Lancap 15 mg/30 mg Capsules

• LANCAP is used in the short - term treatment of gastric (stomach) and duodenal (small intestine) ulcers and inflammation of oesophagus due to reflux of stomach acid.

• LANCAP is indicated for Helicobacter pylori - positive duodenal (small intestine) ulcers in conjunction with appropriate antibiotics as part of an eradication programme.

Do not take LANCAP :

• • if you are hypersensitive (allergic) to lansoprazole, or to any of the ingredients of LANCAP (see section 6)
• • if you are pregnant or breastfeeding your infant
• • if you have severe liver impairment
• • if you are on HIV medicines such as atazanavir or nelfinavir.

Warnings and precautions

Take special care with LANCAP:

Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.

• • if you experience symptoms such as unintentional weight loss, recurrent vomiting, difficulty in swallowing, blood in vomit, dark sticky faeces or if you suspect a stomach ulcer tell your doctor because LANCAP can mask the symptoms of cancerous ulcers
• • if you are using LANCAP over a long period of time (e.g. longer than 3 years) this may lead to a vitamin B 12 deficiency
• • as with all acid reducing medicines, LANCAP may affect the absorption of certain medicines such as vitamin C and calcium.
• • 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 LANCAP. Remember to also mention any other ill-effects like pain in your joints
• • LANCAP may be associated with an increased risk of Clostridium difficile associated diarrhoea (CDAD) (you may develop diarrhoea that does not stop). Contact your doctor or health care provider as soon as possible
• • LANCAP may increase your risk for osteoporosis-related bone fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis

• if you have been told you have low magnesium levels in your blood, or if you experience fatigue, tetany (painful contractions of jaw and neck muscles), delirium, convulsions, dizziness and a change from normal heartbeat, or if you are taking medicines such as digoxin or diuretics (water tablets), tell your doctor as LANCAP can further reduce your magnesium levels

• if you are taking methotrexate (used in the treatment of cancer and leukaemia) as LANCAP may affect the way this medicine works

• if you are taking LANCAP for a long period of time, you may be at risk of gastro-intestinal infections such as Salmonella, and Campylobacter, Shigella or Clostridium difficile

• if you suffer from stomach ulcers you may be at risk of H. pylori (bacterial) infection

• LANCAP may make you drowsy and impair your concentration which could be aggravated by the intake of alcohol

• if you have porphyria, inform your doctor before taking LANCAP

• LANCAP may affect the kidneys (interstitial nephritis). Inform your doctor if you experience any pain while urinating or lower back pain

• if you take LANCAP 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

• LANCAP may cause colitis (an inflammation of the colon) if you experience severe and/or persistent diarrhoea, you should stop taking LANCAP

• tell your doctor before taking LANCAP, if you are due to have a specific blood test (Chromogranin A) as it could interfere with the test results

• if there is a decrease in the amount that you usually urinate or if you have blood in your urine.

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

Take LANCAP before a meal, preferably in the morning.

The usual dose is one LANCAP 15 mg or one LANCAP 30 mg capsule daily depending on the condition you are being treated for.

Your doctor will tell you how long your treatment with LANCAP will last. If you have the impression that the effect of LANCAP is too strong or too weak, tell your doctor or pharmacist.

If you take more LANCAP 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.

If you forget to take LANCAP

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

If you stop taking LANCAP

Do not stop treatment early because you start feeling better. Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.

LANCAP can have side effects.

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

If any of the following happens, stop using LANCAP 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
• • fever
• • fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LANCAP. 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:

• • yellowing of the skin and eyes, severe pain in your upper abdomen or your whole body starts itching, these are signs of severe liver problems including jaundice and hepatitis
• • LANCAP may reduce the number of white cells in your blood, which may decrease your ability to fight infections. If you experience any infection with symptoms such as fever or a serious deterioration in your general health, or a fever with symptoms such as sore throat/mouth, or bladder problems, you should see your doctor immediately
• • chest pain, angina, changes in the way your heart beats, for example, if you notice it beating faster, slower, harder or irregular, difficulty in breathing
• • a persistent, scaly red patch on the skin with irregular borders that sometimes crusts or bleeds (skin cancer)
• • Stevens-Johnson syndrome (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters), toxic epidermal necrolysis (TEN) (a life-threatening skin disorder with symptoms such as a painful red area that spreads quickly, skin peeling without blisters, raw areas of skin) or other serious skin disorders

• serious kidney problems: less urine than is normal for you, swelling of the legs, ankles or feet, nausea or extreme tiredness, seizures or coma in severe cases

• if you experience symptoms of a stroke, such as weakness or numbness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking; dizziness, loss of balance; severe or prolonged headache with no known cause; loss of consciousness or fainting with or without seizure.

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:

• • headache, dizziness
• • diarrhoea, dry mouth or throat, nausea, vomiting (sometimes with blood), constipation, flatulence, stomach pain
• • changes in liver test results (e.g. raised liver enzymes)
• • itching, scaly red or purple inflamed skin or rash
• • fatigue.

Less frequent side effects:

• • changes in your blood cell count, or amount of sugar in your blood which may leave you feeling weak, tired, looking pale or generally feeling unwell, anaemia
• • diabetes, goitre (swelling of the neck due to enlargement of the thyroid gland),
• • vitamin deficiency, dehydration, pain, stiffness or swelling in joints, extreme thirst, swelling of the hands or feet, neck or pelvic pain, neck or muscle stiffness, weight gain or loss, problems with smell or taste, muscle weakness or cramps
• • abnormal dreams, mood changes such as agitation, hostility, memory loss, anxiety, laziness, confusion, a feeling of detachment from oneself, depression, mood swings, hallucinations (seeing or hearing things which are not there), increased or decreased sex drive, nervousness, distress, unable to sleep
• • fit, double vision, paralysis on one side of the body, excessive abnormal body movements, stiff muscles, reduced sensitivity to touch, tingling or burning of the skin, restlessness, strange thoughts, sleepiness, tremor, vertigo (a sensation of spinning when standing still)
• • abnormal or blurred vision, itchy, watery or red eyes, dry eyes, eye pain, sensitivity of eyes to the light, blurred vision and other problems with your vision including double vision
• • deafness, ear problems, ear ache, ringing of the ears
• • flushing, dizziness and feeling lightheaded, migraine, fainting
• • difficulty in breathing/ tight chest, increased coughing, shortness of breath, nose bleed or coughing blood, hiccups, sore or scratchy throat or pain swallowing, sharp chest pain that gets worse when you breathe, runny or blocked nose, sinus headache, abnormal noise when breathing
• • bleeding gums, increased appetite or saliva, mouth ulcer, blood in stool, abnormal tastes, anorexia, thirst, tongue disorder, pain inside the mouth due to white spots on your tongue, inner cheeks, gums, palate and/or tonsils, feeling that you need to have a bowel movement, even if you have already had one, inflammation of the mouth and lips, pancreatitis (upper abdominal pain that radiates into the back, which may be aggravated by eating foods high in fat)
• • acne, hair loss, dry skin, problems with nails, sweating, sensitivity of skin to light, peeling of skin over large areas of the body
• • painful, swollen or stiff joints, bone or joint problems, leg cramps, muscle or bone pain, muscle weakness, fracture of the wrist, hip or spine, neck pain or stiffness, pelvic pain, drooping of the upper eyelid, joint pain, bone disorder
• • pain or discomfort on urination, blood in the urine, back pain (kidney pain), excessive or abnormally large production of urine, frequent urination or the need to constantly urinate, urinary tract infection
• • a type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including LANCAP, 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
• • abnormal periods (heavy, lighter, longer or more painful), breast enlargement or tenderness in both men and women, impotence, whitish or yellowish discharge, penis disorder or inflamed vagina
• • feeling of weakness, chest pain, chills, fever, flu symptoms, smelly breath, infection, generally feeling unwell, swelling or water retention
• • increased sodium, cholesterol and triglyceride (fat) levels in the blood.

The following side effects have been reported but the frequency for them to occur is not known:

• • decreased magnesium, calcium and potassium blood levels with symptoms such as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate.
• • If you get any of these symptoms, please inform 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, calcium and potassium.

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. By reporting side effects, you can help provide more information on the safety of LANCAP. 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 in a dry place at or below 30 ºC.

Keep the capsules in the original container 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).