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OMEPRAZOLE 10 MG GASTRO-RESISTANT CAPSULES HARD - Patient leaflet, side effects, dosage

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

Patient leaflet - OMEPRAZOLE 10 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 for

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

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 10 mg gastro-resistant capsules contains:

  • – The active substance is omeprazole. Each capsule contains 10 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 agents quinoline yellow (E 104) and titanium dioxide (E 171).

What Omeprazole 10 mg gastro-resistant capsules looks like and contents of the pack

Opaque yellow 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, MadridSPAIN

Manufacturer LABORATORIOS LICONSA, S.A.

Av. Miralcampo, N° 7, Poligono 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 is Omeprazole 10 mg used for?

Omeprazole 10 mg is used to treat conditions where your stomach produces too much acid, such as gastroesophageal reflux disease (GERD) and peptic ulcers.

How should I take Omeprazole 10 mg capsules?

Take Omeprazole 10 mg capsules exactly as prescribed by your doctor. Swallow the capsule whole with water, preferably before a meal.

Can I take Omeprazole 10 mg with food?

Yes, you can take Omeprazole with or without food. However, taking it before meals may help it work better.

Are there any common side effects of taking Omeprazole 10 mg?

Common side effects may include headache, nausea, vomiting, diarrhea, constipation, and abdominal pain. If these persist or worsen, contact your doctor.

Can I take Omeprazole if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult your doctor before taking Omeprazole to ensure it is safe for you.

How long can I take Omeprazole 10 mg?

Your doctor will determine the duration based on your condition. Do not take it longer than prescribed without consulting your doctor.

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

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

Can I drink alcohol while taking Omeprazole 10 mg?

It's best to limit alcohol consumption while on Omeprazole because alcohol can irritate the stomach and may worsen your symptoms.

What happens if I overdose on Omeprazole?

If you suspect an overdose of Omeprazole, seek immediate medical attention. Symptoms of overdose may include confusion and drowsiness.

Are there other medications that interact with Omeprazole?

Yes, certain medications like warfarin and methotrexate can interact with Omeprazole. Always inform your doctor about all medications you are taking.

Will I need to change my diet while taking Omeprazole?

While on Omeprazole, it's advisable to avoid spicy foods and fatty foods that might aggravate acid reflux or heartburn.

Is it safe to stop taking Omeprazole suddenly?

Consult your doctor before stopping Omeprazole to avoid rebound acid secretion. Your doctor may recommend a gradual reduction in dosage.

Can children take Omeprazole 10 mg capsules?

Omeprazole is sometimes prescribed for children but only under strict medical supervision. Consult a pediatrician for advice.

How does Omeprazole work in the body?

Omeprazole works by blocking proton pumps in the stomach lining that produce acid, thus reducing stomach acid levels.

What should I do if my symptoms do not improve after taking Omeprazole?

If symptoms persist after taking Omeprazole for the prescribed duration, contact your healthcare provider for further evaluation.

Can I use antacids while taking Omeprazole?

Yes, you can use antacids to relieve symptoms while on Omeprazole; just be sure to space them out to avoid interaction.

Are there any long-term side effects of taking Omeprazole?

Long-term use may lead to vitamin B12 deficiency or an increased risk of bone fractures. Discuss risks with your doctor if taken long-term.

Can lifestyle changes help reduce the need for OMEPRAZOLE 10 MG capsules?

Yes, lifestyle changes such as weight loss, avoiding trigger foods, and quitting smoking may help reduce acid reflux symptoms and lessen reliance on medication.

What is the difference between over-the-counter and prescription omeprazole?

Over-the-counter omeprazole often comes in lower doses and is used for short-term treatment of heartburn; prescription omeprazole is usually higher strength for more severe conditions.

Where can I find more information about my medication?

For more information about omeprazole or any concerns regarding its use, consult your pharmacist or healthcare provider for reliable advice.