Aspirin effect

Patient Information Leaflet

ASPIRIN EFFECT, 500 mg, granules
Acidum acetylsalicylicum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3–5 days, or if you feel worse, consult your doctor.

Table of contents:

1. What Aspirin Effect is and what it is used for
2. Important information before taking Aspirin Effect
3. How to take Aspirin Effect
4. Possible side effects
5. How to store Aspirin Effect
6. Contents of the pack and other information

1. What Aspirin Effect is and what it is used for

Aspirin Effect is an analgesic, anti-inflammatory and antipyretic medicine available in the convenient form of granules for direct oral use.
Indications for use:

• Painful conditions, e.g.: headache, toothache, muscle, joint and back pain,
• Symptoms associated with cold and flu,
• Fever.

2. Important information before taking Aspirin Effect
When not to take Aspirin Effect

• if you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine (listed in section 6),
• if you have a bleeding tendency,
• if you have acute gastric or duodenal ulcer,
• if you have severe heart, liver or kidney failure,
• if you have previously experienced bronchial asthma attacks induced by salicylates or substances with similar action, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
• if you are concurrently taking methotrexate (used, among others, in cancer treatment) at doses of 15 mg per week or higher,
• if you are in the third trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Aspirin Effect, consult your doctor or pharmacist:

• if you have hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• if you are concurrently taking anticoagulant medicines,
• if you have impaired liver function,
• if you have impaired kidney function or circulatory disorders (e.g. renal vascular disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders and severe kidney failure,
• if you have a history of (chronic or recurrent) peptic ulcer or gastrointestinal bleeding,
• if you suffer from a genetic disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
• if you are breastfeeding.

Do not use medicines containing acetylsalicylic acid during the first and second trimesters of pregnancy unless absolutely necessary.
Acetylsalicylic acid may cause bronchospasm and provoke asthma attacks or other hypersensitivity reactions. Patients particularly at risk include those with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
Patients undergoing surgical procedures (including minor procedures, e.g. tooth extraction) should inform their doctor about taking Aspirin Effect.
Aspirin Effect should be discontinued 5–7 days before any planned surgical procedure.
Acetylsalicylic acid, even in small doses, reduces uric acid excretion.
In patients predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.
During certain viral infections, particularly influenza A or B virus or varicella (chickenpox), especially in children and adolescents, there is a risk of Reye’s syndrome—a rare but life-threatening condition. Persistent vomiting during an infection may indicate Reye’s syndrome and requires immediate medical attention.
The risk of Reye’s syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven.
For these reasons, medicines containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, such medicines should only be used on medical advice.
Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with continued dosing.
Long-term use of analgesics, particularly those containing multiple active ingredients, may lead to severe kidney function disorders and kidney failure.

Aspirin Effect and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Special caution is required when using Aspirin Effect with the following medicines, as acetylsalicylic acid may enhance:

• the toxic effect of methotrexate on bone marrow; do not use acetylsalicylic acid concurrently with methotrexate at doses of 15 mg per week or higher; concurrent use of methotrexate at doses below 15 mg per week requires special caution;

• the effect of anticoagulants, thrombolytics (clot-dissolving agents) and antiplatelet agents, which may increase the risk of prolonged bleeding time and hemorrhage;

• the risk of peptic ulcer disease and gastrointestinal bleeding if used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs (NSAIDs), including other salicylates, or if alcohol is consumed during treatment;

• after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison’s disease), the risk of salicylate overdose increases;

• the effect of digoxin (a medicine used in heart conditions), as it increases its plasma concentration;

• the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;

• the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;

• the effect of selective serotonin reuptake inhibitors (antidepressants). Special caution is required when using Aspirin Effect with the following medicines, as acetylsalicylic acid may weaken:

• uricosuric agents used in the treatment of gout that increase uric acid excretion (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;

• diuretics;

• certain antihypertensive medicines (angiotensin-converting enzyme inhibitors).

Aspirin Effect with food, drink and alcohol
See section 3 of the leaflet.
Warning! Alcohol may increase the risk of gastrointestinal adverse effects, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not take Aspirin Effect during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. The medicine may cause kidney and heart dysfunction in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labour. Do not use Aspirin Effect during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or if you are trying to conceive, use the lowest possible dose for the shortest possible time. If Aspirin Effect is used for longer than a few days after the 20th week of pregnancy, it may cause kidney dysfunction in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child’s heart. If prolonged treatment is necessary, your doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.

Fertility
Aspirin Effect belongs to a group of medicines that may adversely affect female fertility. This effect is reversible and resolves after discontinuation of therapy.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

Aspirin Effect contains aspartame
The medicine contains 5 mg of aspartame per sachet, equivalent to 5 mg of aspartame in one sachet of Aspirin Effect. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Aspirin Effect contains sodium
One sachet of Aspirin Effect contains 19 mg of sodium (the main component of table salt). This corresponds to 1% of the maximum recommended daily sodium intake in the diet of adults. The maximum daily dose of this product is equivalent to 8% of the WHO-recommended maximum daily sodium intake. This should be taken into account in patients with impaired kidney function and in patients monitoring sodium intake in their diet.

3. How to take Aspirin Effect

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose of Aspirin Effect is:

• Adults – single dose of 1 to 2 sachets (i.e. 500–1000 mg of acetylsalicylic acid). If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not take more than 8 sachets (i.e. 4000 mg of acetylsalicylic acid) per day.
• Adolescents over 12 years of age – this medicine may be used in adolescents over 12 years of age only on a doctor's advice. Take 1 sachet (i.e. 500 mg of acetylsalicylic acid) as a single dose. If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not take more than 3 sachets (i.e. 1500 mg of acetylsalicylic acid) per day. This medicine should not be used for longer than 3–5 days without consulting a doctor.

The granules should be placed directly on the tongue and allowed to dissolve. Swallow the dissolved granules, drinking water if necessary.
Do not take this medicine on an empty stomach.

Taking more Aspirin Effect than recommended
Poisoning with the active substance in Aspirin Effect may result from long-term use of the medicine (mild poisoning) or from overdose (severe poisoning), which may be life-threatening, for example after accidental ingestion by children or elderly persons.

Symptoms of mild poisoning include: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, impaired thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances, fainting).

In cases of severe poisoning, the following additional symptoms may occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiovascular disorders (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] up to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, blood clotting disorders, and neurological disorders manifesting as lethargy, confusion, up to coma and convulsions.

If you have taken more than the recommended dose, seek immediate medical advice from a doctor or pharmacist. In cases of severe poisoning, the patient must be taken immediately to hospital. Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.

If you forget to take Aspirin Effect
If you miss a dose and symptoms persist, take the next dose of Aspirin Effect as scheduled. Do not take a double dose to make up for a missed dose.

Stopping Aspirin Effect
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Warning!

• If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
• Signs of a severe hypersensitivity reaction may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, breathing difficulties, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure down to life-threatening shock. In case any of these symptoms occur, immediate professional medical care must be provided. The above reactions may occur even after the first dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract,
potentially life-threatening gastrointestinal bleeding: overt (frothy vomiting,
tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric or duodenal ulceration,
perforation, constrictive intestinal enteropathy (especially during long-term use).

Hepatic and biliary disorders:
Rarely, transient disturbances in liver function (increased aminotransferase activity) have been reported.

Nervous system disorders:
Dizziness and tinnitus, usually symptoms of overdose.

Blood and lymphatic system disorders:
Increased risk of bleeding, haemorrhages (postoperative, epistaxis, gingival bleeding, urogenital bleeding),
bruising, prolonged bleeding time and prothrombin time, thrombocytopenia.
Bleeding may lead to iron deficiency anaemia or haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion,
and abnormal laboratory test results.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Intracerebral haemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant medicines), potentially life-threatening.

Renal and urinary disorders:
Renal function impairment and severe kidney damage.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings such as: respiratory disease worsening after acetylsalicylic acid intake, mild to moderate reactions affecting the skin, respiratory system, cardiovascular system, with symptoms such as: rash, urticaria, angioedema (including vasomotor), breathing difficulties and cardiac disturbances, rhinitis, nasal mucosal hyperaemia, and very rarely, severe reactions including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aspirin Effect

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Aspirin Effect contains

• The active substance is acetylsalicylic acid (Acidum acetylsalicylicum).
• Other ingredients: mannitol, sodium hydrogen carbonate, sodium dihydrogen citrate, ascorbic acid, Cola H& R 290053 flavour, orange flavour 290038 HR SPT, citric acid, aspartame (E951).

What Aspirin Effect looks like and contents of the pack
White granules in a sachet. The pack contains 2 or 10 PETP/Aluminium/LDPE sachets in a cardboard box.
One sachet contains 840 mg of granules.
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: + 48 22 572 35 00
Fax: + 48 22 572 35 55
Manufacturer:
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany