Cifran Side Effects

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

What is Cifran?

Cifran contains the active ingredient Ciprofloxacin.

• Active ingredient — Ciprofloxacin
• Registration number — 36/20.1.1/0376; 36/20.1.1/0377
• Registration holder — CIPLA MEDPRO (PTY) LTD

It is approved for:

• CIPLOXX is used in adults to treat severe and/or complicated bacterial infection of the lungs, bladder, gut (diarrhoea), bone, or skin and soft tissues where other antimicrobials used for similar infections were considered not to be an appropriate treatment option, have failed, cannot be used or are not tolerated
• It is also used to prevent you getting an infection caused by a bacterium called Neisseria meningitidis

Common side effects of Cifran

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.

Those that occur frequently side effects

• Sleeplessness, agitation, confusion
• Dizziness, headache, taste loss, impaired sense of taste
• Nausea, loose stools, vomiting, indigestion, stomach pain, loss of appetite, flatulence (gas)
• Joint pain
• General feeling of weakness, tiredness

Those that occur less frequently side effects

• Anxiety, abnormal dreams (nightmares), irritability, restlessness, disorientation, sleep disorders
• Migraine
• Blurred vision, double vision, disturbance in colour vision or eye movement
• Ringing in the ears, temporary deafness / impairment of hearing (especially at high frequencies), feeling that you or your environment is moving or spinning
• Thrush / vaginal yeast infection, yeast infection of the mouth, throat or gut
• Stomach pain, constipation, sores in the mouth, difficulty swallowing
• Back and chest pain, pain in the extremities, worsening gout
• Pain, fever, sweating, tiredness, feeling unwell
• Sudden severe pain in your chest, abdomen (tummy) or back

Those that occur with unknown frequency side effects

• Numbness and tingling in the feet or hands
• Fast or irregular heartbeat, dizziness, light-headedness, shortness of breath, chest pain, fainting spells with or without exercise, or coughing when lying down, or prolonged QT interval on the electrocardiogram
• Inflamed blisters on the skin (acute generalised exanthematous pustulosis) with or without fever, rash, facial swelling, enlarged lymph glands and kidney or liver problems (medicine reaction with eosinophilia and systemic symptoms syndrome)
• Difficulty sleeping, fluid retention or excessive sweating relating to a condition called Syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

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 ciprofloxacin or any of the other ingredients of CIPLOXX (listed in section 6)
• If you or your child are younger than 18 years
• If you are pregnant or breastfeeding your baby
• If you are receiving treatment with tizanidine, a muscle relaxant
• If you have kidney function impairment and are taking medicines to lower your blood pressure, including angiotensin-converting enzyme (ACE) inhibitors (such as enalapril, lisinopril, perindopril), or renin-angiotensin blockers (such as losartan, valsartan, irbesartan)
• If you have previously experienced side effects with the use of quinolone / fluoroquinolone antibiotics relating to your joints, muscles, ligaments, nerves, central nervous system (brain), epilepsy or mental health (psychiatric disorder)
• If you were born with or have any condition with abnormal heart rhythm whether related to QT time prolongation or not (seen on ECG, electrical recording of the heart)
• If you are taking other medicines that result in an abnormal heart rate and/or rhythm tracing (ECG) e.g. (prolongation of the “QT time”)
• If you have an enlargement or “bulge” of a large blood vessel (aortic aneurysm) or a previous episode of aortic dissection (a tear in the aortic wall) or a family history of aortic aneurysm / dissection, or other risk factors or existing predisposing conditions
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis)
• If you are on treatment for high blood pressure with medicines called ACE inhibitors / angiotensin receptor blockers. Ask your doctor if you are unsure
• If you have mitral valve or aortic valve regurgitation (when your heart’s mitral or aortic valve does not close tightly, causing blood to flow back into the heart instead of pumping out)

Use with care, and tell your doctor, if

• Take special care with CIPLOXX: Your doctor may decide to conduct laboratory tests to establish if CIPLOXX will be effective in treating your infection and may also decide to prescribe CIPLOXX together with other medicines, depending on your infection
• Allergic reactions, which may include a skin rash with blister formation, peeling or purple/red inflamed spots on your skin, difficult breathing and swallowing, wheezing, hives, itching, or swelling of the lips, face, tongue or whole body may occur with CIPLOXX, sometimes after the first dose
• If you experience any of these symptoms during treatment stop taking CIPLOXX immediately and contact your doctor as these symptoms may be due to an allergic reaction that may become life-threatening
• Tell your doctor if you have previously suffered a tendon disease / disorder related to other quinolone antibiotics
• Treatment with CIPLOXX may cause inflammation of a tendon and/or a tear in a tendon (particularly of the Achilles tendon – see ʺPossible side effectsʺ), especially in older people and in those treated concurrently with corticosteroids (e.g
• cortisone or prednisone)
• This can occur within 48 hours after starting treatment or several months afterwards
• If you experience pain, swelling or redness of any tendon, immediately stop taking CIPLOXX and rest the affected limb(s)
• Report to your doctor promptly while avoiding any form of physical exercise
• Inform your doctor if you have been diagnosed with myasthenia gravis, as worsening of muscle paralysis has been reported with CIPLOXX

Pregnancy and breastfeeding

• You should not use CIPLOXX during pregnancy or when 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 healthcare professional for advice before taking CIPLOXX

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines to treat abnormal heart rhythms, e.g. quinidine, amiodarone, sotalol
• Erythromycin (an antibiotic), medicines for the treatment of psychosis (e.g. risperidone, quetiapine, olanzapine), or antidepressants (e.g. agomelatine, amitriptyline, clomipramine), since these medicines may increase your risk of developing abnormal heart rhythms
• Antacids or sucralfate (for stomach ulcers), multivitamins or products containing magnesium, calcium, aluminium or iron, sevelamer or lanthanum carbonate (called phosphate binders), and medicines containing magnesium, calcium, or aluminium (e.g. didanosine or other antiretroviral medicines used in the treatment of HIV). These medicines may reduce the absorption of CIPLOXX. CIPLOXX should, therefore, be taken 1 to 2 hours before, or at least 4 hours after any of these medicines
• Non-steroidal anti-inflammatory medicines (NSAIDs), e.g. fenbufen, diclofenac or ibuprofen, for pain and fever. Please discuss this with your doctor, as use of CIPLOXX with any of these medicines may increase the risk of developing convulsions / seizures
• Probenecid (for gout)
• Metoclopramide (for nausea and vomiting or migraines)
• Omeprazole, for stomach ulcers
• Tizanidine, a muscle relaxant
• Zolpidem, for insomnia (sleeplessness)
• Methotrexate or ciclosporin (immune suppressants). Your doctor will need to monitor your blood levels of methotrexate or ciclosporin and may need to adjust your dose
• Theophylline (for chronic bronchitis or emphysema), caffeine, pentoxifylline (for pain associated with your veins), or phenytoin (for epilepsy). Your doctor will need to monitor your blood levels of these medicines, and you may require a dose adjustment
• Warfarin (a blood thinner) and other blood thinners. Concurrent use of CIPLOXX may increase your chance of bleeding. Your doctor will need to monitor your prothrombin time / INR (international normalised ratio) when you are taking CIPLOXX
• Glibenclamide for diabetes mellitus. It is recommended that you monitor your blood sugar levels carefully while taking CIPLOXX, as CIPLOXX may cause low blood sugar levels
• Duloxetine (an antidepressant), ropinirole (for Parkinson’s disease), lidocaine (lignocaine) for local anaesthesia, clozapine (for treatment of psychological disorders, i.e. schizophrenia), or sildenafil (for erectile dysfunction or impotence). Your doctor will need to monitor your blood levels of these medicines, and you may require a dose adjustment
• Enalapril, lisinopril, perindopril (ACE inhibitors), or losartan, valsartan, or irbesartan (renin-angiotensin receptor blockers), for high blood pressure. Combining these medicines with CIPLOXX may cause damage to your kidneys
• If you are on treatment with ACE inhibitors / angiotensin receptor blockers used to control your blood pressure. Ask your doctor if you are not sure. CIPLOXX with food, drink and alcohol CIPLOXX should be swallowed whole with a full glass of water and may be taken with or without meals. CIPLOXX should not be taken with dairy products (e.g. yoghurt, milk) or with mineral fortified drinks (e.g. calcium fortified orange juice), as it will reduce the absorption of CIPLOXX from your stomach. Taking CIPLOXX with alcohol may cause impairment of your ability to drive or operate machinery

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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