Aspirina for pain and inflammation

PACKAGE LEAFLET:

Package Leaflet: Information for the User

Aspirin Pain and Inflammation

500 mg coated tablets
Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine, as it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, consult your doctor or pharmacist. This applies also to any side effect not listed in this leaflet.
• Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 3 days (for fever) or 3–4 days (for pain).

Medicinal product for self-medication

Contents of the leaflet:

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

1. What Aspirin Pain and Inflammation is and what it is used for

Aspirin Pain and Inflammation contains acetylsalicylic acid. Acetylsalicylic acid is an
analgesic (reduces pain) and antipyretic (reduces fever).
Aspirin Pain and Inflammation is used for the symptomatic treatment of fever and/or mild to
moderate pain, such as headache, influenza-like syndrome, toothache, and muscle pain.
Aspirin Pain and Inflammation is specifically intended for adults and adolescents aged 16 years and older.
Consult your doctor or pharmacist regarding other forms of acetylsalicylic acid suitable for patients weighing
less than 40 kg.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3 days
(for fever) or 3–4 days (for pain).

2. What you should know before taking Aspirin Pain and Inflammation

Do not take Aspirin Pain and Inflammation:

• if you are allergic to acetylsalicylic acid or other salicylates, or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced asthma or allergic reactions (e.g. urticaria, angioedema, severe rhinitis, shock) after taking acetylsalicylic acid or related medicines (especially non-steroidal anti-inflammatory drugs);
• if you have gastric or intestinal ulcer (including duodenal);
• if you have a bleeding condition or are at risk of bleeding;
• if you have severe liver, kidney, or heart failure;
• if you are taking methotrexate at doses higher than 15 mg/week;
• if you are taking oral anticoagulants (medicines to "thin" the blood and prevent clot formation);
• if you are beyond the 5th month of pregnancy (more than 24 weeks since last menstrual period);
• in children and adolescents under 16 years of age. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirin Pain and Inflammation:

• if you are taking other products containing acetylsalicylic acid, to avoid the risk of overdose;
• if you develop a headache while taking high doses of acetylsalicylic acid over a prolonged period, do not increase the dose but consult your doctor or pharmacist;
• if you regularly use painkillers, especially different painkillers in combination, as this may lead to reduced kidney function;
• if you have G6PD (Glucose-6-phosphate dehydrogenase) deficiency, an inherited condition affecting red blood cells, because high doses of acetylsalicylic acid may cause haemolysis (destruction of red blood cells);
• if you have a history of gastric or intestinal ulcers, or of gastrointestinal bleeding or gastritis;
• if you have liver or kidney failure;
• if you suffer from asthma: asthma attacks in some patients may be related to an allergic reaction to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In such cases, use of this medicine is not recommended;
• in case of heavy menstrual bleeding;
• if gastrointestinal bleeding occurs during treatment (bleeding from the mouth, blood in stools, dark stools): stop treatment immediately and contact your doctor or emergency services;
• if you are also taking medicines that thin the blood and prevent clotting (anticoagulants);
• if you have mild or moderate impairment of kidney function;
• if you have impaired cardiovascular circulation;
• acetylsalicylic acid increases the risk of bleeding even at low doses and even several days after intake. Inform your doctor, surgeon, anaesthetist or dentist if you are scheduled for any surgical procedure, even minor ones;
• acetylsalicylic acid alters blood uric acid levels. This should be taken into account if you are taking medication for gout;
• it is recommended not to take this medicine during breastfeeding.

Children
Reye's syndrome (a rare but very serious illness primarily involving neurological and liver damage) has been observed in children with viral illnesses who have been given acetylsalicylic acid. Therefore:

• in case of viral illness such as influenza or chickenpox, do not administer acetylsalicylic acid to a child without first consulting a doctor;
• if signs of dizziness or fainting, behavioural changes or vomiting occur in a child taking acetylsalicylic acid, inform the doctor immediately.

Other medicines and Aspirin Pain and Inflammation
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In the following text, the following definitions are used:
acetylsalicylic acid can be used for the treatment of rheumatic diseases at high doses
(called "anti-inflammatory doses") defined as: 1 g or more as a single dose and/or 3 g or more per day.
Acetylsalicylic acid can be used for the treatment of pain and fever at doses defined as follows: 500 mg or more as a single dose and/or no more than 3 g per day.
Do not take Aspirin Pain and Inflammation:

• if you are being treated with methotrexate at doses higher than 15 mg/week. In this case, acetylsalicylic acid must be avoided when used at high doses (anti-inflammatory) or for the treatment of pain and fever.
• if you are being treated with oral anticoagulants and have a history of gastroduodenal ulcer. In this case, acetylsalicylic acid must be avoided when used at high doses (anti-inflammatory) or for the treatment of pain and fever.

Talk to your doctor or pharmacist before taking acetylsalicylic acid with any of the following medicines:

• oral anticoagulants, when acetylsalicylic acid is used for the treatment of pain and fever and there is no history of gastro-duodenal ulcers;
• non-steroidal anti-inflammatory drugs when acetylsalicylic acid is used at high doses (anti-inflammatory) or for the treatment of pain and fever;
• heparins used at therapeutic doses, or in elderly subjects (≥ 65 years) when acetylsalicylic acid is used at high doses (anti-inflammatory), particularly for the treatment of rheumatic diseases or for the treatment of pain and fever;
• thrombolytics;
• clopidogrel;
• ticlopidine;
• uricosuric medicines used for the treatment of gout (e.g. benzbromarone, probenecid);
• glucocorticoids (except replacement therapy with hydrocortisone) when acetylsalicylic acid is used at high doses (anti-inflammatory);
• pemetrexed, in patients with mild to moderate renal impairment;
• anagrelide;
• medicines for the treatment of fluid retention (diuretics);
• angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists;
• methotrexate used at doses equal to or less than 15 mg/week;
• gastrointestinal topical treatments, antacids and activated charcoal;
• deferasirox;
• selective serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

To avoid any potential drug interactions, you must inform your doctor or pharmacist about any other medicines you are taking.

Aspirin Pain and Inflammation and alcohol
Do not take Aspirin Pain and Inflammation together with alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this or any other medicine.

Pregnancy – first and second trimester
You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible duration should be used.
From the 20th week of pregnancy, this medicine may cause kidney problems in the unborn baby if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Pregnancy – third trimester
Do not take this medicine from the beginning of the 6th month of pregnancy (more than 24 weeks since last menstrual period), as it may cause serious harm to you and your baby. It may cause kidney and heart problems in the unborn baby. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond the expected time.
If you have taken this medicine during pregnancy, contact your doctor immediately.

Breastfeeding
This medicine may pass into breast milk. As a precaution, Aspirin Pain and Inflammation is not recommended during breastfeeding.

Fertility
This product belongs to a group of medicines that may affect fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines
Acetylsalicylic acid has no influence on the ability to drive or use machinery.

Aspirin Pain and Inflammation contains sodium
This medicine contains 71.7 mg of sodium (main component of table salt) per dose.
This corresponds to 3.6% of the maximum daily dietary intake recommended for an adult.

3. How to take Aspirin Pain and Inflammation

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If you have any doubts, consult your doctor or pharmacist.
Dosage
For oral use only.
Adults and adolescents (over 16 years of age):

• The recommended single dose is 1 tablet, which may be repeated if necessary after at least 4 hours have passed. In case of more intense fever or pain, the dosage is 2 tablets, which may be repeated if necessary after at least 4 hours have passed.
• The total daily dose must not exceed 6 tablets.

Elderly patients (65 years of age and over):

• The recommended single dose is 1 tablet, which may be repeated if necessary after at least 4 hours have passed.
• The total daily dose must not exceed 4 tablets.

Particular patient groups:

• Patients with impaired liver or kidney function, or circulatory problems (e.g. heart failure or major bleeding events): consult your doctor or pharmacist.
• Children and adolescents under 16 years of age: do not use this medicine without medical prescription.
  Method of administration To open the strip, tear from any edge.
  Take the tablets with a sufficient amount of water.

Duration of use
Do not take this medicine for more than 3 days (in case of fever) or 3–4 days (in case of pain), unless otherwise directed by a doctor.
If you take more Aspirin Pain and Inflammation than you should:
During treatment, you may experience tinnitus, a sensation of hearing loss, headache, or dizziness: these are typical signs of overdose.
If you suspect an overdose of this product, stop treatment immediately and contact your doctor without delay.
If you forget to take Aspirin Pain and Inflammation:
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
Frequencies: not known: frequency cannot be estimated from the available data.
Possible side effects due to acetylsalicylic acid are:
These side effects are all very serious and you may urgently require medical treatment or hospitalization. Immediately inform your doctor or go to the nearest hospital if you notice any of the following symptoms:

• bleeding (bleeding from the nose or gums, red spots under the skin)

• allergic reactions such as skin rash, asthma attack, or facial swelling accompanied by difficulty breathing

• headache, dizziness, sensation of hearing loss, tinnitus (ringing in the ears), which are usually signs of overdose

• cerebral haemorrhage

• stomach ache

• gastrointestinal bleeding. See section "Warnings and precautions". These occur more frequently when high doses are taken.

• Increased liver enzymes, generally reversible upon discontinuation of treatment, alteration
  of liver function (particularly liver cells)

• urticaria, skin reactions

• Reye's syndrome (altered state of consciousness or abnormal behaviour, or vomiting) in children with viral illnesses who are taking acetylsalicylic acid (see Section 2: What you need to know before taking Aspirin Pain and Inflammation)

• renal impairment and acute kidney injury

• intestinal diaphragm disease (a narrowing of the intestine), especially with long-term treatment.

Reporting of side effects
If you experience any side effect, contact your doctor or pharmacist. This advice applies also to any side effect not listed in this leaflet.
You may also report side effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aspirin Pain and Inflammation

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this product if you notice any visible signs of deterioration.
Keep in the original packaging to protect from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aspirina Dolore e Infiammazione contains
The active substance is acetylsalicylic acid.
Each coated tablet contains 500 mg of acetylsalicylic acid.
The other ingredients are:
Colloidal silicon dioxide, Sodium carbonate
Coating:
Carnauba wax, Hypromellose, Zinc stearate

Description of the appearance of Aspirina Dolore e Infiammazione and contents of the pack
This medicine is a white or almost white, round, biconvex coated tablet of 12 mm. The tablets are marked with "BA 500" on one side and the Bayer cross on the other.
Pack contents: 8, 12, 20 or 24 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bayer Spa
Viale Certosa 130 - 20156 Milan - Italy

Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chausee 1
06803 Bitterfeld-Wolfen
Germany

This medicinal product is authorized in European Union Member States under the following brand names
Italy: Aspirina Dolore e Infiammazione

This leaflet was last reviewed on