Nu-Seals 300 Gastro-resistant Tablets

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 Nu-Seals 300 is and what it is taken for
2. What you need to know 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. Contents of the pack and other information

Do not take Nu-Seals 300:

• if you are allergic to aspirin or any of the other ingredients in this medicine (listed in section 6)
• if you have ever had the problem of your blood not clotting properly or suffer from any bleeding problems
• if you have had a cerebral haemorrhage (a type of stroke caused by bleeding in your brain)
• if you are in your last 3 months of pregnancy or are breastfeeding
• if you have ever had an ulcer in your stomach or small intestine.

Warnings and precautions

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
• have been told you have a lack of glucose-6-phosphate dehydrogenase (G6PD)
• are asthmatic, aspirin may induce an asthma attack
• have ever had inflammatory bowel disease (Crohn’s or ulcerative colitis)
• have or have had gout.

Children

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.

Other medicines and Nu-Seals 300

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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).
• Metamizole (substance to decrease pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.

These other medicines may also affect, or be affected by aspirin:

• 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
• an anaesthetic called thiopental
• gold, which is sometimes used in rheumatic conditions
• antiplatelet drugs (such as clopidogrel and dipyridamole)
• selective serotonin re-uptake inhibitors (SSRIs) for depression such as sertraline or paroxetine
• 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.

Nu-seals with alcohol

If you consume excessive amounts of alcohol whilst taking Nu-Seals 300, you may increase the risk of causing bleeding in your stomach or intestines.

Tell your doctor that you are taking Nu-Seals 300 if you are to have a urine test, as it can sometimes interfere with the results.

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, breast-feeding and fertility

Pregnant women should not take aspirin during pregnancy unless advised by their doctor. You must not take Nu-Seals 300 if you are in the last 3 months of pregnancy. 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.

The product belongs to a group of medicines which may impair the fertility in women. This effect is reversible on stopping the medicine.

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.

If you take more Nu-Seals 300 than you should

If you have taken too many tablets, you should go to your nearest accident and emergency department or contact your doctor immediately. Take any leftover medicines or the empty packet to the doctor to show what you have taken.

The following effects may occur; nausea, vomiting, loss of appetite, dizziness, dehydration, ringing in ears or deafness, loss of balance, sweating, headache, tiredness, confusion, warm hands/feet with a fast heart rate, unusually fast or deep breathing.

Less common effects include; vomiting blood, high fever, bleeding or bruising, increased hunger, increased thirst, trembling/shakiness, muscle weakness, twitching, abnormal heart rhythm, difficulty concentrating, swollen ankles/hands/feet, blood in urine/reduced production of urine, severe breathlessness, seizures, coma, cessation of breathing or heartbeat.

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.

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 internet at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 on it in red. Nu-Seals 300 comes in bottles of 100 tablets.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Nu-Seals 300 is manufactured by

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.