Ludiomil

Package leaflet: Information for the patient

LUDIOMIL 50 mg film-coated tablets, 75 mg film-coated tablets

Maprotiline hydrochloride
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

Ludiomil contains the active substance maprotiline hydrochloride. It is a tetracyclic antidepressant belonging to a class of medicines called non-selective monoamine reuptake inhibitors (which prevent the reabsorption of certain substances that influence mood).
Ludiomil is used to treat various forms of depression, including depression not attributable to a triggering event (endogenous depression), depression related to a triggering event (reactive depression), and depression occurring during psychiatric, neurological, or other systemic diseases (depressive phase of manic-depressive psychosis, masked depression, neurotic depression, depression occurring in schizophrenic psychoses, involutional depression, severe depression associated with neurological or other organic conditions).

2. What you should know before taking LUDIOMIL

Do not take LUDIOMIL

• If you are allergic to maprotiline hydrochloride or to any of the other ingredients of this medicine (listed in section 6), or if you have cross-sensitivity to tricyclic antidepressants.
• If you suffer from seizures (epilepsy) or are more prone to seizures (e.g. due to brain damage or alcoholism).
• If you suffer from disorders affecting the electrical activity of the heart or have recently had a myocardial infarction (heart attack).
• If you suffer from severe liver or kidney disease.
• If you have acute angle-closure glaucoma (increased pressure inside the eyes).
• If you have urinary retention, for example due to prostate disorders (you have difficulty completely emptying your bladder).
• If you have acute intoxication with alcohol, hypnotic agents (used for insomnia), or psychotropic agents (acting on the mind).

If you are currently being treated with other antidepressants called monoamine oxidase inhibitors (MAOIs) (see "Other medicines and LUDIOMIL").
Warnings and precautions
Talk to your doctor before taking LUDIOMIL if you have any of the following conditions:

• If you have thoughts of suicide or worsening depression or anxiety. If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or even of suicide. These thoughts may increase when you first start taking antidepressant medicines, as these medicines take time to work—usually about 2 weeks, but sometimes longer. You may be more likely to have such thoughts:
  • if you have previously had thoughts of suicide or self-harm
  • if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders being treated with an antidepressant.
• It may be helpful to inform a relative or friend that you are depressed and have anxiety disorders, and ask them to read this leaflet. You may also ask them to tell you if they feel your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour. Contact your doctor immediately or go to hospital if, at any time, you have thoughts of self-harm or suicide.

It may be helpful to inform a relative or friend that you suffer from depression or anxiety disorders and
ask them to read this leaflet. Ask them to tell you if they feel your depression or anxiety is worsening or if they are concerned about changes in your behaviour.

• If you are being treated with antipsychotics, i.e. medicines used to treat certain mental illnesses (e.g. phenothiazines, risperidone), as they may increase the risk of seizures or cardiac arrhythmias.
• If you are taking medicines to control your heart rate (antiarrhythmics), such as quinidine and propafenone.
• If you suffer from heart or blood vessel diseases. Your doctor will periodically check your cardiac function and perform an electrocardiogram (ECG).
• If you suffer from low blood pressure. Your doctor will also monitor your blood pressure.
• If you suffer from severe mental illnesses (psychoses), characterized by symptoms such as delusions, hallucinations, and gradual personality changes.
• If you have diabetes. Your doctor will regularly check your blood sugar levels.
• If you develop sore throat, fever, and/or flu-like symptoms during treatment with Ludiomil, especially during the first months of treatment. Your doctor will perform a blood test.
• Before undergoing surgery or dental procedures.
• If you have any type of liver or kidney disease. Your doctor will check your liver and kidney function before and during treatment.
• If you have previously experienced increased eye pressure (glaucoma), a particular type of tumour of the adrenal gland (pheochromocytoma), severe chronic constipation, incomplete bladder emptying (urinary retention), especially in the presence of an enlarged prostate (prostatic hypertrophy).
• If you have overactive thyroid (hyperthyroidism) or are being treated with medicines containing thyroid hormone.
• Consult your doctor if you wear contact lenses and develop eye irritation due to reduced tear production.
• Ludiomil may increase skin sensitivity to sunlight. When exposed directly to sunlight, you must wear sunglasses and protect yourself with appropriate clothing.
• Ludiomil contains lactose monohydrate and is not suitable if you have lactase deficiency (lack of an enzyme that helps digest milk and dairy products), galactosaemia (a hereditary disorder of galactose metabolism), or glucose-galactose malabsorption syndrome (a digestive disorder affecting glucose and galactose). While taking Ludiomil, your response to alcohol and barbiturates (sedatives) may be intensified.

If you are taking Ludiomil long-term, you may experience an increased risk of dental caries; therefore, regular dental check-ups are recommended.
Discontinuation of treatment
Abrupt interruption or dose reduction should be avoided due to possible adverse effects. If discontinuation of treatment is decided, the dosage will be gradually reduced as much as possible.
Elderly (over 60 years of age)
Elderly patients require lower doses than other adult patients. The occurrence of adverse effects is much more likely in the elderly. (See "How to take LUDIOMIL")
Children
The use of Ludiomil is not recommended in children and adolescents.
Other medicines and LUDIOMIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interactions may occur when using this medicine with:

• Certain medicines used for depression, including monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) and selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, fluvoxamine, paroxetine, sertraline, and citalopram). Ludiomil must not be used within 14 days after stopping MAO inhibitors to avoid the risk of serious adverse effects. After stopping Ludiomil, wait at least 14 days before starting treatment with MAOIs (see "Do not take LUDIOMIL").
• Medicines used to treat cardiovascular disorders (e.g. adrenaline, noradrenaline, isoprenaline, ephedrine, and phenylephrine), nasal drops, and local anaesthetics (e.g. those used in dentistry).
• Medicines to control heart rhythm disorders (antiarrhythmics), such as quinidine and propafenone.
• Hypoglycaemic agents (medicines used in diabetes), such as oral sulfonylureas or insulin. Your doctor may require more frequent blood glucose monitoring.
• Medicines for psychosis (severe mental illness) (antipsychotics), such as risperidone, phenothiazines, and thioridazine.
• Alcohol, barbiturates (sedatives), and other central nervous system depressants, Parkinson’s disease medicines including biperiden, atropine, antihistamines.
• Medicines used to reduce blood clotting (coumarins).
• Medicines for high blood pressure (antihypertensives), such as propranolol, betanidine, guanethidine, clonidine, reserpine, and alpha-methyldopa.
• A group of sedative medicines that promote sleep, reduce anxiety, and have muscle-relaxant effects (benzodiazepines).
• Methylphenidate (a central nervous system stimulant).
• Cimetidine, a medicine that inhibits gastric acid production.
• Oral antifungals (e.g. terbinafine, used in fungal infections), antiretroviral medicines such as protease inhibitors associated with ritonavir (used in HIV infection), medicines used in certain parasitic infections (e.g. quinine and mefloquine), rifampicin (an antibiotic).
• Disulfiram (a medicine used in alcohol dependence).
• Certain antiepileptics such as carbamazepine, phenobarbital, and phenytoin.
• Medicines that cause changes in the electrocardiogram (prolongation of the QT interval).

LUDIOMIL with food, drinks, and alcohol
Alcohol may enhance the effect of Ludiomil. During treatment with Ludiomil, you should avoid consuming alcohol.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of use during pregnancy has not been established. Ludiomil should not be administered during pregnancy unless the benefits clearly outweigh any potential risks to the fetus.
Ludiomil, if the patient's clinical condition allows, should be discontinued at least 7 weeks before the expected delivery date to avoid possible symptoms in the newborn such as dyspnoea (difficulty breathing), lethargy (marked drowsiness), irritability, tachycardia (increased heart rate), hypotonia (decreased muscle tone), seizures, jaundice (yellowing of the skin), and hypothermia (decreased body temperature).
Breastfeeding
Maprotiline, the active ingredient of Ludiomil, passes into breast milk. Although there are no reported adverse effects on the infant, mothers receiving Ludiomil should not breastfeed.
Fertility
There is no information on the effect of maprotiline on human fertility. Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ludiomil impairs the ability to drive vehicles or operate machinery.
Ludiomil may cause blurred vision, dizziness, drowsiness, and central nervous system symptoms; in such cases, driving, operating machinery, or engaging in potentially hazardous activities is not recommended.
LUDIOMIL contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take LUDIOMIL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is between 75 and 150 mg per day. Your doctor will determine the dose according to the severity of your
symptoms, your response to treatment and your tolerance.
The daily dose may start at 75 mg (once daily) and then be gradually increased to the effective dose.
Daily doses exceeding 150 mg are not recommended.
The dosage is individually determined and adjusted according to your condition and your response to treatment, for example, by increasing the evening dose and reducing the dose administered during the day, or alternatively, by administering a single daily dose.
The tablets should be swallowed whole with an adequate amount of liquid.
Use in the elderly (60 years and older)
Generally, lower doses are recommended both for reaching the effective dose and for the maintenance dose.
Because it is difficult to individualize dosing with the tablets currently available, use of this medicine is not recommended in this patient group.
Use in children and adolescents
The safety and efficacy of Ludiomil in children and adolescents has not been established. Therefore, use in this patient group is not recommended.
Hepatic impairment
Ludiomil must be administered with caution if you have mild to moderate impairment of liver function.
You must not take Ludiomil if you have severe liver impairment.
Renal impairment
Ludiomil must be administered with caution if you have mild to
moderate renal impairment.
You must not take Ludiomil if you have severe renal damage.
If you take more LUDIOMIL than you should
Contact your doctor or the nearest hospital emergency department immediately if you take too many tablets.
Signs and symptoms of overdose with Ludiomil appear within a few hours: drowsiness, coma,
seizures, low blood pressure, fast, slow or irregular heartbeat, cardiac arrest (in some cases fatal), restlessness and agitation, loss of muscle coordination and muscle stiffness, reduced breathing, vomiting, fever, shock, heart failure, dilated pupils, bluish discoloration of the skin, sweating, reduced or cessation of urine production.
If you forget to take Ludiomil
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor.
If you stop taking Ludiomil
Do not stop treatment without consulting your doctor. Inform your doctor if you wish to discontinue taking Ludiomil before completing the treatment course.
Abrupt discontinuation or sudden reduction of the dose should be avoided due to possible adverse effects.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be serious. If you notice the onset of neurological or psychiatric side effects, stop taking the medicine immediately and contact a doctor without delay.

The following side effects have been reported with Ludiomil:

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

• drowsiness
• dizziness
• headache
• tremors, sudden muscle contractions, involuntary muscle jerks (myoclonus)
• dry mouth
• fatigue

Common (may affect up to 1 in 10 people)

• increased appetite
• abnormal weight gain
• restlessness
• anxiety
• agitation
• hyperactive behaviour and excessively euphoric and excited mood (mania and hypomania)
• disturbances in sexual desire
• sexual dysfunction in males (erectile dysfunction)
• aggression
• sleep disorders
• insomnia
• nightmares
• depression
• sedation
• memory problems
• lack of concentration ability (attention disorder)
• paraesthesia (numbness, tingling)
• speech disorder
• difficulty in speaking
• blurred vision, disturbance in the eye's focusing mechanism
• increased heart rate
• heightened perception of heartbeat (palpitations)
• postural hypotension (drop in blood pressure upon standing)
• flushing
• nausea
• vomiting
• abdominal discomfort
• constipation
• dermatitis due to hypersensitivity reaction
• skin rash
• skin eruption consisting of small localized swellings called wheals, with intense itching (urticaria)
• increased skin sensitivity to light
• increased sweating
• muscle weakness
• difficulty in urination (urinary disorders)
• fever
• abnormalities in electrocardiogram (test measuring the heart's electrical activity)

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

• false beliefs leading to misinterpretation of reality due to mental illness (delusions)
• confusion
• hearing or perceiving things that are not actually present (hallucinations)
• nervousness
• suicidal thoughts or suicidal behaviour
• seizures
• inability to remain still (akathisia)
• lack of coordination in movement (ataxia)
• changes in normal heart rhythm (arrhythmia)
• diarrhoea
• increased blood pressure
• abnormalities in liver function tests

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

• reduced level of salt in the blood caused by abnormal hormone secretion (inappropriate antidiuretic hormone secretion)
• reduced white blood cells, blood cells
• reduced white blood cells, particularly neutropenia (reduction in neutrophils, a type of white blood cell)
• increased white blood cell count
• reduced number of platelets in the blood (cells responsible for blood clotting)
• mental disorder causing disturbances in thinking and perception (psychotic disorder)
• hallucinations and/or confusion leading to detachment from self or own feelings (depersonalization)
• movement disorders (dyskinesia)
• abnormal coordination
• altered taste (dysgeusia)
• loss of consciousness (syncope)
• perception of sound or noise in the ears (tinnitus)
• palpitations or sensation of skipped beats (impulse conduction disorders)
• heart arrhythmia characterized by increased heart rate (ventricular tachycardia, Torsade de Pointes)
• severe heart rhythm disorder (ventricular fibrillation)
• lung inflammation due to hypersensitivity reaction (allergic alveolitis)
• bronchial constriction (bronchospasm)
• nasal congestion
• mouth inflammation
• dental caries
• liver inflammation with or without jaundice (yellowing of the skin or eyes)
• itching
• inflammation of blood vessels in the skin
• hair loss
• skin eruption with irregular red patches (erythema multiforme)
• severe hypersensitivity reaction with high fever, red skin patches, blisters, necrosis and skin peeling, mucosal lesions, joint pain and/or eye inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• bruises, bright red haemorrhagic spots on the skin and mucous membranes (purpura)
• urine retention due to impaired bladder emptying (urinary retention)
• breast tissue enlargement (gynaecomastia)
• spontaneous milk discharge from the breast (galactorrhoea)
• fluid retention and swelling
• abnormalities in electroencephalogram (test measuring brain electrical activity)
• falls

Not known (frequency cannot be estimated from available data)

• sexual dysfunction
• disorder that may cause instability, e.g. when standing or walking (balance disorders)

Withdrawal symptoms
After abrupt discontinuation or dose reduction, the following symptoms may occur: nausea, vomiting, abdominal pain, diarrhoea, insomnia, headache, nervousness, anxiety, worsening of depression or recurrence of depressive state.

Fractures
An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LUDIOMIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ludiomil 50 mg film-coated tablets contain

• The active substance is maprotiline hydrochloride. Each film-coated tablet contains maprotiline hydrochloride equivalent to 50 milligrams of maprotiline hydrochloride.
• The other ingredients are: Anhydrous colloidal silica; tricalcium phosphate; monohydrate lactose; magnesium stearate; stearic acid; talc; maize starch; hypromellose; yellow iron oxide; red iron oxide; polysorbate-80; titanium dioxide.

What Ludiomil 75 mg film-coated tablets contain

• The active substance is maprotiline hydrochloride. Each film-coated tablet contains maprotiline hydrochloride equivalent to 75 milligrams of maprotiline hydrochloride.
• The other ingredients are: Anhydrous colloidal silica; tricalcium phosphate; monohydrate lactose; magnesium stearate; stearic acid; talc; maize starch; hypromellose; red iron oxide; yellow iron oxide; polysorbate-80; titanium dioxide.

Description of the appearance of LUDIOMIL and pack contents
Ludiomil 50 mg film-coated tablets. Blister pack containing 30 tablets.
Ludiomil 75 mg film-coated tablets. Blister pack containing 20 tablets.

Marketing Authorization Holder
Amdipharm Limited
3 Burlington Road, Temple Chambers, Dublin 4
Ireland

Manufacturer
Amdipharm UK Limited
Capital House,
85 King William Street,
London EC4N 7BL,
UK
CENEXI SAS
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France