Inside Brus

Document: Inside Brus effervescent tablet ENG PL change

Package leaflet: Information for the user

Inside Brus 150 mg effervescent 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.

In this leaflet:

1. What Inside Brus is and what it is used for

2. What you need to know before you use InsideBrus

3. How to use InsideBrus

4. Possible side effects

How to store Inside Brus

6. Contents of the pack and other information

What Inside Brus is and what it is used for

Inside Brus 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 Brus 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 Brus 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 Brus 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.

BEFORE YOU USE INSIDE BRUS

Do not useInside Brus

if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautionsTalk to your doctor or pharmacist before using Inside Brus:

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.

Inside Brus contains sodium and therefore you need to seek advice from your doctor if you have high blood pressure, heart or blood vessel disease or kidney disease.

Other medicines and Inside Brus

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Inside Brus 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-pill)
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 Brus during pregnancy.

It is possible that a breast-fed child may be affected. Do not use Inside Brus during breast-feeding if not clearly recommended by a doctor.

Driving and using machines

Inside Brus 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 Brus.

Important information about some of the ingredients of Inside Brus

Inside Brus contains lactoseand sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Inside Brus contains aspartamewhich is a source of phenylalanine. May be harmful for people with phenylketonuria.

Inside Brus contains ca 402 mg sodiumper effervescent tablet. To be taken into consideration by patients on a controlled sodium diet.

How to use Inside Brus

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.

Inside Brus should be dissolved in a half glass of water.

If you take more InsideBrus than you should

If you take more Inside Brus than you should, contact your doctor, the hospital or the Poison Information Centre (tel. 112).

If you forget to take InsideBrus

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.

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.

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 and twitching, 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 Brusmay 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 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)

How to store Inside Brus

Keep this medicine out of the sight and reach of children.

Do not store above 30C. Store in the original package in order to protect from moisture. The tubes are closed with a stopper which contains a desiccant.

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.

Contents of the pack and other information

What Inside Brus contains

The active substance is ranitidine hydrochloride corresponding to 150 mg ranitidine.
The other ingredients are sodium cyclamate, aspartame 5 mg, lactose monohydrate 184 mg, saccharin sodium, citric acid, sodium hydrogen carbonate, sodium carbonate (water-free), sorbitol, mannitol, simeticone, curcumin (colouring agent E 100) and fruit flavour (sorbitol, mannitol, water-free silica colloidal, gluconolactone, powder flavor orange, natural orange oil, mandarin oil, maltodextrine).

What Inside Brus looks like and contents of the pack

Yellow effervescent tabletwith slight speckles, round, smooth, with a breaking notch on one side.

Pack sizes: 10, 20, 30 effervescent tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Meda OTC AB, Box 906, 170 09 Solna, Sweden.

Manufacturer: Hermes Arzneimittel GmbH, Grosshesselohe, München, Germany.

Local contact details to be implemented nationally

This leaflet was last approved in 2015-10-05