LUDIOMIL 25 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Ludiomil25mg film-coated tablets

maprotiline hydrochloride

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

1. What Ludiomil is and what it is used for

Each Ludiomil 25 mg tablet contains 25 mg of maprotiline hydrochloride.

It belongs to a group of antidepressants called tetracyclic antidepressants. The known action and clinical use of maprotiline is similar to that of tricyclic antidepressants (TCA), such as amitriptyline. Ludiomil helps to relieve the symptoms of depression, such as anxiety, sadness, loss of interest, difficulty carrying out daily activities, nervousness, and sleep disturbances.

Ludiomil is indicated for adults over 18 years of age.

2. What you need to know before you take Ludiomil

Do not take Ludiomil

• If you are allergic to maprotiline hydrochloride or any of the other ingredients of this medicine (listed in section 6).

If you are allergic to other cyclic antidepressants, such as imipramine, amitriptyline, and doxepin.

• If you have recently suffered from epileptic seizures or convulsions (e.g., in case of brain injuries, alcoholism).

If you have a severe heart disorder or have recently suffered a heart attack.

• If you have severe kidney or liver function disorders.
• If you have high intraocular pressure (narrow-angle glaucoma).
• If you have ever had urinary retention due to an enlarged prostate.
• If you are taking or have taken a specific medicine from the group of monoamine oxidase inhibitors (MAO), such as isocarboxazid, moclobemide, biperiden.
• If you are taking alcohol, narcotics, or medications that affect your mental state.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• If you are going to take the medicine to treat heart rhythm disorders (e.g., quinidine, propafenone).

If you have thought about harming yourself or taking your own life.

• If you have a history of any type of heart function disorder.
• If you have a mental illness such as schizophrenia or mania (a mood disorder).
• If you have diabetes. You will need to have regular checks of your blood sugar levels and may need to adjust your diabetes medication.

If you have frequent and severe constipation.

• If you have hyperthyroidism or are currently taking any thyroid hormone medication.
• If you wear contact lenses.
• If you have ever had an increase in eye pressure.
• If you have ever had difficulty urinating due to prostate problems.
• If your doctor has ever told you that you are intolerant to certain sugars (e.g., lactose).
• There has been an observed increase in the risk of bone fractures in patients treated with this type of medication.

Ludiomil may reduce the convulsive threshold, so if you have an increased tendency to seizures (e.g., withdrawal syndrome after abruptly stopping the use of benzodiazepines or barbiturates), this may lead to an increase in seizures.

Tell your doctor if you experience any of the following symptoms during treatment with this medicine:

• Constipation.
• Fever or sore throat, especially during the first few months of treatment.
• If you feel that life is not worth living, you should seek medical help immediately.

Suicidal thoughts, worsening of depression, or anxiety disorders

If you suffer from depression or anxiety disorders, you may sometimes experience suicidal thoughts or self-harm. These symptoms may intensify when starting treatment with antidepressants for the first time, as these medications take some time to take effect, usually a few weeks, sometimes even longer.

The likelihood of such thoughts may increase if:

• You have previously had suicidal thoughts or self-harm desires.
• You are a young adult. Clinical study data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who have received antidepressants.

If you have suicidal thoughts or self-harm desires, you must contact the doctor who is treating you or go directly to the hospital.

It may be helpful to inform a relative or close friendabout your depression or anxiety disorder and ask them to read this leaflet. You can also ask them to assess whether your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

It is essential that the doctor regularly evaluates the effects of the treatment. This will allow for dose adjustment and reduction of side effects.

During follow-up visits, the doctor may recommend blood tests and analysis of kidney and liver function.

Maprotiline may cause dry mouth and increase the risk of dental caries. For this reason, it is necessary to attend regular dental check-ups during prolonged treatment.

Before undergoing dental or surgical procedures, you should inform the doctor that you are taking Ludiomil.

Ludiomil may cause high, low, or irregular heart rate. During treatment with maprotiline, the doctor may recommend monitoring blood pressure and heart function.

In combination with antidiabetic medications, Ludiomil may cause a reduction in blood sugar levels. Patients with diabetes should closely monitor their blood sugar levels.

Administration of Ludiomil may make your skin more sensitive to sunlight. Even brief exposure to the sun can cause eruptions, itching, redness, or skin discoloration. Stay away from direct sunlight, wear sunglasses, and protect yourself by wearing suitable clothing.

In predisposed and elderly patients, antidepressants may cause confusion or unusual thoughts, especially at night. If this occurs, it usually disappears on its own a few days after stopping the medication.

Sudden withdrawal or dose reduction should be avoided due to the possible appearance of side effects.

Taking Ludiomil with other medicines

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

Some medicines may affect the effects of Ludiomil and vice versa, for example:

• Other antidepressants known as monoamine oxidase inhibitors (MAO) (e.g., moclobemide) and fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram.
• Antihypertensives and medications used in heart diseases (e.g., guanethidine, betanidine, reserpine, clonidine, alpha-methyldopa, propranolol).
• Antiarrhythmic medications (quinidine, propafenone).
• Medications for the treatment of diabetes (e.g., oral antidiabetics of the sulfonylurea group or insulin).
• Medications used to prevent mental disorders (antipsychotics such as thioridazine, risperidone).
• Medications used to prevent blood clotting (anticoagulants, e.g., coumarin, warfarin).
• Adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine (which may be present in medications for heart function disorders, coughs, or colds, and in some anesthetics)
• Medications used for Parkinson's disease (e.g., biperiden).
• Antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital).
• Sedatives (such as benzodiazepine derivatives, barbiturates).
• Medications for the treatment of asthma and allergies (antihistamines).
• Medications used for the treatment of stomach ulcers and heartburn, such as cimetidine.
• A medication called terbinafine, which is used orally to treat fungal infections of the skin, hair, and nails.
• Thyroid hormone preparations.
• Antidepressants such as selective serotonin reuptake inhibitors (e.g., paroxetine, sertraline, or citalopram).
• Medications used for the treatment of attention deficit hyperactivity disorder (ADHD), such as methylphenidate.
• Atropine.
• Rifampicin (antibiotic).
• Other drugs called antiretrovirals (for HIV treatment), antimalarials (e.g., quinine), dihydroergotamine (for migraine treatment), disulfiram (Antabus, for alcoholism treatment), and muscle relaxants (e.g., baclofen).

It is essential to inform your doctor about the use of any of the above medications. It may be necessary to adjust the dose of Ludiomil or interrupt treatment with one of the medications.

Taking Ludiomil with food, drinks, and alcohol

You should inform your doctor if you regularly consume alcohol. This medication may enhance the effect of alcohol, which can increase drowsiness and alter coordination.

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.

Pregnancy

Maprotiline should not be taken during pregnancy, unless a doctor has clearly recommended its administration.

Breastfeeding

You should inform your doctor that you are breastfeeding. Maprotiline passes into breast milk, so it is advisable to stop breastfeeding if you are being treated with Ludiomil.

Driving and using machines

Maprotiline may cause drowsiness, blurred vision, dizziness, or other effects on the central nervous system. If these occur, you should not drive, use machinery, or engage in other potentially hazardous activities. Alcohol consumption may increase these effects.

Ludiomil contains lactose

Ludiomil contains a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Ludiomil

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Do not exceed the recommended dose. Take this medicine until your doctor tells you to stop.

During treatment with Ludiomil, the patient should be under medical supervision.

The doctor will decide what dose is most suitable for you based on your age and the severity of the symptoms.

Adults

The recommended dose is within the range of 75 to 150 mg per day. Depending on the severity of the symptoms, the patient's response, and tolerance to treatment, it can be started with 25 mg (one to three times a day) or 75 mg (once a day) and then gradually increased to an effective dose of maprotiline. Ludiomil should be taken according to the doctor's prescription. Do not exceed the prescribed dose or take the medicine more frequently or for a longer period than indicated by the doctor.

Elderly patients (over 60 years):

Lower doses are usually recommended. The initial dose should be 25 mg once a day. If necessary, the daily dose can be gradually increased at small intervals to 25 mg three times a day or 75 mg once a day, depending on tolerance and response to treatment.

Use in children and adolescents (under 18 years):

This medicine is not recommended for children or adolescents under 18 years of age.

Method of administration

Ludiomil tablets should be swallowed whole with sufficient liquid.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If the effect of Ludiomil seems too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

Patients should take Ludiomil for several weeks before they start to feel better. The treatment should not be interrupted without consulting the doctor. The responsible doctor should decide whether to gradually reduce the dose before stopping the treatment. This procedure will prevent the deterioration of the patient's condition and reduce the risk of withdrawal symptoms associated with sudden interruption of treatment, such as headache, nausea, vomiting, abdominal pain, diarrhea, insomnia, nervousness, and anxiety.

If you take more Ludiomil than you should

If you accidentally take more tablets than prescribed by your doctor, you should seek immediate help from your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. Bring the medicine package with you.

The following symptoms usually occur within several hours after an overdose: drowsiness, loss of consciousness, coma, convulsions, low blood pressure, rapid, low, or irregular heart rate, cardiac arrest, restlessness, agitation, altered motor coordination, and muscle rigidity, difficulty breathing, vomiting, fever, cardiovascular shock, heart failure, bluish skin discoloration, dilated pupils, sweating, and reduced urine output or suppression of urine production.

If you forget to take Ludiomil

If you forget to take a dose of Ludiomil, take the missed dose as soon as possible and take the next dose at the usual time. If it is almost time for the next dose, do not take the missed dose, but take the next dose at the scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking Ludiomil

Do not stop taking the medicine without consulting your doctor first. The doctor will gradually reduce the dose before stopping the treatment to avoid nausea, vomiting, anxiety attacks, diarrhea, insomnia, headache, nervousness, and anxiety.

If you have any further 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.

Some side effects can be serious; if you experience any of the following side effects, stop taking the medicine and seek medical attention immediately:

• Excessive excitement (manic state); worsening of depression, psychotic symptoms.
• Seizures (convulsions).
• Rapid heart rate, abnormal heart rhythm (slow, fast, or irregular), partial or total loss of consciousness (syncope)
• Liver inflammation (hepatitis), with or without yellowing of the skin and eyes.
• Allergic skin reactions, such as unusual bleeding or formation of subcutaneous bruises (erythema multiforme); severe skin reactions characterized by red spots, formation of blisters, or urticaria (Stevens-Johnson syndrome).
• Lung inflammation (characterized by cough, difficulty breathing, and wheezing).
• Abnormal ECG (electrocardiogram) results and changes in the QT segment for longer than normal.
• Excessive levels of antidiuretic hormone, leading to water retention and low sodium levels in the body (SIADH).

If you experience any of the above side effects, inform your doctor immediately,as it may be essential to adjust the dose or change the treatment.

Very common side effects(may affect more than 1 in 10 people)

• Drowsiness.
• Dizziness.
• Headache.
• Tremor.
• Abnormal muscle contractions.
• Dry mouth.
• Fatigue.

Common side effects(may affect up to 1 in 100 people)

• Increased appetite.
• Agitation and restlessness.
• Aggressiveness.
• Anxiety.
• Sleep disorders or insomnia.
• Nightmares.
• Depressed mood.
• Difficulty concentrating.
• Alteration (increase or decrease) of sexual desire or erectile dysfunction in males.
• Mania or hypomania (excited and hyperactive behavior with excessive euphoria).
• Drowsiness (sedation).
• Memory problems.
• Inability to concentrate.
• Speech difficulties.
• Numbness and tingling sensation.
• Vision problems and blurred vision.
• Sinus tachycardia (increased heart rate).
• Nausea.
• Vomiting.
• Stomach pain and cramps.
• Difficulty evacuating feces.
• Increased skin sensitivity to light.
• Increased sweating.
• Difficulty urinating.
• Abnormal weight gain.
• Muscle weakness.
• Skin inflammation, exanthema, red bumps with itching.
• Low blood pressure with dizziness when standing up from a sitting or lying position.
• Hot flashes.
• Palpitations (irregular heartbeats that can be felt).
• Rapid heartbeats.
• Fever.

Rare side effects(may affect up to 1 in 1,000 people)

• Sudden episodes of severe confusion.
• Seeing, hearing, or feeling things that do not exist, especially in elderly people.
• Nervousness.
• Involuntary muscle movements.
• Seizures.
• Restlessness.
• Inability to remain calm.
• Poor coordination.
• Diarrhea.
• Restless movement.
• Increased blood pressure.
• Abnormal liver function test results.

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

• Coordination and involuntary muscle movement disorders.
• Syncope.
• Low sodium levels in the blood.
• Temporary loss of consciousness.
• Abnormal taste sensation.
• Perception of noises in the ears (tinnitus).
• Respiratory problems.
• Cough.
• Nasal mucosa inflammation, purple discoloration of the skin (purpura).
• Mouth inflammation and pain.
• Severe itching on the skin, mild skin reaction.
• Inflammation of blood vessels under the skin.
• Hair loss.
• Purpuric or red exanthema with pain.
• Abnormal EEG (electroencephalogram) results.
• Difficulty urinating.
• Breast inflammation, increased size of the mammary glands (gynecomastia).
• Abnormal milk secretion.
• Localized or generalized edema.
• Falls.
• Liver inflammation (with or without jaundice).
• Reduction in the number of white blood cells and other changes in the blood count.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ludiomil

Store in the original packaging. Store at a temperature below 30°C. Do not use if the packaging is damaged or shows signs of having been opened.

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

Do not use this medicine after the expiration date that appears on the box or packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ludiomil

The active ingredient is maprotiline hydrochloride

Ludiomil 25 mg: Each film-coated tablet contains 25 mg of maprotiline hydrochloride.

The other ingredients are:

Ludiomil 25 mg: Anhydrous colloidal silica, lactose, magnesium stearate, stearic acid, talc, tricalcium phosphate, corn starch, hypromellose, yellow iron oxide (E172), red iron oxide (E172), polysorbate 80, titanium dioxide (E171).

Appearance of the Product and Package Contents

Ludiomil 25 mg film-coated tablets are orange-gray, round, biconvex tablets with a diameter of approximately 6 mm and "DP" marked on one side. The packaging contains 30 tablets.

Only certain package sizes may be marketed.

Marketing Authorization Holder

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

Manufacturer

CENEXI

52 rue Marcel et Jacques Gaucher - Fontenay Sous Bois

94120 – France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona Spain

Date of the last revision of this prospectus:November 2024

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