Omeprazole 20 Mg Capsules
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Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Omeprazole is and what it is used for
2. Before you take Omeprazole
3. How to take Omeprazole
4. Possible side effects
5. How to store Omeprazole
6. Further information
1. What Omeprazole is and what it is used for
The name of your medicine is Omeprazole 20mg Capsules (called Omeprazole in this leaflet). This
belongs to a group of medicines known as “proton pump inhibitors”.
Omeprazole works by lowering the amount of acid in your stomach. It can be used for the following:
• To treat acid from the stomach escaping into the food pipe causing pain, inflammation and heartburn (oesophageal reflux disease and reflux oesophagitis).
• To treat acid indigestion (dyspepsia) which can cause pain, discomfort, nausea or excessive belching
• To treat ulcers in your stomach and duodenum (the part of the gut the stomach empties into).
• In patients who have had previous problems with ulcers and who must continue to take NonSteroidal Anti-Inflammatory Drugs (NSAIDs), Omeprazole can heal ulcers or prevent an ulcer from developing. NSAIDs include medicines such as ibuprofen, aspirin, ketoprofen or piroxicam.
• In combination with antibiotics to treat ulcers which are infected with bacteria called Helicobacter pylori.
• The management of Zollinger-Ellison Syndrome. This is a problem with your pancreas where too much acid in the stomach can cause ulcers in your stomach, duodenum, gut and food pipe.
• For people at risk of breathing in acid from their stomach (aspiration). This might happen during an operation with a general anaesthetic or in women during labour.
Omeprazole is the common (generic) name. Your doctor may have given you this medicine before
from another company and it may have looked slightly different. Either brand will have the same
effect.
2. Before you take Omeprazole
Do not take Omeprazole if:
• You are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medicine (listed in Section 6)
• You have a suspected stomach ulcer and are awaiting confirmation from your doctor
Do not take Omeprazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole.
Take special care with Omeprazole
Check with your doctor or pharmacist before taking your medicine if:
• You are pregnant, might become pregnant or are breast-feeding
• You have any liver problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Omeprazole.
Stomach cancer
Omeprazole may hide the signs of stomach cancer. Your doctor will check to make sure you do not have stomach cancer before you start taking your capsules.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Omeprazole can affect the way some other medicines work. Also some other medicines can affect the way Omeprazole works.
In particular, please tell your doctor or pharmacist if you are taking any of the following:
• Ketoconazole or itraconazole (for fungal infections)
• Diazepam (for your nerves)
• Phenytoin (for epilepsy)
• Warfarin (for thinning of the blood)
• Clarithromycin (for bacterial infections)
• Digoxin (for the heart)
Taking a proton pump inhibitor like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture of 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).
Operations or tests
If you see another doctor or are going to have an operation and anaesthetic (including at the dentist), tell them you are taking Omeprazole and any other medicines you may be taking.
Driving and using machines
You may feel dizzy, have blurred vision or see things that are not there while taking this medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
To heal or prevent stomach and duodenal ulcers
• 20mg once daily for a period of 4 to 8 weeks to treat an ulcer
• Depending on your response your dose may be increased
• 10mg once daily to help prevent an ulcer returning
To heal or prevent ulcers in patients taking NSAIDs
• 20mg once daily
To treat ulcers caused by infection with the bacteria Helicobacter pylori
• 40mg once a day or 20mg twice a day for a period of 1 to 2 weeks
• Your doctor will also tell you to take an antibiotic medication such as: amoxicillin, clarithromycin, metronidazole or tinidazole
Zollinger-Ellison Syndrome
• 60mg once a day
• If your doctor increases the dose to 80mg or more a day, half the dose should be taken in the morning and half at night.
Before an operation with general anaesthetic - to stop you breathing in acid from your stomach
• 40mg the evening before your operation
• Then another 40mg dose two to six hours before your general anaesthetic
How much to take - Children (give only if your hospital paediatrician tells you to)
The total amount will be worked out by your hospital paediatrician as it will depend on how much your child weighs. They will tell you how to split this up and take it throughout the day.
Children 2 years and over for heartburn
• The usual dose is 0.7 to 1.4mg for each kilogram (kg) of bodyweight daily Maximum dose of 40mg daily
If you take more than you should
If you take more Omeprazole than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Omeprazole
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
• Do not take a double dose to make up for a forgotten dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Omeprazole can have side effects, although not everybody gets them. The following side effects may happen with this medicine:
See a doctor straight away, if you notice any of the following serious side effects:
• Allergic reactions - the signs include a skin rash, swollen or lumpy skin, swollen face, lips, tongue or throat, you have difficulty breathing, have a fever or feel faint
• You have liver problems with symptoms such as pain in the abdomen, nausea, flu-like symptoms or yellowing of your skin or whites of your eyes
• Skin peeling off in sheets or serious illness with blistering of the skin including the mouth, eyes and genitals
• You notice that you bruise more easily or have more nose bleeds than usual. You may also get more infections than usual such as a sore throat. These could be signs of changes in your blood cells
Other possible side effects:
Frequency not known:
If you are on Omeprazole 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.
Common side effects (affects between 1 in 10 and 1 in 100 patients):
• headache
• diarrhoea, constipation, abdominal pain, feeling or being sick, flatulence (wind)
Uncommon side effects (affects between 1 in 100 and 1 in 1,000 patients):
• dizziness, a feeling of ‘spinning', light headedness, pins and needles
• feeling faint, feeling sleepy or difficulties sleeping
• liver problems which may have symptoms such as skin colour changes or abdomen pain
• skin problems such as rash, itching, red lumps (hives)
• general feeling of being unwell
• muscoskeletal disorders: Fracture of hip, wrist or spine
Rare side effects (affects between 1 in 1,000 and 1 in 10,000 patients):
• feeling confused, feeling uneasy, aggression, depression , seeing or hearing things not there (hallucinations)
• enlarged male breasts
• dry mouth, soreness and inflammation inside the mouth and throat, thrush fungal infection
• changes in blood component levels or cell counts with symptoms from nausea to coma
• brain disease in patients with pre-existing sever liver disease
• liver problems with symptoms such as pain in the abdomen
• sore joints and muscles, swollen limbs
• inability to develop or maintain an erection in men
• skin reactions such as sensitivity to light, red patches, hair loss
• blurred vision, taste disturbance, increased sweating
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
3. How to take Omeprazole
5. How to store Omeprazole
Always take Omeprazole exactly as your doctor has told you. You should check with your doctor if you are not sure. The length of your course of treatment will depend on what condition you are suffering from. Your doctor will decide the correct dose for you.
Taking this medicine
• You can take your capsules with food or on an empty stomach at any time of the day.
• Swallow the capsules whole with a full glass of water. Do not chew or crush the capsule.
• If you have trouble swallowing the capsules, open the capsule and gently mix the granules with fruit juice or yoghurt and drink immediately. Do not chew or crush the granules.
• Keep taking your capsules until your doctor tells you to stop. Do not stop taking them because you feel better.
How much to take - adults
Depending on what you are taking Omeprazole for, there are different doses. The usual doses are:
Heartburn (oesophageal reflux disease and reflux oesophagitis)
• 20mg once a day for 4 weeks
• Depending on your response your dose may be increased or treatment time extended
• To prevent symptoms returning your treatment may be continued at 20mg or reduced to 10mg per day
Acid indigestion (dyspepsia)
• 10mg or 20mg once daily for a period of 2 to 4 weeks
• If there is no improvement you must return to your doctor
Continued overpage
• Keep out of the reach and sight of children
• Do not use the capsules after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month
• Do not store above 30°C. Store in the original container. Keep the container tightly closed.
• 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.
6. Further information
What Omeprazole contains
• Each capsule contains 20mg of the active substance omeprazole.
• The other ingredients are sugar spheres, sodium starch glycollate, sodium laurilsulfate, povidone, potassium oleate, oleic acid, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, titanium dioxide, talc. The capsule coating contains gelatine, titanium dioxide (E171), quinoline yellow (E104), indigo carmine (E132), erythrosine (E127). The printing ink contains shellac, polyvinylpyrrolidone, propylene glycol, sodium hydroxide and titanium Dioxide (E171).
What Omeprazole looks like and contents of the pack
The capsules have an orange body and blue cap and are marked with ‘O20'.
Omeprazole is only available from your pharmacist on prescription in bottles of 28 capsules.
MA holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park,
Liverpoo l L30 1RD
Distributed by: Zanza Laboratories Limited, Liverpool, UK.
Date of last revision: October 2014 336/01