Adco Retic Side Effects

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Answer the side-effect intent for adco retic without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Adco Retic?

Adco-Retic contains the active ingredient Amiloride hydrochloride.

• Active ingredient — Amiloride hydrochloride
• Registration number — V/18.1/260
• Registration holder — Adcock Ingram Limited

It is approved for:

• heart failure
• fluid retention caused by a liver disease called ‘cirrhosis’
• high blood pressure

Common side effects of Adco Retic

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• blistering or peeling of the skin
• These are all very serious side effects. If you have them, you may have had a serious reaction to ADCO RETIC. 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:
• skin and lip cancer (non-melanoma skin cancer)
• chest pain, changes in the way your heart beats
• build-up of a medicine called digoxin, with symptoms such as feeling sick, being sick, stomach pain, headache, dizziness, confusion, and vision disturbance (digoxin toxicity)
• difficulty in breathing, shortness of breath, rapid breathing, fluid in the lungs
• acute respiratory distress syndrome (ARDS) with symptoms such as severe shortness of breath, fever, low blood pressure, muscle weakness, and mental confusion
• kidney problems including painful or difficulty in urination, excessive urination at night, unintentional urination, excessive urination, bladder spasms, blood in the urine, foamy urine
• a brain disease with symptoms such as deceasing ability to reason and concentrate, memory loss, personality change, fits and twitching (encephalopathy)
• changes in vision, pressure in the eye(s), blurred vision, yellow vision, fluid build-up in the eye(s)
• an inflammation of blood vessel walls with symptoms such as a skin rash, chills, fever, fatigue and weight loss
• internal bleeding of the stomach or intestines (gastrointestinal bleeding), a sore or ulcer that develops on the lining of the food pipe, stomach or small intestine with symptoms such as upper stomach pain (peptic ulcer)
• inflammation of the pancreas which causes severe pain in the stomach and back
• abnormal liver function with symptoms such as yellowing of the skin and eyes (jaundice), abdominal pain and swelling, swellings in the legs and ankles, dark urine and pale stools
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Side effects with unknown frequency:
• infection of the salivary glands with symptoms such as enlargement, tenderness, and redness of one or more salivary glands
• imbalances of certain minerals in your body (such as sodium, calcium, potassium), dehydration, increased levels of sugar in the blood and urine, increased uric acid levels in the blood, gout
• difficulty in falling asleep, nervousness, depression, sleepiness, confusion, headache, restlessness
• state of near unconsciousness (stupor), dizziness, weakness, feeling like you are spinning, pins and needles in your hands and feet, feeling shaky
• blocked nose, cough
• anorexia (an eating disorder), nausea, vomiting, diarrhoea, constipation, appetite changes, stomach fullness, flatulence, hiccups, bad taste, stomach pain, thirst, dry mouth, indigestion, cramping, stomach irritation
• reddening of the face or other areas of the skin (flushing), excessive sweating, loss of hair, sensitivity to light
• leg pain, joint pain, back pain, muscle cramps, neck/shoulder pain, pain in the arms and legs
• loss of male sexual ability (impotence), lower sex drive
• a general feeling of being unwell, fainting, fever, weakness, tiredness
• blood disorders, determined from blood tests conducted by your healthcare provider, with symptoms such as tiredness, weakness, increases risk of bleeding, bruising, shortness of breath, fever and susceptibility to infection
• ringing in the ears
• feeling light headed when you stand quickly
• increase in blood cholesterol and triglyceride (type of cholesterol) levels

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to amiloride, hydrochlorothiazide or to any of the other ingredients of ADCO RETIC (listed in section 6)
• if you are also taking water tablets (diuretics) such as spironolactone or triamterene
• if you have severe liver failure. S3
• if you have a disorder known as Addison’s disease (a disorder in which the adrenal glands don’t produce enough hormones)
• if you are also taking a medicine known as lithium (a medicine used to treat depression or mood disorders)
• if you have been told by your doctor you have high levels of urea, creatinine, calcium or potassium in your blood
• if you are taking a medicine containing potassium or potassium supplement or you eat potassium-rich foods
• if you suffer from kidney disease (which include advanced kidney disease), a kidney disorder known as anuria (your kidneys fail to produce urine) or acute kidney failure
• if you have previously had or currently have cancer of the skin and/or lip
• if you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of some types of skin and lip cancer (nonmelanoma skin cancer). Protect your skin from sun exposure and UV rays while taking ADCO RETIC
• if you have any heart conditions speak to your doctor before taking ADCO RETIC
• if you have liver conditions as ADCO RETIC may cause complications with symptoms such as tremor, confusion or coma. ADCO RETIC may also cause the yellowing of the skin and eyes (jaundice)
• if you are diabetic you may need to have some tests to test your kidney function before receiving treatment with ADCO RETIC. ADCO RETIC may cause increased blood sugar and aggravate or unmask diabetes mellitus. Your blood sugar concentrations should be monitored if you are taking any medicine to treat diabetes. You should stop taking ADCO RETIC 3 days before going for a glucose-tolerance test
• long-term use of ADCO RETIC may cause changes to the parathyroid gland with increases in blood calcium levels and decrease in blood phosphorous levels
• if you been told by your doctor that you have disorders of the adrenal gland
• if you are seriously ill, vomiting excessively or receiving IV fluids
• if you notice that your urine output is less than normal for you
• if you suffer from asthma
• if you have an autoimmune disease called systemic lupus erythematosus
• if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide (as in ADCO RETIC) intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking ADCO RETIC, seek medical attention immediately
• if you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking ADCO RETIC. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy, you can be at higher risk of developing this. Children and adolescents ADCO RETIC should not be given to children under 18 years of age as safety has not been established

Pregnancy and breastfeeding

• You should not take ADCO RETIC if you are pregnant or breastfeeding your baby
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking ADCO RETIC

Interactions and medicines to check

The approved leaflet names these interactions.

• lithium – used for depression
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, celecoxib – used to reduce high temperature (fever), pain or for arthritis
• angiotensin converting enzyme inhibitors (ACE inhibitors) such as enalapril used to treat high blood pressure or heart problems
• angiotensin II receptor antagonists such as losartan – used to treat high blood pressure or diabetics with kidney damage
• other medicines for high blood pressure
• medicines for diabetes such as insulin or chlorpropamide
• barbiturates – used to help you sleep or to reduce anxiety
• painkillers such as codeine, dihydrocodeine, dextropropoxyphene, diamorphine, morphine, pentazocine and pethidine
• cholestyramine and colestipol – used to treat high cholesterol (hyperlipidaemia)
• steroids – used to treat lots of different conditions such as rheumatism, arthritis, allergic conditions, skin problems, asthma or a type of blood disorder
• norepinephrine (also known as noradrenaline) – used to treat life-threatening low blood pressure
• tacrolimus – used after a liver or kidney transplant to prevent rejection
• ciclosporin – used for rheumatoid arthritis or to prevent rejection after a transplant
• non-depolarising muscle relaxants such as tubocurarine
• trilostane – used to treat breast cancer or overactive adrenal glands (such as in Conn’s syndrome, Cushing’s syndrome)
• digoxin – used for heart failure and abnormal heart beat. ADCO RETIC with food, drink and alcohol Your doctor may have asked you to change your diet slightly and not to eat certain foods which contain a lot of potassium. These foods include milk, bananas, raisins and prunes. Your doctor will tell you what food you should not eat. If you are unsure about what food you should avoid, ask your doctor before taking ADCO RETIC tablets. Your doctor may have told you that you should keep alcohol intake to a minimum while you are taking ADCO RETIC. Alcohol may increase the effects of ADCO RETIC so that you feel dizzy or light-headed when you stand up quickly

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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