Pantoprazole apteo med

Package leaflet: Information for the patient

Pantoprazole APTEO MED
20 mg, enteric-coated tablets
Pantoprazolum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 weeks, or if you feel worse, you should contact your doctor.
• Do not take Pantoprazole APTEO MED for longer than 4 weeks without consulting a doctor.

Leaflet contents:

1. What Pantoprazole APTEO MED is and what it is used for
2. Important information before taking Pantoprazole APTEO MED
3. How to take Pantoprazole APTEO MED
4. Possible side effects
5. How to store Pantoprazole APTEO MED
6. Contents of the pack and other information

1. What Pantoprazole APTEO MED is and what it is used for

The active substance in Pantoprazole APTEO MED is pantoprazole, which blocks the "pump" (enzyme)
responsible for producing gastric acid. This way, the medicine reduces the amount of acid in the stomach.
Pantoprazole APTEO MED is used for the short-term treatment of symptoms of gastroesophageal reflux disease (GERD)
(such as heartburn, acid regurgitation) in adults.
Reflux refers to the backflow of stomach acid into the oesophagus, which may lead to inflammation of the oesophagus and cause pain. Other symptoms may include: painful burning sensation in the chest rising up to the throat (heartburn), sour taste in the mouth (acid regurgitation).
Pantoprazole APTEO MED may relieve symptoms related to reflux disease as early as on the first day of treatment, but it is not intended for immediate symptom relief. Complete relief of symptoms may require taking the tablets for 2 to 3 consecutive days.
If there is no improvement after 2 weeks, or if you feel worse, you should consult your doctor.

2. Important information before using Pantoprazole APTEO MED

When not to use Pantoprazole APTEO MED

• 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 HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). See "Pantoprazole APTEO MED with other medicines".

Warnings and precautions
Before starting treatment with Pantoprazole APTEO MED, discuss 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 over-the-counter antacids daily,
• If the patient is over 55 years old and has noticed new alarming symptoms or a change in the nature of existing reflux disease symptoms,
• If the patient has had a peptic ulcer or undergone 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 endoscopic examination or a urea breath test,
• If the patient has ever experienced a skin reaction while taking a medicine similar to Pantoprazole APTEO MED that reduces stomach acid secretion,
• If the patient is scheduled for a specific blood test (chromogranin A levels),
• If the patient is taking HIV protease inhibitors such as atazanavir or nelfinavir (used in the treatment of HIV infection) concomitantly with pantoprazole, the patient should ask the doctor for detailed advice.

Do not take this medicine without consulting a doctor for longer than 4 weeks. 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 Pantoprazole APTEO MED 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;
• Hip, wrist or spine fractures, especially if the patient already suffers from osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis);
• Decreased magnesium levels in the blood (possible symptoms: fatigue, involuntary muscle spasms, 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, consult a doctor. The doctor may recommend regular blood tests to monitor magnesium levels.

Immediately inform the doctor before or after taking this medicine if the patient notices
the appearance of the following symptoms, which may indicate other, more serious conditions:

• Unintentional weight loss (not related to diet or exercise),
• Vomiting, especially recurrent,
• Vomiting blood, which may look like dark coffee grounds,
• Blood in stool, black or tarry stools,
• Difficulty swallowing or pain during swallowing,
• Pallor and weakness (anaemia),
• Chest pain,
• Abdominal pain,
• Severe and (or) persistent diarrhoea (because use of this medicine is associated with a slight increased risk of infectious diarrhoea),
• If the patient develops a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor as soon as possible, because discontinuation of Pantoprazole APTEO MED may be necessary. The patient should also report any other adverse reactions such as joint pain.

The doctor may decide that additional tests are necessary.
If the patient is due to have a blood test, he/she 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 Pantoprazole APTEO MED. However, this is not a medicine intended for immediate
relief of symptoms. It should not be used preventively.
If the patient has been suffering from recurrent heartburn or indigestion symptoms for some time,
he/she should remain under continuous medical supervision.
Children and adolescents
Pantoprazole APTEO MED should not be used in children and adolescents under 18 years of age due to lack of safety data in this age group.
Pantoprazole APTEO MED 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.
Pantoprazole APTEO MED may reduce the effectiveness of other medicines, especially medicines containing one of the following active substances:

• HIV protease inhibitors such as atazanavir, nelfinavir (used in the treatment of HIV infection). Pantoprazole APTEO MED must not be used concomitantly with HIV protease inhibitors. See "When not to use Pantoprazole APTEO MED";
• Ketoconazole (used for fungal infections);
• Warfarin and fenprocoumon (affect blood clotting and prevent thrombosis). Additional blood testing may be necessary;
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis and cancer diseases). When methotrexate is used, the doctor may temporarily discontinue Pantoprazole APTEO MED, because pantoprazole may increase methotrexate blood levels.

Do not take Pantoprazole APTEO MED together with medicines 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).
Pantoprazole APTEO MED may be used if necessary with antacids (e.g.
magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or their
combinations).
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 become
pregnant, 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 visual disturbances,
do not drive vehicles or operate machinery.
Pantoprazole APTEO MED 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 take Pantoprazole APTEO MED
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.
The recommended dose is 1 tablet per day. Do not exceed a daily dose of 20 mg.
Take the medicine for at least 2 to 3 consecutive days. Discontinue use of Pantoprazole APTEO MED after complete resolution of symptoms. Improvement in reflux and heartburn symptoms may occur as early as one day after starting Pantoprazole APTEO MED. However, remember that this medicine is not intended for immediate relief of symptoms.
Consult a doctor if symptoms do not resolve after 2 full weeks of treatment with this medicine.
Do not take Pantoprazole APTEO MED for longer than 4 weeks without consulting
a doctor.
Take tablets before a meal, at the same time each day. Swallow tablets whole, with plenty of water. Do not chew or divide the tablets.
Taking more than the recommended dose of Pantoprazole APTEO MED
Immediately inform the doctor or pharmacist if an overdose has occurred. If possible, bring the medicine and leaflet with you.
Missing a dose of Pantoprazole APTEO MED
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time the following day.
If you have any further questions about using 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 using
this medicine, but take the package leaflet and (or) the tablets with you.

• Serious allergic reactions (rare: may occur in no more than 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock, and 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 excessive sweating.
• Serious skin reactions (frequency unknown: frequency cannot be estimated from available data): rash with swelling, blisters or peeling of the skin, sheet-like peeling of the skin, bleeding from the area around the eyes, nose, mouth or genital organs, and rapid deterioration in general condition, rash after exposure to sunlight.
• Other serious reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin and whites of the eyes (jaundice) due to severe liver damage, kidney problems manifested by painful urination, pain in the lower back accompanied by fever.

Other adverse reactions include:

• Common (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, weakness, fatigue or malaise, sleep disturbances, increased liver enzyme activity (detected 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; swelling of the limbs; depression; increased levels of bilirubin and lipids in the 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): disorientation, decreased platelet count, which may lead to increased tendency to bleeding and development of petechiae (bruises) on the skin; 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 previously experienced such symptoms), decreased sodium concentration in the blood, decreased magnesium concentration in the blood, rash which may be accompanied by joint pain, sensations of tingling, pricking, numbness, burning or paraesthesia, inflammation of the large intestine causing persistent watery diarrhoea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, additional information on the safety of the medicine can be collected.

5. How to store Pantoprazole APTEO MED

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle, blister pack, and
carton. The expiry date refers to the last day of the stated month.
Aluminium/Aluminium blisters – Store below 30°C.
HDPE bottle – No special requirements for storage conditions. After first opening of the HDPE bottle, the medicine remains stable for 28 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pantoprazole APTEO MED contains

• The active substance is pantoprazole. Each enteric-coated tablet contains 20 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• Other ingredients are: disodium phosphate anhydrous, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose (type 6 cP), triethyl citrate, sodium carboxymethyl starch (type A), methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, yellow iron oxide (E 172).

What Pantoprazole APTEO MED looks like and contents of the pack
Pantoprazole APTEO MED is an oval, yellow tablet available in aluminium blisters
containing 7 and 14 tablets* or in HDPE bottles with child-resistant closure,
containing 28 tablets*.
* Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231
e-mail: [email protected]
Manufacturer:
Teva Pharma S.L.U.
Poligono Industrial
Malpica, calle C,
No. 4, 50016 Zaragoza
Spain

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 (if overweight),
• Avoid tight clothing or belts,
• Avoid eating meals less than three hours before lying down,
• 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 or spicy foods, citrus fruits, fruit juices, and tomatoes.