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Ranitidine Tablets Bp 150 Mg

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PACKAGE LEAFLET

Package leaflet: Information for the patient user Ranitidine Tablets BP

ranitidine

Read all of this leaflet carefully before you start taking 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 Ranitidine is and what it is used for

2.    What you need to know before you take Ranitidine

3.    How to take Ranitidine

4.    Possible side effects

5.    How to store Ranitidine

6.    Contents of the pack and other information

1. What Ranitidine is and what it is used for

Ranitidine belongs to a group of medicines called H2 antagonists. These medicines work by reducing the amount of acid in the stomach.

For adults (including the elderly) Ranitidine is used to:

-    heal and prevent ulcers in the stomach or the part of the gut it empties into, the duodenum

-    prevent ulcers from bleeding

-    heal and prevent problems caused by acid in the food pipe (oesophagus) or to much acid in the stomach, which can cause pain or discomfort known as “indigestion”, “dyspepsia” or “heartburn”

-    prevent ulcers, which can be a side effect of some medicines used to treat arthritis especially in women during labour

-    clear up infection with the germ Helicobacter pylori when used with antibiotics For children (3 to 18 years) Ranitidine is used to:

-    heal ulcers in the stomach, or the part of the gut it empties into (the duodenum)

-    heal and stop problems caused by acid in the food pipe (oeosophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as “indigestion”, “dyspepsia” or “heartburn”.

If you are not sure why you are taking these tablets ask your doctor.

2. What you need to know before you take Ranitidine Do not take Ranitidine:

-    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 taking Ranitidine if:

-    you suffer from kidney disease

-    you have a rare condition called porphyria

Ranitidine may hide the symptoms of other diseases. Before starting ranitidine treatment your doctor may carry out tests to confirm your conditions and/or exclude other diseases.

If you are elderly with chronic lung problems, diabetes or a weak immune system, you may be at greater risk of developing a lung condition called “community acquired pneumonia”.

Other medicines and Ranitidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, especially any of the following medicines:

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

-    Non-Steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation (e.g. ibuprofen, diclofenac)

-    lidocaine, a local aneasthetic

-    diazapam, for worry or anxiety

-    phenytoin for epilepsy

-    theophylline, for breathing problems (asthma)

-    warfarin or coumarin, for thinning the blood (ranitidine may change the effect of these drugs and increase or reduce the blood clotting time)

-    glipizide, for lowering blood glucose

-    atazanavir or delviridine, for treating HIV infection

-    triazolam, for insomnia

-    gefitnib, for lung cancer

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

-    midazolam is a medicine that may be given to you just before you have an operation. Tell your doctor if you are taking Ranitidine before your operation in case he/she wants to give you midazolam.

Pregnancy and breast-feeding

Ranitidine can enter the baby’s blood if taken when you are pregnant and is found in human breast milk if taken when you are breast-feeding. Ranitidine should only be taken when you are pregnant or breast-feeding if it is absolutely necessary.

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.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines, however if you get any side effects such as dizziness, uncontrolled movements or blurred vision, speak to your doctor before attempting such activities.

3. How to take use Ranitidine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a drink of water.

Adults (including the elderly)

The usual dosage is either one Ranitidine Tablet BP 150 mg in the morning and one tablet in the evening, or for some conditions one Ranitidine Tablet BP 300 mg at bedtime. Depending on your symptoms, your doctor may wish to prescribe a dose of 300 mg twice daily.

If you have the germ Helicobacter pylori the doctor will also prescribe antibiotics to be taken for two weeks whilst taking Ranitidine tablets BP, relief of your symptoms will usually be rapid. The treatment should last for at least 4 weeks and up to 8 weeks. Most ulcers will have healed by this time. If you have oesophagitis treatment may last for up to 12 weeks and your doctor may prescribe Ranitidine Tablets BP 150 mg four times daily. After your ulcer has healed, your doctor may prescribe a maintenance dose of 150 mg at bedtime, especially if you have had an ulcer return.

To prevent the breathing in of acid from the stomach during general anaesthesia a dose of 150 mg Ranitidine may be given the evening before the operation and 150 mg two hours before the anaesthetic. Or during labour, a dose of 150 mg Ranitidine may be given every six hours.

Use in children and adolescents

For children 12 years and over the adult dosage is given.

For children over 30 kg in weight and from 3 to 11 years:

Your doctor will work out the right dose for you based on your child’s weight

Treatment of stomach or duodenal (small intestine) ulcers:

The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks.

Treatment of heartburn due to too much acid:

The usual dose is 2.5 mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart.

If you take more Ranitidine than you should

It is important to stick to the dose on the label of your medicine. Taking more medication than this is unlikely to be dangerous unless many tablets are taken at once. In that case, do not delay, contact your doctor or hospital emergency department immediately.

If you forget to take Ranitidine

If you forget to take a dose take is as soon as you remember. If it is almost time for your next dose though, do not take a double dose to make up for a forgotten dose, just carry on as before.

If you stop taking Ranitidine

After a few days you should feel much better but do not stop taking this medicine unless your doctor tells you, or the pain and discomfort may return.

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.

If any of the following happen, stop taking Ranitidine and tell your doctor immediately or go to your nearest hospital emergency department:

Rare (may affect up to 1 in 1,000 people)

• Signs of an allergic reaction, which may include swelling or rash on the lips, tongue or face, fever, chest or throat pain, difficulty breathing or low blood pressure.

Very rare (may affect up to 1 in 10,000 people)

•    Inflammation of the pancreas, causing severe stomach pain that can spread to the back.

•    Inflammation of the liver (hepatitis), which may cause yellowing of the skin and whites of the eyes, loss of appetite, fever, feeling generally unwell, pale stools or dark urine.

•    Problems with your heart causing an irregular or slower than usual heart beat or ‘missed’ beats.

•    Difficulty or pain when urinating, with back pain, fever or generally feeling unwell. These may be signs of problems with your kidneys.

•    Changes to the number of cells in your blood that may cause you to feel more tired than usual or have pale skin (fewer red blood cells), have more frequent infections with fever, chills, sore throat of mouth ulcers (fewer white blood cells), or to bleed or bruise more easily or for longer than usual (fewer platelets).

Other possible side effects

Uncommon (may affect up to 1 in 100 people)

•    Feeling sick, stomach pain or constipation

Rare (may affect up to 1 in 1,000 people)

•    Changes in liver or kidney function, which will show up on a blood test

•    Skin rash

Very rare (may affect up to 1 in 10,000 people)

•    Feeling low or sad (depression), seeing or hearing things that are not there (hallucinations) or confusion

•    Fast heart beat

•    Headache (possibly severe), dizziness, uncrontrolled movements or blurred vision

•    Diarrhoea

•    Inflammation of blood vessels often with skin rash (vasculitis)

•    Red patches on the skin

•    Hair loss

•    Joint or muscle pain

•    Inability to get or maintain an erection, swelling of the breasts in men (gynaecomastia) or unexpected production of milk in women

Not known (cannot be estimated from the available data)

•    Shortness of breath

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 Yellow Card Scheme, at the website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ranitidine

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store below 25°C in a dry place. Protect from heat and moisture.

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 Ranitidine contains

The active substance is ranitidine. One 150 mg tablet contains 168 mg Ranitidine Hydrochloride equivalent to 150 mg Ranitidine. Whilst one 300 mg tablet contains 336 mg Ranitidine Hydrochloride equivalent to 300 mg Ranitidine.

The other ingredients areEach tablet also contains microcrystalline cellulose and magnesium stearate and the 300 mg tablet also contains croscarmellose sodium. The coating contains methylhydroxypropyl cellulose, titanium dioxide (E171), polydextrose, triethyl citrate and polyethylene glycol.

What Ranitidine looks like and contents of the pack

Your medicine is in the form of a coated tablet. There are two strengths of Ranitidine Tablets BP available, 150 mg (marked “G” on one side and “00” over “30” on the other) and 300 mg (marked “G” on one side and “0031” on the other).

Ranitidine Tablets BP 150 mg are available in blisters packs of 60 tablets and Ranitidine Tablets BP 300 mg in blister packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL Manufacturer

Generics [UK] Limited, Potters Bar, Herts, EN6 1TL

This leaflet was last revised in November 2014

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