LANSOPRAZOLE 15 MG GASTRO-RESISTANT CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - LANSOPRAZOLE 15 MG GASTRO-RESISTANT CAPSULES

Lansoprazole 15 mg gastro-resistant capsules

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet :

1. What Lansoprazole gastro-resistant capsules are and what they are used for
2. What you need to know before you take Lansoprazole gastro-resistant capsules
3. How to take Lansoprazole gastro-resistant capsules
4. Possible side effects
5. How to store Lansoprazole gastro-resistant capsules
6. Contents of the pack and other information

1. WHAT LANSOPRAZOLE GASTRO-RESISTANT CAPSULES ARE AND WHAT THEY ARE USED FOR

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

Your doctor may prescribe this medicine for the following indications:

Healing ulcers in your stomach or duodenum (gut)
Healing and preventing ulcers caused by medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAlDs).

This includes medicines like aspirin, ibuprofen, ketoprofen and piroxicam

Gastro-Oesophageal Reflux Disease (GORD). This happens when acid from your stomach escapes into your food pipe (oesophagus) causing damage and inflammation

Lansoprazole can relieve symptoms that can happen with the above conditions and stop them from coming back. It can also be used to treat:

The pain of indigestion or heartburn caused by too much acid (acid-related dyspepsia) in your stomach
Illnesses, such as Zollinger-Ellison Syndrome, where the stomach makes large amounts of acid. This can lead to diarrhoea and pain in the stomach
Infections caused by the bacteria Helicobacter pylori when given in combination with antibiotic therapy.

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

2. what you need to know before you take lansoprazole gastro-resistant capsules

Do not take Lansoprazole gastro-resistant capsules:

– if you are allergic to lansoprazole or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Do not take lansoprazole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist

Warnings and precautions

Talk to your doctor of pharmacist before taking Lansoprazole gastro-resistant capsules

If you have serious liver disease. The doctor may have to adjust your dosage.
Your doctor may arrange for you to have an endoscopic examination (where a very small camera is inserted down

your oesophagus (food pipe) to look into your stomach). This will help find out what is causing your symptoms. It can help to exclude more serious causes of your symptoms such as stomach cancer.

If diarrhoea occurs during the treatment with Lansoprazole contact your doctor immediately, as this medicine has been associated with a small increase in infectious diarrhoea.
If your doctor has given you this medicine 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 this medicine 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.
If you have ever had a skin reaction after treatment with a medicine similar to Lansoprazole that reduces stomach acid.
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 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 Lansoprazole. Remember to also mention any other ill-effects like pain in your joints.
If you think any of these apply to you or you are unsure, talk to your doctor or pharmacist before taking lansoprazole. Do this even if they applied only in the past.
Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
If you are due to have a specific blood test (Chromogranin A).
Daily treatment with any acid-suppressing medications over a prolonged period of time (several years) may lead to malabsorption of cyanocobalamin (vitamin B12)

If you think any of these apply to you or you are unsure, talk to your doctor or pharmacist before taking Lansoprazole. Do this even if they applied only in the past.

Other medicines and Lansoprazole

Please tell your doctor or pharmacist if you are taking or have recently or might take any other medicines, including medicines obtained without a prescnption. This includes herbal medicines. This is because lansoprazole can affect the way some other medicines work. Also, some medicines can have an affect on the way lansoprazole works.

In particular, tell your doctor or pharmacist if you are taking any of

the following medicines:

– 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)
– antacids (used to treat heartburn or acid regurgitation)
– sucralfate (used for healing ulcers)
– St John's wort (Hypericum perforatum) (used to treat mild depression)
– HIV protease inhibitors such as atazanavir and nelfinavir (used to treat HIV)
– Methotrexate (used to treat autoimmune disease and cancer)
– Warfarin (used to treat blood clots)

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Lansoprazole with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

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

Use of Lansoprazole Capsules is not recommended during pregnancy, as there is no adequate experience on the use of lansoprazole during pregnancy.

Driving and using machines

You may feel dizzy, tired, sick, have a headache or problems with your eyesight while taking lansoprazole. If this happens, do not drive or use any tools or machines.

Lansoprazole capsules contain sucrose

Lansoprazole gastro-resistant capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. how to take lansoprazole gastro-resistant capsules

Always take this medicine exactly as your doctor has told you. The dose will depend on your needs and the illness being treated. Check with your doctor or pharmacist if you are not sure.

Taking your medicine

Swallow your capsules whole with a glass of water. Do not crush or chew the capsules.
If you are taking lansoprazole once a day, take it at the same time every morning before breakfast.
If you are taking lansoprazole twice a day, take the first dose in the morning before breakfast and the second dose in the evening.

The usual doses for adults are:

Stomach ulcers:

One 30 mg capsule every day for 4 weeks
One 30 mg capsule every day for 2 weeks to heal the ulcer
Your doctor may then decide you need one 15mg capsule every day to stop it coming back
One 30 mg capsule every day for 4 weeks to heal the ulcer
Your doctor may then decide to give you one 15mg or 30mg capsule every day to stop the ulcer or your symptoms coming back
Your doctor will tell you when to stop taking lansoprazole
One 15mg or 30mg capsule every day
Your doctor will tell you when to stop taking lansoprazole

Treatment of infection of Helicobacter pylori :

The usual dose is one 30 mg capsule or two 15 mg capsules in combination with two different antibiotics in the morning and one 30 mg capsule or two 15 mg capsules 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 lansoprazole together with 250–500 mg clarithromycin and 1000 mg amoxicillin
30 mg lansoprazole 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.

Gastro-oesphageal reflux disease:

(GORD):

One 30mg capsule every- day for 4 weeks to heal your food pipe (oesophagus) and/or relieve symptoms
Your doctor may then decide you need one 15mg or 30mg capsule a day to stop your illness coming back
One 15mg or 30mg capsule every day for 2 to 4 weeks
Talk to your doctor once you have completed this course or if your symptoms are not getting better
Two 30mg capsules every day to start with
Your doctor will then decide the dose which is best for you depending on how you respond to treatment with lansoprazole

Patients with liver problems

If you have severe liver problems your doctor may keep your dose to one capsule a day.

Children

Do not give lansoprazole to children.

If you take more lansoprazole than you should

Tell your doctor or go to your nearest hospital straight away. Remember to take with you any lansoprazole capsules that are left and the pack as well. This is so the doctor knows what you have taken.

If you forget to take lansoprazole

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose.

If it is time for your next dose then skip the missed dose and continue with your next dose as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking lansoprazole

Keep taking the medicine until your doctor tells you to stop. Do not stop taking lansoprazole just because you feel better. If you do stop taking lansoprazole your illness may get worse again.

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

4. possible side effects

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

Stop taking lansoprazole and see a doctor or go to a hospital straightaway if:

You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria) This may mean you are having an allergic reaction to this medicine.
You have blistering, peeling or bleeding of the skin around the lips, eyes, mouth, nose and genitals. You may also have flu-like symptoms and a high temperature. These could be signs of something called Stevens-Johnson syndrome
You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. These could be signs of toxic epidermal necrolysis
You bruise more easily than usual or you get more infections than usual. This could be due to a blood problem.
You get severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure.

Your doctor may want to carry out a blood test.

The above side effects are all rare or very rare (affect up to 1 in 1000 people).

If any of the following side effects gets serious or lasts longer than a few days, tell your doctor or pharmacist. Common (affects up to 1 in 10 people)

headaches, feeling dizzy or tired, or a general feeling of being unwell
diarrhoea, constipation, stomach pains, feeling sick (nausea) or being sick (vomiting), wind
dry or sore mouth or throat, benign polyps in the stomach
skin rash, itching
changes in the way your liver is working (shown by a blood test)
low mood (depression)
joint or muscle pain
water retention which may cause swollen arms or legs
fracture of the hip, wrist or spine (if lansoprazole is used in high doses and over a long period of time)
changes in blood cell counts
fever
feeling restless, drowsy or confused
seeing or hearing things which are not there (hallucinations)
numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
difficulty sleeping (insomnia)
problems with your vision
feeling dizzy, possibly with a „spinning“ feeling (vertigo)
taste disturbance, loss of appetite (anorexia), inflammation of your tongue (glossitis)
skin reactions such as burning or pricking feeling under the skin, bruising, red or purple spots which may be

itchy or blister.

excessive sweating
being more sensitive to the sun than usual
hair loss (alopecia)
trembling
feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia.
kidney problems
pancreatitis
Inflammation of the liver (may be seen as yellow skin or eyes)
swelling of the breasts in men (gynaecomastia), being unable to get or keep an erection (impotence)
candidiasis fungal infection, such as thrush, which may affect your oesophagus (food pipe)
inflammation of your mouth (stomatitis)
colitis (bowel inflammation e.g. diarrhoea, abdominal pain, cramping, fever and fatigue, blood in stools)
changes in test values such as sodium, cholesterol and triglyceride levels
very rarely lansoprazole may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. 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).
skin-related forms of lupus or a lupus rash, possibly with pain in the joints.
If you are on lansoprazole 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.
Visual hallucinations

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store lansoprazole gastro-resistant capsules

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

Do not store above 25°C. Store in the original package in order to protect from moisture.

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

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.

6. contents of the pack and other information

What Lansoprazole gastro-resistant capsules contain

The active substance is 15 mg or 30 mg of lansoprazole.
The other ingredients are:

Capsule content: Sugar spheres (sucrose and maize starch), Sodium laurilsulfate, Meglumine, Mannitol (E421), Hypromellose, Macrogol, Talc, Polysorbate 80, Titanium dioxide (E171), Methacrylic Acid-Ethyl Acrylate Copolymer (1:1), Dispersion 30%

Capsule shell: Gelatin, Titanium dioxide (E171)

Capsule shell of 15 mg also contains: Quinoline yellow (E104)

What Lansoprazole gastro-resistant capsules look like and contents of the pack

Lansoprazole 15 mg gastro-resistant capsules are opaque yellow cap and body capsules.

Each capsule contains white or almost white spherical microgranules.

Lansoprazole 30 mg gastro-resistant capsules are opaque white cap and body capsules.