Contix

Package Leaflet: Information for the Patient

CONTIX, 20 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Contix and what is it 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 is Contix and what is it used for

Contix contains the active substance pantoprazole. Contix is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. It is used to treat diseases of the stomach and intestines related to acid production.

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

• Treating symptoms (such as heartburn, acid reflux, pain when swallowing) associated with acid reflux disease of the esophagus.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus caused by acid reflux) and prevention of its recurrence.

Contix is used in adults for:

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

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 (listed in section 6);
• if you have been diagnosed with an allergy to medicines containing other proton pump inhibitors.

Warnings and precautions

Before taking Contix, you should discuss this with your doctor, pharmacist or nurse.

• If you have severe liver problems. You should inform your doctor if you have ever had liver problems. Your doctor may decide to monitor your liver enzymes more frequently, especially if you are taking Contix for a long time. If your liver enzymes increase, your doctor may decide to stop your treatment with Contix.
• If you need to take NSAIDs continuously and take Contix at the same time, due to the increased risk of stomach or intestinal complications. The increased risk will be assessed according to your individual risk factors, such as age (65 years or older), stomach or duodenal ulcers in your medical history, or stomach or intestinal bleeding.
• If you have a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and you are taking pantoprazole long-term. Like all medicines that reduce acid production in the stomach, pantoprazole may lead to reduced absorption of vitamin B12.
• If you are taking HIV protease inhibitors such as atazanavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for specific advice.
• Taking a proton pump inhibitor like pantoprazole, especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should tell your doctor if you have osteoporosis (reduced bone density) or if your doctor has told you that you are at risk of osteoporosis (e.g. if you are taking steroid medicines).
• If you take Contix for more than three months, you may experience a decrease in blood magnesium levels, which can cause fatigue, tremors, confusion, seizures, dizziness, and cardiac arrhythmias. If you experience any of these symptoms, you should inform your doctor. Low blood magnesium levels can also cause low blood potassium and calcium levels. Your doctor may decide to periodically check your blood magnesium levels.
• If you have ever had a skin reaction after taking a medicine that reduces acid production in the stomach.
• If you have ever had a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Contix. You should also tell your doctor about any other side effects, such as joint pain.
• About a planned specific blood test (chromogranin A levels).

You should immediately inform your doctorbefore or during treatment with Contix, if you experience any of the following symptoms, which may be signs of a more serious disease:

• unintentional weight loss (not related to diet or exercise);
• repeated vomiting;
• bloody vomiting, which may look like coffee grounds;
• blood in the stool, black or tarry stools;
• difficulty swallowing or pain when swallowing;
• pale skin and weakness (anemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhea, as Contix may be associated with a small increased risk of infectious diarrhea.

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

Children and adolescents

Contix is not recommended for use in children, as its efficacy has not been established in children under 12 years of age.

Contix with other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to 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 interfere with their proper functioning.
• warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Further tests may be necessary.
• medicines used to treat HIV infection, such as atazanavir.
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate, your doctor may temporarily stop your treatment with Contix, as pantoprazole may increase methotrexate levels in the blood.
• fluvoxamine (used to treat depression and other mental disorders) - if you are taking fluvoxamine, your doctor may reduce your dose.
• rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Contix with food and drink

Contix should be taken one hour before a meal.

Pregnancy and breastfeeding

Experience with Contix in pregnant women is limited. The active substance of Contix has been detected in human breast milk.

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

The medicine may be used in pregnant women or women who are breastfeeding, or who may become pregnant or are breastfeeding, only if the doctor considers that the benefits of the treatment 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, you should 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

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Method of administration

The medicine should be taken one hour before a meal. The tablets should not be chewed or divided. Swallow the tablet whole with water.

Recommended dose

Adults and adolescents aged 12 years and above

• -In the treatment of symptoms (such as heartburn, acid reflux, pain when swallowing) associated with acid reflux disease of the esophagusThe usual dose is one tablet per day. This dose usually provides relief after 2-4 weeks of treatment - at the latest within the next 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms can be controlled by taking one tablet per daywhen needed.
• -In the long-term treatment and prevention of recurrence of reflux esophagitisThe usual dose is one tablet per day. If symptoms of the disease return, your doctor may recommend doubling the dose. In this case, one tablet of Contix 40 mg per day can be taken. After the symptoms have subsided, the dose can be reduced to one tablet (20 mg) per day.

Adults

• -In the prevention of duodenal and (or) gastric ulcers in patients who need to take NSAIDs continuouslyThe usual dose is one tablet per day.

Use in patients with renal impairment

No dose adjustment of Contix is necessary in patients with renal impairment.

Use in patients with hepatic impairment

In patients with severe liver disease, the dose should not exceed one tablet of 20 mg per day.

Use in children and adolescents

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

Overdose

If you have taken more than the recommended dose of Contix, you should immediately consult a doctor or pharmacist. If possible, take the medicine and the package leaflet with you. Symptoms of overdose are not known.

Missed dose

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

Stopping treatment with Contix

Do not stop taking the tablets without consulting your doctor or pharmacist first.

If you have any further questions on the use of this product, ask 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 the tablets and contact a doctor or go to the nearest hospital immediately:

• Severe allergic reactions (rare: less than 1 in 1000 people):swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, allergic swelling of the face (Quincke's edema/anaphylactic shock), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data):the patient may notice one or more of the following symptoms - blistering of the skin and rapid deterioration of the general condition, conjunctivitis, nose, mouth/throat or genital ulcers, or rash, especially on areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g. in the armpits), and changes in blood tests may also occur (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS), hypersensitivity to light).
• Other severe reactions (frequency not known: cannot be estimated from the available data):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney problems, with kidney enlargement, sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which can lead to kidney failure.

Other side effects that may occur:

• Common(less than 1 in 10 people): mild gastric polyps.
• Uncommon(less than 1 in 100 people): headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general feeling of being unwell; sleep disturbances, fractures of the hip, wrist, or spine.
• Rare(less than 1 in 1000 people): disturbances or complete loss of taste; visual disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression; gynecomastia (breast enlargement in men).
• Very rare(less than 1 in 10,000 people): disorientation.
• Frequency not known(cannot be estimated from the available data): hallucinations, confusion (especially in patients who have had these symptoms before); feeling of tingling, prickling, burning, or numbness; rash that may be accompanied by joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects detected by blood tests:

• Uncommon(less than 1 in 100 people): increased liver enzymes.
• Rare(less than 1 in 1000 people): increased bilirubin levels; increased fat levels in the blood; associated with high fever, sudden decrease in the number of circulating granulocytes - white blood cells.
• Very rare(less than 1 in 10,000 people): decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.
• Frequency not known(cannot be estimated from the available data): decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorisation holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

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 stated on the carton and blister after EXP:.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Contix contains

The active substance of Contix is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are:

• - core: corn starch, sodium stearyl fumarate, colloidal anhydrous silica, crospovidone, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium bicarbonate;
• - coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, methacrylic acid copolymer type C, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, iron oxide red (E 172), iron oxide yellow (E 172).

What Contix looks like and contents of the pack

The gastro-resistant tablets are pink-beige, round, biconvex.

Contix is packaged in blisters of OPA/Aluminum/PVC/Aluminum foil, and together with the package leaflet in a cardboard box.

The pack contains 14, 28, 84, or 112 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

LEK-AM Pharmaceutical Company Ltd.

Ostrzykowizna 14 A

05-170 Zakroczym

Tel. +(48) (22) 785 27 60

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

Date of last revision of the package leaflet: