Inside

Document: Inside film-coated tablet ENG PL change

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

How to store Inside

6. Contents of the pack and other information

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.

What you need to know before you use Inside

Do not useInside

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.

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.

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 Insidethan 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.

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, twitching and 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).

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.

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