What you need to know before you take it

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(neartourn) and a sour taste in the mouth (acid |

| _ What this medicine contains The active substance is esomeprazole. . Each capsule contains 20 mg esomeprazole (as

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before you take this medicine | X% Do not take this medicine © If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).

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throw away medicines you no longer use. These

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this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

What are the symptoms of heartburn? The normal symptoms of reflux are a painful sensation in the chest rising up to your throat

6. Contents of the pack and

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2. What you need to know

| _ better or if you feel worse after 14 days.

order to protec from moisture. Do not throw away any medicines via wastewater

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Always take this medicine exactly as described in

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Do not store above 25°C.

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7. Further helpful information

or household waste. Ask your pharmacist how to |

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Keep this medicine in the original package in

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This leaflet was last revised in January 2025.

Do not use this medicine after the expiry date which | _ is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

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

Marketing Authorisation Holder:

Scheme Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google

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Marketing Authorisation Holder and Manufacturer

Heartburn and Acid Reflux Control 20mg Gastro-Resistant Capsules |

This medicine is available in pack sizes of 7 and |

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 national reporting system in the United Kingdom, Yellow Card

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Gastro-Resistant Capsules are gastro-resistant capsules with an opaque yellow cap and an opaque white body imprinted in black with "20 mg" both on the cap and on the body. The capsule contains | off-white to greyish spherical microgranules.

magnesium, you may also have low levels of

Package Leaflet: Information for the User

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What this medicine looks like and contents |

cause weakness, being sick (vomiting), cramps,

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Y Tell your doctor immediately before or after taking this medicine, if you notice any of the following

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symptoms, which could be a sign of another, more

serious, disease. You lose a lot of weight for no reason. You have problems or pain when swallowing.

You get stomach pain or signs of indigestion such as nausea, fullness, bloating especially after food intake.

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You begin to vomit food or blood, which may

appear as dark coffee grounds in your vomit. You pass black stools (blood-stained faeces). You have severe or persistent diarrhoea;

esomeprazole has been associated with a small increased risk of infectious diarrhoea. e You get arash 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 this medicine. Remember to also mention any other ill-effects like pain in your joints.

Seek urgent medical attention if you experience chest pain with light-headedness, sweating, dizziness Cie

or shoulder pain with shortness of breath. This could

be a sign of a serious condition with your heart. Tell your doctor before taking this medicine, if: You are due to have an endoscopy or a urea

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breath test. You are due to have a specific blood test

(Chromogranin A). If any of the above apply to you (or you are not sure), talk to your doctor straight away. Children and adolescents This medicine should not be used by children and

adolescents under 18 years of age. Other medicines and this medicine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because this medicine can affect the way some medicines work and some medicines can have an effect on it. Do not take this medicine if you are also taking a

medicine containing nelfinavir (used to treat HIV infection). You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots). Do not take this medicine with other medicines that limit the amount of acid produced in your stomach such as proton pump inhibitors (¢.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or an He

antagonist (e.g. ranitidine or famotidine). You may take this medicine with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or

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combinations of these) if needed. Tell your doctor or pharmacist if you are taking any of the following medicines: Ketoconazole and itraconazole (used to treat infections caused by a fungus).

"Talk to your doctor as soon as possible =-ss

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© Do not take more than this recommended dose of- one capsule (20 mg) a day, even if you don't feel an improvement immediately.

This medicine may in very rare cases affect the white

and are treated for a long period of time. Erlotinio (used to treat cancer).

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e You may need to take the capsules for 2 or 3 days in a row before your reflux symptoms (for example,

Methotrexate (used to treat cancer and rheumatic

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Voriconazole (used to treat infections caused bya

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fungus) and clarithromycin (used to treat infections). Your doctor may adjust your dose of this medicine if you also have severe liver problems

heartburn and acid regurgitation) get better.

disorders). Digoxin (used for heart problems). Atazanavir, saquinavir (used to treat HIV infection).

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Citalopram, imipramine or clomipramine (used to

® The treatment length is up to 14 days. e When your reflux symptoms have completely

gone you should stop taking this medicine. ® If your reflux symptoms get worse or do not improve

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Diazepam (used to treat anxiety, relax muscles or in

epilepsy). Phenytoin (used to treat epilepsy).

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Medicines that are used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking this medicine.

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Cilostazol (used to treat intermittent claudicationa condition where poor blood supply to the leg muscles causes pain and difficulty in walking). Cisapride (used for indigestion and heartburn). Rifampicin (used to treat tuberculosis).

Common (may affect up to 1 in 10 people)

Taking this medicine

Headache.

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water. Do not chew or crush the capsule. This is

because the capsule contains coated pellets, which stop the medicine from being broken down by the acid in your stomach. It is important not to

damage the pellets.

treat depression).

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If you take more of this medicine than you

should

Pregnancy and breast-feeding As a precautionary measure, you should preferably

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avoid the use of this medicine during pregnancy. You should not use this medicine during breast-feeding. If you are pregnant or breast-feeding, think you

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may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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If you take more of this medicine than

recommended, talk to your doctor or pharmacist straight away. You may experience symptoms such

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If you have any further questions on the use of this

effects such as dizziness and visual disturbances

medicine, ask your doctor or pharmacist.

may uncommonly occur (see section 4). If affected, you should not drive or use machines. This medicine contains sucrose This medicine contains sugar spheres, which contain

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars,

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contact your doctor before taking this medicine. This medicine contains benzoic acid This medicine contains 0.0018 mg benzoic acid in

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If you notice any of the following serious side effects, stop taking this medicine and contact

a doctor immediately: © Sudden wheezing, swelling of your lips, tongue and

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throat, rash, fainting or difficulties in swallowing

This medicine contains less than 1 mmol

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sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.

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(severe allergic reaction, seen rarely). © 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

each capsule

How to take it

this medicine Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have

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told you. Check with your doctor or pharmacist if you are not sure.

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How much to take The recommended dose is one capsule a day. G

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Possible side effects

be 'Stevens-Johnson syndrome' or 'toxic epidermal necrolysis', seen very rarely.

© Yellow skin, dark urine and tiredness, which can be symptoms of liver problems, seen rarely. ® Widespread rash, high body temperature and

enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), seen very rarely.

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Dry mouth.

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Changes in blood tests that check how the liver is working. Rare (may affect up to 1 in 1,000 people) Blood problems such as a reduced number of white blood cells or platelets. This can cause

dose to make up for a forgotten dose.

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Dizziness, tingling feelings such as "pins and needles". Spinning feeling (vertigo).

being sick and weakness. If you forget to take a dose, take it as soon as you

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Uncommon (may affect up to 1 in 100 people) Swelling of the feet and ankles. Disturbed sleep (insomnia), feeling sleepy.

Skin rash, lumpy rash (hives) and itchy skin.

remember it, on the same day. Do not take a double

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

as diarrhoea, stomach ache, constipation, feeling or If you forget to take this medicine

Driving and using machines This medicine has a low likelihood of affecting your ability to drive or use machines. However, side

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Other side effects include:

either with food or on an empty stomach. ¢ Swallow your capsules whole with half a glass of

Tacrolimus (in cases of organ transplantation). St. John's wort (Hypericum perforatum) (used to

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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

recurring symptoms even after treatment with this medicine, you should contact your doctor.

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blood cells leading to immune deficiency. If you have|

you should consult a doctor. If you have persistent or longstanding, frequently

e You can take your capsule at any time of the day

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an infection with symptoms such as fever with a severely reduced general condition or fever with

that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you t give information about your medicine at this time.

after taking this medicine for 14 days in a row,

treat depression).

if you experience any of the following signs

of infection:

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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.

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Eyesight problems such as blurred vision.

Suddenly feeling wheezy or short of breath (bronchospasm). An inflammation on 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 pain (arthralgia) or muscle pain (myalgia). Generally feeling unwell and lacking energy. Increased sweating.

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Very rare (may affect up to 1 in 10,000 people) Low numbers of red blood cells, white blood cells, | and platelets (a condition called pancytopenia). Aggression. Seeing, feeling or hearing things that are not there | (hallucinations). Severe liver problems leading to liver failure and | inflammation of the brain. Muscle weakness.

Severe kidney problems. Enlarged breasts in men.