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Boots Acid Reflux 10 mg Gastro-Resistant Tablets

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THE BOOTS COMPANY PLC


1 Thane Road WestBeestonNottinghamNG2 3AA
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Acid Reflux 10mg Gastro-Resistant Tablets

(Omeprazole)

Read all of this leaflet carefully before you start taking this medicine.

This medicine is available without prescription. However, you still need to take Acid Reflux Tablets carefully to get the best results.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • You must contact a doctor if your symptoms worsen or do not improve after 14 days.
  • If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Acid Reflux Tablets are and what are they used for
2. Before you take Acid Reflux Tablets
3. How to take Acid Reflux Tablets
4. Possible side effects
5. How to store Acid Reflux Tablets
6. Further information

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1. WHAT ACID REFLUX TABLETS ARE AND WHAT ARE THEY USED FOR

Acid Reflux gastro-resistant tablets contain 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.

Acid Reflux Tablets are used in adults for the short-term treatment of reflux symptoms (for example, heartburn, acid regurgitation).

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 burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).

It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.

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2. BEFORE YOU TAKE ACID REFLUX TABLETS

Do not take Acid Reflux Tablets

  • If you are allergic (hypersensitive) to Omeprazole or any of the other ingredients of Acid Reflux Tablets
  • If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
  • If you are taking a medicine containing nelfinavir (used for HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Acid Reflux Tablets.

Take special care with Acid Reflux Tablets

Do not take Acid Reflux Tablets 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 Tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Acid Reflux Tablets or while you are taking it, talk to your doctor straight away:

  • You lose a lot of weight for no reason and have problems swallowing.
  • You get stomach pain or indigestion.
  • You begin to vomit food or blood.
  • You pass black stools (blood-stained faeces).
  • You experience severe or persistent diarrhoea, as omeprazole has been associated with a small increase in infectious diarrhoea.
  • You have had previous gastric ulcer or gastrointestinal surgery.
  • 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 55 years with new or recently changed symptoms.

Patients should not take Acid Reflux Tablets as a preventative medication.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Acid Reflux Tablets can affect the way some medicines work and some medicines can have an effect on Acid Reflux Tablets.

Do not take Acid Reflux Tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a fungus)
  • Digoxin (used to treat heart problems)
  • Diazepam (used to treat anxiety, relax muscles or in epilepsy)
  • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Acid Reflux Tablets
  • 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 Reflux Tablets
  • Rifampicin (used to treat tuberculosis)
  • Atazanavir (used to treat HIV infection)
  • Tacrolimus (in cases of organ transplantation)
  • St John's wort (Hypericum perforatum) (used to treat mild depression)
  • Cilostazol (used to treat intermittent claudication)
  • Saquinavir (used to treat HIV infection)
  • Erlotinib (used to treat cancer)
  • Methotrexate (a chemotherapy medicine used in high amounts to treat cancer). If you are taking high amounts of methotrexate, your doctor may temporarily stop this treatment

Taking Acid Reflux Tablets with food and drink

You can take your tablets with food or on an empty stomach.

Pregnancy and breast-feeding

Before taking Acid Reflux Tablets, tell your doctor or pharmacist if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Acid Reflux Tablets during this time.

Your doctor will decide whether you can take Acid Reflux Tablets if you are breastfeeding.

Driving and using machines

Acid Reflux Tablets 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.

Important information about some of the ingredients of Acid Reflux Tablets

Acid Reflux Tablets 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.

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3. HOW TO TAKE ACID REFLUX TABLETS

Always take Acid Reflux Tablets exactly as described in this leaflet. You should check with your doctor or pharmacist if you are not sure.

The usual dose is two 10 mg tablets once a day for 14 days. Contact your doctor if you are not free from symptoms after this period.

It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.

Taking this medicine

  • It is recommended that you take your tablets in the morning.
  • You can take your tablets with food or on an empty stomach.
  • Swallow your tablets whole with half a glass of water. Do not chew or crush the tablets. This is because the tablets are coated with an enteric coating which stops the medicine from being broken down by the acid in your stomach. The tablets release the active ingredient in the intestine, where it is absorbed by your body to give an effect.

If you take more Acid Reflux Tablets than you should

If you take more Acid Reflux Tablets than recommended, talk to your doctor or pharmacist straight away.

If you forget to take Acid Reflux Tablets

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.

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Acid Reflux Tablets can cause side effects, although not everybody gets them.

If you notice any of the following rare but serious side effects, stop taking Acid Reflux Tablets 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

(affects 1 to 10 users in 100)

  • Headache.
  • Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
  • Feeling sick (nausea) or being sick (vomiting).

Uncommon side effects

(affects 1 to 10 users in 1,000)

  • 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.

Rare side effects

(affects 1 to 10 users in 10,000)

  • 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 of the inside of the 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.

Very rare side effects

(affects less than 1 user in 10,000)

  • 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 the 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.
  • Hypomagnesaemia (low level of magnesium in the blood).

Acid Reflux Tablets 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.

Do not be concerned by this list of possible side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

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5. HOW TO STORE ACID REFLUX TABLETS

  • Keep out of the reach and sight of children.
  • Do not use Acid Reflux Tablets after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
  • Do not store above 30°C.
  • Store this blister in the original package in order to protect from moisture.
  • 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.
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6. FURTHER INFORMATION

What Acid Reflux Tablets contains

The active substance is Omeprazole. Acid Reflux Tablets contain 10 mg of Omeprazole. The other ingredients are: lactose monohydrate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, hypromellose acetate succinate, talc, triethyl citrate, monoethanolamine, sodium laurilsulfate, brownish pink colour (containing propylene glycol, titanium dioxide (E171),red iron oxide (E172), hypromellose and yellow iron oxide (E172)) and carnauba wax.

What Acid Reflux Tablets looks like and contents of the pack

Acid Reflux Omeprazole 10 mg gastro-resistant tablets are brownish pink film coated capsule-shaped tablets.

The pack contains 14 or 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Dexcel-Pharma Ltd.
7 Sopwith Way
Drayton Fields
Daventry
Northamptonshire
NN11 8PB
UK

Distributed by:

The Boots Company PLC
Nottingham
NG2 3AA
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This Leaflet was last revised in June 2013


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