POLPRAZOL 10 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Polprazol Acidcontrol, 10 mg, gastro-resistant hard capsules
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Polprazol Acidcontrol and what is it used for
4. Important information before taking Polprazol Acidcontrol
   1. When not to take Polprazol Acidcontrol
   2. Warnings and precautions
   3. Polprazol Acidcontrol with food and drink
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Polprazol Acidcontrol contains sucrose, sodium
5. How to take Polprazol Acidcontrol
   1. How to take this medicine
   2. What to do if you have difficulty swallowing the capsules
   3. Taking a higher dose of Polprazol Acidcontrol than recommended
   4. Missing a dose of Polprazol Acidcontrol
6. Possible side effects
   1. In case of noticing any of the following rare but serious side effects, stop taking Polprazol Acidcontrol and consult your doctor immediately:
   2. Other side effects include:
   3. Reporting side effects
7. How to store Polprazol Acidcontrol
8. Contents of the packaging and other information
   1. What Polprazol Acidcontrol contains
   2. What Polprazol Acidcontrol looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Polprazol Acidcontrol, 10 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the 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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, you should consult your doctor.

Table of contents of the leaflet

• 1. What is Polprazol Acidcontrol and what is it used for
• 2. Important information before taking Polprazol Acidcontrol
• 3. How to take Polprazol Acidcontrol
• 4. Possible side effects
• 5. How to store Polprazol Acidcontrol
• 6. Contents of the packaging and other information

1. What is Polprazol Acidcontrol and what is it used for

Polprazol Acidcontrol contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of acid produced in the stomach.
Polprazol Acidcontrol is used in adults for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid regurgitation).
Reflux occurs when stomach acid flows back into the esophagus, which can cause inflammation and pain. This can cause symptoms such as a burning sensation in the chest that rises to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation). To achieve symptom improvement, it may be necessary to take capsules for 2-3 consecutive days.

2. Important information before taking Polprazol Acidcontrol

When not to take Polprazol Acidcontrol

Warnings and precautions

Before starting treatment with Polprazol Acidcontrol, discuss it with your doctor or pharmacist.
Before taking the medicine, inform your doctor:

• about a specific blood test planned (chromogranin A concentration).

Do not take Polprazol Acidcontrol for more than 14 days without consulting your doctor. If there is no improvement and if symptoms worsen, consult your doctor.
Polprazol Acidcontrol may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Polprazol Acidcontrol, consult your doctor immediately:

• unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting with food or blood
• passing black stools (stool discolored with blood)
• severe or persistent diarrhea, as the use of omeprazole is associated with a slight increase in the frequency of infectious diarrhea
• previous stomach ulcers or gastrointestinal surgery
• continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks
• persistent indigestion or heartburn for 4 or more weeks
• jaundice or severe liver disease
• age over 55 and new or changing symptoms recently

If a skin rash occurs, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Polprazol Acidcontrol. Also, tell your doctor about any other side effects, such as joint pain.
Patients should not take omeprazole as a preventive measure.
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. Such symptoms should be reported to the attending physician.
Polprazol Acidcontrol may interact with other medicines, and other medicines may affect the action of Polprazol Acidcontrol.
Do not take Polprazol Acidcontrol if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole, itraconazole, or voriconazole (used to treat fungal infections)
• digoxin (used to treat heart rhythm disorders)
• diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy)
• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor your condition when starting and stopping Polprazol Acidcontrol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor your condition when starting and stopping Polprazol Acidcontrol.
• rifampicin (used to treat tuberculosis)
• atazanavir (used to treat HIV infection)
• tacrolimus (used in organ transplants)
• erlotinib (used to treat cancer)
• methotrexate (a chemotherapeutic agent used in high doses to treat cancer) - if you are receiving high doses of methotrexate, your doctor may recommend temporary discontinuation of Polprazol Acidcontrol
• St. John's Wort ( Hypericum perforatum) (used to treat mild depression)
• cilostazol (used to treat intermittent claudication)
• saquinavir (used to treat HIV infection)
• clopidogrel (used to prevent blood clots).

Polprazol Acidcontrol with food and drink

Polprazol Acidcontrol can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Polprazol Acidcontrol at this time.
Whether a breastfeeding woman can take Polprazol Acidcontrol will be decided by the doctor.

Driving and using machines

Polprazol Acidcontrol does not affect the ability to drive or use machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If they occur, do not drive or operate machinery.

Polprazol Acidcontrol contains sucrose, sodium

The medicine contains 40.01 mg of sucrose in one capsule. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains 0.4497 mg (0.01955 mmol) of sodium, i.e., less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

3. How to take Polprazol Acidcontrol

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
The usual dose is two 10 mg capsules once a day for 14 days. If symptoms do not improve after this time, consult your doctor.
To achieve symptom improvement, it may be necessary to take capsules for 2-3 consecutive days.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain gastro-resistant microgranules that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the microgranules. These microgranules contain the active substance omeprazole and are protected from degradation in the stomach to allow it to be absorbed from the intestine. The microgranules release the active substance in the intestine, where it is absorbed and then acts.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, washed down with a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, pineapple), or apple sauce.
• Always mix the mixture immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the entire dose of the medicine is taken, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking a higher dose of Polprazol Acidcontrol than recommended

In case of taking a higher dose of Polprazol Acidcontrol than prescribed by your doctor, consult your doctor or pharmacist immediately.

Missing a dose of Polprazol Acidcontrol

If you miss a dose due to forgetting, take the dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of noticing any of the following rare but serious side effects, stop taking Polprazol Acidcontrol and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver function disorders.

Other side effects include:

Frequently occurring side effects (less than 1 in 10 patients)

• Headache
• Affecting the stomach or intestines: abdominal pain, diarrhea, constipation, gas (bloating)
• Nausea or vomiting
• Mild stomach polyps.

Less common side effects (less than 1 in 100 patients)

• Swelling of the feet and ankles
• Sleep disturbance (insomnia)
• Feeling of dizziness, tingling, and numbness
• Feeling of spinning (vertigo)
• Changes in liver function test results
• Skin rash, papular rash (hives), and itching
• General feeling of being unwell and lack of energy.

Rare side effects (less than 1 in 1,000 patients)

• Blood problems, such as decreased white blood cell or platelet count. This can lead to weakness, easier bruising, or increased risk of infection
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed
• Change in taste
• Vision problems, such as blurred vision
• Sudden feeling of wheezing or shortness of breath (bronchospasm)
• Dry mouth
• Oral mucositis
• An infection called "thrush", which can affect the intestines and is caused by fungi
• Liver disorders, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash during sun exposure
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating.

Very rare side effects (less than 1 in 10,000 patients)

• Changes in blood morphology, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Severe liver disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blistering of the skin or peeling. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men.

Frequency not known (frequency cannot be estimated from available data)

• inflammation of the colon (leading to diarrhea)
• hypomagnesemia. If you have taken Polprazol Acidcontrol for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you notice any of these symptoms, tell your doctor immediately. Very low magnesium levels can lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• rash that may be associated with joint pain.

In very rare cases, Polprazol Acidcontrol may affect the white blood cell count, leading to decreased immunity. If you experience an infection with symptoms such as fever with serious deterioration of general well-being or fever with signs of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, consult your doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is important for the patient to provide the doctor with information about the medicine being taken.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Polprazol Acidcontrol

Blister packs: Store in a temperature below 30°C. Store in the original packaging.
HDPE bottles: Store in a temperature below 30°C. Store the bottle tightly closed. Store in the original packaging.
Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should 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 Polprazol Acidcontrol contains

• The active substance of the medicine is omeprazole. Each capsule contains 10 mg of omeprazole in the form of gastro-resistant microgranules.
• Other ingredients of the medicine are: capsule filling: corn starch and sucrose; sodium carboxymethyl starch (type A); sodium lauryl sulfate; Povidone K30; disodium phosphate dodecahydrate; hypromellose (6 cP); methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%; triethyl citrate; sodium hydroxide; titanium dioxide; talc; capsule cap ingredients: erythrosine (E 127); iron oxide red (E 172); titanium dioxide (E 171); purified water; gelatin; capsule body ingredients: quinoline yellow (E 104); erythrosine (E 127); titanium dioxide (E 171); purified water; gelatin.

ink composition: shellac; anhydrous ethanol; isopropyl alcohol; propylene glycol;
butanol; Povidone; sodium hydroxide; titanium dioxide (E 171).

What Polprazol Acidcontrol looks like and what the pack contains

Capsules are red-orange in color, marked with "O" on the cap and "10" on the body, containing white to light beige microgranules.
HDPE bottles or aluminum/aluminum blisters containing 7, 14, or 28 capsules, in a cardboard box.
Not all pack sizes and types may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański, Poland
phone: +48 22 364 61 01

Manufacturer

Teva Pharma S.L.U.
Poligono Industrial Malpica
c/C no. 4, 50016 Zaragoza
Spain
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Poland
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2
39-460 Nowa Dęba
Poland

Date of last revision of the leaflet: