Skip to Content

UK Edition. Click here for US version.

RANITIDINE 150 MG FILM-COATED TABLETS

Active substance(s): RANITIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Ranitidine 150 mg & 300 mg Tablets
Ranitidine

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

1. WHAT RANITIDINE TABLETS IS AND WHAT IT IS
USED FOR

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)

2. BEFORE YOU TAKE RANITIDINE TABLETS

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:

• 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.

3. HOW TO TAKE RANITIDINE TABLETS

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.

Continued on the next page >>

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 doctorʼs 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 donʼt 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.

4. POSSIBLE SIDE EFFECTS

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

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
pharmacist.

5. HOW TO STORE RANITIDINE TABLETS

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.

6. FURTHER INFORMATION

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 AH Almere, The Netherlands.

This leaflet was last approved in 01/2012

SZ00000LT000

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide