Pantoprazole 40mg gastro-resistant tablets

Main information

  • Trade name:
  • Pantoprazole 40mg gastro-resistant tablets
  • Dosage:
  • 40mg
  • Pharmaceutical form:
  • Gastro-resistant tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pantoprazole 40mg gastro-resistant tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 01030500; GTIN: 5012617017697

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 20075/0700
  • Last update:
  • 21-11-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Pantoprazole 40mg Gastro-resistant Tablets

continued over page

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.

The full name of this medicine is

Pantoprazole 40mg Gastro-resistant Tablets

but within the leaflet it will be referred to

as Pantoprazole tablets.

What is in this leaflet:

1

What Pantoprazole tablets are and

what they are used for

2

What you need to know before you

take Pantoprazole tablets

3

How to take Pantoprazole tablets

4

Possible side effects

5

How to store Pantoprazole tablets

6

Contents of the pack and other

information

1

What Pantoprazole tablets are and

what they are used for

Pantoprazole 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 tablets are 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:

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 tablets

Do not take Pantoprazole tablets if you

are allergic to pantoprazole or any of the

other ingredients of this medicine (listed in

section 6).

are allergic to medicines containing other

proton pump inhibitors.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Pantoprazole tablets 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 tablets as a

long-term treatment. In the case of a rise

of liver enzymes the treatment should be

stopped.

have an increased secretory condition

(e.g. Zollinger–Ellison syndrome), or 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.

are taking a medicine containing atazanavir

(for the treatment of HIV-infection) at the

same time as pantoprazole, ask your doctor

for specific advice.

are due to have a specific blood test

(Chromogranin A).

have ever had a skin reaction after treatment

with a medicine similar to Pantoprazole 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. Remember to

also mention any other ill-effects like pain in

your joints.

Taking a proton pump inhibitor like

Pantoprazole, 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)

Tell your doctor immediately if you

notice any of the following symptoms:

an unintentional loss of weight

repeated vomiting

difficulty swallowing

vomiting blood

you look pale and feel weak (anaemia)

you notice blood in your stools

severe and/or persistent diarrhoea, as

pantoprazole 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.

If you take Pantoprazole tablets 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

tablets

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicine. Pantoprazole tablets may influence

the effectiveness of other medicines.

Medicines such as ketoconazole,

itraconazole and posaconazole (used

to treat fungal infections) or erlotinib

(used for certain types of cancer) because

Pantoprazole tablets 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.

Methotrexate (used in treatment of cancer

and autoimmune diseases)

Atazanavir (used to treat HIV-infection).

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 think you may be pregnant, or

if you are breast-feeding, you should use this

medicine only if your doctor considers the

benefit for you greater than the potential risk

for your unborn child or baby.

Ask your doctor or pharmacist for advice

before taking any medicine.

Driving and using machines

If you experience side effects like dizziness

or disturbed vision, you should not drive or

operate machines.

Pantoprazole tablets contain sodium

This medicinal product contains 34.64mg of

sodium per maximum daily dose of 160mg

(4 tablets). To be taken into consideration by

patients on a controlled sodium diet.

3

How to take Pantoprazole tablets

Always take this medicine exactly as your

doctor or pharmacist has told you. Check with

your doctor or pharmacist if you are not sure.

When and how should you take

Pantoprazole tablets

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 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.

Package leaflet: Information for the patient

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Details

Pantoprazole 40mg Gastro-resistant Tablets PIL - UK

Black

BBBA5943

G. Worth

21/08/2019

190 x 600

11pt

Teva Bulgaria Dupnitsa

21/08/2019

22/08/2019

1

Version 2

01.11.2017

Special patient groups:

If you have kidney problems, moderate

or severe liver problems, you should not

take Pantoprazole tablets for eradication of

Helicobacter pylori.

If you suffer from severe liver problems,

you should not take more than one tablet

20mg pantoprazole a day (for this purpose

tablets containing 20mg pantoprazole are

available).

Children below 12 years. These tablets are

not recommended for use in children below

12 years.

If you take more Pantoprazole tablets

than you should

Contact your doctor or pharmacist. There are

no known symptoms of overdose.

If you forget to take Pantoprazole

tablets

Do not take a double dose to make up for the

forgotten dose. Take your next, normal dose at

the usual time.

If you stop taking Pantoprazole tablets

Do not stop taking these tablets without first

talking to your doctor or pharmacist.

If you have 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 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:

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:

Common (may affect up to 1 in 10 people):

Benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people):

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.

Rare (may affect up to 1 in 1,000 people):

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; agranulocytosis (severe reduction in

number of white blood cells, which makes

infections more likely), taste disorders.

Very Rare (may affect up to 1 in 10,000

people):

disorientation, thrombocytopenia (reduction

in blood platelets, which increases risk of

bleeding or bruising), leukopenia (decrease in

the number of white blood cells (leukocytes)),

pancytopenia (severe reduction in blood cells

which can cause weakness, bruising or make

infections more likely).

Not known (frequency cannot be estimated

from the available data): pins and needles

/ tingling, inflammation in the large bowel,

that causes persistent watery diarrhoea,

hallucination, confusion (especially in patients

with a history of these symptoms); decreased

sodium level, decreased calcium level,

decreased potassium level in blood.

If you are on Pantoprazole 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. Rash, possibly with pain in the

joints

Side effects identified through blood

tests:

Uncommon (may affect up to 1 in 100 people):

an increase in liver enzymes.

Rare (may affect up to 1 in 1,000 people):

an increase in bilirubin; increased fats in the

blood.

Very Rare (may affect up to 1 in 10,000

people):

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, which may lead to more

frequent infections.

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 Website:

www.mhra.gov.uk/yellowcard or search for

MHRA Yellow Card in the Google Play or Apple

App Store.

By reporting side effects you can help provide

more information on the safety of this

medicine.

5

How to store Pantoprazole tablets

Keep this medicine out of the sight and reach

of children.

Do not use Pantoprazole tablets 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.

This medicine does not require any special

storage conditions.

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 Pantoprazole tablets contain

The active substance is pantoprazole. Each

gastro-resistant tablet contains 40mg of

pantoprazole (as sodium sesquihydrate).

The other ingredients are:

Mannitol, Sodium carbonate, Sodium starch

glycolate, Methacrylic acid copolymer,

Calcium stearate, Opadry white OY-D-

7233 (hypromellose, titanium dioxide, talc,

macrogol, sodium lauryl sulfate), Kollicoat

MAE 30 DP yellow (methacrylic acid-

ethyl acrylate copolymer dispersion 30%,

propylene glycol, yellow iron oxide, titanium

dioxide, talc).

What Pantoprazole tablets look like and

contents of the pack

Pantoprazole 40mg Gastro-resistant Tablets are

elliptical, biconvex, dark yellow gastro-resistant

tablets.

Pack sizes: 28

Marketing Authorisation Holder:

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer:

Balkanpharma – Dupnitsa AD,

3 Samokovsko Schosse Str.,

Dupnitsa 2600,

Bulgaria

This leaflet was last revised in August 2019

If you would like a leaflet

with larger text, please

contact 01271 385257.

BBBA5943

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Accord Healthcare Ltd, North Harrow, HA1 4HF, UK

* Please note that only Artwork Studio is permitted to make changes to the above artwork.

No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

approved for print/date

Proof Round

UK-Eire-Artwork-Support@accord-healthcare.com

Technical

Approval

Non Printing Colours

Colours

Date sent:

Date received:

Item number:

Originator:

Origination Date:

Revision Date:

Revised By:

Dimensions:

Min Body Text Size:

Supplier:

FMD info

NA (not a carton)

Details

Pantoprazole 40mg Gastro-resistant Tablets PIL - UK

Black

BBBA5943

G. Worth

21/08/2019

190 x 600

11pt

Teva Bulgaria Dupnitsa

21/08/2019

22/08/2019

1

Version 2

01.11.2017