Ranigast Max

Package Leaflet: Information for the User

Ranigast MAX, 150 mg, Coated Tablets

Ranitidine

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 14 days, a doctor should be consulted.

Table of Contents of the Leaflet

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

1. What is Ranigast MAX and what is it used for

Ranitidine, the active substance of Ranigast MAX, inhibits the secretion of hydrochloric acid in the stomach.
The indication for use of the medication is the symptomatic treatment of gastrointestinal disorders not related to organic gastrointestinal disease: dyspepsia, heartburn, hyperacidity, epigastric pain. The medication acts quickly. The duration of action of 1 tablet is approximately 12 hours.

2. Important information before taking Ranigast MAX

When not to take Ranigast MAX

• if the patient is allergic to ranitidine or any of the other ingredients of this medication (listed in section 6),
• in children and adolescents under 16 years of age.

Warnings and precautions

Before starting treatment with Ranigast MAX, the patient should discuss it with a doctor or pharmacist:

• if the patient has liver or kidney function disorders,
• if the patient has had acute porphyria,
• if the patient experiences weight loss, difficulty swallowing, or persistent abdominal pain along with dyspepsia,
• if the patient has not had gastrointestinal (dyspeptic) symptoms before or if they have changed recently - especially in people of middle or advanced age,
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs), especially in elderly patients and those who have had peptic ulcer disease in the past,
• if the patient is taking other medications, including those available without a prescription,
• if the patient is under regular medical supervision for other reasons,
• if the patient has diabetes, lung disease, or immune system disorders. Ranitidine treatment may mask symptoms of stomach cancer.

Ranigast MAX and other medications

The patient should inform the doctor or pharmacist about all medications being taken or recently taken, as well as any planned to be taken .
Ranigast MAX may affect the rate and extent of absorption of medications such as:

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

Sucralfate (a medication used in stomach ulcer treatment) in doses above 2 g reduces ranitidine absorption.
Ranitidine does not enhance the effects of medications such as amoxicillin (an antibiotic) and metronidazole (an antibacterial and antiprotozoal medication), diazepam (a sedative and anxiolytic medication used in epilepsy treatment), lidocaine (a local anesthetic also used in heart rhythm disorders), phenytoin (an antiepileptic medication), propranolol (a medication used in hypertension and coronary heart disease treatment), theophylline (a medication used in asthma treatment).
Ranigast MAX may prolong prothrombin time when taken with anticoagulant medications - coumarin derivatives (e.g., warfarin), so prothrombin time should be closely monitored during concomitant treatment with these medications.

Ranigast MAX with food and drink

Food does not significantly affect ranitidine absorption.

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 a doctor or pharmacist before taking 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 human fertility. In animal studies, no effect on fertility of either sex was observed.

Driving and using machines

There is no information on contraindications to driving vehicles and operating machinery during ranitidine treatment. However, some patients have experienced side effects such as dizziness and headache or blurred vision, which may impair physical and mental performance. If such side effects occur, the patient should not drive vehicles or operate machinery.

Ranigast MAX contains orange yellow S (E110)

The medication may cause allergic reactions.

3. How to take Ranigast MAX

This medication should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
Adults and adolescents over 16 years of age
For dyspepsia symptoms, 1 tablet of 150 mg is usually taken once a day.
In case of symptom recurrence, 1 tablet of 150 mg can be taken twice a day. The daily dose of the medication should not exceed 300 mg (2 tablets).
The tablet should be swallowed whole, with a small amount of water.
The medication should not be taken without consulting a doctor for more than 2 weeks. If symptoms do not disappear after 2 weeks of treatment, a doctor should be consulted immediately.
Dosing in patients with renal impairment
In patients with renal impairment (creatinine clearance less than 50 ml/min), ranitidine elimination may be reduced, which may lead to increased blood levels.
Hemodialysis reduces blood ranitidine levels. In patients undergoing chronic dialysis, ranitidine should be administered at a dose of 150 mg immediately after dialysis.
The medication can be taken independently of meals.

Overdose of Ranigast MAX

As a result of overdosing on Ranigast MAX, transient side effects may occur, such as those that occur during ranitidine treatment (see section 4 "Possible side effects").
Sometimes, hypotension and gait disturbances may occur.
In case of poisoning, a doctor should be consulted, who will provide appropriate treatment.

Missed dose of Ranigast MAX

In case of missing one dose, it should be taken as soon as possible. If the time for the next dose is near, a double dose should not be taken to make up for the missed dose.

Stopping treatment with Ranigast MAX

In case of further doubts about taking this medication, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Ranigast MAX can cause side effects, although not everybody gets them.
Side effects have been classified by frequency of occurrence:
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
Unknown:frequency cannot be estimated from available data
In patients taking ranitidine, the following side effects have been observed:
Very rare:headache (sometimes severe) and dizziness, transient involuntary movement disorders, transient confusion, depression, and hallucinations (especially in seriously ill patients, elderly patients, and patients with kidney disease), bradycardia, tachycardia, atrioventricular block (conduction disorders in 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 high fever, sore throat, oral, nasal, genital, and anal ulcers) or pancytopenia (deficiency of white blood cells, red blood cells, and platelets), sometimes with bone marrow aplasia or hypoplasia (bone marrow atrophy), gynecomastia (breast enlargement in men), transient impotence, galactorrhea, erythema multiforme, hair loss, anaphylactic shock (symptoms: shortness of breath, difficulty breathing due to laryngeal edema, difficulty exhaling, wheezing, skin itching and redness, headache, feeling of "pressure", dizziness, accelerated or, less often, 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.
Rare:rash, urticaria, angioedema (swelling of the face, lips, tongue, and throat, making breathing difficult, accompanied by itching, skin redness, urticaria, and severe bronchospasm), fever, bronchospasm, transient changes in liver enzyme activity in diagnostic tests, hypotension, chest pain, increased creatinine levels (usually slight; normalizes during treatment).
Uncommon: abdominal pain, constipation, nausea (these symptoms disappear during treatment).
Unknown:dyspnea.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Ranigast MAX

The medication should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Ranigast MAX contains

• The active substance is ranitidine in the form of ranitidine hydrochloride. Each tablet contains 150 mg of ranitidine.
• Other ingredients are:

Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.
Tablet coating: hypromellose (Methocel E 15), orange yellow S (E110), titanium dioxide, triacetin, talc.

What Ranigast MAX looks like and contents of the pack

Ranigast MAX are orange, biconvex, coated tablets with a diameter of 9 mm.
The pack contains 10, 20, or 30 coated tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
For more detailed information, please contact the 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: