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Ranitidine 300mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 14894-0006 change

Package leaflet: Information for the patient

Ranitidine 150mg & 300mg Film-coated Tablets (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 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, which reduce the

amount of acid in your stomach.

Ranitidine is used to treat the following conditions:

For Adults (including the older people)

•    Heal and stop ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer)

•    Too much acid in the stomach caused by a growth in the pancreas (Zollinger Ellison syndrome)

•    Reflux esophagitis. This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

For children (3 to 18 years)

•    Short term treatment of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer)

•    Gastro-esophageal reflux disease’ (GERD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.

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).

If you are not sure, talk to your doctor or pharmacist before taking Ranitidine. Warnings and precautions

Talk to your doctor or pharmacist before taking Ranitidine if you:

•    have stomach cancer

•    have kidney problems

•    are in older age

•    have had ulcer before and you are taking non-steroidal anti-inflammatory (NSAIDs) e.g. indomethacin, aspirin

•    have blood pigment disorder called acute porphyria (rare condition)

•    have long-standing lung disease

•    have weak immune system

•    have diabetes.

If you are not sure if any of the above applies to you, please talk to your doctor or pharmacist for advice before taking Ranitidine.

Other medicines and Ranitidine

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

This is because ranitidine can affect the way some other medicines work. Also some other medicines can affect the way ranitidine works.

This particularly applies to the following:

•    non-steroidal anti-inflammatory (NSAID) medicines, for pain and inflammation

•    coumarin anticoagulants, for thinning your blood e.g. warfarin

•    procainamide or n-acetylprocainamide, for heart problems

•    triazolam, for sleep problems

•    midazolam (a medicine that may be given to you just before you have an operation). Tell the doctor you are taking ranitidine before your operation in case he or she wants to give you midazolam.

•    glipizide, for lowering blood glucose

•    atazanavir or delavirdine, for treating HIV infection

•    gefitnib, for lung cancer

•    ketoconazole, an anti-fungal medicine

•    sucralfate, for ulcers. Sucralfate may be taken after an interval of 2 hours following administration of ranitidine

•    strong antacids, for indigestion.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ranitidine tablets.

Ranitidine with food and drink

Ranitidine can be taken with or without food. The effect of alcohol may be increased if taken with Ranitidine.

Pregnancy and breast-feeding

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

It is unlikely that Ranitidine tablets affect your ability to drive and operate machinery. Even though, if you feel any unusual symptoms which you think, may affect your ability to drive and operate machinery, do not drive and inform to your doctor.

Ranitidine tablets contain castor oil

May cause stomach upset and diarrhoea.

3. How to take Ranitidine

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

The recommended doses of Ranitidine are given below. Your doctor will tell you how long to take the tablets for. This will depend on the type and severity of your illness.

Adults and children (12 years and over)

Treatment of stomach or duodenal ulcers:

One 150 mg tablet to be taken twice daily (one in the morning and one in the evening) or one 300 mg tablet to be taken at bedtime for 4-8 weeks. For the prevention of recurrent ulcers, the usual maintenance dose 150 mg at bedtime.

Treatment of reflux oesophagitis:

One 150 mg tablet to be taken twice daily or one 300 mg tablet at bedtime. The usual duration of treatment for reflux oesophagitis is up to 8 weeks. This may be extended to a maximum of 12 weeks.

Treatment of Severe oesophagitis:

One 150 mg tablet to be taken four times daily to a maximum of 12 weeks. Zollinger-Ellison syndrome:

One 150 mg tablet, three times a day. The dose may be gradually increased to 300 mg three times daily, or more depending on progress.

Older people

The dose will be the same as for young adults.

Patients with kidney problems

If you have kidney disease, your doctor may prescribe a lower dosage. Patients who are on haemodialysis should take this medicine after their dialysis session.

Use in children from 3 to 11 years and over 30 kg of weight

Your doctor will work out the right dose based on your child’s weight. The tablets may be dissolved in water or crushed.

Short term treatment of ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer):

The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for duration of 4 weeks.

Gastro-oesophageal reflux disease:

The recommended oral dose for the treatment of Gastro-oesophageal reflux disease in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses to a maximum of 600 mg ranitidine.

Taking this medicine

The tablets should be swallowed whole with a glass of water. For children taking this medicine, the tablets may be dissolved in water or crushed.

If you take more Ranitidine than you should

If you ever take too much Ranitidine, or if someone else has taken your medicine, you / they should contact your doctor or your nearest hospital casualty department immediately. Please take any remaining medicine with you in the carton in which it came so that staff will know what has been taken.

If you forget to take Ranitidine

Take it as soon as you remember then continue as before. If it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take any more tablets in one day than your doctor has prescribed. Do not take a double dose to make up for a missed dose.

If you feel that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.

If you stop taking Ranitidine

Take your tablets as directed and for as long as directed. Do not stop them, even if you feel better as your symptoms 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 the casualty department at your nearest hospital:

Rarely reported: (may affect up to 1 in 1,000 people)

•    hives (urticaria), rash, itching

•    swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing

•    fever, low blood pressure, chest pain.

Very rarely reported: (may affect up to 1 in 10,000 people)

•    change in rate or rhythm of heart beat, slow or fast heart rate

•    severe condition of the skin that may affect the mouth and other parts of the body

•    sudden severe abdominal pain with or without nausea and vomiting (inflammation of the pancreas).

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Very rarely reported: (may affect up to 1 in 10,000 people)

•    There can be changes in level of certain substances in your blood. This can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infectioninflammation of the blood vessels, often with rash (vasculitis)dark discoloration of urine, bloody or cloudy urine or any change in your urine output (this may be due to a condition called interstitial nephritis) yellowing of the skin or eyes, abdominal pain, unexplained fatigue, dark coloured urine or pale coloured stools (manifestations of liver problems).

Tell your doctor as soon as possible if you develop any of the following:

Uncommonly reported: (may affect up to 1 in 100 people)

•    abdominal pain

•    constipation

•    feeling sick (nausea)

•    loose stool (diarrhoea).

Rarely reported: (may affect up to 1 in 1,000 people)

•    skin rash

Very rarely reported: (may affect up to 1 in 10,000 people)

•    headache and dizziness

•    hair loss

•    joint and muscle pains

•    blurring of vision

•    mental confusion, depression, hallucinations (unrealistic sensations/ perception), especially if you are in older age or severely ill or have kidney problems

•    uncontrolled movements

•    impotence, breast tenderness and/or breast enlargement, breast discharge. Frequency not known: (frequency cannot be estimated from the available data)

shortness of breath (dyspnoea)

Laboratory tests

There may be changes in the results of certain laboratory tests.

Rarely reported: (may affect up to 1 in 1,000 people)

•    abnormal liver function tests - which are for a short period of time and reversible once you stop taking the medicine

•    increase in serum creatinine in the blood

•    changes in blood count (red blood cells, white blood cells, platelets).

Many of these side effects are reversible and go away once ranitidine treatment is stopped.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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 label after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from 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 to protect the environment.

6. Contents of the pack and other information

What Ranitidine contains

The active ingredient is: ranitidine

Each 150 mg tablet contains ranitidine hydrochloride equivalent to 150 mg ranitidine and each 300 mg tablet contains ranitidine hydrochloride equivalent to 300 mg ranitidine.

The other ingredients are:

Microcrystalline cellulose, hypromellose, croscarmellose sodium, castor oil (see 'ranitidine contains castor oil' in section 2), colloidal anhydrous silica, purified talc, magnesium stearate and titanium dioxide (E171). The printing ink contains: Opacode

S-1-17823 Black (containing shellac, isopropyl alcohol, iron oxide black, N-Butyl alcohol, propylene glycol and ammonium hydroxide 28%).

What Ranitidine looks like and contents of the pack

Ranitidine 150mg Film-coated Tablets are white to off-white, biconvex, film-coated tablets imprinted with ‘RAN150’ in black edible ink on one side.

Ranitidine 300mg Film-coated Tablets are white to off-white, biconvex, film-coated capsule-shaped tablets imprinted with ‘RAN300’ in black edible ink on one side.

Ranitidine 150mg and 300mg Film-coated Tablets are available in the following packs: boxes of 5, 7, 8, 10, 14, 15, 16, 20, 24, 28, 30, 32, 40, 45, 48, 50, 56, 60, 64, 72, 75, 80, 88, 90, 96, 98, 100, 105, 112, 120 and 150 tablets per carton.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Ranbaxy (UK) Limited,

Building 4, Chiswick Park,

566 Chiswick High Road,

London, W4 5YE,

United Kingdom

Manufacturer Ranbaxy Ireland Limited,

Spafield, Cork Road,

Cashel, Co. Tipperary,

Ireland.

This leaflet was last revised in January 2015.