Helicid 20: composition and presentation
Helicid 20 is a prescription medicine based on omeprazole, supplied as capsules. One capsule contains either 10 mg or 20 mg of omeprazole, and the figure in the name refers to the larger of those strengths. The same product description also mentions a vial holding 40 mg of omeprazole as the sodium salt: that is a separate form for intravenous use, prepared and given by medical staff in hospital, and it has nothing to do with taking capsules at home.
The choice between the 10 mg and the 20 mg capsule is made by the doctor rather than the patient, and it depends neither on body weight nor on age but on which condition is being treated: the same disease during a flare and during maintenance therapy calls for different strengths. That is why a pack labelled "20" is not universal, and carrying a dosing schedule over from one diagnosis to another is not acceptable.
How Helicid 20 works
Omeprazole belongs to the proton pump inhibitors, the name given to the enzyme system in the cells of the gastric lining that handles the final step of hydrochloric acid production. The drug suppresses both basal secretion, the kind that continues between meals, and stimulated secretion, and it does so regardless of which trigger set it off. In this it differs from agents that block one particular receptor: the shared outlet is closed rather than a single route leading to it.
After a capsule is swallowed, suppression of secretion begins within an hour, peaks within two hours and lasts from 24 to 72 hours, which is why the medicine is taken once a day. Once it is stopped, acid production returns gradually, over a period of three hours to five days. The half-life with normal liver function ranges from 30 minutes to an hour, and in chronic liver disease it lengthens to three hours: this is the only state in which the dose has to be reduced.
Indications
The list of indications for omeprazole is unusually broad for a single active substance, and almost every entry splits in two: treating the flare and then preventing the disease from returning. In adults the capsules are used in the following situations:
- treatment of duodenal ulcer and prevention of its recurrence;
- treatment of gastric ulcer and prevention of its recurrence;
- eradication of Helicobacter pylori in peptic ulcer disease, in combination with suitable antibiotics;
- treatment of gastric and duodenal ulcers that arise during treatment with non-steroidal anti-inflammatory drugs;
- prevention of such ulcers in patients whose risk of developing them is increased;
- treatment of reflux oesophagitis, inflammation of the oesophagus caused by stomach contents flowing back;
- long-term maintenance therapy after reflux oesophagitis has healed;
- treatment of symptomatic reflux disease and of Zollinger-Ellison syndrome.
Paediatric indications are set out separately in the description. Children over one year of age weighing at least 10 kg are given omeprazole for reflux oesophagitis and also for symptomatic relief of heartburn and acid regurgitation in reflux disease. Children and adolescents over four years of age receive it together with antibiotics for duodenal ulcer caused by H. pylori.
Method of use and dosage
The dose and the length of the course are set by the diagnosis, not by how the patient feels: for several indications the expected healing time is known in advance, and if healing has not occurred within it, treatment is extended by another equal period. In renal impairment and in patients over 65 the dose is not changed. In hepatic impairment, by contrast, 10 to 20 mg a day is usually enough. The schedules for adults are given below.
| Indication | Daily dose | Expected period |
| Duodenal ulcer | 20 mg; 40 mg if resistant to treatment | 2 weeks, another 2 if healing is incomplete; resistant: 4 weeks |
| Gastric ulcer | 20 mg; 40 mg if resistant to treatment | 4 weeks, another 4 if healing is incomplete; resistant: 8 weeks |
| Prevention of ulcer recurrence | 20 mg; 10 mg sometimes suffices, up to 40 mg if it fails | long term |
| Ulcers linked to anti-inflammatory drugs | 20 mg | 4 weeks, another 4 if healing is incomplete |
| Prevention of such ulcers in at-risk patients | 20 mg | for as long as the anti-inflammatory is taken |
| Reflux oesophagitis | 20 mg; 40 mg in severe disease | 4 weeks, another 4 if healing is incomplete; severe: 8 weeks |
| Maintenance after healing | 10 mg; 20 to 40 mg if needed | long term |
| Symptomatic reflux disease | 20 mg; 10 mg sometimes suffices | 4 weeks, then investigation |
| Zollinger-Ellison syndrome | started at 60 mg, maintained at 20-120 mg; above 80 mg split into two doses | long term |
For H. pylori eradication the description gives three one-week regimens. The first: omeprazole 20 mg with clarithromycin 500 mg and amoxicillin 1000 mg, all twice a day. The second: omeprazole 20 mg with clarithromycin 250-500 mg and metronidazole 400-500 mg or tinidazole 500 mg, also twice a day. The third: omeprazole 40 mg once a day, with amoxicillin 500 mg and metronidazole 400-500 mg or tinidazole 500 mg three times a day. Paediatric doses are worked out by body weight: at 10-20 kg it is 10 mg, which may be raised to 20 mg; above 20 kg and from the age of two it is 20 mg, which may be raised to 40 mg; oesophagitis is treated for 4 to 8 weeks and symptoms for 2 to 4 weeks, after which the child needs investigation. Paediatric eradication regimens are split into weight bands of 15-30 kg, 31-40 kg and over 40 kg, usually last a week and are carried out under specialist supervision.
Contraindications
The description lists only two outright bans. The first is hypersensitivity to omeprazole or to any of the excipients of the capsules. The second is worded as use in children under 18, with the reservation that safety in this age group has not been established.
That second point deserves a careful reading, because it conflicts with other parts of the same document: both the indications and the dosing schedules there are written for children from one year of age and 10 kg of body weight. A discrepancy of this kind within a single description is no licence to settle the matter on your own in either direction: giving it to a child remains the doctor's decision, weighing the form of the medicine, the strength and the particular diagnosis. For an adult, meanwhile, the shortness of the list of bans should not be reassuring: the main restrictions are gathered not here but in the section on warnings.
Special warnings and precautions
The chief warning concerns diagnosis rather than tolerability. Before treatment starts, a tumour must be ruled out: omeprazole can mask the clinical picture and thereby delay the detection of a malignancy. Put plainly, the pain and the heartburn go away while the cause remains unidentified. For that reason symptoms appearing for the first time after the age of 45-50, along with weight loss, difficulty swallowing, vomiting blood or black stools, call for investigation before the drug is prescribed, not after a month of seemingly successful self-treatment.
The second point concerns duration. Prolonged uninterrupted use is not recommended, because there is not enough evidence confirming that such an approach is worthwhile; the exceptions are the indications where maintenance therapy is planned from the outset, and there the length of treatment is controlled by the doctor. The third concerns the liver: in hepatic impairment doses are reduced, which follows logically from the half-life lengthening to three hours in patients with chronic liver disease.
Interactions with other medicines
Omeprazole slows hepatic metabolism, so that the elimination of a number of drugs is delayed and their blood levels rise. This applies to anticoagulants, to coumarin and indandione derivatives, to phenytoin and also to benzodiazepines processed by cytochrome P-450, diazepam among them. When anticoagulants and omeprazole are taken together, prothrombin time has to be monitored. Benzodiazepines inactivated by glucuronidase, including lorazepam and oxazepam, fall outside that rule, and omeprazole does not alter their effect.
The second group of interactions involves acidity rather than the liver. The absorption of certain substances depends on the pH of the digestive tract, and suppressing secretion changes their bioavailability: this happens with ampicillin esters, iron salts and ketoconazole. Enteric-coated tablets deserve separate mention, since with reduced acidity the coating may dissolve in the stomach already, meaning the drug is released somewhere other than intended. That is why every product being taken should be listed for the doctor, over-the-counter iron supplements included.
Pregnancy and breastfeeding
The safety of omeprazole in pregnant and breastfeeding women has not been studied sufficiently. A simple rule follows from this: in pregnancy the medicine is acceptable only when the benefit to the mother outweighs the potential threat to the foetus, and that balance is judged by the doctor, not by the patient herself. Heartburn in the second half of pregnancy is a common complaint, but it does not make a prescription automatic.
Whether omeprazole passes into breast milk is unknown, and for that reason its use during lactation is not recommended. If treatment is nonetheless necessary, the question of continuing to breastfeed is decided separately. A woman planning a pregnancy, or discovering one while already on the medicine, should tell the doctor before taking the next capsule.
Adverse reactions
Omeprazole is well tolerated, and digestive upset is what occurs most often. The remaining reactions, seen in clinical trials and during the treatment of patients, occurred only sporadically, though they are regarded as probably related to the medicine. By body system they fall out as follows:
- digestive tract: abdominal pain, diarrhoea, constipation, nausea and vomiting, bloating, dry mouth, thrush of the mouth and the bowel;
- nervous system: dizziness, headache, drowsiness, insomnia, numbness;
- skin: rash, hives, erythema multiforme, hair loss;
- muscles and joints: joint pain, muscle fatigability, muscle pain;
- urinary system: urinary tract infections, blood and protein in the urine;
- liver: raised liver enzyme activity, inflammation of the liver with or without jaundice, liver failure and, in patients with severe pre-existing liver damage, encephalopathy;
- blood: a fall in neutrophils, a fall in platelets, absence of granulocytes, aplastic anaemia affecting all cell lines;
- other: breast enlargement in men, general malaise, allergic manifestations.
From that list the changes in the blood and the liver deserve attention. Repeated fever, a sore throat or mouth ulcers may point to a drop in white cells, while yellowing of the skin and eyes, dark urine and persistent nausea suggest liver damage. In both cases the medicine is stopped and a doctor consulted without waiting for the course to end. A skin rash, particularly one with blisters, is likewise a reason for immediate advice.
Overdose
Omeprazole has a noticeable safety margin. During clinical evaluation it was given intravenously at doses of up to 270 mg a day, and up to 650 mg a day for three days, without any dose-dependent adverse effects being found. This is not an invitation to raise the dose on your own, merely an indication that accidentally taking one capsule too many does not usually lead to serious consequences.
Among the described features of overdose were reduced visual acuity, excessive sweating, drowsiness, dry mouth, facial flushing, headache, nausea, a faster heartbeat and disturbances of heart rhythm. All of them were transient. There is no specific antidote: help amounts to symptomatic treatment and support of vital functions, so pronounced complaints after a large dose call for medical attention.
How to get a Helicid 20 prescription online
Helicid 20 is dispensed on prescription, and at e-zdrowie.com the prescription can be obtained remotely. You fill in a medical questionnaire, the doctor reviews the answers and, if the medicine is suitable, issues an electronic prescription: the code arrives by message, and any Polish pharmacy will dispense the capsules against it. No visit to a surgery is needed, yet the consultation itself remains a full one: the doctor may ask follow-up questions or decline to issue the prescription if the situation calls for an examination in person.
To make your answers complete, prepare in advance a description of the complaints and how long they have lasted, together with whether there has been weight loss, vomiting of blood, black stools or difficulty swallowing. Results of gastroscopy and of an H. pylori test will be useful if they were performed, as will information about liver disease. Be sure to list every medicine you take — anticoagulants, phenytoin, diazepam, ketoconazole, iron preparations and non-steroidal anti-inflammatory drugs — and state whether you are pregnant or breastfeeding. These details determine both the dose and whether a prescription can be issued at all.
