Ludiomil 25 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Ludiomil 25 mg film-coated tablets

maprotiline hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ludiomil is and what it is used for
2. What you need to know before taking Ludiomil
3. How to take Ludiomil
4. Possible side effects
5. How to store 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 the group of tetracyclic antidepressants. The known action and clinical use of maprotiline is similar to that of tricyclic antidepressants (TCAs), such as amitriptyline. Ludiomil helps to relieve the symptoms of depression, such as anxiety, sadness, loss of interest, difficulties in 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 taking 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, amitriptiline, and doxepine.

• If you have recently had epileptic seizures or convulsions (e.g., due to brain injury, alcoholism).

• If you have a serious heart disorder or have recently suffered a myocardial infarction.

• If you have severe impairment of kidney or liver function.

• If you have high intraocular pressure (narrow-angle glaucoma).

• If you have ever experienced 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 inhibitors), such as isocarboxazid, moclobemide, or biperiden.

• If you are taking alcohol, narcotics, or drugs affecting mental state.

Warnings and precautions

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

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

• If you have had thoughts of harming yourself or ending your life.

• If you have a history of any type of heart disorder.

• If you have a mental illness such as schizophrenia or mania (a mood disorder).

• If you have diabetes. You should have regular blood glucose checks, and your diabetes medication may need to be adjusted.

• If you frequently suffer from severe constipation.

• If you have hyperthyroidism or are currently taking thyroid hormone medications.

• If you wear contact lenses.

• If you have ever had increased 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).

• An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Ludiomil may lower the seizure threshold, so if you have an increased tendency to seizures (e.g., withdrawal syndrome after abrupt discontinuation of benzodiazepines or barbiturates), this may lead to an increase in seizures.

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

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

Suicidal thoughts, worsening depression, or anxiety disorders

If you suffer from depression or anxiety disorders, suicidal thoughts or self-harm may occasionally occur. These symptoms may worsen when starting antidepressant treatment for the first time, as these medicines take some time to work—usually about two weeks, sometimes even longer.

The likelihood of such thoughts may increase if:

• You have previously had suicidal thoughts or self-harm tendencies.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age who were treated with antidepressants.

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

It may help to inform a close relative or friend about your depression or anxiety disorder and ask them to read this leaflet. You may also ask them to monitor whether your depression or anxiety worsens, or if they notice any changes in your behaviour that concern them.

It is important that your doctor regularly evaluates the effects of treatment. This allows for dose adjustments and reduction of side effects.

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

Maprotiline may cause dry mouth and increase the risk of dental caries. Therefore, regular dental check-ups are necessary during prolonged treatment.

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

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

In combination with antidiabetic medicines, Ludiomil may cause a reduction in blood glucose levels. Diabetic patients should closely monitor their blood glucose levels.

Administration of Ludiomil may make your skin more sensitive to sunlight. Even brief sun exposure may cause skin rashes, itching, redness, or skin discoloration. Avoid direct sunlight, wear sunglasses, and protect your skin with appropriate clothing.

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

Sudden discontinuation or dose reduction should be avoided due to the possible occurrence of side effects.

Taking Ludiomil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

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

It is important to inform your doctor about the use of any of the medicines listed above. Dose adjustment of Ludiomil or discontinuation of one of the medicines may be necessary.

Taking Ludiomil with food, drinks, and alcohol

Inform your doctor if you regularly consume alcohol. This medicine may enhance the effects of alcohol, increasing drowsiness and impairing coordination.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Maprotiline should not be taken during pregnancy unless clearly recommended by a doctor.

Breastfeeding

You must inform your doctor that the mother is breastfeeding. Maprotiline passes into human milk; therefore, it is advisable to discontinue breastfeeding if the woman is being treated with Ludiomil.

Driving and use of machines

Maprotiline may cause drowsiness, blurred vision, dizziness, or other central nervous system side effects. If these occur, the patient must not drive, operate machinery, or perform other potentially dangerous activities. Alcohol consumption may increase these effects.

Ludiomil contains lactose

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

3. How to take Ludiomil

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

During treatment with Ludiomil, the patient must remain under medical supervision.

Your doctor will decide the most appropriate dose for you based on your age and the severity of symptoms.

Adults

The recommended dose ranges between 75 and 150 mg daily. Depending on the severity of symptoms, patient response, and treatment tolerance, treatment may be initiated with 25 mg (one to three times daily) or 75 mg (once daily), and then the amount of maprotiline gradually increased until an effective dose is reached. Ludiomil should be taken according to the doctor's prescription. Do not exceed the prescribed dose, and do not take the medicine more frequently or for a longer period than indicated by your doctor.

Elderly patients (over 60 years of age):

Lower doses are generally recommended. The initial dose should be 25 mg once daily. If necessary, the daily dose should be gradually increased in small increments to 25 mg three times daily or 75 mg once daily, depending on treatment tolerance and response.

Use in children and adolescents (under 18 years of age):

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 tablet score line is intended solely for splitting the tablet if you have difficulty swallowing it whole.

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

Duration of treatment

Patients should take Ludiomil for several weeks before beginning to feel better. Treatment must not be stopped without consulting your doctor. The responsible doctor must decide whether the dose should be gradually reduced before stopping treatment. This procedure will prevent worsening of the patient's condition and reduce the risk of withdrawal symptoms associated with abrupt discontinuation, such as headache, nausea, vomiting, abdominal pain, diarrhea, insomnia, nervousness, and restlessness.

If you take more Ludiomil than you should

If you accidentally take more tablets than prescribed by your doctor, seek immediate medical help at the nearest doctor's office or hospital.

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

The following symptoms may occur within several hours after an overdose: drowsiness, loss of consciousness, coma, seizures, low blood pressure, fast, slow, or irregular heartbeat, cardiac arrest, restlessness, agitation, impaired motor coordination, muscle rigidity, difficulty breathing, vomiting, fever, cardiovascular shock, heart failure, bluish discoloration of the skin, 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 then 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 a missed dose.

If you stop taking Ludiomil

Do not stop taking the medicine without first consulting your doctor. Your doctor will gradually reduce the dose before stopping 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 everyone will experience them.

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

• Excessive excitement (manic state); worsening of depression, psychotic symptoms.
• Seizures (convulsions).
• Rapid heartbeat, abnormal heart rhythm (slow, fast, or irregular), partial or complete loss of consciousness (syncope).
• Inflammation of the liver (hepatitis), with or without yellowing of the skin and eyes.
• Skin allergic reactions, such as unusual bleeding or formation of subcutaneous bruises (erythema multiforme); severe skin reactions characterized by red spots, widespread blistering or hives (Stevens-Johnson syndrome).
• Inflammation of the lungs (characterized by cough, difficulty breathing, and wheezing).
• Abnormal ECG (electrocardiogram) results and prolonged QT segment changes.
• Excess 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.
• Low mood.
• Difficulty concentrating.
• Changes (increase or decrease) in sexual desire or erectile dysfunction in males.
• Mania or hypomania (excited, hyperactive behavior with excessive euphoria).
• Drowsiness (sedation).
• Memory problems.
• Inability to concentrate.
• Speech difficulties.
• Sensation of numbness and tingling.
• Vision problems and blurred vision.
• Sinus tachycardia (increased heart rate).
• Nausea.
• Vomiting.
• Stomach pain and cramps.
• Difficulty passing stools.
• Increased skin sensitivity to light.
• Increased sweating.
• Difficulty urinating.
• Abnormal weight gain.
• Muscle weakness.
• Skin inflammation, rashes, light red itchy lumps.
• Low blood pressure with dizziness upon standing from a sitting or lying position.
• Hot flushes.
• Palpitations (irregular heartbeats that you can feel).
• 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 are not there, especially in elderly people.
• Nervousness.
• Involuntary muscle movements.
• Seizures.
• Restlessness.
• Inability to remain still.
• 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 disturbances and involuntary muscle movements.
• Syncope.
• Low sodium levels in the blood.
• Temporary loss of consciousness.
• Altered taste sensation.
• Perception of noises in the ears (tinnitus).
• Breathing problems.
• Cough.
• Inflammation of the nasal mucosa, purple skin discoloration (purpura).
• Inflammation and pain in the mouth.
• Severe skin itching, mild skin reaction.
• Inflammation of blood vessels under the skin.
• Hair loss.
• Painful purpuric or red rashes.
• Abnormal EEG (electroencephalogram) results.
• Difficulty urinating.
• Breast enlargement, increase in size of mammary glands (gynecomastia).
• Abnormal milk secretion.
• Localized or generalized edema.
• Falls.
• Hepatic inflammation (with or without jaundice).
• Decreased white blood cell count and other blood count changes.

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ludiomil

Keep in the original packaging. Store below 30°C. Do not use if the container 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 expiry date stated on the carton or container following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ludiomil

The active substance is maprotiline hydrochloride.

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

The other components are:

Ludiomil 25 mg: Colloidal anhydrous 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).

Nature of the product and pack size

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Amdipharm Limited
Unit 17, Northwood House
Northwood Crescent
Northwood, Dublin 9,
D09 V504, Ireland

Manufacturer responsible

CENEXI
52 rue Marcel et Jacques Gaucher - Fontenay Sous Bois
94120 – France

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Local representative:

Advanz Pharma Spain S.L.U.
Paseo de la Castellana 135, 7th floor
28046 Madrid (Spain)
Tel. +34 900 834 889
[email protected]

Date of the most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/