10 mg, 20 mg and 40 mg hard capsules of
Omeprazole
What Omeprazole Evolan is and what it is used for
Omeprazole Evolan 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 Evolan 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 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.
A gastric ulcer is caused by so-called NSAIDs (Non-steroidal anti-inflammatory drugs). Omeprazole Evolan can also be used to prevent stomach ulcers when you are taking NSAIDs.
• Too much acid in the stomach is 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 Evolan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions and always follow their
What you need to know before you use Omeprazole Evolan
Do not use Omeprazole Evolan
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 medicines containing nelfinavir (used to treat HIV infection ).
Do not take Omeprazole Evolan if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Evolan.
Warnings and cautions
Talk to your doctor or pharmacist before taking Omeprazole Evolan.
Omeprazole Evolan may mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking Omeprazole Evolan or while you are taking them, 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 is associated with a certain increase in infectious diarrhea.
• You have severe liver problems.
If you have ever had a skin reaction after treatment with medicine like Omeprazole Evolan that reduces stomach acid.
• If you are going to have a specific blood test (chromogranin A).
If you are taking Omeprazole Evolan 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 Evolan, and especially if you use Omeprazole Evolan for more than a year, may increase the risk of 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 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 Evolan. 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 Evolan
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 Evolan can affect the way other medicines work and other medicines can affect the effect of Omeprazole Evolan.
Do not take Omeprazole Evolan if you are also taking medicines containing nelfinavir (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, muscle relaxation, or epilepsy ).
• Phenytoin (used in epilepsy ). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole Evolan.
• 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 Evolan.
Rifampicin (used to treat tuberculosis ).
Atazanavir (used to treat HIV infection )
• Tacrolimus (for 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 )
Erlotinib (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 Evolan.
If your doctor has prescribed antibiotics, amoxicillin, and clarithromycin, in combination with Omeprazole Evolan to treat stomach ulcers caused by Helicobacter pylori infection, you must tell your doctor if you are also taking other medicines.
Omeprazole Evolan with food, drink and alcohol
See section 3.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide if you can take Omeprazole Evolan during this 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 Evolan if you are breastfeeding.
Driving and using machines
Omeprazole Evolan is unlikely to affect your ability to drive or handle 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 attention. 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 Evolan contains sucrose
This medicine 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.
How to use Omeprazole Evolan
Always take Omeprazole Evolan 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 usual dose is 20 mg once a day 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 usual dose after the esophagus has healed is 10 mg once a day.
• If your esophagus is not damaged, the usual 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 wound has 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 wound has 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 once a day. Your doctor may increase the dose 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 to 8 weeks.
To prevent duodenal and gastric ulcers if you are taking NSAIDs :
• The recommended dose is 20 mg once daily.
For the treatment of wounds caused by Helicobacter pylori infection and to prevent recurrence of wounds:
The usual dose is 20 mg Omeprazole Evolan 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.
Children:
For the treatment of GERD symptoms such as heartburn and acid reflux :
• Children over 1 year of age and with a bodyweight of more than 10 kg can be treated with Omeprazole Evolan. 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 Evolan. 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
• You should 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. This is because the capsules contain coated granules that prevent the medicine from being broken down by the acid in the stomach. The granules mustn’t be damaged.
What you can do if you or your child have difficulty swallowing the capsules
• If you or your child has difficulty swallowing the capsules:
– Open the capsule and swallow the contents directly with half a glass of water or mix the contents with a small amount of yogurt, some sour fruit juice (eg apple juice, orange juice, or pineapple juice), or apple puree.
– Always stir mixture one before drinking it ( mixture one will not be ready). Then drink the mixture immediately or within 30 minutes.
– To make sure that you have ingested all the medicine, rinse the glass well with half a glass of water and drink it. The solid particles contain the medicine – they must not be chewed or crushed.
If you use more Omeprazole Evolan 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 use Omeprazole Evolan
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 stop using Omeprazole Evolan
Do not stop taking Omeprazole Evolan without talking to your doctor or pharmacist first.
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 cause side effects, although not everybody gets them.
Stop taking Omeprazole Evolan 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 ).
• Reddening 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”.
Yellowed skin, dark urine, and fatigue, which may be symptoms of liver problems.
Other side effects include:
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 in the stomach.
Uncommon side effects ( may affect up to 1 in 100 people)
• Swelling in the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling, drowsiness.
• Vertigo.
• Changes in the blood picture that show the function of the liver.
• Rash, hives, and itching.
• General malaise and lack of energy.
• Wrist, hip, or vertebral fractures (bone fractures).
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 may 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” can affect the gut and be caused by a fungus.
• Liver problems include jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss ( alopecia ).
• Skin rash when sunbathing.
Joint pain ( arthralgia ) or muscle pain ( myalgia ).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.
Very rare side effects ( may affect up to 1 in 10,000 people)
• Changes in blood count 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 Evolan 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.
• Rash, possibly with joint pain
Omeprazole Evolan 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 have information about your medication.
How to store Omeprazole Evolan
• Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, jar, label, or blister after EXP. The expiration date is the last day of the specified month. HDPE can: 10 / 40mg: Use within 100 days after opening.
• HDPE 20mg can: Use within 105 days of opening.
Store below 25 ° C
• Store the blister in the original packaging or close the jar tightly. Moisture sensitive. Press the lid firmly into place after use.
• Medicines should not be disposed of via wastewater or household waste. Ask the pharmacy staff how to dispose of medicines. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is omeprazole. Each capsule contains 10 mg, 20 mg or 40 mg of omeprazole.
– The other ingredients are:
Capsule content: spherical sugar granules (consisting of maize starch), sodium lauryl sulfate, anhydrous disodium phosphate, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethyl acrylate 1 copolymer (1: 1).
Capsule shell: Gelatin. The 10 and 20 mg capsules also contain the dyes quinoline yellow (E104) and titanium dioxide (E171). The 40 mg capsules contain indigo carmine (E132) and titanium dioxide (E171).
What the medicine looks like and contents of the pack
Omeprazole Evolan 10 mg: Opaque yellow capsule containing off-white to off-white round granules.
Omeprazole Evolan 20 mg: Opaque yellow capsule containing off-white to off-white round granules.
• Omeprazole Evolan 40 mg: Opaque blue and an opaque white capsule containing off-white to off-white round granules.
Pack sizes:
• 10 mg :
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140 or 280 capsules; hospital pack of 500 capsules.
HDPE cans with 5, 7, 14, 15, 28, 30, 50, 56, 60, 90 or 100 capsules, 200 (2×100) capsules (for dose dispensing).
• 20 mg:
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140 or 280 capsules; hospital pack of 500 capsules.
HDPE cans with 5, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100 or 105 capsules, 500 capsules (for dose dispensing).
• 40 mg :
Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140 or 280 capsules; hospital pack of 500 capsules.
HDPE cans with 5, 7, 14, 15, 28, 30, 50, 56, 60, 90 or 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Evolan Pharma AB
SE-Box 120
Danderyd
Manufacturer
LICONSA LABORATORIES, SA
Of. Miralcampo, No. 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN