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Do not take Rani 2 if you are allergic to medicines containing ranitidine or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal. Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. The safety of Rani 2 in pregnancy has not been established.

Rani 2 is not recommended for use during pregnancy. If there is a need to consider Rani 2 during your pregnancy, your doctor will discuss with you the risks and benefits of taking it.

Tell your doctor if you are breastfeeding or wish to breastfeed. Rani 2 passes into breast milk. Your doctor will discuss the risks and benefits of taking Rani 2 when breastfeeding.

Tell your doctor if you smoke. Smoking may worsen your condition. Your doctor may advise you to reduce or stop smoking. Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. The usual dose is mg to mg per day, taken as one mg tablet once or twice a day, or one mg tablet at night.

Your doctor may advise you to take a different dose. This depends on your condition. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

It is very important that you take the full course of Rani 2 prescribed by your doctor so that your condition is properly treated.

Even when you have completed your tablets, your doctor may decide to continue your treatment with Rani 2, possibly at a different dosage, in order to prevent the problem coming back again.

Immediately telephone your doctor or the Poisons Information Centre telephone 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Rani 2.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Before starting any new medicine, tell your doctor or pharmacist that you are taking Rani 2. If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking Rani 2.

Be careful driving or operating machinery until you know how Rani 2 affects you. Rani 2 generally does not cause any problems with your ability to drive a car or operate machinery.

However, as with many other medicines, Rani 2 may cause dizziness or light-headedness in some people. Some self-help measures suggested below may help your condition.

Talk to your doctor or pharmacist about these measures and for more information. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Rani 2.

Like all other medicines, Rani 2 may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not.

You may need medical treatment if you get some of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:.

Some health problems may arise from the condition being treated itself, rather than the treatment. For this reason, contact your doctor immediately if you notice any of the following:.

Keep Rani 2 where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack, they will not keep well.

Do not store Rani 2 or any other medicine in the bathroom or near a sink. Do not leave Rani 2 in the car or on windowsills.

Heat and dampness can destroy some medicines. If your doctor tells you to stop taking Rani 2, or your tablets have passed its expiry date, ask your pharmacist what to do with any that are left over.

Ranitidine hydrochloride is a white or pale yellow, crystalline powder, freely soluble in water and in methanol, sparingly soluble in ethanol, very slightly soluble in methylene chloride.

Ranitidine is an aminoalkyl-substituted furan and is structurally different from cimetidine lacking the imidazole ring and the cyanoguanidine group.

Chemical structure. Chemical name: N- 2- 5- dimethylamino methyl furan-yl methyl thio ethyl -N'- methyl nitro-1,1-ethenediamine hydrochloride.

Molecular weight: CAS number. Each Rani 2 tablet contains ranitidine hydrochloride as the active ingredient equivalent to mg or mg of ranitidine. For the full list of excipients, see Section 6.

Rani 2 mg. Creamish yellow, biconvex, round, film-coated tablets with "G" on one side and "00" over "30" on the reverse.

Creamish yellow, biconvex, capsule shaped, film-coated tablets with "G" on one side and "" on the reverse.

Mechanism of action. Ranitidine hydrochloride is a histamine H 2 -receptor antagonist. Animal experiments both in vitro and in vivo have established that ranitidine is a selective, competitive antagonist of histamine at H 2 -receptor sites.

Ranitidine has no significant interaction at histamine H 1 -receptors, muscarinic receptors or beta adrenoceptors. Ranitidine is a potent inhibitor of gastric secretion in the rat and dog.

Clinical trials. All the evidence from human studies is compatible with a selective, competitive antagonism of histamine H 2 -receptors by ranitidine in man.

Oral or intravenous administration of ranitidine inhibits both basal gastric secretions and gastric acid secretion induced by histamine, pentagastrin and other secretagogues.

On a weight basis ranitidine is between four and nine times more potent than cimetidine. After oral administration of ranitidine, the plasma concentrations of ranitidine achieved are directly related to the dose administered.

Pepsin secretion is also inhibited by ranitidine, but secretion of gastric mucus is not affected. Ranitidine does not alter the secretion of bicarbonate or enzymes from the pancreas in response to secretin and pancreozymin.

Reduction in gastric acid secretion induced by ranitidine mg twice daily for seven days did not cause bacterial overgrowth in the stomach. Pulse rate, blood pressure, electrocardiogram and electroencephalogram were not significantly affected in man following recommended doses of ranitidine.

One study in 30 male duodenal ulcer patients showed a significant decrease in basal thyroxine levels after 4 weeks treatment with mg ranitidine daily, but no significant change in thyroid stimulating hormone was noted.

Acute administration of 50 mg ranitidine intravenously had no effect on plasma aldosterone in healthy male volunteers whereas it caused a significant reduction in vasopressin.

Cimetidine mg intravenously had a similar effect on vasopressin. Peak plasma levels occur about two to three hours after oral administration of ranitidine.

Absorption is not significantly altered by food or concurrent antacid administration. Two distinct peaks or a plateau in the absorption phase suggest reabsorption of drug secreted into the intestine.

The elimination half-life is approximately two hours. Plasma concentrations decline bi-exponentially, with a terminal half-life of 2 to 3 hours.

The major route of elimination of unchanged ranitidine is renal. Patients over 50 years of age. In patients over 50 years of age, half-life is prolonged 3 to 4 hours and clearance is reduced, consistent with the age-related decline of renal function.

This difference exceeds the effect of declining renal function, and indicates increased bioavailability in older patients. Impairment of renal function requires a reduction in dosage see Section 4.

Impairment of liver function may increase the bioavailability of ranitidine but has no significant effect on the elimination half-life.

However, in the presence of normal renal function, no dosage reduction for oral ranitidine appears necessary in patients with hepatic impairment.

Short-term treatment of proven duodenal ulcer and gastric ulcer. Maintenance treatment to reduce the risk of relapse in duodenal ulcer.

Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer.

Treatment of gastrinoma Zollinger-Ellison syndrome. Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative antireflux measures and simple drug therapies such as antacids.

Maintenance treatment to reduce the risk of relapse of reflux oesophagitis. Treatment of scleroderma oesophagitis. Patients with known hypersensitivity to ranitidine hydrochloride or any components of Rani 2 tablets.

Gastric ulcer. Treatment with a histamine H 2 -antagonist may mask symptoms associated with carcinoma of the stomach and, therefore, may delay diagnosis of the condition.

Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with ranitidine is instituted.

Long-term use. The risk of ulcer recurrence is determined by many factors. Evidence from controlled clinical trials of up to 18 months continuous treatment with ranitidine has not revealed any undue untoward effects.

Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.

Gastric pH. Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated intensive care patients receiving mechanical ventilation.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia.

A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H 2 -receptor antagonists versus those that had stopped treatment, with an observed adjusted relative risk of 1.

Use in renal impairment. Ranitidine is excreted via the kidneys and in the presence of renal impairment plasma levels of ranitidine are increased and prolonged.

Accordingly in the presence of significant renal impairment, serum levels should be monitored and dosage adjustments made.

The clearance of ranitidine is increased during haemodialysis. Use in the elderly. No data available. Paediatric use.

Experience with ranitidine tablets in children is limited and such use has not been fully evaluated in clinical studies. It has however, been used successfully in children aged 8 to 18 years in doses up to mg twice daily.

Effects on laboratory tests. Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

Interactions occur by several mechanisms including: 1. Inhibition of cytochrome Plinked mixed function oxygenase system. Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline.

There have been reports of altered prothrombin time with coumarin anticoagulants e. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

Competition for renal tubular secretion. Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route.

High doses of ranitidine e. Alteration of gastric pH. The bioavailability of certain drugs may be affected. This can result in either an increase in absorption e.

If high doses 2 g of sucralfate are coadministered with ranitidine the absorption of the latter may be reduced. This effect is not seen if sucralfate is taken after an interval of two hours.

Effects on fertility. There are no data on the effects of ranitidine on human fertility. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to ranitidine.

Category B1 The safety of ranitidine in pregnancy has not been established. Ranitidine crosses the placenta and should only be used during pregnancy if considered essential.

If the administration of ranitidine is considered to be necessary, its use requires that the potential benefits be weighed against possible hazards to the patient and to the foetus.

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Rani Rain - Severe weather

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