Prazoloc Otc 20 mg Tablets

PRAZOLOC OTC belongs to a group of medicines known as proton pump inhibitors. Proton pump inhibitors reduce the amount of acid secreted by the stomach.

PRAZOLOC OTC is indicated when intended for the temporary short-term relief of heartburn and hyperacidity for a maximum of 14 days.

Do not take PRAZOLOC OTC if you:

• Are allergic (hypersensitive) to pantoprazole or to any of the other ingredients in PRAZOLOC OTC (listed in section 6).
• Have severe impairment of your liver function.
• Are 12 years and younger, as safety has not been established in children.
• Are also taking atazanavir or nelfinavir for the treatment of Human Immunodeficiency Virus (HIV) infection (see other medicines and PRAZOLOC OTC).

Warnings and Precautions

PRAZOLOC OTC should not be used for the treatment of mild gastro-intestinal complaints, such as nervous dyspepsia (indigestion due to stress or anxiety). Before you start treatment with PRAZOLOC OTC, you may have to go for an endoscopic examination (swallow the scope). During this procedure a small piece of tissue may be taken from the stomach, oesophagus, or duodenum for examination under a microscope. This is called a biopsy and biopsies are necessary to rule out the possibility of cancer of the stomach or oesophagus. It is important that you inform your doctor if you recently experienced significant unintentional weight loss, recurrent vomiting, pain with swallowing, vomiting of blood or a substance resembling coffee grounds, or passed dark, foul-smelling, tarry stools. Responding to treatment with PRAZOLOC OTC does not rule out the presence of stomach or oesophageal cancer. Performing an endoscopic examination with biopsy prior to treatment will enable your doctor to make a timely diagnosis of cancer and to institute appropriate treatment.

Daily treatment with any acid-blocking medicine, such as PRAZOLOC OTC, over a long period of time (e.g. longer than 3 years) may lead to malabsorption of vitamin B12. Inadequate absorption of vitamin B12 may lead to anaemia (shortage of red blood cells). Please inform your doctor as soon as possible if you experience weakness, tiredness or light-headedness, rapid heartbeat and breathing, pale skin, sore tongue, easy bruising or bleeding, bleeding gums, or stomach upset.

You may have to go for blood tests to monitor your liver enzyme levels while you are taking PRAZOLOC OTC. While on treatment of PRAZOLOC OTC you may be at risk of developing a kidney disorder called interstitial nephritis, causing the inside of your kidneys to become inflamed. This condition may progress to renal failure as it is not necessarily reversed when treatment with PRAZOLOC OTC is stopped (see "Possible side-effects")

Use of PRAZOLOC OTC as preventative of gastroduodenal ulcers, induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastro-intestinal complications.

Always take PRAZOLOC OTC exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not share medicines prescribed for you with other people.

PRAZOLOC OTC should preferably be taken in the morning. Swallow the tablet whole with a little water either before or during breakfast. Do not crush, break, or chew the tablet.

The maximum daily dose is 20 mg per day and the maximum treatment is for a period of 14 days. No dosage adjustment is necessary if you are an elderly person. No dosage adjustment is required if you have impaired kidney function. If you have liver problems you should not take more than the daily dose of one PRAZOLOC OTC per day.

If you take more PRAZOLOC OTC than you should: In the event of an overdosage, or if someone else has taken your medicine by mistake, you, or this other person, may experience any of the side-effects listed below. In the event of overdosage, consult your doctor or pharmacist. If neither is available, immediately seek help at the nearest hospital or poison control centre.

If you forget to take PRAZOLOC OTC Always take PRAZOLOC OTC as prescribed. If you miss a dose, take it as soon as you remember. If you do not remember the missed dose until the next dose is due, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking PRAZOLOC OTC and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Those that occur less frequently:
• Allergic reactions presenting with tightness of the chest, coughing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids, swelling of the face, lips or tongue, or severe swelling of the whole body, skin rash, and/or collapse.
• Shortness of breath or wheezing.
• Yellow discolouration of the skin or whites of the eyes accompanied by loss of appetite, nausea, and pain over the liver area, as this may indicate inflammation of the liver.
• Blisters on the skin. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PRAZOLOC OTC. You may need urgent medical attention or hospitalization.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Those that occur frequently:
• Diarrhoea (loose stools) accompanied by stomach pain or cramps, loss of appetite and chills or fever.
• Coughing, sneezing, sore throat, skin ulcers and other signs of infection, as this may be due to low white cell counts.
• Pinpoint red spots on the skin, easy bruising or bleeding from the gums, as this may be due to low platelet counts.
• Confusion.
• Seeing or hearing things that are not real.
• Loss of vision with or without severe eye pain.
• Breath with a musty or sweet odour accompanied by confusion, mental fogginess, personality or mood changes, poor concentration, abnormal movements or shaking of the hands or arms, agitation, excitement, seizures/convulsions, slurred speech, slowed or sluggish movement, and/or loss of consciousness, as these symptoms may be due to liver damage.

Those that occur less frequently:

• Pins and needles.
• Blurred vision.
• Ulcers or sores inside the mouth or on the lips.
• Any other skin rash, including a skin rash in areas exposed to the sun.
• Struggling to pass urine, increased frequency and volume or urination, painful urination or change in the colour of your urine.
• Interstitial nephritis (Kidney disease causing the inside of the kidney to become inflamed) which may progress to renal failure as it is not necessarily reversed when treatment is stopped. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Those that occur frequently:
• Sleeplessness or trouble sleeping.
• Headache.
• Flatulence (gas), constipation, or stomach pain.
• Fatigue or tiredness.

Those that occur less frequently:

• Depression, agitation, or sleepiness.
• Dizziness.
• The feeling that your environment is moving or spinning, or ringing in the ears.
• Swelling of the hands or feet.
• Vomiting, or dry mouth.
• Joint or muscle pain.
• Impotence.
• Breast enlargement (in males).
• Generally feeling unwell, or increased sweating.
• Taste disturbances.

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, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of PRAZOLOC OTC.

Store at or below 25 °C. Protect from light. Store all medicines out of reach of children. Keep the blisters in the outer carton until required for use. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.