Ranigast

Package Leaflet: Information for the Patient

Ranigast, 0.5 mg/ml, Solution for Infusion

Ranitidine

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Ranigast and what is it used for
• 2. Important information before using Ranigast
• 3. How to use Ranigast
• 4. Possible side effects
• 5. How to store Ranigast
• 6. Contents of the pack and other information

1. What is Ranigast and what is it used for

Ranigast is a medication that inhibits the secretion of hydrochloric acid in the stomach.
It is used in patients being treated in a hospital, in whom a reduction in acid secretion is indicated and oral administration is not possible, e.g., in:
duodenal and gastric ulcer disease,
other conditions with symptomatic excessive acid secretion.

2. Important information before using Ranigast

When not to use Ranigast

• if the patient is hypersensitive to ranitidine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Before starting treatment with Ranigast, discuss with your doctor:

• if the patient has severe renal impairment, as ranitidine is excreted by the kidneys; in patients with severe renal impairment, smaller doses of the medication are used (as decided by the doctor);
• if the patient has porphyria (ranitidine may cause acute attacks of the disease);
• if the patient has diabetes, respiratory diseases, and immune system disorders (there may be an increased risk of developing hospital-acquired pneumonia);
• if the diagnosis of gastric ulcer is not certain. Before starting treatment, it is necessary to rule out the malignant nature of the ulcer (especially in middle-aged and elderly patients with new dyspeptic disorders, or patients whose symptoms have changed), as ranitidine may mask symptoms accompanying tumors.

Ranigast and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as medications you plan to take.
The medications listed below may occur under several different trade names. They will not be included in this section, only the active substances or their groups are listed. Therefore, you should carefully check the packaging and the leaflet of the medication you are taking for the name of its active substance.
Ranigast does not enhance the effects of medications such as:

• amoxicillin (antibiotic),
• diazepam (sedative and anxiolytic medication used in the treatment of epilepsy),
• lidocaine (anesthetic medication also used in the treatment of arrhythmias),
• phenytoin (antiepileptic medication),
• metronidazole (antifungal and antiprotozoal medication),
• propranolol (medication used, among others, in the treatment of hypertension and coronary heart disease),
• theophylline (medication used in the treatment of asthma).

Ranigast may affect the rate and extent of absorption of medications such as:

• ketoconazole (antifungal medication),
• atazanavir, delavirdine (medications used in viral infections),
• gefitinib (medication used in the treatment of tumors),
• benzodiazepine medications, such as midazolam, triazolam - used in case of insomnia,
• glipizide (medication used in the treatment of diabetes),
• procainamide, N-acetylprocainamide (medications used in arrhythmias).

Ranigast may enhance the effects of anticoagulant medications, such as warfarin, so it is necessary to closely monitor prothrombin time during concomitant treatment with these medications.
Smoking reduces the effectiveness of ranitidine.

Ranigast with food and drink

Food does not affect the intravenously administered Ranigast.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medication.
Pregnancy
The medication should be used in pregnant women only when, in the doctor's opinion, it is absolutely necessary.
Breastfeeding
Ranitidine passes into breast milk, so in breastfeeding women, the medication can be used only when, in the doctor's opinion, it is absolutely necessary.
There are no data on the effect of ranitidine on fertility in humans. In animal studies, no effect on fertility was found.

Driving and operating machinery

Ranigast may cause dizziness or blurred vision in some patients.
In case of such side effects, do not drive or operate machinery.

Ranigast contains sodium

The medication contains 0.1 mmol (2.35 mg) of sodium per 1 ml of solution, which should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to use Ranigast

This medication should always be used as directed by your doctor. In case of doubts, consult your doctor.
Ranigast, 0.5 mg/ml, solution for intravenous infusion, does not require dilution.
Administer intravenously 50 mg of ranitidine in a drip infusion lasting 15-20 minutes (at a rate of 5-7 ml/min). If necessary, the infusion can be repeated every 6-8 hours.
The medication can also be administered in a continuous intravenous infusion at a rate of 6.25 mg/hour.
Do not exceed the dose of 400 mg/day.
After improvement, treatment can be continued with oral ranitidine.

Dosing in patients with renal impairment

In patients with renal impairment (creatinine clearance less than 50 ml/min), it is recommended to reduce the dose by half or administer 50 mg of ranitidine every 18-24 hours. If necessary, the medication can be administered every 12 hours or more frequently.

Use in children

The safety and efficacy of the medication in children have not been established.

Overdose of Ranigast

In case of overdose, consult your doctor immediately.
Symptoms of overdose are similar to side effects that may occur during treatment with ranitidine. Sometimes, hypotension and gait disturbances may occur.

Missed dose of Ranigast

In case of a missed dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Ranigast

In case of further doubts about the use of this medication, consult your doctor.

4. Possible side effects

Like all medications, Ranigast can cause side effects, although not everybody gets them.
In patients using ranitidine, the following side effects have been observed:
Uncommon(occurring in less than 1 in 100 patients):

• abdominal pain, constipation, nausea (these symptoms usually resolve during treatment).

Rare(occurring in less than 1 in 1,000 patients):

• hypersensitivity reactions (urticaria, rash, angioedema - swelling of the face, lips, tongue, and throat, making breathing difficult, accompanied by itching, redness of the skin, urticaria, and severe bronchospasm; fever, bronchospasm, decreased blood pressure, chest pain);
• transient and reversible changes in liver function tests;
• increased creatinine levels in the blood (usually slight, returning to normal during treatment).

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

• decreased white blood cell count (leukocytes), decreased platelet count (thrombocytopenia), absence of a certain type of white blood cell - granulocytes in the blood (agranulocytosis), deficiency of white blood cells, red blood cells, and platelets (pancytopenia) with or without bone marrow disorders;
• anaphylactic shock (symptoms include: shortness of breath, difficulty breathing due to laryngeal edema, difficulty exhaling, stridor, itching of the skin and its redness, headache, feeling of "pressure", dizziness, accelerated or, less often, slowed heart rate, itching, urticaria of varying severity, flushing of the whole body, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening);
• transient disorientation, depression, hallucinations (in seriously ill patients, elderly patients, and patients with kidney disease);
• headache and dizziness, reversible movement disorders;
• blurred vision (accommodation disorders of the eye);
• bradycardia (slow heart rate), tachycardia (fast heart rate), atrioventricular block, other heart problems that can lead to death (asystole);
• vasculitis;
• acute pancreatitis, diarrhea;
• hepatitis (cellular, canalicular, or mixed) with or without jaundice;
• erythema multiforme (severe allergic skin reaction causing spots, red or purple stripes or blisters on the skin or mucous membranes), hair loss;
• arthralgia and myalgia;
• nephritis;
• gynecomastia in men, transient impotence, galactorrhea.

Unknown(frequency cannot be estimated from the available data):

• shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medication.

5. How to store Ranigast

Store the medication out of sight and reach of children.
Protect from light and the effects of chemically active vapors or gases with a strong odor.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ranigast contains

• The active substance of the medication is ranitidine (50 mg/100 ml), in the form of ranitidine hydrochloride.
• The other ingredients are: sodium chloride, citric acid monohydrate, disodium phosphate dodecahydrate, water for injections.

What Ranigast looks like and contents of the pack

Polyethylene container with an Insocap adapter containing 100 ml of solution for infusion.
The pack contains 1 or 40 containers.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
To obtain more detailed information, contact the local representative of the marketing authorization holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warsaw
phone: 22 364 61 01

Date of last revision of the leaflet: