Omeprazole mercapharm

Patient Information Leaflet: Information for the User

Omeprazole Mercapharm, 20 mg, enteric-coated hard capsules
Omeprazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor 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 or doctor.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What Omeprazole Mercapharm is and what it is used for

Omeprazole Mercapharm is a medicine in the form of enteric-coated hard capsules. The medicine contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of hydrochloric acid produced in the stomach.
Omeprazole Mercapharm is used in adult patients:
for short-term treatment of symptoms of gastroesophageal reflux (e.g. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux refers to the backflow of acid from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may lead to 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 relieve symptoms, it may be necessary to take the capsules for 2 or 3 consecutive days.

2. Important information before using Omeprazole Mercapharm

When not to use Omeprazole Mercapharm:

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

If there are any doubts before starting to take Omeprazole Mercapharm, the patient should consult their doctor or pharmacist.

Warnings and precautions

Do not take Omeprazole Mercapharm for longer than 14 days without consulting a doctor.
If symptoms do not improve or worsen, medical advice should be sought immediately.

Omeprazole Mercapharm may mask symptoms of other diseases. Therefore, if any of the following conditions occur, either before starting or during treatment with Omeprazole Mercapharm, the patient should contact a doctor immediately:

• unexplained weight loss (not related to diet or exercise);
• difficulty swallowing;
• stomach pain or indigestion;
• vomiting food or blood;
• passing black stools (stools discolored by blood);
• severe or persistent diarrhoea, as a slight increase in the frequency of infectious diarrhoea has been associated with omeprazole use;
• previous history of stomach ulcer or gastrointestinal surgery;
• continuous use of medications for indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn lasting 4 or more weeks;
• development of jaundice (yellowing of the skin and eyes) or severe liver disease;
• age over 55 years and recent onset of new, worrying symptoms or changes in existing symptoms.

Before starting Omeprazole Mercapharm, the patient should contact a doctor:

• if they have ever had a skin reaction due to treatment with a medicine similar to Omeprazole Mercapharm that reduces gastric acid secretion;
• if they are scheduled for a specific blood test (chromogranin A levels).

Taking proton pump inhibitors such as Omeprazole Mercapharm, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Patients with diagnosed osteoporosis or those taking corticosteroids (which may increase the risk of osteoporosis) should inform their doctor.

If the patient develops a skin rash, particularly in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Omeprazole Mercapharm may be necessary.

Patients should also report any other adverse effects, such as joint pain.

Do not take omeprazole preventively.

Children and adolescents

Do not use in children and adolescents under 18 years of age.

Omeprazole Mercapharm and other medicines

Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.

This is important because Omeprazole Mercapharm may affect how some other medicines work, and some other medicines may affect the action of Omeprazole Mercapharm.

Do not take Omeprazole Mercapharm if using a medicine containing nelfinavir (used to treat HIV infection).

Inform the doctor or pharmacist if taking any of the following medicines:

• antifungal and antidandruff medicines (e.g. ketoconazole, itraconazole, voriconazole);
• digoxin (used to treat heart failure and atrial fibrillation with rapid ventricular response);
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment);
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor the patient’s condition when starting or stopping Omeprazole Mercapharm;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will monitor the patient’s condition when starting or stopping Omeprazole Mercapharm;
• clopidogrel (used to prevent blood clots);
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used after organ transplantation and in the treatment of atopic dermatitis);
• St John’s wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat symptoms of intermittent claudication in the lower limbs);
• saquinavir (used to treat HIV infection);
• erlotinib (used to treat cancer);
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue Omeprazole Mercapharm.

Omeprazole Mercapharm with food and drink

Capsules should be taken before a meal (on an empty stomach). DO NOT chew or crush them. Swallow whole with a glass of water (see section 3).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

The doctor will decide whether the patient can take Omeprazole Mercapharm during pregnancy.

The decision on using Omeprazole Mercapharm during breastfeeding is made by the doctor.

Driving and using machines

Omeprazole Mercapharm does not affect the ability to drive or operate machinery.
However, if dizziness or visual disturbances occur, the patient should not drive or operate machinery.

Omeprazole Mercapharm contains sucrose

This medicine contains sucrose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Omeprazole Mercapharm

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
1 capsule once daily. The medicine may be taken for 14 days.
The medicine should be taken for at least 2 to 3 consecutive days.
If symptoms do not improve within 14 days of continuous treatment, consult your doctor.
How to take

• It is recommended to take the medicine in the morning.
• Capsules should be taken before food (on an empty stomach).
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated pellets that prevent the medicine from being broken down by stomach acid. It is important that the pellets are not damaged. The pellets contain the active substance omeprazole and are protected from degradation in the stomach to allow absorption in the intestine. The pellets release the active substance in the intestine, where it is absorbed and exerts its therapeutic effect.

What to do if you have difficulty swallowing capsules (in adult patients)

• Open the capsule and dissolve its contents in non-carbonated water or mix with any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple puree.
• Always mix the preparation immediately before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the full dose, thoroughly rinse the glass (in which the medicine was dissolved) with half a glass of water and drink this liquid.
• Do not use milk or carbonated water.
• The solid particles contain the medicine – do not chew or crush them.

Use in children and adolescents
Do not use in children and adolescents under 18 years of age.
Taking more than the recommended dose of Omeprazole Mercapharm
Seek immediate advice from a doctor or pharmacist. If possible, bring the medicine and the package leaflet with you.
If you miss a dose of Omeprazole Mercapharm
Do not take a double dose to make up for a missed dose. Take the next scheduled dose at the usual time on the following day.
If you have any doubts about how to use 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 severe adverse reactions occur. You should also stop using this medicine and bring the package leaflet and (or) capsules with you.

• Severe allergic reactions: wheezing, swelling of the lips, tongue or throat or body, rash, fainting, or difficulty breathing or swallowing.
• Severe skin reactions: redness of the skin with blistering or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Other severe reactions (frequency unknown): yellowing of the skin and whites of the eyes, dark urine, and fatigue, which may be symptoms of liver dysfunction (jaundice).

Other adverse reactions include:
Common (occur in 1 to 10 people out of 100):
headache; diarrhoea, constipation, abdominal pain, bloating (gas); nausea or vomiting; mild gastric polyps.
Uncommon (occur in 1 to 10 people out of 1,000):
swelling of the feet and ankles; sleep disturbance (insomnia), tingling or pricking sensations, drowsiness; sensation of spinning (dizziness); changes in liver function test results; general malaise and weakness.
Rare (occur in 1 to 10 people out of 10,000):
reduced number of white blood cells or platelets (this may lead to weakness, easier bruising or increased risk of infection); allergic reactions (see beginning of section 4); low sodium levels in 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 wheezing or shortness of breath (bronchospasm); dry mouth; inflammation of the mucous membrane of the mouth; fungal infection which may affect the intestines; liver dysfunction, 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 (occur in fewer than 1 person out of 10,000):
blood count abnormalities including agranulocytosis (lack of white blood cells); aggression; seeing, feeling or hearing things that are not real (hallucinations); severe liver dysfunction leading to liver failure and encephalopathy; sudden onset of severe rash or blistering or peeling of the skin (may be accompanied by high fever and joint pain) (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis); muscle weakness; breast enlargement in men; hypomagnesaemia (low magnesium levels in blood). Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat.
If you notice any of the above symptoms, you should inform your doctor immediately.
Frequency not known (frequency cannot be estimated from available data):
inflammation of the intestine (leading to diarrhoea); rash which may be accompanied by joint pain.
In very rare cases, Omeprazole Mercapharm may affect the number of white blood cells in the blood, which may lead to reduced immunity. If a patient develops an infection with symptoms such as fever accompanied by a significant deterioration in 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 the patient informs the doctor about the medicine being taken in such a situation.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should tell your doctor or pharmacist. 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 181C, 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 authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Omeprazole Mercapharm

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton (indicated after the abbreviation: EXP). The expiry date refers to the last day of the stated month.
Store below 25°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Omeprazole Mercapharm contains

• The active substance is omeprazole. One gastro-resistant hard capsule contains 20 mg of omeprazole.
• Other ingredients are: sugar spheres (sucrose and maize starch), hypromellose, talc, titanium dioxide (E 171), disodium phosphate dihydrate, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, triethyl citrate.
  Capsule shell composition:
  Body: titanium dioxide, purified water, gelatin;
  Cap: titanium dioxide, purified water, gelatin.
  Printing ink composition: black iron oxide (E 172), potassium hydroxide, shellac.

What Omeprazole Mercapharm looks like and contents of the pack
Omeprazole Mercapharm 20 mg capsules are opaque, made of white hard gelatin, printed with "OM 20", and contain spherical granules.
Pack contains: 14 gastro-resistant hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mercapharm Sp. z o.o.
Świętopełka 39
81-524 Gdynia, Poland
Manufacturer
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona, Spain