ASS

ASS ratiopharm 500 mg tablets

Important notes (mandatory information)

ASS-ratiopharm 500 mg Tablets. 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

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 package leaflet or exactly as directed by your doctor or pharmacist.

• 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 3 -- 4 days, contact your doctor.

What this package leaflet contains

1. WHAT IS ASS-RATIOPHARM 500 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS-RATIOPHARM 500 MG?
3. HOW TO TAKE ASS-RATIOPHARM 500 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ASS-RATIOPHARM 500 MG BE STORED?
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 moderate pain and fever. Notes: However, ASS-ratiopharm 500 mg should only be taken by children and adolescents with feverish illnesses on the instructions of a doctor and only if other measures do not work (see 2. under "Children and adolescents"). ASS-ratiopharm 500 mg should not be taken for a long time or in high doses without consulting a doctor or dentist.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASS-RATIOPHARM 500 MG?

ASS-ratiopharm 500 mg must not be taken:

• if you are allergic to acetylsalicylic acid, salicylates, a group of substances that are related to acetylsalicylic acid or any of the other ingredients of this medicine listed in section 6
• with stomach and intestinal ulcers
• with abnormally 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 relievers, anti-inflammatory drugs or rheumatism drugs or if you have other allergies
• if you are taking anticoagulant medicines (e.g. coumarin derivatives, heparin [except for low-dose heparin treatment]) at the same time
• with bronchial asthma
• with chronic or recurring stomach or duodenal complaints
• with impaired kidney function
• with severe liver dysfunction
• in the first 6 months of pregnancy.

If you have asthma, hay fever, nasal mucosa swelling (nasal polyps) or chronic respiratory infections (especially coupled with hay fever-like symptoms), you are at 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, such as with skin reactions, itching or hives. If you take ASS-ratiopharm 500 mg before surgery, the doctor or dentist should be consulted or informed. If pain relievers are taken in high doses for a long time and not as intended, headaches can occur, which should not be treated with increased doses of the medicine. In general, the habitual use of pain relievers, especially when several pain-relieving active ingredients are combined, 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 fertility in women. 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 feverish illnesses on the instructions of a doctor 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 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 are enhanced:

• the effect of anticoagulant medicines (e.g. coumarin derivatives and heparin)
• the risk of gastrointestinal bleeding when taken together with medicines containing cortisone or cortisone-like substances, or when alcohol is consumed at the same time
• 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 relievers and rheumatism drugs (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 underactive thyroid
• the effect of valproic acid, a medicine for seizures (epilepsy).

ASS-ratiopharm 500 mg reduces the effects of:

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

ASS-ratiopharm 500 mg should therefore not be used together with any of the above substances without the doctor's express instructions.

Taking ASS-ratiopharm 500 mg with food, drink 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, 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

If pregnancy is discovered during prolonged use of ASS-ratiopharm 500 mg, the doctor should be notified. In the 1st and 2nd trimester 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 to date, interrupting breastfeeding will generally not be necessary if the recommended dose is taken for a short period of time for pain or fever. In individual cases, if a longer period of use or higher doses (more than 6 tablets/day, which corresponds to 3 g acetylsalicylic acid/day) have been prescribed, 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 directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is

Age	Single dose	Total daily dose
Children 6 — 14 years	1/2 – 1 tablet (corresponding to 250 – 500 mg acetylsalicylic acid)	1 1/2 – 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 be taken up to 3 times a day at intervals of 4 - 8 hours if necessary. Note: In patients with impaired liver or kidney function, the dose must be reduced or the dosing interval extended.

Method of administration

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

Duration of use

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

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

Dizziness and ringing in the ears, especially in children and elderly patients, can be signs of serious poisoning. If you suspect an overdose of ASS-ratiopharm 500 mg, please notify your doctor. Depending on the severity of the poisoning, the doctor can decide on the measures to be taken, if 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 frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated patients
Common	1 to 10 in 100 treated patients
Uncommon	1 to 10 in 1,000 treated patients
Rare	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Common

Gastrointestinal complaints such as stomach pain and minor bleeding from the gastrointestinal tract (microbleeding).

Uncommon

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

Rare

Stomach or intestinal ulcers, which can very rarely lead to a perforation, and, especially in asthmatics - hypersensitivity reactions (attacks of shortness of breath, skin reactions), swelling of the face, tongue and larynx (Quincke's edema). In individual cases, liver and kidney dysfunction, decreased blood sugar levels (hypoglycemia) and particularly severe skin rashes (up to erythema exsudativum multiforme) have been described.

Serious bleeding such as brain hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulant medicines, has been reported rarely to very rarely, which may be life-threatening in individual cases. Bleeding such as nosebleeds, gum bleeding or skin bleeding can occur with a possible prolongation of bleeding time. This effect can persist for 4 to 8 days after ingestion. Acetylsalicylic acid reduces uric acid excretion in low doses. In patients at risk, this can trigger a gout attack under certain circumstances. With prolonged or chronic use, central nervous disorders such as headache, dizziness, vomiting, tinnitus, visual disturbances or somnolence (drowsiness) as well as anemia due to iron deficiency (iron deficiency anemia) can occur. In rare cases, anemia due to hidden gastrointestinal losses can occur after prolonged use of ASS-ratiopharm 500 mg. Disturbances of the acid-base balance as well as sodium and water retention can occur when high doses are used and when there is a corresponding disposition. If the recommended dosage is exceeded, liver values (transaminases) may increase. Therefore, regular monitoring of liver values is necessary, especially in children.

Countermeasures

If you experience any of the above side effects, ASS-ratiopharm 500 mg should not be taken again. Notify your doctor so that he/she can decide on the severity and any further measures that may be necessary. ASS-ratiopharm 500 mg must not be taken again at the first signs of a hypersensitivity reaction. If black stools (tarry stools, a sign of severe stomach bleeding) occur, a doctor should be notified immediately.

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 ASS-RATIOPHARM 500 MG 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 carton and blister packs after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Store the blister pack in the carton in order to protect from moisture.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ASS-ratiopharm 500 mg contains

The active ingredient is: Acetylsalicylic acid. Each tablet contains 500 mg acetylsalicylic acid. The other ingredients are: Corn starch, cellulose powder.

What ASS-ratiopharm 500 mg looks like and contents of the pack

White, round tablet with a single-sided cross-breaking notch. The tablet can be divided into equal halves. The cross-breaking notch is only used to quarter the tablet to make it easier to swallow, and not to divide it into equal quarters. ASS-ratiopharm 500 mg is available in packs of 30, 50 and 100 tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in March 2017.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Acetylsalicylic acid. Areas of application: for mild to moderate pain and fever.