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 04569/0849
  • Last update:
  • 22-07-2019

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).

if you 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.

Package leaflet: Information for the patient

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Pantoprazole 40mg 28 Tablets PIL - UK

Black

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C.Grant

190 x 380

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Dupnitsa

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04/07/17

02

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.

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, 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

internet at www.mhra.gov.uk/yellowcard

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 anhydrous, 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 July 2017

If you would like a leaflet

with larger text, please contact

01271 385257.

BBBA0994

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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

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Technical

Approval

Non Printing Colours

Colours

Date sent:

Date received:

Item no:

Originator:

Origination Date:

Revision Date:

Revised By:

Dimensions:

Min Body Text Size:

Supplier:

Pantoprazole 40mg 28 Tablets PIL - UK

Black

BBBA0994

C.Grant

28/06/17

04/07/17

C.Grant

190 x 380

9pts

Actavis Bulgaria

Dupnitsa

28/06/17

04/07/17

02