Peploc Side Effects

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

What is Peploc?

Peploc contains the active ingredient Pantoprazole sodium.

• Active ingredient — Pantoprazole sodium
• Registration number — 18/11.4/0081; A43/11.4.3/0344
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• the temporary short-term relief of heartburn and hyperacidity, for a maximum daily dose of 20 mg and a maximum treatment period of 14 days

Common side effects of Peploc

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

• diarrhoea or constipation, abdominal pain, flatulence
• headache

Less frequent side effects

• low numbers of white cells in your blood
• high concentration of fatty products in the blood, increased body temperature
• trouble in sleeping, depression, disorientation
• dizziness, distortion or complete lack of the sense of taste
• nausea and/or vomiting, dry mouth, bloating, stomach pain and discomfort
• other skin conditions
• pain in joints or muscles, fracture of the hip, wrist or spine
• swelling and enlargement of breasts in men
• feeling of weakness, fatigue, malaise (feeling bad), swelling of the hands and feet
• muscle rigidness or stiffness. The following side effects have been reported but the frequency for them to occur is not known:
• inflammation in the large bowel, that causes persistent watery diarrhoea
• low levels of salt or magnesium or calcium in the blood
• hallucination, confusion
• feeling of tingling, prickling, pins and needles, burning sensation or numbness
• muscle spasm as a consequence of electrolyte disturbance
• a type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PEPLOC OTC, may develop a kidney problem called acute interstitial nephritis, that can happen at any time during treatment with PPI medicines. Call your doctor right away if you have a decrease in the amount that you usually urinate or if you have blood in your urine

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 pantoprazole or any of the other ingredients of PEPLOC OTC
• if your liver function is impaired
• PEPLOC OTC should not be given to children
• if you are taking atazanavir (a medicine used in the treatment of HIV)

Use with care, and tell your doctor, if

• if you have impaired kidney function
• if you are taking warfarin (medicine that reduces the risk of blood clotting)
• if you have liver disease
• if you have low levels of magnesium in your blood
• if you are currently being treated or have a history of any malignancies (cancer or tumour) in the stomach area, or you think you have signs of stomach cancer (symptoms include weight loss, dark stools, loss of appetite, feeling full or a sensation of a lump in your stomach)
• if you have a history of a Vitamin B12 deficiency and receive long- term treatment (e.g. longer than 3 years) with PEPLOC OTC. As with all acid reducing agents, PEPLOC OTC may lead to a reduced absorption of vitamin B12
• use of PEPLOC OTC taken to prevent gastroduodenal ulcers, induced by nonselective non-steroidal anti-inflammatory drugs (NSAIDs) should only be taken by patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications
• if you develop diarrhoea that does not improve (contact your doctor or healthcare professional as soon as possible) because PEPLOC OTC has been associated with a small increase in infectious diarrhoea
• if you are over 50 years of age or when you take PEPLOC OTC for a long period of time or in high doses (it may cause a low magnesium level in the body and cause an increase in risk of bone fractures in the hip, wrist or spine)
• if you have or had a bone fracture in the hip, wrist or spine due to low magnesium
• if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice
• if you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as you can, as you may need to stop your treatment with PEPLOC OTC. Remember to also mention any other ill-effects like pain in your joints
• if you take PEPLOC OTC on a long-term basis (longer than 1 year), your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor
• if you are on pantoprazole, as in PEPLOC OTC, for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium
• if there is a decrease in the amount that you urinate or if you have blood in your urine
• if you are due to have a specific blood test (Chromogranin A) PEPLOC OTC treatment should be stopped for at least 5 days before Chromogranin A (CgA) measurements are taken and may require a further test 14 days after stopping therapy with PEPLOC OTC

Pregnancy and breastfeeding

• You should not take PEPLOC OTC if you are pregnant or breastfeeding your baby
• 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 using PEPLOC OTC
• Safety in pregnancy and breastfeeding has not been established
• There is no data on fertility in humans with PEPLOC OTC

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines to thin your blood, such as warfarin. PEPLOC OTC may alter the effect of these medicines so your healthcare provider will want to monitor how well your blood clots
• certain medicines used to treat fungal infections, such as ketoconazole PEPLOC OTC may reduce their absorption
• atazanavir, a compound found in anti-HIV medicines. PEPLOC OTC may reduce the blood levels of this medicine. You should not use PEPLOC OTC concurrently with atazanavir
• methotrexate (high doses used in the treatment of certain cancers). PEPLOC OTC may increase the levels of this medicine and possibly lead to methotrexate toxicity
• fluvoxamine (used to treat depression and other psychiatric diseases) – if you are taking fluvoxamine your doctor may reduce the dose
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• the active ingredient, pantoprazole, is metabolised by certain liver enzymes, which may interact with other medicines or compounds which are also metabolised by these enzymes. PEPLOC OTC with food and drink PEPLOC OTC tablets 20 mg daily should be taken before a meal, preferably in the morning

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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