ASPIRINAACT DOLORE E INFIAMMATSIONE 1000 MG Tabletka powlekana

Treść ulotki

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

Aspirinaact pain and inflammation

1000 mg coated tablets
Acetylsalicylic acid

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days for fever or 3 - 4 days for pain. [for SOP packs - 4, 8 and 12 tablets]
• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. [for RR pack - 24 tablets]

Contents of this leaflet

• 1. What Aspirinaact pain and inflammation is and what it is used for
• 2. What you need to know before you take Aspirinaact pain and inflammation
• 3. How to take Aspirinaact pain and inflammation
• 4. Possible side effects
• 5. How to store Aspirinaact pain and inflammation
• 6. Contents of the pack and other information

1. What is Aspirinaact pain and inflammation and what is it used for

Aspirinaact pain and inflammation contains acetylsalicylic acid, which relieves pain and reduces fever.
It offers rapid pain relief thanks to the rapid dissolution and fast absorption of the acid
acetylsalicylic acid.
Aspirinaact pain and inflammation is used for the symptomatic treatment of fever and/or mild to
moderate pain such as headache, flu-like syndrome, toothache, muscle pain.
Aspirinaact pain and inflammation is reserved for adults and adolescents between the ages of 16 – 65 years.

2. What you need to know before taking Aspirinaact pain and inflammation

Do not take Aspirinaact pain and inflammation:
If you:

• are allergic to

• acetylsalicylic acid;
• salicylates: a group of medicines to reduce pain or fever to which acetylsalicylic acid belongs; or
• any of the other ingredients of this medicine (listed in section 6)
• have previously suffered from asthma or allergic reactions (e.g. urticaria, angioedema, severe rhinitis, shock) caused by the use of acetylsalicylic acid or medicines with similar actions, particularly those called non-steroidal anti-inflammatory drugs (NSAIDs)
• suffer from gastric or intestinal ulcers
• have bleeding, or are at risk of bleeding
• have severely impaired liver or kidney function
• have severely impaired and uncontrolled heart function
• are taking methotrexate in doses greater than 20 mg/week See section 2 “Other medicines and Aspirinaact pain and inflammation”, first point
• are undergoing treatment with oral anticoagulants (medicines to thin the blood and prevent the formation of clots)
• are in the last trimester of pregnancy

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirinaact pain and inflammation if:

• you are being treated with other products containing acetylsalicylic acid, to avoid the risk of overdose
• you have headaches after using Aspirinaact pain and inflammation Do not increase the dosage; consult your doctor or pharmacist if the headache occurs while taking pain relievers at a high dose for a prolonged period.
• you use pain relievers regularly, especially different pain relievers in combination, this can lead to reduced kidney function
• you have a Glucose-6-phosphate dehydrogenase deficiency: an inherited disease that affects red blood cells
• you have a history of gastric or intestinal ulcer or bleeding, or inflammation of the inner walls of the stomach. Do not take Aspirinaact pain and inflammation if you have a gastric or intestinal ulcer, or bleeding. Gastric or intestinal bleeding or ulcers/perforations can occur at any time during treatment. The risk is increased in the elderly, in patients with low body weight and in patients who use medicines to inhibit blood clotting.
• you have impaired kidney or liver function Do not take Aspirinaact pain and inflammation if you have severely impaired liver or kidney function. Regular use of analgesics, especially combinations of analgesics, can lead to persistent kidney damage, with a risk of reduced kidney function.
• you suffer from asthma. Do not take Aspirinaact pain and inflammation if your asthma is caused by the use of acetylsalicylic acid or medicines with similar actions.
• you have abnormally heavy and prolonged menstrual periods, or irregular uterine bleeding. There is a risk of increased volume and duration of menstruation.
• you are about to undergo surgery. Acetylsalicylic acid increases the risk of bleeding even if taken several days before. Inform your doctor or dentist if surgery is planned, even minor surgery.
• gastrointestinal bleeding occurs during treatment (blood from the mouth, blood in the stool, black stools). You should stop treatment and immediately call your doctor or emergency medical service.
• you suffer from gout. Acetylsalicylic acid reduces the excretion of uric acid.
• The use of this medicine is not recommended during breastfeeding.

Children and adolescents
Aspirinaact pain and inflammation is not indicated for children and adolescents under the age of 16.
General advice:
Reye's syndrome is a rare and serious disease associated with damage to the nervous system and liver. It has been
observed in children suffering from viral illnesses, such as influenza and chickenpox, and who use acetyl
salicylic acid. Therefore:

• acetylsalicylic acid should only be given to children suffering from viral illnesses on the advice of a doctor
• if you experience dizziness or fainting, abnormal behavior or vomiting, stop treatment and inform your doctor immediately

Other medicines and Aspirinaact pain and inflammation
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Consult your doctor or pharmacist before taking Aspirinaact pain and inflammation if you are using:

• methotrexate: a medicine to treat e.g. severe joint inflammation, psoriasis (a skin disease) or cancer. Do not take Aspirinaact pain and inflammation if you are taking methotrexate in doses greater than 20 mg per week. Medical monitoring is recommended if you are taking methotrexate in doses less than or equal to 20 mg per week.
• medicines to inhibit blood clotting or dissolve blood clots (e.g. oral anticoagulants, heparins, thrombolytics, clopidogrel, ticlopidine, anagrelide). Do not take Aspirinaact pain and inflammation if you are being treated with oral anticoagulants and if you have a history of gastroduodenal ulcer.
• medicines for the treatment of pain, inflammation or rheumatism belonging to the group of so-called non-steroidal anti-inflammatory drugs. Check that any other medicine used does not contain acetylsalicylic acid.
• oral glucocorticoids, or administered by injection or infusion - except for replacement therapy with hydrocortisone. Glucocorticoids are medicines used to prevent rejection in organ transplants or to reduce inflammation, for example, of the skin and in the case of asthma.
• medicines such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline (so-called SSRIs) used for the treatment of depression and other disorders
• medicines for the treatment of high blood pressure or other diseases that contain active ingredients whose names end in “pril” or “sartan” and medicines to increase the elimination of water through the kidneys. It is recommended to drink enough fluids and monitor kidney function at the start of treatment.
• medicines against gout such as benzbromarone, probenecid
• pemetrexed: a medicine to treat cancer
• deferasirox: a medicine to lower iron levels in the blood
• topical gastrointestinal, antacids and charcoal.

Aspirinaact pain and inflammation with Alcohol
Do not take Aspirinaact pain and inflammation in combination with alcohol.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine during the last trimester of pregnancy as it may harm you or
your baby.
Use Aspirinaact pain and inflammation in the first six months of pregnancy only if your doctor says it is
absolutely necessary. In this case, the dose and duration of treatment should be as low and
as short as possible.
Breastfeeding
Acetylsalicylic acid passes into breast milk. Therefore, acetylsalicylic acid is not recommended
during breastfeeding.
Fertility
The product belongs to a group of drugs (NSAIDs) that can impair fertility in women.
This effect is reversible when you stop using the medicine.

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

Aspirinaact pain and inflammation contains sodium
Contact your doctor or pharmacist if you need to take 3 or more tablets a day for a prolonged
period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Aspirinaact pain and inflammation

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist. [for RR pack – 24 tablets]
Take this medicine following exactly what is stated in this leaflet or the instructions
of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. [for SOP packs – 4, 8 and 12
tablets]
The recommended dose is:

Adults and adolescents from 16 to 65 years

• single dose: 1 tablet (1000 mg of acetylsalicylic acid) The single dose can be repeated after a minimum period of 4-6 hours if necessary.
• maximum daily dose: 1 tablet 3 times a day

Patients with reduced liver or kidney function:
Follow the instructions provided in section 2 under “Do not take Aspirinaact pain and inflammation” and
“Warnings and precautions”.

Elderly Patients (65 years and over):
This product is not indicated for use in adults over 65 years of age. Ask your doctor or
pharmacist for information on other formulations and dosages of products containing acetylsalicylic acid.

Paediatric population
This medicine is not indicated for use in children and adolescents under 16 years of age.

Method of administration
To open the package, tear inwards from any end.
Take the tablet with a glass of water. The score line is only to help you break the
tablet if you have difficulty swallowing it whole.

Duration of treatment
Do not take Aspirinaact pain and inflammation for more than 3 days (in case of fever) or 3-4 days (in case
of pain) unless otherwise indicated by your doctor.

If you take more Aspirinaact pain and inflammation than you should
During treatment, you may experience ringing in your ears, a feeling of hearing loss,
headache, dizziness: these are typical signs of overdose.
Stop treatment and seek immediate medical attention if you suspect an overdose.

If you forget to take Aspirinaact pain and inflammation
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Their frequency cannot be defined based on the available data.

Possible side effects due to acetylsalicylic acid:
These side effects are all very serious and you may urgently need medical attention or
hospitalisation. Tell your doctor immediately or go to the nearest hospital if you notice any of the
following symptoms:

• bleeding, such as:
• epistaxis (nosebleeds), bleeding gums
• reddish or purplish spots on the skin, bruising
• bleeding of the urinary tract and genital organs. The risk of bleeding persists for 4-8 days after stopping the use of Aspirinaact pain and inflammation. It can cause an increased risk of bleeding in case of surgical interventions. Bleeding can also occur inside the skull, stomach or intestines.
• hypersensitivity reactions, severe allergic reactions that can cause swelling of the face or throat, asthma
• headache, dizziness, feeling of hearing loss, ringing in the ears, which are usually indicative of an overdose
• cerebral haemorrhage
• stomach pain
• gastric or intestinal bleeding. Symptoms are vomiting blood and black stools. The risk of bleeding is dose-dependent.
• ulcer and perforation of the stomach
• increased levels of liver enzymes, usually reversible after discontinuation of treatment, liver impairment (mainly hepatocellular)
• urticaria, skin reactions
• Reye's syndrome (see section 2)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Aspirinaact pain and inflammation

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original blisters to protect the medicine from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aspirinaact pain and inflammation contains
The active ingredient is acetylsalicylic acid.
Each coated tablet contains 1000 mg of acetylsalicylic acid.
The other ingredients are:
tablet core: colloidal silicon dioxide, , anhydrous sodium carbonate
coating: carnauba wax, hypromellose, zinc stearate.

Description of the appearance of Aspirinaact pain and inflammation and contents of the pack
Aspirinaact pain and inflammation coated tablets are white or off-white tablets, with
the inscription “BAYER” on one side and a single incision line on the other side. The incision line
is only intended to facilitate breaking the tablet for easy swallowing and not for dividing it into equal
doses.
Aspirinaact pain and inflammation is available in cardboard packs containing 4, 8, 12 or 24
tablets, in child-resistant blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Bayer Spa Viale Certosa 130 , 20156 Milan Italy
Manufacturer:
Bayer Bitterfeld GmbH
Salegaster Chausee 1
06803 Bitterfeld-Wolfen
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Aspirinaact dolore e infiammazione
Portugal: Aspirina Mille 1000 mg coated tablet
Poland : Aspirin Pro Forte