Solvertil

Package Leaflet: Information for the User

Solvertyl, 25 mg/ml, Solution for Injection

Ranitidine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed 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, tell your doctor or pharmacist.

Table of Contents of the Leaflet

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

1. What is Solvertyl and what is it used for

The active substance of Solvertyl is ranitidine, which blocks the H receptors in the gastrointestinal tract. This leads to a decrease in the secretion of hydrochloric acid and pepsin (a protein-digesting enzyme) after meals and on an empty stomach, resulting in a decrease in the acidity of gastric juice. Solvertyl in the form of a solution for injection is used when oral treatment with ranitidine is not possible. Solvertyl is used to treat:

• gastric and duodenal ulcer disease,
• gastroesophageal reflux disease,
• Zollinger-Ellison syndrome, and to prevent:
• bleeding from stress ulcers in critically ill patients,
• repeated bleeding in patients with gastrointestinal ulcers,
• aspiration of acidic gastric contents (Mendelson's syndrome) before general anesthesia, especially in pregnant women during childbirth.

2. Important information before using Solvertyl

When not to use Solvertyl

• if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6.

Warnings and precautions

Before starting treatment with Solvertyl, discuss it with your doctor.

• If you have liver function disorders.
• If you have porphyria (the medicine may trigger an acute attack of this disease).
• If you have kidney function disorders (this may lead to an increase in the concentration of ranitidine in the blood, so your doctor may change the dosage of the medicine).

Ranitidine may cause false-positive results in urine tests for protein (during treatment with ranitidine, a false-positive result of the MULTISTIX test may occur, so it is recommended to use a test with sulfosalicylic acid).

• If you are to undergo a test to detect protein in the urine (during treatment with ranitidine, a false-positive result of the MULTISTIX test may occur, so it is recommended to use a test with sulfosalicylic acid).

Treatment with ranitidine may mask the symptoms of gastric cancer and thus delay proper diagnosis. Therefore, treatment of gastric ulcers with Solvertyl should only be started after cancer has been ruled out. In rare cases, during too rapid intravenous administration, bradycardia (slow heart rate) may occur, especially in people who are at risk of cardiac arrhythmias, so the recommended infusion rate should not be exceeded. When using the intravenous route, administration of higher than recommended doses of the medicine for more than 5 days may lead to an increase in liver enzyme activity. The medicine should be used strictly according to the doctor's instructions and under their supervision. Situations requiring caution should be discussed with the doctor, even if they occurred in the past.

Solvertyl and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. Ranitidine does not enhance the effects of medicines such as diazepam, lidocaine, phenytoin, propranolol, theophylline, and warfarin. In rare cases, the concurrent use of ranitidine and warfarin may lead to prolonged or shortened blood clotting time. Ranitidine may decrease the absorption of ketoconazole and other medicines whose absorption depends on the acidity of gastric juice. No interactions have been found between ranitidine and amoxicillin or metronidazole.

Solvertyl with food and drink

Solvertyl can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine. The medicine may be used during pregnancy and breastfeeding only if necessary.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, do not drive or operate any machinery.

1 ampoule of Solvertyl (2 ml) contains 0.223 mmol of Na+. The product can be diluted with 0.9% sodium chloride solution, 5% glucose solution, 0.18% sodium chloride solution with 4% glucose solution, 4.2% sodium bicarbonate solution with Hartmann's solution.

The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the product.

To obtain accurate information about the sodium content in the solution used to dilute the product, refer to the characteristics of the medicinal product of the diluent used.

3. How to use Solvertyl

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor. The usual dose of Solvertyl is:

• for therapeutic use in adults, including the elderly: 50 mg of ranitidine (1 ampoule) by slow (over 2 minutes) intravenous injection, after dilution of the ampoule contents to a volume of 20 ml; the injection can be repeated every 6 to 8 hours;
• 50 mg of ranitidine (1 ampoule) in intravenous infusion over 2 hours, administered at a rate of 25 mg per hour; the infusion can be repeated every 6 to 8 hours;
• 50 mg of ranitidine (1 ampoule) by intramuscular injection every 6 to 8 hours (dilution of the ampoule contents is not necessary).

For prophylactic use:

• to prevent bleeding from stress ulcers in critically ill patients and to prevent repeated bleeding in patients with gastrointestinal ulcers, ranitidine is recommended in a dose of 50 mg (1 ampoule) by slow intravenous injection, followed by intravenous infusion at a rate of 0.125 to 0.25 mg/kg body weight per hour;
• in case of risk of aspiration of acidic gastric contents (Mendelson's syndrome), the medicine should be administered in a dose of 50 mg (1 ampoule) intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anesthesia.

The medicine can be diluted in the following infusion solutions: 0.9% sodium chloride solution, 5% glucose solution, 0.18% sodium chloride solution with 4% glucose solution, 4.2% sodium bicarbonate solution with Hartmann's solution. Ranitidine should not be administered in the same syringe as the following medicines: amphotericin B, ampicillin, cefazolin, cefuroxime, cephalothin, chlorpromazine, clindamycin, diazepam, hydroxyzine, lorazepam, levopromazine, metaraminol, methotrexate, midazolam, opium alkaloids, phenobarbital.

Patients with renal impairment

Ranitidine is mainly excreted by the kidneys. In patients with a creatinine clearance of less than 50 ml/min, ranitidine excretion may be impaired, leading to an increase in the concentration of the medicine in the blood. Therefore, in these patients, ranitidine in the form of a solution for injection is used in doses of 25 mg (1/2 ampoule).

Use in children

Do not use.

If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Overdose of Solvertyl

Due to the selective mechanism of action of ranitidine, no specific problems are expected in case of overdose. However, if you have taken more of the medicine than recommended, tell your doctor immediately, who will decide on the necessary treatment (if any). If you have used more of the medicine than recommended, seek medical attention or consult a doctor or pharmacist.

Missed dose of Solvertyl

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

Stopping use of Solvertyl

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported in patients taking ranitidine. In many cases, it has not been confirmed whether they were caused by ranitidine. If you experience any of the following symptoms, tell your doctor or nurse immediately:

• severe itching of the skin, rash,
• fever,
• shortness of breath,
• swelling of the face, tongue, or throat,
• difficulty swallowing,
• decrease in blood pressure,
• chest pain. These may be symptoms of a severe allergic reaction. They are rare and very rarely life-threatening.

Tell your doctor if you experience any of the following symptoms:

• abnormal liver test results;
• skin rash.

Rare side effects (more than 1 in 10,000 patients, but less than 1 in 1,000 patients):

• reduction in the number of white blood cells and platelets, and other types of blood cells, sometimes with partial or complete bone marrow failure;
• confusion, depression, and hallucinations (mainly in critically ill patients and the elderly);
• headache, sometimes severe, dizziness, transient involuntary movements;
• blurred vision;
• slow heart rate, cardiac arrest;
• vasculitis;
• acute pancreatitis, diarrhea;
• hepatitis with or without jaundice;
• erythema multiforme, alopecia;
• arthralgia and myalgia;
• kidney inflammation;
• impotence, gynecomastia in men.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. 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 Solvertyl

Store below 25°C.

Store in the original packaging to protect from light.

Store out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP.

The expiry date refers to the last day of the month.

Do not use this medicine if you notice any mechanical contamination in the ampoule or a change in the color of the solution.

Do not use Solvertyl if more than 24 hours have passed since the preparation of the solution for intravenous infusion.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Solvertyl contains

• The active substance is ranitidine (25 mg/ml) in the form of ranitidine hydrochloride
• The other ingredients are disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections.

What Solvertyl looks like and contents of the pack

Solvertyl is a colorless to light yellow, clear liquid, practically free from visible particles. The pack contains 5 ampoules of orange glass, each containing 2 ml, in a cardboard box.

Marketing authorization holder

PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00 Prague 7, Czech Republic

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA, ul. Wincentego Pola 21, 58-500 Jelenia Góra

Date of approval of the leaflet: