Nu-Seals 75

Addition to:

2. What you need to know before you take Nu-Seals 75mg

Nu-Seals 75mg contains benzyl alcohol

This medicine contains 0.128 mg benzyl alcohol in each tablet.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease, or are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Benzyl alcohol may cause allergic reactions.

Amendment to reporting of side effect contact info

Amendment to date of revision

Addition in green and deletions in red:

2            Qualitative and Quantitative Composition

Excipients with known effect

Benzyl Alcohol 0.128mg per tablet

4.2     Posology and method of administration

Posology

           Nu-Seals 75 is for oral administration to adults only.

           Adults

Elderly

The elderly

Paediatric population

Children: doDo 

Method of administration

For oral administration.

4.4        Special warnings and precautions for use

Nu-seals 75 contains benzyl alcohol. High volumes should be used with caution and only if necessary, especially in patients with liver or kidney impairment or those who are pregnant or breast-feeding because of the risk of benzyl alcohol accumulation and toxicity (metabolic acidosis). Benzyl alcohol may also cause allergic reactions.

4.8        Undesirable effects

, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

1             Date of (Partial) Revision of the Text

February July 202220

Please see PIL updates below as track changes

2. What you need to know before you take Nu-Seals 75mg

Other medicines and Nu-Seals 75mg

• 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.

Please see SPC updates below as track changes

4.5 Interaction with other medicinal products and other forms of interaction

Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.

4.9 Overdose

Salicylate toxicity (> 100 mg/kg/day over 2 days may produce toxicity) may result from chronic, therapeutically acquired, intoxication, and from, potentially life-threatening, acute intoxications (overdose), ranging from accidental ingestions in children to incidental intoxications

Chronic salicylate poisoning can be insidious as signs and symptoms are non-specific. Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated use of large doses

Symptoms

Common features include dizziness, vomiting, nausea, dehydration, tinnitus, vertigo, deafness, sweating, headache, confusion, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid base disturbance is present in most cases. Symptoms may be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations of 150 to 300 micrograms/mL. More serious adverse events occur at concentrations above 300 micrograms/mL.

The principle feature of acute intoxication is severe disturbance of the acid-base balance, which may vary with age and severity of intoxication. The most common presentation for a child is metabolic acidosis. The severity of poisoning cannot be estimated from plasma concentration alone. Absorption of acetylsalicylic acid can be delayed due to reduced gastric emptying, formation of concretions in the stomach, or as a result of ingestion of enteric-coated preparations. Management of acetylsalicylic acid intoxication is determined by its extent, stage and clinical symptoms and according standard poisoning management techniques. Predominant measures should be the accelerated excretion of the drug as well as the restoration of the electrolyte and acid-base metabolism.

Uncommon features include tachypnoea, diaphoresis, haematemesis, hyperpyrexia, hypoglycaemia, hyperglycaemia, increased ketone levels, hypokalaemia, hypernatraemia, hypoprothrombina, thrombocytopenia, increased INR/PTR, intravascular coagulation, dehydration, oliguria, renal failure, GI bleeding and non-cardiogenic pulmonary oedema, asphyxation, respiratory arrest, dysarrhythmias, hypotension PT prolongation, and cardiovascular arrest.

Toxic encephalopathy and Central nervous system features including,  confusion, disorientation, lethargy, coma, convulsions and toxic encephalopathy are less common in adults than in children.

Management

Gastric lavage or repeated administration of Give oral activated charcoal if an adult present within one hour of ingestion of more than 125 mg/kg. The plasma salicylate concentration should be measured for patients who have ingested >125mg/kg. However, the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. 

Urea and electrolytes, INR/PTR, blood pressure, ECG alteration and blood glucose should be monitored. Elimination is increased by urinary alkalisation, which is achieved by the administration of intravenous sodium bicarbonate. The urine pH should be monitored, and further intravenous sodium bicarbonate may be required to maintain urinary pH 7.5-8.5 (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema

4.3 Contraindications

Hypoprothrombinaemia, haemophilia, haemorrhagic disease or a history of bleeding disorders, cerebral haemorrhage and active peptic ulceration.

Doses >100 mg/day during the third trimester of pregnancy.

4.4 Special warnings and precautions for use

High doses of aspirin may precipitate acute haemolytic anaemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency.

4.6 Fertility, Pregnancy and Lactation

Pregnancy: 

Low doses (up to 100 mg/day):

Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.

Doses of 100-500 mg/day:

There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendation below for doses of 500 mg/d and above apply also for this dose range.

Doses of 500 mg/day and above:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitor has been shown to results in increased pre- and post-implantation loss and embryo-foetal lethality.  In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

-cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);

-renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

-possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.

-inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.

4.8 Undesirable effects

System Organ Class: Hepatobiliary disorders Undesirable Effect: Transaminase increased

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File format update to PDF

4.5       Interaction with other medicinal products and other forms of interaction

Salicylates inhibit the uricosuric effect of uricosuric drugs.

Antacids:  Patients using gastro-resistant enteric-coated aspirin should be advised against ingesting antacids simultaneously, to avoid premature drug release.

4.8       Undesirable effects

¹May occur following chronic GI blood loss or acute haemorrhage

²May occur in various organ systems and may be fatal

³¹The special coating of Nu-Seals helps to reduce the incidence of side effects resulting from gastric irritation.

⁴²Sometimes fatal, particularly in the elderly

³May occur in various organ systems and may be fatal

⁴May occur following chronic GI blood loss or acute haemorrhage

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;  Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie

4.9       Overdose

With the gastro-resistantenteric coated formulation, peak plasma levels may not occur for up to 12 hours.

5.1     Pharmacodynamic properties

Nu-Seals 75 tablets have an gastro-resistant enteric coat sandwiched between a sealing coat and a top coat.  The gastro-resistant enteric coat is intended to resist gastric fluid whilst allowing disintegration in the intestinal fluid.

Please see amendments highlighted below in red

6.3 Shelf life
As packaged for sale: Two years.

After first opening of HDPE containers: Use within 8 weeks of opening

6.4 Special precautions for storage
Do not store above 25ºC.

Blister packs: Store in the original package in order to protect from moisture.

TabletHDPE containers: Keep the container tightly closed in order to protect from moisture. Store in the original package.

6.5 Nature and contents of container
UPVC/Aluminium foil blister packaging, pack sizes 28 and 56.
High-density polyethylene (HDPE) round plastic container with a plastic child-resistant tamper-evident screw cap, pack size 100. 
 

Changes/amendments highlighted in red text below:

2 Qualitative and Quantitative Composition





Each tablet contains:





Acetylsalicylic Acid Ph.Eur. (Aspirin) 300mg.



Excipients: also includes trace amounts of Ponceau 4R (E124)



For a full list of excipients see section 6.1.











6.1 List of Excipients







Maize Starch

Polyethlene Glycol 3350

Talc

Emulsion silicone

Hypromellose

Propylene Glycol

Benzyl alcohol

Methacrylic acid – ethyl acrylate (1:1) copolymer dispersion 30 per cent



Polyethylene glycol 3350

Propylene glycol

Benzyl alcohol

Emulsion silicone



Edible pPrinting ink containing Ponceau 4R (E124) shellac, iron oxide (E172), isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide (E527) and simeticone