Active ingredient
- omeprazole
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0217.
Omeprazole 40mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Omeprazole 40mg Capsules
Omeprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Omeprazole 40mg Capsules are and what they are used for
2. What you need to know before you take Omeprazole 40mg Capsules
3. How to take Omeprazole 40mg Capsules
4. Possible side effects
5. How to store Omeprazole 40mg Capsules
6. Contents of the pack and other information
1. What Omeprazole 40mg Capsules are and what they are used for
Omeprazole 40 mg Capsules contain 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 40mg Capsules are used to treat the following conditions:
In adults:
In children:
Children over 1 year of age and ≥ 10 kg
Children and adolescents over 4 years of age
2. What you need to know before you take Omeprazole 40mg Capsules
Do not take Omeprazole 40mg Capsules:
Warnings and precautions
Omeprazole may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeprazole 40mg Capsules or while you are taking them, talk to your doctor straight away:
Taking a proton pump inhibitor 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 the risk of osteoporosis).
If you take Omeprazole 40mg Capsules 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.
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.
Tell your doctor before taking this medicine if you are due to have a specific blood test (Chromogranin A).
Other medicines and Omeprazole 40mg Capsules
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Omeprazole 40mg Capsules can affect the way some medicines work and some medicines can have an effect on Omeprazole 40mg Capsules.
Do not take Omeprazole 40mg Capsules 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 40mg Capsules to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
Omeprazole 40mg Capsules with food and drink
You can take your capsules with food or on an empty stomach.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, 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 40mg Capsules if you are breast-feeding.
Driving and using machines
Omeprazole 40mg Capsules 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.
3. How to take Omeprazole 40mg Capsules
Always take this medicine 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 capsules to take, and how long to take them for. This will depend on your condition and how old you are. The usual doses are given below.
Adults:
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):
Use in Children:
To treat symptoms of GORD such as heartburn and acid regurgitation:
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
Taking this medicine
What to do if you or your child have trouble swallowing the capsules
If you or your child have trouble swallowing the capsules:
If you take more Omeprazole 40mg Capsules than you should
If you take more Omeprazole 40mg Capsules than prescribed by your doctor, talk to your doctor or pharmacist straight away.
If you forget to take Omeprazole 40mg Capsules
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, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects stop taking Omeprazole Capsules 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 (cannot be estimated from the available data)
Omeprazole 40mg Capsules 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.
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 affects you can help provide more information on the safety of this medicine.
5. How to store Omeprazole 40mg Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store this blister in the original package.
Do not throw away any medicines 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. Contents of the pack and other information
What Omeprazole 40mg Capsules contain
The active substance is omeprazole. Omeprazole 40mg Capsules contain 40 mg of omeprazole.
The other ingredients are mannitol, crospovidone, hypromellose, poloxamer, meglumine, povidone, methacrylic acid ethyl acrylate copolymer, triethyl citrate and magnesium stearate.
What Omeprazole 40mg Capsules look like and contents of the pack
The granules are supplied in a hard gelatin capsule shell with a yellow cap and purple body. Each capsule is printed with ‘R159 Omeprazole 40mg’ in black ink.
The capsule shell is composed of gelatin, titanium dioxide E171, erythrosine E127, patent blue V E131 and yellow iron oxide E172.
The printing ink is composed of shellac glaze, black iron oxide E172, propylene glycol and ammonium hydroxide.
Omeprazole 40mg Capsules are supplied in boxes containing 7, 14 or 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Omeprazole 40mg Capsules,
PL 08553/0217
Date of preparation: 01/2017
© Dr. Reddy’s Laboratories (UK) Ltd
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