Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 Ulcid 20 mg gastro-resistant capsules

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 One capsule contains 20 mg of omeprazole.

Excipient:

Each gastro-resistant capsule contains 116mg lactose monohydrate.

For a full list of excipients, see 6.1.

3. PHARMACEUTICAL FORM

 Gastro-resistant capsules, hard (capsule)

Opaque, white hard capsules marked with imprint '20' on the body and 'OM' on the cap. The capsules contain gastro-resistant microtablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Ulcid gastro-resistant capsules are indicated for:

Adults:

• Treatment of duodenal ulcers

• Prevention of relapse of duodenal ulcers

• Treatment of gastric ulcers

• Prevention of relapse of gastric ulcers

• In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease

• Treatment of NSAID- associated gastric and duodenal ulcers

• Prevention of NSAID- associated gastric and duodenal ulcers in patients at risk

• Treatment of reflux oesophagitis

• Long-term management of patients with healed reflux esophagitis

• Treatment of symptomatic gastro-oesophageal reflux disease

• Treatment of Zollinger-Ellison syndrome

Paediatric use

Children over 1 year of age and  10 kg

• Treatment of reflux esophagitis

• Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease

Children and adolescents over 4 years of age

• In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori

4.2 Posology and method of administration

 Posology in Adults

Treatment of duodenal ulcers

The recommended dose in patients with an active duodenal ulcer is Ulcid 20 mg once daily. In most patients healing occurs within two weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further two week treatment period. In patients with poorly responsive duodenal ulcer Ulcid 40 mg once daily is recommended and healing is usually achieved within four weeks.

Prevention of relapse of duodenal ulcers

For the prev