Qualitative Composition

Milnacipran hydrochloride, Calcium dihydrate (hydrogen phasphate), carmellose calcium, povidone K30, anhydrous colloidal silicate, magnesium stearate, talcs.

Composition of the capsule: Head (color: pink): titanium dioxide, red iron oxide, yellow iron oxide, gelatin. Body (color: pink): titanium dioxide, red iron oxide, yellow iron oxide, and gelatin.

Quantitative Composition

Milnacipran hydrochloride.... 25mg, for one no.4 capsule.
Quantity equivalent to Milnacipran base.21.77mg

Cases in which this medicine should be used (Therapeutic Indications)

This medicine is an antidepressant. It is recommended in depressive states in adults. This medicine must be take for a number of days before you feel it effect.

Cases in which this medicine should NOT be used (Contra-indications)

This medicine should NOT be used in the following cases:

• Known allergy to Milnacipran or another constituent
• Children less that 15 years of age
• Association with non-selective MAO inhibitors (iproniazide, nialamide), B selective MAO inhibitors (selegiline), digitalis (digoxine) and anti-migraine drugs belonging to that class of Sumatriptan (see interactions with other drugs)
• Lactation

This medicine should generally not be used in the following cases:

• In association with epinephrine or nor epinephrine by parenteral route, clonidine and related compounds and A selective MAO inhibitors (moclobemide, toloxatone), (See interactions with other drugs);
• Difficulties in urinating (prostrate adenoma);
• Pregnancy.

IN CASE OF DOUBT IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST

Special warnings

As in treatment with other antidepressants, this medicine must be taken for a number of days before you feel its effect.

Precautions for use

The use of alcohol is not advised for the duration of the treatment.

Tell your doctor in case of:

• Insomnia or nervousness at the start of treatment
• Renal insufficiency: this may lead your doctor to modify your daily dose
• Adenoma of the prostate or difficulties in urinating
• High blood pressure or heart disease
• Close glaucoma

IN CASE OF DOUBT DO NOT HESITATE TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST

Medicine Interactions and other interactions

You should not take this medicine with:

• Some other antidepressants (iproniazide, nialamide),
• Some anti Parkinson drugs (selegiline),
• Some drugs for cardiac diseases (digitalis, digoxine),
• Some anti-migraine drugs (Sumatriptan and others from the same class).

Unless authorized by your doctor, you should not take this medicine with:

• Some drugs for the cardiovascular system (epinephrine or nor epinephrine by parenteral route, clonidine and related compounds)
• Some other antidepressants (moclobemide, toloxatone)

IN ORDER TO AVOID POSSIBLE INTERACTIONS BETWEEN A NUMBER OF MEDICINES YOU SHOULD ALWAYS TELL YOUR DOCTOR OR PHARMACIST ABOUT ANY TREATMENT YOU ARE CURRENTLY RECEIVING.

Pregnancy - Breast feeding

It is preferable not to take this medicine during pregnancy. If you discover that you are pregnant during the treatment consult your doctor because he is the only person who can judge the necessity of continuing. Because small amounts of Milnacipran are excreted in breast-milk, breast-feeding is contra-indicated.

Car drivers and people operating machinery

Attention is drawn, especially for car drivers and people operating machinery, to the possible risk of dizziness especially at the start of treatment.

How to use this medicine

Dosage

The dosage is 1 capsule in the morning and evening, preferably during meals.

IN ALL CASES YOU SHOULD STRICTLY FOLLOW YOUR DOCTORS PRESCRIPTION.

Mode and route of administration

Oral route, swallow the capsule with a glass of water.

Frequency and time of day at which the medicine should be administered

Take this medicine twice a day, in the morning and the evening, during meals. Follow strictly the prescription of your doctor.

Duration of treatment

The treatment may last several months. Do not stop treatment without medical advice even if you feel an improvement. If necessary, the treatment can be stopped gradually.

What to do in case of overdose

Tell a doctor immediately in case of overdose. Ask for immediate medical assistance.

Undesirable and troublesome effects (Side Effects)

IN COMMON WITH ALL EFFECTIVE MEDICINES, THIS PRODUCT MAY CAUSE MORE OR LESS TROUBLESOME UNDESIRABLE EFFECTS

The undesired effects observed during treatment are observed mainly during the first two weeks of treatment.

• Dizziness, excessive sweating, anxiety, hot flushes and minction problems (urinary complaints);
• Nausea, vomiting, dry mouth, constipation, tremors, palpitations, agitation, headache, cutaneous eruption, erythemateous, prurit; it is to be noted that patients with a history of cardiovascular disorder or concomitant cardiac medication might have a higher incidence of cardiovascular adverse events (e.g., hypertension, hypo tension, postural hypo tension and palpitations);
• Hepatic biological disturbances

Certain symptoms can be part of your depression.

REPORT TO YOUR DOCTOR ANY UNDESIRABLE OR TROUBLESOME EFFECT NOT MENTIONED IN THIS LEAFLET.

Storage

Do not exceed the expiry date printed on the outer pack

Special storage instructions

This medicine should be kept below 30 degrees C in a dry place.