Description

Bioprazol Bio Max - a medicinal product used to reduce the amount of hydrochloric acid secreted in the stomach.

Composition

The active substance is omeprazole (Omeprazole).

1 capsule contains 20 mg of omeprazole.

Excipients: capsule contents: sucrose, seeds, anhydrous lactose, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, hypromellose phthalate, diethyl phthalate, capsule shell: gelatin, indigo carmine (E132), quinoline yellow (E104).

Dosage

Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist.

The usual dose is: 1 capsule once daily for 14 days.

If symptoms do not improve after this time, contact your doctor.

It may be necessary to take the capsules for 2-3 consecutive days to improve symptoms.

Action

Omeprazole belongs to a group of drugs called proton pump inhibitors, which work by reducing the amount of hydrochloric acid secreted in the stomach.

Indications

Bioprazol Bio Max is used for the short-term treatment of symptoms of gastroesophageal reflux disease.

Contraindications

Do not use Bioprazol Bio Max if you: are allergic to omeprazole or any of the other ingredients of this medicine; are allergic to medicines containing other proton pump inhibitors; are taking medicines to treat HIV infection.

Side effects

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

If you experience any of these side effects during treatment, contact your doctor or go to the hospital straight away:

Uncommon (affecting less than 1 in 100 people): unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1,000 people): swelling of skin, tongue, lips or face, or have difficulties breathing or swallowing (allergic reaction); high fever, agitation, confusion, tremors and abrupt contractions of muscles, which may be symptoms of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from the available data): difficulty in urinating; seizures; yellowing of the skin and whites of the eyes, which are symptoms of liver disorder/hepatitis; fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsades de pointes; suicidal thoughts and behavior.

In addition to those described above, the following side effects have also been reported: Very common (more than 1 in 10 people): nausea; headache.

Common (affecting less than 1 in 10 people): blocked or runny nose (sinusitis); decreased or increased appetite; anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, shaking, prickling of the skin; diarrhea, constipation, vomiting, dry mouth; increased sweating; muscle and joint pain; sexual disturbances (delayed ejaculation, erectile dysfunction, decreased sexual drive and women may experience difficulties achieving orgasm); tiredness, fever; weight gain.

Uncommon (may affect up to 1 in 100 people): hives, rash, itching (pruritus); teeth grinding, agitation, nervousness, panic attack, confusion (disorientation); sleep disturbances, taste disturbances, fainting; dilated pupils, visual disturbances, ringing in the ears (tinnitus); hair loss; heavy menstrual bleeding; irregular periods; weight loss; fast heartbeat; swelling of the arms or legs; nose bleed.

Rare (less than 1 in 1000 people): aggression, depersonalisation (sense of loss of identity, the person feels that he or she is not himself or herself), hallucinations; slow heartbeat.

Unknown frequency (frequency cannot be estimated from the available data): decreased sodium levels in the blood (symptoms include nausea and malaise with muscle weakness or confusion); dizziness when standing due to low blood pressure (orthostatic hypotension); abnormal liver function tests (increased liver enzymes in the blood); movement disorders (involuntary muscle movements); painful erection of the penis (priapism); symptoms of increased bleeding frequency, e.g. in the skin and mucous membranes (ecchymoses); sudden swelling of the skin or mucous membranes (angioedema); increased urine output (inappropriate secretion of antidiuretic hormone - vasopressin); milk flow in men and in women who are not breastfeeding; mania; an increased risk of bone fractures has been observed in patients taking medicines from this class; a change in heart rhythm (called "QT prolongation," seen on an ECG, a test that measures how the heart is functioning); heavy vaginal bleeding that occurs shortly after giving birth (postpartum hemorrhage),

Warnings and precautions

Bioprazol Bio Max may cause the symptoms of other diseases to hide.

Patients should not take omeprazole preventively.

If you get a skin rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Bioprazol Bio Max.

Bioprazol Bio Max contains sucrose and anhydrous lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Keep the medicine out of the sight and reach of children.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Bioprazol Bio Max may interact with: antifungal and antiyeast medicines; digoxin; diazepam; medicines used to reduce blood clotting; medicines used to treat tuberculosis; medicines used to treat atopic dermatitis; medicines used for mild depression.

Taking the medicine with food and drink

Bioprazol Bio Max capsules can be taken before eating (on an empty stomach).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Before you start taking Bioprazol Bio Max, tell your doctor if you are pregnant or trying to get pregnant. Your doctor will decide whether you can take Bioprazol Bio Max during this time.

Use of the drug in children and adolescents

Bioprazol Bio Max is not intended for use in children and adolescents.

Driving and operating machinery

Side effects such as dizziness and visual disturbances may occur. If these occur, you should not drive or operate machinery.