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Introduction About OZOLE CAPSULE
OZOLE CAPSULE contains Omeprazole which belongs to the group of medicines called Proton pump inhibitors. It is used in the management of gastro-oesophageal reflux disease (acid contents in the stomach flows back into the tube connecting your mouth and stomach causing heartburn, nausea, vomiting, bitter taste, discomfort in upper abdomen) in children (above 1 years of age) and adults.
It is used in adults to manage gastric (stomach), duodenal ulcer (upper part of the intestine), ulcers infected with Helicobacter pylori bacteria in addition with antibiotics (including children) and ulcers due to the use of non-steroidal anti-inflammatory drugs (NSAIDs).
Also, it is used in adults to manage Zollinger-Ellison syndrome (increased acid secretion in the stomach due to growth in pancreas resulting in abdominal pain, diarrhoea, gnawing or discomfort in upper abdomen, heartburn, nausea and vomiting).
OZOLE CAPSULE is not recommended for use in patients with history of allergic reactions to omeprazole or any other proton pump inhibitors (Ex. pantoprazole, lansoprazole, rabeprazole and esomeprazole).
Before taking OZOLE CAPSULE, tell your doctor if you have any severe liver problems, weight loss, swallowing problems, stomach pain or indigestion, osteoporosis (condition in which bones become weak and brittle), vitamin B12 deficiency, schedule for specific blood test (chromogranin A).
OZOLE CAPSULE can be used in pregnant and breast-feeding women only if advised by the doctor. OZOLE CAPSULE should be used with caution in elderly patients (aged above 65 years) due to increased risk of fractures.
The most common side effects of taking OZOLE CAPSULE are headache, diarrhoea, stomach pain, constipation and flatulence. Consult your doctor if any of the side effects bothers you.
Uses Of OZOLE CAPSULE
Used in the management of the following conditions:
- gastro-oesophageal reflux disease (in adults and children)
- gastric (stomach) ulcer, duodenal ulcer
- ulcers infected with Helicobacter pylori bacteria in addition with antibiotics (in adults and children)
- ulcers due to non-steroidal anti-inflammatory drugs (NSAIDs)
- Zollinger-Ellison syndrome
How OZOLE CAPSULE Works
OZOLE CAPSULE effectively lowers the amount of acid produced in the stomach by irreversibly binding to and inhibiting the hydrogen-potassium ATPase pump that resides on the lining of the digestive tract. This kind of action helps to reduce vomiting, promote healing of damaged stomach tissue in ulcers.
How to use OZOLE CAPSULE
Take OZOLE CAPSULE as advised by your physician. Swallow OZOLE CAPSULE with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of OZOLE CAPSULE for you depending upon your age, body weight and disease condition.
Side Effects Of OZOLE CAPSULE
Common
- headache
- diarrhoea, stomach pain, constipation, flatulence
- nausea, vomiting
- benign polys in the stomach
Uncommon
- swelling of the feet and ankles
- disturbed sleep (insomnia)
- dizziness, tingling or prickling sensation, feeling sleepy
- spinning feeling (vertigo)
- skin rash, lumpy rash (hives) and itchy skin
- generally feeling unwell and lacking energy
- fracture in the hip, wrist or spine
Rare
- signs of reduced sodium in the blood (weakness, 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
- inflammation inside of the mouth, sore mouth or ulcers
- hair loss (alopecia)
- skin rash on exposure to sunshine
- severe kidney problems (interstitial nephritis)
- joint pains (arthralgia) or muscle pains (myalgia)
- increased sweating
Stop taking OZOLE CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- signs of severe allergic reaction (sudden wheezing, swelling of lips, tongue, throat or body, skin rash, fainting, and difficulty in breathing or swallowing)
- signs of toxic epidermal toxic necrolysis or stevens -johnson syndrome (reddening of the skin with peeling or blisters, also severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
- liver problems (signs include yellowing of skin, dark urine and tiredness)
How To Manage Side Effects
Constipation
Take fiber rich foods in your diet such as fresh fruits, vegetables, whole grain cereals and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom does not improve.
Diarrhea
Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for managing diarrhea. Consult your doctor if the symptom does not improve.
Headache
Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom does not improve.
Nausea And Vomiting
Try to take OZOLE CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor if the symptom does not improve.
Stomach Pain
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-manage on your own and consult your doctor if the symptom does not improve.
Warning & Precautions
Pregnancy
Monitoring requiredOZOLE CAPSULE can be used in pregnant women or women planning for pregnancy only if advised by the doctor. Therefore, consult your doctor for advice before taking OZOLE CAPSULE.
Breastfeeding
Monitoring requiredOZOLE CAPSULE is recommended for use in breastfeeding women only if advised by the doctor. Therefore, consult your doctor for advice before taking OZOLE CAPSULE.
Driving and Using Machines
Use with CautionDo not drive or operate any machines if you experience dizziness and visual disturbances after taking OZOLE CAPSULE.
Liver
Use with CautionOZOLE CAPSULE should be used with caution in patients with severe liver problems. Consult your doctor for advice before taking OZOLE CAPSULE.
Allergy
ContraindicatedDo not take OZOLE CAPSULE if you are allergic to omeprazole or any other proton pump inhibitors (Ex. pantoprazole, lansoprazole, rabeprazole and esomeprazole).
Use In Pediatrics
Use with CautionOZOLE CAPSULE should be used with caution in children and adolescents (above 1 year of age). Your child’s doctor may adjust the dose depending upon child’s age and body weight. Consult your child’s doctor for advice.
Use In Geriatrics
Use with CautionOZOLE CAPSULE should be used with caution in elderly patients (aged above 65 years) due to increased risk of fractures, especially if used in higher doses and over long durations (>1 year). Consult your doctor for advice before taking OZOLE CAPSULE.
Others
Before taking OZOLE CAPSULE, inform your doctor if you:
- lose weight for no reason and have swallowing problems
- have stomach pain or indigestion
- vomit the food regularly or the vomit contains blood
- pass black stools (blood-stained faeces)
- have osteoporosis (condition in which bones become weak and brittle)
- have reduced body stores or risk factors for reduced vitamin B12
- are due to have a specific blood test (chromogranin A)
- are intolerant to certain sugars
Interactions
A. Drug-Drug interactions:
Before taking OZOLE CAPSULE, inform your doctor if you are taking any of the following medicines:
- medicines used in fungal infections (Ex. itraconazole, ketoconazole, posaconazole or voriconazole)
- digoxin (used to manage heart problems)
- diazepam (used to manage anxiety and epilepsy)
- St. John’s wort (used to manage depression)
- medicines used to manage HIV infection (Ex. atazanavir, saquinavir, nelfinavir)
- rifampicin (used to manage tuberculosis)
- phenytoin (used to manage epilepsy)
- tacrolimus (used to manage organ rejection after transplant)
- cilostazol (used to manage intermittent claudication)
- blood thinning medicines (Ex. warfarin, clopidogrel)
- erlotinib, methotrexate (used to manage cancer)
Overdosage:
If you or anyone else accidentally take too much of OZOLE CAPSULE, contact your doctor immediately or go to a hospital straight away. Overdosage symptoms of OZOLE CAPSULE includes nausea or vomiting, feeling dizzy, stomach pain, diarrhoea, headache, lack of interest, feeling depressed and confusion.
Synopsis
| Drug | : | Omeprazole |
| Pharmacological Category | : | Proton pump inhibitors |
| Therapeutic Indication | : | Gastro -oesophageal reflux disease, Stomach and Duodenal ulcer, Zollinger-Ellison syndrome |
| Dosage Forms | : | Tablet, Capsule, Injection, Oral suspension, Powder |
More Information
- Keep OZOLE CAPSULE out of reach of children
- Store at room temperature
FAQs About OZOLE CAPSULE
Q: How does OZOLE CAPSULE work?
A: OZOLE CAPSULE effectively lowers the amount of acid produced in the stomach by irreversibly binding to and inhibiting the hydrogen-potassium ATPase pump that resides on the lining of the digestive tract. This kind of action helps to reduce vomiting, promote healing of damaged stomach tissue in ulcers.
Q: Does OZOLE CAPSULE cause constipation?
A: Yes, OZOLE CAPSULE may cause constipation in some individuals. To manage this effect, take fiber rich foods in your diet such as fresh fruits, vegetables, whole grain cereals and drink plenty of fluids. Exercise more regularly (such as daily walk) and stay active. Consult your doctor if the symptom does not improve.
Q: Can OZOLE CAPSULE be used in elderly patients?
A: OZOLE CAPSULE should be used with caution in elderly patients (aged above 65 years) due to increased risk of fractures, especially if used in higher doses and over long durations (>1 year). Consult your doctor for advice before taking OZOLE CAPSULE.
Q: Can I drive or ride a bike after taking OZOLE CAPSULE?
A: Do not drive or operate any machines if you experience dizziness and visual disturbances after taking OZOLE CAPSULE. Consult your doctor for advice before taking this medicine.
Q: What are the common side effects of OZOLE CAPSULE?
A: The most common side effects of taking OZOLE CAPSULE are headache, diarrhoea, stomach pain, nausea, vomiting, constipation and flatulence. Consult your doctor if any of the side effects bothers you.
References
1. KD. Tripathi. Gastrointestinal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 706.
2. Forgerini, Marcela, Stephania Mieli, and Patrícia de Carvalho Mastroianni. Safety assessment of omeprazole use: a review. Sao Paulo Medical Journal. December 2018. [Accessed on 28th May 2022] https://doi.org/10.1590/1516-3180.2018.0019220318
3. Higuera-de-la-Tijera, Fatima. Efficacy of omeprazole/sodium bicarbonate treatment in gastroesophageal reflux disease: a systematic review. Medwave. Europe PMC. [Revised in March 2018][Accessed on 28th May 2022] https://europepmc.org/article/med/29547594
4. Mylan Hungary Kft. The Health Products Regulatory Authority (HPRA). [Revised in March 2017] [Accessed on 28th May 2022] https://www.hpra.ie/img/uploaded/swedocuments/Leaflet-2191137-11072017125746-636353746685625000.pdf
5. Pharmachemie B.V. Omeprazole capsules. [Revised in June 2021] [Accessed on 28th May 2022] https://products.tevauk.com/mediafile/id/51245.pdf
Useful Diagnostic Tests
- Liver Function Test
- Electrolyte panel
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