RANI-DENK 150 Tablet

This is used:

- to treat duodenal ulcer,

- to treat benign gastric ulcer,

- to treat oesophagitis caused by gastric acid reflux (reflux oesophagitis),

- to treat the so-called Zollinger-Ellison syndrome (gastric or duodenal ulcer caused by tumour-related excessive production of a hormone that stimulates secretion of gastric acid),

- prophylaxis of recurrent duodenal ulcer or benign gastric ulcer,

- as continuing treatment of prophylaxis of mucosal gastric or duodenal haemorrhage in seriously ill patients (prophylaxis of haemorrhage from stress ulceration),

- as a single dose during labour to prevent gastric acid aspiration.

Dosage and administration

Swallow the tablet whole with sufficient fluids (e.g. a glass of water). Tablets need not be taken with meals.

Adults with normal renal function.

Duodenal ulcer and benign gastric ulcer

2 tablet (equivalent to 300mg ranitidine) after your evening meal or before going to bed or 1 tablet (equivalent to 150mg ranitidine) in the morning and evening.

The treatment takes 4-8 weeks as a rule.

Prophylaxis of recurrent duodenal ulcer or benign gastric ulcer

1 tablet before going to bed. Treatment can take up to 12 months.

Long-term therapy is indicated in patients with a history of relapse.

Oesophagitis caused by gastric acid reflux

2 tablets after your evening meal or before going to bed or 1 tablet in the morning and evening.

The treatment takes 8-12 weeks.

Zollinger-Ellison syndrome

The starting dose is 1 tablet three times a day. If necessary, the dose can be raised to 4-6 tablets. The patient can be given higher doses if determination of gastric acid secretion shows this to be necessary (up to 6g ranitidine/day have been administered).

Prophylaxis of acid aspiration during labour

Single dose of 1 tablet.

Continuing prophylaxis of haemorrhage from gastric or duodenal stress ulceration

1 tablet two times a day during the critical period, as soon as the patient is able to eat in the normal way again.

Children over the age of 2 years

The daily dose is 2-4mg/kg body weight two times a day. However, 300mg ranitidine a day should not be exceeded.

Due to their active ingredient content, these tablets are only suitable for children who weigh more than 35kg.

Dosage instructions for patients with impaired kidney function

See the package insert about the details.

- if you are hypersensitive (allergic) to ranitidine, other so-called H2 receptor antagonists or any of the other ingredients of this medicine,

- if you suffer from the metabolic disorder “acute porphyria”, as ranitidine may precipitate acute porphyric attacks.

Nervous system disorders

Uncommon: headache, fatigue, dizziness

Very rare: severe headaches, involuntary movement disorders.

Psychiatric disorders

Very rare: mental confusion and restlessness, hallucinations, depression.

Eye disorders

Rare: blurred vision.

Skin and subcutaneous tissue disorders

Uncommon: skin rash

Rare: erythema multiforme (a particular type of skin rash), urticaria

Very rare: alopecia.

Musculoskeletal and connective tissue disorders

Rare: joint pain (arthralgia), muscle pain (myalgia).

Gastrointestinal disorders

Uncommon: diarrhoea, constipation, nausea

Rare: acute pancreatitis.

Hepatobiliary disorders

Uncommon: transient changes in liver function tests

Rare: hepatitis (inflammation of the liver) with or without jaundice.

Renal and urinary disorders

Rare: raised plasma creatinine values (value for renal function)

Very rare: inflammation of the kidneys (interstitial nephritis).

Cardiovascular disorders

Very rare: arrhythmias (tachycardia, bradycardia and A-V block), vasculitis.

Blood and lymphatic system disorders

Very rare: blood count changes (leukopenia and/or thrombocytopenia, agranulocytosis or pancytopenia, sometimes with bone marrow hypoplasia or aplasia (decrease in one, several or all blood cells)).

Reproductive system and breast disorders

Very rare: breast pain and swelling in men, loss of libido and impotence.

Immune system disorders

Very rare: acute hypersensitivity reactions (e.g. eosinophilia, skin rash, fever, hypotension, facial swelling, difficulty swallowing, labored breathing, chest pain, allergic circulatory shock).

(See the package insert about the details.)

Antacids (medication to treat heart burn and gastric acid-related stomach complaints), sucralfate (agent to treat gastric and duodenal ulcers)

Drugs whose absorption is dependent on the presence of gastric acid, such as ketoconazole.

Glipizide in diabetics.

Sedatives or sleeping pills that contain the active ingredients midazolam or triazolam.

Asthmatics with symptoms of theophylline overdose.

Alcohol

Pregnancy

Experience to date of this medicine in pregnant women has not revealed any evidence of toxic effects on the foetus or the pregnancy itself. However, you should always consult your doctor before taking medication during pregnancy.

Lactation

The active ingredient is excreted in human breast milk. There are no studies available on whether absorption of this medicine via human breast milk is toxic for the infant. As a precaution, this medicine should therefore not be taken when nursing.

- If you suffer from a gastric or duodenal ulcer: Your doctor should then test for the presence of the bacteria Helicobacter pylori. If the stomach is affected by this germ, then it should be eradicated where possible.

- If you suffer from a gastric ulcer: Then your doctor should initiate the appropriate measures to exclude malignancy, as so-called H2 antagonists may mask symptoms of stomach cancer and therefore delay diagnosis of this condition.

- If you suffer from renal impairment: As ranitidine is excreted via the kidneys, elevated plasma concentrations may occur in patients with renal impairment (refer to the dosage instructions).

Children

Ranitidine is not generally recommended in children under the age of 2 years.

This is a gastrointestinal agent that belongs to a group of medicines known as the histamine H2 receptor antagonists, which reduce gastric acid production.

Pharmacotherapeutic group: Histamine H2 receptor antagonist, gastrointestinal agent

Ranitidine is a competitive histamine H2 receptor antagonist. It inhibits basal and stimulated secretion of gastric acid, reduces the acid content and to a lesser extent the volume of gastric juice and the pepsin content.