Contix

Package leaflet: Information for the patient

CONTIX, 40 mg, enteric-coated tablets
Pantoprazole

Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Contix is and what it is used for
2. What you need to know 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. Contix is a selective "proton pump inhibitor", a medicine that reduces the production of hydrochloric acid in the stomach. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.

Contix is used in adults and adolescents aged 12 years and older for the treatment of:

• Gastro-oesophageal reflux disease (GORD). This is inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with the backflow of hydrochloric acid from the stomach.

Contix is used in adults for:

• Helicobacter pylori infection in patients with gastric and/or duodenal ulcer, in combination with two antibiotics (eradication therapy), to eliminate the bacteria and prevent ulcer recurrence.
• Gastric and/or duodenal ulcer.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Contix

When not to use Contix:

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Contix, discuss this with your doctor, pharmacist or
nurse.

• If the patient has severe liver function disorders. Inform the doctor if there has ever been any history of liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity, especially if long-term treatment with Contix is required. If liver enzyme activity increases, treatment should be discontinued.
• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels, and is being treated long-term with pantoprazole. Like all medicines that reduce (inhibit) gastric acid secretion, pantoprazole may lead to reduced absorption of vitamin B.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, the patient should seek detailed advice from the doctor.
• Use of a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. Tell the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (for example, if the patient is taking steroid medicines).
• If the patient takes Contix for longer than three months, magnesium levels in the blood may decrease, which could lead to fatigue, tetany, disorientation, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide that periodic blood magnesium monitoring is necessary.
• If the patient has ever had a skin reaction while taking a medicine similar to Contix that reduces gastric acid secretion.
• If the patient ever develops a skin rash, especially in sun-exposed areas, they should inform the doctor as soon as possible, as discontinuation of Contix may be necessary. The patient should also report any other adverse effects, such as joint pain.
• Regarding planned specific blood test (chromogranin A levels).

The patient should immediately inform the doctor before starting or during treatment with Contix if any of the following symptoms occur, as they may indicate another, more serious condition:

• Unintentional weight loss (not related to diet or exercise);
• Vomiting, particularly recurrent;
• Vomiting blood, which may look like dark coffee grounds;
• Blood in the stool, black or tarry stools;
• Difficulty swallowing or pain during swallowing;
• Pallor and weakness (anaemia);
• Chest pain;
• Abdominal pain;
• Severe and/or persistent diarrhoea, as use of Contix is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to carry out tests to exclude an underlying tumour disease, as treatment with pantoprazole may relieve symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If Contix is taken for a prolonged period (longer than 1 year), the patient will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and their circumstances should be reported during every visit to the doctor.

Children and adolescents
Contix is not recommended for use in children, as its effects have not been studied in children under 12 years of age.

Contix with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.

Since Contix may affect the effectiveness of other medicines, inform the doctor if the patient is taking:

• medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Contix may inhibit the proper action of these and other drugs;
• warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be required;
• medicines used in the treatment of HIV infection, such as atazanavir;
• methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancer diseases) – when methotrexate is used, the doctor may temporarily discontinue Contix, as pantoprazole may increase methotrexate blood levels;
• fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend a dose reduction;
• rifampicin (used to treat infections);
• St John's wort (Hypericum perforatum) (used in the treatment of mild depression).

Contix with food and drink
Contix should be taken one hour before a meal.

Pregnancy, breastfeeding and fertility
Experience with use in pregnant women is limited. It has been shown that the active substance passes into human milk.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Contix may be used in pregnant women, women in whom pregnancy cannot be excluded, or women who are breastfeeding only if the doctor considers that the benefits of treatment outweigh the potential risks to the unborn child or infant.

Driving and using machines
Contix has no effect or has a negligible effect on the ability to drive and use machines.

If the patient experiences adverse effects such as dizziness or visual disturbances, driving vehicles or operating machinery should be avoided.

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

3. How to use Contix

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Method of administration
Take the medicine one hour before a meal. Do not chew or split the tablets. Swallow the tablet whole
with water.
Recommended dose
Adults and adolescents aged 12 years and above

• In the treatment of reflux oesophagitis The usual dose is one tablet per day. Your doctor may recommend increasing the dose to two tablets per day. The treatment period for reflux oesophagitis usually lasts 4 to 8 weeks. Your doctor will decide how long you should take the medicine.

Adults

• In the treatment of infection with a bacterium called Helicobacter pylori, in patients with duodenal and (or) gastric ulcers, in combination with two antibiotics (eradication therapy) One tablet twice daily, together with two antibiotic tablets: amoxicillin, clarithromycin or metronidazole (or tinidazole), each taken twice daily together with pantoprazole tablets. The first pantoprazole tablet should be taken 1 hour before breakfast and the second pantoprazole tablet 1 hour before dinner. You must follow your doctor's instructions and read the patient leaflets included in the antibiotic packaging. Treatment is usually given for one to two weeks.
• In the treatment of gastric and (or) duodenal ulcers The usual dose is one tablet per day. After consultation with your doctor, the dose may be doubled. Your doctor will decide how long you should take the medicine. The treatment period for gastric ulcers usually lasts 4 to 8 weeks. The treatment period for duodenal ulcers usually lasts 2 to 4 weeks.
• In long-term treatment of Zollinger-Ellison syndrome and other medical conditions associated with excessive hydrochloric acid secretion in the stomach The usual initial dose is two tablets per day. Both tablets should be taken 1 hour before a meal. Later, the dosage may be adjusted appropriately by your doctor, depending on the amount of hydrochloric acid secreted in the stomach. If more than two tablets per day are prescribed, they should be taken in two divided doses. If your doctor prescribes a daily dose exceeding four tablets per day, you will be given specific instructions on when to stop taking the medicine.

Use in patients with renal impairment
If you have kidney problems, do not take Contix for the eradication of Helicobacter pylori.
Use in patients with hepatic impairment
In patients with severe liver impairment, the dose of this medicine should not exceed 20 mg per day (for this purpose, tablets containing 20 mg of pantoprazole are available).
Contix should not be taken at a dose of 40 mg for the eradication of Helicobacter pylori in patients with moderate or severe liver disease.
Use in children and adolescents
Contix should not be used in children under 12 years of age.
Taking more Contix than recommended
If you take more medicine than recommended, contact your doctor or pharmacist immediately. If possible, bring the medicine and this leaflet with you. Symptoms of overdose are not known.
If you miss a dose of Contix
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time.
Stopping Contix
Do not stop taking the tablets without first consulting your doctor or pharmacist.
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 experiences them.
If any of the following adverse reactions occur, treatment with the tablets must be discontinued and
the doctor must be informed immediately or the nearest hospital with emergency services contacted:

• Severe allergic reactions (rare: no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (rash similar to nettle rash), breathing difficulties, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): the patient may notice one or more of the following symptoms – formation of skin blisters and sudden deterioration in general condition, erosion (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, gland swelling (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity).
• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash and kidney problems manifested by kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), potentially leading to kidney failure.

Other adverse reactions occurring:

• Common (no more than 1 in 10 people): benign gastric polyps.
• Uncommon (no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with flatulence (passing wind); constipation; dry mouth; pain and discomfort in the abdominal area; skin rash, redness, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare (no more than 1 in 1,000 people): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; limb swelling (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (no more than 1 in 10,000 people): disturbances of orientation.
• Frequency unknown (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); sensations of tingling, pricking, burning or numbness; rash possibly accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified through blood tests occurring:

• Uncommon (no more than 1 in 100 people): increased liver enzyme activity.
• Rare (no more than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in circulating granulocytes – white blood cells associated with high fever.
• Very rare (no more than 1 in 10,000 people): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may predispose to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.
• Frequency unknown (frequency cannot be estimated from available data): decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Contix

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP:.
The expiry date refers to the last day of the stated month.
Store in the original packaging, at a temperature below 25 °C, in a dry place.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Contix contains
The active substance is pantoprazole. Each enteric-coated tablet contains 40 mg of pantoprazole (as
pantoprazole sodium sesquihydrate).
The other ingredients are:

• core: pregelatinized starch 1500, sodium stearyl fumarate, colloidal anhydrous silica, crospovidone, mannitol, microcrystalline cellulose, hydroxypropylcellulose, 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 enteric-coated tablets are pinkish-beige, round, and biconvex.
Contix is packed in blisters made of OPA/Aluminium/PVC/Aluminium film and then placed with the leaflet into a cardboard box.
The pack contains 14, 28, 84, or 112 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer:
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14 A
05-170 Zakroczym
Tel. +(48) (22) 785 27 60
Fax +(48) (22) 785 27 60 ext. 106