Peploc Otc 20 mg Tablets

PEPLOC OTC contains pantoprazole, one of a group of medicines called proton pump inhibitors used to treat certain conditions in which there is too much acid in the stomach.

PEPLOC OTC is used 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.

Do not take PEPLOC OTC:

• if you are hypersensitive (allergic) to pantoprazole or any of the other ingredients of PEPLOC OTC (see section 6)
• 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).

Warnings and precautions

Take special care with PEPLOC OTC:

• 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.

Do not share medicines prescribed for you with any other person. Always take/use PEPLOC OTC exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The tablets should be swallowed whole with water. Do not crush, break or chew the tablet. It may take several days before PEPLOC OTC begins to relieve your symptoms.

To help relieve your symptoms, antacids may be taken with PEPLOC OTC tablets, unless your doctor has told you not to use them.

Adults: The usual dose is one 20 mg tablet once a day, for a maximum of 14 days.

Children: Safety and efficacy in children have not been established.

If you take more PEPLOC OTC than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take PEPLOC OTC

If you missed a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take the tablet at the usual time. Do not take a double dose to make up for forgotten individual doses.

PEPLOC OTC can have side effects. Not all side effects reported for PEPLOC OTC are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using PEPLOC OTC, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop using PEPLOC OTC 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 PEPLOC OTC. 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:

• stomach pain (severe)
• fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys), possibly leading to kidney failure
• blistering, loosening, peeling or redness of skin, Stevens-Johnson syndrome or other serious skin disorders such as Lyell-Syndrome, Erythema multiforme, (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters), drug rash with eosinophilia and systemic symptoms (DRESS) which is a type of drug allergy which can occur as a reaction to a large variety of medications
• yellow skin colour and/or yellow eyes, black tarry stools (symptoms of liver disease)
• blurred vision. 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:

• 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.

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/document/adverse-drug-reactions-and-quality-problem-reporting-form/ or https://www.sahpra.org.za/Publications/Index/8.

By reporting side effects, you can help provide more information on the safety of PEPLOC OTC. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).