ASPIRIN

ASPIRIN Direct Chewable Tablets

Important notes (mandatory information)

Aspirin Direkt 500mg, chewable tablets. Active ingredient: Acetylsalicylic acid. Areas of application: for mild to moderate pain such as headaches, toothaches, period pain, painful symptoms that occur during colds (e.g. headaches, sore throats and aching limbs) and for fever.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspirin Direkt 500mg, chewable tablets
Active ingredient: Acetylsalicylic acid

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. This medicine is also available without a prescription. However, to achieve the best possible results, Aspirin Direkt must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 4 days, contact your doctor.

What this package leaflet contains

1. WHAT IS ASPIRIN DIREKT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN DIREKT?
3. HOW SHOULD ASPIRIN DIREKT BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ASPIRIN DIREKT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ASPIRIN DIREKT AND WHAT IS IT USED FOR?

Aspirin Direkt is a pain-relieving, fever-reducing and anti-inflammatory medicine (non-steroidal anti-inflammatory drug/analgesic). Aspirin Direkt is used for mild to moderate pain such as headaches, toothaches, period pain, painful symptoms that occur during colds (e.g. headaches, sore throats and aching limbs) and for fever. Please note the information for children and adolescents (see section 2 "Children and adolescents"). If you do not feel better or if you feel worse after 4 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN DIREKT?

Aspirin Direkt must not be taken:

• if you are allergic to acetylsalicylic acid, other salicylates, yellow orange S (E 110) or any of the other ingredients of this medicine listed in section 6;
• if you have had an allergic reaction to certain medicines for pain, fever or inflammation (salicylates or other non-steroidal anti-inflammatory drugs) in the past with asthma attacks or in any other way;
• in acute gastric and intestinal ulcers;
• in the case of abnormally increased bleeding tendency;
• in liver and kidney failure;
• in severe, uncontrolled heart muscle weakness (heart failure);
• if you are taking 15 mg or more of methotrexate per week at the same time;
• in the last 3 months of pregnancy.

Warnings and precautions

Please talk to your pharmacist before taking Aspirin Direkt:

• in case of hypersensitivity to other painkillers (analgesics)/anti-inflammatories (antiphlogistics)/certain medicines for rheumatism (antirheumatics) or other allergy-triggering substances;
• if you have allergies (e.g. with skin reactions, itching, hives), asthma, hay fever, nasal mucosa swelling (nasal polyps) or chronic respiratory diseases;
• if you are taking blood-thinning medicines at the same time;
• if you have a history of stomach or intestinal ulcers or gastrointestinal bleeding;
• if you have impaired liver function;
• if you have impaired kidney function or reduced cardiovascular circulation (e.g. kidney vascular disease, heart muscle weakness, reduced blood volume, major surgery, blood poisoning or severe bleeding): acetylsalicylic acid can further increase the risk of kidney dysfunction and acute kidney failure;
• before operations (even minor procedures such as tooth extraction); increased bleeding tendency may occur. Please inform your doctor or dentist if you have taken Aspirin Direkt;
• in patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated degradation or breakdown of red blood cells or a specific form of anaemia. This risk can be increased by factors such as high dosage, fever or acute infections.

With continuous use of painkillers, headaches can occur, which can lead to renewed use and thus a continuation of the headaches. The habitual use of painkillers can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). This risk is particularly high if you take several different painkillers in combination. Acetylsalicylic acid reduces uric acid excretion in low doses. In appropriately susceptible patients, this can potentially trigger a gout attack.

Children and adolescents

Aspirin Direkt should only be used in children and adolescents with feverish illnesses on doctor's orders and only if other measures do not work. If persistent vomiting occurs during these illnesses, this may be a sign of Reye's syndrome, a very rare but life-threatening illness that requires immediate medical attention.

Taking Aspirin Direkt with other medicines

Please tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The effect of the following active ingredients or groups of preparations can be influenced by simultaneous treatment with Aspirin Direkt.

Increased effect up to increased risk of side effects:

• Anticoagulants (e.g. coumarin, heparin) and thrombolytic medicines: acetylsalicylic acid can increase the risk of bleeding if it was taken before thrombolytic treatment. Therefore, if you are to undergo such treatment, you must watch out for signs of external or internal bleeding (e.g. bruising).
• Medicines that inhibit the aggregation and clumping of platelets (thrombocyte aggregation inhibitors), e.g. ticlopidine, clopidogrel: increased risk of bleeding.
• Other pain-relieving and anti-inflammatory medicines (non-steroidal analgesics/antiphlogistics) at dosages of 6 or more Aspirin Direkt chewable tablets per day: increased risk of ulcers and bleeding in the gastrointestinal tract.
• Medicines containing cortisone or cortisone-like substances (with the exception of products that are applied to the skin or in cortisone replacement therapy for Addison's disease): increased risk of side effects in the gastrointestinal tract.
• Alcohol: the risk of gastrointestinal ulcers and bleeding is increased.
• Digoxin (medicine to strengthen the heart).
• Blood sugar-lowering medicines (antidiabetics): blood sugar levels may drop.
• Methotrexate (medicine for treating cancer or certain rheumatic diseases).
• Valproic acid (medicine for treating epileptic seizures of the brain [epilepsy]).
• Selective serotonin reuptake inhibitors (certain medicines for treating depression): the risk of bleeding in the gastrointestinal tract increases.

Weakening of the effect:

• Diuretics (medicines to promote urine excretion) at dosages of 6 or more Aspirin Direkt chewable tablets per day.
• ACE inhibitors (certain blood pressure-lowering medicines) at dosages of 6 or more Aspirin Direkt chewable tablets per day.
• Uric acid-excreting gout medicines (e.g. probenecid, benzbromarone).

Taking Aspirin Direkt with alcohol

Alcohol increases the risk of gastrointestinal ulcers and bleeding.

Pregnancy, breastfeeding and

fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take Aspirin Direkt in the first and second trimesters of pregnancy. Therefore, be sure to talk to your doctor before taking Aspirin Direkt. In the last three months of pregnancy, you must not take acetylsalicylic acid, the active ingredient in Aspirin Direkt, because of an increased risk of complications for mother and child before and during birth.

Breastfeeding

The active ingredient acetylsalicylic acid and its degradation products pass into breast milk in small amounts. Since adverse effects for the infant have not been reported to date, it is not necessary to interrupt breastfeeding if the recommended dose is used occasionally. However, if used for a longer period of time or in high doses, you should stop breastfeeding.

Fertility

This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can impair fertility in women. This effect is reversible after discontinuation of the medication.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Aspirin Direkt

Contains aspartame as a source of phenylalanine and may be harmful if you have phenylketonuria.

3. HOW SHOULD ASPIRIN DIREKT BE TAKEN?

Always take Aspirin Direkt exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is:

• Children aged 12 and over: single dose 1 chewable tablet; total daily dose up to 3 chewable tablets.
• Adolescents and adults: single dose 1–2 chewable tablets; total daily dose 3–6 chewable tablets.

Method of administration

Chew the Aspirin Direkt chewable tablets. If desired, a little liquid can be drunk afterwards, this promotes the onset of action. You should not take the chewable tablets on an empty stomach.

Duration of use

The single dose can be taken up to 3 times a day at intervals of 4-8 hours if necessary. However, the total daily dose must not be exceeded. Do not take Aspirin Direkt for more than 4 days without medical or dental advice.

If you have taken more Aspirin Direkt than you should

Tinnitus (ringing in the ears), hearing disorders, sweating, nausea, vomiting, headaches and dizziness can be signs of severe poisoning, especially in children and elderly patients. If you suspect an overdose of Aspirin Direkt, please notify your doctor immediately. Depending on the severity of an overdose/poisoning, the doctor can decide on the measures that may be necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Aspirin Direkt can have side effects, although not everybody gets them. The following list of undesirable effects includes all known side effects under treatment with acetylsalicylic acid, including those under high-dose long-term therapy in rheumatism patients. The frequency information beyond individual cases refers to the short-term use of up to a maximum of 6 Aspirin Direkt chewable tablets per day.

Common (1 to 10 in 100 treated):

• Gastrointestinal complaints such as heartburn, nausea, vomiting, abdominal pain.

Occasional (1 to 10 in 1,000 treated):

• Hypersensitivity reactions such as skin reactions.

Rare (1 to 10 in 10,000 treated):

• serious bleeding such as brain haemorrhages, especially in patients with uncontrolled high blood pressure and/or simultaneous treatment with anticoagulant medicines (anticoagulants), which in individual cases can be life-threatening.
• Gastrointestinal bleeding, which can very rarely lead to iron deficiency anaemia. If black stools or bloody vomit occur, which may be signs of severe gastric bleeding, you must notify your doctor immediately.
• Gastrointestinal ulcers, which can very rarely lead to a perforation.
• Hypersensitivity reactions of the respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following symptoms may occur: e.g. drop in blood pressure, attacks of shortness of breath, inflammation of the nasal mucosa, blocked nose, allergic shock, swelling of the face, tongue and larynx (Quincke's oedema).
• Hypersensitivity reactions such as severe skin reactions (up to severe febrile skin rashes with mucosal involvement [erythema exsudativum multiforme]).
• The dye yellow orange S (E 110) can cause allergic reactions.
• Gastrointestinal inflammation.

Very rare (less than 1 in 10,000 treated):

• Increased liver values.

Not known (frequency cannot be estimated from the available data):

• Accelerated degradation or breakdown of red blood cells and a specific form of anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
• Kidney dysfunction and acute kidney failure.
• Bleeding such as nosebleeds, gum bleeding, skin bleeding or bleeding of the urinary tract and genitals with a possible prolongation of the bleeding time. This effect can persist for 4 to 8 days after ingestion.
• Headaches, dizziness, impaired hearing, tinnitus (ringing in the ears) and mental confusion can be signs of an overdose.

If you experience any of the above side effects, you should stop taking Aspirin Direkt. Notify your doctor so that they can decide on the severity and any further measures that may be necessary.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD ASPIRIN DIREKT BE STORED?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date stated on the blister strip and the outer carton. The expiry date refers to the last day of the month indicated. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aspirin Direkt contains

The active ingredient is acetylsalicylic acid. 1 chewable tablet contains 500 mg acetylsalicylic acid (Ph.Eur.). The other ingredients are: D-mannitol, magnesium carbonate, pregelatinised starch, citric acid, maize starch, carmellose sodium, sodium carbonate, ascorbic acid, aspartame, calcium stearate, yellow orange S (E 110), flavourings.

What Aspirin Direkt looks like and contents of the pack

Aspirin Direkt is a light orange chewable tablet and is available in packs of 10 or 20 chewable tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Bayer Vital GmbH
51368 Leverkusen
Germany
Telephone: (0214) 301
Telefax: (0214) 30 57 209
E-mail address: bayer-vital@bayerhealthcare.com

Manufacturer

Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany

This leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Acetylsalicylic acid. Areas of application: for mild to moderate pain such as headaches, toothaches, period pain, painful symptoms that occur during colds (e.g. headaches, sore throats and aching limbs) and for fever.