el-GRen-US

 

Name of the medicinal product: SIERAL

Content: Each gastro-resistant capsule contains 20 mg of omeprazole.

Pharmaceutical Form: Gastro-resistant capsules, hard

Pharmacotherapeutic group: Proton pump inhibitors

Packaging Description: Paper Carton containing 30 capsules placed in plastic bottle HDPE.

SIERAL belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.
SIERAL 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 intestines (duodenal ulcer) or stomach (gastric ulcer).
  • Ulcers which are also infected with a 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). SIERAL 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).
Children over 1 year of age and ≥ 10kg:
  • ‘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.
Do not take SIERAL if you:
  • Are allergic to omeprazole or any of the other ingredients of this medicine.
  • Are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
  • Are taking a medicine containing nelfinavir (used for HIV infection).
If you are not sure, talk to your doctor or pharmacist before taking SIERAL.

Warnings and Precautions
SIERAL may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking SIERAL, or whilst you are taking it, talk to your doctor or pharmacist:
  • 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 feces).
  • You experience severe or persistent diarrhea, as omeprazole has been associated with a small increase in infectious diarrhea
  • You have severe liver problems
  • You are due to have a specific blood test (Chromogranin A).
If you take SIERAL 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 SIERAL, 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 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 a pain in your joints.

Other medicines and SIERAL
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because SIERAL can affect the way some medicines work and some medicines can have an effect on SIERAL.

Do not take SIERAL if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:
  • Ketoconazole, itraconazole, posaconazole 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 SIERAL.
  • 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 SIERAL.
  • Rifampicin (used to treat tuberculosis).
  • Atazanavir (used to treat HIV infections).
  • Tacrolimus (in cases of organ transplantation).
  • St John’s Wort (Hypericum perforatum) (used to treat mild depression).
  • Cilostazol (used to treat intermittent claudication).
  • Saquinavir (to treat HIV infections).
  • Clopidogrel (used to prevent blood clots (thrombi)).
  • Erlotinib (used to treat different types of cancer).
  • • Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your SIERAL treatment.
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as SIERAL to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.
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 whether you can take SIERAL if you are breastfeeding.
Driving and using machines
SIERAL 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. If affected, you should not drive or operate machinery.

Important information about some of the ingredients of SIERAL
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 medicinal product.
Like all medicines, SIERAL can cause side effects, although not everybody gets them.
If you notice any of the following rare but serious side effects, stop taking SIERAL and contact your doctor immediately:
  • Sudden wheezing, swelling of the 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 bleed in the lips, eyes, mouth, nose, and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’.
  • Severe liver problems leading to liver failure and inflammation of the brain. Symptoms include jaundice which can cause yellow skin, dark urine and tiredness.

Other side-effects include:

Common side effects (may affect up to 1 in 10 people): • Headache. • Effects on your stomach or gut: diarrhea, stomach pain, constipation, wind (flatulence), benign polyps in the stomach. • Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects (may affect up to 1 in 100 people): • 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. • Fracture of the hip, wrist or spine.

Rare side effects (may affect up to 1 in 1000 people): • Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely. • 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 pain (arthralgia) or muscle pains (myalgia). • Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people): • Aggression. • Seeing, feeling or hearing things that are not there (hallucinations). • Sudden onset of severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiform). • Muscle weakness. • Enlarged breasts in men.

Not known side effects (frequency cannot be estimated from the available data): • Inflammation of the gut (leading to diarrhea). • If you are on omeprazole 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.

Do not be concerned by this list of possible side-effects. You may not get any of them.

What SIERAL contains:
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 carton or label after “EXP”. The expiry date refers to the last day of that month.
HDPE bottle: Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.