Omeprazole 20 Mg Capsules
Package leaflet: Important informations for the user/patient
meprazole 20mg Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Omeprazole is and what it is used for
2. What you need to know before you take Omeprazole
3. How to take Omeprazole
4. Possible side effects
5. How to store Omeprazole
6. Contents of the pack and other 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 rreat ulcers which are infected with bacteria called Helicobacter pylori
. The management of Zollinger-Ellison Syndrome. This is a problem with your pancreas where it cuases too much acid in the stomach which 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. What you need to know 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 are allergic to medicines containing proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• If you are taking a medicine called nelfinavir (used for HIV infection).
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.
Warnings and precautions
Tell your doctor before taking this medicine if:
' You are pregnant, might become pregnant or are breast-feeding
• You have any liver problems
• You lose a lot of weight for no reason and are having problems swallowing
• You get stomach pain or indigestion
• You begin to vomit food or blood
• You pass black stools (blood-stained faeces)
• You experience severe or persistent diarrhoea, as Omeprazole has been associated with a small increase in infectious diarrhoea
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazole that reduces stomach acid
• You are due to have a specific blood test (Chromogranin A).
If you take Omeprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Taking proton pump inhibitors like Omeprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase risk of osteoporosis).
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeprazole. Remember to also mention any other ill-effects like pain in your joints.
Taking proton pump inhibitors like Omeprazole may lead to very low levels of magnesium (see section 4).
Omeprazole can interfere with some laboratory tests. Please tell your doctor if your are taking omeprazole before undergoing any tests.
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.
Other medicines and Omeprazole
Please tell your doctor or pharmacist if you are taking, have recently taken or might take 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.
Do not take Omeprazole if you are taking a medicine containing nelfinavir (used to treat HIV .infection). Tell your doctor or pharmacist if you are taking any of the following:
• Ketoconazole, posaconazole, voriconazole or itraconazole (for fungal infections)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (for epilepsy) If you are taking phenytoin, your doctor will need to monitor you when I you start or stop taking Omeprazole.
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your I doctor may need to monitor you when you start or stop taking Omeprazole
• Digoxin (used to treat heart problems)
• Rifampicin (used to treat tuberculosis)
*> Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases 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 you are taking a high dose of methotrexate, your doctor may temporarily stop your Omeprazole treatment.
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Pregnancy, breast-feeding and fertility
If you are pregnant or are breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeprazole if you are breast-feeding.
Driving and using machines
Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Omeprazole contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Omeprazole
Always take this medicine 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 recommended dose is:
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
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 rhroughout 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 Omeprazole 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.
The signs of overdose are nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache. Single cases of lack of interest, depression and confusion have been seen.
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, this medicine can have side effects, although not everybody gets them. The following side effects may happen with this medicine:
If you notice any of the following rare but serious side effects, stop taking Omeprazole and contact a doctor immediately
• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction)
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems
• 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'
• 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.
. If you have 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, you must consult your 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 you to give information about your medicine at this time.
Other possible side effects:
Common: may affect up to 1 in 10 people
• Headache
• Diarrhoea, constipation, abdominal pain, feeling or being sick (nausea or vomiting), flatulence (wind). Uncommon: may affect up to 1 in 100 people
. Dizziness, a feeling of ‘spinning', vertigo, tingling feelings such as ‘pins and needles'
. Feeling sleepy, difficulties sleeping or disturbed sleep (insomnia)
. Swelling of feet and ankles
. Skin problems such as rash, itching, red lumps (hives)
. General feeling of being unwell or lacking energy
• Muscoskeletal disorders: fracture of hip, wrist or spine
• Changes in blood tests that check how the liver is working.
Rare: may affect up to 1 in 1,000 people
. Feeling confused, feeling uneasy, depression
. 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
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Suddenly feeling wheezy or short of breath (bronchospasm)
• Severe kidney problems (interstitial nephritis)
• Sore joints and muscles (arthralgia and myalgia), swollen limbs
• Skin reactions such as sensitivity to light, red patches, hair loss (alopecia)
• Blurred vision, taste disturbance, increased sweating.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely
Very rare: may affect up to 1 in 10,000 people
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and inflammation of the brain
• Muscle weakness
. Enlarged breasts in men.
. Changes in blood count including agranulocytosis (lack of white blood cells)
Not known: frequency cannot be estimated from the available data
• 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. Very low levels of magnesium can lead to a reduction in the blood levels of calcium. Your doctor may decide to perform regular blood tests to monitor
1 your magnesium level. Low magnesium levels may also be associated with low levels of potassium.
. Rash, possibly with pain in the joints.
. Inflammation in the gut (leading to diarrhoea)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide information on the safety of this medicine.
5. How to store Omeprazole
• Keep out of the sight and reach 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 measure will help to protect the environment.
6. Contents of the pack and other 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, Liverpool L30
1RD, UK
This leaflet was last revised in October 2016
336/05