Patient Information Leaflet

ULTRAPIRYNA FORTE, 500 mg, enteric-coated tablets
Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 10 days (in case of pain) or 3 days (in case of fever), or if you feel worse, you should consult your doctor.

Leaflet contents:

What ULTRAPIRYNA FORTE is and what it is used for
Important information before taking ULTRAPIRYNA FORTE
How to take ULTRAPIRYNA FORTE
Possible side effects
How to store ULTRAPIRYNA FORTE
Contents of the pack and other information

1. What ULTRAPIRYNA FORTE is and what it is used for

Acetylsalicylic acid is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. It exerts antipyretic effects by dilating peripheral blood vessels and increasing blood flow, and analgesic and anti-inflammatory effects by inhibiting the release and biosynthesis of prostaglandins, which influence inflammatory response.
The pharmaceutical form of the medicine – enteric-coated tablet – protects the gastric mucosa from the irritating effect of acetylsalicylic acid.
ULTRAPIRYNA FORTE is indicated for use in the following conditions:

mild to moderate pain, such as toothache, joint pain, muscle pain, headache;
painful menstruation;
pain and inflammatory conditions in rheumatic diseases;
fever.

2. Important information before using ULTRAPIRYNA FORTE

When not to use ULTRAPIRYNA FORTE:

if the patient is allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
if the patient has hypersensitivity to salicylates or other non-steroidal anti-inflammatory drugs, manifested by asthma attacks, nasal mucosa swelling (nasal polyps);
if the patient has active peptic ulcer disease;
if the patient has a bleeding tendency;
during the third trimester of pregnancy and breastfeeding;
in case of viral infections (especially influenza and varicella) in children under 12 years of age;
if the patient has severe heart failure.

Warnings and precautions
Special caution should be exercised when using ULTRAPIRYNA FORTE in the following cases: allergic conditions (bronchial asthma, hay fever), uterine bleeding, excessive menstrual bleeding, pregnancy and breastfeeding (see section: "Pregnancy and breastfeeding"), prior to surgical procedures (do not take acetylsalicylic acid at least 5 days before surgery), gout, uric acid diathesis, history of gastric or duodenal ulcer, previous gastrointestinal bleeding; concomitant treatment with anticoagulant drugs (oral antivitamin K agents, heparin, low molecular weight heparins, antiplatelet agents – ticlopidine, indobufen), renal and hepatic impairment, use of intrauterine contraceptive devices, hypertension, anaemia, heart failure, glucose-6-phosphate dehydrogenase deficiency (inherited deficiency of a certain blood enzyme).
Administration of acetylsalicylic acid in children under 12 years of age with viral infections such as varicella or influenza may result in Reye's syndrome, a rare but serious illness causing liver and brain damage.
Use of medicines such as ULTRAPIRYNA FORTE may be associated with a small increased risk of myocardial infarction or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended (see section 3).
In case of heart disorders, history of stroke or suspicion of such disorders (e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking), discuss the treatment approach with your doctor or pharmacist.
This medicine belongs to a group of medicines that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of therapy.

ULTRAPIRYNA FORTE and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Acetylsalicylic acid enhances the hypoglycaemic effect (lowering blood sugar levels) of oral antidiabetic sulfonylureas (e.g. tolbutamide, chlorpropamide, glimepiride, glipizide), enhances the anticoagulant effect of coumarin derivatives (e.g. warfarin, dicoumarol, acenocoumarol), and intensifies the effects of methotrexate. It increases the risk of gastrointestinal bleeding when used concomitantly with other non-steroidal anti-inflammatory drugs and alcohol, and intensifies adverse effects caused by non-steroidal anti-inflammatory drugs. When used with vancomycin, it increases the risk of transient hearing loss. Probenecid enhances the effect of acetylsalicylic acid. Long-term use of high doses of the drug may lead to increased excretion of ascorbic acid (vitamin C).
Acetylsalicylic acid increases serum concentrations of digoxin, barbiturates, lithium compounds, intensifies the effects and adverse reactions of sulfonamides and their combinations, and intensifies the effect of valproic acid. It reduces the efficacy of aldosterone antagonists and loop diuretics, antihypertensive drugs, and uricosuric agents (sulfinpyrazone, probenecid).
Metamizole (a substance with analgesic and antipyretic properties) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when both drugs are used simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

ULTRAPIRYNA FORTE and alcohol
Consuming alcohol during treatment with acetylsalicylic acid may intensify gastrointestinal irritation.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. The medicine may be used during the first and second trimesters of pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus. The medicine should not be used during the last trimester of pregnancy, as it may cause fetal abnormalities and complications during delivery.
Acetylsalicylic acid passes into human milk; therefore, the use of this medicine should be avoided during breastfeeding.

Driving and operating machinery
When used as directed, this medicine does not impair psycho-physical performance.

3. How to use ULTRAPIRYNA FORTE

Adults and adolescents over 12 years of age:
For pain relief and antipyretic effect: orally, 1 tablet (500 mg) every 3-4 hours. The maximum daily dose is 4 g. If pain persists beyond 10 days or fever beyond 3 days of treatment, medical advice should be sought.
In rheumatic diseases (anti-inflammatory): orally, 3.5 to 5.5 g per day in divided doses, usually initially 1 or 2 tablets 4 times daily, with meals and before bedtime. The dose may then be increased until maximum effectiveness is achieved. Doses should not be increased if tinnitus occurs.
The average daily dose is 4.5 g per day in divided doses.
In acute rheumatic fever, up to 7-8 g per day in divided doses.

Taking more ULTRAPIRYNA FORTE than recommended
Symptoms of overdose include: headache, dizziness, tinnitus, visual disturbances, respiratory stimulation, restlessness, balance disorders, drowsiness, elevated body temperature. If any of these symptoms occur, the drug should be discontinued and fluids consumed, particularly fruit juices.
If symptoms worsen and/or cardiac rhythm disturbances occur, auditory hallucinations (ringing in the ears) or visual disturbances, hearing loss, excessive sweating, nosebleeds, or gastrointestinal bleeding, medical advice should be sought immediately.

Missed dose of ULTRAPIRYNA FORTE
If a dose is missed, do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The occurrence of adverse effects depends on the dose used and the individual response of the patient.
Blood and lymphatic system disorders: thrombocytopenia (low platelet count, platelet deficiency),
hypoprothrombinemia (deficiency of prothrombin in the blood – a factor responsible for blood clotting).
Immune system disorders: hypersensitivity reactions with corresponding laboratory and clinical
symptoms including: bronchial asthma attacks, skin changes such as erythema or urticaria.
Nervous system disorders: dizziness and tinnitus.
Eye disorders: disturbances of visual acuity.
Ear and labyrinth disorders: hearing disturbances.
Cardiac disorders: circulatory failure, increased risk of arterial embolism (e.g. myocardial infarction or
stroke).
Respiratory, thoracic and mediastinal disorders: increased breathing rate, bronchial asthma attacks.
Gastrointestinal disorders: dyspeptic disturbances (nausea, vomiting), exacerbation of peptic ulcer disease,
erosions of the mucous membrane, sometimes with bleeding.
Skin and subcutaneous tissue disorders: excessive sweating.
Renal and urinary disorders: kidney stones, disturbances of acid-base balance.
Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) has been associated with the occurrence of
edema, hypertension and heart failure.
Use of medicines such as ULTRAPIRYNA FORTE may be associated with a small
increased risk of heart attack (myocardial infarction or stroke).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C 02-222 Warsaw
tel.: +48 22 49 21 301
fax.: +48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store ULTRAPIRYNA FORTE

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25 °C.
Keep in the original packaging in order to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What ULTRAPIRYNA FORTE contains
The active substance is acetylsalicylic acid. One enteric-coated tablet contains 500 mg of acetylsalicylic acid.
Other components are:
Core of the tablet: maize starch, microcrystalline cellulose, talc.
Coating composition: methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, povidone, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What ULTRAPIRYNA FORTE looks like and contents of the pack
The medicine is in the form of yellow enteric-coated tablets with a uniform surface, convex on both sides.
The pack contains 10, 20 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
SUN-FARM Sp. z o.o.
Cłekówka 75
05-340 Kołbiel