ESOMEPRAZOLE 20 MG GASTRO-RESISTANT TABLETS, GUARDIUM ACID REFLUX CONTROL 20 MG GASTRO-RESISTANT TABLETS - patient leaflet, side effects, dosage

what it is used for

_ _ This medicine contains the active substance_eso­meprazole. Ifbelongs to a_group_of_ medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

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This medicine is used in adults for the short-term treatment of reflux symptoms (for example, heartburn and acid regurgitation).

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Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”) which may become inflamed and painful. This may cause you symptoms such as a painful sensation in the chest rising up to your throat (heartburn) anda sour taste in the mouth (acid regurgitation).

_ _ —This medicine js not meant to bring immediate relief. Youmay nee,d totake the _ _ tablets for 2–3 days in a row before you feel better. You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

2. what you need to know before you take guardium acid reflux control

20 mg gastro-resistant tablets

Do not take Guardium Acid Reflux Control 20 mg gastro-resistant tablets

• – If you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).

• – If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lanzoprazole, rabeprazole and omeprazole).

"- If you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• have had a stomach ulcer or stomach surgery in the past.
• have been taking treatment continuously for reflux or heartburn for 4 or more weeks.
• have jaundice (yellowing of skin or eyes) or severe liver problems.
• have severe kidney problems.
• are aged over 55 years and have new or recently changed reflux symptoms or need to take a non-prescription indigestion or heartburn remedy treatment every day.
• have ever had a skin reaction after treatment with a medicine similar to this medicine that reduces stomach acid.

Tell your doctor or pharmacist immediately before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious disease.

• _ — You losea lot of weight for "ho 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.
• 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.
• — —You get -a- rash on your skin.-especially- inareas -exposed to the sun.-YeHyour— 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.

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Seek urgent medical attention if you experience chest pain with light-headedness. sweating. dizziness or shoulder pain with shortness of breath. This could be a sign ofa serious condition with your heart.

Tell your doctor before taking this medicine. if:

• You are due to have an endoscopy or a urea breath test.
• You are due to have a specific blood test (Chromogranin A)

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^Ifanyoflheabo­veapply-to-you(or you ore_not3ure)._talk toyour doctorstraight _ away.

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Children and adolescents

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This medicine should not be used by children and adolescents under 18 years of age.

Other medicines and Guardium Acid Reflux Control 20 mg gastro-resistant tablets 1

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 this medicine can affect the way some medicines work and some – — —medicinescan -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 (e.g. pantoprazole. lansoprazole. rabeprazole or omeprazole) or an H2 antagonist (e.g. ranitidine or famotidine).

“You maydake this’medicihe'with antacids-Yig. magaldrate. alginic-acid. sodiumbicarbonate. aluminium hydroxide. magnesium carbonate or 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)
• Voriconazole (used to treat infections caused by a fungus) and clarithromycin (used to treat infections). Your doctor may adjust your dose of this medicine if you also have severe liver problems and are treated for a long period of time.
• Erlotinib (used to treat cancer)
• – — — —Methotrexate (used- tertreat caneerand-rheumatic disorders) — — — — — — —
• Digoxin (used for heart problems)
• Atazanavir. saquinavir (used to treat HIV infection)
• Citalopram. imipramine or clomipramine (used to treat depression)
• Diazepam (used to treat anxiety. relax muscles or in epilepsy)
• Phenytoin (used to treat epilepsy)
• 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
• Cilostazol (used to treat intermittent claudication – a condition where poor blood – — —I —supply to-the leg muscles-causes pain-and-difficulty-in-walking)— — — — — —
• Cisapride (used for indigestion and heartburn)
• Rifampicin (used to treat tuberculosis)
• Tacrolimus (in cases of organ transplantation)
• St. John’s wort (Hypericum perforatum) (used to treat depression)

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. As a precautionary measure. you should preferably avoid the use of this medicine _ _ —during pregnancy. You should not-use-this medicine-during breast-feeding. — — —

Driving and using machines

This medicine is not likely to affect your ability to drive or to use any tools or machines. However. side effects such as dizziness and visual disturbances may uncommonly occur (see section 4). If affected. you should not drive or use machines.

Guardium Acid Reflux Control 20 mg gastro-resistant tablets contains sucrose and lactose monohydrate

This medicine contains sugar spheres. which contain sucrose. a type of sugar. Please be aware that this medicine also contains a small amount of lactose. If you have been _ _ —told by your_doctorthat you have an intolerance-teL-some-sugars-ordo lactose. _ _ contact your doctor before taking this medicine.

Information on sodium content:

This medicine contains less than 1 mmol sodium (23 mg) per tablet. that is to say essentially ‘sodium-free’.

3. how to take guardium acid reflux control 20 mg gastro-resistant tablets always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. check with your doctor or pharmacist if you are not sure.

How much to take

– — —Adults aged-18_years-and-over:— — — — — — — — — — — — — — — — — – The recommended dose is one tablet a day.

• – Do not take more than this recommended dose of one tablet (20 mg) a day. even if you don’t feel an improvement immediately.

• – You may need to take the tablets for 2 or 3 days in a row before your reflux symptoms (for example. heartburn and acid regurgitation) get better.

• – The treatment length is up to 14 days.

• – When your reflux symptoms have completely gone you should stop taking this medicine.

_ _ – _If-your reflux symptoms-getworse-or-do.notimprove after taking this medicine— for 14 days in a row. you should consult a doctor.

Children and adolescents less than 18 years of age:

• – Do not give this medicine to children or adolescents under 18 years of age. 1

If you have persistent or longstanding. frequently recurring symptoms even after treatment with this medicine. you should contact your doctor.

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Taking this medicine

• – You can take your tablet at any time of the day either with food or on an empty stomach.

_ _ _- _Swalhow_your tablet whole witha glass of water. Do not chew or crushthe. tablet.

This is because the tablet 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.

Alternative method of taking this medicine

• – Put the tablet in a glass of still (non-fizzy) water. Do not use any other liquids.

• – Stir until the tablet breaks up (the mixture will not be clear) then drink the mixture straight away or within 30 minutes. Always stir the mixture just before drinking it.

-- 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 Guardium Acid Reflux Control 20 mg gastro-resistant tablets than you should

If you take more Guardium Acid Reflux Control 20 mg gastro-resistant tablets than recommended. talk to your doctor or pharmacist straight away. You may experience symptoms such as diarrhoea. stomach ache. constipation. feeling or being sick and weakness.

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- — —If-you forget to take-Guardium Acid- Reflux Control 20 mg gastro-resistant— — tablets

If you forget to take a dose. take it as soon as you remember it. on the same day. Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine. ask your doctor or pharmacist.

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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 serious side-effects, stop-taking this-medicine-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. 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 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.

_ _ _Talk-to your doctor as soon- as-possibleif youexperience any-of-the-following _ signs of infection:

This medicine 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.

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Other side effects include:

~Common(mavaf­fectupToTin~10~pe­ople) ~

• – Headache.

• – Effects on your stomach or gut: diarrhoea. stomach ache. constipation. wind (flatulence).

• – Feeling sick (nausea) or being sick (vomiting).

• – Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• – Swelling of the feet and ankles.

• – Disturbed sleep (insomnia). feeling sleepy.

• – Dizziness. tingling feelings such as “pins and needles”.

• – Spinning feeling (vertigo).

• – Dry mouth.

• – Changes in blood tests that check how the liver is working.

• – Skin rash. lumpy rash (hives) and itchy skin.

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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 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).

• – 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

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

• – Low levels of magnesium in the blood. This may cause weakness. being sick (vomiting). cramps. tremor and changes in heart rhythm (arrhythmias). If you have very low levels of magnesium. you may also have low levels of calcium and/or potassium in your blood.

• – Inflammation ofthe gut (leading to diarrhoea).

• – — Rash/possibly-with painYn the-foints-

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 or search for MHRA Yellow Card in the Google Play or Apple App. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store guardium acid reflux control 20mg gastro-resistant tablets 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 carton and the blister after “EXP”. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and 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 Guardium Acid Reflux Control 20mg gastro-resistant tablets contains

• The active substance is esomeprazole. Each gastro-resistant tablet contains 20 mg 1 esomeprazole (as esomeprazole magnesium).
• The other ingredients are: Microcrystalline cellulose. Macrogol 8000. Lactose monohydrate. Talc (E 553b). Methacrylic acid-ethyl acrylate copolymer. Copovidone K 28. Crospovidone. Sucrose. Povidone K 90. Maize starch. Magnesium oxide. light (E 530). Silica colloidal. anhydrous. Magnesium stearate. Diethyl phthalate. Polysorbate 80. Ethylcellulose. Sodium laurilsulfate. Hypromellose (E464). Titanium dioxide (E 171). Iron oxide red (E172). Shellac glaze. Iron oxide black (E172) and Propylene glycol.

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What Guardium Acid Reflux Control 20 mg gastro-resistant tablets looks like - — —and contents of the pack — — — — — — — — — — — — — — — — — —

Guardium Acid Reflux Control 20 mg gastro-resistant tablets are Brick-red coloured. round shape. biconvex. film-coated tablet. imprinted with “20” on one side and plain on the other side.

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This medicine is available in pack sizes of 7 and 14 gastro-resistant tablets in blisters.

Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer

Torrent Pharma (UK) Ltd. 3rd Floor. Nexus Building. 4 Gatwick Road. Crawley.

West Sussex. RH10 9BG. United Kingdom

“Distributedbyi ”

RB UK Commercial Ltd. 103–105 Bath Road. Slough SL1 3UH. United Kingdom PL 36687/0395

This leaflet was last issued in 01/2022

Further helpful information

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What are the symptoms of heartburn?

The normal symptoms of reflux are a painful sensation in the chest rising up to your throat (heartburn) and a sour taste in the mouth (acid regurgitation).

Why do you get these symptoms?

Heartburn can be a result of eating too much. eating high fat food. eating too quickly and drinking lots of alcohol. You may also notice that when you lie down. that your heartburn gets worse. If you are overweight or smoke you increase the probability of suffering from heartburn.

What can I do to help relieve my symptoms?

• Eat healthier food and try to avoid spicy and fatty foods and large meals late before bedtime.
• Avoid fizzy drinks. coffee. chocolate and alcohol.
• Eat slowly and eat smaller portions.
• Try to lose weight.
• Stop smoking.