LABORATORY POLFAŁÓDŹ COLD AND FLU

Package leaflet: Information for the patient

Laboratoria PolfaLodz COLD AND FLU
500 mg + 300 mg + 200 mg, effervescent powder
(Acetylsalicylic acid + Ascorbic acid + Calcium)
Please read carefully the entire leaflet before taking 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3-5 days, or if your condition worsens, consult your doctor.

Table of contents:

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

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

Laboratoria PolfaLodz 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 acts as an antipyretic, analgesic, and anti-inflammatory agent.
Ascorbic acid (vitamin C) and calcium support normal vascular wall function. They reduce vascular permeability and exert anti-exudative and anti-edematous effects.
Laboratoria PolfaLodz COLD AND FLU contains ingredients enabling rapid and complete dissolution of its components in water. This ensures good absorption and tolerability.
This medicine is indicated for the treatment of:

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

If there is no improvement after 3-5 days, or if your condition worsens, consult your doctor.

2. Important information before using Laboratoria PolfaŁódź COLD AND FLU

When not to use Laboratoria PolfaŁódź COLD AND FLU
Do not use the medicine if the patient is allergic (hypersensitive) to acetylsalicylic acid or other salicylates, ascorbic acid, calcium, or any of the other ingredients of the medicine.
Do not use if the patient has active peptic ulcer disease of the stomach or duodenum; inflammatory conditions of the gastrointestinal tract.
Do not use if the patient has an increased tendency to bruising or bleeding (bleeding diathesis, coagulation disorders).
Do not use if the patient is taking anticoagulant drugs or drugs that inhibit platelet aggregation.
Do not use if the patient has acid-base balance disorders (e.g. diabetes, uremia, tetany).
Do not use if the patient has significantly elevated blood calcium levels.
Do not use if the patient has asthma and nasal polyps.
Do not use if the patient has severe kidney disease.
Do not use if the patient has severe liver disease.
Do not use if the patient has severe heart failure.
Do not use if the patient is pregnant or breastfeeding.
Do not use if the patient has phenylketonuria (a genetic disorder characterized by deficiency of the enzyme phenylalanine hydroxylase).
Do not use in children under 12 years of age suffering from chickenpox or influenza, as this may lead to the development of a rare but serious condition called Reye’s syndrome.

Warnings and precautions
Before starting treatment with Laboratoria PolfaŁódź COLD AND FLU, consult a doctor or pharmacist.
Exercise special caution when using Laboratoria PolfaŁódź COLD AND FLU:

• if the patient is allergic (hypersensitive) to other nonsteroidal anti-inflammatory drugs (NSAIDs).
• if the patient has allergies (e.g. hay fever) or asthma.
• if the female patient experiences 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 in the past.
• if the patient has mild kidney or liver disease.
• if the patient has moderate heart failure (a heart condition that may present with 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 glucose-6-phosphate dehydrogenase.
• if the patient is over 65 years of age.
• if the patient is on a low-sodium diet.

Other important information:
In case of heart disorders, history of stroke, or suspected risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with a doctor or pharmacist.
Taking medicines 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. Do not use higher doses or longer treatment duration than recommended (3–5 days).

Children and adolescents
The use of medicines containing acetylsalicylic acid, such as Laboratoria PolfaŁódź COLD AND FLU, in children under 12 years of age with chickenpox or influenza virus infections may lead to the development of a rare condition causing liver and brain damage known as Reye’s syndrome.

Laboratoria PolfaŁódź COLD AND FLU and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not use Laboratoria PolfaŁódź COLD AND FLU if the patient is simultaneously taking:

• anticoagulants or drugs that inhibit platelet aggregation (e.g. coumarin derivatives, heparin, ticlopidine), as they may increase the risk of bleeding and prolong bleeding time;
• antidiabetic drugs (insulin, sulfonylurea derivatives);
• sulfonamides (used in bacterial infections);
• phenytoin or valproic acid (antiepileptic drugs);
• digoxin (used in heart failure treatment);
• methotrexate (used, among others, in cancer and rheumatoid arthritis).

Laboratoria PolfaŁódź COLD AND FLU may weaken or enhance the effects of other medicines. Exercise particular caution when taking concomitantly:

• corticosteroids and other nonsteroidal anti-inflammatory drugs (NSAIDs), as this may lead to adverse gastrointestinal effects and kidney damage;
• cardiac glycosides (derivatives of digoxin and strophanthin, drugs used in heart diseases), as cardiac arrhythmias may occur;
• drugs used in the treatment of gout (e.g. probenecid);
• diuretics (e.g. furosemide, thiazide diuretics);
• antihypertensive drugs (captopril, enalapril);
• amphetamine derivatives;
• tricyclic antidepressants (e.g. opipramol, doxepin);
• fluorine compounds;
• certain antibiotics (fluoroquinolones and tetracyclines, used in bacterial infections); a 3-hour interval should be maintained between these antibiotics and Laboratoria PolfaŁódź COLD AND FLU;
• vitamin D and calcium channel blockers (a group of drugs used in hypertension).

Laboratoria PolfaŁódź COLD AND FLU with food, drink, and alcohol
The medicine should be taken after a meal.
Consuming alcohol during treatment may intensify the irritating effect of acetylsalicylic acid on the gastrointestinal tract.

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.
Do not use Laboratoria PolfaŁódź COLD AND FLU during pregnancy or breastfeeding.
Laboratoria PolfaŁódź COLD AND FLU may cause reversible impairment of fertility in women. This effect reverses after discontinuation of treatment.

Driving and operating machinery
Laboratoria PolfaŁódź COLD AND FLU, when used at recommended doses, has no effect or a negligible effect on the ability to drive vehicles or operate machinery.

Laboratoria PolfaŁódź COLD AND FLU 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 on a controlled sodium diet.

Laboratoria PolfaŁódź COLD AND FLU contains aspartame – a source of phenylalanine.
May be harmful to patients with phenylketonuria.

The ascorbic acid (vitamin C) contained in the medicine may interfere with the results of certain tests based on redox methods (e.g. blood and urine glucose or creatinine tests, fecal occult blood testing).

3. How to use Laboratoria PolfaŁódź COLD AND FLU

This medicine should always be used exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Laboratoria PolfaŁódź COLD AND FLU is indicated for use in adults and children above 12 years of age.
Recommended dose:
Adults:
1 or 2 sachets three times daily.
Maximum daily dose is 6 sachets.
Elderly patients (over 65 years of age):
1 sachet three times daily.
Maximum daily dose is 3 sachets.
Use in children and adolescents
Children aged above 12 years:
1 sachet three times daily.
Maximum daily dose is 3 sachets.
Dissolve the contents of one sachet in half a glass of lukewarm water, mix well and drink.
It is recommended to take the medicine after meals.
Do not use Laboratoria PolfaŁódź COLD AND FLU for longer than the recommended 3–5 days.
Use of a higher than recommended dose of Laboratoria PolfaŁódź COLD AND FLU
If a dose exceeding the recommended daily dose is accidentally taken, symptoms of overdose (related to the presence of acetylsalicylic acid) may occur: increased breathing rate, nausea, vomiting, visual and hearing disturbances (tinnitus), dizziness and headache, acid-base and electrolyte imbalances (e.g. potassium deficiency), decreased blood glucose levels, skin reactions.
In cases of acute poisoning, symptoms may include: confusion, tremor, shortness of breath, excessive sweating, psychomotor agitation, high fever, coma.
If a higher than recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Laboratoria PolfaŁódź COLD AND FLU
Laboratoria PolfaŁódź COLD AND FLU is used 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.
Discontinuation of Laboratoria PolfaŁódź COLD AND FLU
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

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

Other adverse reactions 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.

The use of medicines containing acetylsalicylic acid may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
The medicine, when used at recommended doses, is generally well tolerated.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail:
[email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Laboratoria PolfaLodz COLD AND FLU

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month. Do not use the medicine if the appearance of the powder in the sachets has changed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Laboratoria PolfaŁódź COLD AND FLU contains

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

What Laboratoria PolfaŁódź COLD AND FLU looks like and contents of the pack
The medicine is in the form of effervescent granular powder packed in sachets.
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 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