Inside Brus

Document: Inside Brus effervescent tablet OTC 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.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
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.
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is 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 Brusis a histamine (H₂-) receptor blocker which acts by reducing the production of hydrochloric acid in the stomach. The gastric juice is normally very acidic and may cause heartburn and acid reflux by leaking up to the esophagus. One effervescent tablet reduces the production of gastric acid and may relieve symptoms after about 20 minutes. The acid inhibiting effect remains for up to 12 hours.

Inside Brusrelieves symptoms in temporary heartburn and acid reflux.

Acid production may be stimulated by smoking, alcohol, very spicy food and stress. Certain drugs such as aspirin and other anti-inflammatory agents for joint and muscle problems may cause heartburn and other gastric acid related disorders. Heartburn and acid reflux may also be present in patients with peptic ulcer disease and in rare cases in patients with a serious disease in the stomach or esophagus.

Heartburn and acid reflux may be caused by gastric acid which passes up into the esophagus when laying flat or lifting heavy items. A change in life style may be important in order to relieve heartburn and acid reflux symptoms. This could for example include the following; reduction of smoking and intake of coffee, alcohol, very spicy food, late evening meals and avoiding to lift heavy things. You should aim at having a regular life style without stress. A head-up position when sleeping may also relieve the symptoms. Another action may be treatment with a medicine available without prescription. If these measures do not give satisfactory symptom relief you should consult a doctor. This is especially important if you have persistent or recurrent problems, difficulties when swallowing or if your doctor has told you that you have an impaired kidney function.

What you need to know 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 precautions

Talk 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

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

Adults and children over 12 years: 1 effervescent tablet is taken when needed for symptomatic relief. Do not take more than 2 effervescent tablets per day unless a doctor has prescribed a different dose. If you still have symptoms after having taken Inside Brus for two consecutive weeks you should contact a doctor, since your stomach disorders may have another reason.

Inside Brus is not to be given to children younger than 12 years.

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 Brus 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 orurinary 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> <or nurse>.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 to 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 184.4 mg, saccharin sodium, citricacid, sodium hydrogen carbonate, sodium carbonate (water-free), sorbitol, mannitol, simeticone, curcumin (colouring agent E 100) and fruit flavour (sorbitol, mannitol, water-free silica colloidal, glucono-lactone, powder flavour 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