The active ingredient in Takepron is lansoprazole, which is a proton pump inhibitor. Proton pump inhibitors reduce the amount of acid that your stomach makes.

Your doctor may prescribe Takepron for the following indications:

• Treatment of duodenal and stomach ulcer
• Treatment of inflammation in your oesophagus (reflux oesophagitis)
• Prevention of reflux oesophagitis
• Treatment of heartburn and acid regurgitation
• Treatment of infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy
• Treatment or prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment (NSAID treatment is used against pain or inflammation)
• Treatment of Zollinger-Ellison syndrome.

Your doctor may have prescribed Takepron for another indication or with a dose different from that which is written in this information leaflet. Please follow your doctor’s instructions for taking your medicine.

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

Do not take Takepron:

• If you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Takepron.

Please tell your doctor if you have serious liver disease. The doctor may have to adjust your dosage.

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 diarrhoea occurs during the treatment with lansoprazole contact your doctor immediately, as lansoprazole has been associated with a small increase in infectious diarrhoea.

If your doctor has given you Takepron 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.

Taking a proton pump inhibitor like lansoprazole, 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 take Takepron 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.

Talk to your doctor before taking Takepron:

• If you have low vitamin B12 levels or have risk factors for low vitamin B12 levels and receive long-term treatment with Takepron. As with all acid reducing agents, Takepron may lead to a reduced absorption of vitamin B12.
• If you are due to have a specific blood test (Chromogranin A).
• If you have ever had a skin reaction after treatment with a medicine similar to Takepron that reduces stomach acid.

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 Takepron. Remember to also mention any other ill-effects like pain in your joints.

If you are on Takepron 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.

Other medicines and Takepron

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

• HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
• Methotrexate (used to treat autoimmune disease and cancer)
• Ketoconazole, itraconazole, rifampicin (used to treat infections)
• Digoxin (used to treat heart problems)
• Warfarin (used to treat blood clots)
• Theophylline (used to treat asthma)
• Tacrolimus (used to prevent transplant rejection)
• Fluvoxamine (used to treat depression and other psychiatric diseases)
• Antacids (used to treat heartburn or acid regurgitation)
• Sucralfate (used for healing ulcers)
• St John´s wort (Hypericum perforatum) (used to treat mild depression)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Side effects such as dizziness, vertigo, tiredness and visual disturbances sometimes occur in patients taking lansoprazole. If you experience side effects like these you should take caution as your ability to react may be decreased.

You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines.  

Descriptions of these effects can be found in other sections.

Read all the information in this leaflet for guidance.

Discuss with your doctor or pharmacist if you are unsure about anything.

Takepron contains sucrose

Takepron contains sucrose. Each gastro-resistant hard capsule of Takepron 15 mg and 30 mg Gastro-resistant Hard Capsules contains 84.9 mg or 169.8 mg sucrose; respectively. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsule whole with a glass of water. If you find the capsules difficult to swallow your doctor may advise on alternative ways to take your medicine. Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly.

For the best results from your medicine you should take Takepron at least 30 minutes before food.

If you are taking Takepron once a day, try to take it at the same time each day. You may get best results if you take lansoprazole first thing in the morning.

If you are taking Takepron twice a day, you should have the first dose in the morning and the second dose in the evening.

The dose of Takepron depends on your condition. The recommended doses of Takepron for adults are given below. Your doctor will sometimes prescribe you a different dose and will tell you how long your treatment will last.

Treatment of heartburn and acid regurgitation: one 15 mg or 30 mg capsule every day for 4 weeks. If symptoms persist you should report to your doctor. If your symptoms are not relieved within 4 weeks, please contact your doctor.

Treatment of duodenal ulcer: one  30 mg capsule every day for 2 weeks.

Treatment of stomach ulcer: one  30 mg capsule every day for 4 weeks.

Treatment of inflammation in your oesophagus (reflux oesophagitis): one 30 mg capsule every day for 4 weeks.

Long-term prevention of reflux oesophagitis: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.

Treatment of infection of Helicobacter pylori: The recommended dose is one 30 mg capsule in combination with two different antibiotics in the morning and one 30 mg capsule in combination with two different antibiotics in the evening. Treatment will usually be every day for 7 days.

The recommended combinations of antibiotics are:

• 30 mg Takepron together with 250-500 mg clarithromycin and 1000 mg amoxicillin
• 30 mg Takepron together with 250 mg clarithromycin and 400-500 mg metronidazole

If you are being treated for infection because you have an ulcer, it is unlikely that your ulcer will return if the infection is successfully treated. To give your medicine the best chance of working, take it at the right time and do not miss a dose.

Treatment of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 30 mg capsule every day for 4 weeks.

Prevention of duodenal or stomach ulcer in patients requiring continued NSAID treatment: one 15 mg capsule every day, your doctor may adjust your dose to one 30 mg capsule every day.

Zollinger-Ellison syndrome: The recommended dose is two 30 mg capsules every day to start with, then depending on how you respond to Takepron the dose that your doctor decides is best for you.

Use in children

Takepron should not be given to children.

If you take more Takepron than you should

If you take more Takepron than you have been told to, seek medical advice quickly. Contact your nearest casualty department or tell your doctor or pharmacist at once.

If you forget to take Takepron

If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. If this happens, skip the missed dose and take the remaining capsules as normal. Do not take a double dose to make up for a forgotten capsule.

 If you stop taking Takepron

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects, stop taking lansoprazole and tell your doctor immediately, or contact the casualty department at your nearest hospital:

• Angioedema (symptoms may include swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath)
• Severe hypersensitivity reactions including anaphylactic shock (symptoms may include fever, rash, swelling and sometimes a fall in blood pressure)
• Very severe skin reactions with reddening, blistering, severe inflammation and skin loss (Stevens-Johnson Syndrome, toxic epidermal necrolysis, erythema multiforme)
• Inflammation of the liver (may be seen as yellow skin or eyes).

Other side effects

The following side effects are common (may affect up to 1 in 10 people):

• Headache, dizziness
• Diarrhoea, constipation, stomach pains, feeling or being sick, wind, dry or sore mouth or throat
• Skin rash, itching
• Changes in liver function test values
• Tiredness
• Benign polyps in the stomach.

The following side effects are uncommon (may affect up to 1 in 100 people):

• Depression
• Joint or muscle pain
• Fluid retention or swelling
• Changes in blood cell counts
• Fracture of the hip, wrist or spine

The following side effects are rare (may affect up to 1 in 1,000 people):

• Fever
• Restlessness, drowsiness, confusion, hallucinations, insomnia, visual disturbances, vertigo
• A change in the way things taste, loss of appetite, inflammation of your tongue (glossitis)
• Skin reactions such as burning or pricking feeling under the skin, bruising, reddening and excessive sweating
• Sensitivity to light
• Hair loss
• Feelings of ants creeping over the skin (paraesthesia), trembling
• Anaemia (paleness)
• Kidney problems
• Pancreatitis
• Breast swelling in males, impotence
• Candidiasis (fungal infection, may affect skin or the mucosa)

The following side effects are very rare (may affect up to 1 in 10,000 people):

• Inflammation of your mouth (stomatitis)
• Colitis (bowel inflammation)
• Changes in test values such as sodium, cholesterol and triglyceride levels
• A reduction in the number of white blood cells which may decrease your resistance to infection. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).

Frequency not known (frequency cannot be estimated from the available data)

• Rash, possibly with pain in the joints.
• Low levels of magnesium in your blood (hypomagnesaemia), low levels of calcium in your blood (hypocalcaemia), low levels of potassium in your blood (hypokalaemia) (see section 2)
• Visual hallucinations

Keep this medicine out of the sight and reach of children.

Store below 30°C.

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.