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VENTRA 40 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE / ESOMEPRAZOLE MAGNESIUM DIHYDRATE / ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Package leaflet: Information for the user
Ventra 20 mg gastro-resistant capsules, hard
Ventra 40 mg gastro-resistant capsules, hard
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, pharmacist
or nurse.
- 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Ventra is and what it is used for
2. What you need to know before you take Ventra
3. How to take Ventra
4. Possible side effects
5. How to store Ventra
6. Contents of the pack and other information

1. What Ventra is and what it is used for
Ventra contains a medicine called esomeprazole, which belongs
to a group of medicines called ’proton pump inhibitors’. They
work by reducing the amount of acid that your stomach produces.
Ventra is used to treat the following conditions:
Adults and adolescents aged 12 years and above
- ‘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 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 (NonSteroidal Anti-Inflammatory Drugs). Ventra can 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 Ventra
Do not take Ventra:
- 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 (e.g.
pantoprazole, lansoprazole, rabeprazole, omeprazole).
- if you are taking a medicine containing nelfinavir (used to treat
HIV).
Do not take Ventra if any of the above applies to you. If you are
not sure, talk to your doctor or pharmacist before taking Ventra.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ventra:
- if you have severe liver problems.
- if you have severe kidney problems.
- if you have ever had a skin reaction after treatment with a
medicine similar to Ventra that reduces stomach acid.
- if you are due to have a specific blood test (Chromogranin A).
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 Ventra. Remember to also mention any other
ill-effects like pain in your joints.
Ventra may hide the symptoms of other diseases. Therefore, if
any of the following happen to you before you start taking
Ventra 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).
Taking a proton pump inhibitor like Ventra, 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).
If you have been prescribed Ventra “on demand” you should
contact your doctor if your symptoms continue or change in
character.
Talk to your doctor, pharmacist or nurse before taking Ventra.
Other medicines and Ventra
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 Ventra can
affect the way some medicines work and some medicines can
have an effect on Ventra.
Do not take Ventra 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 or saquinavir (used to treat HIV).
- Ketoconazole, itraconazole or voriconazole (used to treat
infections caused by a fungus).
- Erlotinib (used to treat cancer).
- 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
Ventra.
- Medicines that are used to thin your blood, such as warfarin.
Your doctor may need to monitor you when you start or stop
taking Ventra.
- Cilostazol (used to treat intermittent claudication – a pain in your
legs when you walk which is caused by an insufficient blood
supply).

- Cisapride (used for indigestion and heartburn).
- Digoxin (used for heart problems).
- Clopidogrel (used to treat or prevent blood clots).
- Tacrolimus (organ transplantation).
- 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 Ventra treatment).
- Rifampicin (used for treatment of tuberculosis).
- St. John’s wort (Hypericum perforatum) (used to treat
depression).
If your doctor has prescribed the antibiotics amoxicillin and
clarithromycin as well as Ventra to treat ulcers caused by
Helicobacter pylori infection, it is very important that you tell your
doctor about any other medicines you are taking.
Ventra with food and drink
You can take your capsules with food or on an empty stomach.
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. Your doctor will decide
whether you can take Ventra during this time.
It is not known if Ventra passes into breast milk. Therefore, you
should not take Ventra if you are breast-feeding.
Driving and using machines
Ventra is not likely to affect your ability to drive or use any tools
or machines. However, side effects such as dizziness and blurred
vision may uncommonly or rarely occur (see section 4). If
affected, you should not drive or use machines.
Ventra contains sucrose and parahydroxybenzoates
Ventra contains sucrose, which is a type of sugar, propyl-phydroxybenzoate (E216) and methyl-p-hydroxybenzoate (E218):
- If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking this
medicine,
- Parahydroxybenzoates may cause allergic reactions (possibly
delayed).

3. How to take Ventra
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
- Ventra 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 capsules at any time of the day.
- You can take your capsules with food or on an empty stomach.
- Swallow your capsules whole with a glass of water. Do not chew
or crush the capsules or their contents. This is because the
capsules contain coated granules which stop the medicine from
being broken down by the acid in your stomach. It is important
not to damage the granules.
What to do if you have trouble swallowing the capsules
- If you have trouble swallowing the capsules:
1) Open the capsule carefully above a glass of still (non-fizzy)
water and empty the content of the capsule (granules) into the
glass. Do not use any other liquids.
2) Stir. Then drink the mixture straight away or within 30
minutes. Always stir the mixture just before drinking it.
3) 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 content of the capsule can be
mixed with some water and put into a 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 capsules to take and how
long to take them for. This will depend on your condition and
how well your liver works.
- The recommended doses are given below.
To treat heartburn caused by gastro-esophageal reflux disease
(GERD):
Adults and children aged 12 or above:
- If your doctor has found that your food pipe (gullet) has been
slightly damaged, the recommended dose is one capsule of
Ventra 40 mg 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 recommended dose once the gullet has healed is one
capsule of Ventra 20 mg once a day.
- If your gullet has not been damaged, the recommended dose
is one capsule Ventra 20 mg 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 capsule of
Ventra 20 mg 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 and children aged 12 or above:
- The recommended dose is one capsule of Ventra 20 mg twice a
day for one week.
- Your doctor will also tell you to take antibiotics called amoxicillin
and clarithromycin.
To treat stomach ulcers caused by NSAIDs (Non-Steroidal AntiInflammatory Drugs):
Adults aged 18 and above:
- The recommended dose is one capsule of Ventra 20 mg once a
day for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (NonSteroidal Anti-Inflammatory Drugs):
Adults aged 18 and above:
- The recommended dose is one capsule of Ventra 20 mg 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 recommended dose is one capsule of Ventra 40 mg 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.

Ventra 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.

Prolonged treatment after prevention of rebleeding of ulcers with
intravenous esomeprazole:
The recommended dose is one capsule of Ventra 40 mg once a
day for 4 weeks.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on the safety of
this medicine.

Children under the age of 12 years
Ventra is not recommended for children less than 12 years old.
Elderly
Dose adjustment is not required in the elderly.
If you take more Ventra than you should
If you take more Ventra than prescribed by your doctor, talk to
your doctor or pharmacist straight away.
If you forget to take Ventra
- 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 notice any of the following serious side effects, stop
taking Ventra 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:
Common (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 (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).
- 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 (if Ventra is used in high
doses and over long duration).
Rare (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.
- 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 (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.
- Severe kidney problems.
- Enlarged breasts in men.
Not known (frequency cannot be estimated from the available
data)
- If you are on Ventra 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.
- Inflammation in the gut (leading to diarrhoea).
- Rash, possibly with pain in the joints.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to store Ventra
- Keep this medicine out of the sight and reach of children.
- Do not store above 25°C.
- Keep this medicine in the original container (blister) or keep the
container tightly closed (bottle) in order to protect from moisture.
- Do not use this medicine after the expiry date shown on the
carton or bottle or blister foil. The expiry date refers to the last
day of that month.
- After opening of the bottle, the capsules should be used within
3 months.
- 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. Contents of the pack and other information

What Ventra contains
- The active substance is esomeprazole. Ventra capsules come
in two strengths containing 20 mg or 40 mg of esomeprazole (as
magnesium dihydrate).
-The other ingredients are:
Capsule content:
sugar spheres (sucrose and maize starch), hypromellose,
dimethicone emulsion 35% (containing dimethicone, propyl-phydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218),
sorbic acid, sodium benzoate, polyethylene glycol sorbitan
monolaureate, octylphenoxy polyethoxy ethanol and propylene
glycol), polysorbate 80, mannitol, diacetylated monoglycerides,
talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion
30% (containing copolymer of methacrylic acid and ethyl
acrylate, sodium lauryl sulfate and polysorbate 80), triethyl
citrate and stearoyl macrogolglycerides.
Capsule shell:
black iron oxide (E 172), shellac, gelatin, yellow iron oxide
(E 172) and titanium dioxide (E 171)
What Ventra looks like and contents of the pack
- Ventra 20 mg capsules have an opaque yellow cap and an
opaque white body. “20 mg” is printed in black both on the cap
and on the body.
- Ventra 40 mg capsules have an opaque yellow cap and an
opaque yellow body. “40 mg” is printed in black both on the cap
and on the body.
- Your capsules will come in packs of:
Bottles of 28, 30, 90 or 98 capsules
Blisters of 3, 7, 14, 15, 25, 28, 30, 50, 56, 60, 90, 98, 100 or
140 capsules
Not all pack size may be marketed.
Marketing Authorisation Holder: Ethypharm, 194, Bureaux de
la Colline – Bâtiment D, 92213 Saint-Cloud cedex, France
Manufacturer: Ethypharm,
Z.I. de Saint Arnoult,28170 Châteauneuf en Thymerais, France
or
Ethypharm,
Chemin de la Poudrière, 76120 Le Grand Quevilly, France
For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:
United Kingdom: Ethypharm UK Ltd
Medical information tel: +44(0)1483 662805
This medicinal product is authorised in the Member States of
the EEA under the following names:
Iceland
UK

Esoprax
Ventra 20/40 mg gastro-resistant capsules, hard

This leaflet was last revised in November 2016.

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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