Ludiomil

Package Leaflet: Information for the Patient

LUDIOMIL, 25 mg, coated tablets

LUDIOMIL, 75 mg, coated tablets

Maprotiline hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ludiomil and what is it used for
• 2. Important information 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 is Ludiomil and what is it used for

Each Ludiomil 25 mg tablet contains 25 mg of maprotiline hydrochloride, and each Ludiomil 75 mg tablet contains 75 mg of maprotiline hydrochloride.
The medicine belongs to the group of tetracyclic antidepressants. Ludiomil helps to alleviate symptoms of depression, such as: anxiety, sadness, loss of interest, difficulty in performing daily activities, nervousness, and self-reproach. It also alleviates symptoms associated with depression, such as:
low mood, fatigue, sleep disturbances, dizziness, headaches, nausea, and pain.
Ludiomil is indicated for the treatment of depressive episodes, recurrent depressive disorders, and major depression (endogenous).
Ludiomil is indicated for use in adults aged 18 and above.

2. Important information before taking Ludiomil

When not to take Ludiomil:

• if the patient is allergic to maprotiline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other tetracyclic antidepressants, such as imipramine, amitriptyline, doxepin;
• if the patient has recently had seizures or a tendency to seizures (e.g., in the case of brain damage, alcoholism);
• if the patient has severe heart disorders or has recently had a heart attack;
• if the patient has severe liver or kidney disorders;
• if the patient has glaucoma;
• if the patient has had problems with urination;
• if the patient is taking or has recently taken monoamine oxidase inhibitors (MAOIs), such as isocarboxazid, moclobemide, or biperiden;
• if the patient consumes alcohol or uses narcotics or other medicines that affect mental state.

Warnings and precautions

Caution should be exercised in the following situations:

• if the patient is taking medicines for heart rhythm disorders (e.g., quinidine, propafenone);
• if the patient has had any heart disorders in the past;
• if the patient has suicidal thoughts or behaviors;
• if the patient has a psychiatric disorder called schizophrenia or a mood disorder called mania;
• if the patient has diabetes. It is necessary to regularly monitor blood sugar levels, and a change in the diabetes medication may be necessary;
• if the patient experiences frequent and severe constipation;
• if the patient has hyperthyroidism or is currently taking thyroid hormone preparations;
• if the patient wears contact lenses;
• if the patient has had elevated intraocular pressure in the past.

If any of the following symptoms occur during treatment, the patient should inform their doctor:

• if the patient experiences constipation.
• if the patient experiences fever and (or) sore throat, especially during the first few months of treatment.

Suicidal thoughts, worsening of depression or anxiety disorders

If the patient has depression and (or) anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These thoughts may be more likely to occur:

• If the patient has had suicidal thoughts or self-harm in the past.
• If the patient is a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 with mental disorders who were taking antidepressants.

If the patient has suicidal thoughts or self-harm, they should contact
their doctor or go to the hospital immediately.
It may be helpful for the patient to inform their relatives or friendsthat they are depressed or have anxiety disorders, and ask them to read this leaflet. The patient can ask these people to inform them if they notice any worsening of depression or anxiety, or if they are concerned about changes in the patient's behavior.
It is essential for the doctor to regularly assess the effectiveness of the treatment. This allows for adjusting the dose of the medicine and reducing side effects.
During the follow-up visit, the doctor may recommend a blood test and liver or kidney function tests.
Maprotiline may cause dry mouth, which can increase the risk of tooth decay. Therefore, during long-term treatment, it is necessary to regularly monitor the condition of the teeth.
Before any surgical or dental procedure, the patient should inform their doctor about taking Ludiomil.
Ludiomil may cause increased sensitivity of the skin to sunlight. Even short-term exposure to sunlight can cause skin rash, itching, redness, and (or) discoloration of the skin. The patient should avoid direct exposure to sunlight and wear protective clothing and sunglasses.
Ludiomil may cause rapid, slow, or irregular heartbeats. During treatment with maprotiline, the doctor may recommend measuring blood pressure and performing heart function tests.
Ludiomil, when taken with diabetes medications, may cause a decrease in blood sugar levels. Therefore, patients with diabetes should carefully monitor their blood sugar levels.

Elderly patients (over 60 years old)

Elderly patients require smaller doses of the medicine than patients from other age groups. Side effects occur more frequently in elderly patients. The doctor should provide the patient with detailed information about dosing and the need for careful self-observation.

Children and adolescents (under 18 years old)

Ludiomil should not be given to children and adolescents, as its safety and efficacy in this age group have not been established.

Ludiomil and other medicines

Before starting treatment with maprotiline, the patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Ludiomil, and Ludiomil may interact with other medicines. These include:

• other antidepressants known as monoamine oxidase inhibitors (MAOIs) (e.g., moclobemide) and fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram;
• medicines for high blood pressure and heart diseases (e.g., guanethidine, betanidine, reserpine, clonidine, alpha-methyldopa, propranolol);
• anti-arrhythmic medicines (quinidine, propafenone);
• medicines for diabetes (e.g., oral anti-diabetic medicines of the sulfonylurea type or insulin);
• medicines for preventing mental disorders (antipsychotic medicines, such as thioridazine, risperidone);
• medicines for preventing blood clotting (anticoagulants, e.g., coumarin, warfarin);
• medicines for heart disorders (e.g., adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine);
• medicines for Parkinson's disease (e.g., biperiden);
• anti-epileptic medicines (e.g., carbamazepine, phenytoin, phenobarbital);
• sedatives (e.g., benzodiazepine derivatives, barbiturates);
• medicines for psychomotor disorders, such as methylphenidate;
• medicines for asthma and allergies (antihistamines);
• medicines for stomach ulcers and heartburn, such as cimetidine;
• an antifungal medicine called terbinafine (used orally for skin, hair, and nail infections);
• thyroid hormone preparations;
• selective serotonin reuptake inhibitors (e.g., paroxetine, sertraline, or citalopram);
• medicines for attention deficit hyperactivity disorder (ADHD);
• atropine;
• rifampicin (an antibiotic);
• other antiretroviral medicines (for HIV infection), antimalarial medicines (e.g., quinine), dihydroergotamine derivatives (for migraine), disulfiram (used for alcoholism), and muscle relaxants (e.g., baclofen).

It is essential to inform the doctor about taking any of the above medicines.
It may be necessary to adjust the dose of Ludiomil or stop treatment with one of these medicines.

Ludiomil with food, drink, and alcohol

The patient should inform their doctor if they regularly consume alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Maprotiline should not be used during pregnancy, unless explicitly recommended by a doctor.
Breastfeeding
The patient should inform their doctor about breastfeeding. Maprotiline passes into breast milk. Mothers treated with Ludiomil are advised not to breastfeed.

Driving and using machines

Maprotiline in tablets has a significant impact on the ability to drive vehicles and operate machinery.

Maprotiline may cause drowsiness, blurred vision, dizziness, or other central nervous system side effects. If these occur, the patient should not drive vehicles, operate machinery, or perform other potentially hazardous activities. Drinking alcohol may enhance these effects.

Ludiomil contains lactose

If the patient has an intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Ludiomil

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Do not exceed the recommended dose. The patient should take this medicine for as long as the doctor recommends.
During treatment with Ludiomil, the patient should remain under medical supervision.

Recommended dose

The doctor will determine the most suitable dose of the medicine, depending on the severity of symptoms, response to treatment, tolerance, and the patient's age.
Adults
The recommended dose is between 75 mg and 150 mg per day.
Usually, treatment can start with 25 mg (once to three times a day) or 75 mg (once a day), and then the dose of maprotiline can be gradually increased to achieve an effective dose. Ludiomil should be taken as directed by the doctor. The patient should not take the medicine more frequently or for a longer period than recommended by the doctor.

Elderly patients (over 60 years old)

Generally, smaller doses are recommended. Initially, the dose should be 25 mg once a day. If necessary, the daily dose can be gradually increased by a small dose 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 old)

The efficacy and safety of maprotiline in children and adolescents have not been established.
Therefore, the use of this medicine is not recommended in this age group.

Method of administration

Ludiomil tablets should be swallowed whole, with a sufficient amount of liquid.
If the patient feels that the effect of Ludiomil is too strong or too weak, they should inform their doctor or pharmacist.

Duration of treatment

Patients usually take Ludiomil for several weeks before they feel better. The patient should not stop treatment without consulting their doctor. The doctor may decide to gradually reduce the dose of the medicine before stopping treatment completely. This will prevent worsening of the patient's condition and reduce the risk of side effects associated with sudden withdrawal of the medicine, such as headache, nausea, vomiting, abdominal pain, diarrhea, insomnia, nervousness, and anxiety.

Taking a higher dose of Ludiomil than recommended

If the patient has taken more tablets than prescribed by the doctor, they should immediately seek medical help or go to the nearest hospital. The patient should take the medicine packaging with them.
Usually, within a few hours after overdosing, the following symptoms appear: drowsiness, loss of consciousness, coma, seizures, low blood pressure, rapid, slow, or irregular heart rate, cardiac arrest, restlessness, agitation, coordination disorders, and muscle stiffness, shortness of breath, vomiting, fever, shock, circulatory failure, cyanosis, dilated pupils, sweating, and reduced or absent urine output.

Missing a dose of Ludiomil

If the patient misses a dose of Ludiomil, they should take the missed dose as soon as possible and return to the prescribed dosing schedule. If it is almost time for the next dose, the patient should not take the missed dose, but take the next dose as scheduled. The patient should not take a double dose to make up for the missed dose.
In case of doubts, the patient should consult their doctor.

Stopping treatment with Ludiomil

The patient should not stop taking this medicine without consulting their doctor. The doctor will gradually reduce the dose of the medicine to avoid nausea, anxiety attacks, vomiting, diarrhea, insomnia, headaches, nervousness, and anxiety.
If the patient has any further doubts about taking this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Ludiomil can cause side effects, although not everybody gets them.
Side effects are grouped by frequency of occurrence:
Very common (more than 1 in 10 patients)
Common (more than 1 in 100, but less than 1 in 10 patients)
Uncommon (more than 1 in 1000, but less than 1 in 100 patients)
Rare (more than 1 in 10,000, but less than 1 in 1000 patients)
Very rare (less than 1 in 10,000)
Unknown (frequency cannot be estimated from available data)
Usually, side effects are mild to moderate and transient.
Some side effects can be serious, including:

• excessive stimulation (mania, mild manic state), worsening of depression, psychotic symptoms;
• seizures;
• abnormal heart rhythm (slow, fast, irregular), partial or complete loss of consciousness (fainting);
• hepatitis with or without jaundice (yellowing of the skin and whites of the eyes);
• allergic skin reactions, unusual bleeding in the skin, severe skin reactions characterized by red spots, blistering, or other skin reactions on a large area;
• pneumonia (symptoms may include cough, difficulty breathing, and wheezing). If any of the above side effects occur, the patient should immediately inform their doctor, as a change in treatment may be necessary.

The following side effects are listed according to their frequency of occurrence.

Very common side effects

• drowsiness;
• dizziness;
• headaches;
• tremors;
• muscle spasms;
• dry mouth;
• feeling of fatigue.

Common side effects

• increased appetite, excessive weight gain;
• anxiety;
• restlessness;
• agitation;
• mania (excessively euphoric mood, increased activity) or mild manic state;
• aggression;
• sleep disturbances, insomnia;
• nightmares;
• depression;
• sexual function disorders;
• orthostatic hypotension (low blood pressure when standing up from a sitting or lying position);
• calmness;
• memory loss;
• speech difficulties;
• feeling of tingling or prickling;
• blurred vision, vision disturbances;
• nausea (morning sickness);
• vomiting;
• abdominal pain;
• difficulty with bowel movements;
• increased sensitivity of the skin to sunlight;
• excessive sweating;
• skin inflammation, rash, red-purple blisters on the skin;
• urination disorders;
• erection disorders;
• pathological weight gain;
• dizziness when changing position from lying or sitting to standing;
• hot flashes;
• irregular heartbeat;
• rapid heartbeat, abnormal ECG (electrocardiogram) results;
• increased intraocular pressure;
• fever;
• muscle weakness.

Rare side effects

• confusion (disorientation);
• seeing, hearing, or feeling things that are not there, especially in elderly patients;
• nervousness;
• lack of voluntary muscle coordination;
• feeling of inner restlessness;
• seizures;
• inability to remain still;
• increased blood pressure;
• heart rhythm disorders;
• abnormal liver function test results;
• diarrhea.

Very rare side effects

• thrombocytopenia (reduced platelet count in the blood);
• leukopenia (reduced white blood cell count in the blood);
• agranulocytosis (lack of white blood cells - granulocytes in the blood);
• eosinophilia (increased eosinophil count in the blood);
• feeling of unreality of one's personality or uncertainty (depersonalization), activation of psychosis;
• low sodium levels in the blood;
• coordination and involuntary muscle movement disorders;
• fainting;
• taste disturbances;
• ringing in the ears;
• breathing difficulties;
• balance disorders (feeling uncertain when walking or standing);
• cough;
• nasal inflammation;
• purple discoloration of the skin (purpura);
• oral inflammation and ulcers;
• severe itching of the skin, mild skin reaction;
• inflammation of blood vessels under the skin;
• permanent hair loss;
• painful red or purple rash;
• heart conduction disorders;
• abnormal EEG (electroencephalogram) results;
• inability to fully empty the bladder;
• breast swelling, breast enlargement (gynecomastia);
• localized or generalized edema;
• tooth decay;
• falls;
• hepatitis (with or without jaundice).

Unknown:

• thoughts of self-harm or suicide;
• sexual function disorders.

During treatment with Ludiomil, there is an increased risk of bone fractures.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products – Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ludiomil

• The medicine should be stored out of sight and reach of children.
• Do not store above 30°C
• Store in the original packaging.
• Do not use damaged or opened packaging.
• Do not use this medicine after the expiry date stated on the packaging.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ludiomil contains

The active substance of the medicine is maprotiline hydrochloride.
One coated tablet contains 25 mg or 75 mg of maprotiline hydrochloride.
The other ingredients are: colloidal silicon dioxide, calcium phosphate, lactose, magnesium stearate, stearic acid, talc, cornstarch.
The coating contains: hypromellose, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), polysorbate 80, talc.

What Ludiomil looks like and contents of the pack

Ludiomil, 25 mg and 75 mg coated tablets, are available in Al/PVC/PVDC foil blisters, in a cardboard box.
One pack contains 30 coated tablets of 25 mg or 20 coated tablets of 75 mg.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Manufacturer:
CENEXI
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

Date of last revision of the leaflet: