Patient Information Leaflet

Upsarin C, 330 mg + 200 mg, effervescent tablets
Acidum acetylsalicylicum + Acidum ascorbicum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician, pharmacist, or nurse.

Keep this leaflet for future reference.
If you need advice or further information, consult your doctor or pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days of treatment for fever or after 5 days for pain, or if your condition worsens, consult a doctor.

Table of Contents

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

1. What Upsarin C is and what it is used for

Upsarin C is a combination medicine containing two active substances: acetylsalicylic acid and ascorbic acid (vitamin C).
Acetylsalicylic acid has anti-inflammatory, antipyretic, and analgesic properties. Ascorbic acid, also known as vitamin C, plays an essential role in redox, immune, and detoxification processes occurring in the body's cells. The presence of vitamin C in the medicine is beneficial during colds and influenza, when the body's demand for vitamin C increases.
Indications:

Symptomatic treatment of flu and colds.
Feverish conditions.
Pain of various origins (headache, joint and muscle pain, toothache, neuralgia).

2. Information before using Upsarin C

When not to use Upsarin C:

if the patient is allergic to acetylsalicylic acid, ascorbic acid (vitamin C), or any of the other ingredients of this medicine (listed in section 6),
in patients with a history of gastrointestinal perforation or bleeding associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs),
in patients with a history of bronchial asthma induced by salicylates or substances with similar activity (especially NSAIDs),
in patients with active gastric or duodenal ulcer,
if the patient has bleeding disorders or coagulation disturbances,
if the patient has severe hepatic insufficiency,
if the patient has severe renal insufficiency,
if the patient has severe heart failure,
during the third trimester of pregnancy and while breastfeeding (see "Pregnancy, breastfeeding and fertility"),
if the patient is being treated concomitantly with methotrexate at doses exceeding 20 mg/week,
if the patient is taking oral anticoagulants and has a history of gastric or duodenal ulcer,
in children under 12 years of age with feverish illnesses, particularly influenza or varicella, due to the risk of Reye's syndrome (a rare but serious disease causing liver and brain damage).

Warnings and precautions
Before starting treatment with Upsarin C, consult a doctor, pharmacist, or nurse.
Avoid concomitant use of this medicine with non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.
This medicine contains acetylsalicylic acid. To avoid overdose, check whether other medicines currently taken (including those prescribed or available without prescription) contain acetylsalicylic acid.
Consult a doctor before using Upsarin C in the following situations:

first and second trimesters of pregnancy;
during heavy menstruation;
before and after surgical procedures (even minor ones such as tooth extraction), because acetylsalicylic acid may prolong bleeding time (due to its antiplatelet effect, which may last several days);
when taking anticoagulant medicines concurrently (see section "Upsarin C and other medicines");
if the patient has a genetic disorder known as glucose-6-phosphate dehydrogenase deficiency, as administration of acetylsalicylic acid may trigger hemolysis;
if the patient has reduced uric acid excretion, the product may provoke an attack of gout (acetylsalicylic acid, even in low doses, reduces uric acid excretion);
if the patient is breastfeeding (see "Pregnancy, breastfeeding and fertility");
during treatment of rheumatic diseases.

Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
Long-term use of medicines containing acetylsalicylic acid may cause headache that worsens with continued dosing.
Regular use of painkillers, particularly those containing multiple active ingredients, may lead to serious kidney dysfunction and renal failure.
Cases of acute renal failure have been reported after initiating treatment with multiple doses of NSAIDs or in patients with impaired renal function treated with tenofovir. Renal function should be monitored when tenofovir is used concomitantly with NSAIDs.

Upsarin C and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Do not use Upsarin C with the following medicines:
Oral anticoagulants – increased risk of hemorrhage, especially in patients with a history of gastric or duodenal ulcer.
Methotrexate (used in cancer treatment) at doses exceeding 20 mg/week – increased bone marrow toxicity.

Avoid using Upsarin C with the following medicines:
Methotrexate (used in cancer treatment) at doses less than or equal to 20 mg/week – increased bone marrow toxicity.
Oral anticoagulants, low molecular weight heparins (and similar agents), unfractionated heparins, thrombolytic agents (increased risk of prolonged bleeding time, hemorrhage, and gastric mucosal damage due to salicylates), and drugs inhibiting platelet aggregation (e.g., ticlopidine, ticagrelor, clopidogrel).
Acetazolamide – increased adverse effects (metabolic acidosis) have been observed.
Anagrelide – increased incidence of hemorrhagic events.
Other non-steroidal anti-inflammatory drugs (NSAIDs), deferasirox – increased risk of gastrointestinal ulceration and bleeding.
Glucocorticosteroids – administered systemically, except hydrocortisone used as replacement therapy in Addison's disease.
Glucocorticosteroids (except hydrocortisone) when salicylic acid is used at anti-inflammatory doses (> 1 g per dose and/or > 3 g daily), especially in the treatment of rheumatic diseases.
Pemetrexed in patients with mild to moderate renal impairment – increased risk of pemetrexed toxicity (reduced renal clearance due to the effect of acetylsalicylic acid at anti-inflammatory doses, i.e., ≥ 1 g per dose and/or ≥ 3 g daily).
Uricosuric agents (e.g., probenecid, benzbromarone) – reduced efficacy of antigout drugs (used in the treatment of gout).
Diuretics (when used concomitantly with acetylsalicylic acid at doses of 3 g/day or higher).
Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists – when used concomitantly with acetylsalicylic acid at doses of 3 g/day or higher – reduced antihypertensive effect.
Locally acting gastrointestinal medicines, antacids, and activated charcoal.
Deferoxamine – concomitant use with ascorbic acid (vitamin C) may increase tissue toxicity of iron, especially in the heart, leading to cardiac failure.
Selective serotonin reuptake inhibitors (SSRIs) (citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) – increased risk of gastrointestinal bleeding.

Ascorbic acid (vitamin C)
Used in high doses (exceeding 2 g/day), it may interfere with laboratory test results obtained by redox methods (measurement of creatinine concentration and glucose levels in blood and urine – diabetes monitoring using glucose oxidase test strips).

Use of Upsarin C with alcohol
Alcohol may increase the risk of adverse gastrointestinal effects, such as mucosal ulceration and bleeding.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
In the first and second trimesters of pregnancy, the medicine may be used only if clearly necessary. In the third trimester of pregnancy, the medicine is contraindicated.
The medicine is contraindicated during breastfeeding.

Pregnancy
Acetylsalicylic acid may be used during the first and second trimesters of pregnancy only if clearly necessary, after careful consideration of the benefit-risk balance of treatment. If use of acetylsalicylic acid is necessary in women attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be used for the shortest possible duration.
In the third trimester of pregnancy, acetylsalicylic acid may cause premature closure of the ductus arteriosus in the fetus and disturbances in renal function. It may also prolong the duration of pregnancy, inhibit uterine contractions, and cause complications during delivery.
The medicine is contraindicated in the third trimester of pregnancy.

Breastfeeding
The medicine is contraindicated during breastfeeding because acetylsalicylic acid passes in small amounts into breast milk.

Fertility
Not applicable.

Driving and operating machinery
Upsarin C does not affect the ability to drive or operate machinery.

Upsarin C contains sodium and sodium benzoate (E211)
Each effervescent tablet contains 485 mg of sodium (a major component of table salt). This corresponds to 24.3% of the maximum recommended daily dietary sodium intake for adults. Patients, especially those monitoring dietary sodium intake, who take 1 or more effervescent tablets daily over a long period, should consult a doctor or pharmacist.
The medicine contains 48 mg of sodium benzoate (E211) in each effervescent tablet.

3. How to use Upsarin C

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Do not take other medicines (including prescription or over-the-counter medicines) containing acetylsalicylic acid at the same time.
Recommended dose:
Adults: 1 to 2 effervescent tablets; the dose may be repeated every 4 to 8 hours if necessary.
The maximum daily dose for adults is 3 g of acetylsalicylic acid and 1 g of ascorbic acid. Do not exceed 5 effervescent tablets per day.
Adolescents over 12 years to 15 years of age: 1 effervescent tablet; the dose may be repeated every 6 hours if necessary. The maximum daily dose of acetylsalicylic acid is 50 mg/kg body weight.
Do not exceed 4 effervescent tablets per day.
For adolescents over 12 years of age, this medicine should only be used after consultation with and on the advice of a doctor.
Elderly patients: 1 effervescent tablet; the dose may be repeated every 4 hours if necessary.
The maximum daily dose for elderly patients is 2 g of acetylsalicylic acid and 1 g of ascorbic acid.
Do not exceed 5 tablets per day.
Method of administration
Oral use. The effervescent tablet should be dissolved in a glass of water and the solution drunk immediately after dissolving. Take after meals.
Frequency of administration
Regular administration of the medicine helps avoid fluctuations in pain and fever intensity. The interval between doses should be at least 4 hours. Do not exceed the maximum daily doses.
Duration of treatment
If pain persists for more than 5 days or fever for more than 3 days despite taking the medicine, consult a doctor.
Taking a higher than recommended dose of Upsarin C
Poisoning with Upsarin C may result from long-term use or overdose due to accidental ingestion, which may be life-threatening, especially in elderly individuals and young children.
Symptoms of overdose include: headache, dizziness, tinnitus, sensation of hearing loss, which may resolve after reducing the dose of the medicine.
In severe poisoning, the following may occur: hyperventilation (excessively deep and intense breathing leading to excessive elimination of CO₂ and reduced blood CO₂ levels), fever, respiratory alkalosis, metabolic acidosis, cardiovascular shock, respiratory failure, and severe hypoglycemia (blood glucose concentration below normal), coma.
Missing a dose of Upsarin C
Do not take a double dose to make up for a missed dose.
If you have any doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine may cause adverse effects, although not everyone experiences them.
Related to acetylsalicylic acid
Infections and parasitic invasions
Reye's syndrome.
Nervous system disorders
Headache, dizziness, sensation of hearing loss, tinnitus, which are usually symptoms of overdose.
Gastrointestinal disorders
Nausea, vomiting, diarrhoea, bloating, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease. Gastric or duodenal peptic ulcer, perforation, gastrointestinal bleeding.
Blood and lymphatic system disorders
Increased risk of bleeding, haemorrhages (epistaxis, gingival bleeding, purpura, etc.), prolonged bleeding time, prolonged prothrombin time, thrombocytopenia. The risk of bleeding may persist for 4 to 8 days after discontinuation of acetylsalicylic acid. This may lead to an increased risk of haemorrhage in the event of surgery.
Intracranial haemorrhage and cerebral haemorrhage.
Immune system disorders
Urticaria, bronchial asthma, skin reactions, anaphylactic reactions, angioedema.
Cardiac and vascular disorders
Edema, hypertension, and heart failure have been reported in association with NSAID therapy.
Skin and subcutaneous tissue disorders
Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
Related to ascorbic acid
Blood and lymphatic system disorders
At doses exceeding 3 g/day, there is a risk of haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Nervous system disorders
Dizziness.
Gastrointestinal disorders
At doses exceeding 1 g/day, digestive disturbances (dyspepsia, diarrhoea, abdominal pain) may occur.
Skin and subcutaneous tissue disorders
Urticaria, rash.
Renal and urinary disorders
At doses exceeding 1 g/day, urinary system disorders may occur (oxalate, cystine and/or uric acid stone formation).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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 Upsarin C
Keep the medicine out of sight and reach of children.
Store below 25°C. After use, the tube should be tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Upsarin C contains
The active substances are: acetylsalicylic acid 330 mg and ascorbic acid 200 mg.
The other ingredients are: sodium hydrogen carbonate, anhydrous citric acid, sodium benzoate (E211),
povidone.

What Upsarin C looks like and contents of the pack
Effervescent tablet.
Pack: polypropylene tube closed with a polyethylene stopper containing a hygroscopic substance (molecular sieve), with a tamper-evident ring, containing 10 effervescent tablets in a cardboard box.
The cardboard box contains 1 or 2 tubes with 10 tablets each.

Marketing Authorisation Holder
UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison, France

Manufacturer
UPSA SAS
979, Avenue des Pyrénées
47520 Le Passage, France
UPSA SAS
304, Avenue du Dr. Jean Bru
47000 Agen, France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel: +48 22 570 27 00