Upsarin C

Leaflet attached to the packaging: patient information

Upsarin C, 330 mg + 200 mg, effervescent tablets

Acetylsalicylic acid + Ascorbic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
your doctor, pharmacist, or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor,
  pharmacist, or nurse. See section 4.
• If after 3 days in the case of fever or 5 days in the case of pain, no improvement occurs, or if you feel worse,
  you should consult your doctor.

Table of contents of the leaflet

• 1. What is Upsarin C and what is it used for
• 2. Important information before taking Upsarin C
• 3. How to take Upsarin C
• 4. Possible side effects
• 5. How to store Upsarin C
• 6. Contents of the packaging and other information

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

Upsarin C is a combination medicine that contains two active substances, acetylsalicylic acid and ascorbic
acid (vitamin C).
Acetylsalicylic acid has anti-inflammatory, antipyretic, and analgesic effects. Ascorbic acid, or vitamin C,
is essential for oxidation-reduction, immune, and detoxification processes in the body. The presence of
vitamin C in the medicine is beneficial in the course of colds, during which there is an increased demand for
vitamin C.
Indications for use:

• Symptomatic treatment of flu, colds.
• Feverish conditions.
• Pains of various origins (headaches, joint and muscle pain, toothaches, neuralgia).

2. Important information before taking Upsarin C

When not to take Upsarin C:

• if you are 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 nonsteroidal anti-inflammatory drugs (NSAIDs),
• in patients with a history of bronchial asthma caused by the administration of salicylates or substances with
  similar effects (especially NSAIDs),
• in patients with active peptic ulcer disease of the stomach or duodenum,
• if you have bleeding disorders or blood coagulation disorders,
• if you have severe liver failure,
• if you have severe kidney failure,
• if you have severe heart failure,
• in the third trimester of pregnancy and during breastfeeding (see "Pregnancy, breastfeeding, and fertility"),
• if you are being treated with methotrexate at doses above 20 mg/week,
• if you are taking oral anticoagulants in a history of peptic ulcer disease of the stomach or duodenum,
• in children under 12 years of age with febrile conditions, especially flu or chickenpox, due to the risk of
  Reye's syndrome (a rare but serious disease that causes liver and brain damage).

Warnings and precautions

Before starting treatment with Upsarin C, you should consult your doctor, pharmacist, or nurse.
You should avoid taking this medicine with nonsteroidal anti-inflammatory drugs (NSAIDs), including
selective cyclooxygenase-2 inhibitors.
This medicine contains acetylsalicylic acid. To avoid overdose, you should check if other medicines taken
concurrently (including those available on prescription or over-the-counter) contain acetylsalicylic acid.
You should consult your doctor before taking Upsarin C in the following situations:

• first and second trimester of pregnancy;
• during heavy menstrual bleeding;
• before and after surgical procedures (even such as tooth extraction), as acetylsalicylic acid may lead to
  prolonged bleeding time (due to anti-aggregatory effects that can last for several days);
• while taking anticoagulant medications (see section Upsarin C and other medicines);
• if you have a genetic disorder characterized by a deficiency of glucose-6-phosphate dehydrogenase,
  as administration of acetylsalicylic acid may cause hemolysis;
• if you have decreased uric acid excretion, the product may cause a gout attack (acetylsalicylic acid, even
  in small doses, reduces uric acid excretion);
• if you are breastfeeding (see "Pregnancy, breastfeeding, and fertility");
• while being treated for rheumatic diseases.

Taking the medicine in the smallest effective dose for the shortest necessary time to alleviate symptoms
reduces the risk of side effects.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each
subsequent dose.
Regular use of painkillers, especially those containing multiple active substances, can lead to severe kidney
function disorders and kidney failure.
There have been reports of acute kidney failure after starting treatment with multiple doses of NSAIDs or in
patients with kidney function disorders treated with tenofovir. When taking tenofovir with NSAIDs, kidney
function should be monitored.

Upsarin C and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to take.
You should not take Upsarin C with the following medicines
Oral anticoagulants - increased risk of bleeding, especially in the case of a history of peptic ulcer disease of
the stomach or duodenum.
Methotrexate (a medicine used in cancer treatment) at a dose greater than 20 mg/week - increased
toxic effect on the bone marrow.
You should avoid taking Upsarin C with the following medicines
Methotrexate (a medicine used in cancer treatment) at a dose less than or equal to 20 mg/week -
increased toxic effect on the bone marrow.
Oral anticoagulants, low molecular weight heparins (and similar), unfractionated heparins, thrombolytic
medicines (increased risk of prolonged bleeding time and bleeding, as well as gastric mucosa damage by
salicylates) and medicines that inhibit platelet aggregation (e.g., ticlopidine, ticagrelor, clopidogrel).
Acetazolamide - increased risk of side effects (metabolic acidosis).
Anagrelide - increased risk of bleeding incidents.
Other nonsteroidal anti-inflammatory drugs (NSAIDs), deferiprone - increased risk of ulcers and bleeding
from the gastrointestinal tract.
Corticosteroids - administered systemically, except for hydrocortisone used as replacement therapy in
Addison's disease.
Corticosteroids (except hydrocortisone), in anti-inflammatory doses (> 1 g per dose and/or > 3 g per day)
of salicylic acid, especially in the treatment of rheumatic diseases.
Pemetrexed in patients with mild to moderate kidney function impairment - increased risk of pemetrexed
toxicity (reduced renal clearance due to the effect of acetylsalicylic acid in anti-inflammatory doses, i.e., ≥
1 g per dose and/or ≥ 3 g per day).
Medicines that increase uric acid excretion in the urine (e.g., probenecid, benzbromarone) - reduced effect
of anti-gout medicines (used to treat gout).
Diuretics (used with acetylsalicylic acid at a dose of 3 g/day and higher).
Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor antagonists - used
concomitantly with acetylsalicylic acid at doses of 3 g/day and higher - reduced antihypertensive effect.
Locally acting medicines on the gastrointestinal tract, antacids, and activated charcoal.
Deferoxamine - concomitant use with ascorbic acid (vitamin C) may increase tissue toxicity of iron, especially
in the heart, leading to its failure.
Selective serotonin reuptake inhibitors (citalopram, dapoxetine, escitalopram, fluoxetine, fluvoxamine,
paroxetine, sertraline) - increased risk of gastrointestinal bleeding.

Ascorbic acid (vitamin C)

When taken in large doses (exceeding 2 g/day), it may interfere with laboratory test results performed using
oxidation-reduction methods (determination of creatinine levels and glucose levels in blood and urine -
diabetes control using a test strip with glucose oxidase).

Using Upsarin C with alcohol

Alcohol may increase the risk of side effects from the gastrointestinal tract, such as ulcers and bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult
your doctor or pharmacist before taking this medicine.
In the first and second trimester of pregnancy, the medicine may be used only if necessary, in the third
trimester of pregnancy, the medicine is contraindicated.
The medicine is contraindicated during breastfeeding,
Pregnancy
Acetylsalicylic acid may be used in the first and second trimester of pregnancy only if necessary, after careful
consideration of the benefit-risk ratio. If acetylsalicylic acid needs to be used in women trying to conceive or in
the first and second trimester of pregnancy, the smallest dose should be taken for the shortest possible time.
In the third trimester of pregnancy, acetylsalicylic acid may cause premature closure of the fetal ductus
arteriosus and kidney function disorders. Additionally, it may prolong 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, as acetylsalicylic acid passes into breast milk in small
amounts.
Fertility
Not applicable.

Driving and using machines

Upsarin C does not affect the ability to drive and use machines.

Upsarin C contains sodium and sodium benzoate (E211)

Each effervescent tablet contains 485 mg of sodium (the main component of common salt). This corresponds
to 24.3% of the maximum recommended daily intake of sodium in the diet for adults. If you take 1 or more
effervescent tablets per day for a long time, you should consult your doctor or pharmacist, especially if you are
controlling your sodium intake.
The medicine contains 48 mg of sodium benzoate (E211) in each effervescent tablet.

3. How to take Upsarin C

This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
You should not take other medicines (including those available on prescription or over-the-counter) that
contain acetylsalicylic acid at the same time.

Recommended dose:

Adults: 1 to 2 effervescent tablets, if necessary, the dose can be repeated every 4 to 8 hours.
Maximum daily dose for adults is 3 g of acetylsalicylic acid and 1 g of ascorbic acid. You should not take
more than 5 effervescent tablets per day.
Adolescents over 12 years to 15 years: 1 effervescent tablet, if necessary, the dose can be repeated every 6
hours. Maximum daily dose of acetylsalicylic acid is 50 mg/kg body weight. You should not take more than 4
effervescent tablets per day.
For adolescents over 12 years, the medicine can only be used after consulting a doctor and on their advice.
Elderly patients: 1 effervescent tablet, if necessary, the dose can be repeated every 4 hours. Maximum daily
dose for elderly patients is 2 g of acetylsalicylic acid and 1 g of ascorbic acid.
You should not take more than 5 tablets per day.
Method of administration
Oral use. The effervescent tablet should be dissolved in a glass of water and the prepared solution should
be taken immediately after dissolution. Take after meals.
Frequency of use
Regular administration of the medicine will help avoid fluctuations in pain and fever intensity. The interval
between consecutive doses should be at least 4 hours. Do not exceed the maximum daily doses.
Duration of treatment
If, despite taking the medicine, painful symptoms persist for more than 5 days or fever for more than 3 days,
you should consult your doctor.

Taking a higher dose of Upsarin C than recommended

Upsarin C overdose can be caused by prolonged use of the medicine or overdose due to accidental ingestion,
which can be life-threatening, especially in the elderly and small children.
Symptoms of overdose are: headaches and dizziness, tinnitus, feeling of hearing loss, which may resolve after
reducing the dose of the medicine taken.
In the case of severe poisoning, the following may occur: hyperventilation (too deep and intense breathing,
which causes excessive elimination of CO2 from the blood), fever, respiratory alkalosis, metabolic acidosis,
cardiovascular shock, respiratory failure, and severe hypoglycemia (reduced glucose levels in the blood),
coma.

Missing a dose of Upsarin C

You should not take a double dose to make up for a missed dose.
If you have any doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Related to acetylsalicylic acid

Infections and infestations
Reye's syndrome.
Nervous system disorders
Headaches, dizziness, feeling of hearing loss, tinnitus, which are usually symptoms of overdose.
Gastrointestinal disorders
Nausea, vomiting, diarrhea, bloating, constipation, dyspepsia, abdominal pain, black stools, bloody
vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease. Gastric or duodenal
ulcer, perforation, gastrointestinal bleeding.
Blood and lymphatic system disorders
Increased risk of bleeding, bleeding (nosebleeds, gum bleeding, petechiae, etc.), prolonged bleeding time,
prothrombin time, thrombocytopenia. The risk of bleeding may persist for 4 to 8 days after discontinuation of
acetylsalicylic acid. This may increase the risk of bleeding during surgery.
Cerebral hemorrhage and intracranial hemorrhage.
Immune system disorders
Urticaria, bronchial asthma, skin reactions, anaphylactic reactions, angioedema.
Cardiovascular disorders
Reports of edema, hypertension, and heart failure associated with NSAID treatment.
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 hemolysis in individuals with glucose-6-phosphate
dehydrogenase (G6PD) deficiency.
Nervous system disorders
Dizziness.
Gastrointestinal disorders
At doses greater than 1 g/day, there is a possibility of gastrointestinal disturbances (heartburn, diarrhea,
abdominal pain).
Skin and subcutaneous tissue disorders
Urticaria, rash.
Renal and urinary disorders
At doses greater than 1 g/day, there is a possibility of urinary disorders (oxalate, cystine, and/or uric acid
stones).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor,
pharmacist, or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Upsarin C

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. After using the medicine, the tube should be tightly closed to protect the
medicine from moisture.
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 specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how
to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Upsarin C contains

The active substances of the medicine are: acetylsalicylic acid 330 mg and ascorbic acid 200 mg.
The other ingredients are: sodium bicarbonate, anhydrous citric acid, sodium benzoate (E211), povidone.

What Upsarin C looks like and what the packaging contains

Effervescent tablet.
Packaging: polypropylene tube with a polyethylene cap containing a desiccant (molecular sieve), with a
security ring, containing 10 effervescent tablets in a cardboard box.
The cardboard box contains 1 or 2 tubes of 10 effervescent tablets each.

Marketing authorization 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
To obtain more detailed information about this medicine, you should contact the local representative of the
marketing authorization holder:
MagnaPharm Poland sp. z o.o.
ul. Inflancka 4
00-189 Warsaw
tel: +48 22 570 27 00

Date of last revision of the leaflet: