Contix

Package Leaflet: Information for the Patient

CONTIX, 40 mg, gastro-resistant tablets

Pantoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

• 1. What Contix is and what it is used for
• 2. Important information before taking Contix
• 3. How to take Contix
• 4. Possible side effects
• 5. How to store Contix
• 6. Contents of the pack and other information

1. What Contix is and what it is used for

Contix contains the active substance pantoprazole, a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. It is used to treat conditions where the stomach produces too much acid, such as reflux oesophagitis, and peptic ulcers.

Contix is used in adults and adolescents aged 12 years and above for:

• Treatment of reflux oesophagitis, a condition in which the stomach acid flows back into the oesophagus (the tube that carries food from the mouth to the stomach), causing pain and discomfort.

Contix is used in adults for:

• Treatment of Helicobacter pylori (a type of bacteria) infections in combination with two antibiotics (eradication therapy) to eliminate the bacteria and prevent recurrence of ulcers.
• Treatment of peptic ulcers, including stomach and duodenal ulcers.
• Treatment of Zollinger-Ellison syndrome and other conditions where the stomach produces too much acid.

2. Important information before taking Contix

When not to take Contix:

• If you are allergic to pantoprazole or any of the other ingredients of this medicine.
• If you have previously experienced an allergic reaction to other proton pump inhibitors.

Warnings and precautions

Before taking Contix, tell your doctor or pharmacist or nurse if:

• You have severe liver problems. Your doctor may need to monitor your liver function more closely during treatment with Contix.
• You have a deficiency of vitamin B12 or have risk factors for a deficiency, as pantoprazole may reduce the absorption of vitamin B12.
• You are taking HIV protease inhibitors, such as atazanavir, as Contix may reduce their effectiveness.
• You have osteoporosis or are at risk of osteoporosis, as long-term use of proton pump inhibitors may increase the risk of fractures of the hip, wrist, or spine.
• You have ever had a skin reaction after treatment with a medicine that reduces stomach acid, as you may be at a higher risk of developing a skin reaction with Contix.
• You have ever had a skin rash or other allergic reactions, especially after taking medicines, as you may be at a higher risk of developing a skin reaction with Contix.
• A specific blood test (chromogranin A) is planned.

Tell your doctor or pharmacist or nurse immediately if you notice any of the following symptoms, which could be a sign of a more serious condition:

• Unintentional weight loss (not due to diet or exercise).
• Vomiting, especially if it is repeated.
• Blood in your vomit or black, tarry stools.
• Difficulty swallowing or pain when swallowing.
• Pale or tired skin (anaemia).
• Chest pain.
• Abdominal pain.
• Severe and/or persistent diarrhoea, as Contix may increase the risk of infectious diarrhoea.

Your doctor may decide to perform tests to rule out a malignant condition, as treatment with pantoprazole may alleviate symptoms of a malignant condition and delay diagnosis. If symptoms persist despite treatment, further tests should be considered.

Children and adolescents

Contix is not recommended for children under 12 years of age, as the safety and efficacy have not been established.

Contix with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Contix may reduce their effectiveness.
• Warfarin and phenprocoumon, which affect blood clotting, may require additional monitoring.
• Medicines used to treat HIV, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer), as pantoprazole may increase the levels of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental health conditions), as the dose may need to be reduced.
• Rifampicin (used to treat infections).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).

Contix with food and drink

Take Contix on an empty stomach, at least 1 hour before a meal.

Pregnancy, breastfeeding, and fertility

There is limited experience with the use of Contix in pregnant women. Pantoprazole has been detected in human breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Contix should only be used during pregnancy or breastfeeding if the potential benefits outweigh the potential risks to the unborn child or baby.

Driving and using machines

Contix has no or negligible influence on the ability to drive and use machines.

If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery.

Contix contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Contix

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Take the tablet 1 hour before a meal. Swallow the tablet whole with water. Do not chew or break the tablet.

Adults and adolescents aged 12 years and above

• Treatment of reflux oesophagitisThe usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The duration of treatment is usually 4 to 8 weeks.

Adults

• Treatment of Helicobacter pylori infectionOne tablet twice a day plus two antibiotics: amoxicillin, clarithromycin, or metronidazole (or tinidazole) twice a day. Take the first pantoprazole tablet 1 hour before breakfast and the second tablet 1 hour before dinner.
• Treatment of peptic ulcersThe usual dose is one tablet per day. Your doctor may increase the dose to two tablets per day. The duration of treatment is usually 4 to 8 weeks for stomach ulcers and 2 to 4 weeks for duodenal ulcers.
• Long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive acid productionThe recommended initial dose is two tablets per day. Both tablets should be taken 1 hour before a meal. Your doctor may adjust the dose later, depending on the amount of acid produced in the stomach.

Use in patients with kidney problems

Do not take Contix for the eradication of Helicobacter pylori if you have kidney problems.

Use in patients with liver problems

Do not take more than 20 mg of pantoprazole per day if you have severe liver problems.

Use in children and adolescents

Contix should not be used in children under 12 years of age.

What to do if you take more Contix than you should

If you have taken more Contix than you should, contact your doctor or pharmacist immediately. If possible, take the medicine and the package leaflet with you.

What to do if you forget to take Contix

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

What to do if you stop taking Contix

Do not stop taking Contix without first talking to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Contix can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Contix and contact your doctor or go to the nearest hospital:

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face (angioedema), severe dizziness with rapid heartbeat and sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):blistering of the skin, rapid deterioration of the condition, ulcers in the eyes, nose, mouth, or genital areas, or rash, especially on areas of skin exposed to sunlight. You may also experience joint pain or flu-like symptoms, fever, swelling of the lymph nodes, and changes in blood test results.
• Other severe reactions (frequency not known: cannot be estimated from the available data):yellowing of the skin and eyes (severe liver damage, jaundice) or fever, rash, and kidney problems, which may lead to kidney failure.

Other side effects:

• Common (may affect up to 1 in 10 people):mild polyps in the stomach.
• Uncommon (may affect up to 1 in 100 people):headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the stomach and bloating with gas; constipation; dry mouth; stomach pain and discomfort; skin rash, redness, or itching; weakness, fatigue, or general feeling of being unwell; sleep disturbances; fractures of the hip, wrist, or spine.
• Rare (may affect up to 1 in 1,000 people):changes in taste; changes in vision, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; increased body temperature; high fever; swelling of the limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (may affect up to 1 in 10,000 people):disorientation.
• Frequency not known (cannot be estimated from the available data):hallucinations, confusion (especially in patients who have experienced these symptoms before); feeling of tingling, prickling, burning, or numbness; rash that may be associated with joint pain, and/or fever.

Side effects detected in blood tests:

• Uncommon (may affect up to 1 in 100 people):increased liver enzyme levels.
• Rare (may affect up to 1 in 1,000 people):increased bilirubin levels; increased fat levels in the blood; decreased white blood cell count, which may lead to increased risk of infections.
• Very rare (may affect up to 1 in 10,000 people):decreased platelet count, which may lead to increased risk of bleeding; decreased white blood cell count; changes in blood test results, including decreased sodium, magnesium, calcium, or potassium levels.
• Frequency not known (cannot be estimated from the available data):changes in blood test results, including decreased sodium, magnesium, calcium, or potassium levels (see section 2).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Contix

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 blister after EXP.

The expiry date refers to the last day of that month.

Store in the original package, in a cool, dry place, below 25°C.

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 Contix contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are:

• Core: starch maize, sodium stearyl fumarate, silica colloidal anhydrous, crospovidone, mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium hydroxide.
• Coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, silica colloidal anhydrous, sodium hydroxide, sodium lauryl sulfate, iron oxide red (E 172), iron oxide yellow (E 172).

What Contix looks like and contents of the pack:

The tablets are pink, round, and biconvex.

Contix is available in blisters of 14, 28, 84, or 112 tablets, together with the package leaflet, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

LEK-AM Pharmaceutical Company Ltd.

Ostrzykowizna 14 A

05-170 Zakroczym

Poland

Tel: +48 (22) 785 27 60

Fax: +48 (22) 785 27 60 ext. 106

Date of last revision of the package leaflet: