ASPIRIN

ASPIRIN Effect Granulat

Important notes (mandatory information)

Aspirin Effect 500 mg Granules. Active ingredient: Acetylsalicylic acid. Areas of application: for mild to moderate pain and fever.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspirin Effect 500 mg Granules
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 treatment results, Aspirin Effect 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 EFFECT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN EFFECT?
3. HOW TO TAKE ASPIRIN EFFECT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ASPIRIN EFFECT BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Aspirin Effect is a pain-relieving, fever-reducing and anti-inflammatory medicine (non-steroidal anti-inflammatory/analgesic). Aspirin Effect is used for mild to moderate pain and 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 EFFECT?

Aspirin Effect must not be taken:

• 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 had hypersensitivity reactions to certain medicines for pain, fever or inflammation (salicylates or other non-steroidal anti-inflammatory drugs) in the past with asthma attacks or in other ways;
• in acute gastric and intestinal ulcers;
• in the case of abnormally increased bleeding tendency;
• in liver and kidney failure;
• in severe, non-drug-controlled 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 Effect:

• 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 Effect;
• in patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated degradation or breakdown of red blood cells or a certain form of anemia. 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 Effect should only be used in children and adolescents with febrile 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 Effect 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 Effect.

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. bruises).
• Medicines that inhibit the adhesion 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 Aspirin Effect from 6 sachets per day and more: 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 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 Aspirin Effect from 6 sachets per day and more.
• ACE inhibitors (certain blood pressure-lowering medicines) at dosages of Aspirin Effect from 6 sachets per day and more.
• Uric acid-excreting gout medicines (e.g. probenecid, benzbromarone).

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

Breastfeeding

The active ingredient acetylsalicylic acid and its breakdown products pass into breast milk in small amounts. Since no adverse effects on the infant have been reported to date, occasional use of the recommended dose does not require discontinuation of breastfeeding. However, if used for longer periods or at 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 medicine.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Aspirin Effect

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

3. HOW TO TAKE ASPIRIN EFFECT?

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

Dosage

The recommended dose is: Adolescents* and adults: Single dose 1 - 2 sachets of granules, total daily dose 3 - 6 sachets of granules
* Please note the information for children and adolescents (see section 2 "Children and adolescents").

Method of administration

Place Aspirin Effect directly into the mouth on the tongue. The granules dissolve in the saliva and can then be swallowed. If desired, some liquid can be drunk afterwards. The medicine should not be taken 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 Effect for more than 4 days without medical or dental advice.

If you have taken more Aspirin Effect than you should

Tinnitus (ringing in the ears), hearing problems, sweating, nausea, vomiting, headache and dizziness can be signs of severe poisoning, especially in children and elderly patients. If you suspect an overdose of Aspirin Effect, 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 Effect 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 data beyond individual cases refer to the short-term use of the maximum daily dose of 3 g acetylsalicylic acid.

Common (1 to 10 out of 100 treated):

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

Uncommon (1 to 10 out of 1,000 treated):

• Hypersensitivity reactions such as skin reactions.

Rare (1 to 10 out of 10,000 treated):

• Serious bleeding such as brain hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulant medicines (anticoagulants), which may be life-threatening in individual cases.
• Gastrointestinal bleeding, which can very rarely lead to iron deficiency anemia. If black stools or bloody vomit occur, which may be signs of severe gastric bleeding, you must notify your doctor immediately.
• Hypersensitivity reactions such as severe skin reactions (up to severe febrile skin rashes with mucous membrane involvement [erythema exsudativum multiforme]).
• Gastrointestinal ulcers, which can very rarely lead to 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 edema).
• Gastrointestinal inflammation.

Very rare (less than 1 out of 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 certain form of anemia 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 possible prolongation of bleeding time. This effect can persist for 4 to 8 days after ingestion.
• Headache, 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 Effect. 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 EFFECT BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the sachet and the outer carton. The expiry date refers to the last day of the month indicated. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aspirin Effect contains

The active ingredient is acetylsalicylic acid. 1 sachet of granules contains 500 mg acetylsalicylic acid (Ph.Eur). The other ingredients are: D-mannitol, sodium hydrogen carbonate, sodium dihydrogen citrate, ascorbic acid, flavorings, citric acid, aspartame.

What Aspirin Effect looks like and contents of the pack

Aspirin Effect is a white, fine granulate and is available in packs of 10 and 20 sachets of granulate. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

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

Manufacturer

Bayer Bitterfeld GmbH
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen, Germany

This package 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 and fever.