ASS

ASS ratiopharm 500 mg tablets

Important Information (Mandatory Information)

ASS-ratiopharm 500 mg Tablets. Active ingredient: Acetylsalicylic acid. Areas of application: for mild to moderately severe pain and fever.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

ASS-ratiopharm 500 mg Tablets
Active ingredient: Acetylsalicylic acid

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as instructed by your doctor or pharmacist.

• Keep this package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse after 3 - 4 days, contact your doctor.

What is in this leaflet

1. WHAT IS ASS-RATIOPHARM 500 MG AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASS-RATIOPHARM 500 MG?
3. HOW TO TAKE ASS-RATIOPHARM 500 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASS-RATIOPHARM 500 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ASS-RATIOPHARM 500 MG AND WHAT IS IT USED FOR?

ASS-ratiopharm 500 mg is a pain-relieving and fever-reducing medicine from the group of anti-inflammatory substances. ASS-ratiopharm 500 mg is used for mild to moderately severe pain and fever. Note: However, ASS-ratiopharm 500 mg should only be taken by children and adolescents with febrile illnesses on medical advice and only if other measures are ineffective, due to the possible occurrence of Reye's syndrome (see 2. under "Children and adolescents"). ASS-ratiopharm 500 mg should not be taken for a long time or in higher doses without consulting a doctor or dentist.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASS-RATIOPHARM 500 MG?

ASS-ratiopharm 500 mg must not be taken:

• if you are allergic to acetylsalicylic acid, salicylates, a group of substances related to acetylsalicylic acid, or any of the other ingredients of this medicine listed in section 6.
• in case of stomach and intestinal ulcers
• in case of pathologically increased bleeding tendency
• in the last three months of pregnancy.

Warnings and precautions

Please talk to your doctor or pharmacist before taking ASS-ratiopharm 500 mg. You should only take ASS-ratiopharm 500 mg with special caution (i.e. at longer intervals or in reduced doses) and under medical supervision:

• if you are hypersensitive to other pain, anti-inflammatory or anti-rheumatic medicines or if you have other allergies
• if you are being treated concomitantly with anticoagulant medicines (e.g. coumarin derivatives, heparin [with the exception of low-dose heparin treatment])
• in case of bronchial asthma
• in case of chronic or recurrent stomach or duodenal complaints
• in case of pre-damaged kidneys
• in case of severe liver dysfunction
• in the first 6 months of pregnancy.

If you suffer from asthma, hay fever, swelling of the nasal mucous membranes (nasal polyps) or chronic respiratory infections (especially coupled with hay fever-like symptoms) or if you have a hypersensitivity to pain and anti-rheumatic medicines of all kinds, there is a risk of asthma attacks (so-called analgesic intolerance/analgesic asthma) when taking ASS-ratiopharm 500 mg. Please consult your doctor before use. The same applies to patients who are also hypersensitive (allergic) to other substances, e.g. with skin reactions, itching or hives. If ASS-ratiopharm 500 mg is taken before surgical procedures, the doctor or dentist must be consulted or informed. Prolonged high-dose, non-intended use of painkillers can lead to headaches that should not be treated by increasing the dose of the medicine. In general, the habitual use of painkillers, especially when combining several pain-relieving active ingredients, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). ASS-ratiopharm 500 mg belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can impair female fertility. This effect is reversible after discontinuation of the medicine.

Children and adolescents

ASS-ratiopharm 500 mg should only be taken by children and adolescents with febrile illnesses on medical advice and only if other measures are ineffective. If prolonged vomiting occurs with these illnesses, this may be a sign of Reye's syndrome, a very rare but life-threatening illness that absolutely requires immediate medical attention.

Taking ASS-ratiopharm 500 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

The following effects are enhanced:

• the effect of anticoagulant medicines (e.g. coumarin derivatives and heparin)
• the risk of gastrointestinal bleeding with concomitant treatment with medicines containing cortisone or cortisone-like substances, or with concomitant alcohol consumption
• the effect of certain blood sugar-lowering medicines (sulfonylureas)
• the desired and undesired effects of methotrexate
• the blood levels of digoxin, barbiturates and lithium
• the desired and undesired effects of a certain group of pain and anti-rheumatic medicines (non-steroidal analgesics/anti-inflammatories)
• the effect of certain antibiotics (sulfonamides and sulfonamide combinations [e.g. sulfamethoxazole/trimethoprim])
• the effect of triiodothyronine, a medicine for hypothyroidism
• the effect of valproic acid, a medicine for seizure disorders (epilepsy).

ASS-ratiopharm 500 mg reduces the effects of:

• certain medicines that cause increased urine excretion (so-called aldosterone antagonists and loop diuretics)
• blood pressure-lowering medicines
• uric acid-excreting gout medicines (e.g. probenecid, sulfinpyrazone).

ASS-ratiopharm 500 mg should therefore not be used together with any of the above-mentioned substances unless expressly instructed by the doctor.

Taking ASS-ratiopharm 500 mg with food, drinks and alcohol

Alcohol consumption should be avoided as much as possible while taking ASS-ratiopharm 500 mg.

Pregnancy and

breastfeeding

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

Pregnancy

If pregnancy is detected during prolonged use of ASS-ratiopharm 500 mg, the doctor must be notified. In the 1st and 2nd trimesters of pregnancy, ASS-ratiopharm 500 mg should only be taken after consulting a doctor. In the last 3 months of pregnancy, acetylsalicylic acid must not be taken due to an increased risk of complications for mother and child 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 so far, interruption of breastfeeding will generally not be necessary for short-term use of the recommended dose for pain or fever. However, if prolonged use or higher doses (more than 6 tablets/day, corresponding to 3 g acetylsalicylic acid/day) have been prescribed in individual cases, early weaning should be considered.

Driving and operating machinery

No special precautions are required.

3. HOW TO TAKE ASS-RATIOPHARM 500 MG?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the recommended dose is

Age Single dose Total daily dose
Children 6 - 14 years ½ - 1 tablet (corresponding to 250 - 500 mg acetylsalicylic acid) 1½ - 3 tablets (corresponding to 750 - 1500 mg acetylsalicylic acid)
Adolescents and adults 1 - 2 tablets (corresponding to 500 - 1000 mg acetylsalicylic acid) 3 - 6 tablets (corresponding to 1500 - 3000 mg acetylsalicylic acid)

The single dose can, if necessary, be taken up to 3 times a day at intervals of 4 - 8 hours. Note: In patients with liver or kidney dysfunction, the dose must be reduced or the dosing interval extended.

Method of administration

Take ASS-ratiopharm 500 mg whole with plenty of liquid and not on an empty stomach.

Duration of use

Do not take ASS-ratiopharm 500 mg for pain or fever for longer than 3 - 4 days without medical or dental advice.

If you have taken more ASS-ratiopharm 500 mg than you should

Dizziness and ringing in the ears can be signs of serious poisoning, especially in children and elderly patients. If you suspect an overdose of ASS-ratiopharm 500 mg, please notify your doctor. He or she can decide on any necessary measures depending on the severity of the poisoning.

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.

When evaluating side effects, the following frequency information is used as a basis:
Very common:	more than 1 in 10 people treated
Common	1 to 10 in 100 people treated
Uncommon	1 to 10 in 1,000 people treated
Rare	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	Frequency cannot be estimated from the available data.

Common

Gastrointestinal complaints such as stomach pain and minor blood loss from the gastrointestinal tract (micro-bleeding).

Uncommon

Nausea, vomiting and diarrhoea, as well as stomach or intestinal bleeding.

Rare

Stomach or intestinal ulcers, which can very rarely lead to perforation, as well as, especially in asthmatics - hypersensitivity reactions (attacks of shortness of breath, skin reactions), swelling of the face, tongue and larynx (Quincke's oedema). In individual cases, liver and kidney dysfunction, reduction in blood sugar levels (hypoglycaemia) and particularly