Download Inside film-coated tablet Rx ENG PL

Package leaflet: Information for the user
Inside 150 mg tablet
ranitidine
Read all of this leaflet carefully before you start using 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 Inside is and what it is used for
2.
What you need to know before you use Inside
3.
How to use Inside
4.
Possible side effects
5.
How to store Inside
6.
Contents of the pack and other information
1.
What Inside is and what it is used for
Inside is a histamine (H2-) receptor blocker which acts by reducing the production of gastric juice and
thereby expediting the healing of an ulcer in the stomach or the duodenum. In heartburn and acid reflux
Inside gives symptom relief after about 20 minutes. The acid inhibiting effect remains for up to 12 hours.
In peptic ulcer disease the amount of gastric juice is often increased. The gastric juice which is very acidic is
considered to contribute to the occurrence of peptic ulcers. An increased amount of gastric juice may also
inhibit the healing of already formed peptic ulcers. The acidic gastric juice may also cause heartburn and
acid reflux by leaking up to the esophagus.
Inside is used to heal ulcers in the stomach and the duodenum and for inflammatory changes in the
esophagus, which are caused by acid reflux. Inside is also used for the treatment of heartburn and acid reflux.
The medicine may also be used for long term treatment to prevent chronic recurrence of ulcers in the
duodenum.
2.
What you need to know before you use Inside
Do not use Inside
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 or pharmacist before using Inside:
if you have kidney disease, severe liver disease or acute porphyria (an unusual condition with
increased turnover of porphyrins).
if you are elderly or have chronic lung disease, diabetes or are immunocompromised since there may
be an increased risk of developing community acquired pneumonia.
Other medicines and Inside
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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Inside may have an effect on certain other medicines if taken at the same time. Discuss with your doctor
before using medicines with the following content:
ketoconazole (antifungal agent)
glipizide (diabetes drug)
triazolame or midazolam (sleeping-pills)
procainamide and N-acetylprocainamide (antiarrhythmic agent)
coumarin anticoagulants (e.g. warfarin)
atazanavir or delaviridine (antiviral drug)
gefitnib (cancer drug)
other acid neutralizing agents
Pregnancy, breast-feeding and fertility
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.
Ranitidine crosses the placenta. Ask your doctor or pharmacist for advice before taking Inside during
pregnancy.
It is possible that a breast-fed child may be affected. Do not use Inside during breast-feeding if not clearly
recommended by a doctor.
Driving and using machines
Inside may in some persons cause dizziness and tiredness. Do not drive or use any tools or machines which
require precision, until you know how you react to Inside.
3.
How to use Inside
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The dose is adjusted individually by the doctor.
The tablets should be taken with a half glass of water.
If you take more Inside than you should
If you take more Inside than you should, contact your doctor, the hospital or the Poison Information Centre
(tel. 112).
If you forget to take Inside
Do not take a double dose to make up for a forgotten dose.
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.
Most of the side effects listed below are rare, but if you get an unusual reaction which you suspect may be a
side effect, discontinue the treatment and seek medical advice.
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Common side effects (occurring in more than 1 of 100 users): tiredness.
Uncommon side effects (occurring in less than 1 of 100 and more than 1 of 1,000 users): abdominal
pain, diarrhoea, constipation, nausea.
Rare side effects (occurring in less than 1 of 1,000 and more than 1 of 10,000 users): hypersensitivity
reactions such as urticaria, allergic shock, swelling, fever, bronchospasm, low blood pressure and chest
pain. Skin rash, erectile dysfunction, transient effects on liver values, elevated plasma-creatinine.
Very rare side effects (occurring in less than 1 of 10,000 users): Anaphylactic shock, headache,
dizziness, tenderness/swelling of the breasts in men, blurred vision, inflammation of the pancreas
(pancreatitis), inflammation of the liver (hepatitis), jaundice, involuntary movements, twitching and
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tremor. Slow pulse rate, fast pulse rate, effects on the heart rhythm. Inflammation of the kidney(s),
reduced kidney function, effects on blood values. Transient confusion, depression and hallucinations,
especially in elderly patients, patients with serious illness and kidney disease. Loss of hair, reversible
impotence, skin reaction (erythema multiforme) and joint and muscle ache.
Effects with unknown frequency (cannot be estimated from available data): Dyspnoea. Contact
dermatitis (inflammation of the skin).
Inside may cause a reduction in the number of white blood cells and your resistance to infection may be
decreased. If you experience an infection with symptoms such as fever and serious deterioration of your
general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary
problems you should see your doctor immediately. A blood test will be taken to check possible reduction of
white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
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.
(to be completed nationally).
5.
How to store Inside
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from light and moisture.
Do not use this medicine after the expiry date which is stated on the package. 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 protect the environment.
6.
Contents of the pack and other information
What Inside contains
The active substance is ranitidine hydrochloride corresponding to 150 mg ranitidine.
The other ingredients are microcrystalline cellulose, maize starch, water-free silica colloidal,
copovidone, pregelatinized starch, magnesium stearate, hypromellose, glycerol triacetate, talc,
titanium dioxide (colouring agent E 171).
What Inside looks like and contents of the pack
White tablet, round, biconvex with a diameter of approx. 9.5 mm and with a breaking notch. The score line is
only to facilitate breaking for ease of swallowing and not to divide to equal doses.
Pack sizes: 10, 20, 30, 40, 60 and 90 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Meda OTC AB, Box 906, 170 09 Solna, Sweden.
Local contact details to be implemented nationally
This leaflet was last approved in 2015-10-05
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