Proton

Omeprazole.

The capsules are opaque, white/white in colour, containing gastro-resistant granules, white to slightly beige, round and with a smooth surface.
Proton is a medication in the form of capsules (hard, gastro-resistant capsule), for oral administration, containing 20 mg of omeprazole (active substance).
Excipients/Inactive Ingredients: Proton also contains the following inactive ingredients (excipients): Anhydrous lactose, hydroxypropylcellulose, sodium laurylsulfate, disodium phosphate dodecahydrate, diethyl phthalate, hypromellose, phthalate and sugar spheres.
The outer capsule contains gelatin, titanium dioxide (E171) and purified water.

Omeprazole, the active ingredient in Proton. It belongs to a group of medicines called 'proton pump inhibitor'. They work by reducing the amount of acid that the stomach produces.

Proton is used to treat the following conditions: In adults: Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet causing pain, inflammation and heartburn.
Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
Ulcers which are infected with bacteria called 'Helicobacter pylori'. If the patient has this condition, antibiotics may also be prescribed to treat the infection and allow the ulcer to heal.
Ulcers caused by medicines called NSAIDs. PROTON can also be used to stop ulcers from forming if the patient is taking NSAIDs.
Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
In children: Children over 1 year of age and ≥10kg: Gastro-oesophageal reflux disease (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain, inflammation and heartburn.
In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.
Children and adolescents over 4 years of age: Ulcers which are infected with bacteria called 'Helicobacter pylori'. If the child has this condition, antibiotics may also be prescribed to treat the infection and allow the ulcer to heal.

Proton 20 mg capsules are administered orally and must be swallowed whole with sufficient liquid, recommended to take in the morning with food or on an empty stomach.
If the patient has difficulty in swallowing the capsules, the patient can open the capsule and swallow the contents (granules) directly with water, taking care not to chew or crush the granules.
The dose must be established. Advise patients not to alter the dose or interrupt the treatment without consultation. If the patient feels that the medication is not having the desired effect, advise the patient to contact the doctor.
For Adults: To treat symptoms of GORD such as heartburn and acid regurgitation: For patients with food pipe (gullet) that has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. A dose of 40 mg may be taken for a further 8 weeks.
The recommended dose once the gullet has healed is 10 mg* once a day.
If the gullet has not been damaged, the usual dose is 10 mg* once a day.
*Other preparation(s) should be used for dose below 20 mg.
To treat ulcers in the upper part of the intestine (duodenal ulcer): The recommended dose is 20 mg once a day for 2 weeks. The same dose may be taken for a further 2 weeks if the ulcers are not yet healed.
If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer): The recommended dose is 20 mg once a day for 4 weeks. The same dose may be taken for a further 4 weeks if the ulcers are not yet healed.
If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming back: The recommended dose is 10 mg or 20 mg once a day. The dose may be increased to 40 mg once a day.
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs): The recommended dose is 20 mg once a day for 48 weeks.
To prevent duodenal and stomach ulcers if the patient is taking NSAIDs: The recommended dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back: The recommended dose is 20 mg of Proton twice a day for one week.
Two antibiotics would be taken among amoxicillin, clarithromycin and metronidazole.
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome): The recommended dose is 60 mg daily.
The dose would be adjusted depending on the patient's needs and how long the patient needs to take the medicine for would be decided.
Use in children and adolescents: To treat symptoms of Gastro-Oesophageal Reflux (GORD) such as heartburn and acid regurgitation: Children over 1 year of age and with a body weight of more than 10 kg may take Proton. The dose for children is based on the child's weight and the correct dose would be decided.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back: Children aged over 4 years may take Proton. The dose for children is based on the child's weight and the correct dose would be decided.
Two antibiotics would also be prescribed called amoxicillin and clarithromycin for the child.
Forgotten intake of Proton: If the patient forgets to take a dose, it should be taken as soon as the patient remembers. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for a forgotten dose.
Stopping intake of Proton: Advise patient not to stop taking Proton without first talking to the doctor or pharmacist.

If Proton was taken more than prescribed, patients must be advised to seek medical advice straight away.

Proton should not be taken: If the patient is allergic to omeprazole or any other ingredient of this medication; If the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole); If the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Proton should not be taken if any of the previously mentioned applies to the patient. Patients must be advised before taking Proton.

Patients must be advised before taking Proton.
Proton may hide the symptoms of other diseases. Therefore, if any of the following happens to the patient before starting Proton or while taking it, patients must be advised to seek medical advice straight away: Patient loses a lot of weight for no reason and have problems swallowing; gets stomach pain or indigestion; begins to vomit food or blood; passes black stools (blood-stained faeces); experiences severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infections diarrhoea; has severe liver problems; has ever had a skin reaction after treatment with medicine similar to Proton that reduces stomach acid; due to have specific blood test (Chromogranin A).
If the patient takes Proton on a long-term basis (longer than 1 year), the patient would probably be kept under regular surveillance. Advise the patient to report any new and exceptional symptoms and circumstances.
Taking a proton pump inhibitor like Proton, especially over a period of more than one year, may slightly increase the patient's risk of fracture in the hip, wrist or spine. Advise the patient to inform the doctor if the patient has osteoporosis or if the patient is taking corticosteroids (which can increase the risk of osteoporosis).
If the patients gets a rash on the skin, especially in areas exposed to the sun, advise the patient to inform the doctor as soon as the patient can (as the treatment may need to be stopped with Proton). Advise the patient to also mention any other ill-effects like pain in the joints.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton pump inhibitors for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients treatment of hypomagnesemia required magnesium replacement and discontinuation of the proton pump inhibitors.
For patients expected to be on prolonged treatment or who take proton pump inhibitors with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of proton pump inhibitors treatment and periodically.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE), proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Proton. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Proton capsule contain lactose: Proton capsule contain lactose. If the patient has been told by the doctor that he/she has an intolerance to some sugars, advise the patient to contact the doctor before taking this medicinal product.
Driving or operate machinery: Treatment with omeprazole is not likely to affect the ability to drive or operate machinery. Side effects such as dizziness and visual disturbance may occur, if affected, the patient should not drive or operate machinery.
Use in Children: Some children with chronic illnesses may require long-term treatment although it is not recommended. This medicine should not be given to children under 1 year of age or <10 kg.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
In long term use, especially for more than 1 year, the treatment must be reviewed regularly and assess the risk benefit ratio periodically.

If the patient is pregnant or breastfeeding, thinks that she may be pregnant or is planning to have a baby, she must be advised before taking this medicine.
Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. The doctor will decide whether the patient can take Proton if the patient is breastfeeding.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph.
If the patient notices any of the following rare but serious side effects, Proton should be stopped and patient must be advised to seek medical advice immediately: Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction); Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis'; Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Common side effects (may affect up to 1 in 10 people): Headache; Effects on the stomach or gut: diarrhoea, stomach pain, constipation, flatulence; Feeling sick (nausea) or being sick (vomiting); Benign polyps in the stomach.
Uncommon side effects (may affect up to 1 in 100 people): Swelling of the feet and ankles; Insomnia (disturbed sleep); Dizziness, tingling feelings such as "pins and needles", feeling sleepy; Spinning feeling (vertigo); Changes in blood tests that check how the liver is working; Skin rash, lumpy rash (hives) and itchy skin; Generally feeling unwell and lacking energy.
Rare side effects (may affect up to 1 in 1,000 people): Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitation, confusion or depressed.
Taste changes.
Eyesight problems such as blurred vision.
Suddenly feeling wheezy or short of breath (bronchospasm).
Dry mouth.
An inflammation of the inside of the mouth.
An infection called "thrush" which can affect the gut and is caused by a fungus.
Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
Hair loss (alopecia).
Skin rash on exposure to sunshine.
Joint pains (arthralgia) or muscle pains (myalgia).
Severe kidney problems (interstitial nephritis).
Increased sweating.
Very rare side effects (may affect up to 1 in 10,000 people): Change in blood count including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
Muscle weakness.
Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data): Inflammation in the gut (leading to diarrhoea).
If the patient is on Proton for more than three months it is possible that the levels of magnesium in the blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If the patient gets any of these symptoms, advise the patient to seek medical advice promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Regular blood tests may be performed to monitor the levels of magnesium. Rash, possibly with pain in the joints.
Proton may in very rare cases affect the white blood cells leading to immune deficiency. If the patient has an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, advise the patient to consult the doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for the patient to give information about the medicine at this time.

Taking Proton with other medicines: Advise the patient to inform the doctor or pharmacist if the patient is taking, has recently taken, or might take any other medicines. This includes medicines bought without a prescription. This is because Proton can affect the way some medicines work and some medicines can have an effect on Proton.
Proton should not be taken if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Advise the patient to inform the doctor or pharmacist if the patient is taking any of the following medicines: Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus); Digoxin (used to treat heart problems); Diazepam (used to treat anxiety, relax muscles or in epilepsy); Phenytoin (used in epilepsy). If the patient is taking phenytoin, the patient should be monitored when starting or stopping taking Proton; Anticoagulant medication, such as warfarin or other vitamin K blockers; Rifampicin (used to treat tuberculosis); Atazanavir (used to treat HIV infection); Tacrolimus (in case of organ transplantation); St. John's wort (Hypericum perforatum) (used to treat mild depression); Cilostazol (used to treat intermittent claudication); Saquinavir (used to treat HIV infection); Clopidogrel (used to prevent blood clots (thrombi)); Erlotinib (used to treat cancer); Methotrexate (a chemotherapy medicine used in high doses to treat cancer) - if the patient is taking a high dose of methotrexate, the Proton treatment may temporarily be stopped.
Omeprazole may increase the methotrexate level temporary, withdrawal of omeprazole may need to consider.
Literature suggests that concomitant use of proton pump inhibitors with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possible leading to methotrexate toxicities. A temporary withdrawal of the proton pump inhibitors may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of proton pump inhibitors and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with proton pump inhibitors have been conducted.
Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitors that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart.
If the antibiotics amoxicillin and clarithromycin as well as Proton to treat ulcers caused by Helicobacter pylori infection have been prescribed, it is very important to advise the patient to inform the doctor about any other medicines being taken.
Proton with food and drink: Proton can be taken with food or on an empty stomach.

Keep the capsules always in their original packaging, since Proton capsules are very sensitive to moisture.
Store below 25°C.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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