Laboratoria polfa łódź for cold and flu lemon flavor

Package leaflet: Information for the patient

Laboratoria PolfaLodz COLD AND FLU lemon flavour,
500 mg + 300 mg + 200 mg, effervescent powder
(Acetylsalicylic acid + Ascorbic acid + Calcium)
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, consult your doctor.

Table of contents of the leaflet:

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

1. What Laboratoria PolfaLodz COLD AND FLU lemon flavour is and what it is used for

Laboratoria PolfaLodz COLD AND FLU lemon flavour 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 properties.
Ascorbic acid (vitamin C) and calcium support normal function of blood vessel walls. They reduce vascular permeability and exert anti-exudative and anti-edematous effects.
Laboratoria PolfaLodz COLD AND FLU lemon flavour contains substances enabling rapid and complete dissolution of ingredients in water. This ensures good absorption and tolerability.
Medicine with analgesic, antipyretic, and anti-inflammatory action.
Indicated for the treatment of:

• symptoms of cold and flu;
• fever;
• muscle and joint pain;
• headache, including migraine;
• toothache;
• neuralgia.

If no improvement occurs or if you feel worse after 3 to 5 days, consult your doctor.

2. Important information before using the medicine Laboratoria PolfaLodz COLD

AND FLU lemon-flavoured
When not to use the medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured
if the patient is allergic to acetylsalicylic acid (present in many medicines 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 peptic ulcer disease of the stomach or duodenum; inflammatory conditions of the
gastrointestinal tract;
if the patient has increased tendency to bruising or bleeding (bleeding diathesis, coagulation disorders);
if the patient is taking anticoagulant medicines, inhibiting platelet aggregation;
if the patient has acid-base balance disorders (diabetes, uraemia, tetany);
if the patient has significantly increased calcium levels in blood;
if the patient has a history of bronchial asthma attacks triggered by
administration of salicylates or substances with similar action, particularly non-steroidal 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 last trimester of pregnancy;
if the patient has phenylketonuria (a genetic disorder characterized by deficiency of an enzyme
called phenylalanine hydroxylase);
in children under 12 years of age during viral infection, as it may cause
a rare condition known as Reye's syndrome;
do not administer simultaneously with methotrexate taken at doses of 15 mg per week or
higher.
Warnings and precautions
Exercise special caution when using the medicine Laboratoria PolfaLodz COLD AND FLU
lemon-flavoured:
if the patient is allergic to other medicines from the group of non-steroidal anti-inflammatory drugs;
if the patient has allergies (e.g. hay fever) or asthma;
if the female patient has uterine 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 gastric or intestinal ulcers, or gastrointestinal bleeding;
if the patient has mild kidney or liver disease;
if the patient has moderate heart failure (heart disease which may manifest as
shortness of breath and swelling of the feet);
if the female patient uses an intrauterine contraceptive device;
if the patient has hypertension;
if the patient lacks 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 impaired kidney function and in patients monitoring
sodium intake in their diet;
the medicine contains a source of phenylalanine. It may be harmful to patients with phenylketonuria.
Other important information:
Taking medicines containing acetylsalicylic acid may be associated with a slight
increased 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 or longer treatment duration
than recommended 3–5 days.
In case of heart disorders, previous stroke, or suspicion of risk of such disorders
(e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking), discuss the treatment approach with a doctor or pharmacist.
Young people and children suffering from viral infection (with or without fever) should not
take the medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured without
consulting a doctor. Otherwise, Reye's syndrome – a rare but life-threatening condition – may occur.
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used by the patient, as well as about medicines the patient plans to use.
The medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured must not be used
simultaneously with methotrexate taken at doses of 15 mg per week or higher, as this increases the toxic effect of methotrexate on bone marrow.
Concomitant use of selective serotonin reuptake inhibitors (SSRIs, medicines used, among others, for depression) with acetylsalicylic acid increases the risk of upper gastrointestinal bleeding due to synergistic action of these medicines.
The medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured should not be used
if the patient is simultaneously taking:
anticoagulants, inhibiting platelet aggregation (e.g. coumarin derivatives, heparin,
ticlopidine);
antidiabetic medicines (insulin, sulfonylurea derivatives);
sulfonamides (used for bacterial infections);
phenytoin or valproic acid (antiepileptic medicines);
digoxin (used in treatment of heart failure);
methotrexate at doses lower than 15 mg (used, among others, in cancer diseases
and rheumatoid arthritis).
The medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured may cause weakening or intensification of the effect of other medicines. Special caution is required when taking concomitantly:
corticosteroids and other non-steroidal anti-inflammatory drugs, as this may lead to adverse effects on the gastrointestinal tract and kidney damage;
cardiac glycosides (digoxin and strophanthin derivatives, medicines used in heart diseases) as cardiac arrhythmias may occur;
medicines used to treat gout (e.g. probenecid);
diuretics (e.g. furosemide, thiazide diuretics);
medicines lowering blood pressure (captopril, enalapril);
amphetamine derivatives;
tricyclic antidepressants (e.g. opipramol, doxepin);
fluorine compounds;
certain antibiotics (fluoroquinolones and tetracyclines, medicines used for bacterial infections); a 3-hour interval should be maintained between these medicines and the medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured;
vitamin D and calcium channel blockers (a group of medicines used for hypertension).
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured with food, drink and
alcohol
It is recommended to take the medicine after a meal.
Drinking alcohol during treatment may intensify the irritating effect of acetylsalicylic acid
on the gastrointestinal tract.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Do not use the medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured during
pregnancy and breastfeeding.
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured may adversely affect
fertility in women. This effect is transient and resolves after discontinuation of treatment.
Driving and operating machinery
The medicine Laboratoria PolfaLodz COLD AND FLU lemon-flavoured, when used at recommended
doses, has no effect or negligible effect on the ability to drive
vehicles and operate machinery.
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured contains sodium.
The medicine contains 178–356 mg of sodium per dose (1–2 sachets); this should be taken into account in patients with
impaired kidney function and in patients monitoring sodium content in their diet.
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured contains aspartame – a source
of phenylalanine. It may be harmful to patients with phenylketonuria.
Laboratoria PolfaLodz COLD AND FLU lemon-flavoured contains a small amount of
sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking the medicine.
The ascorbic acid (vitamin C) contained in the medicine may interfere with the results of certain tests performed by redox methods (e.g. determination of glucose or creatinine in blood and urine, faecal occult blood testing).

3. How to use the medicine Laboratoria PolfaLodz COLD AND FLU lemon flavour

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine Laboratoria PolfaLodz COLD AND FLU lemon flavour is indicated for use in adults and children aged over 12 years.
Recommended dose:
Adults:
1 or 2 sachets 3 times daily.
Maximum daily dose is 6 sachets.
Elderly patients (over 65 years of age):
1 sachet 3 times daily.
Maximum daily dose is 3 sachets.
Use in children and adolescents
Children over 12 years of age:
1 sachet 3 times daily.
Maximum daily dose is 3 sachets.
Dissolve the contents of one sachet in ½ glass of lukewarm water, stir and drink.
It is recommended to take the medicine after a meal.
Do not use Laboratoria PolfaLodz COLD AND FLU lemon flavour for longer than the recommended 3–5 days.
Taking more than the recommended dose of Laboratoria PolfaLodz COLD AND FLU lemon flavour
If a dose exceeding the recommended daily dose is accidentally taken, symptoms of overdose may occur (related to the presence of acetylsalicylic acid): rapid breathing, nausea, vomiting, visual and hearing disturbances (tinnitus), headache and dizziness, acid-base and electrolyte imbalances (e.g. potassium deficiency), decreased blood glucose concentration, skin changes.
In case of acute poisoning, the following may occur: delirium, tremor, shortness of breath, excessive sweating, psychomotor agitation, high fever, coma.
If an overdose is taken, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Laboratoria PolfaLodz COLD AND FLU lemon flavour
Laboratoria PolfaLodz COLD AND FLU lemon flavour is taken as needed. If a dose is missed and symptoms persist, take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.
Stopping the use of Laboratoria PolfaLodz COLD AND FLU lemon flavour
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
You should contact your doctor if any of the following serious adverse effects occur:

• gastrointestinal bleeding appearing as coffee-ground vomit or tarry stools;
• erosion of the gastrointestinal mucosa;
• allergic reactions (such as severe breathing difficulties or wheezing, shortness of breath).

Other adverse effects may also occur:

• increased risk of bleeding;
• exacerbation or recurrence of peptic ulcer disease;
• nausea, vomiting, abdominal pain;
• increased menstrual bleeding;
• skin reactions: erythema, urticaria;
• edema;
• hypertension;
• heart failure;
• dizziness;
• tinnitus;
• sweating.

Medicines containing acetylsalicylic acid may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
The medicine, when used at recommended doses, is generally well tolerated.
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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921301
Fax: +48 22 4921309
Email: [email protected]
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 the medicine Laboratoria PolfaLodz PRZEZIEBIENIE I GRYPA lemon flavour

lemon flavour
Do not store above 25°C.
Keep 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 stated month. Do not use the medicine if you notice
any changes in the appearance of the powder in the sachets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Laboratoria PolfaŁódź COLD AND FLU lemon flavour contains

• The active substances are:
  • acetylsalicylic acid 500 mg
  • ascorbic acid (vitamin C) 300 mg
  • calcium (as calcium lactogluconate) 200 mg
• Other ingredients (excipients) are: sodium hydrogen carbonate, anhydrous citric acid, povidone K-25, lemon flavour, aspartame, beta-carotene 1% (contains sucrose), sodium lauryl sulphate.

What Laboratoria PolfaŁódź COLD AND FLU lemon flavour looks like and contents of the pack
The medicine is a yellow effervescent granular powder, packed in sachets.
The outer packaging – a cardboard box – contains 6, 8, 10, 14, 20 or 28 sachets and the patient information leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
URGO Sp. z o.o.
Al. Jerozolimskie 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
ul. gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki