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DEXCEL REFLUX RELIEF 10MG TABLETS

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PIL – FINAL TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXCEL REFLUX RELIEF 10 mg TABLETS
OMEPRAZOLE
Read all of this leaflet carefully 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 result from it.
S

S

- 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.
2.
3.
4.
5.
6.

What Omeprazole tablets are and what are they used for
Before you take Omeprazole tablets
How to take Omeprazole tablets
Possible side effects
How to store Omeprazole tablets
Further information

1. WHAT OMEPRAZOLE TABLETS ARE AND WHAT ARE THEY 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 is 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.
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)

If you are not sure, talk to your doctor or pharmacist before taking Omeprazole
tablets.

Take special care with Omeprazole tablets
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 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 omeprazole 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 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 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 and breast-feeding
Before taking Omeprazole tablets, tell your doctor or pharmacist if you are pregnant or
trying to get pregnant. Your doctor will decide whether you can take Omeprazole tablets
during this time.

Your doctor will decide whether you can take Omeprazole tablets if you are
breastfeeding.
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.
Important information about some of the ingredients of Omeprazole tablets
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.
2. 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 usual 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 entering 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 ‘StevensJohnson 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
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind
(flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon side effects
• 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
• 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
• 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 magnesium in the blood).

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
Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

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. FURTHER INFORMATION
What Omeprazole tablets contains

Each gastro-resistant coated tablet contains Omeprazole 10mg, which is the active
ingredient.
As well as the active ingredient, the tablets also contain 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 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 May 2013

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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