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PANTOPRAZOLE DISTRIQUIMICA 40 MG GASTRO-RESISTANT TABLETS

Active substance(s): PANTOPRAZOLE SODIUM SESQUIHYDRATE

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Package leaflet: Information for the patient
Pantoprazole Distriquimica 40 mg
gastro-resistant tablets
Pantoprazole
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 side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Pantoprazole Distriquimica 40 mg is and what it is used for
2.
What you need to know before you take Pantoprazole Distriquimica 40 mg
3.
How to take Pantoprazole Distriquimica 40 mg
4.
Possible side effects
5.
How to store Pantoprazole Distriquimica 40 mg
6.
Contents of the pack and other information

1.

What Pantoprazole Distriquimica 40 mg is and what it is used for

Pantoprazole Distriquimica 40 mg is a selective “proton pump inhibitor”, a medicine which reduces the
amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach
and intestine.
Pantoprazole Distriquimica 40 mg is used for treating:
Adults and adolescents 12 years of age and above:
Reflux oesophagitis.An inflammation of your oesophagus (the tube which connects your throat
to your stomach) accompanied by the regurgitation of stomach acid.
Adults:
An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and
stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of
the bacteria and so reduce the likelihood of these ulcers returning.
Stomach and duodenal ulcers.
Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.

2.

What you need to know before you take Pantoprazole Distriquimica 40 mg

Do not take Pantoprazole Distriquimica 40 mg
If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this
medicine (listed in section 6).
If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precauticions
If you have severe liver problems. Please tell your doctor if you ever had problems with your
liver in the past. He will check your liver enzymes more frequently, especially when you are
taking Pantoprazole Distriquimica 40 mg as a long-term treatment. In the case of a rise of liver
enzymes the treatment should be stopped.

-

-

If you have reduced body stores or risk factors for reduced vitamin B12 and receive pantoprazole
long-term treatment. As with all acid reducing agents, pantoprazole may lead to a reduced
absorption of vitamin B12.
If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the
same time as pantoprazole, ask your doctor for specific advise.
If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole
Distriquimica 40 mg that reduces stomach acid.

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 Pantoprazole Distriquimica 40 mg. Remember to also
mention any other ill-effects like pain in your joints.
Tell your doctor immediately if you notice any of the following symptoms:
an unintentional loss of weight
repeated vomiting
difficulty in swallowing
vomiting blood
you look pale and feel weak (anaemia)
you notice blood in your stools
severe and/or persistent diarrhoea, as Pantoprazole Distriquimica 40 mg has been associated with
a small increase in infectious diarrhoea.
Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole
also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms
continue in spite of your treatment, further investigations will be considered.
Taking a proton pump inhibitor like Pantoprazole Distriquimica 40 mg, 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 take Pantoprazole Distriquimica 40 mg 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.
Other medicines and Pantoprazole Distriquimica 20 mg
Pantoprazole Distriquimica 40 mg may influence the effectiveness of other medicines, so tell you
doctor if you are taking
Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections)
or erlotinib (used for certain types of cancer) because Pantoprazole Distriquimica 40 mg may
stop these and other medicines from working properly.
Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may
need further checks.
Atazanavir (used to treat HIV-infection).
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 treatment with Pantoprazole
Distriquimica 40 mg.
Tell your doctor or pharmacist if you are taking , have recently taken or might take any other
medicines.
Pregnancy and breast-feeding
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human
milk has been reported.
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.
Driving and using machines

If you experience side effects like dizziness or disturbed vision, you should not drive or operate
machines.
Pantoprazole Distriquimica 40 mg contains lactose and sodium
This medicine contains lactose. Please only take Pantoprazole Distriquimica 40 mg after you have
consulted your doctor, if you know that you suffer from tolerance problems with certain sugars.
This medicinal product contains 2.68 mg sodium per dose. This should be taken into consideration by
patients on a controlled sodium diet.

3.

How to take Pantoprazole Distriquimica 40 mg

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with
some water.
Unless told otherwise by your doctor, the recommended dose is:
Adults and adolescents 12 years of age and above:
To treat reflux oesophagitis
The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The
treatment period for reflux oesophagitis is usually between 4 and 8 weeks. Your doctor will tell you
how long to take your medicine.
Adults:
For the treatment of an infection with a bacterium called Helicobacter pylori in patients with
duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).
One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and
metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet. Take the
first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your
evening meal. Follow your doctor’s instructions and make sure you read the package leaflets for these
antibiotics. The usual treatment period is one to two weeks.
For the treatment of stomach and duodenal ulcers.
The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled. Your
doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually
between 4 and 8 weeks. The treatment period for duodenal ulcers is usually between 2 and 4 weeks.
For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too
much stomach acid is produced.
The recommended starting dose is usually two tablets a day.
Take the two tablets 1 hour before a meal. Your doctor may later adjust the dose, depending on the
amount of stomach acid you produce. If prescribed more than two tablets a day, the tablets should be
taken twice daily.
If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to
stop taking the medicine.
Special patient groups:
If you have kidney problems, moderate or severe liver problems, you should not take
Pantoprazole Distriquimica 40 mg for eradication of Helicobacter pylori.
- If you suffer from severe liver problems, you should not take more than one tablet 20 mg
pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available).
Use in children below 12 years:

These tablets are not recommended for use in children below 12 years.
If you take more Pantoprazole Distriquimica 40 mg than you should
Consult your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole Distriquimica 40 mg
Do not take a double dose to make up for a forgotten dose. Take your next, normal dose at the usual
time.
If you stop taking Pantoprazole Distriquimica 40 mg
Do not stop taking these tablets without first talking to your doctor or pharmacist.
If you have any further questions on the use of this medicinet, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data)
If you get any of the following side effects, stop taking these tablets and tell your doctor
immediately, or contact the casualty department at your nearest hospital:
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-

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Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in
swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke’s
oedema/angioedema), severe dizziness with very fast heartbeat and heavy sweating.
Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of
your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals
(Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.
Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes
(severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with
painful urination and lower back pain (serious inflammation of the kidneys).

Other side effects are:
Uncommon (affects 1 to 10 users in 1,000)
headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind);
constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching;
feeling weak, exhausted or generally unwell; sleep disorders; fracture of the hip, wrist or spine (if
pantoprazole is used in high doses and over a long period of time)
Rare (affects 1 to 10 users in 10,000)
disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight
changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic
reactions; depression; breast enlargement in males; distortion or complete lack of the sense of
taste.
Very Rare (affects less than 1 user in 10,000)
disorientation.
Not known (frequency cannot be estimated from the available data)
Hallucination, confusion (especially in patients with a history of these symptoms); decreased
sodium level in blood; tingling feelings such as ‘pin and needles’; muscle spasm.

Side effects identified through blood tests:
Uncommon (affects 1 to 10 users in 1,000)
an increase in liver enzymes.
Rare (affects 1 to 10 users in 10,000)
an increase in bilirubin; increased fats in the blood; severe reduction in the number of white
blood cells (agranulocytosis), which may lead to more frequent infections.
Very Rare (affects less than 1 user in 10,000)
a reduction in the number of blood platelets, which may cause you to bleed or bruise more than
normal; a reduction in the number of white blood cells (leucopenia), which may lead to more
frequent infections; coexisting abnormal reduction in the number of both, red and white blood
cells (pancytopenia).
Not known (frequency cannot be estimated from the available data)
rash, possibly with pain in the joints.
If you are on Pantoprazole Distriquimica 40mg 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.
Reporting of side effects
If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. By reporting
side effects you can help provide more information on the safety of this medicine.
Website: www.mhra.gov.uk/yellowcard
5.

How to store Pantoprazole Distriquimica40 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and the container after
EXP. The expiry date refers to the last day of that month.
Tablet container: Shelf life after first opening: 28 days.
Storage conditions:
Tablet container: Do not store above 25 °C.
Blister: Do not store above 30 °C.
Do not throw away medicines should not be disposed of 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 Pantoprazole Distriquimica 40 mg contains
The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole
(as sodium sesquihydrate).
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The other ingredients are:

Tablet Core:
microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, colloidal anhydrous
silica, magnesium stearate
Colour coating:
polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172)

Gastro-resistant coating:
methacryl acid-ethyl acrylate copolymer, sodium lauryl sulphate, polysorbate 80, triethyl citrate
(E1505), talcum (E553b)
What Pantoprazole Distriquimica 40 mg looks like and contents of the pack
Pantoprazole Distriquimica 40 mg are pale yellow to ochre, elongated coated tablets.
Pantoprazole Distriquimica 40 mg is available in:
Tablet containers (HDPE bottles with HDPE or PP screw cap closure with desiccant) in packages of 7,
14, 28, 30, 50 or 90 gastro-resistant tablets.
Blisters (Aluminium-Aluminium foil blisters) in packages of 7, 14, 28, 30, 56, 90 or 98 gastro-resistant
tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Distriquimica, S.A.
Avda. Mare de Déu de Montserrat, 221 – Bajos
08041 Barcelona
Spanien

Manufacturer:
Laboratorios Dr. Esteve S. A.
Sant Marti, s/n. Poligon Industrial
08107 Martorelles (Barcelona)
Spain
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria

Denmark

Pantoprazol A-med 40 mg
magensaftresistente Tabletten
Pantoprazole Distriquimica 40 mg maagsapresistente
tablet/Comprimé gastro-résistant/magensaftresistente Tablette
Pantoprazole Pensa 40 mg Enterotabletter

Finland

Pantoprazole Pensa 40 mg Enterotabletti

Norway

Pantoprazole Pensa 40 mg Enterotabletter

Poland

Pantoprazole Distriquimica 40 mg Tabletki dojelitowe

The Netherlands

Pantoprazole Pensa 40 mg, maagsapresistente tabletten

Belgium

This leaflet was last approved in December 2015.

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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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