Patient leaflet - Omeprazole 20 mg capsules

1. What Omeprazole Capsule is and what it is used for

The active ingredient, omeprazole, belong to a group of medicines called “proton pump inhibitor”. It works by reducing the production of acid in your stomach. Omeprazole is used to treat the following conditions: ln adults:

'Gastro-Oesophageal reﬂux disease' where acid from the stomach escapes into the food pipe (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 caused by medicines called NSAIDs (Non- Steroidal Anti-Inﬂammatory Drugs). Omeprazole can also be used to stop ulcers from forming if you are taking NSAIDs.
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.
Zollinger-Ellison syndrome, when excess stomach acids are produced due to a growth in the pancreas. 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 Omeprazole

Do not take Omeprazole Capsules:

If you are allergic to omeprazole or to any other 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 Omeprazole Capsules if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Omeprazole Capsules. Warnings and precautions

Talk to your doctor or pharmacist before taking Omeprazole Capsules

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 Omeprazole treatment. Stop using Omeprazole and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

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

If you take Omeprazole 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.

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 Omeprazole.

Remember to also mention any other ill-eﬀects like pain in your joints.

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.

Children

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 Omeprazole Capsules

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 Omeprazole can aﬀect the way some medicines work and some medicines can have an eﬀect on Omeprazole.

Do not take Omeprazole if you are taking a medicine containing nelﬁnavir (used to treat HIV infection). Talk to your doctor or pharmacist if you are taking any of the following medicines:

Diazepam (for anxiety, relax muscles or in epilepsy)
Phenytoin (for epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Omeprazole
Medicines that are used to thin your blood, such as warfarin or other vitamin K blockers (for thinning of blood)
Digoxin (for the heart)
Ketoconazole, ltraconazole, Posaconazole or Voriconazole (for fungal infections)
Tacrolimus (for immune suppression)
Rifampicin (used to treat tuberculosis)
Atazanavir (used to treat HIV Infection)
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 Omeprazole treatment.

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

Omeprazole with food and drink

See section 3.

Pregnancy and Breast-feeding

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 omeprazole if you are breast-feeding.

Driving and using machines

These capsules on rare occasions may make you hallucinate, confused and feel light- headed. Other possible side eﬀects are sleepiness and visual impairment. Make sure you are not aﬀected before you drive or operate machinery.

Omeprazole capsules contains sucrose and sodium

Omeprazole capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Omeprazole capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

3. How to take Omeprazole Capsules

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. The length of your course of treatment will depend on what condition you are suﬀering from:-

The recommended dose is 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.

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

The recommended dose is 20 mg omeprazole 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. Treatment and prevention of stomach ulcers:
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

160 mm

Omeprazole 20mg Capsules

(Omeprazole)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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. Treatment of Ulcers caused by infection with the bacteria called Helicobacter Pylori
The recommended dose is omeprazole 20 mg twice a day for a period of weeks. Your doctor will also tell you to take one or two of the following antibiotics; amoxicillin, clarithromycin, metronidazole. To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger - Ellison Syndrome)
The recommended starting dose is omeprazole 60 mg once a day.
Your doctor will tell you how many capsules to take and when to take them.
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 Omeprazole. 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 Omeprazole. 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 Omeprazole capsules than you should:

If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. If you forget to take Omeprazole capsules:

If you forget to take a dose, take it as soon as you remember. If it is nearly time for your next dose just take the next dose and forget about the one you missed. Do not take a double dose to make up for a forgotten dose. If you stop taking Omeprazole capsules:

Do not stop taking Omeprazole capsules without ﬁrst discussing it with 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 everyone gets them.

If you notice any of following rare (may aﬀect up to 1 in 1,000 people) or very rare (may aﬀect up to 1 in 10,000 people) serious side eﬀects, stop taking Omeprazole Capsules and tell a doctor or contact the casualty department at your nearest hospital straight away:

Sudden wheezing, swelling of the face, lips, tongue, throat or body rash, fainting or diﬃculty in swallowing (severe allergic reaction). (rare)
Reddening of skin with blisters or peeling. There may also be severe blisters and bleeding in 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 hypersensitivity 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 can be symptoms of liver problems.(rare)

Other Side eﬀects

Common: (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: may aﬀect up to 1 in 100 people

Disturbed sleep (Insomnia)
Dizziness, Tingling feelings such as 'pins and needles', feeling sleepy
Spinning feeling (Vertigo)
Skin rash, lumpy rash (hives), itchy skin
- Changes in blood tests that show how well your liver is working
- Generally feeling unwell and lacking energy
- Swelling of the feet and ankles

Rare: may aﬀect up to 1 in 1,000 people

Dry mouth
An infection called 'thrush' which can aﬀect the mouth or gullet and is caused by a fungus
An inﬂammation of the inside of the mouth
Taste changes
Feeling agitated, confused or depressed
Aggression
Seeing, feeling or hearing things that are not there (hallucinations)
Skin rash on exposure to sunshine
Eyesight problems such as blurred vision
Hair loss (alopecia)
Joint pains (arthralgia) or muscle pains (myalgia). Increased sweating
Severe kidney problems (interstitial nephritis)
Low levels of sodium in blood. this may cause weakness, being sick (vomiting) and cramps.
Blood problems such as reduced number white cells or platelets. This can cause weakness, bruising or make infections more likely.
Suddenly feeling wheezy or short of breath (bronchospasm).

Very rare: 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 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 Omeprazole 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, 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

Omeprazole 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 at: www.mhra.gov.uk/yellowcard. By reporting side eﬀects you can help provide more information on the safety of this medicine

5. How to store Omeprazole Capsules

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package. Do not use Omeprazole Capsules after the expiry date which is stated on the label. 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. Package contents and other information

What Omeprazole Capsules contains

The active substance is omeprazole and each capsule contains 20mg of omeprazole as enteric coated pellets. The other ingredients are sugar spheres, sodium starch glycollate, sodium lauryl sulfate, povidone, potassium hydroxide, oleic acid, hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide and talc, puriﬁed water, ammonium hydroxide. The capsule coating also contains gelatine, titanium dioxide (E171), iron oxide yellow , iron oxide red, patent blue V and puriﬁed water. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, , ammonium hydroxide (E527), potassium hydroxide (E525) and titanium dioxide (E171), puriﬁed water.

What Omeprazole 20mg Capsules look like and contents of the pack

The capsules have an orange body and blue cap and are marked with RIA & 20. The capsules are supplied in bottles of 28 capsules.

Marketing Authorisation Holder:

RIA Generics Limited.

36 Ingleby Way, Wallington, Surrey, SM6 9LR, United Kingdom

Manufacturer:

RIA Generics Limited

36 Ingleby Way

Wallington

SM6 9LR, United Kingdom

PL No. 36282/0004

If you would like more information or would like to report side eﬀects, please email safety@riagenerics.com This leaﬂet was last revised in: February 2024