ESOMEPRAZOLE 40 MG GASTRO-RESISTANT TABLETS

Active substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PIL-606UK_ESO_V5.qxp

21/05/2012

11:37

Page 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 20 mg gastro-resistant tablets
Esomeprazole 40 mg gastro-resistant tablets
Esomeprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Esomeprazole is and what it is used for
2. What you need to know before you take Esomeprazole
3. How to take Esomeprazole
4. Possible side effects
5. How to store Esomeprazole
6. Contents of the pack and other information
1. WHAT ESOMEPRAZOLE IS AND WHAT IT IS USED FOR
Esomeprazole contains a medicine called esomeprazole. This belongs
to a group of medicines called "proton pump inhibitors". They work by
reducing the amount of acid that your stomach produces.
Esomeprazole is used to treat the following conditions:
Adults and young people aged 12 years and above
• Gastro-oesophageal reflux disease' (GORD). This is where acid from
the stomach escapes into the gullet (the tube which connects your
throat to your stomach) causing pain, inflammation and heartburn.
• Ulcers in the stomach or upper part of the gut (intestine) that are
infected with bacteria called 'Helicobacter pylori'. If you have this
condition, your doctor may also prescribe antibiotics to treat the
infection and allow the ulcer to heal.
Adults
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs). Esomeprazolecan also be used to stop
stomach ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison syndrome).
• Prolonged treatment after prevention of rebleeding of ulcers with
intravenous Esomeprazole.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ESOMEPRAZOLE
Do not take Esomeprazole
- If you are allergic to esomeprazole or any of the other ingredients of
this medicine (listed in section 6).
- If you are allergic to other proton pump inhibitor medicines.
- If you are taking a medicine containing nelfinavir (used to treat HIV).
Do not take Esomeprazole if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Esomeprazole.
Warnings and precautions
Check with your doctor or pharmacist before taking Esomeprazole:
- If you have severe liver problems.
- If you have severe kidney problems.
Esomeprazole may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you
start taking Esomeprazole or while you are taking them,
talk to your doctor straight away:
- If you lose a lot of weight for no reason and have problems
swallowing.
- If you get stomach pain or indigestion.
- If you begin to vomit food or blood.
- If you pass black stools (blood-stained faeces).
If you have been prescribed Esomeprazole "on demand" you should
contact your doctor if your symptoms continue or change in character.
Taking a proton pump inhibitor like Esomeprazole, especially over
a period of more than one year, may slightly increase your risk of
fracture in the hip, wrist or spine. Tell your doctor if you have
osteoporosis or if you are taking corticosteroids (which can
increase the risk of osteoporosis).
Other medicines and Esomeprazole
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. This is because Esomeprazole can
affect the way some medicines work and some medicines can have
an effect on Esomeprazole.
Do not take Esomeprazole if you are taking a medicine containing
nelfinavir (used to treat HIV).
Tell your doctor or pharmacist if you are taking any of the following
medicines:
- Atazanavir (used to treat HIV).
- Ketoconazole, itraconazole or voriconazole (used to treat infections
caused by a fungus).
- Citalopram, imipramine or clomipramine (used to treat depression).
- 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 Esomeprazole.

- Medicines that are used to thin your blood, such as warfarin.
Your doctor may need to monitor you when you start or stop
taking Esomeprazole.
- Cisapride (used for indigestion and heartburn).
- Digoxin (used to treat heart failure).
If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Esomeprazole to treat ulcers caused by
Helicobacter pylori infection, it is very important that you tell your
doctor about any other medicines you are taking.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you might be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine. Your doctor will decide whether you can
take Esomeprazole during this time. It is not known if Esomeprazole
passes into breast milk. Therefore, you should not take Esomeprazole
if you are breastfeeding.
Esomeprazole with food and drink
Esomeprazole may be taken with or without food.
Driving and using machines
Esomeprazole is not likely to affect you being able to drive or use any
tools or machines.
3. HOW TO TAKE ESOMEPRAZOLE
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
- Esomeprazole is not recommended for children less than 12 years old.
- If you are taking this medicine for a long time, your doctor will want
to monitor you (particularly if you are taking it for more than a year).
- If your doctor has told you to take this medicine as and when you
need it, tell your doctor if your symptoms change.
Taking this medicine
- You can take your tablets at any time of the day.
- You can take your tablets with food or on an empty stomach.
- Swallow your tablets whole with a drink of water. Do not chew or
crush the tablets. This is because the tablets 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 tablets
• If you have trouble swallowing the tablets:
- Put them into a glass of still (non-fizzy) water. Do not use any other
liquids.
- Stir until the tablets break up (the mixture will not be clear).
Then drink the mixture straight away or within 30 minutes. Always
stir the mixture just before drinking it.
- To make sure that you have drunk 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 cannot swallow at all, the tablet can be mixed with some
water and put into syringe. It can then be given to you through a
tube directly into your stomach ("gastric tube").
How much to take
• Your doctor will tell you how many tablets to take and how long to
take them for. This will depend on your condition, how old you are
and how well your liver works.
• The recommended dose is:
To treat heartburn caused by gastro-oesophageal reflux
disease (GORD)
Adults and children aged 12 or above:
• If your doctor has found that your food pipe (gullet) has been
slightly damaged, the usual dose is one Esomeprazole 40 mg
gastro-resistant tablet once a day for 4 weeks.
Your doctor may tell you to take the same dose for a further 4
weeks if your gullet has not yet healed.
• The usual dose once the gullet has healed is one Esomeprazole
20 mg gastro-resistant tablet once a day.
• If your gullet has not been damaged, the usual dose is one
Esomeprazole 20 mg gastro-resistant tablet each day. Once the
condition has been controlled, your doctor may tell you to take
your medicine as and when you need it, up to a maximum of one
Esomeprazole 20 mg gastro-resistant tablet each day.
• If you have severe liver problems, your doctor may give you a lower
dose.
To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back
• Adults aged 12 or above: the usual dose is one Esomeprazole 20 mg
gastro-resistant tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics called amoxicillin
and clarithromycin.
10289
PC 300

PIL-606UK_ESO_V5.qxp

21/05/2012

11:37

Page 3

To treat stomach ulcers caused by NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs)
• Adults aged 18 and above: the usual dose is one Esomeprazole
20 mg gastro-resistant tablet once a day for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs)
• Adults aged 18 and above: the usual dose is one Esomeprazole
20 mg gastro-resistant tablet once a day.
To treat too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome)
• Adults aged 18 and above: the usual dose is one Esomeprazole
40 mg gastro-resistant tablet twice a day.
• Your doctor will adjust the dose depending on your needs and
will also decide how long you need to take the medicine for.
The maximum dose is 80 mg twice a day.
Prolonged treatment after prevention of rebleeding of ulcers
with intravenous esomeprazole
• The usual dose is one Esomeprazole 40 mg gastro-resistant tablet
once a day for 4 weeks.
If you take more Esomeprazole than you should
If you take more Esomeprazole than prescribed by your doctor,
talk to your doctor or pharmacist straight away.
If you forget to take Esomeprazole
• 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 (two doses at the same time) 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, this medicine can cause side effects, although
not everybody gets them.
If you get any of the following serious side effects, stop taking
Esomeprazole and contact a doctor immediately:
• Sudden wheezing, swelling of your lips, tongue and throat or body,
rash, fainting or difficulties to swallow (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.
These effects are rare, affecting less than 1 in 1,000 people.
Other side effects include:
Very common: Affects more than 1 user in 10
Common:
Affects 1 to 10 users in 100
Uncommon:
Affects 1 to 10 users in 1,000
Rare:
Affects 1 to 10 users in 10,000
Very rare:
Affects less than 1 user in 10,000
Not known:
Frequency cannot be estimated from available data
Common
• Headache.
• Effects on your stomach or gut: diarrhoea, stomach pain,
constipation, wind (flatulence).
• Feeling sick (nausea) or being sick (vomiting).
Uncommon
• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling feelings such as "pins and needles",
feeling sleepy.
• Spinning feeling (vertigo).
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Skin rash, lumpy rash (hives) and itchy skin.
• Fracture of the hip, wrist or spine.
Rare
• 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.
• Eyesight problems such as blurred vision.
• Suddenly feeling wheezy or short of breath (bronchospasm).
• 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).
• Generally feeling unwell and lacking energy.
• Increased sweating.

Very rare
• 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 extensive brain
dysfunction.
• 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.
• Severe kidney problems.
• Enlarged breasts in men.
Esomeprazole 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 medication at this time.
Not Known
If you are on Esomeprazole for more than three months it is possible
that the levels of magnesium in your blood may fall. Low levels of
magnesium can be seen as fatigue, involuntary muscle contractions,
disorientation, convulsions, dizziness, increased heart rate. If you get
any of these symptoms, please tell your doctor promptly. Low levels of
magnesium can also lead to a reduction in potassium or calcium levels
in the blood. Your doctor may decide to perform regular blood tests to
monitor your levels of magnesium.
Do not be concerned by this list of possible side effects. You may not
get any of them. If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this leaflet.
5. HOW TO STORE ESOMEPRAZOLE
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 packaging. The expiry date refers to the last day of that month.
Do not store above 25ºC.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. CONTENTS OF THE PACK AND INFORMATION
What Esomeprazole contains,
Each gastro-resistant tablet, contains 20 mg esomeprazole
(as magnesium dihydrate).
Each gastro-resistant tablet, contains 40 mg esomeprazole
(as magnesium dihydrate).
The other ingredients are:
Tablet core:
Mannitol (E421); Cellulose, Microcrystalline; Sodium Laurilsulfate;
Hydroxypropylcellulose; Talc (E553b); Methacrylic Acid-Ethyl Acrylate
copolymer 1:1, dispersion 30%; Propylene Glycol; Triethyl Citrate;
Polysorbate 80; Glycerol Monostearate 40-55; Silica Colloidal
Anhydrous; Hypromellose; Magnesium Stearate; Calcium Hydrogen
Phosphate Dihydrate; Crospovidone.
Tablet coating:
Hypromellose 15cP (E464); Titanium Dioxide (E171); Polydextrose
(E1200); Talc (E553b); Maltodextrin; Triglycerides, Medium Chain;
Iron Oxide Yellow (E172); Iron Oxide Red (E172).
What Esomeprazole looks like and contents of the pack
Esomeprazole 20mg gastro-resistant tablets are light pink, oblong,
biconvex, film-coated tablets, with "20" engraved on one side and
dimensions of approximately 14.9 x 7.6 mm.
Esomeprazole 40mg gastro-resistant tablets are pink, oblong,
biconvex, film coated tablets, with "40" engraved on one side
and dimensions of approximately 17.2 x 8.7 mm.
The tablets are available in boxes of 7, 14, 15, 28, 30, 50, 56, 60,
90, 98 and 100 tablets in OPA/Aluminium/PVC/Aluminium blisters.
The blisters are subsequently packed into cardboard boxes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Specifar S.A.
1, 28 Octovriou str.,
Ag. Varvara 123 51
Athens, Greece
This leaflet was last revised in
08/2012

10289
PC 300

Expand view ⇕

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.

Hide
(web2)