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OMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES HARD - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - OMEPRAZOLE 40 MG GASTRO-RESISTANT CAPSULES HARD

What is in this leaflet

  • 1. What Omeprazole is and what it is used for

  • 2. What you need to know before you take Omeprazole

  • 3. How to take Omeprazole

  • 4. Possible side effects

  • 5. How to store Omeprazole

  • 6. Contents of the pack and other information

  • 1. What Omeprazole is and what it is used

Omeprazole contains the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Omeprazole is used to treat the following conditions:

In adults:

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

2. what you need to know before you take omeprazole

Do not take Omeprazole

Taking a proton pump inhibitor like , 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).

Your doctor will decide whether you can take Omeprazole if you are breastfeeding.

Driving and using machines

Omeprazole 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 (see section 4). If affected, you should not drive or operate machinery.

Omeprazole 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.

3. how to take omeprazole

Always take Omeprazole exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many capsules to take and how long to take them for. This will depend on your condition and how old you are.

The recommended dose is:

Adults :

To treat symptoms of GERD such as heartburn and acid regurgitation :

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Omeprazole and contact a doctor immediately:

Uncommon side effects

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store omeprazole

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, bottle, label or blister after “EXP:”. The expiry date refers to the last day of that month. HDPE bottle: Use within 100 days after first opening.

Store below 25

Store this blister in the original package or keep the bottle tightly closed in order to protect from moisture. Replace cap firmly after use.

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 Omeprazole 40 mg gastro-resistant capsules contains:

  • – The active substance is omeprazole. Each capsule contains 40 mg of omeprazole.

  • – The other ingredients are:

  • Capsule content: sugar spheres (consisting of corn starch and sucrose), sodium laurilsulfate, Disodium phosphate, anhydrous, mannitol, hypromellose 6 cP, macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), and methacrylic acid-ethylacrylate copolymer (1:1).
  • Capsule shell: gelatine, the colouring agent indigo carmine (E 132) and titanium dioxide (E 171).

What Omeprazole 40 mg gastro-resistant capsules looks like and contents of the pack

Opaque blue and opaque white capsule containing off-white to cream white spherical microgranules.

Pack sizes:

Blisters of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 140 or 280 capsules; hospital pack of 500 capsules.

HDPE bottles of 5, 7, 14, 15, 28, 30, 50, 56, 60, 90 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder: Laboratorios Liconsa S.A.

C/Dulcinea S/N

28805 Alcala de Henares

Madrid Spain

Manufacturer LABORATORIOS LICONSA, S.A.

Av. Miralcampo, N° 7, Poiigono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara)

SPAIN

This leaflet was last revised in March 2020.

8/8

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A02 DRUGS FOR ACID RELATED DISORDERS

A02B DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

A02BC Proton pump inhibitors for peptic ulcer and GORD

A02BC01 omeprazole

Frequently Asked Questions

What are the common uses of Omeprazole 40 mg capsules?

Omeprazole 40 mg gastro-resistant capsules are commonly used to treat conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome.

How should I take Omeprazole 40 mg capsules?

You should take Omeprazole 40 mg capsules as directed by your doctor, typically once daily before a meal, preferably in the morning.

Are there any dietary restrictions while taking Omeprazole?

While taking Omeprazole, it is best to avoid spicy foods, citrus fruits, and caffeine that may aggravate your condition.

Can I take Omeprazole with other medications?

It’s important to discuss all your current medications with your doctor, as some can interact with Omeprazole.

What should I do if I miss a dose of Omeprazole?

If you miss a dose of Omeprazole, take it as soon as you remember. If it's almost time for your next dose, skip the missed one and resume your schedule.

Are there any side effects associated with Omeprazole?

Common side effects may include headache, nausea, diarrhea, or abdominal pain. Consult your doctor if you experience severe side effects.

How long can I safely take Omeprazole 40 mg capsules?

Long-term use of Omeprazole should be monitored by a healthcare professional. It’s important to follow their advice on duration.

Can pregnant women take Omeprazole?

Pregnant women should consult their healthcare provider before taking Omeprazole to weigh the benefits and risks.

Can I crush or chew the capsules?

No, you should swallow Omeprazole capsules whole; crushing or chewing them can affect their effectiveness.

What happens if I overdose on Omeprazole?

In case of an overdose, seek immediate medical attention. Symptoms may include confusion or drowsiness.

Is there a risk of dependence on Omeprazole?

Omeprazole is not known to cause physical dependence; however, long-term use may lead to rebound acid production when discontinued.

Can children take Omeprazole 40 mg capsules?

Omeprazole can be prescribed for children in certain conditions but always under strict medical supervision.

How does stress affect my condition while taking Omeprazole?

Stress can worsen gastrointestinal symptoms. It’s advisable to manage stress through relaxation techniques while on medication.

Will using antacids interfere with my Omeprazole treatment?

Antacids can be taken while on Omeprazole but they should be spaced out; check with your doctor for specific recommendations.

Can alcohol consumption affect the efficacy of Omeprazole?

It’s best to limit alcohol intake while taking Omeprazole as it may aggravate gastrointestinal issues.

Does smoking affect how well Omeprazole works?

Yes, smoking can reduce the effectiveness of acid-reducing medications like Omeprazole. Consider quitting for better results.

What lifestyle changes can help while taking Omeprazole?

Eating smaller meals, avoiding trigger foods, losing weight if overweight, and keeping upright after meals can help improve symptoms.

Is it safe to stop taking Omeprazole suddenly?

Consult your healthcare provider before stopping; they may suggest tapering off to avoid rebound symptoms.

How does Omeprazole interact with food and drink?

Omeprazole is best absorbed on an empty stomach; therefore, take it at least 30 minutes before meals for optimal effects.

What should I do if my symptoms don’t improve after taking Omeprazole?

If symptoms persist after several weeks of treatment with Omeprazole, consult your doctor for further evaluation and possible adjustments in treatment.