Package leaflet: Information for the user
/.../ 150 mg and 300 mg film-coated tablets
Ranitidine
Read all of this leaflet carefully, before you start taking this medicine because it contains
important information for you.
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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What /.../ is and what it is used for
2.
What you need to know before you take /.../
3.
How to take /.../
4.
Possible side effects
5.
How to store /.../
6.
Contents of the pack and further information
1.
What /.../ is and what it is used for
Effect:
The gastric acid in the stomach is an important cause of ulcers of the duodenum and stomach.
Ranitidine, the active substance in /.../, lowers the production of histamine (a substance occurring
naturally in the body) that stimulates the acid-producing cells of the stomach mucosa, so that the
production of gastric juice is reduced.
Use in adults:
/.../ is used to treat:
Ulcers of the duodenum
Benign ulcers of the stomach
Symptoms caused by reflux of gastric juice into the oesophagus (gastrooesophageal reflux
disease)
Inflammation in the lower oesophagus caused by reflux of gastric juice into the oesophagus
(reflux oesophagitis)
Diseases associated with an abnormally large production of gastric juice (Zollinger-Ellison’s
syndrome).
Chronically recurrent ulcers of the duodenum
Ranitidine, which is contained in /.../, may also be authorised to treat other illnesses, which are not
mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have
further questions and always follow their instructions.
Use in children:
/.../ can also be used in children from 3 years of age for treating stomach ulcers and symptoms caused
by reflux of gastric juice into the oesophagus.
2.
What you need to know before you take /.../
Do not take /.../:
-
If you are allergic to ranitidine or any of the other ingredients of this medicine (listed in
section 6)
Warnings and precautions
Talk to your doctor before taking /…/ if:
You are elderly or have lowered function of the kidneys and/or liver. Your doctor may need to
lower your ranitidine dose.
You are elderly, have pulmonary disease, diabetes, heart failure or an impaired immune system,
as you may have an increased risk of pneumonia.
You are taking medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work
by reducing pain, inflammation and fever.
You suffer from acute porphyria (a genetic disorder, one of the symptoms being reddish
discolouration of the urine).
Other medicines and /.../
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are being treated with one of the medicines below, please consult your doctor as your treatment
may need to be adjusted:
-
-
Warfarin (medicine against blood clots)
Glipizide (medicine against diabetes)
Midazolam, triazolam (sleeping medicine)
Phenytoin (medicine against epilepsy)
Ketoconazole (medicine against fungal infections), atazanavir, delaviridine (medicines against
viral infections) and gefitnib for treating cancer. The use of ranitidine may impact on the effect
of such medicines, whose absorption in the body depends on the acidity of the stomach.
Procainamide (medicine against heart arrhythmia). High doses of ranitidine may reduce the
excretion of procainamide from the body.
If you use antacids or high doses (2 g) of sucralfate (medicine against ulcers), you should take
ranitidine about 2 hours before taking such medicine, as such medicine reduces the absorption of
ranitidine.
/.../ with food and drink
The effect of ranitidine is not altered by food, the tablets can be taken during or between meals.
Tablets can be swallowed whole, divided or crushed.
Simultaneous use of ranitidine and alcohol may increase the effect of alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Experience in use of ranitidine in pregnant women is limited. Only take /.../ according to your doctor’s
instructions.
Breast-feeding
Ranitidine is excreted in breast milk which may affect the child. Only take /.../ according to your
doctor’s instructions.
Driving and using machines
/.../ can sometimes cause side effects like headache, dizziness, tiredness, confusion and hallucinations.
If you suffer from these side effects, do not drive any vehicle and/or operate machines that require
concentration.
You alone are responsible to decide if you are in fit condition to drive a motor vehicle or perform
other tasks that demand increased concentration. Because of their effects or undesirable effects, one of
the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions
of these effects can be found in other sections. Read all the information in this leaflet for guidance.
Discuss with your doctor, nurse or pharmacist if you are unsure about anything.
3.
How to take /.../
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose is:
Adults and adolescents 12 years and older:
Ulcers of the duodenum, benign stomach ulcers
300 mg per day, either as 300 mg as an evening dose or 150 mg morning and evening. Normal
duration of treatment is four weeks, but if the ulcer has not healed up after four weeks’ treatment,
treatment should continue for another four weeks. If necessary, the dose may be increased to 300 mg
morning and evening for four weeks.
Preventive treatment of chronic recurrent ulcer of the duodenum
150 mg in the evening.
Treatment of symptoms of gastric juice reflux into the oesophagus (gastro-oesophageal reflux disease)
150 mg in the morning and evening for 2-4 weeks.
Treatment of inflammation in the lower oesophagus caused by reflux of gastric juice into the
oesophagus (reflux oesophagitis)
150 mg in the morning and evening or 300 mg as an evening dose for 4-8 weeks. In severe cases,
doses may be increased to a total of 600 mg per day, distributed on several doses for up to 12 weeks.
For maintenance treatment, the recommended dose is 150 mg morning and evening.
Treatment of abnormally large production of stomach juice (Zollinger-Ellison’s syndrome)
150 mg 3 times daily, but, if necessary, the dose may be increased according to your doctor’s
instructions.
Reduced function of kidneys and/or liver
Adjustment of dose is necessary. Follow your doctor’s instructions.
Elderly patients
Adjustment of dose is necessary. Follow your doctor’s instructions.
Children 12 years and over
For children 12 years and over the adult dosage is given.
Children from 3 to 11 years and above 30 kg of weight
Acute treatment of stomach ulcer
The doctor decides which dose should be given dependant upon the body weight of the child, but
never more than 300 mg daily. The treatment normally lasts 4 weeks but in case of incomplete healing
of the ulcer another 4 weeks of treatment may be needed.
Treatment of symptoms of gastric juice reflux into the oesophagus (gastro-oesophageal reflux disease)
The doctor decides which dose should be given dependant upon the body weight of the child, but
never more than 600 mg daily.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Tablets can be swallowed whole, divided or crushed.
If you take more /.../ than you should
Contact your doctor, emergency room or pharmacist if you have taken more /.../ than stated in this
leaflet or more than prescribed by your doctor.
Symptoms of overdose may be slow pulse, shortness of breath, uncoordinated muscle activity,
seizures.
If you forget to take /.../
Do not take a double dose to make up for a forgotten dose. Continue treatment as instructed by your
doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
Tiredness
Skin reactions.
Uncommon side effects (may affect up to 1 in 100 people)
Stomach pain
Nausea
Diarrhoea
Constipation.
Rare side effects (may affect up to 1 in 1,000 people)
Hives
Severe hypersensitivity reaction with swelling of face, tongue and throat or cramps in airways
Hepatitis due to hypersensitivity to ranitidine
Low blood pressure
Reduced content of haemoglobin in the blood (haemolytic anaemia)
Fever
Erectile dysfunction
Transient effect on liver function
Effect on kidney function
Liver failure.
Very rare side effects (may affect up to 1 in 10,000 people)
Headache
Dizziness
Involuntary movements
Muscle and joint pains (Myalgia and Arthralgia)
Slow heart rate (Bradycardia)
Effect on heart function (AV block)
Fast or irregular heart rate (Tachycardia)
Unusual secretion of breast milk or breast enlargement in men
Reversible impotence
Acute inflammation of the pancreas and kidneys
Hepatitis with or without jaundice
Patchy red rash (Erythema multiforme)
-
Hair loss
Blurred vision
Effect on blood composition and bone marrow
Inflammation of the blood vessels (vasculitis)
Severe allergic reactions.
Unknown (frequency cannot be estimated from the available data)
Shortness of breath
Elderly, seriously ill people and those with kidney problems may in particular experience transient
confusion, depression and hallucinations.
You should stop taking /.../ and see your doctor immediately if you experience symptoms of
angioedema such as swollen face, tongue or pharynx, difficulty to swallow, hives and
difficulties to breath
reduced number of white blood cells (agranulocytosis) which can cause increased infection
sensitivity with fever, sore throat/pharynx/mouth or urinary problems.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.
How to store /.../
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use /.../ after the expiry date which is stated on the carton after EXP. The expiry date refers to
the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6.
Contents of the pack and further information
What /.../ contains
The active substance is ranitidine. Each tablet contains 150 mg or 300 mg ranitidine (in the form
of ranitidine hydrochloride).
The other ingredients are:
Tablet core: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Film coating: Polymethacrylic acid (Eudragit E 100), hypromellose, macrogol 6000, talc,
titanium dioxide (E171).
What /.../ looks like and contents of the pack
150 mg: Round, convex, white to yellowish, film-coated tablets, scored on one side.
300 mg: Oblong, convex, white to yellowish, film-coated tablets, scored on one side.
Pack sizes
150 mg: 10, 20, 30, 60 and 90 film-coated tablets.
300 mg: 10, 14, 20, 30, 60 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
<[To be completed nationally]>
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
Manufacturer
Actavis ehf.
Reykjavikurvegi 78
220 Hafnarfjordur
Iceland
Actavis Ltd.
BLB 016
Bulebel Industrial Estate
Zejtun
ZTN 3000
Malta
<[To be completed nationally]>
This leaflet was last revised in 2015-07-27
<[To be completed nationally]>