Trepiline Tablets

TREPILINE contains amitriptyline. Amitriptyline belongs to a group of medicines called tricyclic antidepressants. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression. TREPILINE is used to treat the symptoms of depression in patients 18 years and older.

Do not take TREPILINE:

• If you are allergic (hypersensitive) to amitriptyline, other tricyclic antidepressants or to any inactive ingredients (see WHAT TREPILINE CONTAINS).
• If you have recently had a heart attack.
• If you are taking monoamine oxidase inhibitors (MAOIs) or you have taken MAOIs within the previous 14 days for the treatment of depression.
• If you are taking certain medicines for the treatment of high blood pressure.
• If you are pregnant or breastfeeding.
• If the child is under 18 years of age.
• If you have heart disease such as irregular heart beats, heart block or failure, coronary artery disease.
• If you suffer from periods of increased and exaggerated behaviour (mania).
• If you have severe liver disease.
• If you are taking linezolid (which is an antibiotic).

Take special care with TREPILINE:

• TREPILINE should at all times be kept out of sight and reach of children, as even small doses may be fatal to them.
• TREPILINE may cause drowsiness at the start of therapy.
• If you experience dry mouth, constipation, difficulty to urinate and blurred vision or other vision disturbances, consult your doctor.
• If you have drowsiness, agitation, restlessness or insomnia (inability to sleep).
• If you have hypertension (high blood pressure) or a heart disorder.
• If you have changes in libido (sex drive), interference with sexual function, gynecomastia (enlargement of man’s breasts), breast enlargement in women, galactorrhoea (flow of milk from breast not whilst breastfeeding).
• If you have diabetes (high blood sugar levels).
• If you have a psychiatric disorder (such as mania or depression).
• If you have thoughts of harming or killing yourself.
• If you are due to have any surgery that involves an anaesthetic.
• If you are taking medicines called epinephrine or norepinephrine, TREPILINE can increase these medicines’ effects.
• If you have a condition called porphyria.
• If you have a thyroid gland disorder.
• If you have a liver disorder.
• If you suffer from epilepsy (seizures or fits).
• If you have an eye condition called glaucoma (increased pressure in the eye).
• If you are not able to pass water (urinate) or have an enlarged prostate gland.
• If you have constipation.
• If you develop allergic skin reactions.
• If you are taking medicines called barbiturates or alcohol - their effects can be increased.
• If you are being given electroconvulsive therapy (ECT) (procedure when electric currents are passed through the brain).
• If you develop low levels of sodium in your blood that can arise as the following symptoms: if you feel drowsy, confused or have fits.
• If you are an elderly person (older than 65 years of age).

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

Adults: The usual dose is 75 mg to 150 mg daily in divided doses. The maintenance dose is 50 mg to 100 mg daily in divided doses. Your doctor will tell you how long your treatment with TREPILINE will last.

If you have the impression that the effect of TREPILINE is too strong or too weak, tell your doctor or pharmacist.

If you take more TREPILINE than you should 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 TREPILINE If you miss a dose take it as soon as possible. Then continue with your regular dosing schedule. If it is almost time for your next dose, do not take the missed dose at all and do not take a double dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time.

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

If any of the following happens, stop taking TREPILINE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TREPILINE. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Heart attack (symptoms may include pain or pressure in the chest, discomfort spreading to the back, jaw, throat or arm, nausea, indigestion or heartburn, weakness, anxiety or shortness of breath and rapid or irregular heartbeats).
• Stroke (symptoms may include sudden numbness or weakness of the face, arm or leg, especially on one side of the body, sudden confusion, trouble speaking or understanding speech, sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination and sudden severe headache with no known cause).
• Yellowing of the skin and eyes, also known as jaundice.
• Feeling faint when getting up (postural hypotension), increased blood pressure, fast/racing heart, palpitations, irregular or slow heart beats and very low blood pressure.
• Bone marrow depression or reduction in some blood cells (you may experience mouth ulcers and recurring infections, bleeding or bruising easily).
• Difficulty passing water (urine).
• Coma (state of unconsciousness).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been frequently reported:

• Drowsiness, sleepiness.
• Blurred vision, accommodation disturbance (difficulty to focus when looking at an object), increased pressure within the eye ball.
• Dry mouth, constipation.
• Hyperthermia (body temperature above the normal value).

The following side effects have been reported less frequently:

• Urticaria (skin rash characterised by pale red itchy bumps), photosensitisation (reaction of skin to sunlight).
• Inappropriate secretion of ADH (antidiuretic hormone) which may make you urinate more frequently, changes in blood sugar levels, changes blood sodium levels.
• Increased appetite, weight gain, weight loss, anorexia (loss of appetite).
• Confusion, disorientation (not knowing where you are), agitation (state of anxiety), insomnia (difficulty sleeping), nightmares, anxiety (feeling of worry), restlessness, disturbed concentration, dysarthria (condition where the muscles used for speech is weak), change in behaviour, suicidal thoughts or behaviour.
• Dizziness, headache, peripheral neuropathy (weakness, numbness or pain in hands and feet), pins and needles, lack of coordination, ataxia (loss of full control of body movements), tremors, fits, tardive dyskinesia (involuntary movements of the face and jaw).
• Mydriasis (enlargement of the pupil of the eyes).
• Tinnitus (ringing in the ears).
• Nausea (feeling sick), vomiting (being sick), diarrhoea, paralysis of the intestine, epigastric distress (characterised by slow bowel movements), inflammation in the mouth, dysgeusia (distortion of taste), swelling of the parotid gland (which produces saliva or spit), black tongue.
• Hepatitis (inflammation of the liver).
• Skin rash, alopecia (temporary hair loss).
• Increased passing of urine, urinary tract dilation (can be caused by infection).
• Breast swelling in men and women, galactorrhoea (milky nipple discharge unrelated to the normal milk production of breastfeeding), swelling of testicles, disturbances in sexual function or sex drive.
• Weakness, feeling tired, increased sweating.

The following side effects have been reported with an unknown frequency:

• Increased risk of bone fractures.

Store at or below 25 °C. Protect from light and moisture. Do not use after the expiry date printed on the label or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets). KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.