Patient leaflet - Omeang 10 mg gastro-resistant capsules hard

1. What Omeang is and what it is used for

Omeang 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.

Omeang is used to treat the following conditions:

In adults:

‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Omeang can also be used to stop ulcers from forming if you are taking NSAIDs.
Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
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

Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before you take Omeang

Do not take Omeang

If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
If you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole, lansoprazole, rabeprazole, esomeprazole).
If you are taking a medicine containing nelfinavir (used for HIV infection).

Do not take Omeang if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeang.

Warnings and precautions

Talk to your doctor or pharmacist before taking Omeang.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Omeang treatment. Stop using Omeang and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Omeang may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Omeang or while you are taking it, talk to your doctor straight away:

You lose a lot of weight for no reason and have problems swallowing.
You get stomach pain or indigestion.
You begin to vomit food or blood.
You pass black stools (blood-stained faeces).
You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
You have severe liver problems.
You have ever had a skin reaction after treatment with a medicine similar to Omeang that reduces stomach acid.
You are due to have a specific blood test (Chromogranin A).

This medicine may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time. Please contact your doctor if you notice any of the following symptoms, which could indicate low levels of Vitamin B12:

Extreme tiredness or lack of energy
Pins and needles
Sore or red tongue, mouth ulcers
Muscle weakness
Disturbed vision
Problems with memory, confusion, depression

When taking omeprazole, inflammation in your kidney may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.

If you take Omeang 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.

Taking a proton pump inhibitor like Omeang, 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).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Omeang. Remember to also mention any other ill-effects like pain in your joints.

Children and adolescents

Some children with chronic illnesses may require long-term treatment although it is not recommended. Do not give this medicine to children under 1 year of age or < 10 kg.

Other medicines and Omeang

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Omeang can affect the way some medicines work and some medicines can have an effect on Omeang.

Do not take Omeang if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
Digoxin (used to treat heart problems)
Diazepam (used to treat anxiety, relax muscles or in epilepsy)
Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeang
Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Omeang
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV infection)
Tacrolimus (in cases of organ transplantation)
St John’s wort (Hypericum perforatum) (used to treat mild depression)
Cilostazol (used to treat intermittent claudication)
Saquinavir (used to treat HIV infection)
Clopidogrel (used to prevent blood clots (thrombi))
Erlotinib (used to treat cancer)
Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Omeang treatment

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Omeang to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Omeang with food, drink and alcohol

You can take your capsules with food or on an empty stomach.

Omeprazole is not recommended to be taken with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Omeang if you are breastfeeding.

Driving and using machines

Omeang 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.

Omeang contains sucrose

Omeang 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.

Omeang contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit that is to say essentially “sodium free”.

3. How to take use Omeang

Always take this medicine 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 doses are given below.

Use in Adults:

To treat symptoms of GORD such as heartburn and acid regurgitation:

If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.
The recommended dose once the gullet has healed is 10 mg once a day.
If your gullet has not been damaged, the usual dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
If the ulcers do not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is 20 mg once a day for 4–8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

The recommended dose is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

The recommended dose is 20 mg Omeang twice a day for one week.
Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

The recommended dose is 60 mg daily.
Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Use in children and adolescents

To treat symptoms of GORD such as heartburn and acid regurgitation:

Children over 1 year of age and with a body weight of more than 10 kg may take Omeang. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

Children aged over 4 years may take Omeang. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

It is recommended that you take your capsules in the morning.
You can take your capsules with food or on an empty stomach.
Swallow your capsules whole with half a glass of water. Do not chew or crush the capsules. This is because the capsules contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you or your child have trouble swallowing the capsules

If you or your child have trouble swallowing the capsules:

Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

If you take more Omeang than you should

If you take more Omeang than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Omeang

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Omeang

Do not stop taking Omeang without first talking to your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Omeang and contact a doctor immediately:

Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction). (rare)
Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson syndrome’ or ‘toxic epidermal necrolysis’. (very rare)
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensivity syndrome) (rare)
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis). (rare)
Yellow skin, dark urine and tiredness which can be symptoms of liver problems.(rare)

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

Headache.
Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
Feeling sick (nausea) or being sick (vomiting).
Benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
Spinning feeling (vertigo).
Changes in blood tests that check how the liver is working.
Skin rash, lumpy rash (hives) and itchy skin.
Generally feeling unwell and lacking energy.

Rare side effects (may affect up to 1 in 1,000 people)

Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
Feeling agitated, confused or depressed.
Taste changes.
Eyesight problems such as blurred vision.
Suddenly feeling wheezy or short of breath (bronchospasm).
Dry mouth.
An inflammation of the inside of the mouth.
An infection called “thrush” which can affect the gut and is caused by a fungus.
Hair loss (alopecia).
Skin rash on exposure to sunshine.
Joint pains (arthralgia) or muscle pains (myalgia).
Severe kidney problems (interstitial nephritis).
Increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

Changes in blood count including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling or hearing things that are not there (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Erythema multiforme.
Muscle weakness.
Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)

Inflammation in the gut (leading to diarrhoea).
If you are on Omeang for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness or increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Rash, possibly with pain in the joints.

Omeang may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Omeang

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 pack after EXP. The expiry date refers to the last day of that month.

PVC/PE/PVDC/Alu: Store below 25^oC; store in the original package in order to protect from moisture

HDPE bottles: This medicine does not require any special temperature storage conditions; keep the bottle tightly closed in order to protect from moisture

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 protect the environment.

6. Contents of the pack and other information

What Omeang contains

The active substance is omeprazole. Omeang hard gastro-resistant capsules (gastro-resistant capsules) contain 10 mg, 20 mg or 40 mg of omeprazole.

The other ingredient(s) are Maize starch, Sucrose, Magnesium hidroxide, Disodium Phosphate, Hypromellose Type 2910, Sodium Laurilsulfate, Mannitol, Sodium Starch Glycolate (Type A), Talc, Titanium Dioxide, Macrogols 6000, Polysorbate 80, Methacrylic Acid-Ethyl Acrylate Copolymer (1:1) Dispersion 30% (dry substance), Brilliant Blue FCF (E133), Yellow iron oxide (E172), FD&C Blue 2 (E132) (Indigotine), Titanium Dioxide (E171), Black iron oxide (E172), Gelatin.

What Omeang looks like and contents of the pack

Omeang 10 mg capsules: Hard gelatin capsule size “4”, with green cap and white body, containing white to off-white of white cream spherical r pellets

Omeang 20 mg capsules: Hard gelatin capsule size “4”, with blue cap and white body, containing white to off-white of white cream spherical pellets

Omeang 40 mg capsules: Hard gelatin capsule size “3”, with white cap and grey body, containing white to off-white or white cream spherical pellets

Pack sizes:

10mg:

The capsules are supplied in PVC/PE/PVDC/aluminium blisters of 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, 98, 100, 140, 280 and 500 capsules; and in HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120 and 250 capsules.

20mg:

The capsules are supplied in PVC/PE/PVDC/aluminium blisters of 7, 14, 15, 28, 30, 35, 42, 50, 56, 60, 90, 98, 100, 140, 280, 500; and in HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100, 105, 120 and 250 capsules.

40mg:

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Liconsa, S.A.

Dulcinea, s/n

28805 Alcalá de Henares (Madrid), Spain

Manufacturer: