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DEXCEL HEARTBURN RELIEF 20 MG TABLETS

Active substance(s): OMEPRAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pyrocalm Control 20mg Gastro-Reistant Tablets

Text size 9pt
300x155mm

Omeprazole

(Referred to as Omeprazole Tablets throughout this leaflet)
Read all of this leaflet carefully before you start • You are on continuous symptomatic treatment of
indigestion or heartburn for 4 or more weeks.
taking this medicine because it contains important
• You continuously suffer from indigestion or heartburn
information for you.
for 4 or more weeks.
This medicine is available without prescription. However,
you still need to take Omeprazole Tablets carefully to get • You have jaundice or severe liver disease.
• You are aged over 55 years with new or recently
the best results from it.
changed symptoms.
Always take this medicine exactly as described in this
• You have ever had a skin reaction after treatment with
leaflet or as your doctor or pharmacist have told you.
a medicine similar to Omeprazole Tablets that reduces
- Keep this leaflet. You may need to read it again.
stomach acid.
- Ask your pharmacist if you need more information or
If you get a rash on your skin, especially in areas
advice.
- If you get any side effects, talk to your doctor or exposed to the sun tell your doctor as soon as you can,
pharmacist. This includes any possible side effects not as you may need to stop your treatment with Omeprazole
Tablets. Remember to also mention any other ill-effects
listed in this leaflet. (See section 4.)
- You must talk to a doctor if you do not feel better or if like pain in your joints.
Patients should not take omeprazole as a preventative
you feel worse after 14 days.
- If any of the side effects gets serious, or if you notice medication.
any side effect not listed in this leaflet, please tell your Other medicines and Omeprazole Tablets
doctor or pharmacist.
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
What is in this leaflet:
medicines obtained without a prescription. This is
1. What Omeprazole Tablets are and what they are
because Omeprazole Tablets can affect the way some
used for
medicines work and some medicines can have an effect
2. What you need to know before you take
on Omeprazole Tablets.
Omeprazole Tablets
3. How to take Omeprazole Tablets
Do not take Omeprazole Tablets if you are taking a
4. Possible side effects
medicine containing nelfinavir (used to treat HIV
5. How to store Omeprazole Tablets
infection).
6. Contents of the pack and other information
You should specifically tell your doctor or pharmacist if
1. WHAT OMEPRAZOLE TABLETS ARE AND WHAT you are taking clopidogrel (used to prevent blood clots
(thrombi)).
THEY ARE USED FOR
Omeprazole Tablets contain the active substance Tell your doctor or pharmacist if you are taking any of the
omeprazole. It belongs to a group of medicines called following medicines:
‘proton pump inhibitors’. They work by reducing the • Ketoconazole, itraconazole, posaconazole or
amount of acid that your stomach produces.
voriconazole (used to treat infections caused by a
Omeprazole Tablets are used in adults for the short-term
fungus)
treatment of reflux symptoms (for example, heartburn, • Digoxin (used to treat heart problems)
acid regurgitation).
• Diazepam (used to treat anxiety, relax muscles or in
Reflux is the backflow of acid from the stomach into
epilepsy)
the gullet “foodpipe”, which may become inflamed • Phenytoin (used in epilepsy). If you are taking
and painful. This may cause you symptoms such as a
phenytoin, your doctor will need to monitor you when
painful burning sensation in the chest rising up to the
you start or stop taking Omeprazole Tablets
throat (heartburn) and a sour taste in the mouth (acid • Medicines that are used to thin your blood, such as
regurgitation).
warfarin or other vitamin K blockers. Your doctor may
It might be necessary to take the tablets for 2-3
need to monitor you when you start or stop taking
consecutive days to achieve improvement of symptoms.
Omeprazole Tablets
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE • Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
OMEPRAZOLE TABLETS
• Tacrolimus (in cases of organ transplantation)
Do not take Omeprazole Tablets
• If you are allergic (hypersensitive) to omeprazole or • St John’s wort (Hypericum perforatum) (used to treat
mild depression)
any of the other ingredients of this medicine (listed in
• Cilostazol (used to treat intermittent claudication)
section 6).
• If you are allergic to medicines containing other proton • Saquinavir (used to treat HIV infection)
pump inhibitors (e.g. pantoprazole, lansoprazole, • Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high
rabeprazole, esomeprazole).
doses to treat cancer) - if you are taking a high dose of
• If you are taking a medicine containing nelfinavir (used
methotrexate, your doctor may temporarily stop your
for HIV infection).
Omeprazole treatment
Do not take Omeprazole Tablets if any of the above
applies to you. If you are not sure, talk to your doctor or Taking Omeprazole tablets with food and drink
pharmacist before taking Omeprazole Tablets.
You can take your tablets with food or on an empty
stomach.
Warnings and precautions
Do not take Omeprazole Tablets for more than 14 days Pregnancy, breast-feeding and fertility
without consulting a doctor. If you do not experience If you are pregnant or breast-feeding, think you may be
relief, or if you experience a worsening of symptoms, pregnant or are planning to have a baby, ask your doctor
consult your doctor.
or pharmacist for advice before taking this medicine.
Omeprazole Tablets may hide the symptoms of other Omeprazole is excreted in breast milk but is not likely
diseases. Therefore, if any of the following happen to to influence the child when therapeutic doses are used.
you before you start taking Omeprazole Tablets or while Your doctor will decide whether you can take Omeprazole
you are taking it, talk to your doctor straight away:
Tablets if you are breast-feeding.
• You lose a lot of weight for no reason and have
Driving and using machines
problems swallowing.
Omeprazole Tablets is not likely to affect your ability to
• You get stomach pain or indigestion.
drive or use any tools or machines. Side effects such
• You begin to vomit food or blood.
as dizziness and visual disturbances may occur (see
• You pass black stools (blood-stained faeces).
• You experience severe or persistent diarrhoea, as section 4). If affected, you should not drive or operate
omeprazole has been associated with a small increase machinery.
Omeprazole tablets contain Lactose
in infectious diarrhoea.
• You have had previous gastric ulcer or gastrointestinal Omeprazole Tablets contain lactose. If you have been
told by your doctor that you have an intolerance to some
surgery.

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 check with your doctor or
pharmacist if you are not sure.
The recommended dose is one 20 mg tablet 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.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
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.

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• 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, 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.
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 Tablets
contain 20 mg of Omeprazole. The other ingredients
are lactose monohydrate, sodium starch glycolate,
sodium stearyl fumarate, sodium stearate, hypromellose
acetate succinate, brownish pink colour (which contains
propylene glycol, titanium dioxide (E171), red iron oxide
(E172), hypromellose and yellow iron oxide (E172)), talc,
triethyl citrate, monoethanolamine, sodium lauryl sulfate
and traces of carnauba wax.
What Omeprazole Tablets looks like and contents of
the pack
Omeprazole 20 mg Gastro-Resistant Tablets are
brownish-pink film coated capsule shaped tablets.
Blisters of 7, 14 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 November 2015

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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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