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OMEPRAZOLE 20 MG GASTRO-RESISTANT CAPSULES HARD - Patient leaflet, side effects, dosage

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

Patient leaflet - OMEPRAZOLE 20 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 105 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 20 mg gastro-resistant capsules contains:

  • – The active substance is omeprazole. Each capsule contains 20 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 20 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, 100, 105 or 250 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 is the purpose of Omeprazole 20 mg gastro-resistant capsules?

Omeprazole 20 mg is used to treat conditions like gastroesophageal reflux disease (GERD), stomach ulcers, and Zollinger-Ellison syndrome by reducing stomach acid.

How should I take Omeprazole capsules?

You should take Omeprazole 20 mg capsules once daily, preferably in the morning before a meal, swallowed whole with water.

Can I take Omeprazole with food?

While it's best taken on an empty stomach for maximum effectiveness, if you have difficulty, you can take it with food.

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 close to your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Are there any foods or drinks I should avoid while taking Omeprazole?

Yes, avoid alcohol and spicy foods as they can aggravate symptoms of acid reflux.

Can I buy Omeprazole over the counter?

In some countries, lower doses of Omeprazole are available over the counter. However, it's best to consult your doctor or pharmacist.

What are common side effects of taking Omeprazole?

Common side effects include headache, nausea, vomiting, diarrhea, constipation, and flatulence.

Is Omeprazole safe for long-term use?

Long-term use of Omeprazole should be discussed with a healthcare provider as it may lead to certain risks like vitamin B12 deficiency or bone fractures.

Can children take Omeprazole?

Yes, Omeprazole can be prescribed for children under certain conditions. Always consult a pediatrician.

What should I do if I experience severe side effects from Omeprazole?

If you experience severe side effects such as rash, difficulty breathing, or swelling of your face or throat, seek medical attention immediately.

Does Omeprazole interact with other medications?

Yes, Omeprazole can interact with certain medications like warfarin and clopidogrel. Inform your doctor about all medications you're taking.

Can pregnant or breastfeeding women take Omeprazole?

Consult your healthcare provider before taking Omeprazole if you are pregnant or breastfeeding to weigh the benefits and risks.

How long does it take for Omeprazole to work?

You may start feeling relief from heartburn within one day; however, full effects may take up to four days.

Will I need to change my diet while taking Omeprazole?

You might benefit from avoiding acidic foods and beverages that can exacerbate acid problems while on this medication.

Can I stop taking Omeprazole suddenly?

It's best to consult your doctor before stopping Omeprazole abruptly as this might worsen your condition. A gradual reduction might be recommended.

What happens if I overdose on Omeprazole?

An overdose may lead to symptoms like nausea and vomiting. If you suspect an overdose, contact your healthcare provider or poison control immediately.

Does Omeprazole cause weight gain or weight loss?

Weight changes are not common but can occur in some individuals. Monitor your weight and speak with a doctor if you're concerned.

Are there alternative medications to treat acid-related stomach issues besides Omeprazole?

Yes, alternatives include other proton pump inhibitors (PPIs) like lansoprazole and esomeprazole or H2 blockers like ranitidine.

What storage conditions are recommended for Omeprazole capsules?

Store at room temperature away from moisture and heat. Keep out of reach of children.