Ultrapirina Plus

Leaflet attached to the packaging: patient information

ULTRAPIRYNA PLUS (500 mg + 300 mg + 200 mg)/sachet, effervescent powder
Acetylsalicylic acid + Ascorbic acid + Calcium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3-5 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Ultrapiryna Plus and what is it used for
• 2. Important information before taking Ultrapiryna Plus
• 3. How to take Ultrapiryna Plus
• 4. Possible side effects
• 5. How to store Ultrapiryna Plus
• 6. Package contents and other information

1. What is Ultrapiryna Plus and what is it used for

Ultrapiryna Plus contains acetylsalicylic acid, ascorbic acid (vitamin C), and calcium.
Acetylsalicylic acid belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). It has antipyretic, analgesic, and anti-inflammatory effects.
Ascorbic acid (vitamin C) and calcium affect the proper functioning of blood vessel walls. They reduce their permeability, have anti-edematous and anti-inflammatory effects.
Calcium, by reducing the permeability of blood vessel walls, has anti-edematous, anti-inflammatory, and anti-allergic effects. Additionally, calcium ions stimulate the body's defense mechanisms and are necessary for blood clotting and bone remodeling processes.
The medicine is used to treat symptoms of colds and flu, as well as:
fever,
muscle and joint pain,
headaches, including migraines,
toothaches,
neuralgia.

2. Important information before taking Ultrapiryna Plus

When not to take Ultrapiryna Plus

if the patient is allergic to acetylsalicylic acid or other salicylates, ascorbic acid, calcium, or any of the other ingredients of this medicine (listed in section 6),
if the patient has active gastric or duodenal ulcer disease, inflammatory conditions of the digestive tract,
if the patient has an increased tendency to bruising or bleeding (hemorrhagic diathesis, coagulation disorders),
if the patient is taking anticoagulant medications,
if the patient has disturbances of acid-base balance (diabetes, uremia, tetany),
if the patient has significantly elevated calcium levels in the blood,
if the patient has a history of asthma attacks triggered by salicylates or substances with similar effects, especially nonsteroidal anti-inflammatory drugs,
if the patient has severe kidney disease,
if the patient has severe liver disease,
if the patient has severe heart failure,
if the patient is in the third trimester of pregnancy,
if the patient has phenylketonuria (a genetic disorder characterized by a deficiency of the enzyme phenylalanine hydroxylase),
in children under 12 years of age,
if the patient is taking methotrexate (used in cancer and rheumatoid arthritis) in doses of 15 mg per week or higher.

Warnings and precautions

Before starting to take Ultrapiryna Plus, the patient should discuss it with their doctor or pharmacist:
if the patient is allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs,
if the patient has an allergy (e.g., hay fever) or asthma,
if the patient has menstrual bleeding or excessive menstrual bleeding,
if the patient uses an intrauterine contraceptive device,
if the patient is scheduled for surgery (the medicine should not be taken at least 5 days before the procedure),
if the patient has gout,
if the patient has had stomach or duodenal ulcers, as well as gastrointestinal bleeding,
if the patient has kidney or liver function disorders,
if the patient has moderate heart failure (heart disease that may manifest as shortness of breath and swelling of the feet),
if the patient has high blood pressure,
if the patient's body does not produce the enzyme glucose-6-phosphate dehydrogenase, due to the risk of hemolytic anemia,
if the patient has heart problems, has had a stroke, or there are suspicions of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol, smoking).
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of adverse effects (e.g., on the digestive tract and cardiovascular system).
Long-term use of high doses may cause overdose.
Taking medications containing acetylsalicylic acid may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not take higher doses or longer treatment than recommended (3-5 days).
In the course of some viral diseases, especially in the case of influenza A or B virus infection or chickenpox, mainly in children and adolescents, there is a risk of developing Reye's syndrome - a rare but life-threatening disease. The occurrence of persistent vomiting during infection may indicate the development of Reye's syndrome, which requires immediate medical attention.
The risk of developing Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered at the same time, although a causal relationship has not been proven.
For these reasons, in children under 12 years of age, medications containing acetylsalicylic acid should not be used, and in adolescents over 12 years of age, medications containing acetylsalicylic acid can only be used on a doctor's prescription.
Ascorbic acid (vitamin C) contained in the medicine may falsify the results of some tests performed using redox methods (e.g., glucose or creatinine determination in blood and urine, stool test for occult blood).

Ultrapiryna Plus and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially if they are taking:
methotrexate used in cancer and rheumatoid arthritis (see also above),
anticoagulant medication, inhibiting platelet aggregation (e.g., coumarin derivative, heparin, ticlopidine),
antidiabetic medication (insulin, sulfonylurea derivative),
sulfonamide (used in bacterial infections),
phenytoin or valproic acid (antiepileptic drugs),
anti-inflammatory medication: from the group of corticosteroids or nonsteroidal anti-inflammatory drugs,
cardiac glycoside (digoxin and strophanthin derivative, medication used in heart disease),
medication used in the treatment of gout (e.g., probenecid),
diuretic medication (e.g., furosemide, thiazide medication),
medication lowering blood pressure (from the group of angiotensin-converting enzyme inhibitors, e.g., captopril, enalapril),
amphetamine derivative (used e.g., in ADHD treatment),
medication used in the treatment of depression: from the group of selective serotonin reuptake inhibitors (SSRI) and tricyclic antidepressants (e.g., opipramol, doxepin),
fluoride compounds,
vitamin D and calcium channel blocker (used in hypertension).
A 3-hour interval should be maintained between taking a medication used in bacterial infections: from the group of fluoroquinolones, tetracyclines, and Ultrapiryna Plus.
Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (platelet aggregation and clot formation) if these medications are taken simultaneously. Therefore, caution should be exercised when using metamizole in patients receiving acetylsalicylic acid.

Ultrapiryna Plus with food, drink, and alcohol

The medicine is recommended to be taken after a meal.
Consuming alcohol during treatment with the medicine may enhance the irritating effect of acetylsalicylic acid on the digestive tract.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not take Ultrapiryna Plus during pregnancy and breastfeeding.
Acetylsalicylic acid contained in Ultrapiryna Plus may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Ultrapiryna Plus, taken in recommended doses, has no effect or a negligible effect on the ability to drive vehicles and operate machines.

Warnings regarding excipients

The medicine contains 178 mg of sodium per dose (1 sachet), which corresponds to 8.9% of the maximum daily dose of sodium recommended by the WHO for adults.
The medicine contains 25 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Ultrapiryna Plus contains 0.75 g of sucrose per dose (1 sachet) (in the composition of the dye). The medicine contains glucose (as a component of maltodextrin). If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains 0.055 mg of sodium benzoate (E211) in each dose (1 sachet).
Ultrapiryna Plus contains cochineal (E120) (in the composition of the raspberry flavor).

3. How to take Ultrapiryna Plus

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dose:
Adults:
1 or 2 sachets. If necessary, the dose can be repeated every 4 to 8 hours, up to 3 times a day.
The maximum daily dose is 6 sachets.
Elderly patients (over 65 years):
1 sachet. If necessary, the dose can be repeated every 4 to 8 hours, up to 3 times a day.
The maximum daily dose is 3 sachets.

Use in children and adolescents

Do not give to children under 12 years of age (section 2).
Adolescents over 12 years of age - only on a doctor's prescription:
1 sachet. If necessary, the dose can be repeated every 4 to 8 hours, up to 3 times a day.
The maximum daily dose is 3 sachets.
The contents of one sachet should be dissolved in half a glass of cool water, mixed, and drunk.
Take after a meal.
Do not take Ultrapiryna Plus for more than 3-5 days.

Overdose of Ultrapiryna Plus

In case of accidental ingestion of a dose exceeding the recommended daily dose, symptoms of overdose may occur (related to the presence of acetylsalicylic acid): rapid breathing, nausea, vomiting, vision and hearing disturbances (tinnitus), headaches, and dizziness, acid-base and electrolyte disturbances (e.g., potassium deficiency), decreased blood glucose levels, skin changes.
In case of acute poisoning, the following may occur: hallucinations, tremors, shortness of breath, excessive sweating, psychomotor agitation, high fever, coma.
In case of overdose, the patient should immediately consult a doctor or pharmacist.
In case of any further doubts related to the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should contact their doctor immediately in case of:

• gastrointestinal bleeding in the form of coffee grounds vomiting and black stools,
• allergic reactions (such as skin changes: rash, urticaria, severe breathing difficulties or wheezing, shortness of breath).

Other side effects may also occur:

• increased risk of bleeding,
• worsening or recurrence of ulcer disease,
• nausea, vomiting, abdominal pain,
• blood clotting disorders,
• increased menstrual bleeding,
• gastric mucosa erosion,
• asthma attacks in adults or shortness of breath,
• edema,
• hypertension,
• heart failure,
• dizziness,
• tinnitus,
• sweating.

Taking medications containing acetylsalicylic acid may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ultrapiryna Plus

Do not store above 25°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the given month.
Do not use this medicine if the appearance of the powder in the sachets has changed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ultrapiryna Plus contains

• The active substances of the medicine are: acetylsalicylic acid 500 mg/sachet, ascorbic acid (vitamin C) 300 mg/sachet, calcium (in the form of calcium lactogluconate) 200 mg/sachet.
• Other ingredients (excipients) are: sodium bicarbonate, citric acid, povidence K-25, raspberry flavor (containing, among others: maltodextrin, sodium benzoate (E211), cochineal (E120)), aspartame (E951), betacarotene 1% (E160a) (containing: DL-alpha-tocopherol, sucrose, triglycerides of saturated fatty acids of medium chain length, betacarotene, crystalline, sodium ascorbate, crystalline, maltodextrin, arabic gum, silicon dioxide), sodium lauryl sulfate.

What Ultrapiryna Plus looks like and what the package contains

The medicine is in the form of a pink effervescent powder with visible white particles, packaged in sachets.
The outer packaging - a cardboard box, contains 6, 8, 10, 12, 14, 20, or 28 sachets and patient information.
Not all package sizes may be marketed.

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
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Manufacturer

Wӧrwag Pharma Operations spółka z ograniczoną odpowiedzialnością ul. gen. Mariana Langiewicza
58, 95-050 Konstantynów Łódzki
To obtain more detailed information, please contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa
tel.: +48 (22) 543 60 00

Date of last revision of the leaflet: April 2022