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MEZZOPRAM 20 MG DISPERSIBLE GASTRO-RESISTANT TABLETS

Active substance(s): OMEPRAZOLE MAGNESIUM

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 ‘proton pump inhibitors’. They work by reducing the
amount of acid that your stomach produces.

Mezzopram is used to treat the following conditions:
In adults:
• ‘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 upper part of the intestine (duodenal ulcer) or
stomach (gastric ulcer).
• Ulcers which 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.
• 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).

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
See section 3.

In children:
Children over 1 year of age and ≥ 10 kg
• ‘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.
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.

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 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.

Children over 4 years of age and adolescents
• Ulcers which are infected with bacteria called ‘Helicobacter
pylori’. If your child has this condition, your doctor may also
prescribe antibiotics to treat the infection and allow the ulcer
to heal.

2

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 medicine.

What you need to know before you take
Mezzopram

3

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).

How to take Mezzopram

Always take this medicine exactly as your doctor or pharmacist 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 recommended dose is:

Do not take Mezzopram if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Mezzopram.

Adults:
To treat symptoms of GORD such as heartburn and acid
regurgitation:
• If your doctor has found that your food pipe (gullet) has been
slightly damaged, the recommended 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 recommended 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mezzopram.
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.
• You are due to have a specific blood test (Chromogranin A).
• You have ever had a skin reaction after treatment with a
medicine similar to Mezzopram that reduces stomach acid.

To treat ulcers in the upper part of the intestine (duodenal ulcer):
• The recommended 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 ulcers 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 recommended 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 ulcers does not fully heal, the dose can be increased to
40 mg once a day for 8 weeks.

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).

To prevent the duodenal and stomach ulcers from coming back:
• The recommended 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 recommended dose is 20 mg once a day for 4 to 8 weeks.

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 Mezzopram. Remember to also
mention any other ill-effects like pain in your joints.

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

Children
Some children with chronic illnesses may require long-term
treatment although it is not recommended. Do not give this
medicine to children under 1 year of age or < 10 kg.

To treat ulcers caused by Helicobacter pylori infection and to
stop them coming back:
• The recommended 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.

Other medicines and Mezzopram
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes
medicines that you buy without a prescription. This is because
Mezzopram can affect the way some medicines work and some
medicines can have an effect on Mezzopram.

To treat too much acid in the stomach caused by a growth in
the pancreas (Zollinger-Ellison syndrome):
• The recommended 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.

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).

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• 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 John’s 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.

Continued on the next page >>

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Your doctor may decide to perform regular blood tests to
monitor your levels of magnesium.
• Rash, possibly with pain in the joints.

Use in Children and adolescents
To treat symptoms of GORD 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 child’s weight and the doctor will decide the correct dose.

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.

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 child’s weight and the doctor will
decide the correct dose.
• Your doctor will also prescribe two antibiotics called
amoxicillin and clarithromycin for your child.

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.

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.

5

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.

Keep this medicine out of the sight and reach 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.

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.

For Aclar/aluminium blister:
Do not store above 25°C.

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.

Do not throw away any 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

The 20 mg and 40 mg tablet can be divided into equal doses.

If you stop taking Mezzopram
Do not stop taking Mezzopram without first talking to your doctor
or pharmacist.

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

Possible side effects

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.

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 ‘Stevens-Johnson syndrome’ or
‘toxic epidermal necrolysis’.
• Yellow skin, dark urine and tiredness which can be symptoms
of liver problems.

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).

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).
• Benign polyps in the stomach.

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 doses (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 doses (18.2 x 9.0 mm).

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.

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.

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.

This leaflet was last revised in 03/2017.

The following information is intended for healthcare
professionals only:

Stomach tube administration for doctors:
If the patient is unable to swallow, the tablets can be dissolved
in still water and administered via a stomach tube. It is important
to ensure that the suitability of the selected syringe and tube is
carefully verified.

Administration via a stomach tube
1. Put the tablet into an appropriate syringe and fill the syringe
with approximately 25 ml water and approximately 5 ml air.
For some tubes, dispersion in 50 ml water is needed to
prevent the pellets from clogging the tube.
2. Immediately shake the syringe for approximately 2 minutes to
disperse the tablet.
3. Hold the syringe with the tip up and check that the tip has not
clogged.
4. Attach the syringe to the tube whilst maintaining the above
position.
5. Shake the syringe and position it with the tip pointing down.
Immediately inject 5-10 ml into the tube. Invert the syringe
after injection and shake it. Keep the syringe tip pointed
upward as this will avoid clogging.
6. Turn the syringe with the tip down and immediately inject
another 5-10 ml into the tube. Repeat this procedure until the
syringe is empty.
7. Fill the syringe with 25 ml water and 5 ml air and repeat step
5 if necessary to wash down any sediment left in the syringe.
Some tubes will require 50 ml water.

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.
Not known (frequency cannot be estimated from the
available data)
• Inflammation in the gut (leading to diarrhoea).
• 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 or
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.

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Contents of the pack and other information

What Mezzopram contains
The active substance is omeprazole (as omeprazole magnesium).

If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4

How to store Mezzopram

00000000
SZ00000LT000

Artwork Proof Box
Ref: V016: To conform our SPC and PIL to include PRAC rec
Proof no.
012.0

Date prepared:
28/03/2017

Font size:
7pt

Colours:
Black
Black 20%

none
none

Fonts:
Helvetica

Dimensions: 165 x 420 mm

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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