Zotrole

Stomach acid is produced in the stomach as a normal part of the digestive process. Normally the linings of the stomach and duodenum (an area of the small intestine directly after the stomach) are protected by a layer that resists attack from this acid. However, if this layer is damaged, or large amounts of stomach acid are formed, an ulcer can develop on the lining of the stomach or duodenum. This is called a peptic ulcer.

Acid produced in the stomach can also sometimes flow back into the food pipe (oesophagus). This is called gastro-oesophageal reflux, and can cause pain and a burning sensation known as heartburn. It can also irritate and damage the lining of the oesophagus, causing a condition called reflux oesophagitis.
By reducing the production of stomach acid, Zotrole can be used to treat all these and certain other conditions.

By reducing the amount of acid in the stomach and duodenum, Zotrole relieves the symptoms of indigestion caused by excess stomach acid. It also allows peptic ulcers to heal, and can be continued after they have healed to help prevent them recurring.

Zotrole stops excess acid flowing back into the foodpipe and can be used to relieve heartburn symptoms associated with acid reflux. It also allows the oesophagus to heal in reflux oesophagitis.

Zotrole can also be used to prevent and treat peptic ulcers that can occur as a side effect of non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac. NSAIDs relieve pain and inflammation by reducing the production of substances called prostaglandins. Unfortunately, prostaglandins are also produced in the stomach and help to protect the stomach lining from acid, so NSAIDs can allow the acid to irritate the stomach. Zotrole is used to treat peptic ulcers that occur due to this irritation. It also relieves side effects such as indigestion that can be associated with taking these medicines. Zotrole is also sometimes prescribed in combination with NSAIDs to help prevent peptic ulcers from developing.

Zotrole is also given together with antibiotics (usually clarithromycin plus metronidazole or amoxicillin) to help eradicate a type of bacteria called Helicobacter pylori from the stomach of people with a peptic ulcer, or ulcer-like indigestion symptoms. These bacteria can contribute to the formation of peptic ulcers. Zotrole allows the ulcers to heal and helps create an environment in the gut in which the antibiotics can be more effective at killing the bacteria.

Zotrole is used in varying doses and for varying lengths of time depending on the condition being treated.

What is it used for?

• Gastro-oesophageal reflux disease.
• Indigestion symptoms related to excess stomach acid, such as heartburn and abdominal pain.
• Treatment of peptic ulcers.
• Prevention and treatment of peptic ulcers associated with non-steroidal anti-inflammatory painkillers (NSAIDs).
• Eradicating a type of bacteria called Helicobacter pylori from the gut of people with a peptic ulcer (in combination with antibiotics).
• Excessive secretion of stomach acid due to a tumour or enlargement of the pancreas (Zollinger-Ellison syndrome).

How do I take it?

• The number of tablets to take, how often and for how long will depend on the condition being treated. It is important to follow the instructions given by your doctor. These will also be printed on the dispensing label that your pharmacist has put on the packet of medicine.
• Zotrole should be placed on the tongue and gently sucked. The tablet rapidly disperses in the mouth, releasing the microgranules which can then be swallowed with the saliva. Alternatively, the tablet can be swallowed whole with a drink of water. Do not chew, break or crush the tablets or the microgranules.
• The tablets should be taken on an empty stomach, at least 30 minutes before food.
• If you forget to take a dose take it as soon as you remember. However, if it is almost time for your next dose just skip the missed dose and take your next dose as normal. Don't take a double dose to make up for a missed dose.

Use with caution in

• Elderly people.
• People with moderate to severely decreased liver function.
• People with osteoporosis or who are at risk of osteoporosis, for example people taking long-term corticosteroid medicines and women who have passed the menopause. (This medicine may increase the risk of breaking a bone - see the warning section above.)
• Vitamin B12 deficiency.
• Zotrole contain aspartame and should be used with caution in people with an inherited disorder of protein metabolism called phenylketonuria.

Pregnancy and Breastfeeding

Pregnancy:

For Zotrole no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Therefore, the use of Zotrole during pregnancy is not recommended.

Lactation:

It is not known whether Zotrole is excreted in human breast milk. Animal studies have shown excretion of Zotrole in milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Zotrole should be made taking into account the benefit of breastfeeding to the child and the benefit of Zotrole therapy to the woman.

Possible side effects

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

The following side effects are common (occur in more than 1 in 100 patients):

• 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.

The following side effects are uncommon (occur in less than 1 in 100 patients):

• depression
• joint or muscle pain
• fluid retention or swelling
• changes in blood cell counts.

The following side effects are rare (occur in less than 1 in 1000 patients):

• 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 (paresthesiae), trembling
• anaemia (paleness)
• kidney problems
• pancreatitis
• inflammation of the liver (may be seen as yellow skin or eyes)
• breast swelling in males, impotence
• candidiasis (fungal infection, may affect skin or the mucosa)
• angioedema; You should see your doctor immediately if you experience symptoms of angioedema, such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath.

The following side effects are very rare (occur in less than 1 in 10000 patients):

• severe hypersensitivity reactions including shock. Symptoms of a hypersensitivity reaction may include fever, rash, swelling and sometimes a fall in blood pressure
• inflammation of your mouth (stomatitis)
• colitis (bowel inflammation)
• changes in test values such as sodium, cholesterol and triglyceride levels
• very severe skin reactions with reddening, blistering, severe inflammation and skin loss
• very rarely Zotrole 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).

Frequency not known

If you are on Zotrole 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.

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How to store Zotrole

• Keep out of the reach and sight of children.
• Do not use Zotrole 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 store above 25°C. Do not keep it in the fridge. Keep your medicine in the packaging that it came in to help protect it from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

How can Zotrole affect other medicines?

You should tell your doctor or pharmacist what medicines you are taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. This is particularly important if you taking any of the medicines mentioned below, because your doctor may need to monitor your treatment or alter your medicine doses. Similarly, you should check with your doctor or pharmacist before taking any new medicines during treatment with this one, to make sure that the combination is safe.

Zotrole should not be taken by people taking the anti-HIV medicines atazanavir or rilpivirine. This is because Zotrole reduces the absorption of these medicines from the gut and could make them less effective at treating HIV infection.

Proton pump inhibitors such as Zotrole are not recommended for people taking the anti-HIV medicines raltegravir or saquinavir, because they may increase the blood level of these medicines and may therefore increase the risk of their side effects.

Due to its effect on the acidity in the stomach, Zotrole may reduce the absorption of the following medicines from the stomach, which could make them less effective:

• erlotinib
• itraconazole
• ketoconazole
• lapatinib
• pazopanib
• posaconazole
• ulipristal
• vandetanib.

Zotrole may increase the amount of the immunosuppressant tacrolimus in the blood, and you should let your doctor or pharmacist know if you are taking this medicine before starting treatment with Zotrole:

Antacids and sucralfate decrease the absorption of this medicine from the gut and may make it less effective. For this reason, antacids and sucralfate should not be taken within an hour of taking Zotrole.

The antidepressant fluvoxamine may increase the amount of Zotrole in the blood. Your doctor may prescribe you a lower dose of Zotrole if you are taking this antidepressant and seem to be getting a lot of Zotrole side effects.

There may be a greater chance of the level of magnesium in your blood falling too low if you are taking this medicine with digoxin, diuretics (such as bendroflumethiazide or furosemide) or other medicines that can lower blood magnesium levels. If you are taking one of these your doctor may want you to have a blood test to check your magnesium levels before you start taking Zotrole and then regularly during treatment.

References:

http://www.patient.co.uk/medicine/Lansoprazole.htm

http://www.netdoctor.co.uk/digestive-health/medicines/zoton.html

http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/pfczotft/$File/pfczotft.pdf

http://www.medicines.ie/medicine/11849/SPC/ZOTON+FASTAB+15MG+%26amp%3B+30MG/#PREGNANCY

http://www.drugs.com/uk/zoton-fastab-15mg-leaflet.html

http://www.nhs.uk/medicine-guides/pages/selectorshow.aspx?medicine=Lansoprazole

http://www.medicines.org.uk/emc/medicine/10427/pil