Omeprazole 20 Mg Gastro-Resistant Capsules
Out of date information, search anotherPackage leaflet: Information for the patient user
Omeprazole 20 mg gastro-resistant capsules, hard Omeprazole 40 mg gastro-resistant capsules, hard Omeprazole
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Omeprazole Tablets is and what it is 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 other information
1. What Omeprazole Tablets is and what it is 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:
In adults:
• 'Gastro-esophageal reflux disease' (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer or stomach (gastric ulcer).
• Ulcers which are infected with bacteria called 'Helicobacter pylori'. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Omeprazole Tablets can also be used to stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
In children:
Children over 1 year of age and > 10 kg
'Gastro-esophageal reflux disease' (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn. In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.
Children and adolescents over 4 years of age
• Ulcers which are infected with bacteria called 'Helicobacter pylori'. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
2. What you need to know before you take Omeprazole Tablets Do not take Omeprazole Tablets:
• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used for HIV infection)
If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Omeprazole Tablets
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:
• You lose a lot of weight for no reason and have 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 severe liver problems.
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.
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).
Other medicines and Omeprazole Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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:
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole Tablets
• Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole Tablets
• 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))
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.
Omeprazole Tablets with food, drink and alcohol
You can take your gastro-resistant capsules 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 ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Omeprazole Tablets if you are breastfeeding.
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.
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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many gastro-resistant capsules 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.
Adults:
To treat symptoms of GERD such as heartburn and acid regurgitation:
• If your doctor has found that your food pipe (gullet) has been slightly damaged, the usual dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.
• The usual dose once the gullet has healed is 10 mg once a day.
• If your gullet has not been damaged, the usual dose is 10 mg once a day.
To treat ulcers in the upper part of the intestine (duodenal ulcer):
• The usual dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
• If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.
To treat ulcers in the stomach (gastric ulcer):
• The usual dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
• If the ulcer do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming back:
• The usual dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.
To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
• The usual dose is 20 mg once a day for 4-8 weeks.
To prevent duodenal and stomach ulcers if you are taking NSAIDs:
• The usual dose is 20 mg once a day.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• The usual dose is 20 mg Omeprazole Tablets twice a day for one week.
• Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.
To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):
• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.
Use in children:
To treat symptoms of GERD such as heartburn and acid regurgitation:
• Children over 1 year of age and with a body weight of more than 10 kg may take Omeprazole Tablets. The dose for children is based on the child's weight and the doctor will decide the correct dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
• Children aged over 4 years may take Omeprazole Tablets. The dose for children is based on the child's weight and the doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.
Taking this medicine
• It is recommended that you take your gastro-resistant capsules in the morning.
• You can take your gastro-resistant capsules with food or on an empty stomach.
• Swallow your gastro-resistant capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.
What to do if you or your child have trouble swallowing the gastro-resistant capsules
• If you or your child have trouble swallowing the gastro-resistant capsules:
- Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
- To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.
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 capsule dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you noticed any of the following rare but serious side effects, stop taking Omeprazole Tablets 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).
• 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'.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
Side effects may occur with certain frequencies, which are defined as follows:
|
Very common: |
affects more than 1 user in 10 |
|
Common: |
affects 1 to 10 users in 100 |
|
Uncommon: |
affects 1 to 10 users in 1,000 |
|
Rare: |
affects 1 to 10 users in 10,000 |
|
Very rare: |
affects less than 1 user in 10,000 |
|
Not known: |
frequency cannot be estimated from the available data |
Other side effects include:
Common side effects
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as "pins and needles", feeling sleepy.
• Spinning feeling (vertigo).
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Generally feeling unwell and lacking energy.
Rare side effects
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Taste changes.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• Dry mouth.
• An inflammation of the inside of the mouth.
• An infection called "thrush" which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.
Very rare side effects
• Changes in blood count including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and inflammation of the brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlarged breasts in men.
• Hypomagnesaemia
Frequency not known
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 you get any side effects, talk to your doctor, pharmacist or nurse This includes any side effects not listed in this leaflet.
5. How to store Omeprazole Tablets
• 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Omeprazole Tablets contains
- The active substance is omeprazole. Omeprazole Tablets gastro-resistant capsules contain 20 mg or 40 mg of omeprazole.
- The other ingredients are: Sugar spheres; Lactose anhydrous; Sodium lauryl sulphate; disodium phosphate dihydrate; hypromellose, hydroxypropylcellulose, hypromellose Phthalate, ethyl Phthalate, gelatine, indigo carmine (E-132); Quinoline Yellow (E-104) (capsule of Omeprazole Tablets 20 mg) and Erythrosine (E-127) (Capsule of Omeprazole Tablets 40 mg).
What Omeprazole Tablets looks like and contents of the pack
Omeprazole Tablets 20 mg gastro-resistant capsules, have a green body and a green cap.
Omeprazole Tablets 40 mg gastro-resistant capsules have a blue body and a blue cap. Pack sizes:
Omeprazole Tablets 20 mg:
Blisters of 7, 14, 28, 30, 60, 500 gastro-resistant capsules.
Omeprazole Tablets 40 mg:
Blisters of 7, 14, 28, 30, 60, 500 gastro-resistant capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Uquifa - Union Quimico Farmaceutica, S.A.
Calle Mallorca, 262 - 3°
E-08008 Barcelona Spain
+34 934 674 810 (phone)
+34 934 880 491 (fax)
Manufacturer
Industria Qulmica y Farmaceutica Vir, S.A.
C/Laguna, 40-42, Pol. Industrial Urtinsa II 28923 Alcorcon (Madrid)
Espanha
Tel.: 0034 91 4862990 Fax: 0034 91 4862991 E-mail: iqf-Vir@iqf-Vir.es
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Name of the Member State |
Name of the medicinal product |
|
Estonia |
Omeprazole Uqfar 20 mg |
|
France |
Omeprazole Uqfar 20 mg, gelule gastro-resistante |
|
Germany |
Omeprazol Uqfar 20 mg magensaftresistente Kapsel Omeprazol Uqfar 40 mg magensaftresistente Kapsel |
|
Italy |
Omeprazolo Uqfar |
|
Latvia |
Omeprazole Uquifa 20 mg, skrandyje neiri kapsule |
|
Lithuania |
Omeprazole Uqfar 20 mg, skrandyje neirios kietosios kapsules |
|
Poland |
Omeprazole Uquifa |
|
Portugal |
Omeprazol Uqfar |
|
Spain |
Omeprazol Uqfar 20 mg capsulas duras gastrorresistentes Omeprazol Uqfar 40 mg capsulas duras gastrorresistentes |
|
United Kingdom |
Omeprazole 20 mg Gastro-Resistant Capsule, hard Omeprazole 40 mg Gastro-Resistant Capsule, hard |