What you need to know before you take it

e low levels of Vitamin B12: Acid Reflux Capsules. Extreme tiredness or lack of energy

How to take it

Acid Reflux Capsules. Pins and needles e Possible side effects. Sore or red tongue, mouth ulcers

Possible side effects

, although not everybody gets them. If you notice any of the following rare (may affect up to1 in 1,000 peo le) or very rare (may affect up to | in 10,000 people) but serious side effects, stop taking Acid Reflux Capsules and contact a doctor immediately: Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (signs of a severe allergic reaction) Reddening of the skin with blisters or peeling. There may also be severe blisters and pieeding of the lips, eyes, mouth, nose or genitals. This could be 'Stevens-Johnson syndrome or 'toxic epidermal necrolysis' Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) Yellow skin (jaundice), dark urine and tiredness which can be symptoms of liver problems. Other side effects include: Common side effects (may affect up to1 in 10 people): Headache Diarrhoea, stomach pain, constipation, wind (flatulence) Feeling sick (nausea) or being sick (vomiting) Benign polyps in the stomach (symptoms may include stomach tenderness, blood in your stools or anaemia). Uncommon side effects (may affect up to 1in 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 Fractures of the hip, wrist and spine. 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 Blurred vision Suddenly feeling wheezy or short of breath (bronchospasm) Dry, inflamed or sore mouth An infection called "thrush" which can affect the stomach and is caused by a fungus Hair loss (alopecia) Increased sensitivity of skin to sunlight, causing redness, itching, swelling or blistering Swollen or painful joints (arthralgia) or muscle aches and tenderness (myalgia) Severe kidney problems (interstitial nephritis) Increased sweating.

eflux Capsules treatment.

• You experience severe or persistent

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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) Clarithromycin (used to treat infections) Digoxin (used to treat heart problems) Diazepam (used to treat anxiety, relax muscles or in epilepsy) Phenytoin (used in epilepsy) 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 Acid eflux Capsules Rifampicin (used to treat tuberculosis) Atazanavir, saquinavir (used to treat HIV infection) Tacrolimus (used in cases of organ transplantation) St John's wort (Hypericum perforatum) (used to treat mil depression) Cilostazol (used to treat intermittent claudication) 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 Acid:

Warnings and precautions

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To make sure that you have taken 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 Acid Reflux Capsules than you should If you take more capsules than recommended, talk to your doctor or pharmacist straight away. You may experience symptoms such as diarrhoea, stomach ache, feeling or being sick, dizziness, headache, depression, confusion and apathy (lack of motivation). If you forget to take Acid Reflux Capsules 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 to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

You should specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots (thrombi).

you take Acid Reflux Capsules

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It might be necessary to take the capsules for 2-3 consecutive days to achieve improvement of symptoms. Do not take more than the recommended dose (one 20mg capsule a day) even if you don't feel an improvement immediately. When your reflux symptoms have gone completely you should stop taking this medicine. Do not take this medicine if you do not have symptoms of reflux (e.g. heartburn or acid regurgitation). 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 have trouble swallowing the capsules If you 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

One-a-day Acid Reflux Relief 20mg Gastro Resistant Capsules

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Very rare side effects (may affect up tol | in 10,000 people): 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)

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Hypomagnesaemia (low level of magnesium in the blood) Rash, possibly with pain in the joints. ! Acid Reflux Capsules 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 ack of white blood cells (agranulocytosis) | can be ruled out by ablood 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 ossible side effects not listed in this eaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 satety of this medicine.

5, How to store Acid Reflux

Capsules

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 after 'EXP'. The expiry date refers to the last day of that month, Do not store above 25°C.

Store in the original package 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 elp protect the environment.

How to store it

Acid Reflux Capsules. Muscle weakness ! 6. Contents of the pack and other Disturbed vision ! information. Problems with memory, confusion, depression 1. What Acid Reflux Capsules are Do not take this medicine if youdo not -! and what they are used for have symptoms of reflux (e.g. heartburn or ' This medicine contains the active acid regurgitation). substance omeprazole. It belongs to a group of medicines called 'proton pump Children and adolescents ! inhibitors'. It works by reducing the This medicine should not be used by amount of acid that your stomach children and adolescents under 18 years of; produces. age. The capsules are used in adults for the Other medicines and Acid Reflux short-term treatment of reflux symptoms Capsules (for example, heartburn, acid Tell your doctor or pharmacist if you are | regurgitation). taking, have recently taken or mighttake | any other medicines. This includes Reflux is the backflow of acid from the stomach into the gullet "foodpipe" which medicines that you buy without a may become inflamed and painful. This prescription. This is because this medicine ! may cause you symptoms such as a can affect the way some medicines work, painful burning sensation in the chest and some medicines can have an effect rising up to the throat (heartburn) and a on these capsules. sour taste in the mouth (acid Do not take Acid Reflux Capsules if you regurgitation). are taking any of the following medicines: This medicine is not meant to bring Nelfinavir (used to treat HIV infection) immediate relief. It might be necessary to Medicines that reduce stomach acid such take the capsules for 2-3 consecutive days as other proton pump inhibitors (e.g. to achieve improvement of symptoms. pantoprazole, rabeprazole or You must talk to a doctor if you do not feel esomeprazole) or an H2 antagonist (e.g. better or if you feel worse after 14 days. ranitidine or famotidine).

you need to know before

Do not take Acid Reflux Capsules if you are:

• Allergic (hypersensitive) to omeprazole or any of the other ingredients of this medicine (listed in section 6)
• Allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• Taking a medicine containing nelfinavir (used for HIV infection). Do not take Acid Reflux Capsules if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Talk to your doctor or pharmacist before taking Kei Reflux Capsules if:
• You are due to have a specific blood test (Chromogranin A)
• You are due to have an endoscopy or a urea breath test
• Your body does not absorb vitamin B12 very well (cobalamin deficiency). 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. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4. Do not take Acid Reflux Capsules for more than 14 days without consulting a doctor. If you do not experience relief, or if you experience a worsening of symptoms, consult your doctor. Acid Reflux Capsules may hide the signs and symptoms of other conditions. Therefore, if you notice any of the following while you are taking this medicine, talk to your doctor straight awoy:
• You lose a lot of weight for no reason and have problems swallowing
• You get stomach pain or signs of indigestion (such as nausea, fullness, bloating especially after eating) You begin to vomit food or blood You pass black stools (blood-stained faeces)

Acid Reflux Capsules with food, drink and

alcohol

You can take your capsules with food or on, an empty stomach. Omeprazole isnot -! recommended to be taken with alcohol. Pregnancy, breast-feeding and fertility Before taking this medicine, tell your doctor or pharmacist if you are pregnant or trying :

to get pregnant. Your doctor willdecide whether you can take these capsules during this time. 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 this medicine if you are breast-feeding. There is no evidence that this medicine has, any effect on fertility. ! Driving and using machines This medicine 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. ! Information on sucrose and sodium

diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea

• You have ever had a skin reaction after treatment with a medicine similar to Acid ReMux Capsules that reduces stomach aci
• You have had previous gastric ulcer or

content

This medicine contains sucrose. If you have: been told by your doctor that you have an | intolerance to some sugars, contact your

• You are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• You continuously suffer from indigestion or heartburn for 4 or more weeks You have jaundice or severe liver disease You are aged over 59 years with new or recently changed symptoms. 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 bee

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doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially "sodium free'. !

gastrointestinal surgery

. How to take Acid Reflux

Capsules Always take this medicine exactly as

described in this leaflet or as your doctor or

pharmacist has told you. Check with your doctor or pharmacist if you are not sure. | The recommended dose is one 20mg ! capsule once a day for up to 14 days. Contact your doctor if you are not free from! EEE

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Like all medicines, this medicine can cause

Contents of the pack and other information

What Acid Reflux Capsules contain The active substance is omeprazole. Acid Reflux Capsules contain 20mg of omeprazole. The other ingredients are maize starch, sucrose, magnesium hydroxide, disodium phosphate, ypromellose, sodium aurilsulfate, mannitol, sodium starch glycolate, talc, titanium dioxide (E171), macrogol, polysorbate, methacrylic acid-ethyl acrylate copolymer, FD&C Blue 2 (E132) (Indigotine), gelatin. What Acid Reflux Capsules look like and contents of the pack Acid Reflux Capsules are hard gelatin capsules with a blue cap and white body, containing white to off-white or cream spherical pellets. The pack contains 7 or 14 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Maxwellia Ltd., Alderley Park, Alderley Edge, Cheshire, SKI0 41G, UK. Manufacturer: Laboratorios Liconsa, S.A., Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain. Distributed by: Ine Boots Company PLC Nottingham NG2 This leaflet was prepared in February 2025. Further Helpful Information 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 notice that when you lie down your heartburn gets worse. If you are overweight or smoke, you increase the chance of suffering from heartburn. What can | do to help relieve my symptoms? 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. When should | seek advice or help? You should seek urgent medical advice if ou experience chest pain with

ight-headedness, sweating, dizziness or shoulder pain with shortness of breath If you experience any of the symptoms

detailed in Section 2 of this leaflet and it

advises you to talk to your doctor or pharmacist If you are suffering from any of the side effects detailed in Section 4 which require medical attention. Reference number: PL 42807/0005.

If you would like any further information about this medicine, please contact The Backs Company PLC Nottingham NG2

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