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VENTRA 20 MG GASTRO-RESISTANT CAPSULES HARD

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Esomeprazole 20 mg and 40 mg, gastro-resistant capsules, hard
1.3.1.2 – Package Leaflet (English version)

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
‘Gastroesophageal 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 (Non-Steroidal 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).

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1.3.1.2 – Package Leaflet (English version)

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
Check with your doctor or pharmacist before taking Ventra:
if you have severe liver problems.
if you have severe kidney problems.
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).

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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 and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
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.
VENTRA contains sucrose and parahydroxybenzoates
Ventra contains sucrose, which is a type of sugar, propyl-p-hydroxybenzoate (E216) and methyl-phydroxybenzoate (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

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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 usual doses are given below.

To treat heartburn caused by gastroesophageal 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 usual 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 usual dose once the gullet has healed is one capsule of Ventra 20 mg once a day.
If your gullet has not been damaged, the usual 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 usual 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 Anti-Inflammatory Drugs):
Adults aged 18 and above: the usual 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 (Non-Steroidal Anti-Inflammatory Drugs):
Adults aged 18 and above: the usual 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 usual 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.
Prolonged treatment after prevention of rebleeding of ulcers with intravenous Esomeprazole:
The usual dose is one capsule of Ventra 40 mg once a day for 4 weeks.
If you take more VENTRA than you should
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).

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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.
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)
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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).

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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
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 national reporting system listed in Appendix V. By
reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store VENTRA

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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 Ventra 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.

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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-p-hydroxybenzoate (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.

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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 Grand-Quevilly - FRANCE
Or
FAMAR L'AIGLE
Zone industrielle N°1, Route de Crulai
61300 L'Aigle - FRANCE
Or
LAPHAL INDUSTRIES
248 avenue de la Victoire
13106 Rousset - FRANCE
This medicinal product is authorised in the Member States of the EEA under the following
names:
Iceland
Esoprax
UK
Ventra
This leaflet was last revised in 11/2014

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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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