ASPIRIN

ASPIRIN Caffeine Tablets

Important notes (mandatory information)

Aspirin Caffeine 500 mg/50 mg, tablet. Areas of application: for mild to moderate pain, e.g. headaches, toothaches, period pain and inflammation.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

Aspirin Caffeine 500 mg/50 mg, tablet
Active ingredients: Acetylsalicylic acid/caffeine

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. This medicine is available without a prescription. However, to achieve the best possible results, Aspirin Caffeine 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 CAFFEINE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN CAFFEINE?
3. HOW SHOULD ASPIRIN CAFFEINE BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ASPIRIN CAFFEINE BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Aspirin Caffeine is a pain-relieving, fever-reducing and anti-inflammatory medicine (non-steroidal analgesic/anti-inflammatory). Aspirin Caffeine is used for mild to moderate pain, e.g. headaches, toothaches, period pain and inflammation. If you do not feel better or if you feel worse after 4 days, contact your doctor. Please note the information for children and adolescents (see section 2 "Children and adolescents").

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN CAFFEINE?

Aspirin Caffeine 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 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 stomach and intestinal ulcers;
• in the case of abnormally increased bleeding tendency;
• in liver and kidney failure;
• in severe, uncontrolled heart muscle weakness (heart failure);
• in severe cardiovascular disease;
• in severe, uncontrolled high blood pressure;
• 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 doctor or pharmacist before taking Aspirin Caffeine:

• if you are hypersensitive 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 heart and circulatory blood flow (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 Caffeine;
• in patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated breakdown or disintegration 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;
• overactive thyroid (hyperthyroidism);
• in the case of cardiac arrhythmias;
• in the case of anxiety disorders.

What else do you need to watch out for?
With prolonged use of painkillers, headaches can occur, which can lead to renewed intake 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 patients who are already prone to lower uric acid excretion, this can in some circumstances trigger a gout attack.

Children and adolescents

Aspirin Caffeine is intended for use in adults. In general, acetylsalicylic acid, one of the active ingredients in Aspirin Caffeine, should only be used in children and adolescents with feverish illnesses on the instructions of a doctor and only if other measures do not work. If persistent vomiting occurs in 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 Caffeine 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 may be influenced by concomitant treatment with Aspirin Caffeine.

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 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 Aspirin Caffeine from 6 tablets 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.
• Medicines that have a heart rate accelerating effect, e.g. sympathomimetics (certain circulatory medicines), thyroxine (certain thyroid medicines), etc.
• Medicines with active ingredients of the ephedrine type: the potential for dependence is increased.

Weakening of the effect:

• Diuretics (medicines to promote urine excretion) at dosages of Aspirin Caffeine from 6 tablets per day and more.
• ACE inhibitors (certain blood pressure lowering medicines) at dosages of Aspirin Caffeine from 6 tablets per day and more.
• Uric acid excreting gout medicines (e.g. probenecid, benzbromarone).
• Medicines with a sedative effect (e.g. sleeping and sedatives (barbiturates), medicines for allergies (antihistamines etc.).

Other interactions of caffeine:

• With broad-spectrum substances, the interactions in detail can be different and unpredictable, e.g. certain sedatives (benzodiazepines).
• Oral contraceptives (the pill), cimetidine (a certain medicine for treating stomach ulcers) and disulfiram (a certain alcohol withdrawal medicine) reduce the breakdown of caffeine in the liver.
• Barbiturates (certain sleeping pills) and smoking accelerate the breakdown of caffeine in the liver.
• The excretion of theophylline (a certain medicine for treating lung diseases) is reduced by caffeine.
• The simultaneous administration of gyrase inhibitors of the quinolone carboxylic acid type (certain medicines for treating infections) can delay the excretion of caffeine and its breakdown product paraxanthine.

Taking Aspirin Caffeine 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 become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

The active ingredients and their 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. The infant's condition and behaviour may be affected by caffeine taken in with breast milk.

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 (reversible).

Driving and operating machinery

No special precautions are required.

3. HOW SHOULD ASPIRIN CAFFEINE BE TAKEN?

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

Dosage

The recommended dose is: Adults Single dose 1 tablet, total daily dose up to 3 tablets.

Method of administration

The tablets are taken with liquid or dissolved in water, preferably after meals. It is recommended to drink plenty of liquid (1/2 to 1 glass of water) afterwards. You should not take the tablets on an empty stomach.

Duration of use

The single dose can be taken up to 3 times daily at intervals of about 6 hours if necessary. However, the total daily dose must not be exceeded. Do not take Aspirin Caffeine for more than 4 days without medical or dental advice.

If you have taken more Aspirin Caffeine 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. In case of overdose with Aspirin Caffeine, additional poisoning symptoms (central nervous symptoms (e.g. seizures), cardiovascular reactions up to damage to the heart muscle) can occur due to caffeine. If you suspect an overdose of Aspirin Caffeine, please notify your doctor immediately. Depending on the severity of an overdose/poisoning, he/she 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, this medicine can cause 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 rheumatic 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 haemorrhage, 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 anaemia. If black stools or bloody vomiting occur, which may be signs of severe gastric bleeding, you must notify your doctor immediately.
• 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 oedema).
• Hypersensitivity reactions such as severe skin reactions (up to severe febrile skin rashes with mucosal involvement [erythema exsudativum multiforme]).
• 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 breakdown or disintegration 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 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) can be signs of an overdose.
• Caffeine can cause insomnia, restlessness, facial flushing, high blood pressure, palpitations, rapid heartbeat and irregular heartbeat or stomach upset.

If you experience any of the above side effects, you should stop taking Aspirin Caffeine. Notify your doctor so that he/she 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 CAFFEINE 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 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 Caffeine contains

The active ingredients are: acetylsalicylic acid and caffeine. 1 tablet contains 500 mg acetylsalicylic acid (Ph.Eur.) and 50 mg caffeine. The other ingredients are: cellulose powder, maize starch.

What Aspirin Caffeine looks like and contents of the pack

Aspirin Caffeine is a white tablet with the imprint "Aspirin F" on one side and the Bayer cross on the other. Aspirin Caffeine is available in packs of 20 tablets.

Pharmaceutical entrepreneur

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