Patient Leaflet Updated 27-Sep-2018 | Dexcel Pharma Ltd
Omeprazole 10mg, 20mg, 40mg Gastro Resistant Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
OMEPRAZOLE 10mg / 20mg / 40mg GASTRO-RESISTANT TABLETS
(Referred to as Omeprazole tablets throughout this leaflet)
Read all of this leaflet carefully before you start taking this medicine.
What is in this leaflet:
1. What Omeprazole tablets are and what they are used for
2. What you need to know before you take Omeprazole tablets
3. How to take Omeprazole tablets
4. Possible side effects
5. How to store Omeprazole tablets
6. Contents of the pack and otherinformation
1. WHAT OMEPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Omeprazole tablets contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
Omeprazole tablets is used to treat the following conditions:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE TABLETS
Do not take Omeprazole tablets
Do not take Omeprazole tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole tablets.
Warnings and precautions
Tell your doctor before taking this medicine, if:
Omeprazole tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole tablets or while you are taking it, talk to your doctor straight away:
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 tablets. Remember to also mention any other ill-effects like pain in your joints.
Omeprazole may reduce magnesium level in blood, especially if you are taking it for more than 3 months; Talk to your doctor if you are taking Digoxin or water tablets, as they may increase the risk of low magnesium level.
Taking a proton pump inhibitor like Omeprazole tablets, 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 the risk of osteoporosis).
If you take Omeprazole tablets 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.
Other medicines and Omeprazole tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Omeprazole tablets can affect the way some medicines work and some medicines can have an effect on Omeprazole tablets.
Do not take Omeprazole tablets 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 medicines:
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeprazole tablets to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Taking Omeprazole tablets with food and drink:
You can take your tablets with food or on an empty stomach.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may 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 tablets if you are breast-feeding.
Driving and using machines:
Omeprazole tablets is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.
Important information about some of the ingredients of Omeprazole tablets:
Omeprazole tablets contain lactose. 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 TABLETS
Always take Omeprazole tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many tablets to take and how long to take them for. This will depend on your condition and how old you are.
The recommended doses are given below.
To treat symptoms of GORD such as heartburn and acid regurgitation:
To treat ulcers in the upper part of the intestine (duodenal ulcer):
To treat ulcers in the stomach (gastric ulcer):
To prevent the duodenal and stomach ulcers from coming back:
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
This formulation is not suitable for children.
Taking this medicine
If you take more Omeprazole tablets than you should
If you take more Omeprazole tablets than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Omeprazole tablets
If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole tablets can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking Omeprazole tablets and contact a doctor immediately:
Other side effects include:
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects ( may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not Known (Frequency cannot be estimated from the available data)
If you are on Omeprazole tablets 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.
Omeprazole tablets may in very rare cases affect the white blood cells leading to immune deficiency.
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.
Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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 directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE OMEPRAZOLE TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Omeprazole tablets contains
The active substance is omeprazole. Omeprazole tablets contain 10 mg, 20 mg and 40mg of omeprazole. The other ingredients are lactose monohydrate, sodium starch glycolate, sodium stearyl fumarate, sodium stearate, hypromellose acetate succinate, brownish pink colour [contains propylene glycol, titanium dioxide (E171), red iron oxide (E172), hypromellose and yellow iron oxide (E172)], talc, triethyl citrate, monoethanolamine, sodium laurilsulfate and traces of carnauba wax.
What Omeprazole tablets looks like and contents of the pack
1. Omeprazole 10 mg gastro-resistant tablets are brownish-pink film coated capsule shaped tablets. Blisters of 28 tablets
2. Omeprazole 20 mg gastro-resistant tablets are brownish-pink film coated capsule shaped tablets. Blisters of 28 tablets
3. Omeprazole 40 mg gastro-resistant tablets are brownish-pink film coated capsule shaped tablets. Blisters of 7, 28 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
This leaflet was last revised in June 2018.
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
+44 (0)1327 312 266
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+44 (0) 1748 828 784
+44 (0) 1748 828 784