Contix

Patient Information Leaflet

CONTIX, 20 mg, enteric-coated tablets
Pantoprazole

Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• 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 you personally. Do not share it with 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 inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Contix is and what it is used for
2. What you need to know before you take 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 stomach acid. It is used to treat conditions of the stomach and intestines related to hydrochloric acid secretion.

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

• Treating symptoms (e.g. heartburn, acid regurgitation, painful swallowing) associated with gastroesophageal reflux disease (GERD) caused by backflow of hydrochloric acid from the stomach;
• Long-term treatment of reflux esophagitis (inflammation of the oesophagus associated with backflow of gastric acid) and prevention of its recurrence.

Contix is used in adults for:

• Prevention of duodenal and/or gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continuous NSAID therapy.

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 previously experienced 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 impairment. Inform the doctor if there has ever been a 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 increased liver enzyme activity occurs, the medicine should be discontinued.
• If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) long-term and is also using Contix, due to an increased risk of gastrointestinal complications. The level of risk will be assessed based on individual patient risk factors such as age (65 years or older), history of gastric or duodenal ulcers, or gastrointestinal bleeding.
• If the patient has vitamin B deficiency or risk factors indicating possible reduced vitamin B levels and is receiving long-term pantoprazole therapy. 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) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
• The 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. Inform 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 (e.g. 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 may subsequently cause fatigue, tetany, confusion, 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 to perform periodic blood tests to monitor magnesium levels.
• If the patient has ever experienced a skin reaction after taking a medicine similar to Contix that reduces gastric acid secretion.
• If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Contix may be necessary. The patient should also report any other adverse reactions, such as joint pain.
• Regarding planned specific blood tests (chromogranin A levels).

Contact the doctor immediately before starting or during treatment with the medicine 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, especially if 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 slightly increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour disease, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
If the patient is taking Contix for a prolonged period (longer than 1 year), they will likely be under continuous medical supervision. In such cases, any new or unexpected symptoms and the circumstances of their occurrence should be reported during each 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 or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.

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

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), as Contix may inhibit the proper action of these and other medicines.
• 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 conditions) – when methotrexate is used, the doctor may temporarily discontinue Contix, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders) – if the patient is taking fluvoxamine, the doctor may recommend reducing the 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 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 plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used in pregnant women, women in whom pregnancy cannot be excluded, or breastfeeding women only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.

Driving and operating machinery
Contix has no effect or has a negligible effect on the ability to drive motor vehicles and operate machinery.
However, if the patient experiences adverse effects such as dizziness or visual disturbances, they should not drive motor vehicles or operate machinery.

Contix contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the 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 in doubt,
consult your doctor or pharmacist.
Method of administration
Take the medicine one hour before a meal. Do not chew or divide the tablets. Swallow the tablet
whole with water.
Recommended dose
Adults and adolescents aged 12 years and above

• For treatment of symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated with gastro-oesophageal reflux disease
  The usual dose is one tablet per day. This dose usually provides relief within 2–4 weeks of treatment – at the latest within the following 4 weeks. Your doctor will decide how long you should take the medicine. Recurring symptoms may be managed by taking one tablet per day as needed.
• For long-term treatment and prevention of relapse of reflux oesophagitis
  The usual dose is one tablet per day. If symptoms return, your doctor may recommend doubling the dose. In such case, one tablet of Contix 40 mg per day may be taken. After symptoms resolve, the dose may be reduced again to one tablet (20 mg) per day.

Adults

• For prevention of gastric and/or duodenal ulcers in patients who must continuously take NSAIDs
  The usual dose is one tablet per day.

Use in patients with renal impairment
There is no need to adjust the dose of Contix in patients with impaired kidney function.
Use in patients with hepatic impairment
In patients with severe liver disease, the dose should not exceed one 20 mg tablet per day.
Use in children and adolescents
Contix should not be used in children and adolescents under 12 years of age.
Taking more Contix than recommended
If you take more Contix than recommended, contact your doctor or pharmacist immediately. If possible, bring the medicine and the package 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 Contix 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 everybody will experience them.
If any of the following adverse reactions occur, treatment with the tablets must be discontinued and a doctor must be consulted immediately or contact must be made with the nearest hospital providing emergency care:

• Severe allergic reactions (rare: no more than 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria (rash resembling nettle rash), difficulty breathing, angioedema (Quincke's oedema/angio-oedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from the available data): the patient may notice one or more of the following symptoms – development of skin blisters and sudden deterioration in general condition, erosions (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, and swollen glands (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 the 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 pain in the lower back (severe kidney inflammation), potentially leading to kidney failure.

Other adverse reactions that may occur:

• Common (no more than 1 in 10 people): mild 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; dryness of the mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disorders, fractures of the hip, wrist or spine.
• Rare (no more than 1 in 1000 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; swelling of limbs (peripheral oedema); allergic reactions; depression; breast enlargement in men.
• Very rare (no more than 1 in 10,000 people): disturbances in orientation.
• Frequency unknown (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); sensations of tingling, pricking, burning or numbness, rash possibly associated with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

• Uncommon (no more than 1 in 100 people): increased liver enzyme activity.
• Rare (no more than 1 in 1000 people): increased bilirubin levels; increased blood lipid levels; fever-related, sudden decrease in circulating granulocytes - white blood cells.
• Very rare (no more than 1 in 10,000 people): decreased platelet count, which may lead to increased 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 the available data): decreased concentration of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also 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 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 specified 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 packaging and other information

What Contix contains
The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as
pantoprazole sodium sesquihydrate).
The other ingredients are:

• core: pregelatinized starch 1500, sodium stearyl fumarate, anhydrous colloidal silica, crospovidone, mannitol, microcrystalline cellulose, hydroxypropylcellulose, sodium hydrogen carbonate;
• coating: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, methacrylic acid copolymer type C, triethyl citrate, anhydrous colloidal silica, sodium hydrogen carbonate, 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 foil 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 Authorisation Holder and Manufacturer:
LEK-AM Pharmaceutical Company Sp. z o.o.
ul. Ostrzykowizna 14 A
05-170 Zakroczym
Tel. +(48) (22) 785 27 60
Fax +(48) (22) 785 27 60 ext. 106