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Ranitidine Effervescent 150mg Effervescent Tablets

Informations for option: Ranitidine Effervescent 150mg Effervescent Tablets, show other option

Package leaflet: Information for the user

Ranitidine 150mg & 300mg effervescent 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 any further questions, please 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 effervescent tablets is and it is used for

2.    What you need to know before you take Ranitidine effervescent tablets

3.    How to take Ranitidine effervescent tablets

4.    Possible side effects

5.    How to store Ranitidine effervescent tablets

6.    Contents of the pack and further information

1.    What Ranitidine effervescent tablets is and what it is used for

Ranitidine effervescent tablets contains the active substance ranitidine which belongs to a group of medicines called H2 receptor antagonists. It works by reducing the amount of acid produced in your stomach.

In adults, Ranitidine effervescent tablets may be used for the:

•    treatment of ulcers in the stomach or duodenum (part of the small intestine).

•    prevention of recurrent ulcers in the duodenum (part of the small intestine).

•    treatment of inflammation of the gullet (oesophagus) caused by reflux (leaking back into the gullet from the stomach) of gastric acid (reflux oesphagitis).

•    treatment of a disease in which the stomach produces too much acid (Zollinger-Ellison Syndrome).

This medicine is not meant for the treatment of mild stomach aches or intestinal complaints, such as an irritated stomach due to tension.

For children (3 to 18 years) Ranitidine effervescent tablets is used for:

•    healing ulcers in the stomach, of the part of the gut it empties into (the duodenum)

•    treating symptoms caused by reflux of gastric juice into the oesophagus (gastro-oesophageal reflux) or too much acid in the stomach.

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

•    are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6)

•    have a history of a blood problem known as porphyria.

Warnings and precautions

Check with your doctor or pharmacist before taking your medicine if you:

   suffer from reduced kidney or liver function

•    are elderly, suffer from a chronic lung disease, diabetes or an immunological disorder.

There may be an increased risk of developing community acquired pneumonia.

•    have stomach ulcers caused by a certain bacteria (Helicobacterpylori). If your doctor finds out that this applies to you, he/she will prescribe other medicines (antibiotics) that are able to kill these bacteria.

•    have had stomach ulcers before and you are taking Non-Steroidal Anti Inflammatory (NSAID) medicines

Before starting treatment with Ranitidine effervescent tablets, your doctor may check that the stomach or intestinal ulcer is not malignant as ranitidine may mask the symptoms of stomach cancer

Other medicines and Ranitidine effervescent tablets

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

•    warfarin (medicine against blood clots)

•    procainamide and N-acetylprocainamide (certain medicines used for heart problems); high doses of ranitidine may reduce the excretion of procainamide from the body.

•    triazolam, midazolam (sleeping medicines), glipizide (medicine against diabetes), ketoconazole (medicine against fungal infections), atazanavir, delaviridine (medicines against viral infections), gefitnib (for treating cancer). The use of ranitidine may impact on the effect of such medicines, whose absorption in the body depends on the acidity of the stomach

•    sucralfate at high doses (2g) (medicine against ulcers). Sucralfate must be taken two hours after 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. You should not take this medicine during pregnancy or breast-feeding unless your doctor advises it is essential.

Driving and using machines

This medicine can sometimes cause side effects. Use extreme caution when driving or operating heavy machinery until you’re aware of how this drug affects you.

Ranitidine effervescent tablets contains lactose monohydrate and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Ranitidine effervescent 150 mg contains 120 mg sodium per tablet. Ranitidine effervescent 300 mg contains 240 mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.

3. How to take Ranitidine effervescent tablets

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

The recommended dose is:

Adults and adolescents 12 years and older

   Stomach or duodenal ulcers - 300mg after supper or at bedtime; or 150mg in the morning and evening for four weeks. If your ulcer is not fully healed the doctor may give you another four weeks treatment. If you have a history of repeated ulcers your doctor may continue your treatment for up to 12 months with 150mg ranitidine at bedtime.

   Reflux oesophagitis - 150mg in the morning and evening or 300mg after supper or at bedtime for up to 8 or 12 weeks (if necessary, up to 300 mg twice a day may be prescribed by your doctor).

   Patients with Zollinger-Ellison Syndrome - 150mg three times a day. If necessary your doctor may increase the dose, to a maximum of 6g a day.

•    If you have a kidney disease your doctor may prescribe a lower dose.

Children 12 years and over

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

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. o Treatment of stomach or duodenal (small intestine) ulcers - The recommended oral dose is 4 to 8 mg/kg body weight per day, administered as two divided doses to a maximum of 300 mg ranitidine per day.

o Gastro-oesophageal reflux - The recommended oral dose is 5 to 10 mg/kg body weight per day administered as two divided doses in a maximum dose of 600 mg.

Method of administration

The effervescent tablets should be dissolved in a large quantity of water (1 full glass) without breaking them, wait until the effervescent tablets are completely dissolved and then drink the solution.

If you take more Ranitidine effervescent tablets than you should

Do not take more tablets than your doctor tells you to. If you have accidentally taken more than the prescribed dose, go to the nearest hospital casualty department or tell your doctor/pharmacist immediately.

If you forget to take Ranitidine effervescent tablets

If you forget to take a dose, take it as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Ranitidine effervescent tablet

Do not stop taking the tablets until your doctor tells you to as the pain and discomfort may return.

If you notice that the effect of this medicine is too strong or inadequate, consult your doctor or pharmacist.

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.

Stop taking Ranitidine effervescent tablets and see a doctor straight away if you notice any of the following side effects, as they may be serious:

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

-    Severe allergic reactions, the signs may include:

-    swelling of face, tongue and throat or cramps in airways

-    rash, itching or hives on the skin

-    chest pain, shortness of breath, wheezing or having trouble breathing

-    unexplained fever and feeling faint, especially when standing up

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

-    Severe stomach pain, this may be a sign of something called ‘pancreatitis’

-    Kidney problems, which can lead to back pain,    fever, pain when passing urine, blood in

the urine and changes in blood tests

-    A slow or irregular heartbeat

Other side effects:

Uncommon side effects (may affect up to 1 in 100 people)

-    Stomach pain, nausea, diarrhoea, constipation

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

-    Skin rash, itching

-    Transient and reversible effect on liver function.

-    Effect on kidney function tests (serum creatinine)

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

-    Headache, dizziness, involuntary movements

-    Muscle and joint pains

-    Unusual secretion of breast milk or breast enlargement in men

-    Reversible impotence

-    Your liver can become swollen. This can lead to nausea or vomiting, loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine.

-    Patchy red skin rash (‘erythema    multiforme’)

-    Unexplained hair loss

-    Blurred vision

Changes in the 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 infection Inflammation of the small blood vessels. Signs can include a rash, swollen joints or kidney problems

Reversible mental confusion, depression and hallucinations (seeing or hearing unexplained things). Mainly experienced in elderly and seriously ill people

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 effervescent tablets

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

Do not store the tablets above 30°C and keep in the well-closed package.

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

Do not take Ranitidine effervescent tablets if you notice the effervescent tablets become discoloured or show any other signs of deterioration.

Do not throw away anymedicines 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 further information

What Ranitidine effervescent tablets contains

•    The active substance is ranitidine hydrochloride.

•    Each tablet contains 168 mg or 336 mg ranitidine hydrochloride, equivalent to 150mg and 300 mg ranitidine respectively.

•    The other ingredients are tartaric acid (E334), sodium hydrogen carbonate, lactose monohydrate, polyvidone, Riboflavin (E101), simethicone emulsion (contains simethicone, methylcellulose, sorbic acid, purified water), sodium cyclamate, saccharin sodium, lemon flavour (contains citral, citronella oil, coriander oil, lime, acacia), macrogol, sodium hydroxide.

What Ranitidine effervescent tablets look like and contents of the pack

Ranitidine effervescent tablets are yellow-white to light yellow, circular, flat tablets with bevelled edges.

The product is packed in polypropylene tubes closed with a polyethelene cap containing a desiccant. The tubes are packed in carton outer boxes.

Pack sizes: 15, 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands

Manufacturer:

Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands

or

Losan Pharma GmbH Otto-Hahn Strasse 13 79395 Neuenburg Germany

This leaflet was last approved in March 2016


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