1. What Esomeprazole gastro-resistant tablets are and what they are used for
Esomeprazole gastro-resistant tablets contain a medicine called esomeprazole. This belongs to a group of medicines called "proton pump inhibitors". They work by reducing the amount of acid that your stomach produces.
Esomeprazole gastro-resistant tablets are used to treat the following conditions:
Adults
- "Gastroesophageal 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 stomach or upper part of the gut (intestine) that 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.
- Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti Inflammatory Drugs). Esomeprazole gastro-resistant tablets can also be used to stop stomach ulcers from forming if you are taking NSAIDs.
- Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).
- Prolonged treatment after prevention of rebleeding of ulcers with intravenous esomeprazole.
Adolescents aged 12 years and above
- Gastroesophageal 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 stomach or upper part of the gut (intestine) that 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.
2. What you need to know before you take Esomeprazole gastro-resistant tablets
Do not take Esomeprazole gastro-resistant tablets if:
- You are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine.
- You are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lanzoprazole, rabeprazole, omeprazole).
- You are taking a medicine containing nelfinavir (used to treat HIV infection).
- Do not take Esomeprazole gastro-resistant tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Esomeprazole gastro-resistant tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole gastro-resistant tablets if:
- You have severe liver problems.
- You have severe kidney problems.
- You have ever had a skin reaction after treatment with a medicine similar to Esomeprazole gastro-resistant tablets.
Esomeprazole gastro-resistant tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Esomeprazole gastro-resistant 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).
If you have been prescribed Esomeprazole gastro-resistant tablets "on demand" you should contact your doctor if your symptoms continue or change in character.
If you get a rash on your skin, especially in the areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Esomeprazole gastro-resistant tablets. Remember to also mention any other ill-effects like pain in your joints.
Taking a proton pump inhibitor like Esomeprazole gastro-resistant 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).
Children under the age of 12 years
Esomeprazole gastro-resistant tablets should not be used in children younger than 12 years. More appropriate pharmaceutical forms of esomeprazole may be available.
Other medicines and Esomeprazole gastro-resistant tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines. This includes medicines that you buy without a prescription. This is because Esomeprazole gastro-resistant tablets can affect the way some medicines work and some medicines can have an effect on Esomeprazole gastro-resistant tablets.
Do not take Esomeprazole gastro-resistant 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:
- Atazanavir (used to treat HIV infection).
- Clopidogrel (used to prevent blood clots).
- Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus).
- Erlotinib (used to treat cancer).
- Citalopram, imipramine or clomipramine (used to treat depression).
- 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 Esomeprazole gastro-resistant tablets.
- Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeprazole gastro-resistant tablets.
- Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk which is caused by an insufficient blood supply).
- Cisapride (used for indigestion and heartburn).
- Digoxin (used for heart problems).
- 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 esomeprazole treatment.
- Tacrolimus (organ transplantation).
- Rifampicin (used for treatment of tuberculosis).
- St. John's wort (Hypericum perforatum) (used to treat depression).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Esomeprazole gastro-resistant 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.
Esomeprazole gastro-resistant tablets with food and drink
You can take your tablets 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 doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazole gastro-resistant tablets during this time.
It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole gastro-resistant tablets if you are breast-feeding.
Driving and using machines
Esomeprazole gastro-resistant tablets are not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly or rarely occur. If affected, you should not drive or use machines.
3. How to take Esomeprazole gastro-resistant tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
For acid reflux (GERD)
- To treat inflammation of the food pipe (erosive esophagitis): Take 40 mg once a day for 4 weeks. Your doctor may advise another 4 weeks if your symptoms have not improved.
- To prevent symptoms from coming back: Take 20 mg once a day.
- To relieve symptoms (if no inflammation is present): Take 20 mg once a day. If symptoms do not improve after 4 weeks, contact your doctor. Once symptoms improve, your doctor may advise you to take 20 mg when needed.
For infection caused by Helicobacter pylori (H. pylori)
To treat ulcers and prevent them from coming back, you will take this medicine together with antibiotics:
- 20 mg esomeprazole + 1 g amoxicillin + 500 mg clarithromycin, all taken twice daily for 7 days
If you are taking NSAIDs (painkillers like ibuprofen)
- To treat stomach ulcers: Take 20 mg once daily for 4–8 weeks
- To prevent ulcers: Take 20 mg once daily
After treatment for bleeding stomach ulcers
- Take 40 mg once daily for 4 weeks
For Zollinger-Ellison syndrome (a rare condition causing excess stomach acid)
- Starting dose: 40 mg twice daily
- Your doctor will adjust the dose depending on your needs
- The usual total daily dose is 80–160 mg
Special patient groups
- Elderly (65 years and older): No dose adjustment is needed
- Kidney problems: No dose adjustment is usually needed. Use with caution in severe kidney problems.
- Liver problems: Mild to moderate: no dose change needed. Severe: do not take more than 20 mg per day.
Use in children and adolescents
Adolescents (12 years and older): Same doses as adults for GERD.
For H. pylori infection: Weight 30–40 kg: Esomeprazole 20 mg + appropriate doses of antibiotics taken twice daily for 1 week. Weight over 40 kg: Esomeprazole 20 mg + amoxicillin 1 g + clarithromycin 500 mg taken twice daily for 1 week.
Children under 12 years: This medicine is not recommended for children under 12 years.
How to take this medicine
- Swallow the tablet whole with a glass of water
- Do not chew or crush the tablet
If you take more medicine than you should
Contact your doctor or go to the nearest hospital immediately.
If you forget to take a dose
- Take it as soon as you remember
- If it is almost time for your next dose, skip the missed dose
- Do not take a double dose
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and seek medical help immediately if you notice:
- Swelling of the face, lips, tongue or throat, difficulty breathing (serious allergic reaction)
- Severe skin rash with blistering or peeling
- Yellowing of the skin or eyes (liver problems)
- Severe or persistent diarrhoea
Common (may affect up to 1 in 10 people)
- Headache
- Abdominal pain
- Constipation
- Diarrhoea
- Flatulence
- Nausea or vomiting
- Benign stomach polyps
Uncommon (may affect up to 1 in 100 people)
- Swelling of feet or ankles
- Insomnia
- Dizziness
- Tingling sensation
- Sleepiness
- Vertigo
- Dry mouth
- Rash, itching, hives
- Increased liver enzymes
- Bone fractures (hip, wrist or spine)
Rare (may affect up to 1 in 1,000 people)
- Reduced white blood cells or platelets
- Hypersensitivity reactions (fever, swelling)
- Low sodium levels
- Agitation, confusion, depression
- Taste disturbance
- Blurred vision
- Bronchospasm
- Inflammation of the mouth
- Gastrointestinal fungal infection
- Hair loss
- Photosensitivity
- Joint or muscle pain
- Malaise, increased sweating
Very rare (may affect up to 1 in 10,000 people)
- Severe blood disorders
- Aggression, hallucinations
- Severe liver disease or liver failure
- Severe skin reactions
- Muscle weakness
- Kidney inflammation
- Breast enlargement in men
Not known (frequency cannot be estimated)
- Low magnesium levels (may cause weakness, cramps, confusion)
- Low calcium or potassium levels
- Microscopic colitis (diarrhoea)
- Subacute cutaneous lupus erythematosus
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Esomeprazole gastro-resistant tablets
- Keep this medicine out of the sight and reach of children.
- Store protected from light & moisture, at a temperature not exceeding 30°C.
- Keep this medicine in the original package tightly closed to protect from moisture.
- Do not use this medicine after the expiry date which is stated on the blister and carton 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 to protect the environment.
6. Contents of the pack and other information
What Esomeprazole gastro-resistant tablets contains
- The active substance is esomeprazole.
- Each Enteric Coated Tablet Contains: Esomeprazole Magnesium Trihydrate IP equivalent to Esomeprazole 40 mg
Marketing Authorization Holder
Zorvia Healthcare Limited
Suite 4, 10th Floor, Centaurus, Central Avenue,
Hiranandani Estate, Ghodbunder Road,
Thane West, Maharashtra, India—400607.
