10 mg, 20 mg, 40 mg hard enteric capsules
omeprazole
What Omeprazole Actavis is and what it is used for
Omeprazole Actavis contains the drug substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These work by reducing the amount of acid produced in the stomach.
Omeprazole Actavis is used to treat the following conditions:
Adults:
- Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation and heartburn / heartburn.
- Ulcers in the duodenum ( duodenal ulcer ) or in the stomach ( gastric ulcer ).
- Wounds that are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
- Gastric ulcer caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Omeprazole Actavis can also be used to prevent stomach ulcers when you are taking NSAIDs .
- Too much acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
Children:
Children over 1 year and ≥ 10 kg
- Gastroesophageal reflux disease ( GERD ). This is when acid from the stomach leaks into the esophagus (the connection between the mouth and the stomach) and causes pain, inflammation and heartburn / heartburn.
- In children, symptoms may include vomiting of stomach contents into the mouth, vomiting and decreased weight gain.
Children and adolescents over 4 years
- Wounds that are infected by a bacterium called ” Helicobacter pylori “. If you have such wounds, your doctor may also prescribe antibiotics to treat the infection and to allow wound healing.
Omeprazole contained in Omeprazole Actavis may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Omeprazole Actavis
Do not use Omeprazole Actavis
- 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 (for example pantoprazole, lansoprazole, rabeprazole, esomeprazole).
- if you are taking medicines containing nelfinavir (used to treat HIV infection ).
If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Actavis.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Omeprazole Actavis.
Omeprazole Actavis can mask the symptoms of other diseases. Therefore, if any of the following occur before you take Omeprazole Actavis or while you are taking it, contact your doctor immediately:
- You lose a lot of weight for no reason and have trouble swallowing.
- You get stomach pains or indigestion.
- You start vomiting food or blood.
- You get black (blood-mixed) stools.
- You get severe or persistent diarrhea, as omeprazole has been shown to be associated with a certain increase in infectious diarrhea.
- You have severe liver problems.
- Have you ever had a skin reaction after treatment with a medicine like Omeprazol Actavis that reduces stomach acid.
- You must undergo a specific blood test (chromogranin A).
If you are taking Omeprazole Actavis for a long time (over a year), your doctor will probably check you regularly. You should discuss any new or unusual symptoms and circumstances with your doctor.
Using proton pump inhibitors such as Omeprazole Actavis and especially if you use Omeprazole Actavis for more than a year may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
If you are taking Omeprazole Actavis for a long time (over a year), your doctor will probably check you regularly. You should discuss any new or unusual symptoms and circumstances with your doctor.
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Omeprazole Actavis. Also remember to mention any other side effects, such as joint pain.
Children
Some children with chronic illnesses may need long-term treatment, although it is not recommended. Do not give this medicine to children under one year of age or under 10 kg.
Other medicines and Omeprazole Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Omeprazole Actavis can affect the way other medicines work and other medicines can affect the effect of Omeprazole Actavis.
Do not take Omeprazole Actavis if you are also taking nelfinavir-containing medicines (used to treat HIV infection ).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Ketoconazole , itraconazole, posaconazole or voriconazole (used to treat fungal infections).
- Digoxin (used to treat heart problems)
- Diazepam (used to treat anxiety, for muscle relaxation or for epilepsy ).
- Phenytoin (used in epilepsy ). If you are taking phenytoin , your doctor will need to monitor you when you start or stop taking Omeprazole Actavis.
- Drugs used for blood thinning, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeprazole Actavis.
- Rifampicin (used to treat tuberculosis ).
- Atazanavir (used to treat HIV infection )
- Tacrolimus (in organ transplantation).
- St. John’s wort ( Hypericum perforatum ) (used to treat mild depression)
- Cilostazol (used to treat “peephole”)
- Sakvinavir (used to treat HIV infection )
- Clopidogrel (used to prevent blood clots ( thrombosis )
- Erlonitinib (used to treat cancer)
- Methotrexate (a chemotherapeutic drug used in high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily discontinue your treatment with Omeprazole Actavis.
If your doctor has prescribed antibiotics, amoxicillin, and clarithromycin, in combination with Omeprazole Actavis for the treatment of stomach ulcers caused by Helicobacter pylori infection, you must tell your doctor if you are also taking other medicines.
Omeprazole Actavis with food and drink
See section 3 ‘How to take Omeprazole Actavis’.
Pregnancy and breastfeeding
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. Your doctor will decide if you can take Omeprazole Actavis during that time.
Omeprazole passes into breast milk, but it is unlikely that the baby will be affected at the recommended dose. Your doctor will decide if you can take Omeprazole Actavis if you are breastfeeding.
Driving and using machines
Omeprazole Actavis is unlikely to affect your ability to drive or use tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If you are affected by these symptoms, you should not drive or operate machinery.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Omeprazole Actavis contains sucrose and sodium
Omeprazole Actavis contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Omeprazole Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How to take Omeprazole Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will tell you how many capsules to take and how long to take them. Dosage one depends on your condition and how old you are.
The recommended dose is listed below.
Adults :
For the treatment of symptoms of heartburn and acid reflux caused by gastroesophageal reflux disease ( GERD ):
- If your doctor has found that your esophagus is slightly damaged, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may recommend that you take a dose of 40 mg for another 8 weeks if the damage to your esophagus is not healed.
- The recommended dose after the esophagus has healed is 10 mg once daily.
- If your esophagus is not damaged, the recommended dose is 10 mg once a day.
For the treatment of duodenal ulcers ( duodenal ulcers ) :
- The recommended dose is 20 mg once daily for 2 weeks. Your doctor may recommend that you take the same dose for another 2 weeks if the wound has not healed.
- If the wounds have not healed completely, the dose can be increased to 40 mg once daily for 4 weeks.
For the treatment of ulcers in the stomach ( gastric ulcer ):
- The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend that you take the same dose for another 4 weeks if the wound has not healed.
- If the wounds have not healed completely, the dose can be increased to 40 mg once daily for 8 weeks.
To prevent recurrence of duodenal and gastric ulcers :
- The recommended dose is 10 or 20 mg capsules once daily. Your doctor may increase the dose from one to 40 mg once a day.
For the treatment of stomach ulcers caused by NSAIDs (Non-steroidal anti-inflammatory drugs):
- The recommended dose is 20 mg once daily for 4-8 weeks.
To prevent duodenal and gastric ulcers if you are taking NSAIDs :
- The usual dose is 20 mg once a day.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- The recommended dose is 20 mg omeprazole twice daily for 1 week.
- Your doctor will also recommend that you take two antibiotics of amoxicillin, clarithromycin and metronidazole.
For the treatment of excess acid in the stomach caused by a tumor of the pancreas (Zollinger-Ellison syndrome) :
- The recommended dose is 60 mg daily.
- Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.
Use for children and adolescents:
For the treatment of GERD symptoms such as heartburn and acid reflux :
- Children over 1 year of age and with a body weight of more than 10 kg can be treated with Omeprazole Actavis. Dosage one is based on the weight of the child and the correct dose one is decided by the doctor.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
- Children over 4 years of age can be treated with Omeprazole Actavis. Dosage one is based on the weight of the child and the correct dose one is decided by the doctor.
- Your doctor will also prescribe two antibiotics for your child, amoxicillin and clarithromycin.
Taking the medicine
- It is recommended that you take the capsules in the morning.
- You can take the capsules with food or on an empty stomach.
- Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. The capsules contain film-coated granules that prevent the medicine from being broken down by the stomach acid in your stomach. It is important not to damage the granules.
What you can do if you or your child have difficulty swallowing the capsules
If you or your child has difficulty swallowing the capsule:
- Open the capsule and swallow the contents directly with half a glass of water or pour the contents into a glass of water (not carbonated), a sour fruit juice (eg apple, orange or pineapple) or apple puree.
- Drink the mixture immediately or within 30 minutes. Always mix immediately before drinking ( mix one will not be ready).
- To make sure you have drunk everything, rinse the glass thoroughly with half a glass of water and drink up. The film-coated grains do not contain the medicine, do not chew or crush them.
If you take more Omeprazole Actavis than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Omeprazole Actavis
If you forget to take a dose, take it as soon as you notice it. If it is near the time of 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, pharmacist, or nurse.
If you stop taking Omeprazole Actavis
Do not stop taking Omeprazole Actavis without first consulting your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Omeprazole Actavis and contact your doctor immediately, if you notice any of the following unusual but serious side effects:
- Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing (severe allergic reaction ).
- Redness of the skin with blistering or flaking. Severe blistering and bleeding on the lips, eyes, mouth, nose and genitals may also occur. This can be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
- Yellowing skin, dark urine and fatigue, which can be symptoms of liver problems.
Additional side effects:
Common side effects (may affect up to 1 in 10 people)
- Headache.
- Effects on the stomach or intestines: diarrhea, abdominal pain, constipation, flatulence (flatulence).
- Nausea or vomiting.
- Benign polyps are in the stomach
Uncommon side effects (may affect up to 1 in 100 people)
- Swelling of the feet and ankles.
- Sleep disorders (insomnia).
- Dizziness, tingling, drowsiness.
- Scams ( vertigo ).
- Changes in the blood picture that show the function of the liver.
- Skin rash, hives and itching .
- General malaise and lack of energy.
- Hip, wrist or vertebral fractures (if Omeprazole Actavis is used in high doses and for a long time).
Rare side effects (may affect up to 1 in 1,000 people)
- Altered blood count such as reduced number of white blood cells or platelets . This can cause weakness, bruising or susceptibility to infection.
- Allergic reactions, sometimes very severe, such as swelling of the lips, tongue and throat, fever, wheezing.
- Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
- Feeling of agitation, confusion or depression.
- Taste changes.
- Vision problems, such as blurred vision.
- Sudden wheezing or shortness of breath ( bronchospasm ).
- Dry mouth .
- Inflammation of the oral cavity.
- A fungal infection called “cod” that can affect the gut and is caused by a fungus.
- Liver problems including jaundice, which can cause yellowing skin, dark urine and fatigue.
- Hair loss ( alopecia ).
- Skin rash when sunbathing.
- Joint pain ( arthralgia ) or muscle pain ( myalgia ).
- Severe kidney problems (interstitial nephritis, which can lead to kidney failure ).
- Increased sweating.
Very rare side effects (may affect up to 1 in 10,000 people)
- Changes in the blood picture including agranulocytosis (lack of white blood cells ).
- Aggression.
- Hallucinations (seeing, feeling or hearing things that do not exist).
- Severe liver problems leading to liver failure and encephalitis.
- Sudden onset of severe rash, blistering or flaky skin. This may be associated with high fever and joint pain (Erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis ).
- Muscle weakness.
- Enlargement of the mammary glands in men.
Has been reported (occurs in an unknown number of users)
- Inflammation of the intestine (which causes diarrhea)
- If you use Omeprazole Actavis for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
- Skin rash, possibly with joint pain
Omeprazole Actavis can in very rare cases affect the white blood cells so that the immune system is weakened. If you get an infection with symptoms such as fever and severe general malaise or fever with symptoms of local infection such as pain in the neck, throat, or mouth or difficulty urinating, you must contact a doctor as soon as possible so that any lack of white blood cells ( agranulocytosis ) can be excluded by a blood test. It is important that you then information about your medicine.
How to store Omeprazole Actavis
Keep out of sight and reach of children.
Capsule jar: Do not store above 30 ° C. Close the package tightly. Moisture sensitive.
Blister pack: Do not store above 25 ° C. Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the label, carton, and blister after “EXP”: “EXP”. The expiration date is the last day of the specified month.
The medicine 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.
Contents of the pack and other information
Content declaration
The active substance is omeprazole. One capsule contains 10 mg, 20 mg, and 40 mg omeprazole respectively.
The other ingredients are sugar spheres (sucrose, maize starch, water), methacrylic acid-methyl methacrylate copolymer (1: 1), dispersion, hypromellose, talc, mannitol, macrogol 6000, titanium dioxide (E171), polysorbate 80, disodium phosphate, anhydrous sodium sulfate, anhydrous sulfate.
Capsule capsules (10 mg and 20 mg): gelatin, water, titanium dioxide (E171), quinoline yellow (E104).
Capsule shell (40 mg): gelatin, water, titanium dioxide (E171), indigo carmine (E132).
What the medicine looks like and contents of the pack
10 mg: opaque yellow capsule
20 mg: opaque yellow capsule
40 mg: opaque blue and white capsule
The capsules contain off-white to creamy white round micro granules.
Pack sizes
Blister pack: 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140, 280, and 500 capsules
Capsule jar: 7, 14, 28, 30, 56, 60, 90, 100 and 500 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
LICONSA LABORATORIES, SA
Avda Miralcampo, Nº 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (GUADALAJARA)
Spain
MPF BV (Manufacturing Packaging Farmacia)
Neptune 12
8448 CN Heerenveen
Netherlands
MPF BV (Manufacturing Packaging Farmacia)
Appelhof 13
8465 RX Oudehaske
Netherlands