Lexamil

LEXAMIL belongs to a group of medicines known as antidepressants. LEXAMIL is used to treat:

• Major depressive episodes.
• Panic disorder with or without agoraphobia (fear of open/public spaces).
• Social anxiety disorder (social phobia).
• Generalised anxiety disorder.
• Obsessive-compulsive disorder.

Do NOT take LEXAMIL

• If you are allergic (hypersensitive) to escitalopram oxalate or to any of the inactive ingredients of LEXAMIL. Please discuss this with your doctor or pharmacist if you are unsure.
• If you are younger than 18 years of age, as safety and efficacy in children have not been proven (see "Take special care with LEXAMIL").
• If you are also taking monoamine oxidase inhibitors (MAOIs) for the treatment of depression or other mood disorders (see "Taking LEXAMIL with other medicines"). Please speak to your doctor or pharmacist if you are unsure.
• If you are taking linezolid, an antibiotic (see "Taking LEXAMIL with other medicines").
• If you have been diagnosed with an abnormal heart rhythm or heart block or if you have previously been told that the medicines you are using may slow your heart rate (see "Taking LEXAMIL with other medicines").

Take special care with LEXAMIL

• Before you start treatment with LEXAMIL, tell your doctor if any of the following applies to you as you may then require a lower dose or special precautions:
• Previously been diagnosed with mania or manic episodes.
• Seizures (convulsions) or epilepsy.
• Diabetes mellitus.
• You think about suicide.
• Previously been diagnosed with a bleeding disorder. Please inform your doctor immediately if you develop bruising, blood in the urine, bleeding from the gums, or pinpoint red spots on the skin while taking LEXAMIL.
• You are scheduled to undergo electroconvulsive therapy (ECT).
• Your heart rate is very slow, you recently suffered a heart attack or if you are in heart failure. Please speak to your doctor if you are unsure.

Do not share medicines prescribed for you with any other person. Always take LEXAMIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Depending on your diagnosis and your individual response to treatment, your doctor will decide on the dosage of LEXAMIL and how long treatment will last. The usual dose in adults is a single, once daily dose of 5 mg, 10 mg or 20 mg as determined by your doctor. Usually, 2 to 4 weeks or longer are needed before LEXAMIL will make you feel better if you have been diagnosed with major depressive episodes or social anxiety disorder; at least 3 months of treatment are needed for panic disorder and several months or even longer for obsessive compulsive disorder.

When stopping LEXAMIL therapy, the doctor may consider decreasing the dose gradually before stopping treatment. LEXAMIL can be taken with or without food.

If you have the impression that the effect of LEXAMIL is too strong or too weak, please discuss this with your doctor or pharmacist.

If you take more LEXAMIL than you should

In the event of an overdosage, or if someone else has taken your medicine by mistake, you, or this other person, may experience side-effects such as those listed below. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take LEXAMIL

Always take LEXAMIL as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule of one tablet once daily. Do not take a double dose to make up for forgotten individual doses.

Effects when treatment with LEXAMIL is stopped

After using LEXAMIL for a long period, abruptly stopping your treatment may cause withdrawal symptoms. There have even been reports of withdrawal symptoms in patients who have accidentally missed a dose. Withdrawal symptoms usually start within the first few days of stopping LEXAMIL treatment and usually disappear within 2 weeks. LEXAMIL withdrawal symptoms may include dizziness, pins and needles and electric shock sensations, sleep disturbances (including sleeplessness and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea (runny stomach), palpitations, emotional instability, irritability, and visual disturbances. Generally, these symptoms are mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. Always follow your doctor’s instructions carefully when treatment with LEXAMIL is stopped. Do NOT stop treatment without your doctor’s consent.

LEXAMIL can have side-effects. Not all side-effects reported for LEXAMIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LEXAMIL, please consult your doctor, pharmacist or other healthcare professional for advice.

The side-effects of LEXAMIL are most frequent during the first 1 or 2 weeks of treatment and may decrease in intensity and frequency with continued treatment. After using LEXAMIL for a long period, abruptly stopping your treatment may cause withdrawal symptoms (see "Effects when treatment with LEXAMIL is stopped"). Serious side-effects that you, or a family member, should report to your doctor as a matter of urgency include:

• Those that occur less frequently:
• Severe allergic reactions presenting with shortness of breath, hives or itching, swelling of the face, tongue, or whole body, tightness of the chest, nausea, vomiting or fever.
• Any combination of the following: rapidly developing changes in consciousness or alertness with confusion, elevated mood, agitation, hyperactive behaviour, shivering, fever, tremor, abnormal eye movements, severe muscle spasms, and inability to co-ordinate movements. These symptoms may be due to serotonin syndrome (see "Take special care with LEXAMIL").
• Vomiting of blood or a substance that resembles coffee-grounds, or passing blood per rectum or passing black, tarry, foul-smelling stools.
• Confusion, aggression, personality changes or hallucinations (seeing or hearing things that are not real).
• Slow heart rate or palpitations.

Those for which the frequency is not known:

• Convulsions (seizures).
• Yellow discolouration of the skin or whites of the eyes accompanied by loss of appetite, nausea and/or vomiting with or without pain over the liver area.
• Pinpoint red spots on the skin, easy bruising, bleeding from the gums or blood in the urine, since any combination of these symptoms may be due to low platelet counts.
• Extremely elevated mood with inappropriate behaviour.
• Inability to pass urine.
• Persistent painful erection.

Other side-effects that you should report to your doctor as soon as possible include:

• Those that occur frequently:
• Pins and needles.
• Fever.
• Those that occur less frequently:
• Visual disturbances.
• Nose bleeds.
• Hives, skin rash or itching.
• Panic attacks.
• Fainting spells.
• Rapid heart rate.
• Swelling of the legs or feet.
• Those for which the frequency is not known:
• Nausea and vomiting, confusion, loss of energy, fatigue, muscle weakness, muscle spasms or muscle cramps, since a combination of these symptoms may be due to low blood sodium levels (see "Take special care with LEXAMIL").
• Abnormal movements over which you do not have control.
• Thoughts about suicide.
• Akathisia (see "Take special care with LEXAMIL").
• Feeling faint or dizzy after standing up.
• Milky secretion from the breasts.

Please report the following side-effects to your doctor or pharmacist if they continue or become bothersome:

• Those that occur frequently:
• Decreased or increased appetite, weight gain.
• Anxiety, restlessness, abnormal dreams, decreased libido or inability to reach orgasm.
• Headache.
• Inability to sleep or excessive sleepiness, dizziness, or tremor.
• Pain over the sinuses with blocked or runny nose.
• Nausea, runny stomach, constipation, vomiting or dry mouth.
• Muscle or joint pain.
• Ejaculation disorder or impotence.
• Yawning.
• Increased sweating.
• Fatigue.
• Those that occur less frequently:
• Heavy menstruation or more frequent menstruation.
• Weight loss.
• Grinding of the teeth or clenching of the jaw, agitation, nervousness.
• Taste disturbances.
• Dilation of the pupil.
• Ringing in the ears.
• Hair loss.
• Those for which the frequency is not known:
• Loss of appetite.

Store at or below 30 ºC. Keep the blisters in the outer carton until required for use. Do not take the medicine after the expiry date stated on the package. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Store all medicines out of reach of children.