Ranigast Max – composition, indications, dosage. Withdrawal from the market

Proven content

Ranigast Max is a well-known and popular drug used to reduce heartburn and indigestion symptoms. Its action primarily affects the metabolism and the digestive system, which helps in the treatment of stomach ailments. Due to the detection of excessive amounts of NDMA (a toxic compound), this preparation was withdrawn from the market. Currently, Famotidna Ranigast and Ranigast SOS, whose active substance is famotidine, are available on the market.

Ranigast Max – general characteristics of the drug

Ranigast Max is a popular Polish drug that has been available without a prescription for many years. Action of the drug Ranigast Max works by inhibiting the secretion of acid in the stomach. This drug quickly reduces the symptoms of heartburn and indigestion, and a single dose of the drug works for 12 hours.

The active substance of Ranigast Max is ranitydynawhich inhibits the secretion of hydrochloric acid and pepsin in the stomach.

Ranigast Max are orange, biconvex, film-coated tablets with a diameter of 9 mm. The package contains 10, 20 or 30 film-coated tablets.

The entity responsible for the production and distribution of Ranigast Max is Zakłady Farmaceutyczne POLPHARMA SA. Zakłady Farmaceutyczne Polpharma SA is a Polish pharmaceutical company based in Starogard Gdański. This concern mainly produces drugs that are used in cardiology, gastroenterology and neurology. The company was founded in 1935 as the Polish Chemical and Pharmaceutical Factory “Polpharma”. The company has 7 production plants located in Poland, Our Country and Kazakhstan, as well as seven research and development centers.

What is heartburn and how can you combat it? Check: Heartburn

Ranigast Max – composition and action

The active substance responsible for the healing properties of Ranigast Max is ranitydyna. Each tablet contains 150 mg of ranitidine.

Ranitidine is a medicine that blocks histamine from attaching to histamine receptors in the stomach. Histamine is an amine that occurs naturally in the body. It participates in the formation of inflammatory processes and belongs to the so-called mediators of the inflammatory process. The human body produces, among others in the lungs, skin, nasal mucosa and stomach.

It works by stimulating histamine receptors. As a result of stimulation of histamine receptors in the gastric mucosa, the secretion of hydrochloric acid increases.

Ranitidine blocks these receptors and reduces basal and postprandial acid secretion. The secretion of pepsin in the stomach is also reduced. Ranitidine is rapidly absorbed from the gastrointestinal tract after oral administration. The biological half-life is approximately 2,5 hours. It is mainly excreted unchanged in the urine.

The other ingredients of Ranigast Max are crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, hypromellose (Methocel E 15), sunset yellow lake (E110), titanium dioxide, triacetin and talc.

What is ranitidine and why was it withdrawn from the market? Check: Ranitidine – substance withdrawn from sale

Ranigast Max – indications for use

Ranigast Max is a preparation that was used most often in cases of heartburn or indigestion.

The indication for the use of Ranigast Max was the symptomatic treatment of stomach ailments not related to the organic disease of the gastrointestinal tract, such as:

1. indigestion (dyspepsia);
2. heartburn;
3. hyperacidity;
4. upper abdominal pain.

The drug acted very quickly, and the duration of action of one tablet was estimated at about 12 hours.

Why does heartburn occur after a meal? Check: Heartburn after a meal

Ranigast Max – contraindications to use

The drug Ranigast Max, despite its effectiveness in the treatment of symptoms of gastric ailments, could not be used by every patient struggling with this type of ailments.

Contraindications to the use of Ranigast Max are:

1. allergic to ranitidine or any of the other ingredients of this medicine;
2. age of the patient – the drug should not be used in patients under 16 years of age.

How to deal with heartburn quickly? Read: Six express remedies for heartburn

Ranigast Max – precautions

Before and during the use of Ranigast Max, follow the precautions included in the package leaflet.

Particular caution should be exercised especially in the following cases:

1. if you have liver or kidney problems;
2. if you have had acute porphyria;
3. if you experience weight loss, difficulty swallowing or persistent stomach pain together with indigestion;
4. if you have not had any stomach problems (dyspeptic) or have had it recently, but it has changed recently – especially in middle-aged or elderly people;
5. if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), especially in elderly patients and people who have had peptic ulcer disease in the past;
6. if the patient is taking other drugs, including those sold without a prescription;
7. if the patient is under constant medical supervision for other reasons;
8. if you have diabetes, lung diseases and immunity disorders.

How to choose the right remedy for heartburn? Read: Which heartburn remedy is the best?

Ranigast Max – dosage

Ranigast Max should always be used exactly as described in the patient information leaflet or according to the doctor’s or pharmacist’s instructions.

In case of indigestion symptoms, 1 tablet of 150 mg per day is usually suggested. In case of recurrence of symptoms, 1 tablet of 150 mg twice a day could be used.

The daily dose of Ranigast Max should not exceed 300 mg (2 tablets).

The tablet was to be swallowed whole with a little water. The drug should not be used without consulting a doctor for more than 2 weeks. If symptoms persist after 2 weeks of treatment, a doctor should be consulted immediately.

In patients with renal insufficiency (creatinine clearance less than 50 ml / min), excretion of ranitidine may be reduced, which could lead to an increase in blood levels. Hemodialysis reduces the concentration of ranitidine in the blood. In chronic dialysis patients, 150 mg ranitidine was administered immediately after dialysis.

How to take medication correctly? Check: How to take medications effectively?

Ranigast Max – side effects

The drug Ranigast Max, like any other drug, could cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The following side effects have been reported in patients taking ranitidine:

1. very rarely: headache (sometimes severe) and dizziness, temporary disturbances of involuntary movements, transient confusion, depression and hallucinations (especially in seriously ill patients, elderly patients and patients with kidney problems), slow heart rate (bradycardia) , acceleration of the heart rate (tachycardia), atrioventricular block (disturbance of the conduction of stimuli in the cells of the heart muscle), vasculitis, usually transient hepatitis (cellular, tubular or mixed) with or without jaundice, acute pancreatitis, diarrhea, joint pain and muscles, usually reversible leukopenia (decrease in white blood cells) and thrombocytopenia (decrease in blood platelets), agranulocytosis (a disease with symptoms of high fever, sore throat, mouth, nose, throat, genital and rectal ulcers) or pancytopenia (deficiency of white blood cells, red blood cells and platelets), sometimes with aplasia bone marrow hypoplasia (bone marrow atrophy), gynaecomastia (male breast enlargement), transient impotence, galactorrhoea, erythema multiforme, hair loss, anaphylactic shock (symptoms: dyspnoea, difficulty drawing air due to laryngeal edema, difficulty exhaling, wheezing) , itching and redness of the skin, headache, feeling of “tightness”, dizziness, increased or less frequent slowing of the heart rate, itching, hives of various severity, erythema of the whole body, severe weakness up to and including loss of consciousness; may be life-threatening in severe cases), blurred vision (accommodation disorder), inflammation of the kidneys;
2. rarely: rash, urticaria, angioedema (swelling around the face, lips, tongue and throat, making breathing difficult, associated with itching, reddening of the skin, hives and severe bronchospasm), fever, bronchospasm, transient changes in the activity of liver enzymes in diagnostic tests, hypotension , chest pain, increase in creatinine levels (usually mild; normalizes with continued treatment);
3. Not so often: abdominal pain, constipation, nausea (these symptoms disappear with continued treatment);
4. unknown: shortness of breath.

Ranigast Max – interactions with other drugs

Before the patient started the treatment with Ranigast Max, he provided the attending physician or pharmacist with information about all the medications he or she was currently or recently taken. It was also necessary to inform what medications the patient planned to take in the near future.

The use of Ranigast MAX could affect the speed and degree of absorption of drugs, such as:

1. ketoconazole – an antifungal drug;
2. atazanavir and delaviridine – medicines for viral infections;
3. gefitinib – a drug used to treat cancer;
4. drugs from the benzodiazepine group, such as midazolam, triazolam – used for insomnia;
5. glipizide – a drug used to treat diabetes;
6. procainamide and N-acetylprocainamide – medicines for heart rhythm problems. 

In addition, the drug Sucralfate used in the treatment of gastric ulcer in doses above 2 g reduces the absorption of ranitidine.

Which drugs should never be combined with each other? Check: Dangerous interactions

Ranigast Max and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If the patient is pregnant or breastfeeding, thinks that she may be pregnant or is planning to have a baby, consult a doctor or pharmacist before taking Ranigast Max.

Ranigast Max could be used in pregnant women only when, according to the doctor, it was absolutely necessary.

In addition, ranitidine passes into breast milk, and therefore it should only be used in breast-feeding women when the doctor considered it absolutely necessary.

Why does heartburn occur during pregnancy and how to treat it? Check: Heartburn in pregnancy – symptoms, causes, treatment

Ranigast Max – withdrawal from the market

The drug Ranigast Max was withdrawn from circulation in stores and pharmacies due to the detection of excessive amounts of the NDMA compound in ranitidin, which is believed to have a carcinogenic effect. The withdrawal was made by the Main Pharmaceutical Inspector at the request of the producers.

The abbreviation NDMA is derived from N-nitrosodimethylamine. It is a strong toxic compound and its action increases the risk of developing cancer and liver disease. However, the exact size of its harmfulness is not known, because research in this direction has been conducted only on animals.

They are currently available on the market Famotydyna Ranigast and Ranigast SOS, whose active ingredient is famotidine.

Which heartburn medications are withdrawn from the market? Check: Drugs for heartburn withdrawn by the European Medicines Agency. What does this mean for patients?