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Pantoprazole 20mg gastro-resistant tablets

Last Updated on eMC 24-Aug-2017 View changes  | Actavis UK Ltd Contact details

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: PL30306/0298 .



Pantoprazole 20mg gastro-resistant tablets

Package leaflet: Information for the patient

Pantoprazole 20mg Gastro-resistant Tablets

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 20mg 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 20mg tablets are used for:

Adults and adolescents 12 years of age and above:

  • Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease caused by reflux of acid from the stomach.
  • Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid) and preventing its return.

Adults:

  • Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.

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 have ever had problems with your liver. 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.
  • need to take medicines called NSAIDs continuously and receive Pantoprazole tablets because you have an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to your own personal risk factors such as your age (65 years old or more), a history of stomach or duodenal ulcers or of stomach or intestinal bleeding.
  • 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 in 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 a 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.

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 symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease

The usual dose is one tablet a day. This dose usually brings relief within 2 - 4 weeks – at most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this any recurring symptoms can be controlled by taking one tablet daily, when required.

For long-term management and for preventing the return of reflux oesophagitis

The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use Pantoprazole 40mg tablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20mg a day.

Adults:

To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously

The usual dose is one tablet a day.

Special patient groups

  • If you suffer from severe liver problems, you should not take more than one 20mg tablet a day.
  • 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

Tell 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 a forgotten tablet. 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 this medicine after the expiry date which is stated on the label and carton 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 20mg 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 3cP, 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 20mg Gastro-resistant Tablets are elliptical, biconvex, light 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.

Accord Healthcare Ltd
North Harrow
HA1 4HF
UK

BBBA0993

Company contact details

Company image
Address

Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346 106

Medical Information e-mail
Telephone

+44 (0)1271 385 200

Medical Information Direct Line

+44 (0)1271 385 257

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

pantoprazole sodium sesquihydrate

Legal categories

POM - Prescription Only Medicine

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