Package leaflet: Information for the patient

Contix ZRD, 20 mg, enteric-coated tablets
Pantoprazolum

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days, or if your condition worsens, consult your doctor.
Do not take Contix ZRD for longer than 4 weeks without consulting a doctor.

Table of contents:

What Contix ZRD is and what it is used for
Important information before taking Contix ZRD
How to take Contix ZRD
Possible side effects
How to store Contix ZRD
Contents of the pack and other information

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

The active substance in Contix ZRD is pantoprazole, which blocks the enzyme responsible for producing
gastric acid. This way, the medicine reduces the amount of acid in the stomach.
Contix ZRD is used for the short-term treatment of symptoms of gastroesophageal reflux disease (such as
heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of acid from the stomach into the oesophagus, which may lead to
inflammation of the oesophagus and cause pain. Other symptoms may include a burning sensation in the
chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Contix ZRD may relieve symptoms associated with reflux disease (such as heartburn, acid regurgitation)
as early as on the first day of treatment, but it is not intended for immediate relief of symptoms.
To achieve complete symptom resolution, it may be necessary to take the tablets for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if your condition worsens, consult your doctor.

2. Important information before using Contix ZRD

When not to use Contix ZRD:

if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking protease inhibitors for HIV, such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Contix ZRD with other medicines".

Warnings and precautions
Before starting to take Contix ZRD, discuss this with your doctor:

if the patient has been treated for heartburn or indigestion continuously for 4 or more weeks;
if the patient is over 55 years old and takes antacids daily without a prescription;
if the patient is over 55 years old and has noticed any new or changed symptoms of reflux disease;
if the patient has had peptic ulcer disease or stomach surgery;
if the patient has liver problems or jaundice (yellowing of the skin and eyes);
if the patient is under continuous medical care due to other serious conditions or diseases;
if the patient is scheduled for an endoscopy or urease test;
if the patient has ever had a skin reaction after taking a medicine similar to Contix ZRD that reduces stomach acid secretion;
if the patient plans to undergo a specific blood test (chromogranin A level);
if the patient is taking protease inhibitors for HIV, such as atazanavir or nelfinavir (used in the treatment of HIV infection) together with pantoprazole, please ask your doctor for detailed advice.

Do not take this medicine for longer than 4 weeks without consulting a doctor. If symptoms of reflux disease (heartburn or acid regurgitation) persist for more than 2 weeks, consult a doctor who will decide whether long-term treatment is necessary.
Long-term use of Contix ZRD may be associated with additional risks, such as:

reduced absorption of vitamin B__ and vitamin B__ deficiency in case of low vitamin B__ levels in the body. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B__ levels:
extreme fatigue or lack of energy,
numbness and tingling,
pain or redness of the tongue, mouth ulcers,
muscle weakness,
vision disturbances,
memory problems, disorientation, depression;
fracture of the hip, wrist, or spine, especially if the patient already has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g. if the patient is taking steroid medicines);
decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat). Low magnesium levels may also lead to decreased potassium and calcium levels in the blood. If the medicine is used for longer than 4 weeks, contact your doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

Immediately inform your doctor before or after using this medicine if the patient experiences any of the following symptoms, which may indicate other, more serious conditions:

unintentional weight loss (not related to diet or exercise);
vomiting, especially recurrent;
bloody vomit, which may look like dark coffee grounds;
blood in stool, black or tarry stool;
difficulty swallowing or pain during swallowing;
paleness and weakness (anemia);
chest pain;
abdominal pain;
severe and/or persistent diarrhea (because use of Contix ZRD is associated with a slight increased risk of infectious diarrhea);
if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue Contix ZRD. Also report any other adverse reactions, such as joint pain;
serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with pantoprazole. Discontinue pantoprazole and seek immediate medical advice if any symptoms related to these serious skin reactions occur, as described in section 4.

The doctor may decide that additional tests are necessary.
If the patient is to undergo blood tests, they should inform the doctor about taking this medicine.
The patient may notice improvement in reflux and heartburn symptoms as early as one day after starting Contix ZRD. However, this is not a medicine intended for immediate symptom relief. It should not be used preventively.
If the patient has recurrent heartburn or indigestion symptoms over time, they 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 lack of safety data in this age group.

Contix ZRD with other medicines
Tell your doctor or pharmacist about all other medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take.
Contix ZRD may reduce the effectiveness of other medicines, especially those containing any of the following active substances:

protease inhibitors for HIV, such as atazanavir, nelfinavir (used in the treatment of HIV infection). Do not use Contix ZRD together with protease inhibitors for HIV. See "When not to use Contix ZRD";
ketoconazole (used for fungal infections);
warfarin and phenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be necessary;
methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer conditions). When methotrexate is used, the doctor may temporarily discontinue Contix ZRD, as pantoprazole may increase methotrexate levels in the blood.

Do not take Contix ZRD together with other medicines that reduce the amount of acid produced in the stomach, such as other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H__-antagonists (e.g. ranitidine, famotidine).
Contix ZRD may be used if necessary together with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or their combinations).
Before starting to take Contix ZRD, discuss this with your doctor if the patient is scheduled for a specific urine test for tetrahydrocannabinol (THC).

Contix ZRD with food and drink
Take Contix ZRD before a meal, with water.

Pregnancy and breastfeeding
Do not use this medicine if the patient is pregnant or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
If the patient experiences adverse effects such as dizziness or vision disturbances, do not drive or operate machinery.

Contix ZRD contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Contix ZRD

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is 1 tablet per day. The daily dose should not exceed 20 mg.
This medicine should be taken for at least 2–3 consecutive days. Treatment with Contix ZRD should be discontinued after complete resolution of symptoms. Relief of reflux and heartburn symptoms may occur as early as one day after starting Contix ZRD; however, it should be noted that this medicine is not intended for immediate relief of symptoms.
Consult a doctor if symptoms have not improved after taking this medicine for a full 2 weeks.
Do not take Contix ZRD for longer than 4 weeks without consulting a doctor.
Contix ZRD should be taken before a meal, at the same time each day. Tablets should be swallowed whole with plenty of water; do not chew or divide the tablets.
Taking more Contix ZRD than recommended
If a higher than recommended dose has been taken, contact a doctor or pharmacist immediately. If possible, bring the medicine and the package leaflet with you.
Missing a dose of Contix ZRD
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time on the following day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor or contact the nearest hospital if any of the following serious adverse reactions occur. You should also stop taking this medicine, but bring the package leaflet and (or) tablets with you.

Severe allergic reactions (rare: may occur in no more than 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, angioedema. Typical symptoms include: swelling of the face, lips, mouth, tongue and (or) throat, which may cause difficulty in swallowing or breathing, urticaria, severe dizziness with rapid heartbeat and profuse sweating.
Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms:
skin rash with swelling, blisters or skin peeling, sheet-like skin peeling, bleeding from the eyes, nose, mouth or genital areas, rapid worsening of general health condition, or rash, particularly in skin areas exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
red, non-elevated spots or circular patches on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. Such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other severe reactions (frequency unknown): yellowing of the skin and whites of the eyes (due to severe liver damage) or fever, rash and kidney enlargement sometimes with painful urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

Common adverse reactions (may occur in no more than 1 in 10 people): benign gastric polyps.
Uncommon (may occur in no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea; vomiting; flatulence and bloating with gas release; constipation; dryness of the mouth; abdominal pain and discomfort; skin rash or urticaria; itching of the skin; weakness, fatigue or malaise; sleep disturbances; increased liver enzyme activity in blood tests; fracture of the hip, wrist or spine.
Rare (may occur in no more than 1 in 1,000 people): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; elevated body temperature; limb swelling; depression; increased levels of bilirubin and lipids in blood (detected in blood tests); breast enlargement in men; high fever and sudden decrease in circulating granulocytes – white blood cells (detected in blood tests).
Very rare (may occur in no more than 1 in 10,000 people): disturbances in orientation; decreased platelet count, which may lead to increased tendency to bleeding and development of skin petechiae (bruises); decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets (detected in blood tests).
Frequency unknown (frequency cannot be estimated from available data): hallucinations; confusion (particularly in patients who have previously experienced such symptoms); decreased blood sodium, magnesium, calcium or potassium levels (see section 2); painful rash associated with joint pain; sensations of tingling, pricking, numbness, burning or pins and needles; inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store the medicine Contix ZRD

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton after EXP:. The expiry date refers to the last day of the stated month.
Store in the original packaging, at a temperature not exceeding 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Contix ZRD contains
The active substance in the medicine is pantoprazole. One enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
Other ingredients are:

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

What Contix ZRD looks like and contents of the pack
Enteric-coated tablets are pink-beige, round, biconvex.
Contix ZRD is packed in blisters made of OPA/Aluminium/PVC/Aluminium foil, then placed with the patient leaflet into a cardboard box.
The pack contains 10 or 14 enteric-coated tablets.
Marketing authorisation holder and manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
tel.: +48 22 785 27 60
fax: +48 22 785 27 60 ext. 106
The following lifestyle recommendations and dietary changes may also help relieve heartburn or other symptoms related to gastric acid.

Avoid large meals.
Eat slowly.
Stop smoking.
Limit alcohol and caffeine intake.
Reduce body weight (in case of overweight).
Avoid tight clothing or belts.
Avoid eating meals less than three hours before going to bed.
Sleep with the head elevated (in case of nocturnal symptoms).
Limit consumption of foods that usually trigger heartburn, such as: chocolate, peppermint, spearmint, fatty and fried foods, acidic and spicy foods, citrus fruits and fruit juices, tomatoes.