Ranitidine 150 Mg Film-Coated Tablets



Ranitidine 150 mg & 300 mg Tablets

Ranitidine    ASANDOZ

Read all of this leaflet carefully before you start taking

this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ranitidine Tablets is and what it is used for

2.    Before you take Ranitidine Tablets

3.    How to take Ranitidine Tablets

4.    Possible side effects

5.    How to store Ranitidine Tablets

6.    Further information


Ranitidine belongs to a group of medicines called histamine (H2) antagonists. These medicines reduce the amount of acid in your stomach.

This medicine is used in adults:

•    to heal ulcers in the stomach or duodenum

•    to prevent the recurrence of ulcers in the stomach or duodenum

•    to treat inflammation of the gullet (oesophagus) caused by reflux of gastric acid (reflux oesophagitis usually with heartburn)

•    to treat a disease in which the stomach produces too much acid (Zollinger - Ellison syndrome).

This medicine is used in children:

•    to heal ulcers in the stomach or duodenum

•    to treat inflammation of the gullet (oesophagus) caused by re flux of gastric acid (reflux oesophagitis)

•    Non-Steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation

•    lidocaine, a local anaesthetic

•    propranolol, procainamide or n-acetylprocainamide, for heart problems

•    diazepam, for worry or anxiety problems

•    phenytoin, for epilepsy (fits)

•    theophylline, for breathing problems (asthma)

•    warfarin, for thinning your blood.

•    glipizide, for lowering blood glucose

•    atazanavir or delaviridine, for treating HIV infection

•    triazolam, for sleep problems

•    gefitnib, for lung cancer

•    ketoconazole, an anti fungal medicine.

•    gastric acid-binding medicinal products (antacids) and sucralphate (another product used for e.g. stomach or duodenal ulcers): the uptake of ranitidine in the blood (and thus its effect) may be reduced. These medicines must therefore be taken about 2 hours after ranitidine.

Midazolam is a medicine that may be given to you just before you have an operation. Tell the doctor you are taking Ranitidine tablets before your operation in case he or she wants to give you midazolam.

Taking Ranitidine Tablets with food and drink

You are advised not to drink alcohol with this medicine. It can intensify the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant, might become pregnant or are breast-feeding, you should not take this medicine unless your doctor advises it is essential.Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

Ranitidine Tablets has no or negligible effect on the ability to drive or use machines. However, this medicine can sometimes cause side effects like headache, dizziness, fatigue, confusion, and hallucinations. If you suffer from these side effects, do not drive any vehicle and/or operate machines that require concentration.



Do not take Ranitidine Tablets:

•    if you are allergic (hypersensitive) to ranitidine or any of the other ingredients of this medicine (see section 6).

Take special care with Ranitidine Tablets

Tell your doctor before taking Ranitidine Tablets if:

•    you suffer from kidney or liver disease because this is important for your doctor in order to give you the right dose.

•    you have stomach ulcer caused by a certain bacteria (Helicobacter pylori). If your doctor finds out that this applies for you he/she can prescribe other medicines that are able to kill these bacteria (antibiotics).

•    you have stomach cancer

•    you have a rare condition called acute intermittent porphyria.

•    you have lung disease.

•    you are diabetic.

•    you have any problems with your immune system.

•    you are elderly and/or are taking Non-Steroidal Anti-Inflammatory (NSAIDs) medicines.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to mention to your doctor if you are also taking:

Always take Ranitidine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Take this medicine with or without food.

•    Swallow the tablets whole, with a glass of water.

•    In children the tablets may be dissolved in water or crushed.

Usual dosage in adults:

For duodenal or stomach ulcer:

•    150 mg in the morning and 150 mg in the evening or a single dose of 300 mg in the evening.

•    Duration of the treatment: 4 weeks, but can be extended to 8 weeks.

To prevent the recurrence of duodenal or stomach ulcers:

•    150 mg in the evening.

•    Duration of the treatment: according to the doctor's instructions.

For inflammation of the oesophagus through reflux of gastric acid:

•    150 mg in the morning and 150 mg in the evening or a single dose of 300 mg in the evening.

•    Duration of treatment: 8 weeks, but can be extended to 12 weeks.

Patients with extreme gastric hyperacidity, as in Zollinger-Ellison syndrome:

•    Initial dosage: 150 mg in the morning, 150 mg in the afternoon, and 150 mg in the evening.

If necessary, the daily dose can be raised to 600 to 900 mg.

•    Duration of treatment: according to the doctor’s instructions.

Dosage in patients with reduced renal function:

The dose will be reduced by your doctor, depending on the extent to which your renal function is impaired.

Usual dosage in children (3 to 11 years and over 30 kg of weight):

For duodenal or stomach ulcer:

The standard recommended dosage is 4 to 8 mg per kg body weight per day, with a maximum of 300 mg per day, split into 2 separate doses. Children should only take this medicine for up to 4 weeks. If healing is incomplete at that time, give Ranitidine another 4 weeks.

For inflammation of the oesophagus through reflux of gastric acid: The recommended dosage is 5 to 10 mg per kg body weight per day, with a maximum of 600 mg per day, split into 2 separate doses.

If you take more of this medicine than you should

Do not take more than your doctor tells you to. If you have accidentally taken more than the prescribed dose, go to the nearest hospital casualty department or tell your doctor/ pharmacist immediately. Take the container and any remaining tablets or this leaflet with you so the medical staff knows exactly what you have taken.

If you forget to take your medicine

If you forget to take a dose, take another as soon as you remember. Then carry on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ranitidine Tablets:

After a few days you should feel much better but don’t stop taking the tablets until your doctor tells you to or the pain and discomfort may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Rare (affecting less than 1 in 1,000 people):

•    skin rash

•    blood tests which show changes in the way the kidney or the liver is working

Very rare (affects less than 1 out of 10,000 people):

•    fast, slow, or irregular heart beat

•    blurred vision

•    uncontrolled movements, this effect is usually reversible

•    severe headache

•    dizziness

•    restlessness, confusion, hallucinations, or depression in predominantly severely ill or elderly patients

•    hair loss

•    skin rash with pink-red blotches

•    muscle pain, joint pain

•    enlarged breasts in males and inability to achieve an erection

•    allergic inflammation of blood vessels, often as skin rash (allergic vasculitis)

•    changes in blood count, reduction in white blood cell which makes infections more likely, reduction in blood platelets which makes bruising or bleeding more likely, reduction in red blood cells which can make the skin pale and cause weakness

If any of the side effects gets serious, or if you notice any

side effects not listed in this leaflet, please tell your doctor or



Keep out of the reach and sight of children.

Do not use Ranitidine Tablets after the expiry date which is stated on the packaging after. The expiry date refers to the last day of that month.

Do not store above 25°C.

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



Like all medicines, Ranitidine Tablets can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor straight away if you have any of the following symptoms of a severe allergic reaction (isolated cases):

•    sudden difficulty in breathing, speaking and swallowing

•    swelling of the lips, face and neck,

•    skin rash, itching

•    fever

•    chest pain

•    abdominal pain

•    extreme dizziness or collapse

•    increased number of red blood cells

Contact your doctor as soon as possible if you experience any of the following side effects (affecting less than 1 out of 10,000 people):

•    yellowing of the skin or whites of the eyes caused by liver problems

•    increased or reduced urine output, or traces of blood in your urine, sometimes with flank pain, fever, drowsiness caused by kidney problems

•    severe pain in the abdomen and back caused by inflammation of the pancreas

These are all serious side effects. You may need urgent medical attention.

Other possible side effects

Uncommon (affecting less than 1 in 100 people):

•    abdominal pain, diarrhoea, constipation, feeling sick

•    fatigue

What Ranitidine Tablets contain

The active substance is Ranitidine hydrochloride. Each tablet contains Ranitidine Hydrochloride equivalent to 150 mg or 300 mg Ranitidine.

The other ingredients are:

Core, Croscarmellose sodium, Magnesium stearate (E572), Microcrystalline cellulose (E460).

Film coating:

Polymethylmethacrylic acid copolymer (Eudragit E), Hypromellose (E464), Titanium dioxide (E171), Talc, Macrogol 6000.

What Ranitidine Tablets looks like and contents of the pack

Ranitidine 150 mg Tablets:

Aluminium//aluminium blister pack containing 10 tablets.

Cartons containing 10, 20, 30, 50, 60, 100 and 120 tablets.

Ranitidine 300 mg Tablets:

Aluminium//aluminium blister pack containing 10 tablets.

Cartons containing 10, 20, 30, 50, 60 and 100 tablets. Aluminium/aluminium blister pack containing 5 tablets.

Carton containing 15 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Sandoz B.V., Postbus 10332, 1301 AHAlmere, The Netherlands.

This leaflet was last approved in 01/2012