Contix Zrd

Package Leaflet: Information for the Patient

Contix ZRD, 20 mg, Gastro-Resistant Tablets

Pantoprazole

Read the Package Leaflet Carefully Before Taking the Medicinal Product

This package leaflet contains important informationfor you.
This medicinal product should always be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If after 14 days you do not feel better or if your symptoms worsen, you should consult a doctor.
• You should not take Contix ZRD for more than 4 weeks without consulting a doctor.

Table of Contents of the Package Leaflet:

• 1. What is Contix ZRD and what is it used for
• 2. Important Information Before You Take Contix ZRD
• 3. How to Take Contix ZRD
• 4. Possible Side Effects
• 5. How to Store Contix ZRD
• 6. Contents of the Pack and Other Information

1. What is Contix ZRD and What is it Used For

The active substance of Contix ZRD is pantoprazole, which blocks an enzyme that produces stomach acid. In this way, the medicinal product reduces the amount of acid in the stomach.
Contix ZRD is used for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn, acid regurgitation) in adults.
Reflux occurs when stomach acid flows back into the esophagus, which can lead to inflammation of the esophagus and cause pain. Other symptoms may also occur, such as burning chest pain extending to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Contix ZRD can relieve symptoms of reflux disease (such as heartburn, acid regurgitation) as early as the first day of treatment, but it is not a medicinal product intended for immediate relief of symptoms.
To achieve complete relief of symptoms, it may be necessary to take the tablets for 2-3 consecutive days.
If after 2 weeks there is no improvement or if you feel worse, you should consult a doctor.

2. Important Information Before You Take Contix ZRD

When Not to Take Contix ZRD:

• if you are allergic to pantoprazole or any of the other ingredients of this medicinal product (listed in section 6);
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). See "Contix ZRD and Other Medicinal Products".

Warnings and Precautions

Before taking Contix ZRD, you should discuss with your doctor:

• if you have been treated for heartburn or indigestion continuously for 4 or more weeks;
• if you are over 55 years old and have been taking over-the-counter indigestion remedies every day for more than 3 years;
• if you are over 55 years old and have noticed any unusual symptoms or a change in the pattern of your reflux symptoms;
• if you have had stomach ulcers or surgery on the stomach;
• if you have liver or jaundice (yellowing of the skin and eyes) problems;
• if you are under regular medical supervision for other serious conditions or diseases;
• if you are going to have an endoscopy or urea breath test;
• if you have ever had a skin reaction after taking a medicinal product that reduces stomach acid;
• if you are going to have a specific blood test (chromogranin A levels);
• if you are taking HIV protease inhibitors such as atazanavir or nelfinavir (used to treat HIV infection) at the same time as pantoprazole, you should ask your doctor for specific advice.

Your doctor may decide that you need to have additional tests.
If you are going to have a blood test, tell your doctor that you are taking this medicinal product.
You may feel relief from reflux symptoms and heartburn after the first day of treatment with Contix ZRD. However, this medicinal product is not intended for immediate relief of symptoms. Do not take it as a preventative measure.
If you have been experiencing recurring heartburn or indigestion, you should remain under regular medical supervision.

Children and Adolescents

Contix ZRD should not be used in children and adolescents under 18 years of age due to a lack of data on the safety of this medicinal product in this age group.

Contix ZRD and Other Medicinal Products

Tell your doctor or pharmacist about all othermedicinal products you are taking, have recently taken, or might take, including those obtained without a prescription.
Contix ZRD may affect the efficacy of other medicinal products, especially those containing one of the following active substances:

• HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). Do not take Contix ZRD at the same time as HIV protease inhibitors. See "When Not to Take Contix ZRD";
• ketokonazole (used to treat fungal infections);
• warfarin and phenprocoumon (which affect blood clotting and prevent thrombosis). Additional blood tests may be necessary;
• methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). Your doctor may temporarily stop treatment with Contix ZRD because pantoprazole may increase methotrexate levels in the blood.

Do not take Contix ZRD with other medicinal products that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 antagonists (e.g., ranitidine, famotidine).
Contix ZRD can be taken with antacids (e.g., magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or their combinations) if necessary.
Before taking Contix ZRD, you should discuss with your doctor if you are going to have a specific urine test for the presence of tetrahydrocannabinol (THC).

Contix ZRD with Food and Drink

Take Contix ZRD before a meal, with water.

Pregnancy and Breast-Feeding

Do not take this medicinal product if you are pregnant or breast-feeding.
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 medicinal product.

Driving and Using Machines

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

Contix ZRD Contains Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to Take Contix ZRD

Always take this medicinal product exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one tablet per day. Do not take more than 20 mg per day.
Take the medicinal product for at least 2-3 consecutive days. Stop taking Contix ZRD when your symptoms have completely gone. You may feel relief from reflux symptoms and heartburn after the first day of treatment with Contix ZRD, but remember that this medicinal product is not intended for immediate relief of symptoms.
Consult your doctor if your symptoms do not improve after 2 weeks of treatment with this medicinal product.
Do not take Contix ZRD for more than 4 weeks without consulting a doctor.
Take Contix ZRD before a meal, at the same time every day. Swallow the tablets whole with plenty of water, do not chew or break them.

What to Do if You Take More Contix ZRD Than You Should

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately. If possible, take the medicinal product and this package leaflet with you.

What to Do if You Forget to Take Contix ZRD

Do not take a double dose to make up for a forgotten dose. Take the next planned dose at the usual time the next day.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Contix ZRD can cause side effects, although not everybody gets them.
Tell your doctor immediatelyor contact the nearest hospital if you experience any of the following serious side effects. At the same time, stop taking this medicinal product, but take the package leaflet and (or) the tablets with you.

• Severe allergic reactions (rare: may affect up to 1 in 1,000 people): allergic reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms are: swelling of the face, lips, tongue, and/or throat, which may cause difficulty in swallowing or breathing, hives, severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known: cannot be estimated from the available data): you may notice one or more of the following symptoms:
• a rash with swelling, blisters, or peeling of the skin, flaking of the skin, bleeding from the eyes, nose, mouth, or genitals, and rapid deterioration of your general health or a rash, especially on areas of skin exposed to the sun. You may also experience joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g., in the armpits), and changes in blood test results showing changes in some white blood cells or liver enzymes.
• red, non-raised spots or circular patches on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat or nose ulcers, genital or eye ulcers. The appearance of such a severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Other serious reactions (frequency not known): yellowing of the skin and the whites of the eyes (caused by severe liver damage) or fever, rash, and kidney enlargement, sometimes with painful urination, and back pain, which can lead to kidney failure.

Other side effects include:

• Common side effects (may affect up to 1 in 10 people): mild stomach polyps.
• Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhea; nausea; vomiting; bloating and gas; constipation; dry mouth; abdominal pain and discomfort; skin rash or hives; itching; weakness, fatigue, or malaise; sleep disorders; increased liver enzymes in blood tests; hip, wrist, or spine fractures.
• Rare side effects (may affect up to 1 in 1,000 people): disturbances or complete loss of taste; vision disturbances, such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; depression; elevated bilirubin and lipid levels in the blood (found in blood tests); breast enlargement in men; high fever and sudden decrease in the number of circulating granulocytes - white blood cells (found in blood tests).
• Very rare side effects (may affect up to 1 in 10,000 people): disorientation; decreased platelet count, which can lead to increased tendency to 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 (found in blood tests).
• Frequency not known (cannot be estimated from the available data): hallucinations; confusion (especially in patients who have experienced such symptoms before); decreased sodium, magnesium, calcium, or potassium levels in the blood (see section 2); rash that may be accompanied by joint pain; feeling of tingling, prickling, burning, or numbness; inflammatory bowel disease causing persistent watery diarrhea.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.
Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181 C,
02-222 Warsaw,
Phone: +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 medicinal product.

5. How to Store Contix ZRD

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date which is stated on the carton after EXP:. The expiry date refers to the last day of that 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 no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Contix ZRD Contains

The active substance is pantoprazole. One gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
The other ingredients are:

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

What Contix ZRD Looks Like and Contents of the Pack

The gastro-resistant tablets are pink-beige, round, biconvex.
Contix ZRD is packaged in blisters of OPA/Aluminum/PVC/Aluminum foil, and together with the package leaflet in a cardboard box.
The pack contains 10 or 14 gastro-resistant tablets.

Marketing Authorisation Holder and Manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of Last Revision of the Package Leaflet:

The following lifestyle and dietary recommendations may also help alleviate heartburn or other acid-related symptoms:

• Avoid large meals.
• Eat slowly.
• Stop smoking.
• Limit alcohol and caffeine consumption.
• Lose weight (if overweight).
• Avoid tight clothing or belts.
• Avoid eating meals later than three hours before bedtime.
• Sleep with your head elevated (if you experience nighttime symptoms).
• Limit consumption of foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty or fried foods, acidic, spicy, citrus fruits, and fruit juices, tomatoes.