Laboratoria Polfavudi Pzheziembienie i Gripa smak citrinovi

Leaflet attached to the packaging: patient information

Laboratoria PolfaŁódź COLD AND FLU lemon flavor,

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.

• 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 a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions 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 lemon flavor and what is it used for
• 2. Important information before using Laboratoria PolfaŁódź COLD AND FLU lemon flavor
• 3. How to use Laboratoria PolfaŁódź COLD AND FLU lemon flavor
• 4. Possible side effects
• 5. How to store Laboratoria PolfaŁódź COLD AND FLU lemon flavor
• 6. Contents of the packaging and other information

1. What is Laboratoria PolfaŁódź COLD AND FLU lemon flavor

and what is it used for
Laboratoria PolfaŁódź COLD AND FLU lemon flavor 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-exudative effects.
Laboratoria PolfaŁódź COLD AND FLU lemon flavor contains substances that allow for rapid and complete dissolution of the ingredients in water. Thanks to this, it is easily absorbed and well tolerated.
A medicine with analgesic, antipyretic, and anti-inflammatory effects.
Treatment of:

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

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

2. Important information before using Laboratoria PolfaŁódź COLD AND FLU

lemon flavor

When not to use Laboratoria PolfaŁódź COLD AND FLU lemon flavor

if the patient is allergic to acetylsalicylic acid (found in many medications used for colds and flu) or other salicylates, ascorbic acid, calcium or any of the other ingredients of this medicine (listed in section 6);
if the patient has active stomach or duodenal ulcers; 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, antiplatelet agents;
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 induced 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 called phenylalanine hydroxylase);
in children under 12 years of age with viral infections, as it may cause the occurrence of a rare disease called Reye's syndrome;
do not administer simultaneously with methotrexate used in doses of 15 mg per week or higher.

Warnings and precautions

Particular caution should be exercised when using Laboratoria PolfaŁódź COLD AND FLU lemon flavor:
if the patient is allergic 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 is scheduled for surgery (do not take the medicine 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 uses 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 on a low-sodium diet: the medicine contains 178-356 mg of sodium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling sodium intake in their diet;
the medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Other important information:
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 of the medicine. Do not use higher doses and longer treatment periods than recommended 3-5 days.
In case of heart disorders, previous stroke or suspected risk of these disorders (e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking) consult your doctor or pharmacist about the treatment method.
Young people and children suffering from viral infections (with or without fever) should not take Laboratoria PolfaŁódź COLD AND FLU lemon flavor without consulting a doctor. Otherwise, they may develop Reye's syndrome - a rare but life-threatening disease.

Laboratoria PolfaŁódź COLD AND FLU lemon flavor and other medicines

Tell your doctor or pharmacist about all the medicines you are currently taking, as well as those you plan to take.
Do not use Laboratoria PolfaŁódź COLD AND FLU lemon flavor simultaneously with methotrexate used in doses of 15 mg per week or higher, as it increases the toxic effect of methotrexate on the bone marrow.
Using selective serotonin reuptake inhibitors (SSRIs, medications used for depression) simultaneously with acetylsalicylic acid increases the risk of bleeding from the upper gastrointestinal tract due to the synergistic effect of these medications.
Do not use Laboratoria PolfaŁódź COLD AND FLU lemon flavor if you are taking:
anticoagulant medications, antiplatelet agents (e.g. coumarin derivatives, heparin, ticlopidine);
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 in doses less than 15 mg (used in cancer and rheumatoid arthritis).
Laboratoria PolfaŁódź COLD AND FLU lemon flavor may weaken or enhance the effect of other medications. Particular caution should be exercised when taking:
corticosteroids and other nonsteroidal anti-inflammatory drugs, as gastrointestinal side effects and kidney damage may occur;
cardiac glycosides (digoxin and strophanthin derivatives, medications used for heart disease) as cardiac arrhythmias may occur;
medications used to treat gout (e.g. probenecid);
diuretics (e.g. furosemide, thiazide medications);
blood pressure lowering medications (captopril, enalapril);
amfetamine derivatives;
tricyclic antidepressants (e.g. opipramol, doxepin);
fluorine 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 lemon flavor;
vitamin D and calcium channel blockers (a group of medications used in hypertension).

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

The medicine is recommended to be taken after a meal.
Drinking alcohol while taking the medicine may enhance the irritating effect of acetylsalicylic acid on the digestive tract.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Laboratoria PolfaŁódź COLD AND FLU lemon flavor during pregnancy and breastfeeding.
Laboratoria PolfaŁódź COLD AND FLU lemon flavor may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving vehicles and operating machines

Laboratoria PolfaŁódź COLD AND FLU lemon flavor used in recommended doses has no effect or a negligible effect on the ability to drive vehicles and operate machines.

Laboratoria PolfaŁódź COLD AND FLU lemon flavor 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 controlling sodium intake in their diet.
Laboratoria PolfaŁódź COLD AND FLU lemon flavor contains aspartame- a source of phenylalanine. It may be harmful to patients with phenylketonuria.

Laboratoria PolfaŁódź COLD AND FLU lemon flavor contains a small amount of sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The ascorbic acid (vitamin C) contained in the medicine may affect the results of some tests performed using redox methods (e.g. glucose or creatinine measurement in blood and urine, stool test for occult blood).

3. How to use Laboratoria PolfaŁódź COLD AND FLU lemon flavor

This medicine should always be used exactly as described in the patient leaflet or as directed by
a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Laboratoria PolfaŁódź COLD AND FLU lemon flavor 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 lukewarm water, mixed and drunk.
The medicine is recommended to be taken after a meal.
Do not use Laboratoria PolfaŁódź COLD AND FLU lemon flavor for longer than the recommended 3-5 days.

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

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 ingestion of a higher dose than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Laboratoria PolfaŁódź COLD AND FLU lemon flavor

Laboratoria PolfaŁódź COLD AND FLU lemon flavor is used as needed. If a dose is missed and symptoms persist, take the next dose of the medicine.
Do not take a double dose to make up for the missed dose.

Stopping the use of Laboratoria PolfaŁódź COLD AND FLU lemon flavor

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Consult your doctor if you experience any of the following serious side effects:

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

Other side effects may also occur:

• increased risk of bleeding;
• exacerbation or recurrence of stomach ulcers;
• nausea, vomiting, abdominal pain;
• increased menstrual bleeding;
• skin changes: rash, urticaria;
• edema;
• hypertension;
• heart failure;
• dizziness;
• tinnitus;
• excessive 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 used in recommended doses is generally well tolerated.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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 lemon flavor

Do not store above 25°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of the 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 specified month. Do not use the medicine if you notice a change in the appearance of the powder in the sachets.
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. Contents of the packaging and other information

What does Laboratoria PolfaŁódź COLD AND FLU lemon flavor 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
• The other ingredients (excipients) are: sodium bicarbonate, anhydrous citric acid, povidence K-25, lemon flavor, aspartame, beta-carotene 1% (contains sucrose), sodium lauryl sulfate.

What does Laboratoria PolfaŁódź COLD AND FLU lemon flavor look like and what does the packaging contain

The medicine is a yellow, effervescent powder, packaged in sachets.
The outer packaging - a cardboard box, contains 6, 8, 10, 14, 20 or 28 sachets and a patient information leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

SENSILAB Polska Spółka z ograniczoną odpowiedzialnością – Spółka komandytowo-akcyjna
General Langiewicz Street 58
95-050 Konstantynów Łódzki
Date of last update of the leaflet:September 2022