Ranigast

Package Leaflet: Information for the User

Ranigast, 150 mg, Film-Coated Tablets

Ranitidine

Read the package leaflet carefully before taking 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 only. 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. See section 4.

Table of Contents of the Leaflet

• 1. What is Ranigast and what is it used for
• 2. Important information before taking Ranigast
• 3. How to take 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

This is a histamine H2-receptor antagonist, which inhibits the secretion of hydrochloric acid in the stomach. Ranitidine, the active substance of Ranigast, is rapidly absorbed from the gastrointestinal tract, and maximum blood concentrations are reached within 2-3 hours after administration. The duration of action of a single dose of 150 mg ranitidine is approximately 12 hours. Food does not significantly affect the absorption of the medicine.

Ranigast is used for:

• treatment of duodenal and gastric ulcer disease.
• prevention and treatment of duodenal ulcers that occur during the use of non-steroidal anti-inflammatory drugs.
• treatment of duodenal ulcers associated with Helicobacter pylori infection.
• treatment of gastroesophageal reflux disease:
• symptomatic treatment of gastroesophageal reflux disease,
• reflux esophagitis.
• symptomatic treatment of recurring dyspeptic symptoms not related to organic gastrointestinal disease.
• prevention of Mendelson's syndrome.

2. Important information before taking Ranigast

When not to take Ranigast

• 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 Ranigast, discuss with your doctor:

• in patients with renal impairment, as ranitidine is excreted by the kidneys; in patients with renal impairment, lower doses of the medicine are used (as decided by the doctor);
• in patients treated concurrently with non-steroidal anti-inflammatory drugs and ranitidine, especially in patients over 65 years of age and those with a history of peptic ulcer disease;
• in patients with porphyria (ranitidine may precipitate acute attacks of the disease);
• if you have diabetes, respiratory or immune system disorders (may increase the risk of developing community-acquired pneumonia);
• if the diagnosis of gastric ulcer disease is uncertain. Before starting treatment, it should be ensured that the ulcer is not malignant (especially in middle-aged and elderly patients with new dyspeptic symptoms, or patients whose symptoms have changed), as ranitidine treatment may mask the symptoms of a malignancy.

Ranigast with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.

• ketokonazole (an antifungal medicine),
• atazanavir, delavirdine (medicines used to treat viral infections),
• gefitinib (a medicine used to treat cancer),
• benzodiazepines, such as midazolam, triazolam (used for insomnia),
• glipizide (a medicine used to treat diabetes),
• procainamide, N-acetylprocainamide (medicines used to treat heart rhythm disorders).

Ranitidine does not enhance the effects of medicines such as amoxicillin (an antibiotic) and metronidazole (an antifungal and anti-protozoal medicine), diazepam (a sedative and anxiolytic medicine used to treat epilepsy), lidocaine (a local anesthetic used to treat heart rhythm disorders), phenytoin (an antiepileptic medicine), propranolol (a medicine used to treat hypertension and heart disease), theophylline (a medicine used to treat asthma). Ranigast may enhance the effects of anticoagulant medicines such as warfarin, so it is necessary to closely monitor prothrombin time during concomitant treatment with these medicines.

Ranigast with food and drink

Food does not significantly affect the absorption of ranitidine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The medicine should be used in pregnant women only when it is absolutely necessary.

Breastfeeding

Ranitidine passes into breast milk, so in breastfeeding women, the medicine can be used only when it is absolutely necessary.

There are no data on the effects of ranitidine on human fertility. In animal studies, no effects on fertility were observed.

Driving and using machines

There is no information on contraindications to driving or operating machinery during ranitidine treatment.

However, some patients have experienced side effects such as dizziness, headache, or blurred vision, which may affect physical and mental performance. If such side effects occur, do not drive or operate machinery.

Ranigast contains sunset yellow FCF (E110)

The medicine may cause allergic reactions.

3. How to take Ranigast

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Typically, the following dosing is recommended:

Adults: Duodenal and Gastric Ulcer Disease

Usually, 1 tablet of 150 mg is taken twice a day or a single dose of 300 mg before bedtime.

Most patients heal within 4 weeks of treatment. In patients who do not respond adequately to treatment after 4 weeks, treatment should be continued for another 4 weeks.

Prevention and Treatment of Duodenal Ulcers Associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

In the treatment of ulcers associated with NSAIDs, ranitidine is recommended at a dose of 150 mg twice a day or 300 mg once at bedtime, if necessary, for 8-12 weeks.

For prevention during NSAID treatment, 150 mg of ranitidine is taken twice a day.

Duodenal Ulcer and Gastric Ulcer Associated with Helicobacter pylori Infection

The recommended dose is 150 mg twice a day or 300 mg once at bedtime, concurrently with amoxicillin (750 mg 3 times a day) and metronidazole (500 mg 3 times a day) for 2 weeks.

For the next two weeks, only ranitidine should be taken. Treatment according to this scheme significantly reduces the frequency of duodenal ulcer relapses.

Maintenance Treatment

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

Gastroesophageal Reflux Disease

In symptomatic treatment of gastroesophageal reflux disease, 150 mg of ranitidine is recommended once or twice a day for 2 weeks.

If necessary, the treatment time can be extended by another 2 weeks.

In adults with reflux esophagitis, 150 mg of ranitidine is usually taken twice a day or 300 mg (2 tablets of 150 mg) once at bedtime for 8 weeks or, if necessary, for 12 weeks.

In cases of severe esophagitis symptoms, the dose of the medicine can be increased to 150 mg of ranitidine 4 times a day for 12 weeks.

A beneficial effect on treatment has a proper body position during sleep (10-15 cm elevation of the head in relation to the rest of the body).

Recurring Dyspeptic Symptoms

150 mg of ranitidine is recommended once a day, and if necessary, twice a day for 6 weeks.

In patients for whom such treatment is ineffective or symptoms recur quickly, the previous diagnosis should be verified.

Prevention of Mendelson's Syndrome

In patients at risk of developing Mendelson's syndrome, 150 mg of ranitidine is taken 2 hours before the start of general anesthesia, and preferably also 150 mg of ranitidine in the evening on the day before anesthesia.

In obstetrics, ranitidine can be used from the beginning of labor at a dose of 150 mg orally every 6 hours.

Alternatively, ranitidine can be administered as an injection solution.

Use in Children

In the treatment of ulcer disease, ranitidine is recommended at a dose of 2 mg/kg to 4 mg/kg twice a day. The maximum dose of the medicine should not exceed 300 mg per day.

Dosing in Renal Impairment

In patients with renal impairment (creatinine clearance less than 50 ml/min), the excretion of ranitidine may be reduced, which may lead to an increase in its concentration in the blood serum.

Therefore, in these patients, it is not recommended to take more than 150 mg of ranitidine per day.

Hemodialysis reduces the concentration of ranitidine in the blood serum. In patients undergoing chronic dialysis, ranitidine should be administered at a dose of 150 mg immediately after dialysis.

The medicine can be taken independently of meals.

Overdose of Ranigast

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.

Overdose symptoms may be similar to side effects that may occur during ranitidine treatment (see section 4 "Possible side effects"). Sometimes, hypotension and gait disturbances may occur.

In case of poisoning, consult a doctor immediately.

Missed Dose of Ranigast

If you miss a dose, take it as soon as possible. If it is almost time for the next dose, do not take a double dose to make up for the missed dose.

Stopping Ranigast Treatment

If you have any further questions about taking this medicine, ask your doctor.

4. Possible Side Effects

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

Side effects are classified according to their frequency:

Very common:occur in more than 1 in 10 patients

Common:occur in less than 1 in 10 patients

Uncommon:occur in less than 1 in 100 patients

Rare:occur in less than 1 in 1,000 patients

Very rare:occur in less than 1 in 10,000 patients

Not known:frequency cannot be estimated from the available data

In patients taking ranitidine, the following side effects have been observed:

Uncommon:abdominal pain, constipation, nausea (these symptoms usually disappear during treatment).

Rare:rash, urticaria, angioedema (swelling of the face, lips, tongue, and throat, making breathing difficult, associated with itching, redness of the skin, urticaria, and severe bronchospasm), fever, bronchospasm, increased creatinine levels in the blood (usually slight, returning to normal during treatment), hypotension, chest pain, transient changes in liver enzyme activity.

Very rare:headache (sometimes severe) and dizziness, transient involuntary movement disorders, transient confusion, depression, and hallucinations (especially in severely ill patients, elderly patients, and patients with kidney disease), bradycardia, tachycardia, atrioventricular block (conduction disorders in the heart muscle cells), vasculitis, usually transient hepatitis (cellular, canalicular, or mixed) with or without jaundice, acute pancreatitis, diarrhea, arthralgia and myalgia, usually transient leukopenia (reduced white blood cell count) and thrombocytopenia (reduced platelet count), agranulocytosis (a disease characterized by symptoms of high fever, sore throat, ulcers in the mouth, nose, throat, genitals, and anus) or pancytopenia (deficiency of white blood cells, red blood cells, and platelets), sometimes with bone marrow aplasia or hypoplasia (bone marrow failure), gynecomastia (breast enlargement in men), transient impotence, galactorrhea, erythema multiforme, hair loss, anaphylactic shock (symptoms include: shortness of breath, difficulty breathing due to laryngeal edema, difficulty exhaling, wheezing, itching of the skin and its redness, headache, feeling of "pressure", dizziness, accelerated or (rarely) slowed heart rate, itching, urticaria of varying severity, erythema of the whole body, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening), blurred vision (accommodation disorders), nephritis.

Not known:dyspnea.

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 Adverse Reaction Monitoring 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

e-mail: [email protected]

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 Ranigast

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

Do not store above 25°C.

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

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

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

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

6. Contents of the Pack and Other Information

What Ranigast contains

• The active substance is ranitidine in the form of ranitidine hydrochloride. Each tablet contains 150 mg of ranitidine.
• The other ingredients are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica. Tablet coating: hypromellose (Methocel E15), sunset yellow FCF (E110), titanium dioxide, triacetin, talc.

What Ranigast looks like and contents of the pack

Ranigast is film-coated tablets with a diameter of 9 mm, biconvex, orange.

The pack contains 30 or 60 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Polpharma S.A.

ul. Pelplińska 19

83-200 Starogard Gdański