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Nu-Seals 300

Document: leaflet MAH BRAND_PL 16853-0063 change

ALLIANCE

PATIENT INFORMATION LEAFLET

Nu-Seals® 300

aspirin (acetylsalicylic acid)

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

The information in this leaflet has been divided into the following sections:

1.    What Nu-Seals 300 is and what it is taken for

2.    Check before you take Nu-Seals 300

3.    How to take Nu-Seals 300

4.    Possible side effects

5.    How to store Nu-Seals 300

6.    Further information


1. What Nu-Seals 300 is and what it is taken for


Nu-Seals 300 contains aspirin. Aspirin is used:

•    as an anti-inflammatory analgesic which can relieve pain and swelling

•    to bring down high body temperatures

•    to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Nu-Seals 300 regularly, it reduces the risk of a blood clot occurring in the heart or brain. This can prevent further heart attacks or strokes.

If you take aspirin in high doses or over a long period of time, it can irritate your stomach lining. To prevent stomach irritation, these tablets have a special coating (called enteric) so that the aspirin is not released until it has passed through the stomach.

Aspirin is released slowly from these tablets, so Nu-Seals 300 is not suitable for the short-term relief of pain, such as headaches or toothache.

2. Check before you take Nu-Seals 300


Do not take Nu-Seals 300:

•    if you are allergic to aspirin or if you are allergic to any of the ingredients in Nu-Seals 300 (see Section 6 Further information)

•    if you have ever had the problem of your blood not clotting properly

•    if you have ever had an ulcer in your stomach or small intestine.

Take special care with Nu-Seals 300

Before you take Nu-Seals 300 tell your doctor if you:

•    think you may be dehydrated (you may feel thirsty with a dry mouth)

•    have trouble with your kidneys or liver

•    have high blood pressure

•    are asthmatic, aspirin may induce an asthma attack.

When given to children aspirin may cause Reye’s syndrome. Reye’s syndrome is a very rare disease, which can be fatal. For this reason, aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Nu-Seals 300.

Taking other medicines

The effect of treatment may be influenced if aspirin is taken at the same time as some other medicines for:

•    thinning of the blood/prevention of clots (e.g. warfarin)

•    organ rejection after transplantation (e.g. ciclosporin, tacrolimus)

•    high blood pressure (e.g. diuretics and ACE-inhibitors)

•    pain and inflammation (e.g. anti-inflammatory medicines such as ibuprofen, or steroids)

•    gout (e.g. probenecid)

•    cancer or rheumatoid arthritis (e.g. methotrexate)

•    insulin or any other drug to treat diabetes

•    corticosteroids (used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or to treat inflammation, including rheumatic diseases and inflammation of the intestines)

•    phenytoin or sodium valproate (used to control epilepsy)

•    sulphonamides (a type of antibiotic) such as sulfamethoxazole

•    medicines such as acetazolamide used to treat glaucoma

•    antacids (indigestion medicine). Do not take antacids just before or after taking Nu-Seals 300 as they may cause the aspirin to be released too soon.

Before using aspirin you should inform a healthcare professional about the medicines you are taking. If you are using aspirin regularly you should seek advice before taking any other medicine (including other medicines you may have bought).

Pregnancy and breast-feeding

Pregnant women should not take aspirin during pregnancy unless advised by their doctor. Regular or high dose aspirin therapy during late pregnancy can cause serious complications in the mother or baby.

Do not take Nu-Seals 300 if you are breast-feeding because some of the aspirin may be in your breast milk, and could harm your baby.

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

3. How to take Nu-Seals 300



Always take Nu-Seals 300 exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

The usual dose is different in the following circumstances:

•    Pain and swelling, or fever

Take up to three 300 mg tablets three or four times a day.

•    Acute rheumatic disorders (joint and muscle problems)

Your doctor will tell you how many tablets to take and how often. You will usually take 4 to 8 grams of Nu-Seals 300 a day.

•    Prevention of heart attacks, angina or mini-strokes

The usual dose is one or two 75 mg tablets each day. Sometimes, your doctor may tell you to take one 300 mg tablet each day.

Swallow the tablets whole with water. Do not cut, crush or chew them as this will damage the special coating. If the coating is damaged the tablets are more likely to irritate your stomach.

If you may be taking this medicine for a long time, you should talk to your doctor about it.

What to do if you take more Nu-Seals 300 than you should

If you (or someone else) accidentally take too many tablets, you should tell your doctor at once or contact the nearest casualty department. Show any left over medicines or the empty packet to the doctor.

If you forget to take Nu-Seals 300

Do not worry. If you miss a dose, wait until it is time for your next dose, then go on as normal. DO NOT take a double 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, Nu-Seals 300 can cause side effects, although not everyone gets them. The more common side effects of aspirin include:

•    hypersensitivity (which may mean you have skin rashes or itching, or wheezing or coughing or difficulty breathing)

•    nausea and vomiting

•    ringing in your ears

•    pain or discomfort in your stomach or lower chest after eating.

Aspirin may sometimes cause asthma or bronchospasm (narrowing of the airways that causes wheezing or difficulty breathing).

Aspirin may cause bleeding, and you must tell your doctor if you experience any unusual bleeding.

Rarely, you may suffer more serious side effects, tell your doctor immediately if you get any of the following:

•    blood in your vomit

•    blood in your urine

•    bruising with purple spots

•    coughing up blood (however small the amount)

•    any swellings

•    black stools

•    kidney stones (which can cause severe stomach or back pains).

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

5. How to store Nu-Seals 300


Keep out of the reach and sight of children.

Do not use Nu-Seals 300 after the expiry date which is stated on the bottle and carton.

Do not store above 25°C. Keep the bottle tightly closed in order to protect from moisture. Do not take Nu-Seals 300 if you notice the appearance has changed in any way.

If your doctor decides to stop your treatment, return any unused medicine to the pharmacist. Only keep it if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information


What Nu-Seals 300 contains

The active ingredient in this medicine is aspirin (acetylsalicylic acid).

Each tablet of Nu-Seals 300 contains 300 milligrams (mg) of aspirin.

The other ingredients are maize starch, hypromellose, talc, methacrylic acid-ethyl acrylate (1:1) copolymer dispersion 30 percent, polyethylene glycol 3350, propylene glycol, benzyl alcohol, emulsion silicone. Printing ink containing shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone.

What Nu-Seals 300 looks like and contents of the pack

Nu-Seals 300 is a white tablet, with 300 printed on it in red. Nu-Seals 300 used to be a red tablet. Nu-Seals 300 comes in bottles of 100 tablets.

Marketing Authorisation Holder and Manufacturer

The product licence holder is: Alliance Pharmaceuticals Ltd, Avonbridge House, Chippenham, Wiltshire,

SN15 2BB, UK.

Nu-Seals 300 is manufactured by Chanelle Medical, Loughrea, Co Galway, Ireland.

The information in this leaflet applies only to Nu-Seals 300. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last approved: October 2011

Nu-seals is a registered trademark of Alliance Pharmaceuticals Limited.

Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Limited, 2011

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