ASPIRIN

ASPIRIN plus C effervescent tablets

Important notes (mandatory information)

Aspirin plus C 400 mg/240 mg effervescent tablets. Areas of application: for mild to moderate pain such as headaches, toothaches, period pain, painful symptoms that occur in the context of 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 USERS

Aspirin plus C 400 mg/240 mg effervescent tablets
Active ingredients: acetylsalicylic acid/ascorbic acid

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. This medicine is available without a prescription. However, to achieve the best possible treatment results, Aspirin Plus C 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 even worse after 4 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS ASPIRIN PLUS C AND WHAT IS IT USED FOR?

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

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPIRIN PLUS C?

Aspirin Plus C must not be taken:

• if you are allergic to acetylsalicylic acid, other salicylates, ascorbic acid (vitamin C) or any of the other ingredients listed in section 6 of this medicine;
• if you have had hypersensitivity reactions to certain medicines for pain, fever or inflammation (salicylates or other non-steroidal anti-inflammatory drugs) 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 doctor or pharmacist before taking Aspirin Plus C:

• 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): there may be an increased tendency to bleed. Please inform your doctor or dentist if you have taken Aspirin Plus C;
• 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;
• in patients with a tendency to or recurrent calcium oxalate kidney stones;
• in iron storage diseases (thalassemia, haemochromatosis).

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 appropriately vulnerable patients, this can under certain circumstances trigger a gout attack.

Children and adolescents

Aspirin Plus C 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 Plus C 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 concomitant treatment with Aspirin Plus C.

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 Plus C from 7 effervescent 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 epileptic seizures).
• 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 output) at dosages of Aspirin Plus C from 7 effervescent tablets per day and more.
• ACE inhibitors (certain blood pressure lowering medicines) at dosages of Aspirin Plus C from 7 effervescent tablets per day and more.
• Uric acid excreting gout medicines (e.g. probenecid, benzbromarone).
• Deferoxamine (antidote for iron poisoning): possible worsening of heart function when taken with ascorbic acid (vitamin C).

Taking Aspirin Plus C 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 Plus C in the first and second trimesters of pregnancy. Therefore, be sure to talk to your doctor before taking Aspirin Plus C. In the last three months of pregnancy, you must not take acetylsalicylic acid, the active ingredient in Aspirin Plus C, 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 adverse effects on the infant have not been reported to date, it is not necessary to interrupt breastfeeding when used occasionally at the recommended dose. However, if used for a longer period of time 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 medication.

Driving and operating machinery

No special precautions are required.

Aspirin Plus C contains sodium

One effervescent tablet contains 20.3 mmol (466.4 mg) of sodium. If you need to follow a low-salt diet, you should take this into account.

3. HOW SHOULD ASPIRIN PLUS C BE TAKEN?

Always take Aspirin Plus C exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The recommended dose is

Age	Single dose	Total daily dose
Children* 9 – 12 years	1 effervescent tablet	3 effervescent tablets
Adolescents* and adults	1 – 2 effervescent tablets	3 – 6 effervescent tablets

* Please note the information for children and adolescents (see section 2 "Children and adolescents").

Method of administration

Dissolve the effervescent tablets completely in a glass of water before taking them and drink the entire glass immediately. You should not take the dissolved effervescent 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 Plus C for more than 4 days without medical or dental advice.

If you have taken more Aspirin Plus C than you should

Tinnitus (ringing in the ears), hearing problems, 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 Plus C, 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, Aspirin Plus C 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 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 in 100 treated):

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

Uncommon (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 concomitant treatment with anticoagulant medicines (anticoagulants) have been reported, 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 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 mucous membrane involvement [erythema exsudativum multiforme]).
• 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 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.
• Headaches, dizziness, impaired hearing, tinnitus (ringing in the ears) and mental confusion can be signs of an overdose.

The following list of undesirable effects includes all known side effects under treatment with ascorbic acid (vitamin C).

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

• Diarrhoea, nausea, vomiting, pain in the gastrointestinal tract, abdominal pain.
• Hypersensitivity reactions, allergic shock.

If you experience any of the above side effects, you should stop taking Aspirin Plus C. 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 PLUS C BE STORED?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date stated on the effervescent tablet strip 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 Plus C contains

The active ingredients are: acetylsalicylic acid and ascorbic acid (vitamin C). 1 effervescent tablet contains: 400 mg acetylsalicylic acid (Ph.Eur.) and 240 mg ascorbic acid. The other ingredients are: sodium dihydrogen citrate, sodium hydrogen carbonate, citric acid, sodium carbonate (H2O-free).

What Aspirin Plus C looks like and contents of the pack

Aspirin Plus C is a white effervescent tablet with one-sided embossing of the Bayer cross. Aspirin Plus C is available in packs of 10, 20 or 40 effervescent 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