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:

-    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).

-    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 Deu de Montserrat, 221 - Bajos

08041 Barcelona

Spanien

Man ufacturer:

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	Pantoprazol A-med 40 mg magensaftresistente Tabletten
Belgium	Pantoprazole Distriquimica 40 mg maagsapresistente tablet/Comprime gastro-resistant/magensaftresistente Tablette
Denmark	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

This leaflet was last approved in December 2015.