Detryp 10 mg Film-Coated Tablets

Amitriptyline belongs to a group of medicines called tricyclic antidepressant medicines. DETRYP is used to treat:

• depression in adults (major depressive episodes)
• bed-wetting at night in children over 6 years of age, only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved to all other non-medicinal and medicine treatments, including muscle relaxants and desmopressin.

Do not take DETRYP:

• if you are hypersensitive (allergic) to amitriptyline, tricyclic antidepressants or to any of the ingredients of DETRYP (see section 5)
• if you have recently had a heart attack (myocardial infarction) or have heart problems
• for the treatments of depression in children
• if you are taking medicines used to treat depression, known as monoamine oxidase inhibitors (MAOIs)
• if you have taken MAOIs within the last 14 days
• if you are taking the antibiotic, linezolid
• if you are taking medicine for high blood pressure
• if you have a severe liver disease
• if you are pregnant or breastfeeding your baby
• if you suffer from a mental illness marked by periods of great excitement or euphoria, delusions, and overactivity.

DETRYP should not be used for children below 18 years of age to treat depression.

Warnings and precautions

Take special care with DETRYP:

• DETRYP should at all times be kept out of the reach of children, as even small doses may be fatal to them.
• you may experience a dry mouth, constipation, less frequent urination, blurred vision and visual disturbances. If this occurs, discontinue use or seek advice from your healthcare professional regarding reducing the dose.
• when therapy starts, do not drive a motor vehicle, climb dangerous heights or operate dangerous machinery for at least several days as DETRYP can impair your decision making and could lead to accidents due to drowsiness or excessive sedation. You may also experience disorientation, agitation, sleeplessness and restlessness especially when taken with other medicine which can influence the central nervous system – i.e. alcohol and barbiturates (treatments for anxiety and sleeplessness)
• elderly patients are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure, they can be especially sensitive to the side effects of DETRYP and therefore should take a lower dose. In addition, if you suffer from an enlarged prostate, you may experience a condition in which your bladder doesn't empty completely even if it's full and you often feel like you really have to urinate.
• some patients with manic-depressive illness may enter into a manic phase. This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medicine.
• heart rhythm disorders and hypotension (low blood pressure) may occur if you receive a high dosage of DETRYP. This might also occur in usual doses if you have pre-existing heart disease.
• a heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heartbeat) have been reported with DETRYP. Tell your doctor if you:
• have slow heart rate
• have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure)
• are taking any other medicines that may cause heart problems
• have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
• there might be a change in your sex drive, interference with sexual function, males may develop breasts and breast enlargements may occur, as well as excessive or inappropriate milk production.
• your blood sugar levels may change, and you may suffer from a condition where the body retains water instead of excreting it normally in urine, which may interfere with your electrolyte balance.
• low sodium levels in your blood which is characterized by drowsiness, confusion or fits.
• if you develop an allergic skin reaction, discontinue use
• you may experience above normal body temperature especially when taken in combination with medicine called anticholinergics (i.e. atropine (used to treat nerve poisoning), clidinium (used to treat stomach cramps and pain by reducing stomach acid) or medicine called neuroleptics (used to manage psychosis), especially in hot weather.
• if you are depressed, you can sometimes have thoughts of harming or killing yourself. These feelings may be increased when first starting antidepressants such as DETRYP, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult as information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
• If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
• You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
• tell your doctor if you have, or have had in the past, any medical problems, especially if you have
• have an over-active thyroid gland or receive thyroid medicine
• epilepsy, a history of convulsions or fits, difficulty in passing urine, enlarged prostate, thyroid disease, paranoid personality disorder, severe liver disease, severe heart disease, pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)
• narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye), vision problems (near sighed, far sighted)
• diabetes as you might need an adjustment of your antidiabetic medicine
• liver problems and phaeochromocytoma (a rare tumour of the adrenal gland)
• conditions called porphyria (disorders that can cause skin or nerve problems)
• if you are undergoing electroconvulsive therapy
• if you stop taking DETRYP after prolonged use, withdrawal symptoms may occur such as headache, general discomfort, sleeplessness and irritability.
• your doctor will do an ECG on you before starting treatment for bed-wetting.
• suicidal thoughts and behaviours may also develop during early treatment with antidepressants such as DETRYP for disorders other than depression; the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis
• do not take medicine called anticholinergics (i.e. atropine (used to treat nerve poisoning), clidinium (used to treat stomach cramps and pain by reducing stomach acid) when you are treated for enuresis (bed-wetting).
• if you have a surgery planned as it might be necessary to stop the treatment with amitriptyline before you are given anaesthetics. In the case of acute surgery, the anaesthetist should be informed about the treatment of DETRYP.

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

Adults: Depression: The recommended initial dose is 25 mg three times daily. Depending on the response to the medicine, your doctor may gradually increase the dose to 150 mg per day. As with other medicines for the treatment of depression it may take a few weeks before you feel any improvement. In treating depression, the duration of treatment is individual, and is usually at least 3 months before treatment is gradually withdrawn. The duration of treatment is decided by your doctor. If you are being treated for depression in hospital, you may receive a dose of 200 mg daily, and occasionally up to 300 mg daily.

Children: Enuresis (Bed-wetting at night): The recommended dose for treatment of bed-wetting is:

• Children 6 to 10 years: 10 to 20 mg at bedtime
• Children 11 to 16 years: 25 to 50 mg at bedtime

Do not exceed the recommended dose. Treatment should not be continued for more than 3 months and should be withdrawn gradually.

The effects of long-term treatment with DETRYP on growth and development in children has not been established.

If you take more DETRYP than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include:

• dilated pupils, difficulty urinating, dry mouth and tongue, intestinal blockage, fits, fever or shivering, agitation, confusion, hallucinations, uncontrolled movements, weak pulse, pallor, difficulty breathing, blue discolouration of the skin, decreased heart rate, drowsiness, loss of consciousness, coma, various heart-related symptoms such as low blood pressure, high blood pressure, fast or irregular heartbeats, heart block, heart failure, cardiogenic shock, metabolic acidosis, hypokalemia.

If you forget to take DETRYP, take as soon as you remember on the same day. If you do not take a tablet that same day, take your normal dose the next day. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DETRYP Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. nausea, chills, headache, itching, sweating, anxiety, agitation, feeling unwell, irregular heartbeats, sleeplessness and irritability).

Not all side effects reported for DETRYP are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using DETRYP, please consult your healthcare provider for advice.

If any of the following happens, stop using DETRYP 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 DETRYP. 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, drooping face, arm weakness and slurred speech (stroke), heart block, worsening of cardiac failure, heart muscle disease
• changes in the way your heart beats, for example, if you notice it is beating faster or experience uneven heartbeat (palpitations), increased, irregular or fast heartbeat (tachycardia), unusually fast or irregular heartbeat (torsades des pointes)
• seizures (fits), tremors, convulsions, coma
• attacks of intermittent blurring of vision, rainbow vision, eye pain
• bad constipation, a swollen stomach, fever and vomiting (these symptoms may be due to parts of the intestine becoming paralysed)
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)
• hepatitis (inflammation of the liver with symptoms such as nausea, mild fever, abdominal pain), abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite)
• bruising, bleeding, pallor or persistent sore throat and fever (these symptoms can be the first signs that your blood or bone marrow may be affected)
• passing less urine than is normal for you. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following: Frequent side effects:

• aggression, feeling confused, a state of anxiety or nervous excitement
• sleepiness, shakiness, dizziness, headache, drowsiness, slurred speech, disturbance in speech, disturbance in attention, taste disturbances, tingling feeling, prickling, or numbness of the skin (pins and needles), loss of full control of bodily movements
• vision disturbances, pupil dilation, blurred vision
• low or drop in blood pressure when getting up from a lying position
• blocked nose
• dry mouth, constipation, nausea, sour or metallic taste, gas, abdominal pain, rumbling noises, bloated feeling, belching
• excessive sweating
• passing more or less urine than is normal for you
• sexual disturbances (decreased sex-drive, problems with erection)
• fatigue, thirst, abnormal high body temperature
• abnormal electrocardiogram (ECG) results, abnormally low sodium levels in the blood.

Less frequent side effects:

• effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting), bleeding into the tissues and slow blood clotting after injury (thrombocytopenia)
• a condition where your body retains water instead of passing it normally through urine, high or low blood sugar
• decreased or increased appetite, weight gain or loss, lack of appetite
• mood changes or mood swings or changes in personality, delusions, abnormal behaviour, mood-swings, feeling unusually excited, over-active and uninhibited (mania), anxiety
• insomnia (sleep disturbances), nightmares, restlessness, disorientation and confusion (especially of you are elderly), excitement, changes in behavior, struggling to concentrate
• thinking about or feeling like killing yourself
• hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
• movement disorders, numbness, burning pain
• ringing in the ear
• high blood pressure, fainting
• allergic inflammation of the lung alveoli and of the lung tissue
• diarrhoea, vomiting, tongue swelling, swelling of the salivary glands, altered taste, stomach inflammation, black tongue
• skin rash, rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling (urticaria), face swelling, hair loss, increased sensitivity to sunlight
• unexpected production of breast milk without breastfeeding, breast enlargement in men
• fever, weakness
• abnormal results of liver function tests, abnormal blood test results.

The following side effects have been reported but the frequency for them to occur is not known:

• paranoia
• dry eyes
• severe itching of the skin (pruritis).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8. An email can be sent directly to the company, [email protected] to ensure safety of the product. By reporting side effects, you can help provide more information on the safety of DETRYP.

Store all medicines out of reach of children. Store at or below 25 °C. Store/keep in a tight, light-resistant container.

Do not use after the expiry date stated on the container or carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).