Ranisan 150 mg

Leaflet attached to the packaging: patient information

RANISAN 150 mg

(Ranitidine hydrochloride)

150 mg, coated tablets

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is RANISAN 150 mg and what is it used for
• 2. Important information before taking RANISAN 150 mg
• 3. How to take RANISAN 150 mg
• 4. Possible side effects
• 5. How to store RANISAN 150 mg
• 6. Contents of the packaging and other information

1. What is RANISAN 150 mg and what is it used for

RANISAN contains ranitidine, which is a specific, fast-acting histamine H₂-receptor antagonist. It inhibits both basal and postprandial gastric acid secretion as well as pepsin secretion in the gastric juice. Ranitidine has a relatively long half-life, which allows a single 150 mg dose to inhibit gastric acid secretion for 12 hours.

The indication for the use of RANISAN 150 mg in adultsis:

• Treatment of duodenal ulcer and mild gastric ulcer, including ulcers caused by non-steroidal anti-inflammatory drugs.
• Prevention of duodenal ulcers in patients taking non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), especially in patients with a history of peptic ulcer disease.
• Duodenal ulcer associated with Helicobacter pylori infection.
• Treatment of postoperative ulcer.
• Treatment of reflux esophagitis.
• Zollinger-Ellison syndrome.
• Relief of symptoms of gastroesophageal reflux.
• Recurring dyspeptic symptoms characterized by pain (in the epigastric or retrosternal area), related to meals or disturbing sleep, but not due to the conditions mentioned above.
• Prevention of Mendelson's syndrome (before general anesthesia in patients at risk of acid aspiration, especially in pregnant women).
• Prevention of bleeding from stress ulcer in critically ill patients.
• Prevention of recurrent bleeding from peptic ulcer.

In children (aged 3 to 18 years), RANISAN 150 mg is used for:

• Short-term treatment of peptic ulcer.
• Treatment of gastroesophageal reflux, including reflux esophagitis and symptomatic relief of gastroesophageal reflux.

2. Important information before taking RANISAN 150 mg

When not to take RANISAN 150 mg:

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with RANISAN 150 mg, the patient should discuss it with their doctor or pharmacist. Treatment with an H₂-receptor antagonist may mask symptoms associated with gastric cancer and thus delay its diagnosis. Therefore, in patients with gastric ulcer and if the indication is dyspeptic symptoms, it is necessary to exclude a malignant nature of the disease (especially in middle-aged and older patients, or patients who have new symptoms or a change in symptoms) before starting treatment with ranitidine.

Ranitidine is excreted by the kidneys, and therefore, in patients with impaired renal function, the plasma concentration of the medicine is increased. In these patients, the medicine should be dosed individually, depending on the degree of renal impairment (see also Dosage in renal impairment).

Patients taking non-steroidal anti-inflammatory drugs and ranitidine should be regularly monitored, especially the elderly and patients with a history of peptic ulcer disease.

There are rare reports suggesting that ranitidine may cause acute porphyria attacks. Therefore, the medicine should be avoided in patients with a history of acute porphyria.

Smoking promotes recurrence of duodenal ulcer, so patients are advised to quit smoking.

It has been found that in certain patient groups taking ranitidine, such as the elderly, patients with diabetes, chronic pulmonary disease, or immunocompromised patients, there may be an increased risk of developing community-acquired pneumonia.

RANISAN 150 mg and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Ranitidine may affect the absorption, metabolism, and renal excretion of certain other medicines. Therefore, it may be necessary to modify their doses or discontinue treatment. This may apply to the following medicines:

• Non-steroidal anti-inflammatory drugs (pain and anti-inflammatory medicines),
• Warfarin (anticoagulant medicines),
• Triazolam, midazolam (sedative and hypnotic medicines),
• Ketoconazole (antifungal medicine),
• Atazanavir and delavirdine (medicines used to treat HIV infection),
• Gefitinib (oncology medicine),
• Glipizide (antidiabetic medicine),
• In the case of high doses of ranitidine, also procainamide and N-acetylprocainamide (medicines used to treat arrhythmias).

Other medicines and RANISAN 150 mg

In the case of taking a medicine containing erlotinib, used to treat certain types of cancer, the patient should consult their doctor before taking RANISAN 150 mg. Ranitidine in RANISAN 150 mg may decrease the amount of erlotinib in the blood. Therefore, in the case of concurrent administration of erlotinib, the doctor may adjust the treatment accordingly. No interactions have been found between ranitidine and amoxicillin or metronidazole. If large doses of sucralfate (2 g) are administered concurrently with RANISAN 150 mg, the absorption of ranitidine may be reduced. Therefore, sucralfate should be taken at least two hours after ranitidine.

The patient should inform their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The medicine should only be used during pregnancy if absolutely necessary. Ranitidine passes into breast milk, so it should only be taken during breastfeeding if absolutely necessary. There are no data on the effect of ranitidine on human fertility. In animal studies, no effect on fertility was found.

Driving and using machines

If side effects such as dizziness or blurred vision occur, there may be a decrease in psychophysical fitness.

3. How to take RANISAN 150 mg

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is:

Duodenal ulcer and mild gastric ulcer

Treatment:

Usually, one tablet of ranitidine 150 mg is given twice a day or a single dose of 300 mg before bedtime. In most cases, healing of duodenal or mild gastric ulcers occurs after four weeks. In patients who have not fully healed at this stage of treatment, healing usually occurs within another four weeks of treatment.

Ulcers caused by non-steroidal anti-inflammatory drugs

Treatment:

Patients with ulcers caused by non-steroidal anti-inflammatory drugs may require treatment with ranitidine for a period of 8 to 12 weeks at a dose of 150 mg twice a day or 300 mg before bedtime.

Results of treatment of duodenal ulcer with a dose of ranitidine 300 mg twice a day for four weeks were better than with a dose of 150 mg twice a day or a single dose of 300 mg before bedtime. Increasing the dose did not result in a greater number of side effects.

Prevention:

To prevent the occurrence of duodenal ulcers during treatment with non-steroidal anti-inflammatory drugs, it is recommended to administer ranitidine at a dose of 150 mg twice a day.

Duodenal ulcer associated with Helicobacter pylori infection

Ranitidine at a dose of 300 mg before bedtime or 150 mg twice a day can be used with amoxicillin at a dose of 750 mg three times a day and metronidazole at a dose of 500 mg three times a day for two weeks. Then, ranitidine should be administered for another two weeks. This treatment effectively reduces the frequency of duodenal ulcer recurrences.

Maintenance treatment:

In maintenance treatment for patients who respond well to short-term treatment, especially if they have a history of peptic ulcer disease, a dose of 150 mg of ranitidine is usually given before bedtime.

Postoperative ulcer

In the treatment of postoperative ulcer, a dose of ranitidine 150 mg twice a day is used. In most cases, the ulcer heals within four weeks. If the ulcer has not fully healed, it is recommended to continue treatment for another four weeks.

Gastroesophageal reflux

To alleviate symptoms of gastroesophageal reflux, a dose of ranitidine 150 mg twice a day is recommended for two weeks. If symptoms do not resolve, the patient can continue this dosage for another two weeks.

Reflux esophagitis

Patients with reflux esophagitis are recommended to take ranitidine at a dose of 150 mg twice a day or 300 mg in a single dose before bedtime for up to eight weeks or, if necessary, for 12 weeks. In patients with moderate or severe esophagitis, the dose of ranitidine can be increased to 150 mg four times a day for 12 weeks.

Zollinger-Ellison syndrome

In patients with Zollinger-Ellison syndrome, the initial dose is 150 mg three times a day and may be increased as needed. Doses up to 6 g per day have been well tolerated.

Recurring dyspeptic symptoms

In patients with recurring dyspeptic symptoms, ranitidine is given at a dose of 150 mg twice a day for six weeks. If treatment fails, the diagnosis should be verified.

Prevention of Mendelson's syndrome

Patients at risk of developing Mendelson's syndrome can be given 150 mg of ranitidine two hours before general anesthesia, and preferably also one tablet of 150 mg the previous evening. Alternatively, ranitidine can be administered by injection in these cases. In obstetrics, from the beginning of labor, ranitidine can be administered orally at a dose of 150 mg every six hours. If general anesthesia is necessary, it is recommended to administer an antacid before anesthesia.

Prevention of bleeding from stress ulcer in critically ill patients and prevention of recurrent bleeding from peptic ulcer

In the prevention of bleeding from stress ulcer and in the prevention of recurrent bleeding from peptic ulcer, ranitidine should be administered parenterally. An oral dose of 150 mg can be given twice a day as an alternative to intravenous treatment, after the start of feeding.

Dosage in renal impairment

In patients with a creatinine clearance of less than 50 ml/min, ranitidine may accumulate, and plasma concentrations may increase. In these patients, the recommended daily dose of ranitidine is 150 mg.

Dosage in children aged 12 years and older

In children aged 12 years and older, the dosage is the same as in adults.

Dosage in children aged 3 to 11 years and weighing over 30 kg

Treatment of peptic ulcer

The recommended oral dose for the treatment of peptic ulcer in children is from 4 mg/kg per day to 8 mg/kg per day in two divided doses, up to a maximum dose of 300 mg of ranitidine per day for four weeks. In patients who have not fully healed, another four weeks of therapy are recommended, as complete healing usually occurs within eight weeks.

Gastroesophageal reflux

The recommended oral dose for the treatment of gastroesophageal reflux in children is from 5 mg/kg per day to 10 mg/kg per day in two divided doses, up to a maximum dose of 600 mg (the maximum dose is intended for children with a larger body mass and adolescents with severe symptoms).

Dosage in newborns

The safety and efficacy of ranitidine in newborns have not been established.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of RANISAN 150 mg than recommended

In case of overdose of ranitidine, symptomatic and supportive treatment is recommended. If a higher dose of the medicine is taken than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of RANISAN 150 mg

The patient should not take a double dose to make up for a missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, RANISAN 150 mg can cause side effects, although not everybody gets them. The following side effects have been reported in people taking ranitidine:

• ● Allergic reactions, which may include:
• skin rash (hives) or redness,
• swelling, mainly of the face, lips, tongue, or throat (angioedema),
• wheezing, coughing, or difficulty breathing, chest pain,
• sudden feeling of weakness or dizziness (may lead to falls or loss of consciousness).
• Kidney problems, which may be indicated by back pain, fever, pain when urinating, abnormal blood and urine test results (acute interstitial nephritis).
• Severe abdominal pain, which may be a sign of pancreatitis.
• Slow or irregular heartbeat.

The patient should immediately contact their doctor if they experience any of the above symptoms. They should stop taking RANISAN 150 mg.

Uncommon side effects(occurring in less than 1 in 100 patients, but more than 1 in 1,000 patients taking the medicine):

• Abdominal pain.
• Constipation.
• Nausea. These symptoms usually disappear during continued treatment.

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

• Skin rash.

Rare side effects that may appear in blood test results:

• Increased creatinine levels in the blood (usually slight; returns to normal during continued therapy).
• Transient changes in liver enzyme activity.

Very rare side effects(occurring in less than 1 in 10,000 patients taking the medicine):

• Usually transient changes in the number of blood elements. The patient may feel tired, short of breath, may be more prone to infections, or may experience easier bruising.
• Transient confusion, depression, and hallucinations, mainly in critically ill patients, elderly patients, and patients with nephropathy (kidney disease).
• Headache, sometimes severe, dizziness, joint and muscle pain, transient involuntary movements.
• Transient blurred vision, probably due to accommodation disorder.
• Accelerated heartbeat.
• Vasculitis.
• Diarrhea.
• Usually transient hepatitis with or without jaundice.
• Polymorphic erythema, alopecia.
• Transient impotence, symptoms, and conditions related to the breast in men (such as gynecomastia and galactorrhea).

Side effects with unknown frequency(the frequency cannot be estimated from the available data):

• Dyspnea.

If any of the side effects worsen or if any side effects not listed in the leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including those not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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, more information can be collected on the safety of the medicine.

5. How to store RANISAN 150 mg

The medicine should be stored out of sight and reach of children. There are no special precautions for storage temperature. Store in a dry place. Protect from light. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What does RANISAN 150 mg contain

• The active substance of the medicine is ranitidine in the form of ranitidine hydrochloride.
• The other ingredients of the medicine are: cornstarch, microcrystalline cellulose, polyvinylpyrrolidone VA-64, polyvinylpyrrolidone 25, magnesium stearate, coating: hypromellose 5, hypromellose 15, macrogol 6000, titanium dioxide, magnesium stearate, simethicone emulsion.

What RANISAN 150 mg looks like and what the pack contains

RANISAN 150 mg is available in the form of white, coated, lens-shaped tablets with a diameter of 9.6 mm, with a dividing line on one side. The tablets are packaged in aluminum/aluminum blisters, 2, 3, or 6 blisters of 10 tablets in a cardboard box.

Marketing authorization holder and manufacturer:

PRO.MED.CS. a.s., Telćská 1, 140 00 Prague 4, Czech Republic. For more detailed information, please contact the local representative of the marketing authorization holder.

Date of the last revision of the leaflet: