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DEXCEL HEARTBURN RELIEF 10 MG TABLETS

Active substance(s): OMEPRAZOLE / OMEPRAZOLE / OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

HEARTBURN RELIEF 10mg TABLETS
Omeprazole

(Referred to as Omeprazole tablets throughout this leaflet)

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you. This medicine is available without prescription.
However, you still need to take Omeprazole tablets carefully to get the best results from it.
Always take this medicine exactly as described in this leaflet or as your doctor or
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 effects not listed in this leaflet. (See section 4.)
• You must talk to a doctor if you do not feel better or if you feel worse 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.
What is in this Leaflet:
1. What Omeprazole tablets are and what they are used for
2. What you need to know before you take Omeprazole tablets
3. How to take Omeprazole tablets
4. Possible side effects
5. How to store Omeprazole tablets
6. Contents of the pack and other information
1. WHAT OMEPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Omeprazole gastro-resistant tablets 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.
Omeprazole 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OMEPRAZOLE TABLETS
Do not take Omeprazole tablets
• If you are allergic (hypersensitive) to omeprazole or any of the other ingredients of
Omeprazole 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).
Do not take Omeprazole tablets if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before taking Omeprazole tablets.
Warnings and precautions
Tell your doctor before taking this medicine, if:
• You are due to have a specific blood test (Chromogranin A)
Do not take Omeprazole 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.
Omeprazole tablets may hide the symptoms of other diseases. Therefore, if any of
the following happen to you before you start taking Omeprazole tablets or while you
are taking them, 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.
• You have ever had a skin reaction after treatment with a medicine similar to Omeprazole
tablets that reduces stomach acid.
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 stop your treatment with Omeprazole tablets.
Remember to also mention any other ill-effects like pain in your joints.
Patients should not take Omeprazole as a preventative medication.
Other medicines and Omeprazole tablets
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 Omeprazole tablets can affect the way some medicines work and some
medicines can have an effect on Omeprazole tablets.
Do not take Omeprazole tablets if you are 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 (thrombi)).
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)
• 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 Omeprazole 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
Omeprazole 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 doses to treat cancer) – if you are
taking a high dose of methotrexate, your doctor may temporarily stop your Omeprazole
tablets treatment
Taking Omeprazole tablets with food and drink
You can take your tablets with food or on an empty stomach.
Pregnancy, breast-feeding and fertility
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.
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 Omeprazole tablets if you are
breast-feeding.
Driving and using machines
Omeprazole 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.
Omeprazole tablets contain
Omeprazole 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.
3. HOW TO TAKE OMEPRAZOLE TABLETS
Always take Omeprazole tablets exactly as described in this leaflet. You should

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check with your doctor or pharmacist if you are not sure.
The recommended dose is one 20 mg tablet or 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 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 Omeprazole tablets than you should
If you take more Omeprazole tablets than recommended, talk to your doctor or
pharmacist straight away
.
If you forget to take Omeprazole 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Omeprazole tablets can cause side effects, although not
everybody gets them.
If you notice any of the following rare but serious side effects, stop taking
Omeprazole 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 (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).
Uncommon side effects (may affect up to 1 in 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.
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.
• 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.
• Inflammation in the gut (leading to diarrhoea).
Very rare side effects (may affect up to 1 in 10,000 people )
• 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).
Not Known (Frequency cannot be estimated from the available data)
• Rash, possibly with pain in the joints.
Omeprazole 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 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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE OMEPRAZOLE TABLETS
• Keep out of the reach and sight of children.
• Do not use Omeprazole 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Omeprazole tablets contains
The active substance is Omeprazole. Omeprazole gastro-resistant tablets contain 10
mg of Omeprazole. The other ingredients are: lactose monohydrate, sodium starch
glycolate, sodium stearate, sodium stearyl furmarate, 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 Omeprazole tablets looks like and contents of the pack
Omeprazole 10 mg gastro resistant tablets are brownish-pink film coated capsule
shaped tablets.
Blisters of 7, 14, 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK.
This leaflet was last revised in August 2016
V18-160822

Heartburn Relief Omeprazole PIL

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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