Peptazol 40 mg Tablets

PEPTAZOL 40 contains pantoprazole. Pantoprazole belongs to a class of medicine called proton pump inhibitors, which reduces stomach acid production.

PEPTAZOL 20, available in a different formulation, is used for the symptomatic improvement (e.g., heartburn, acid regurgitation, pain on swallowing) and healing of mild gastro-oesophageal reflux disease i.e., a disease which causes mucosal damage and inflammation of the food pipe due to stomach acid being pushed back up into the food pipe (reflux).

For long-term management and prevention of relapse in gastro-oesophageal reflux disease. If you are on chronic treatment with anti-inflammatories and you are at an increased risk of developing gastro-intestinal complications, your doctor will prescribe PEPTAZOL 20 (available in a different formulation, as PEPTAZOL 40 cannot be divided) to prevent stomach and duodenal ulcers which are caused when using these medicines.

PEPTAZOL 40 is used to treat acid reflux (a type of heartburn) and ulcers in the stomach (gastric ulcer) or in the upper part of the intestine (duodenal ulcer). PEPTAZOL 40 is used for the treatment of Zollinger-Ellison syndrome (a disorder that causes one or more tumours to form in the pancreas or the upper part of the small intestine).

Do not take PEPTAZOL 40

• If you are hypersensitive (allergic) to pantoprazole or any of the other ingredients of PEPTAZOL 40 (listed in section 6).
• If you suffer from severe liver disease.
• Safety and efficacy have not been established in children.
• If you are taking atazanavir (a medicine used in the treatment of HIV-infection).

Warnings and precautions

Take special care with PEPTAZOL 40:

• Your doctor may decide that you need some tests to rule out cancer because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue despite your treatment, further investigations will be considered.
• PEPTAZOL 40 is not indicated for long-term management and prevention in gastro-oesophageal reflux disease i.e., a disease which causes mucosal damage and inflammation of the food pipe due to stomach acid being pushed back up into the food pipe (reflux). Your doctor will confirm if you are suffering from acid reflux by means of an endoscopy (looking inside the stomach using a medical tool called an endoscope).
• If you have a history of a Vitamin B12 deficiency, as PEPTAZOL 40 may further reduce the absorption of this vitamin.
• If you have or develop problems with your kidneys, e.g. difficulty to urinate, or blood in your urine stop taking PEPTAZOL 40 and talk to your doctor or pharmacist (see section 4).
• If you have severe liver problems, you should not take PEPTAZOL 40. Please tell your doctor if you have ever had problems with your liver in the past. Your doctor will check your liver enzymes more frequently, especially when you are taking PEPTAZOL 40 as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.
• If you develop diarrhoea that does not improve, contact your doctor or healthcare professional as soon as possible.
• If you have low levels of magnesium or if you notice any of the following: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to low levels of potassium and/or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor these levels.
• If you have osteoporosis (reduced bone density) or if you have been told that you are at risk of getting osteoporosis (for example, if you are taking steroids). Taking PEPTAZOL 40, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine.
• If you ever had a skin reaction with medicine similar to PEPTAZOL 40 or if you get a skin reaction while taking PEPTAZOL 40, especially in areas exposed to the sun, tell your doctor as soon as you can. You may have a severe reaction and may need to stop PEPTAZOL 40 treatment. Remember to also mention any other ill-effects like pain in your joints to your doctor (see section 4).
• If you are due to have a specific blood test (Chromogranin A). PEPTAZOL 40 can influence the results of this test.

Children and adolescents

Do not give PEPTAZOL 40 to children, as safety and efficacy have not been established in children below the age of 12 years.

Other medicines and PEPTAZOL 40

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Tell your doctor or pharmacist if you are taking any of the following as PEPTAZOL 40 may increase or decrease the effect of these medicines:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as PEPTAZOL 40 may change their absorption.
• Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
• Medicines used to treat HIV-infection, such as atazanavir.
• Methotrexate used to treat rheumatoid arthritis, psoriasis, and cancer.
• Fluvoxamine used to treat depression and other psychiatric diseases.
• Rifampicin used to treat infections.
• St John’s wort (Hypericum perforatum) used to treat mild depression.

Pregnancy and breastfeeding

You should not take PEPTAZOL 40 if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking PEPTAZOL 40.

Driving and using machines

PEPTAZOL 40 may affect your ability to drive and to use machinery. Possible side effects (see section 4) such as dizziness and disturbances in vision e.g. blurred vision may decrease your ability. It is not always possible to predict to what extent PEPTAZOL 40 may interfere with your daily activities. You should ensure that you do not engage in activities requiring mental alertness, judgment and/or sound coordination and vision e.g. driving, riding, flying, sailing or operating machines/equipment until you are aware of the measure to which PEPTAZOL 40 affects you.

PEPTAZOL 40 contains tartrazine and sodium PEPTAZOL 40 contains FD & C Yellow N°5 (tartrazine) which may cause allergic reactions. PEPTAZOL 40 contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.

Do not share medicines prescribed for you with any other person. Always take PEPTAZOL 40 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

The usual dose is one tablet PEPTAZOL 40 per day. Swallow the tablet(s) whole, with water in the morning before or during breakfast. Do not crush, break, or chew the tablet.

Your doctor will tell you how long your treatment with PEPTAZOL 40 will last. Dosages may differ according to different conditions

Mild gastro-oesophageal reflux disease (GERD)

One 20 mg of PEPTAZOL per day (the recommended dose), which is available in a different formulation, as PEPTAZOL 40 cannot be divided. A 4-week period is usually required for healing of mild GERD. Your doctor may recommend further long-term treatment. If symptom control has not been achieved after four weeks of treatment with the prescribed daily dose, further investigation is recommended.

Duodenal and stomach ulcers

One PEPTAZOL 40 tablet daily. Your doctor will tell you how long to take your medicine. The treatment for stomach ulcers is usually between 4 and 8 weeks. The treatment period for duodenal ulcers is between 2 and 4 weeks.

Reflux oesophagitis

One PEPTAZOL 40 tablet daily in the morning. Treatment is usually between 4 to 8 weeks.

Zollinger-Ellison syndrome

Treatment is started with 80 mg (2 tablets of PEPTAZOL 40). Thereafter, the dose may be adjusted by your doctor depending on the amount of acid you produce.

If you take more PEPTAZOL 40 than you should In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of PEPTAZOL 40 If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

PEPTAZOL 40 can have side effects. Not all side effects reported for PEPTAZOL 40 are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking PEPTAZOL 40, please consult your health care provider for advice.

If any of the following happens, stop taking PEPTAZOL 40 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Allergic reaction such as skin rash, itchiness, swelling of the mouth, lips or tongue, or if you experience increased pulse rate or increased sweating.
• Serious skin reaction such as skin rash, itching, blistering, loosening or peeling of the skin (including slight bleeding), skin sensitivity/rash, particularly in areas of skin exposed to light/the sun. You may also have joint pain or flu-like symptoms, a fever, swollen glands (e.g. in the armpit).
• Damage to liver cells or jaundice with symptoms such as yellowing of the skin or whites of the eyes.
• Kidney damage with symptoms such as fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain (serious inflammation of the kidneys), possibly leading to kidney failure.

These are all very serious side effects. If you have them, you may have had a serious reaction to PEPTAZOL 40. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• Headache
• Pain in your stomach, diarrhoea, nausea, vomiting, constipation, flatulence or wind, dry mouth
• Benign polyps in the stomach.

Less frequent side effects

• Blood test show reduction in the number of blood platelets and/or white cells, which may cause you to bleed or bruise more easily and/or have more infections
• Blood tests show increase liver enzymes, lipids (fat levels) and bilirubin.
• Changes in weight
• Sleep disorders, feeling depressed and disorientated
• Dizziness, distortion or complete lack of the sense of taste
• Disturbances in vision such as blurred vision
• Skin hives (urticaria), rash, itching
• Pain in muscles (myalgia), pain in the joints (arthralgia), fracture of the hip, wrist or spine
• Swelling of male breasts (gynaecomastia)
• Increase in body temperature, swelling of hands and feet.

Frequency unknown side effects

• Blood tests show decreased level of sodium, magnesium, calcium or potassium. You may have muscle cramps (spasms).
• Hallucination, confusion (especially if you have a history of these symptoms)
• Inflammation in the large bowel.

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. In addition, side-effects can also be reported to [email protected]. By reporting side effects, you can help provide more information on the safety of PEPTAZOL 40.

• Store all medicines out of reach of children.
• Store at or below 25 °C
• Store in outer unit carton until required for use.
• Do not use after the expiry date stated on the blister / carton.
• Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).