Laboratoria Polfavudi Pzheziembienie i Gripa

Leaflet attached to the packaging: patient information

Laboratoria PolfaŁódź COLD AND FLU

500 mg + 300 mg + 200 mg, effervescent powder

(Acetylsalicylic acid + Ascorbic acid + Calcium)

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 used exactly as described in the patient leaflet or as directed by
a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, they should contact their doctor .

Table of contents of the leaflet:

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

1. What is Laboratoria PolfaŁódź COLD AND FLU and what is it used for

used for
Laboratoria PolfaŁódź COLD AND FLU contains acetylsalicylic acid, ascorbic acid (vitamin C) and calcium.
Acetylsalicylic acid belongs to the group of non-steroidal 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 a decongestant and anti-edematous effect.
Laboratoria PolfaŁódź COLD AND FLU contains substances that enable rapid and complete dissolution of the ingredients in water. Thanks to this, it is easily absorbed and well tolerated.
The medicine is used to treat:

• symptoms of cold and flu, fever, muscle and joint pains, headaches, including migraines, toothaches, neuralgia.

If after 3-5 days there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Laboratoria PolfaŁódź COLD AND FLU

COLD AND FLU

When not to take Laboratoria PolfaŁódź COLD AND FLU

If the patient is allergic (hypersensitive) to acetylsalicylic acid or other salicylates, ascorbic acid, calcium or any of the other ingredients of the medicine.
If the patient has active stomach or duodenal ulcer; inflammatory conditions of the digestive tract.
If the patient has an increased tendency to bruising or bleeding (hemorrhagic diathesis, blood coagulation disorders).
If the patient is taking anticoagulant medications, platelet aggregation inhibitors.
If the patient has disturbances of acid-base balance (diabetes, uremia, tetany).
If the patient has significantly elevated blood calcium levels.
If the patient has asthma and nasal polyps.
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 pregnant or breastfeeding.
If the patient has phenylketonuria (a genetic disease characterized by a deficiency of the enzyme called phenylalanine hydroxylase).
In children under 12 years of age suffering from chickenpox or flu, as this may cause the occurrence of a rare but serious disease called Reye's syndrome.

Warnings and precautions

Before starting treatment with Laboratoria PolfaŁódź COLD AND FLU, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Laboratoria PolfaŁódź COLD AND FLU:
if the patient is allergic (hypersensitive) to other non-steroidal 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 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 intestinal ulcers, as well as gastrointestinal bleeding.
if the patient has mild kidney or liver disease.
if the patient has moderate heart failure (heart disease that may manifest as shortness of breath and swelling of the feet).
if the patient is using an intrauterine contraceptive device.
if the patient has high blood pressure.
if the patient's body does not produce the enzyme called glucose-6-phosphate dehydrogenase.
if the patient is over 65 years old.
if the patient is on a low-sodium diet.
Other important information:
In the event of heart disorders, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), the patient should discuss the treatment with their doctor or pharmacist.
Taking medications containing acetylsalicylic acid, such as Laboratoria PolfaŁódź COLD AND FLU, 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 of the medicine. The patient should not take higher doses or use the medicine for longer than the recommended 3-5 days.

Children and adolescents

Using medications containing acetylsalicylic acid, such as Laboratoria PolfaŁódź COLD AND FLU, in children under 12 years of age with viral infections such as chickenpox or flu may cause the occurrence of a rare disease that damages the liver and brain, called Reye's syndrome.

Laboratoria PolfaŁódź COLD AND FLU 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.
Laboratoria PolfaŁódź COLD AND FLU should not be taken if the patient is also taking:
anticoagulant medications, platelet aggregation inhibitors (e.g. coumarin derivatives, heparin, ticlopidine), as they may increase the risk of bleeding and prolong bleeding time,
antidiabetic medications (insulin, sulfonylurea derivatives),
sulfonamides (used in bacterial infections),
phenytoin or valproic acid (antiepileptic medications),
digoxin (used in the treatment of heart failure),
methotrexate (used in cancer and rheumatoid arthritis),
Laboratoria PolfaŁódź COLD AND FLU may weaken or enhance the effect of other medicines. Particular caution should be exercised when taking:
corticosteroids and other non-steroidal anti-inflammatory drugs, as gastrointestinal side effects and kidney damage may occur,
cardiac glycosides (digoxin and strophanthin derivatives, medications used in heart disease), as cardiac arrhythmias may occur,
medications used in the treatment of gout (e.g. probenecid),
diuretics (e.g. furosemide, thiazide medications),
blood pressure-lowering medications (e.g. captopril, enalapril),
amfetamine derivatives,
tricyclic antidepressants (e.g. opipramol, doxepin),
fluoride compounds,
certain antibiotics (fluoroquinolones and tetracyclines, medications used in bacterial infections); a 3-hour interval should be maintained between these medications and Laboratoria PolfaŁódź COLD AND FLU,
vitamin D and calcium channel blockers (a group of medications used in hypertension).

Laboratoria PolfaŁódź COLD AND FLU with food, drink, and alcohol

The medicine should be taken after a meal.
Drinking 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, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Laboratoria PolfaŁódź COLD AND FLU should not be taken during pregnancy and breastfeeding.
Laboratoria PolfaŁódź COLD AND FLU may cause fertility problems in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

Laboratoria PolfaŁódź COLD AND FLU, when used in the recommended doses, has no or negligible influence on the ability to drive and use machines.

Laboratoria PolfaŁódź COLD AND FLU contains sodium

The medicine contains 178-356 mg of sodium per dose(1-2 sachets), which should be taken into account in patients with reduced kidney function and in patients on a controlled sodium diet.
Laboratoria PolfaŁódź COLD AND FLU contains aspartame– a source of phenylalanine.
This may be harmful to patients with phenylketonuria.
Ascorbic acid (vitamin C) contained in the medicine may interfere with the results of certain tests performed using redox methods (e.g. glucose or creatinine determination in blood and urine, fecal occult blood test).

3. How to take Laboratoria PolfaŁódź COLD AND FLU

This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Laboratoria PolfaŁódź COLD AND FLU is indicated for use in adults and children over 12 years of age.
Recommended dose:
Adults:
1 or 2 sachets 3 times a day.
Maximum daily dose is 6 sachets.
Patients over 65 years of age:
1 sachet 3 times a day.
Maximum daily dose is 3 sachets.

Use in children and adolescents

Children over 12 years of age:
1 sachet 3 times a day.
Maximum daily dose is 3 sachets.
The contents of one sachet should be dissolved in ½ glass of cold water, mixed, and drunk.
The medicine should be taken after a meal.
The medicine should not be taken for longer than the recommended 3-5 days.

Using a higher dose of Laboratoria PolfaŁódź COLD AND FLU than recommended

AND FLU

In the event 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 the case of acute poisoning, the following may occur: hallucinations, tremors, shortness of breath, excessive sweating, psychomotor agitation, high fever, coma.
In the event of taking a higher dose than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Laboratoria PolfaŁódź COLD AND FLU

Laboratoria PolfaŁódź COLD AND FLU is used as needed. If a dose is missed and symptoms persist, the next dose should be taken. A double dose should not be taken to make up for a missed dose.

Stopping treatment with Laboratoria PolfaŁódź COLD AND FLU

In case of any further doubts related to the use of the medicine, the patient should consult their 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 in case of the following serious side effects:

• gastrointestinal bleeding in the form of coffee ground vomiting and black stools,
• gastric mucosa erosion,
• allergic reactions (such as severe breathing difficulties or wheezing, shortness of breath).

Other side effects may also occur:

• increased risk of bleeding,
• worsening or recurrence of stomach ulcers,
• nausea, vomiting, abdominal pain,
• increased menstrual bleeding,
• skin changes: rash, urticaria,
• 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.
The medicine is generally well tolerated when used in the recommended doses.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail:
ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Laboratoria PolfaŁódź COLD AND FLU

The medicine should be stored out of sight and reach of children.
It should not be stored at a temperature above 25°C.
It should be stored in the original packaging to protect it from moisture.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month. The medicine should not be used if the appearance of the powder in the sachets has changed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 does Laboratoria PolfaŁódź COLD AND FLU contain

• The active substances of the medicine are: acetylsalicylic acid 500 mg
• ascorbic acid (vitamin C) 300 mg
• calcium (in the form of calcium lactogluconate) 200 mg
• Other ingredients (excipients) are: sodium bicarbonate (178 mg of sodium ions), citric acid anhydrous, aspartame, grapefruit flavor, sodium lauryl sulfate, beta-carotene 1%, povidone K-25.

What Laboratoria PolfaŁódź COLD AND FLU looks like and what the packaging contains

The medicine is in the form of an effervescent powder packed in sachets.
The outer packaging – a cardboard box containing 6, 10, 14, 20 or 28 sachets and a patient leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

URGO Sp. z o.o.
Jerozolimskie Avenue 142 B
02-305 Warsaw
tel/fax:
22 616 33 48 / 22 617 69 21

Manufacturer

SENSILAB Polska Spółka z ograniczoną odpowiedzialnością – Spółka komandytowo-akcyjna
gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
Date of last revision of the leaflet:September 2022