Polprazol acidcontrol

Package leaflet: Information for the user

Polprazol Acidcontrol, 10 mg, enteric hard capsules
Omeprazolum
Please read this leaflet carefully before taking this medicine, because 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 doctor or pharmacist.

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

Contents of the leaflet

1. What Polprazol Acidcontrol is and what it is 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 pack and other information

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

Polprazol Acidcontrol contains an active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of hydrochloric acid produced in the stomach.
Polprazol Acidcontrol is used in adults for the short-term treatment of symptoms of gastro-oesophageal reflux disease (e.g. heartburn and regurgitation of acidic stomach contents – acid reflux).
Reflux occurs when acid from the stomach flows back into the oesophagus, where it may cause inflammation and associated pain. This may result in symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents). To achieve symptom relief, it may be necessary to take the capsules for 2–3 consecutive days.

2. Important information before using Polprazol Acidcontrol

When not to use Polprazol Acidcontrol

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a known allergy to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing atazanavir or nelfinavir (used in the treatment of HIV infection).

Warnings and precautions
Before starting to take Polprazol Acidcontrol, discuss this with your doctor or
pharmacist.
Before taking the medicine, inform your doctor:

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

Do not take Polprazol Acidcontrol for longer than 14 days without consulting a doctor. If symptoms do not improve or worsen, seek medical advice.
Polprazol Acidcontrol may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Polprazol Acidcontrol, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting of food or blood
• passing black stools (stools discoloured by blood)
• severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea
• previous history of gastric ulcer or gastrointestinal surgery
• ongoing symptomatic treatment for indigestion or heartburn for 4 weeks or more
• persistent indigestion or heartburn lasting 4 weeks or more
• presence of jaundice or severe liver disease
• age over 55 years and new onset of symptoms or recent change in existing symptoms
• if the patient has ever had a skin reaction due to a medicine similar to Polprazol Acidcontrol that reduces gastric acid secretion.

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as this may require discontinuation of Polprazol Acidcontrol. Also report any other adverse effects such as joint pain.
Patients should not take omeprazole preventively.
During treatment with omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in urine and/or allergic reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.

Polprazol Acidcontrol and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is important because Polprazol Acidcontrol may affect how some other medicines work, and some other medicines may affect the action of Polprazol Acidcontrol.
Do not take Polprazol Acidcontrol if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole or voriconazole (used to treat fungal infections)
• digoxin (used to treat heart disorders)
• diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting or stopping Polprazol Acidcontrol.
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient’s condition when starting or stopping Polprazol Acidcontrol.
• rifampicin (used to treat tuberculosis)
• atazanavir (used to treat HIV infection)
• tacrolimus (used in organ transplantation)
• erlotinib (used to treat cancers)
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is receiving high-dose methotrexate, the doctor may advise temporarily stopping 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 food or on an empty stomach.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The doctor will decide whether she can take Polprazol Acidcontrol during this time.
The decision on whether a breastfeeding woman can take Polprazol Acidcontrol will be made by the doctor.

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

Polprazol Acidcontrol contains sucrose and sodium
The medicine contains 40.01 mg of sucrose per capsule. If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains 0.4497 mg (0.01955 mmol) of sodium, i.e. less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to take Polprazol Acidcontrol

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is two 10 mg capsules once daily for 14 days. If symptoms do not improve after this time, consult your doctor.

It may take 2–3 additional days of continued treatment to achieve symptom relief.

How to take this medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain enteric-coated microgranules that protect the medicine from being broken down by stomach acid. It is essential that the microgranules remain intact. These microgranules contain the active substance omeprazole and are specially coated to prevent breakdown in the stomach, allowing absorption from the intestine. The microgranules release the active substance in the intestine, where it is absorbed and then exerts its effect.

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 with a glass of water, or mix the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, pineapple juice), or apple puree.
• 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 the full dose is taken, thoroughly rinse the glass with half a glass of water and drink this liquid as well. The solid particles contain the medicine—do not chew or crush them.

Taking more Polprazol Acidcontrol than recommended
If you take more Polprazol Acidcontrol than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Polprazol Acidcontrol
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following rare but serious side effects, stop taking Polprazol Acidcontrol and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver function disorders.

Other side effects include:
Common side effects (occurring in less than 1 in 10 patients)

• Headache
• Effects on the stomach or intestines: abdominal pain, diarrhoea, constipation, gas (bloating)
• Nausea or vomiting
• Benign gastric polyps

Uncommon side effects (occurring in less than 1 in 100 patients)

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling and prickling sensations, drowsiness
• Sensation of spinning (vertigo)
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itching
• General malaise and lack of energy

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

• Blood-related problems, such as reduced number of white blood cells or platelets. This may 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 may lead to weakness, vomiting, and muscle cramps
• Feeling of restlessness, confusion, or depression
• Altered sense of taste
• Vision problems, such as blurred vision
• Sudden sensation of wheezing or shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Fungal infection known as "thrush", which may affect the intestines and is caused by fungi
• Liver-related disorders, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash occurring during exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

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

• Blood count abnormalities, including agranulocytosis (absence of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not real (hallucinations)
• Severe liver-related disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash, blistering or peeling of the skin. This may 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 large intestine (leading to diarrhoea)
• Hypomagnesaemia. If Polprazol Acidcontrol has been taken for longer than three months, blood magnesium levels may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Very low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

In very rare cases, Polprazol Acidcontrol may affect the number of white blood cells in the blood, leading to reduced immunity. If a patient develops an infection with symptoms such as fever accompanied by a significant worsening of general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that, in such a situation, the patient informs the doctor about the medicine being taken.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor. Side effects can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Polprazol Acidcontrol

Blister packs: Store below 30 °C. Keep in the original packaging.
HDPE bottles: Store below 30 °C. Keep the bottle tightly closed. Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Polprazol Acidcontrol contains

• The active substance is omeprazole. Each capsule contains enteric microgranules with 10 mg of omeprazole.
• Other ingredients are: capsule contents: maize starch and sucrose; sodium carboxymethylstarch (type A); sodium lauryl sulfate; Povidone K30; trisodium phosphate dodecahydrate; hypromellose (6 cP); methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion; triethyl citrate; sodium hydroxide; titanium dioxide; talc; capsule cap composition: erythrosine (E 127); iron oxide red (E 172); titanium dioxide (E 171); purified water; gelatin; capsule body composition: quinoline yellow (E 104); erythrosine (E 127); titanium dioxide (E 171); purified water; gelatin.

Ink composition: shellac; anhydrous ethanol; isopropyl alcohol; propylene glycol;
n-butyl alcohol; Povidone; sodium hydroxide; titanium dioxide (E 171).

What Polprazol Acidcontrol looks like and contents of the pack
Red-orange capsules marked with "O" on the cap and "10" on the body,
containing white to off-white microgranules.
HDPE bottles or Aluminium/Aluminium blisters containing 7, 14 or 28 capsules,
packaged in a cardboard box.
Not all pack sizes and types may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański, Poland
Tel. +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.
Pelplińska Street 19
83-200 Starogard Gdański
Poland

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
Metalowca Street 2
39-460 Nowa Dęba
Poland