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

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.

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