Pronizor 30 mg

PRONIZOR 30 mg is used to treat certain conditions in which there is too much acid in the stomach and to reduce the amount of acid your stomach makes.

• PRONIZOR 30 mg is used in the short-term to:
• Treat ulcers in your stomach or duodenum.
• Heal your oesophagus (gullet) if it has become damaged or inflamed. This is called gastro-oesophageal reflux disease (GORD).
• Stop these conditions from coming back.
• To manage heartburn or Indigestion.
• Sometimes PRONIZOR 30 mg is used in combination with antibiotics to treat ulcers associated with Infection caused by the H. pylori bacteria (a germ).

Do not take PRONIZOR 30 mg if:

• you are allergic to lansoprazole or any of the ingredients of lansoprazole capsules.
• you are pregnant or trying to become pregnant or are breastfeeding.
• you have any liver problems.
• You are taking other medicines such as
• atazanavir and nelfinavir - used to treat HIV

Warnings and precautions

Tell your doctor or healthcare professional before taking PRONIZOR 30 mg:

• Take special care with PRONIZOR - If you have serious liver disease. The doctor may have to adjust your dosage.
• If you think you have signs of stomach cancer. These include persistent weight loss, dark stools, loss of appetite, feeling full or a lump in your stomach.
• may affect the kidneys (interstitial nephritis). Inform your doctor if you experience any pain while urinating or lower back pain.
• if you are taking vitamin B12, vitamin C or calcium supplements
• If you have been previously treated with another proton pump inhibitor and have experienced skin lesions or reactions.
• If you drink alcohol or are on any anti-depressants
• If you are on PRONIZOR 30 mg 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, 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
• Taking a proton pump inhibitor like PRONIZOR 30 mg, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have other chronic medical conditions and are taking other antibiotics
• Long term treatment may cause stomach glandular cysts
• If you experience severe and/or persistent diarrhoea, as PRONIZOR 30 mg has been associated with a small increase in infectious diarrhoea.
• If you are experiencing weight loss, vomiting, inability to eat, blood in the vomit or stool as malignancy (cancer) should be excluded since treatment with PRONIZOR 30 mg may relieve/mask symptoms thereby delaying diagnosis.
• If your doctor has given you PRONIZOR 30 mg in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your pain or rheumatic disease: please also read the package leaflets of these medicines carefully
• If you take PRONIZOR 30 mg 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.

Other medicines and PRONIZOR 30 mg

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

In particular tell your doctor or pharmacist if you are taking medicines containing any of the following active substances as PRONIZOR 30 mg may affect the way these medicines work:

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• ketoconazole, itraconazole, rifampicin (used to treat infections)
• digoxin (used to treat heart problems)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and other psychiatric diseases)
• St John´s wort (Hypericum perforatum) (used to treat mild depression)
• warfarin (used to treat blood clots)
• antacids (used to treat heartburn or acid regurgitation)
• methotrexate (used to treat autoimmune disease and cancer)
• sucralfate (used for healing ulcers)

Ask your doctor or pharmacist if you are not sure whether your other medicines contain any of the above substances.

Do not share medicines prescribed for you with any other person.

Always take PRONIZOR 30 mg exactly as or as your doctor, or pharmacist, has instructed you. You should check with your doctor or pharmacist if you are not sure.

Take PRONIZOR 30 mg by mouth. The recommended once daily dosage should preferably be taken before a meal. The usual dose is one 30 mg capsule once a day for up to eight weeks.

Duodenal ulcer:

One 30 mg capsule per day for 2-4 weeks. Patients may respond adequately to 15 mg daily for 2-4 weeks, and therefore individual dose adjustment should be considered.

Oesophagitis due to gastro-oesophageal reflux:

One 30 mg capsule per day for 4 weeks with a second 4-week treatment period, at the same dosage, depending on endoscopic results.

Use in children and adolescents

Lansoprazole should not be used in children

If you take more PRONIZOR 30 mg than you should

In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take PRONIZOR 30 mg

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking PRONIZOR 30 mg

Do not stop taking your tablets just because you feel better. It is important that you carry on taking PRONIZOR 30 mg for as long as your doctor tells you.

PRONIZOR 30 mg can have side effects. Not all side effects reported for PRONIZOR 30 mg are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRONIZOR 30 mg, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking PRONIZOR 30 mg and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Shortness of breath, face swelling or another symptom of a serious allergic reaction
• Skin rash or itching
• Reddening or blistering of your skin

These are all very serious side effects. If you have them, you may have had a serious reaction to PRONIZOR 30 mg. 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:

• Chest pain
• Angina
• Changes in the way your heart beats
• Difficulty breathing

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 may include:
• Headache, dizziness
• Diarrhea, nausea, vomiting, constipation, stomach pain, flatulence or gas, dry mouth or throat
• Increase in liver enzymes
• Skin rash and itching
• Tiredness

• less frequent effects include:
• Fungal infection and flu - like infection
• Throat, skin and stomach cancers
• a reduction in the number of white blood cells (which may lead to frequent infections) or red blood cells.
• Hypersensitivity or allergic reactions
• Inability to eat, increased uric acid in the blood, dehydration, increased or decreased sugar levels, swelling, weight gain or loss, decreased magnesium levels which causes cramping.
• Problems with sleeping, depression, hallucinations, feeling nervous, abnormality in thinking, mood or mental changes
• Shakes, abnormal dreams, fits, double-vision, “pins and needles”, dizziness, restlessness, forgetfulness, paralysis of one side of the body, muscle spasms
• Vision disturbances (blurred vision), abnormal vision, “pink eye”, dry eyes, eye pain, and light sensitivity
• Inability to hear, ear infections, ringing in the ears
• Chest pain, abnormal heartbeat, heart attack, fast heart beat
• Swelling, stroke, high or low blood pressure, shock, fainting
• Asthma, chest and throat infection, cough, inability to breath, hiccups, nose-bleeds
• Inability to taste, bad breath, stool discoloration, inflammation in the gut, vomiting blood, bleeding gums, increased appetite, increased production of saliva, blood in the stool
• liver injury causing jaundice (yellowing), inflammation of the liver
• hair loss, acne, dry skin, rash, increased sweating, blistering, loosening, peeling or redness of the skin, skin rash, hives or itching
• joint and muscle pain, back pain, chills, stiff neck, arthritis, bone disorders, fractures of the hip, wrist or spine
• kidney problems, bladder infection, urgent need to urinate, passing excessive amounts of urine
• pelvic pain, increased or decreased libido, menstrual abnormalities, increase in breast size, breast pain and tenderness, impotence, vaginal white-yellow discharge, milk-like discharge from the nipple
• fever, tiredness, pain, abnormal physical weakness
• increase in cholesterol levels, decrease in sodium levels

Frequency unknown

• Collagenous colitis - a type of microscopic colitis (inflammation of the inner lining of the colon) that causes periods of watery, non-bloody diarrhoea that can last for days to months.
• Cysts in the stomach

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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Macleods Pharmaceuticals SA (Pty) Ltd. at [email protected]. By reporting side effects, you can help provide more information on the safety of PRONIZOR 30 mg.

Store at or below 25 °C (room temperature). Protect from light.

Keep the blisters in the carton until required for use.

Keep the HDPE container tightly closed.

Store in the original package in order to protect from light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

Do not store in a bathroom.

Do not use after the expiry date stated on the blister / label / carton / bottle.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).