Omeprazole 40mg Capsules

Please read this leaflet carefully before you start taking this medicine. If you have any questions or are unsure about anything relating to your treatment, ask your doctor or pharmacist.

What you need to know about Omeprazole Capsules

Each capsule contains 40mg of omeprazole as gastro-resistant granules.

The active substance is omeprazole. The other ingredients are: mannitol, crospovidone, hypromellose, poloxamer, meglumine, povidone, methacrylic acid ethyl acrylate copolymer, triethyl citrate, magnesium stearate, titanium dioxide E171, patent blue V E131, yellow iron oxide E172iii, and gelatin.

The 40mg capsules have a rich yellow opaque cap and standard purple opaque body. The capsule shells are imprinted with black ink (shellac glaze, black iron oxide E172i, lecithin soya E322, antifoam (DC 1510)). Your hard capsules will come in a carton containing 7, 14 or 28 capsules. Omeprazole is a type of drug called a ‘proton pump inhibitor’. It reduces the production of acid in your stomach.

What Omeprazole Capsules are used for

Omeprazole capsules have been prescribed by your doctor to treat:

  • An inflamed and painful windpipe (reflux oesophagitis and oesophageal reflux disease).
  • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer). If you have previously had trouble with an ulcer and need to continue taking a non-steroidal-anti-inflammatory drug (NSAID), Omeprazole capsules heal an ulcer. For such patients, Omeprazole capsules protect your stomach or duodenum whilst you are taking NSAIDs.
  • Ulcers infected with bacteria called Helicobacter pylori which live in the protective lining of the gut and have been recognised as an important cause of many ulcers.
  • Acid related indigestion.
  • Excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
  • Omeprazole capsules can be used to prevent damage to the lungs caused by breathing in stomach fluids (acid aspiration). For instance, it may be used before an operation.

Before taking your medicine

If you are allergic to any of the ingredients in Omeprazole capsules do not take this medicine.

If you have reduced liver function and are taking an antibiotic called clarithromycin, do not take this medicine.

Make sure you have told your doctor or pharmacist about any other medicines that you are taking, including those you have bought without a prescription.

If you answer yes to any of the following questions, talk to your doctor before taking this medicine

  • Are you pregnant, think you might be pregnant or considering becoming pregnant?
  • Are you breast feeding?
  • Are you taking any of the following medicines: diazepam (for your nerves), phenytoin (for epilepsy), warfarin (for thinning of the blood), digoxin (for the heart), ketoconazole or itraconazole (for fungal infections)?
  • Do you have any kidney or liver problems? If so, you should discuss this with your doctor, as he may wish to reduce the dose.

Your medicine may make you feel sleepy, dizzy or faint. Do not drive or operate machinery if you experience any of these symptoms.

Taking your medicine

You may take your capsules at any time of the day. Your doctor will tell you how many capsules to take, and when to take them. The strength of capsule you take and the length of time you take them for will depend on what condition you are suffering from.

You can take your capsules 1 hour before food or on an empty stomach. The capsules should not be chewed or crushed, they should always be swallowed whole, with a drink of water.

If you have trouble swallowing the capsules, you may suck the actual capsule then swallow it whole. Alternatively, the capsules may be opened and then the granules can be poured out and mixed with some fruit juice or yoghurt which you should drink immediately.

The only indication for which children may take Omeprazole capsules is severe reflux oesophagitis.

Treatment for children with severe reflux oesophagitis.

Treatment must be initiated by a hospital paediatrician. The dose of Omeprazole given will be dependent on their weight and treatment should be given for 4 -12 weeks. If children have trouble swallowing the capsules, the capsules should be opened and the granules mixed with some fruit juice or yoghurt and then drunk immediately.

Treatment for reflux oesophagitis and oesophageal reflux disease

Omeprazole capsules can be taken by adults and children with severe heartburn. The usual dose is 20mg omeprazole once daily for 4 weeks, but your doctor will prescribe the exact dose and length of treatment that is right for you. After this initial treatment, your doctor may tell you to continue taking Omeprazole capsules at the same or at a higher dose, depending on how well you have responded to the initial treatment.

To stop your symptoms returning, your doctor may tell you to continue taking Omeprazole capsules at a dose of 10mg or 20mg once daily.

Treatment for stomach ulcers (gastric ulcer) and ulcers in the upper part of the intestine (duodenal ulcer)

The usual dose is 20mg omeprazole daily. The usual length of treatment is 4 weeks for duodenal ulcers and 8 weeks for gastric ulcers, but your doctor will prescribe the exact dose and length of treatment that is right for you. If your symptoms have not improved during this time, your doctor may increase your dose to 40mg omeprazole once daily until you are feeling better. To stop your ulcer coming back the usual dose is 10mg omeprazole, once daily, unless your symptoms return. If your symptoms return, your doctor may increase the dose to 20mg omeprazole, once daily.

Treatment for ulcers caused by infection with bacteria called Helicobacter pylori

The usual dose is 20mg omeprazole twice daily or 40mg omeprazole once daily for 1-2 weeks, but your doctor will prescribe the exact dose and length of treatment that is right for you. Your doctor will also tell you to take one or two antibiotics. Follow the directions for taking your medicines very carefully and ask your doctor if you are unsure about anything.

Patients at risk of acid aspiration (breathing in stomach fluids) during a general anaesthetic

The usual dose is 40mg omeprazole on the evening prior to a general anaesthetic followed by 40mg omeprazole 2-6 hours before surgery.

Treatment for excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome)

The usual dose is 60mg omeprazole once daily, but your doctor will prescribe the exact dose and length of treatment that is right for you. If your dose is above 80mg omeprazole, this should be taken as half the dose in the morning and half at night. Your doctor will tell you exactly how many capsules you should take and how to take them.

Treatment for patients with liver disease

Patients with liver disease as well as any of the indications outlined above should usually be treated with no more than 20mg omeprazole per day. If you forget to take a dose, take it as soon as you remember unless it is almost time for the next dose. Do not take a double dose to make up for forgotten individual doses.

Overdose

If you take more than the recommended number of capsules, contact your doctor or pharmacist straight away.

After taking your medicine

Like all medicines, Omeprazole Capsules may sometimes cause side effects, as well as the effects that are needed. These are usually mild and go away when you stop taking this medicine. Common side effects seen: diarrhoea, headache, constipation, feel sick or be sick, wind, stomach ache. Uncommon side effects are: skin rash, itchy skin, dizziness, light headedness, feeling faint, pins and needles, feel sleepy or have difficulty sleeping, general feeling of being unwell and liver problems. Rare side effects are: sensitivity to light, severe allergic skin reactions with skin blistering, swollen lips, swelling or soreness of the mouth; dry mouth, low blood sodium, hair loss, sore joints, aching muscles, muscle weakness, blurred vision, swollen limbs, increased sweating, larger breasts in men, impotence, stomach infection, blood or taste disorders, a high temperature, wheezing, feel confused or more sleepy (if you already have severe liver disease), liver disease which may make your skin or eyes yellow and kidney problems. If you are very ill, you may feel confused, nervous, aggressive, depressed or hallucinate.

It is not known whether these side-effects are caused directly by Omeprazole capsules.

If you suffer from any of these side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing your medicine

Do not store above 30°C. Store in the original package. Keep container in the outer carton.

Keep out of the reach and sight of children.

Do not take your capsules after the expiry date shown on the carton. Remember to return any unused capsules to your pharmacist.

Reminder:

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it to others. It may harm them, even if their symptoms are the same as yours.

Marketing Authorisation Holder and Manufacturer:

Dr Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD UK.

PL08553/0217

Revision date: 16.06.05

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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