MEZZOPRAM 40 MG DISPERSIBLE GASTRO-RESISTANT TABLETS

Active substance: OMEPRAZOLE MAGNESIUM

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PACKAGE LEAFLET : INFORMATION FOR THE USER

Mezzopram 10 mg Dispersible Gastro-resistant Tablets
Mezzopram 20 mg Dispersible Gastro-resistant Tablets
Mezzopram 40 mg Dispersible Gastro-resistant Tablets

SZ00000LT000

Omeprazole

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1. What Mezzopram is and what it is used for
2. What you need to know before you take Mezzopram
3. How to take Mezzopram
4. Possible side effects
5. How to store Mezzopram
6. Contents of the pack and other information

1

What Mezzopram is and what it is used for

Mezzopram Dispersible Gastro-resistant Tablets contain the
active substance omeprazole. It belongs to a group of medicines
called ʻproton pump inhibitorsʼ. They work by reducing the
amount of acid that your stomach produces.

Mezzopram is used to treat the following conditions:
In adults:
• ʻGastro-oesophageal reflux diseaseʼ (GERD). 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 upper part of the intestine (duodenal ulcer) or
stomach (gastric ulcer).
• Ulcers which are infected with bacteria called ʻHelicobacter
pyloriʼ. If you have this condition, your doctor may also
prescribe antibiotics to treat the infection and allow the ulcer
to heal.
• Ulcers caused by medicines called NSAIDs (Non-Steroidal
Anti-Inflammatory Drugs). Mezzopram can also be used to
stop ulcers from forming if you are taking NSAIDs.
• Too much acid in the stomach caused by a growth in the
pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and ≥ 10 kg
• ʻGastro-oesophageal reflux diseaseʼ (GERD). 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.
In children, the symptoms of the condition can include the
return of stomach contents into the mouth (regurgitation),
being sick (vomiting) and poor weight gain.
Children and adolescents over 4 years of age
• Ulcers which are infected with bacteria called ʻHelicobacter
pyloriʼ. If your child has this condition, your doctor may also
prescribe antibiotics to treat the infection and allow the ulcer
to heal.

2

What you need to know before you take
Mezzopram

Do not take Mezzopram
• if you are allergic to omeprazole or any of the other
ingredients of this medicine (listed in section 6).
• 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 (for HIV
infection).
If you are not sure, talk to your doctor or pharmacist before
taking Mezzopram.

Warnings and precautions
Mezzopram may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start
taking Mezzopram 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 severe liver problems.

If you take Mezzopram on a long-term basis (longer than 1 year)
your doctor will probably keep you under regular surveillance.
You should report any new and exceptional symptoms and
circumstances whenever you see your doctor.
Taking a proton pump inhibitor like Mezzopram, 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 Mezzopram
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This is because
Mezzopram can affect the way some medicines work and some
medicines can have an effect on Mezzopram.
Do not take Mezzopram 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, 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 Mezzopram.
• 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 Mezzopram.











Rifampicin (used to treat tuberculosis).
Atazanavir (used to treat HIV infections).
Tacrolimus (in cases of organ transplantation).
St Johnʼs wort (Hypericum perforatum) (used to treat mild
depression).
Cilostazol (used to treat intermittent claudication).
Saquinavir (used to treat HIV infection).
Clopidogrel (used to prevent blood clots (thrombi).
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 Mezzopram treatment.

If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Mezzopram to treat ulcers caused by
Helicobacter pylori infection, it is very important that you tell your
doctor about any other medicines you are taking.
Mezzopram with food and drink
You can take your tablets with food or on an empty stomach.

Pregnancy and breast-feeding
Before taking Mezzopram, tell your doctor if you are pregnant or
trying to get pregnant. Your doctor will decide whether you can
take Mezzopram during this time.
Your doctor will decide whether you can take Mezzopram if you
are breast-feeding.
Driving and using machines
Mezzopram 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.

Mezzopram gastro-resistant tablets contain glucose and
sucrose
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 Mezzopram

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many tablets to take and how long
to take them for. This will depend on your condition and how old
you are. The usual doses are given below.

Adults:
To treat symptoms of GERD such as heartburn and acid
regurgitation:
• If your doctor has found that your food pipe (gullet) has been
slightly damaged, the usual dose is 20 mg once a day for 4-8
weeks. Your doctor may tell you to take a dose of 40 mg for a
further 8 weeks if your gullet has not yet healed.
• The usual dose once the gullet has healed is 10 mg once a
day.
• If your gullet has not been damaged, the usual dose is 10 mg
once a day.
To treat ulcers in the upper part of the intestine (duodenal
ulcer):
• The usual dose is 20 mg once a day for 2 weeks. Your doctor
may tell you to take the same dose for a further 2 weeks if
your ulcer has not yet healed.
• If the ulcer does not fully heal, the dose can be increased to
40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):
• The usual dose is 20 mg once a day for 4 weeks. Your doctor
may tell you to take the same dose for a further 4 weeks if
your ulcer has not yet healed.
• If the ulcer does not fully heal, the dose can be increased to
40 mg once a day for 8 weeks.
To prevent the duodenal and stomach ulcers from coming
back:
• The usual dose is 10 mg or 20 mg once a day. Your doctor
may increase the dose to 40 mg once a day.
To treat duodenal and stomach ulcers caused by NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs):
• The usual dose is 20 mg once a day for 4 to 8 weeks.

To prevent duodenal and stomach ulcers if you are taking
NSAIDs:
• The usual dose is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back:
• The usual dose is 20 mg Mezzopram twice a day for one
week.
• Your doctor will also tell you to take two antibiotics among
amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome):
• The usual dose is 60 mg daily.
• Your doctor will adjust the dose depending on your needs and
will also decide how long you need to take the medicine for.
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Children:
To treat symptoms of GERD such as heartburn and acid
regurgitation:
• Children over 1 year of age and with a body weight of more
than 10 kg may take Mezzopram. The dose for children is
based on the childʼs weight and the doctor will decide the
correct dose.

To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back:
• Children aged over 4 years may take Mezzopram. The dose
for children is based on the childʼs weight and the doctor will
decide the correct dose.
• Your doctor will also prescribe two antibiotics called
amoxicillin and clarithromycin for your child.
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 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 or your child have trouble swallowing the
tablets
• If you or your child have trouble swallowing the tablets:
- Break the tablet and disperse it in a spoonful of water
(non-fizzy), any acidic fruit juice (e.g. apple, orange or
pineapple) or apple sauce.
- Always stir the mixture just before drinking (the mixture will
not be clear). Then drink the mixture straight away or
within 15 minutes.
- 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. Do not use milk or fizzy water. The solid pieces
contain the medicine - do not chew or crush them.

If you take more Mezzopram than you should
If you take more Mezzopram than prescribed by your doctor, talk
to your doctor or pharmacist straight away.
If you forget to take Mezzopram
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, this medicine can cause side effects,
although not everybody gets them.

If you notice any of the following rare but serious side
effects, stop taking Mezzopram 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 ʻStevens-Johnson syndromeʼ or
ʻtoxic epidermal necrolysisʼ.
• 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
• Fracture in the hip, wrist or spine.

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.
• Dyspepsia (indigestion).
Not known (frequency cannot be estimated from the
available data)
If you are on Mezzopram 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.
Mezzopram 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.
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 (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 Mezzopram

Keep out of the reach and sight of children.

Do not use Mezzopram after the expiry date which is stated on
the outer and inner pack after EXP. The expiry date refers to the
last day of that month.
For HDPE containers, before first opening:
Do not store above 25°C.

For HDPE containers, after first opening:
Shelf life after first opening: 6 months
Do not store above 25ºC.
Keep the container tightly closed, in order to protect from
moisture.
For Aluminium/aluminium blister:
Do not store above 25°C.
For Aclar/aluminium blister:
Do not store above 25°C.

Medicines should not be disposed 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 Mezzopram contains
The active substance is omeprazole (as omeprazole
magnesium).

Each gastro-resistant tablet contains 10 mg omeprazole.
Each gastro-resistant tablet contains 20 mg omeprazole.
Each gastro-resistant tablet contains 40 mg omeprazole.

The other ingredients are:
Tablet core:
Sucrose, maize starch, liquid glucose, copovidone, povidone,
talc, titanium dioxide (E171), methacrylic acid-ethyl acrylate
copolymer (1:1), glycerol monostearate, propylene glycol,
stearic acid, polysorbate 80, simeticone, cellulose
microcrystalline, macrogol 6000, crospovidone, silica colloidal
anhydrous, magnesium stearate.

Tablet coating:
Hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron
oxide, red (E172). Only for Mezzopram 10 mg and Mezzopram
40 mg: Iron oxide, yellow (E172).
What Mezzopram look like and contents of the pack
Mezzopram 10 mg Dispersible Gastro-resistant Tablets:
Light pink oval film-coated tablet (11.2 x 5.8 mm).

Mezzopram 20 mg Dispersible Gastro-resistant Tablets:
Pink, oval film-coated tablet with a breaking notch on both sides.
The tablet can be divided into equal halves (14.2 x 7.2 mm).
Mezzopram 40 mg Dispersible Gastro-resistant Tablets:
Reddish oval film-coated tablet with a score line on both sides.
The tablet can be divided into equal halves (18.2 x 9.0 mm).

Pack sizes:
Mezzopram is available in blister packs with 5, 7, 10, 14, 15, 20,
28, 30, 49, 50, 56, 60, 90, 98, 100 gastro-resistant tablets and in
containers with 7, 14, 15, 28, 30, 56, 98, 100 gastro-resistant
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany. or
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany. or
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana,
Slovenia. or
Lek Pharmaceuticals d.d.,Trimlini 2 D, 9220 Lendava, Slovenia.
or
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland. or
LEK S.A., Ul. Domaniewska 50, 02-672 Warszawa, Poland.
This leaflet was last revised in 01/2014

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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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