Ludiomil

Package leaflet: Information for the patient

LUDIOMIL, 25 mg, coated tablets
LUDIOMIL, 75 mg, coated tablets
Maprotilini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your 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 relieve symptoms of depression such as: anxiety, sadness, loss of interest, difficulties in performing daily activities, nervousness, and self-blame. It also alleviates symptoms associated with depression such as: low mood, fatigue, sleep disturbances, dizziness, headaches, indigestion, 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 years 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 cyclic antidepressant medicines such as imipramine, amitriptyline, doxepin;
• if the patient has recently experienced epileptic seizures or has a tendency to seizures (e.g. due to brain damage, alcohol-related disease);
• if the patient has severe heart disorders or has recently suffered a heart attack;
• if the patient has severe liver or kidney dysfunction;
• if the patient suffers from glaucoma;
• if the patient has ever had problems with urination;
• if the patient is currently taking or has recently taken medicines from the group of monoamine oxidase inhibitors (MAOIs), such as isocarboxazid, moclobemide or bipridine;
• if the patient consumes alcohol or uses narcotics or other medicines affecting mental state.

Warnings and precautions
Exercise caution in the following situations:

• if the patient is taking medicines for heart rhythm disorders (e.g. quinidine, propafenone);
• if the patient has previously experienced any heart function disorders;
• if the patient has suicidal thoughts or behaviors;
• if the patient suffers from a mental disorder called schizophrenia or a mood disorder called mania;
• if the patient has diabetes. Regular blood sugar monitoring is necessary, and a change in antidiabetic medication may also be required;
• if the patient suffers from 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 ever had increased intraocular pressure.

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

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

Suicidal thoughts, worsening depression or anxiety disorders
If the patient has depression and (or) anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These may increase at the beginning of treatment with Ludiomil, as the medicine takes some time to become effective.
The occurrence of such thoughts may be more likely:

• If the patient previously had thoughts of killing themselves or self-harming.
• If the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient has suicidal thoughts or desires to self-harm, they should contact their doctor or go immediately to hospital.
It may be helpful for the patient to inform relatives or friends that they are suffering from depression or anxiety disorders, and to ask them to read this leaflet. The patient may ask these people to inform them if they notice worsening of depression or anxiety, or if they are concerned about changes in the patient's behavior.
It is important that the doctor regularly evaluates the treatment effects. This allows adjustment of the dose and reduction of adverse effects.
During follow-up visits, the doctor may recommend blood tests and assessment of liver or kidney function.
Maprotyline may cause dry mouth, thereby increasing the risk of dental caries. For this reason, regular dental check-ups are recommended during long-term treatment.
Before any surgical or dental procedure, the doctor must be informed about the use of Ludiomil.
Ludiomil may increase skin sensitivity to sunlight. Even brief sun exposure may cause skin rash, itching, redness and (or) skin discoloration. Direct exposure to sunlight should be avoided, and protective clothing and sunglasses should be used.
Ludiomil may cause rapid, slow or irregular heartbeats. During treatment with maprotyline, the doctor may recommend monitoring of blood pressure and heart function.
Ludiomil, when used concomitantly with medicines used in diabetes treatment, may reduce blood glucose concentration. Therefore, diabetic patients should closely monitor their blood glucose levels.

Elderly patients (over 60 years of age)
Elderly patients require lower doses of the medicine than patients in other age groups. Adverse effects occur more frequently in elderly patients. The treating doctor should provide the patient with detailed information regarding dosage and the necessity of careful self-monitoring.

Children and adolescents (under 18 years of age)
Ludiomil should not be given to children and adolescents, as the safety and efficacy of its use have not been established in this age group.

Ludiomil and other medicines
Before starting treatment with maprotyline, inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Some medicines may affect the action of Ludiomil, and Ludiomil may affect other medicines. These include:

• other antidepressants known as monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide), and fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram;
• antihypertensive medicines and medicines used for heart diseases (e.g. guanethidine, betanidine, reserpine, clonidine, alpha-methyldopa, propranolol);
• antiarrhythmic medicines (quinidine, propafenone);
• medicines used in diabetes treatment (e.g. oral sulfonylurea derivatives or insulin);
• medicines used to prevent mental disorders (antipsychotics such as thioridazine, risperidone);
• medicines used to prevent blood clotting (anticoagulants, e.g. coumarin, warfarin);
• medicines used in heart disorders (e.g. adrenaline, noradrenaline, isoprenaline, ephedrine, phenylephrine);
• medicines used in Parkinson's disease (e.g. bipridine);
• antiepileptic medicines (e.g. carbamazepine, phenytoin, phenobarbital);
• sedatives (e.g. benzodiazepines, barbiturates);
• medicines used in the treatment of psychomotor disorders, such as methylphenidate;
• medicines used in asthma and allergy treatment (antihistamines);
• medicines used in peptic ulcer disease and heartburn, such as cimetidine;
• an antifungal medicine called terbinafine (used orally in the treatment of skin, hair and nails);
• thyroid hormone preparations;
• selective serotonin reuptake inhibitors (e.g. paroxetine, sertraline or citalopram);
• medicines used in attention deficit disorders (ADHD);
• atropine;
• rifampicin (an antibiotic);
• other so-called antiretroviral medicines (for HIV infection), antimalarial medicines (e.g. quinine), dihydroergotamine derivatives (for migraine treatment), disulfiram (used in alcoholism treatment), and muscle relaxants (e.g. baclofen).
  It is important to inform the doctor about taking any of the above-mentioned medicines.
  Dosage adjustment of Ludiomil or discontinuation of one of these medicines may be necessary.

Ludiomil with food, drink and alcohol
Inform the doctor if the patient regularly consumes alcohol.

Pregnancy, breastfeeding and effect on fertility
Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Maprotyline should not be used during pregnancy unless clearly recommended by a doctor.

Breastfeeding
Inform the doctor about breastfeeding. Maprotyline passes into breast milk. Breastfeeding mothers treated with Ludiomil are advised not to breastfeed.

Driving and operating machinery
Maprotyline tablets have a significant effect on the ability to drive and operate mechanical equipment.

Maprotyline may cause drowsiness, blurred vision, dizziness or other adverse effects on the central nervous system. If these occur, the patient should not drive, operate machinery or perform any other potentially dangerous activities. Alcohol consumption may worsen these effects.

Ludiomil contains lactose
If the patient suffers from intolerance to certain sugars, they should consult their doctor before using this medicine.

3. How to use Ludiomil

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Do not exceed the recommended dose. This medicine should be taken until the doctor advises
stopping treatment.
During treatment with Ludiomil, the patient should remain under medical supervision.
Recommended dose
The treating doctor will determine the most appropriate dose depending on the severity of symptoms,
response to treatment, treatment tolerance, and the patient's age.
Adults
The recommended dosage range is 75 mg to 150 mg per day.
Treatment is usually started with 25 mg (once to three times daily) or 75 mg (once daily), and the
dose of maprotiline is then gradually increased until an effective dose is reached. Ludiomil should
be taken as directed by the doctor. Do not take the medicine more frequently or for longer than
prescribed by the 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 tolerance and response to treatment.
Use in children and adolescents (under 18 years of age)
The efficacy and safety of maprotiline in children and adolescents have not been established.
Therefore, use of the medicine is not recommended in this age group.
Method of administration
Ludiomil tablets should be swallowed whole with sufficient liquid.
If the effect of Ludiomil seems too strong or too weak, inform the doctor or pharmacist.
Duration of treatment
Patients usually take Ludiomil for several weeks before feeling better. Do not stop treatment without
consulting the doctor. The treating doctor may decide to gradually reduce the dose before finally
stopping treatment. This approach helps prevent worsening of the patient's condition and reduces
the risk of adverse effects associated with abrupt discontinuation of the medicine, such as headache,
nausea, vomiting, abdominal pain, diarrhea, insomnia, nervousness, and anxiety.
Taking more Ludiomil than recommended
If more tablets are taken by accident than prescribed by the doctor, seek immediate medical help
from a doctor or the nearest hospital. Take the medicine packaging with you.
Usually, within a few hours after overdose, the following symptoms may appear: drowsiness, loss of
consciousness, coma, seizures, low blood pressure, fast, slow, or irregular heartbeat, cardiac arrest,
restlessness, agitation, coordination disturbances and muscle stiffness, shortness of breath, vomiting,
fever, shock, heart failure, skin cyanosis, dilated pupils, sweating, and reduced urine output or
absence of urine output.
Missed dose of Ludiomil
If a dose of Ludiomil is missed, take the missed dose as soon as possible and return to the prescribed
dosing schedule. If it is almost time for the next dose, do not take the missed dose; instead, take the
next dose according to the prescribed schedule. Do not take a double dose to make up for a missed
dose.
If in doubt, consult the treating doctor for advice.
Stopping Ludiomil treatment
Do not stop taking this medicine without consulting your doctor. The doctor will gradually reduce the
dose to avoid nausea, anxiety attacks, vomiting, diarrhea, insomnia, headaches, nervousness, and
anxiety.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are grouped according to their frequency of occurrence:
Very common (more than 1 in 10 people)
Common (more than 1 in 100, but less than 1 in 10 people)
Uncommon (more than 1 in 1,000, but less than 1 in 100 people)
Rare (more than 1 in 10,000, but less than 1 in 1,000 people)
Very rare (less than 1 in 10,000)
Not known (frequency cannot be estimated from the available data)
Usually, adverse reactions are mild to moderate and transient.
Some adverse reactions may be serious and include:

• excessive excitement (mania, hypomanic state), worsening of depression, psychotic symptoms;
• seizures;
• irregular heartbeat (slow, fast, or irregular), partial or complete loss of consciousness (fainting);
• hepatitis with or without yellowing of the skin or whites of the eyes (jaundice);
• allergic skin reactions, unusual skin bleeding, severe skin reactions characterized by red patches, blistering, or other widespread skin reactions;
• lung inflammation (symptoms may include cough, difficulty breathing, and wheezing).
  If any of the above adverse reactions occur, inform your doctor immediately, as a change in treatment may be necessary.

Below is a list of adverse reactions categorized by frequency of occurrence.
Very common adverse reactions

• drowsiness;
• dizziness;
• headache;
• tremor;
• muscle spasms;
• dry mouth;
• feeling of fatigue.

Common adverse reactions

• increased appetite, excessive weight gain;
• anxiety;
• psychomotor agitation;
• excitement;
• mania (excessively euphoric mood, increased activity) or hypomanic state;
• aggression;
• sleep disturbances, insomnia;
• nightmares;
• depression;
• disturbances in sexual drive;
• orthostatic hypotension (low blood pressure upon standing from a sitting or lying position);
• sedation;
• memory loss;
• difficulty speaking;
• tingling or prickling sensation;
• blurred vision, visual disturbances;
• nausea;
• vomiting;
• abdominal pain;
• difficulty in defecation;
• skin photosensitivity;
• excessive sweating;
• skin inflammation, rash, pale red blisters on the skin;
• urinary disorders;
• erectile dysfunction;
• pathological weight gain;
• dizziness upon sudden change from lying or sitting to standing position;
• hot flushes;
• irregular heartbeat;
• rapid heartbeat, abnormal ECG (electrocardiogram) results;
• increased intraocular pressure;
• fever;
• muscle weakness.

Uncommon adverse reactions

• confusion (disorientation);
• seeing, hearing, or feeling things that are not real, especially in elderly patients;
• nervousness;
• lack of conscious coordination of muscle movements;
• inner restlessness;
• seizures;
• inability to remain calm;
• increased blood pressure;
• heart rhythm disturbances;
• abnormal liver function tests;
• diarrhea.

Rare adverse reactions

• thrombocytopenia (decreased number of platelets in peripheral blood);
• leukopenia (decreased number of white blood cells in peripheral blood);
• agranulocytosis (absence of neutrophil granulocytes in peripheral blood);
• eosinophilia (increased number of eosinophil granulocytes in peripheral blood);
• feelings of unreality of one's own personality or sense of uncertainty (depersonalization), activation of psychosis;
• low sodium levels in blood;
• disturbances in coordination and involuntary muscle movements;
• fainting;
• disturbances in taste sensation;
• ringing in the ears;
• breathing difficulties;
• unsteadiness while walking or standing (balance disturbances);
• cough;
• inflammation of the nasal mucosa;
• purplish skin discoloration (purpura);
• inflammation and ulceration of the oral cavity;
• intense skin itching, mild skin reaction;
• inflammation of blood vessels under the skin;
• permanent hair loss;
• painful red or purplish rash;
• disturbances in cardiac conduction;
• abnormal EEG (electroencephalogram) results;
• inability to completely empty the bladder;
• breast swelling, enlargement of breast glands (gynecomastia);
• localized or generalized edema;
• dental caries;
• falls;
• hepatitis (with or without jaundice).

Not known:

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

During treatment with Ludiomil, there is an increased risk of bone fractures.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Faks: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ludiomil

• Keep the medicine out of the sight and reach of children.
• Do not store above 30°C.
• Store in the original packaging.
• Do not use packages that are damaged or show signs of tampering.
• Do not use this medicine after the expiry date stated on the packaging.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ludiomil contains
The active substance is maprotiline hydrochloride.
Each coated tablet contains 25 mg or 75 mg of maprotiline hydrochloride, respectively.
The other ingredients are: colloidal anhydrous silica, calcium hydrogen phosphate, lactose,
magnesium stearate, stearic acid, talc, maize starch.
Coating composition: 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 blisters made of Al/PVC/PVDC foil, packed in a cardboard box.
One pack contains either 30 coated tablets of 25 mg or 20 coated tablets of 75 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland

Manufacturer:
CENEXI
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France