Package Leaflet: Information for the User

Ranitidine 25 mg/ml Solution for Injection or Infusion (Ranitidine Hydrochloride)

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The name of your medicine is Raniditine 25 mg/ml solution for Injection or infusion, which will be called Ranitidine Injection throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine.

-    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ranitidine Injection is and what it is used for

2. Before you are given Ranitidine Injection

3. How you are given Ranitidine Injection

4. Possible side effects

5. How to store Ranitidine Injection

6. Further information

1.    WHAT RANITIDINE INJECTION IS AND WHAT IT IS USED FOR

Ranitidine Injection belongs to a group of medicines called H2 receptor antagonists. Ranitidine lowers the amount of acid in your stomach. Your doctor has prescribed Ranitidine Injection for:

•    treatment of stomach ulcers and ulcers in the duodenum (where the stomach empties into),

•    treatment of reflux oesophagitis (acid in the food pipe) often called heartburn

•    treatment of Zollinger-Ellison-Syndrome (a condition where too much acid is produced in the stomach)

•    prevention of bleeding in the gut in seriously ill patients

•    prevention of bleeding in the gut in patients with bleeding stomach ulcers

•    prevention of acid coming up from the stomach while under anaesthesia during an operation

2.    BEFORE YOU ARE GIVEN RANITIDINE INJECTION You should not be given Ranitidine Injection, if you:

-    are allergic (hypersensitive) to Ranitidine or any of the other ingredients of Ranitidine Injection (see list

of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue

-    have a rare condition called acute porphyria (an enzyme deficiency affecting the blood)

Take special care with Ranitidine Injection and tell your doctor if any of the following apply to you:

-    kidney disorder

-    stomach Carcinoma (tumour)

-    bradycardia (Slowness of the heart rate)

-    your immune system is not working properly

-    you are elderly

Taking other medicines

Please tell your doctor or pharmacist, if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking the following medicines, as they may react with Ranitidine Injection:

•    diazepam, for worry or anxiety problems

•    lidocaine, a local anaesthetic

•    phenytoin, for epilepsy

•    propranolol, procainamide or n-acetylprocainamide, for heart problems

•    theophylline, for breathing problems (asthma)

•    warfarin, for thinning your blood

•    glipizide, for lowering blood glucose

•    atazanavir or delaviridine, for treating HIV infection

•    triazolam, for insomnia

•    gefitnib & erlotinib, for treating certain cancers

•    ketoconazole, an anti fungal medicine, sometimes used for treating thrush

•    itraconazole & posaconazole, for fungal infections

•    midazolam, a sedative sometimes used before an operation

•    Procainamide or N-acetylprocainamide, used to treat an irregular heart rhythm

•    Cyanocobalamin, for anaemia

It may still be all right for you to be given Ranitidine Injection. Your doctor will be able to decide what is suitable for you.

Fertility, Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

You should not be given Ranitidine Injection while pregnant unless your doctor tells you to.

Clinical experience with a large number of pregnancies does not indicate adverse effects on pregnancy or the health of the unborn child/newborn.

Breast-feeding

The active substance passes into breast milk. You should avoid breast-feeding while you are being given Ranitidine Injection as this may cause stomach acid secretion disorders in your child.

Fertility

Ranitidine had no effect on male or female fertility in animals.

Driving and using machines

Ranitidine Injection may cause hallucinations (seeing or hearing things), dizziness, confusion or headache. If you are affected you should not drive or use machinery.

Important information about some of the ingredients of Ranitidine Injection

Ranitidine Injection contains less than 1 mmol sodium (0.08475 mmol per mL) per dose and is essentially ‘sodium-free’ and less than 1 mmol (0.718 mmol) potassium per 100ml, i.e. essentially “potassium free”.

3.    HOW YOU ARE GIVEN RANITIDINE INJECTION

Ranitidine Injection will be given to you by your doctor or pharmacist.

Adults (including elderly): Ranitidine Injection will be given to you either:

•    as a slow infusion into a vein (where the drug is slowly given to you over a few minutes).

•    as a continuous infusion into a vein (where the drug is slowly given to you over a few hours)

Different doses may also be given to you as a slow infusion or continuous infusion, depending on what condition you are being treated for.

Patients with a kidney disorder may need a lower dose. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Children: Ranitidine Injection may be given as a slow (over 2 minutes) i.v. Injection up to a maximum of 50 mg every 6 to 8 hours.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you are given more Ranitidine Injection than you should:

It is unlikely you will be given too much Ranitidine Injection, however no problems would be expected.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Ranitidine Injection can cause side effects, although not everybody gets them.

Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Side effects can be listed according to how often they occur:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 100 users in 1,000

rare: affects 1 to 1000 users in 10,000

very rare: affects less than 1 user in 10,000

unknown: cannot be estimated from the available data.

Common: Headache (sometimes severe), dizziness, diarrhoea.

Uncommon: nettle rash, serious allergic reaction that causes swelling of the face or throat, fever, asthma-like symptoms, low blood pressure, chest pain, blurred vision, skin rash, hallucinations (seeing or hearing things), mental confusion (these symptoms disappear when treatment is stopped).

Very rare: depression, movement disorders (including tremors or eye movements), changes in liver function tests

Unknown: changes in the number of blood cells or platelets (these can be detected by a test carried out by a doctor), Anaphylactic shock, laryngeal spasm, confusion and hallucinations, agitation, slow or irregular heartbeat, inflammation of the veins, pancreas or liver, nausea, yellow eyes and skin, red spots, hair loss, joint or muscle pain, kidney damage (this can be detected by a test carried out by a doctor), failure to get an erection, breast development in men, severe itching, increased plasma creatinine, weakness, feeling sick, and constipation

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE RANITIDINE INJECTION

The hospital pharmacist will know how to store Ranitidine Injection. It should be kept out of the reach and sight of children and do not stored above 25°C. It should be stored in the original carton to protect from light and not refrigerated or frozen.

Ranitidine Injection should not be autoclaved.

Do not use Ranitidine Injection after the expiry date which is stated on the label or carton after Exp. The expiry date refers to the last day of the month.

Medicines should not be disposed of in waste-water or with household garbage. Ask your pharmacist what you should do with medications you no longer need. These measures will help to protect the environment.

Single dose container.

Shelf life after first opening of the container: From a microbiological point of view, the product should be used immediately.

Shelf life after dilution: This medicinal product must not be mixed with other medicinal products except those mentioned in the following:

0.9% Sodium Chloride BP 5% Dextrose BP

0.18% Sodium Chloride and 4% Dextrose BP 4.2% Sodium Bicarbonate BP Hartmann's Solution.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated conditions.

6.    FURTHER INFORMATION

What Ranitidine Injection contains

1ml of Solution for Injection contains 25 mg Ranitidine.

Each 2 ml ampoule contains 50 mg Ranitidine (as Ranitidine Hydrochloride).

The other ingredients are:

Sodium Chloride (for tonicity adjustment),

Potassium Dihydrogen Phosphate,

Anhydrous Disodium Hydrogen Phosphate and Water for Injections.

What Ranitidine Injection looks like and contents of the pack

Ranitidine Injection comes as a 2 ml solution in a clear glass ampoule, which are blister packed in cartons of 5, 10 and 25 ampoules.

Ranitidine Injection looks as a clear, colourless to pale yellow solution, free from visible particles.

Marketing Authorisation Holder

Claris Lifesciences (UK) Limited

Crewe Hall, Crewe, Cheshire, CW1 6UL, United Kingdom.

Manufacturer:

Peckforton Pharmaceuticals Limited

Crewe Hall, Crewe, Cheshire, CW1 6UL, United Kingdom.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom

Austria

Germany

France

Ireland

Romania

Portugal

Ranitidine Claris 25mg/ml Solution for Injection or Infusion Ranitidine Claris 25mg/ml Injektionslosung Ranitidine Claris Ranitidine Claris

Ranitidine Claris 25mg/ml Solution for Injection or Infusion Ranitidina Claris 25mg/ml solutie injectabila/perfuzabila Ranitidine Claris

This leaflet was last revised in Nov’2010