SODIUM BICARBONATE 600 mg TABLETS version 3

SODIUM BICARBONATE 600 mg TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to take Sodium Bicarbonate tablets carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after 24 hours.

•    If any of the side effects get serious, or if you notice any side effects not listed

in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Sodium Bicarbonate is and what it is used for

2.    Before you take Sodium Bicarbonate

3.    How to take Sodium Bicarbonate

4.    Possible side effects

5.    How to store Sodium Bicarbonate

6.    Further information

1.    WHAT SODIUM BICARBONATE IS AND WHAT IT IS USED FOR

Sodium Bicarbonate belongs to a group of drugs known as antacids.

Sodium Bicarbonate tablets are used to treat:

•    Rapid relief of stomach acidity and heartburn due to stomach acidity

2.    BEFORE YOU TAKE SODIUM BICARBONATE

Take special care with Sodium Bicarbonate

Talk to your doctor before you start to take this medicine if you:

•    have kidney problems

•    have liver problems

•    suffer from high blood pressure or heart failure

•    are elderly

•    are on a low sodium (salt) diet (see also ‘Important information about some of the ingredients of Sodium Bicarbonate’ below).

Please talk to your doctor if your symptoms remain same after taking this medicine.

Taking other medicines

Talk to your doctor if you are taking any of the following:

•    antibiotics (tetracyclines, azithromycin, pivampicillin and rifampicin), antifungals (to treat an infection) e.g. ketoconazole, itraconazole.

•    phenothiazines (to treat anxiety and depression)

•    drugs to treat high blood pressure (e.g. fosinopril)

•    bisphosphonates (to treat Paget’s disease, where bone forms too quickly)

•    lithium (to treat mental illness)

•    quinidine or hydroxychloroquine (to treat heart rhythm disorder)

•    phenytoin or gabapentin (for fits)

•    chloroquine (to prevent or treat malaria)

•    penicillamine, diflunisal (for rheumatism or pain)

•    amphetamines for attention deficit disorder

•    antibacterial (e.g. cefpodoxime, ciprofloxacin, isoniazid, norfloxacin, ofloxacin) as sodium bicarbonate may impair their absorption

•    salicylates (for pain or fever)

•    enteric coated tablets (please speak to your doctor if you are not sure)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Sodium Bicarbonate

•    Patients who are intolerant to sucrose should note that Sodium Bicarbonate tablets contain a small amount of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    This tablet contains significant amount of sodium. This should be taken into account if you are on a low sodium diet.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

Sodium Bicarbonate is not known to affect your ability to drive or operate machinery.

3. HOW TO TAKE SODIUM BICARBONATE

If your doctor has prescribed this medicine, always take Sodium Bicarbonate tablets exactly as your doctor has told you. Otherwise, follow the instructions below. If you are not sure how to take this medicine, talk to your doctor or pharmacist.

Do not take more than prescribed dose.

Do not take the tablets for too long without seeing your doctor. If your indigestion does not get any better after taking the tablets, go and see your doctor.

Adults and children over 12 years:

Indigestion: 1-3 tablets sucked when required.

Elderly

If you are elderly, you should consult your doctor before taking this medicine, and must be particularly careful to follow your doctor’s instructions.

Children under 12 years

Sodium Bicarbonate is not recommended for use in children under 12 years.

If you take more Sodium Bicarbonate than you should

If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. A severe overdose is likely to cause feeling unwell, vomiting, drowsiness or bad breath.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Sodium Bicarbonate

If you have been prescribed regular doses of this medicine, and you forget to take your dose at the correct time, take your dose as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Bicarbonate can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

Tell your doctor if you suffer from any of the following for more than a few days:

•    stomach pains

•    feeling bloated

•    belching

•    wind

•    return of acidity in stomach

The following effects may also occur:

•    if you use Sodium Bicarbonate for a long time, your body tissues and fluids may become too alkaline. This is called alkalosis and you may notice muscle weakness and cramps.

•    Sodium Bicarbonate tablets contain a lot of sodium, which could make your blood pressure go up or cause fluid accumulation in your body and lungs.

•    if you already have a low level of potassium in your blood (hypokalaemia), Sodium Bicarbonate tablets may make this worse.

If you experience these effects, or if you are worried about them, you should contact your doctor or pharmacist.

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

5.    HOW TO STORE SODIUM BICARBONATE Keep out of the reach and sight of children.

You should keep your tablets in a cool, dry place..

Do not store above 25°C Store in the original container.

Do not use Sodium Bicarbonate after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

This tablets are only for you. Do not give them to anyone else.

6.    FURTHER INFORMATION

What Sodium Bicarbonate tablets contain:

•    The active ingredient is sodium bicarbonate 600mg BP.

•    The other ingredients are syrup, purified water and magnesium stearate.

What Sodium Bicarbonate tablets look like and contents of the pack:

•    The Sodium Bicarbonate tablets are white tablets.

•    They come in packs of 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Your tablets are made by Teva UK Limited, Eastbourne, BN22 9AG Manufacturer

Sussex Pharmaceutical Limited, Charleswood Road, East Grinstead, Sussex RH19 2HL

This leaflet was last revised: October 2012

PL 00289/1809