Read through this prospectus carefully before taking this medication. It contains important information on your treatment and your illness. If you have any doubts or questions, consult your physician or pharmacist. This medication has been prescribed for you personally. Never give it to others, even though their symptoms may be the same as your own. It may prove harmful to them.

INGREDIENTS: The active ingredient is moclobemide. The other ingredients are: lactose, corn starch, povidone K30, sodium carboxy methyl starch, magnesium stearate, hypromellose, talc, titanium dioxide, macrogol 6000, ethyl cellulose, yellow iron oxide (E172).

WHAT MOCLAMINE TABLETS ARE AND WHAT THEY ARE FOR:
CATEGORY: SELECTIVE MONOAMINE OXIDASE TYPE A INHIBITOR. This medication is an antidepressant. It is recommended for the treatment of certain types of depression.

2. BEFORE TAKING MOCLAMINE:

Do not take or administer Moclamine

• If you know you are allergic to moclobemide.
• If you are under 15 years of age.
• In association with sumatriptan, almotriptan, rizatriptan, zolmitriptan, pethidine, tramadol, selegiline, dextromethotorphan or bupropion.
• If you are breast-feeding.
• If you are feeling confused or disoriented.

Unless your physician instructs you otherwise, this medication should generally not be used in the following cases: In association with citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, clomipramine, imipramine, amitriptyline, milnacipran, venlafaxine, sibutramine, naratriptan, frovatriptan or eletriptan. IF YOU HAVE ANY DOUBTS OR QUESTIONS, CONSULT YOUR PHYSICIAN OR PHARMACIST.

BE ESPECIALLY CAREFUL WITH MOCLAMINE: Due to the presence of lactose, this medication should not be used by patients suffering from galactosemia, a syndrome caused by the body’s inability to absorb glucose and galactose, or lactose deficit (both are rare metabolic disorders). Avoid alcoholic drinks during treatment.

Advise your physician in the case of:

• Insomnia.
• Nervousness.
• Hypertension.
• Hepatic insufficiency (liver disease).
• Pheochromocytoma (abnormal excrescence of the adrenal medulla, a gland that secretes substances that cause severe high blood pressure).
• Thyrotoxicosis (a condition caused by the overproduction of thyroid hormones).
• Pregnancy (see Pregnancy and Breast-feeding).

During treatment, those suffering from high blood pressure are advised to avoid food rich in tyramine, and especially brewer’s yeast, certain cheeses or certain beers. IF YOU HAVE ANY DOUBTS OR QUESTIONS, CONSULT YOUR PHYSICIAN OR PHARMACIST.

Pregnancy: As a precautionary measure, do not use this medication during pregnancy unless your physician instructs you to do so. CONSULT YOUR PHYSICIAN OR PHARMACIST BEFORE TAKING ANY MEDICATION.

Breast-feeding: The use of this medication is contraindicated during breast-feeding since it is excreted into mother's milk. CONSULT YOUR PHYSICIAN OR PHARMACIST BEFORE TAKING ANY MEDICATION.

Driving and operating machinery: Drivers and machinery operators should be aware of the possible risks of dizziness when using this medication.

List of potentially problematic excipients: Lactose.

Taking or using other medications: TO PREVENT POSSIBLE INTERACTIONS WITH OTHER MEDICATIONS and more specifically with citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, clomipramine, imipramine, amitriptyline, milnacipran, venlafaxine, sibutramine, naratriptan, frovatriptan, and eletriptan, YOU SHOULD SYSTEMATICALLY REPORT ANY OTHER TREATMENT YOU ARE UNDERGOING TO YOUR PHYSICIAN OR PHARMACIST.

Furthermore, the utmost caution is recommended when consuming symptomatic medications concomitantly with this medication, particularly vasoconstrictors. These may be sold over the counter for soothing certain symptoms of benign winter pathologies (congestion, nasal hypersecretion, watery eyes). Do not exceed the dosage recommended in the prospectus, even if it is a vasoconstrictor to be taken nasally, or consult your physician before using them. INFORM YOUR PHYSICIAN OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICATIONS, INCLUDING THOSE SOLD OVER THE COUNTER.

3. HOW TO TAKE MOCLAMINE:

Dosage: This medication is reserved for adults over 15 years of age. Your physician will progressively modify the dosage. If you think that the effect of Moclamine is too strong or too mild, consult your physician or pharmacist.

Directions: To be taken orally. Swallow the tablets with a large glass of water.

Frequency of dosage: The total dosage must be fractioned into 2 or 3 doses. Be careful not to take them too late in the day. Take the tablets after meals.

Length of treatment: The treatment can last several months. Do not stop treatment without first consulting your physician.

If you take more Moclamine than you should: Advise a physician at once. Ask for medical assistance immediately in case of overdose. CONSULT YOUR PHYSICIAN OR PHARMACIST IMMEDIATELY.

4. POSSIBLE SIDE EFFECTS OF MOCLAMINE:

Like all medications, Moclamine may have side effects:

• Troubled sleep, agitation, anxiety, irritability, dizziness, nausea, headache, a tingling or prickly feeling, dry mouth, digestive problems, skin reactions (extended skin rash, itching).
• More rarely, confused states that quickly disappear once the treatment has been concluded.

These side effects are most noticeable at the beginning, especially during the first two weeks of treatment and will subside with the improvement of the depression episode. Furthermore, certain side effects are linked to the very nature of the depression: the possibility of psychological, mood or behavioral problems. If you notice any unpleasant side effect not mentioned in this prospectus, report it to your physician or pharmacist.

5. STORING MOCLAMINE:

Store at a temperature no higher than 25º C. Keep out of children’s reach and sight. Do not use after the expiry date marked on the box.

The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.