PACKAGE LEAFLET: INFORMATION FOR THE USER /.../ 10 mg, 20 ...

PACKAGE LEAFLET: INFORMATION FOR THE USER
/.../
10 mg, 20 mg og 40 mg, gastro-resistant capsules, hard
Omeprazole
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What /.../ is and what it is used for
2. Before you take /.../
3. How to take /.../
4. Possible side effects
5. How to store /.../
6. Further information
1. WHAT /.../ IS AND WHAT IT IS USED FOR
/.../ may be used to treat or prevent the following conditions:
Adults:
‣ Ulcers in the top end of your intestine (duodenal ulcer) or stomach (gastric ulcer).
‣ To stop heartburn caused by acid from the stomach flowing back into your gullet and to heal the
inflammation of your gullet caused by this backflow of acid (reflux oesophagitis and gastrooesophageal
reflux disease)
‣ Ulcers which are infected with bacteria (called Helicobacter pylori). Omeprazol is to be given in
addition to antibiotics because it helps them work better in getting rid of the bacterium
(“eradication”).
‣ Excess acid causing recurrent ulcers in the stomach and upper end of your intestine (duodenum)
caused by a growth in the pancreas (Zollinger-Ellison syndrome)
‣ Prevention and therapy of ulcers in the top end of your intestine (duodenal ulcers) or stomach
(gastric ulcer) that are caused by the intake of medicines which reduces inflammations (NSAIDs;
e.g. ibuprofen).
Children over 1 year of age and with a body weight of 10 kg or more:
‣ To stop heartburn caused by acid from the stomach flowing back into your gullet and to heal the
inflammation of your gullet caused by this backflow of acid (reflux oesophagitis and gastrooesophageal
reflux disease)
/.../ belongs to a group of medicines called proton pump inhibitors. Your stomach naturally produces acid
which helps with digestion of food. Too much acid can cause painful irritation and damage to the lining of
your stomach and upper intestine. Proton pump inhibitors work by reducing the acid in the stomach,
relieving the pain and helping repair any damage.
Your doctor may have prescribed another use. Always follow your doctor’s instructions.
2. BEFORE YOU TAKE /.../

Do not take /.../
- If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of /.../.
- If you are also taking clarithromycin (an antibiotic) and you have an impaired liver function.
Take special care with /.../
Tell your doctor or pharmacist if
• you have already been using omeprazole or other proton pump inhibitors for a long time, over 1
year. If this is the case or if you are expected to take omeprazole capsules on a long-term basis
(longer than 1 year) your doctor will probably keep you under regular surveillance. You should
report any new and exceptional symptoms and circumstances whenever you see your doctor.
• you suffer or have recently suffered from any of the following symptoms: unintentional weight loss,
recurrent vomiting or vomiting of blood, or dark stool. Your doctor may then perform an additional
investigation called endoscopy in order to diagnose your condition and/or exclude malignant disease.
• you are elderly or if you have previously experienced any complication (e.g. bleeding or ulcer) from
the intake of non-steroidal anti-inflammatory medicines (NSAIDs), e.g. ibuprofen.
• you are already taking NSAIDs. Your doctor might stop you taking these.
• you have or have had problems with your liver or kidneys. Your doctor may check how they are
working with blood tests especially if you have to take omeprazole capsules for a long time.
• you experience diarrhoea during the treatment with /…/. Omeprazole has been associated with a
small increase in infectious diarrhoea.
If your doctor has given you /…/ in addition to other medicines intended for the treatment of
Helicobacter pylori infection (antibiotics) or together with anti-inflammatory medicines to treat your
pain or rheumatic disease: please also read the package leaflets of these medicines carefully.
Some children with chronic illnesses may require long-term treatment although it is not recommended.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Always inform your doctor or pharmacist if you are taking any of the following medicines as their effect
may be changed; your doctor may need to change the dose:
• Sedatives called benzodiazepines (such as diazepam, triazolam, flurazepam)
• Atazanavir (to treat infections with HIV)
• Citalopram, imipramine, clomipramine (medicines taken for depression)
• Phenytoin (medicine to treat epilepsy)
• Phenobarbital (medicine to treat epilepsy)
• Warfarin (medicine for thinning your blood)
• Ketoconazole or itraconazole (medicines used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Clarithromycin (antibiotic)
• Disulfiram (used to treat alcohol dependence)
• Ciclosporin, tacrolimus (medicines used to suppress the immune reaction)
• Vitamin B 12 supplements
• St. John’s Wort
Taking /.../ with food and drink
You may take /.../ with food and drink.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy:
You must take /.../ only as per your doctor’s instructions.
Breast-feeding:
Experiences with /.../ are limited. You must therefore as far as possible not take /.../ if you are breast-feeding.
Ask your doctor.
Driving and using machines
/.../ may in individual cases cause effects that may influence your occupational safety and ability to drive
safely in traffic.
Important information about some of the other ingredients of /.../
This medicine 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 /.../
Always take /…/ exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.
The capsules ought to be taken with plenty of water (e.g. 1 glass of water) before a meal (e.g. before
breakfast or dinner) or on an empty stomach. The capsules should not be chewed or crushed.
The usual dose is
Adults:
Duodenal ulcer
20 mg once daily. Treatment time is 2-4 weeks.
In particular cases, the dose can be increased to 40 mg once daily. Maintenance dose is 10 mg once daily.
Gastric ulcer
20 mg once daily. Treatment time is 4-8 weeks.
In particular cases, the dose can be increased to 40 mg once daily.
Oesophagitis
20 mg once daily. Treatment time is 4-8 weeks.
In particular cases, the dose can be increased to 40 mg once daily. Maintenance dose is 10-20 mg once daily.
Zollinger-Ellison syndrome
Dosage should be adapted individually. Follow your doctor’s instructions.
Treatment of duodenal and gastric ulcers caused by treatment with medicines reducing inflammation
(NSAIDs)

20 mg once daily. Treatment time is 4-8 weeks.
Maintenance dose is 20 mg once daily.
Heartburn
10-20 mg once daily. Treatment time is 2-4 weeks.
If you experience no improvement after 2 weeks of treatment, you should contact your doctor.
Treatment of ulcers caused by Helicobacter pylori bacteria
The usual dose is 20 mg omeprazole twice a day.
The recommended combinations with antibiotics are the following:
20 mg omeprazole + 1000 mg amoxicillin + 500 mg clarithromycin
20 mg omeprazole + 250 mg clarithromycin + 400-500 mg metronidazole
all given twice daily. Your doctor will tell you which of the combinations you should use.
The treatment duration is usually one week. Your doctor may prescribe 20 mg omeprazole once daily for an
additional 1-3 weeks to get the ulcer healed. Make sure you take all the doses for the full week, to stop the
bacteria becoming resistant to treatment.
Children
Reflux oesophagitis
The treatment time is 4-8 weeks.
Symptomatic treatment of heartburn and gastro oesophageal reflux disease
The treatment time is 2-4 weeks. If symptom control has not been achieved after 2-4 weeks the child should
be investigated further.
The dosage recommendations are as follows:
Age Weight Dosage
≥1 year of age 10-20 kg 10 mg once daily.
The dose can be increased, follow your doctor’s advice.
≥2 years of age >20 kg
20 mg once daily.
The dose can be increased, follow your doctor’s advice.
Children over 4 years of age
In combination with antibiotics in treatment of duodenal ulcer caused by Helicobacter pylori.
Duration of treatment (most commonly 7 days but sometimes up to 14 days). The treatment should be
supervised by a specialist. The dose depends on the child’s age and weight:
Weight Dosage
15-≤30 kg Combination with two antibiotics: /…/ 10 mg, amoxicillin 25 mg/kg body weight and
clarithromycin 7.5 mg/kg body weight are all administered together twice daily for 1 week
30-≤40 kg Combination with two antibiotics: /…/ 20 mg, amoxicillin 750 mg and clarithromycin 7.5
mg/kg body weight are all administered twice daily for 1 week.

40 kg Combination with two antibiotics: /…/ 20 mg, amoxicillin 1 g and clarithromycin 500 mg
are all administered twice daily for 1 week.
Always follow your doctor’s instructions.
Elderly
The same dose as stated under ”Adults”.
Reduced kidney function
It is not necessary to adjust the dose. You must follow your doctor’s instructions.
Reduced liver function
Here, it is necessary to adjust the dose. You must follow your doctor’s instructions.
Always follow your doctor’s instructions. Each individual has different needs. You should not change or stop
your treatment without consulting your doctor.
If you take more /.../ than you should
Contact your doctor, casualty department or the pharmacist if you have taken more /.../ than stated in this
information, or more than your doctor has prescribed and you feel unwell.
If you forget to take /.../
If you forget to take a dose, take one as soon as you remember, unless it is almost time for you to take your
next dose. Then go on as before. Do not ever double the dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, /.../ can cause side effects, although not everybody gets them.
Most side effects will disappear either with continued treatment or after your treatment is over.
Common side effects (occur in between 1 and 10 out of 100 patients):
- Sleepiness, trouble sleeping, vertigo, headache and drowsiness.
- Diarrhoea, constipation, wind (sometimes with stomach pain), feeling sick or being sick.
Uncommon side effects (occur in between 1 and 10 out of 1 000 patients):
- Visual disturbances (blurred or poorer vision).
- Ringing in the ears (e.g. tinnitus).
- Taste disturbances.
- Changes in liver enzymes (detected through blood tests).
- Itching, rash, hair loss, widespread reddening and blistering of the skin (erythema multiforme),
hypersensitivity to light, increased sweating.
- Oedemas.
Rare side effects (occur in between 1 and 10 out of 10 000 patients):

- A certain type of anaemia (hypochrome monocytic anaemia) in children.
- Pins and needles, lightheadedness. Mental confusion or hallucinations (occurring mainly in the very ill
and elderly).
- Reversible brown-black tongue discolouration when taken with clarithromycin (for infection). Benign
swelling of the glands.
- Muscle weakness, muscle or joint pain.
Very rare side effects (occur in fewer than 1 out of 10 000 patients):
- Stop taking /.../ and contact your doctor immediately if you experience any of the following allergic
reactions:
- Swelling of the face, tongue or throat.
- Difficulty swallowing.
- Difficulty breathing or anaphylactic shock (severe allergic reaction).
- Inflammation of the liver with or without yellowing of the skin and whites of the eyes through jaundice,
liver failure or brain disease (encephalopathy) in those who already have severe liver problems.
- Skin disease with peeling of the top layer of the skin.
Additional very rare side effects
- Changes in numbers and types of blood cells. Hives, elevated body temperature. Inflammation of the soft
tissues under the skin and fever.
- Agitation and depressive reactions mainly in very ill or elderly.
- Dry or sore mouth, inflammation in the mouth, fungal infection (candidiasis) or inflammation of the
pancreas.
- Kidney inflammation.
- Low blood sodium levels, swollen breasts in men.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE /…/
- Do not store /.../ above 25°C.
- Keep /.../ out of the reach and sight of children.
- Do not use /.../ after the expiry date which is stated on the packaging. The expiry date refers to the last
day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What /.../ contains
- The active substance in /.../ is: omeprazole 10 mg, 20 mg or 40 mg, respectively.
- The other ingredients are: sucrose, hypromellose, talc, titanium dioxide (E171). methacrylic acid-ethyl
acrylate copolymer (1:1) dispersion 30%, triethyl citrate, maize starch.
- Capsule shell: gelatin, titanium dioxide (E 171), black iron oxide (E 172).
- Printing-ink: shellac, anhydrous ethanol, isopropyl alcohol , butyl alcohol, propyleneglycol, purified
water, concentrated ammonia solution, potassium hydroxide, black iron oxide (E172).
What /.../ looks like and contents of pack
What /.../ looks like:

Hard gastro-resistant capsules. Opaque white capsules printed “OM10”, “OM20” or “OM40”.
Pack sizes:
Plastic container with screw cap closure containing desiccant.
Pack sizes: 7, 14, 28, 50, 56, 100 hard gastro-resistant capsules.
Not all pack sizes and strengths may be marketed.
Marketing Authorisation Holder and Manufacturer
{Name and address}
This medicinal product is authorised in the Member States of the EEA under the following names:
This leaflet was last approved in

PARTICULARS TO APPEAR ON
Box for HDPE bottle, 10 mg, 20 mg, 40 mg and label
1. NAME OF THE MEDICINAL PRODUCT
[Invented name] 10 mg gastro-resistant capsule, hard
[Invented name] 20 mg gastro-resistant capsule, hard
[Invented name] 40 mg gastro-resistant capsule, hard
Omeprazole
2. STATEMENT OF ACTIVE SUBSTANCE(S)
One gastro-resistant capsule, hard contains 10 mg omeprazole
One gastro-resistant capsule, hard contains 20 mg omeprazole
One gastro-resistant capsule, hard contains 40 mg omeprazole
3. LIST OF EXCIPIENTS
Sucrose, the colours E 171 and E 172 and other excipients.
See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Gastro-resistant capsule, hard.
= 7, 14, 28, 50, 56, 100 gastro-resistant capsules, hard
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Swallow whole. Should not be chewed or crushed
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP
9. SPECIAL STORAGE CONDITIONS
Store below 25 °C

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally]
15. INSTRUCTIONS ON USE
N/A
16. INFORMATION IN BRAILLE
Invented name] 10 mg [carton only]
[Invented name] 20 mg [carton only]
[Invented name] 40 mg [carton only]

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
{NATURE/TYPE}
1. NAME OF THE MEDICINAL PRODUCT
{(Invented) name strength pharmaceutical form}
[For referral procedures]
{Active substance(s)}
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[For referral procedures]
{Name}
3. EXPIRY DATE
[For terms on Batch number and Expiry date see Appendix IV]
4. BATCH NUMBER
[For terms on Batch number and Expiry date see Appendix IV]
5. OTHER

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
{NATURE/TYPE}
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
{(Invented) name strength pharmaceutical form}
[For referral procedures]
{Active substance(s)}
{Route of administration}
2. METHOD OF ADMINISTRATION
3. EXPIRY DATE
[For terms on Batch number and Expiry date see Appendix IV]
4. BATCH NUMBER
[For terms on Batch number and Expiry date see Appendix IV]
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
[For referral procedures, as appropriate]
6. OTHER