Zartan Side Effects

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

What is Zartan?

Zartan contains the active ingredient Losartan potassium.

• Active ingredient — Losartan potassium
• Registration number — A41/7.1.3/0286; A41/7.1.3/0287; A41/7.1.3/0288; A41/7.1.3/0289
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• because you have a condition known as hypertension, “high blood” or high blood pressure
• to protect the kidneys in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria(a condition in which urine contains an abnormal amount of protein)

Common side effects of Zartan

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.

Frequent side effects

• upper airway infection, shortness of breath
• difficulty falling asleep
• headache, head spinning sensation (vertigo)
• cough, stuffy nose, throat infection, sinus infection
• tiredness, swelling from water retention, abnormal physical weakness or lack of energy
• increased potassium level in blood, low blood sugar which will be seen in a blood test (you may feel weak, tired, numbness, nausea, shortness of breath, chest pain, fast or skipped heartbeat)
• decrease sodium level in blood which will be seen in a blood test (you may experience the following symptoms: weakness, tiredness, headache, nausea, vomiting, muscle cramps or spasms, confusion, irritability)
• increased liver enzymes which will be seen in a blood test

Less frequent side effects

• lack of iron in blood, low platelet count which will be seen in a blood test (you may experience the following symptoms: tiredness, weakness, pale skin, shortness of breath, dizziness, tingling sensation in your legs, tongue swelling, sore mouth, swollen gums)
• orthostatic hypotension (low blood pressure – you may be feeling dizzy when standing upright from a sitting position)
• diarrhoea, heartburn, nausea, stomach pain
• rash, hives
• back pain, muscle cramps, leg pain
• dizziness, migraine, metallic taste in mouth. The following side effects have been reported but the frequency for them to occur is not known:
• bruising, and slow blood clotting after injury
• inflammation of the blood vessels (symptoms include fever, fatigue, weight loss and muscle and joint pain)
• change in sense of taste, losing sense of taste, vomiting
• severe itching of the skin, sun sensitivity, inflammatory skin disease with redness and scaling that affects nearly the entire body, a rare skin condition that may be characterized by non-cancerous (benign) buildup of white blood cells, which present as lesions or lumps on the skin
• muscle pain, joint pain
• kidney problems (you may experience the following symptoms: nausea, vomiting, less urine than normal, ankles swelling, puffiness around the eyes, unpleasant taste in the mouth, stinky breath, tiredness, shortness of breath, no appetite)
• inability to develop or sustain an erection, impotence
• general feeling of discomfort, illness, or unease with no apparent cause

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 losartan potassium, or to any of the ingredients of ZARTAN
• if you are taking fluoroquinolones (type of antibiotic) such as ciprofloxacin or levofloxacin with ZARTAN, contact your doctor to re- evaluate your treatment
• if you or your family have a history of serious allergic reaction which includes swelling of the face or throat
• if you have abnormally thickened heart muscles
• if you have severe kidney or liver disease
• if you only have one kidney
• if you have a heart condition
• if you are taking other medicines which retain potassium, such as spironolactone, triamterene or amiloride
• if you suffer from porphyria (a rare blood disorder)
• if you are taking lithium medicines
• if you are pregnant or breastfeeding
• if you are taking high blood pressure medicines which are in the renin inhibitors or aliskiren-containing group. The safety and efficacy of ZARTAN in children has not been established

Use with care, and tell your doctor, if

• if you fall pregnant while taking ZARTAN, you should stop taking ZARTAN immediately and inform your doctor as soon as possible
• if you are currently on any fluoroquinolones, such as ciprofloxacin or levofloxacin, as the concomitant use of fluoroquinolone and AngiotensinReceptor Blockers (ARBs), such as ZARTAN, may cause acute kidney injury, contact your doctor to re-evaluate your treatment
• if you are currently being treated for hypertension with other medicines used to lower blood pressure including aliskiren, as your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals
• if you have recently suffered from excessive vomiting or diarrhoea
• if you have liver or kidney disease
• if you are taking high-dose diuretics (water tablets)
• if you are an elderly patient or if you have problems with your kidneys, the potassium levels in your body should be carefully monitored
• if you have problems with your liver

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding your baby, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine
• The use of ZARTAN while you are pregnant or breast feeding is contraindicated

Interactions and medicines to check

The approved leaflet names these interactions.

• Fluoroquinolones (type of antibiotic), such as ciprofloxacin or levofloxacin, may lead to acute kidney injury, contact your doctor to re- evaluate your treatment
• anti-inflammatory medicines, NSAIDs, especially indomethacin
• sympathomimetic medicines (which include some of the active ingredients in cold and flu preparations, some heart medicines, medicines used to treat glaucoma), as concurrent use with sympathomimetic medicines may reduce the blood pressure lowering effects of ZARTAN
• potassium-sparing diuretics (water tablets), potassium containing medicine, potassium supplements, medicines which retain potassium (amiloride, triamterene, spironolactone) or increases potassium levels (heparin)
• lithium (to treat depression). ZARTAN with food and drink ZARTAN can be taken with or without food

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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