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

Losec® 20 mg gastro-resistant capsules

This medicine is also available in other strengths.

Your medicine is known by the above name, but will be referred to as Losec® throughout this leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Losec® is and what it is used for

• 2. What you need to know before you take Losec®

• 3. How to take Losec®

• 4. Possible side effects

• 5. How to store Losec®

• 6. Contents of the pack and other information

1. what losec® is and what it is used for

Losec® 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.

Losec® 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 'Helicobacter­pylori’. 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). Losec® 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 'Helicobacter­pylori’. 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 losec®

Do not take Losec®:

• 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 Losec® if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Losec®.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losec®.

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

Driving and using machines

Losec® 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.

Losec® capsules contain lactose and sodium

Losec® capsules contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Losec® capsules contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take losec®

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 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.

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 Losec®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.
• Children over 1 year of age and with a body weight of more than 10 kg may take Losec®. 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 Losec®. 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.
• 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.
• 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 dear). 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 Losec®than you should

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

If you forget to take Losec®

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 Losec®

Do not stop taking Losec®without first talking to your doctor or pharmacist.

If you have any further questions on the use ofthis 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 but serious side effects, stop taking Losec® 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).
• 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’.
• Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

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.
• 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.
• Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• 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 ofthe inside ofthe mouth.
• An infection called “thrush” which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunshine.
• Joint pains (arthralgia) or muscle pains (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.
• 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 ofthe brain.
• Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlarged breasts in men.
• Inflammation in the gut (leading to diarrhoea).
• If you are on Losec®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.

Losec® 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: 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 losec®

• Keep this medicine out ofthe sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Keep container tightly closed in order to protect from moisture.
• Do not store above 30°C.
• Do not throw away 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 Losec® contains

The active substance is : Omeprazole. Each capsule contains 20 mg of omeprazole.

The other components are : Mannitol, hydroxypropyl­cellulose, microcrystalline cellulose, lactose anhydrous, sodium lauryl sulphate, disodium phosphate dihydrate, hypromellose, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%, macrogol (polyethylene glycol 400), magnesium stearate.

Composition of the capsule shell : red iron oxide (E 172), titanium dioxide (E 171), gelatin, magnesium stearate, sodium lauryl sulphate, ink (containing lacquer, ammonia, potassium hydroxide and black iron oxide (E 172)), colloidal anhydrous silica, liquid paraffin (see section 2: Losec® capsules contain lactose).

What Losec®looks like and contents ofthe pack

The capsules of Losec® 20 mg gastro-resistant capsule have an opaque pink body marked with 20 and an opaque reddish-brown cap marked with A I OM in black ink, containing gastro-resistant granules.

Pack size available as 30 capsules.

Manufactured by AstraZeneca AB, Gartunavagen, S –151 85, Sbdertalje, Sweden.

Procured from within the EU and repackaged by the Product Licence Holder Beachcourse Ltd., 20 Alliance Court, London W3 ORB, UK.

Revision date: 16.02.2021

PL 16378/0685 |POM|

Losec® is a registered trademark of AstraZeneca AB.

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Tel: 020 8896 9054

for help.

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