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PRENOME 10 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): OMEPRAZOLE

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Prenome 10-20-40 mg
gastro-resistant capsules, hard (UK)

Package leaflet: Information for the user

Prenome 10 mg gastro-resistant capsules, hard
Prenome 20 mg gastro-resistant capsules, hard
Prenome 40 mg gastro-resistant capsules, hard
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 Prenome is and what it is used for
2. What you need to know before you take Prenome
3. How to take Prenome
4. Possible side effects
5. How to store Prenome
6. Contents of the pack and other information
1. What Prenome is and what it is used for
Prenome 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.
Prenome is used to treat the following conditions:
Adults:
• ‘Gastro-esophageal reflux disease’ (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
‘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). Prenome
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).
Children over 1 year of age and ≥ 10 kg
• ‘Gastro-esophageal reflux disease’ (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 aged over 4 years 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. What you need to know before you take Prenome
Do not take Prenome:
• 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 (eg pantoprazole, lansoprazole,
rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used
for HIV infection)
Talk to your doctor or pharmacist before taking Prenome.
Warnings and precautions
Prenome may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before
you start taking Prenome 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.

MA-PRO-161 (420 x 170 mm)
Times New Roman 9 pt.

• Ketoconazole, posoconazole, 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 Prenome
• 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 Prenome
• 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)
• 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
Prenome treatment
If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Prenome to treat ulcers caused by
Helicobacter pylori infection, it is very important that you
tell your doctor about any other medicines you are taking.
Prenome with food and drink
You can take your capsules with food or on an empty
stomach. They should NOT be chewed or crushed. They
should be swallowed whole with a glass of water.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, 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 Prenome if you
are breastfeeding.
Driving and using machines
Prenome 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.
Prenome contains 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 Prenome
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 capsules to take and
how long to take them for. This will depend on your
condition and how old you are.
The recommended dose is:
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 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 recommended
dose is 10 mg once a day.
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 ulcer do 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 ulcer do 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 recommended dose is 10 mg or 20 mg once a day.
Your doctor may increase the dose to 40 mg once a day.

If you take Prenome 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.

To treat duodenal and stomach ulcers caused by
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):
• The recommended dose is 20 mg once a day for 4–8
weeks.

Taking a proton pump inhibitor like Prenome, 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 duodenal and stomach ulcers if you are
taking NSAIDs:
• The recommended dose is 20 mg once a day.

Other medicines and Prenome
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription. This
is because Prenome can affect the way some medicines
work and some medicines can have an effect on Prenome.
Do not take Prenome 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:

To treat ulcers caused by Helicobacter pylori infection
and to stop them coming back:
• The recommended dose is 20 mg Prenome 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 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.

Use in 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 Prenome. The dose for
children is based on the child’s 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 Prenome. 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.
Taking this medicine
• It is recommended that you take your capsules in the
morning.
• You can take your capsules with food or on an empty
stomach.
• Swallow your capsules whole with half a glass of water.
Do not chew or crush the capsules. This is because the
capsules 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 capsules
• If you or your child have trouble swallowing the capsules:
- Open the capsules and swallow the contents directly
with half a glass of water or put the contents into a
glass of still (non-fizzy) water, any acidic fruit juice
(e.g. apple, orange or pineapple) or apple sauce.
- Always stir the mixture just before drinking it (the
mixture will not be clear). Then drink the mixture
straight away or within 30 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. The solid pieces contain the medicine - do not
chew or crush them.
If you take more Prenome than you should
If you take more Prenome than prescribed by your doctor,
talk to your doctor or pharmacist straight away.
If you forget to take Prenome
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 Prenome 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 (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.
• 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.
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
available data)
• Inflammation in the gut (leading to diarrhoea).
• If you are on Prenome 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. Your doctor
may decide to perform regular blood tests to monitor
your levels of magnesium.
Prenome 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 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5. How to store Prenome
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is
stated on the carton after EXP. The expiry date refers to
the last day of that month.
• For Al/Al blister:
Store below 30ºC.
Store in the original package in order to protect from
moisture.
• For PVC-PVDC/Al blister:
Store below 30ºC.
Store in the original package in order to protect from
moisture.
• For bottles:
Does not require any special storage conditions.
Shelf life after first opening of the bottle: 100 days.
Keep the bottle tightly closed in order to protect from
moisture.
• 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 to protect the environment.
6. Contents of the pack and other information
What Prenome contains
- The active substance is omeprazole. Prenome
gastro-resistant capsules, hard contain 10 mg, 20 mg or
40 mg of omeprazole.
- The other ingredients are sugar spheres (sucrose and
maize starch), hypromellose (E-464), Talc (E-553b),
titanium dioxide (E-171), disodium phosphate
dihydrate (E-339 ii), sodium lauryl sulphate,
polysorbate 80, methacrylic acid-ethyl acrylate
copolymer, triethyl citrate (E-1505). Capsule: gelatine,
titanium dioxide (E-171). See section 2 Prenome
contains Sucrose.
What Prenome looks like and contents of the pack
Prenome capsules are opaque white hard gelatine capsule,
containing spherical pellets.
White HDPE bottle with a cap and a tamper evident ring
closure with a desiccant agent: 14 & 28 capsules.
Al/Al blister: 14 & 28 capsules.
PVC-PVDC/Al blister: 14 & 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DISTRIQUIMICA, S.A.
Avda. Mare de Déu de Montserrat. 221
08041 Barcelona - Spain
Manufacturer
Laboratorios Dr. Esteve, S.A.
Sant Martí, s/n. Pol. Industrial La Roca
08107 - Martorelles (Barcelona) - Spain
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium: Prenome 10, 20, 40 mg gélule gastro-résistante
Netherlands: Prenome 10, 20, 40 mg maagsapresistente
capsule, hard
Poland: Prenome 10, 20, 40 mg kapsulka dojelitowa,
twarda
Romania: Prenome 10, 20, 40 mg capsule gastrorezistente
Spain: Prenome 20, 40 mg cápsula dura gastrorresistente
United Kingdom: Prenome 10, 20, 40 mg gastro-resistant
capsule, hard
This leaflet was last revised in 01/2015

MU3071-15-4

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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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