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (predominantly aggression, oppositional behaviour, and anger) when they take this type of medicine. Despite this, your doctor may prescribe duloxetine to patients under 18 years because they decide that it can be beneficial for the patient. If your doctor has prescribed duloxetine to a patient under 18 years and you want to discuss it, please go back to the doctor. You must tell your doctor if any of the above symptoms occur or get worse in patients under 18 years who are taking duloxetine. Additionally, in this age group, the long-term safety effects of duloxetine on growth, maturation, and cognitive and behavioural development have not yet been demonstrated.

Other medicines and Ludotim

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

The main component of Ludotim, duloxetine, is used in other medicines for other treatments: diabetic neuropathic pain, depression, anxiety, and urinary incontinence.

You should avoid using more than one of these medicines at the same time. Talk to your doctor if you are already taking another medicine that contains duloxetine.

Your doctor will decide if you can take duloxetine with other medicines. Do not start or stop taking any medicine, including those obtained without a prescription, without talking to your doctor first.

You should also tell your doctor if you are taking any of the following medicines:

Monoamine oxidase inhibitors (MAOIs):do not take duloxetine if you are taking, or have taken within the last 14 days, another medicine for depression called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking an MAOI with many prescription medicines, including duloxetine, can cause serious side effects, even life-threatening ones. You should wait at least 14 days after stopping an MAOI before taking duloxetine. Similarly, you should wait at least 5 days after stopping duloxetine before starting an MAOI.

Medicines that cause drowsiness:include medicines prescribed by your doctor such as benzodiazepines, strong painkillers, antipsychotics, phenobarbital, and antihistamines.

Medicines that increase serotonin levels:triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (such as paroxetine and fluoxetine), serotonin and noradrenaline reuptake inhibitors (such as venlafaxine), tricyclic antidepressants (such as clomipramine and amitriptyline), pethidine, St. John's Wort, and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you notice any unusual symptoms when taking any of these medicines with duloxetine, you should talk to your doctor.

Oral anticoagulants or antiplatelet agents:medicines that thin the blood or prevent blood clots. These medicines may increase the risk of bleeding.

Taking Ludotim with food, drinks, and alcohol

This medicine can be taken with or without food. You should be cautious if you drink alcohol while being treated with duloxetine.

Pregnancy and breast-feeding

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 are planning to become pregnant while being treated with duloxetine. You should only take duloxetine after discussing the potential benefits and risks of treatment with your doctor.

• Make sure your midwife and/or doctor know you are taking duloxetine. Other similar medicines (called SSRIs) taken during pregnancy may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

• If you take duloxetine near the end of your pregnancy, your baby may have some symptoms when it is born. These usually start at birth or in the first few days after birth. The symptoms are: weak muscles, trembling, restlessness, difficulty feeding, breathing problems, and seizures. If your baby has any of these symptoms at birth, or if you are worried about your baby's health, contact your doctor or midwife, who can advise you.

• If you take duloxetine near the end of your pregnancy, there is a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have had bleeding problems. Your doctor or midwife should know that you are taking duloxetine so they can advise you.

• Data on the use of duloxetine during the first three months of pregnancy do not show an increased overall risk of birth defects in the baby. If you take duloxetine during the second half of pregnancy, there may be a higher risk that the baby will be born early (6 additional premature babies per 100 women taking duloxetine in the second half of pregnancy), especially between weeks 35 and 36 of pregnancy.

• Tell your doctor if you are breast-feeding. Duloxetine is not recommended during breast-feeding. Ask your doctor or pharmacist for advice.

Driving and using machines

During treatment with duloxetine, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment affects you.

Ludotim contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ludotim contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially ‘sodium-free’.

3. How to take Ludotim

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

Duloxetine should be taken by mouth. You should swallow the capsule whole with water.

For depression:

The recommended dose of duloxetine is 60 mg once a day, but your doctor will prescribe the dose that is best for you.

For generalized anxiety disorder:

The usual starting dose of duloxetine is 30 mg once a day, after which most patients are given 60 mg once a day, but your doctor will prescribe the dose that is best for you. The dose may be adjusted up to 120 mg a day depending on your response to duloxetine.

This medicine can be taken with or without food.

Taking the capsule at the same time every day can help you remember to take duloxetine.

Talk to your doctor about how long you should take this medicine. Do not stop taking duloxetine, or change your dose, without talking to your doctor. It is important to treat your condition properly to help you improve. If you do not treat your condition, it may not get better and may become more serious and more difficult to treat.

If you take more Ludotim than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Symptoms produced by an overdose include drowsiness, coma, serotonin syndrome (a rare reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness), seizures, vomiting, and rapid heart rate.

If you forget to take Ludotim

If you forget to take a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take a single dose as you normally would. Do not take a double dose to make up for a missed dose. Do not take more Ludotim than prescribed for you in one day.

If you stop taking Ludotim

Do not stop taking your capsules without your doctor's advice, even if you feel better. If your doctor thinks you do not need to take duloxetine anymore, they will tell you to reduce your dose over at least 2 weeks before stopping treatment.

Some patients who stop taking duloxetine abruptly have experienced symptoms such as:

• dizziness, tingling sensations like pins and needles or electric shock-like sensations (especially in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, drowsiness, feeling restless or agitated, feeling anxious, nausea or vomiting, tremor, headache, muscle pain, feeling irritable, diarrhea, and excessive sweating or dizziness.

These symptoms are usually not serious and go away within a few days, but if you have symptoms that are bothering you, ask your doctor for advice.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. These effects are usually mild to moderate and disappear, often, within a few weeks.

Very Common Adverse Effects (may affect more than 1 in 10 patients)

• Headache, drowsiness
• Nausea, dry mouth

Common Adverse Effects (may affect up to 1 in 10 patients)

• Loss of appetite
• Difficulty sleeping, feeling of agitation, decreased sexual desire, anxiety, difficulty or inability to have an orgasm, unusual dreams
• Dizziness, feeling of slowness, tremors, numbness, including numbness, itching, or tingling of the skin
• Blurred vision
• Tinnitus (perception of sounds in the ear when there is no external sound)
• Feeling palpitations in the chest
• Increased blood pressure, flushing
• Increased yawning
• Constipation, diarrhea, stomach pain, vomiting, heartburn or indigestion, gas
• Increased sweating, rash (itching)
• Muscle pain, muscle spasms
• Painful urination, frequent urination
• Difficulty getting an erection, changes in ejaculation
• Falls (mostly in elderly people)
• Weight loss

Children and adolescents under 18 years of age with depression treated with this medicine experienced a decrease in weight when they started taking this medicine. After six months of treatment, the weight normalized to similar levels of other children and adolescents of the same age and sex.

Uncommon Adverse Effects (may affect up to 1 in 100 patients)

• Inflammation of the throat that causes hoarseness
• Suicidal thoughts, difficulty sleeping, grinding or clenching teeth, feeling of disorientation, lack of motivation
• Muscle spasms and involuntary movements, feeling of restlessness or inability to stay seated or still, nervousness, difficulty concentrating, changes in taste, difficulty controlling movements, e.g., lack of coordination or involuntary muscle movements, restless legs syndrome, poor quality sleep.
• Dilation of the pupils (the black dot in the center of the eye), vision problems
• Feeling of dizziness or vertigo, ear pain
• Fast and/or irregular heartbeats
• Fainting, dizziness, feeling of dizziness or fainting when standing up, coldness in the fingers of the hands and/or feet
• Throat spasms, nosebleeds
• Vomiting blood, or black stools, gastroenteritis, belching, difficulty swallowing
• Inflammation of the liver that can cause abdominal pain and yellowing of the skin or the white part of the eyes
• Night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• Muscle stiffness, muscle spasms
• Difficulty or inability to urinate, difficulty starting urination, need to urinate at night, need to urinate more than usual, decreased urine flow
• Abnormal vaginal bleeding, abnormal menstrual periods, including heavy, painful, irregular, or prolonged menstrual periods, very light or absent menstrual periods, testicular or scrotal pain
• Chest pain, feeling of cold, thirst, chills, feeling of heat, alteration in gait
• Weight gain
• Duloxetine may cause effects that you may not be aware of, such as increased liver enzymes or potassium levels in the blood, creatine phosphokinase, sugar, or cholesterol.

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• Severe allergic reactions that cause difficulty breathing or dizziness with swelling of the tongue or lips, allergic reactions
• Decreased activity of the thyroid gland, which can cause fatigue or weight gain
• Dehydration, low sodium levels in the blood (mostly in elderly people; symptoms may include feeling of dizziness, weakness, confusion, sleepiness, or excessive tiredness, nausea, or vomiting. The most serious symptoms are fainting, seizures, or falls), syndrome of inadequate secretion of antidiuretic hormone (SIADH)
• Suicidal behavior, mania (hyperactivity, accelerated thinking, and decreased need for sleep), hallucinations, aggression, and anger
• «Serotonin syndrome» (a rare reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness), convulsions
• Increased pressure in the eye (glaucoma)
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever
• Inflammation of the mouth, bright red blood in the stool, bad breath, inflammation of the large intestine (leading to diarrhea)
• Liver failure, yellowing of the skin or the white part of the eyes (jaundice)
• Stevens-Johnson syndrome (a serious disease with blistering of the skin, mouth, eyes, and genitals), severe allergic reactions that cause swelling of the face or throat (angioedema)
• Jaw muscle contractions
• Unusual urine odor
• Menopausal symptoms, abnormal milk production in men or women
• Excessive vaginal bleeding shortly after birth (postpartum hemorrhage)

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients)

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

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ludotim

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

Do not use this medicine after the expiration date (EXP) that appears on the box. The expiration date is the last day of the month indicated.

PVC/PVDC-Aluminum Blister: Do not store at a temperature above 30 °C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ludotim 120 mg

The active ingredient is duloxetine.

Each hard gastro-resistant capsule contains 120 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content:hypromellose, talc, titanium dioxide (E-171), copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion at 30% (contains sodium lauryl sulfate and polysorbate 80), triethyl citrate, sugar spheres (contain sucrose and cornstarch), sucrose.

Capsule body:gelatin, brilliant blue FCF (E-133), printing ink (black iron oxide [E-172], potassium hydroxide, shellac gums).

Appearance of the Product and Package Contents

Duloxetine is a hard gastro-resistant capsule. Each hard duloxetine capsule contains duloxetine hydrochloride in the form of pelletscoated to protect them from gastric acid.

Ludotim 120 mg hard gastro-resistant capsules are hard gelatin capsules of size 00 with a transparent blue cap and a transparent blue body, printed with black ink (cap «DU»/body «120») approximately 23.2 mm in length.

This medicine is available in blisters of 28 hard gastro-resistant capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

NewLine Pharma S.L.U.

C/ Tarragona, 151-157

Planta 11, Puerta 01, Bloque A

08014 Barcelona (Spain)

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107, Barcelona,

Spain

Date of the Last Revision of this Leaflet: June 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/