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What Refluxend is and what it is used for
Refluxend contains the drug esomeprazole. It belongs to a group of medicines called "proton pump inhibitors". These drugs work by reducing the amount of acid produced by the stomach.
Refluxend is used to treat the following conditions:
Adults and adolescents ages 12 and older
- Gastro-oesophageal reflux disease (GERD) - stomach acid returns to the esophagus (the tube that connects the throat and stomach) and causes pain, inflammation and burning.
- Ulcers in the stomach or upper intestine infected with bacteria called Helicobacter pylori. If you have this condition, your doctor may prescribe antibiotics to treat the infection to allow the ulcer to heal.
- Gastric ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Refluxend can also be used to prevent the formation of gastric ulcers if you are taking NSAIDs.
- Excessive amount of stomach acid caused by pancreatic formation (Zollmger-Ellison syndrome).
- Long-term treatment after therapy to prevent recurrent ulcers with intravenous esomeprazole.
2. What you need to know before you take Reflux
Do not take Reflux
- If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other proton pump inhibitors (eg, pantoprazole, lansoprazole, rabeprazole, omeprazole).
- If you are taking a medicine that contains nelfinavir (used to treat HIV).
Do not take Refluxend if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you start taking Refluxend.
Warnings and precautions
Talk to your doctor or pharmacist before taking REFLUX.
- If you have severe liver problems.
- If you have severe kidney problems.
- If you need a specific blood test (on chromogranin A).
If you have ever experienced skin reactions after treatment with a medicine similar to Refluxend , which reduces the amount of acid produced by the stomach.
If you get a skin rash, especially in areas exposed to the sun, tell your doctor as soon as possible, you may need to stop your reflux treatment. Be sure to mention other adverse effects such as joint pain.
Refluxend may mask the symptoms of other diseases. Therefore, if any of the following happened to you before you start taking Refluxend or it happens while you are taking it, contact your doctor immediately.
- If you have lost weight without cause and have difficulty swallowing.
- If you have stomach pain or indigestion.
- If you start vomiting blood or food.
- If your stools turn black (bloody).
If you are prescribed to take Refluxend as needed, you should contact your doctor if your symptoms persist or change in character.
The use of proton pump inhibitors such as Refluxend, especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. Talk to your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase your risk of developing osteoporosis).
Children under 12 years of age
Glucose-resistant tablets should not be used in children below 12 years of age, as there are no data available. Other pharmaceutical forms of esomeprazole may be available that are more appropriate for this age group (ask your doctor or pharmacist if you require further information).
Other medicines and reflux
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to over-the-counter medicines. This is necessary because REFluxend may affect the action of some medicines, and some medicines may affect the action of Refluxend
Do not take REFLUXEND tablets if you are taking a medicine containing nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Atazanavir (used to treat HIV).
- Clopidogrel (used to treat blood clots)
- Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
- Erlotinib (used to treat cancer).
- Citalopram, imipramine or clomipramine (used to treat depression). Diazepam (used to treat anxiety, muscle relaxation, or epilepsy).
- Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start and stop taking Refluxend.
- Medicines used to thin the blood, such as warfarin. Your doctor may need monitoring when it starts
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin with Refluxend for the treatment of an ulcer caused by Helicobacter pylori infection, it is very important that you be informed of any other medicines you are taking.
Taking Refluxend with food and drink
You can take the tablets with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Your doctor will decide if you can take Refluxend during this time.
It is unknown whether Refluxend passes into breast milk. Therefore, you should not take Refluxend if you are breast-feeding.
Driving and using machines
Refluxend is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur infrequently or infrequently (see section 4). If this happens, you should not drive or operate machinery.
Refluxend contains sucrose, lactose and glucose.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Reflux
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
- If you have been taking this medicine for a long time, your doctor will want to monitor you (especially if you have been taking it for more than a year).
- If your doctor has told you to take this medicine as needed, consult your doctor if your symptoms change.
How to take this medicine
- You can take the tablets at any time of the day.
- You can take the pill with food or on an empty stomach.
- Swallow the tablets whole with some water. Do not chew or crush the tablets. This is necessary because the tablets contain coated pellets that prevent the medicine from breaking down from the acid in the stomach. It is important not to damage the pellets.
What to do if you have difficulty in swallowing the tablets
If you have difficulty in swallowing the tablets
- Put them in a glass of drinking (still) water. Do not use other liquids.
- Stir until the tablet breaks down (the mixture will not be clear). Drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking it.
- To make sure you drink all the medicine, rinse the glass with half a glass of water and drink it. Solids contain the drug - do not chew or crush them.
If you can't swallow at all
The tablet can be mixed with some water and placed in a syringe. In this way, it can be applied directly to the stomach via a tube ("gastric tube").
How much to take
- Your doctor will tell you how many tablets to take and how long to take them.
- It depends on your condition, your age and how your liver works. The usual doses are given below.
For the treatment of acids caused by gastroesophageal reflux disease (GERD)
Adults and children over 12 years
- If your doctor has found that your esophagus is slightly damaged, the usual dose is one 40 mg Refluxend gastro-resistant tablet once a day for 4 weeks. Your doctor may advise you to take the same dose for another 4 weeks if your esophagus has not healed yet.
- When the esophagus heals, the usual dose is a 20 mg Refluxend gastro-resistant tablet once a day.
- If your esophagus is not damaged, the usual dose is a 20 mg Refluxend gastro-resistant tablet every day. When the condition is controlled, your doctor may advise you to take your medicine as needed, but not more than one 20 mg Refluxend gastro-resistant tablet each day.
- If you have severe liver problems, your doctor may give you a lower dose.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence
Adults and adolescents over 12 years
- the usual dose is a 20 mg twice-daily gastro-resistant Refluxend tablet for one week.
- Your doctor will also prescribe antibiotics, such as amoxicillin and clarithromycin.
For the treatment of gastric ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs ^
Adults 18 years and older
- the usual dose is one gastro-resistant 10 mg refluxend tablet once daily for 4 to 8 weeks.
To prevent gastric ulcers if you are taking NSAIDs (non-steroidal anti-inflammatory drugs)
Adults 18 years and older
- the usual dose is a 20 mg Refluxend gastro-resistant tablet once a day.
For the treatment of excessive amount of stomach acid caused by pancreatic formation (Pöllinger-Allison syndrome)
Adults 18 years and older:
- the usual dose is Refluxend 40 mg twice daily.
- Your doctor will determine the dose according to your needs and will
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Refluxend and contact your doctor immediately
- Sudden onset of wheezing, swelling of the lips, tongue and throat or body, rash, nausea or difficulty swallowing (severe allergic reaction).
- Redness of the skin with blisters and flaking. There may also be major blisters and bleeding from the lips, eyes, mouth, nose and genitals. This may be Stevens-Johnson or toxic epidermal necrolysis.
- Skin yellowing, dark urine and fatigue, which can be symptoms of liver problems.
These reactions are rare and can affect less than 1 in 1,000 people.
Other side effects include
Common (may affect less than 1 in 10 people)
- Gastric or intestinal reactions: diarrhea, abdominal pain, constipation, gas (flotation)
- Nausea or vomiting
- Benign gastric polyps
Uncommon (may affect less than 1 in 100 people)
- Swelling of the feet and ankles.
- Disturbed sleep (insomnia).
- Dizziness, numbness and tingling, drowsiness.
- Vertigo (vertigo).
- Dry mouth.
- Changes in blood test results related to liver function.
- Skin rashes, raised rash (nettle fever) and itchy skin.
- Fracture of the hip, wrist or spine (if Refluxend is used in high doses and for a prolonged period).
Rare (may affect less than 1 in 1,000 people)
- Blood problems such as decreased white blood cells or platelets. This can lead to fatigue, bruising or an increased incidence of infection.
- Low levels of sodium in the blood. This can cause fatigue, vomiting and cramps.
- Excitement, confusion or depression.
- Taste disorders.
- Visual problems such as blurred vision.
- Sudden onset of wheezing or shortness of breath (bronchospasm).
- Oral inflammation.
- Inflammation called '' thrush * 1, which can affect the intestines and is caused by fungi.
- Liver problems, including jaundice, which can cause skin yellowing, dark urine and fatigue.
- Hair loss (alopecia).
- Skin rash after sun exposure.
- Joint pain (arthralgia) and muscle pain (myalgia).
- Total malaise and lack of energy.
- Increased sweating.
Very rare (may affect less than 1 in 10,000 people)
- Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
- Seeing, sensing or hearing things that are not real (hallucinations).
- Severe impairment of liver function leading to liver failure and inflammation of the brain.
- Sudden onset of severe rash or blisters or flaking of the skin. This may be accompanied by fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Muscle weakness.
- Severe impaired renal function.
- Male breast enlargement.
Not known (frequency cannot be estimated from available data)
- If you have been taking Refluxend for more than three months, your blood magnesium level may decrease. Low levels of magnesium can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and palpitations. If you experience any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to lower levels of potassium or calcium in the blood. Your doctor may prescribe you regular blood tests to control your magnesium levels.
- Inflammation of the intestine (leading to diarrhea).
- A rash, probably with joint pain.
In very rare cases, Refluxend can affect white blood cells and lead to immune deficiency. If you have an infection with symptoms such as high fever and severely compromised general condition or high fever with symptoms of a local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible so that you can blood test to exclude the absence of white blood cells (agranulocytosis). It is very important that you provide information about the treatment you are currently undergoing.
How to store refluxend
Keep out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton or blister foil after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Refluxend contains
- The active substance is esomeprazole. Each tablet contains 40 mg of esomeprazole as esomeprazole magnesium dihydrate.
- The other ingredients are: hypromellose (3cP & 15cP) (E464), sugar spheres (sucrose 80,0-91,5%, corn starch 8,5-20,0%, glucose, liquid, max. 5,0%, purified water, max 1.5%), talc (E553), methacrylic acid-ethacrylate copolymer (1: 1) 30% dispersion, triethyl citrate (E 1505), macrogol 6000, microcrystalline cellulose (PH 102) (E460) , stearyl alcohol, crospovidone CL-SF (E1202), colloidal anhydrous silica, microceliac 100 (75 parts lactose monohydrate and 25 parts microcrystalline cellulose,), magnesium stearate (E572), titanium dioxide (E171), iron oxide (E171) ), erythrosine aluminum lacquer ( 127), ferric oxide black (E172)
What Refluxend looks like and contents of the pack
REFLUXEND 40 mg gastro-resistant tablets are pink, oblong, biconvex film-coated tablets, with a concave embossed "40" on one side and smooth on the other. The dimensions of the tablet are 19.1 mm x 8.1 mm x 5.8 mm.
Refluxend is available in blisters of 10 (1 x 10), 20 (2 x 10) or 30 (3 x 10) gastro-resistant tablets.
Not all pack sizes may be marketed.
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