Coldrex o smaku citrinovim

Patient Information Leaflet: User Information

Coldrex Lemon Flavor,

(750 mg + 10 mg + 60 mg)/ sachet, powder for oral solution preparation
Paracetamol + Phenylephrine Hydrochloride + Ascorbic Acid

Read the 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 information leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Coldrex Lemon Flavor and what is it used for
• 2. Important information before taking Coldrex Lemon Flavor
• 3. How to take Coldrex Lemon Flavor
• 4. Possible side effects
• 5. How to store Coldrex Lemon Flavor
• 6. Other information

1. What is Coldrex Lemon Flavor and what is it used for

Coldrex Lemon Flavor is a medicine with analgesic and antipyretic effects, constricting blood vessels in the nasal mucosa and reducing its congestion, thereby relieving nasal and sinus congestion. The medicine contains vitamin C (ascorbic acid).
Coldrex Lemon Flavor is indicated for the treatment of flu and cold symptoms such as: headaches, chills, sore throats, nasal and sinus congestion with pain.

2. Important information before taking Coldrex Lemon Flavor

When not to take Coldrex Lemon Flavor:

• if you are allergic to paracetamol, phenylephrine, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6).
• in patients taking monoamine oxidase inhibitors (MAOIs) and within 2 weeks after their discontinuation.
• in patients with hypertension,
• in patients with cardiovascular diseases,
• in patients with hyperthyroidism,
• in patients with diabetes,
• in patients with pheochromocytoma,
• in patients taking tricyclic antidepressants or beta-blockers (see section 4.5),
• in patients taking antihypertensive drugs (debrisoquine, guanethidine, reserpine, methyldopa)
• in patients with angle-closure glaucoma,
• in patients with severe coronary heart disease,
• in patients taking other sympathomimetic drugs (such as nasal decongestants, appetite suppressants, psychostimulants similar to amphetamines)
• in patients with liver or severe kidney failure
• in patients with alcoholism
• in patients taking zidovudine
• in children under 6 years of age.

Warnings and precautions

The medicine contains paracetamol.

Do not take with other medicinal products containing paracetamolor medicinal products used for colds and flu such as painkillers and
antipyretics.
Overdose of paracetamol may lead to irreversible liver damage.
The risk of overdose is higher in patients with alcoholic liver disease without cirrhosis.
Patients who have been diagnosed with liver or kidney dysfunction must consult a doctor before taking the medicine. The use of a medicinal product with paracetamol further increases the risk of liver damage in patients with liver disease.

Before taking the medicine, consult a doctor if:

• you have liver cell dysfunction (Child-Pugh score <9)
• you regularly consume alcohol
• you have kidney dysfunction
• you have Gilbert's syndrome (mild jaundice)
• you are taking other medicines that affect liver function
• you have a deficiency of glucose-6-phosphate dehydrogenase
• you have hemolytic anemia
• you have a glutathione deficiency
• you are dehydrated
• you have chronic malnutrition
• you are elderly, adult, or adolescent with a body weight below 50 kg
• you have urinary retention or prostate enlargement
• you have thromboembolic disease (e.g., Raynaud's syndrome) In these cases, special caution should be exercised.

While taking Coldrex Lemon Flavor, immediately inform your doctor if you experience severe illnesses, including severe kidney or septicemia (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a severe disease called metabolic acidosis (blood and body fluid disorder), when they took paracetamol in regular doses for a longer period or when they took paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
Liver damage is possible in individuals who have ingested more than 10 grams of paracetamol at once.
Consuming 5 grams of paracetamol may lead to liver damage in patients with the following risk factors:

• Patient taking carbamazepine, phenobarbital, phenytoin, primidone (medicines used, among others, in epilepsy), rifampicin (medicines used, among others, in tuberculosis), St. John's Wort (used, among others, in depression), or other liver enzyme-inducing drugs.
• Patient regularly abusing alcohol.
• Patient who may have a glutathione deficiency, e.g., with eating disorders, cystic fibrosis, HIV infection, malnourished, or exhausted. Chronic use of various types of painkillers for headache may worsen it. If such a situation occurs or is suspected, consult a doctor and discontinue treatment.

Caution should be exercised in patients with asthma who are also taking acetylsalicylic acid, as minor bronchospasm has been observed with paracetamol use (cross-reaction).
Keep the medicine out of the sight and reach of children.

Children

Do not give the medicine to children under 16 years of age.

Coldrex Lemon Flavor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Consult a doctor if you are taking the following medicines:

• anticoagulant medicines (e.g., warfarin) in case of a need for long-term use of painkillers,
• cholestyramine (used to reduce high cholesterol levels in the blood), probenecid,
• chloramphenicol,
• metoclopramide, domperidone (used against nausea and vomiting),
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid),
• digoxin and cardiac glycosides,
• monoamine oxidase inhibitors,
• other sympathomimetic amines,
• beta-adrenergic blockers and other antihypertensive medicines (including debryzochine, guanethidine, reserpine, methyldopa),
• tricyclic antidepressants (e.g., amitriptyline),
• ergot alkaloids (e.g., ergotamine and methysergide)
• flucloxacillin (an antibiotic), due to the serious risk of blood and body fluid disorders (called metabolic acidosis), which must be treated urgently (see section 2).

Concomitant use of paracetamol and medicines that increase liver metabolism, such as certain sedatives or antiepileptic drugs (e.g., phenobarbital, phenytoin, carbamazepine, St. John's Wort), and rifampicin may lead to liver damage even when using the recommended doses of paracetamol.
Salicylamide prolongs the elimination of paracetamol.
Caffeine enhances the analgesic effect of paracetamol.
Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Phenylephrine may enhance the blood pressure-increasing effect of labor-accelerating drugs.
Ascorbic acid increases iron absorption and increases aluminum absorption from aluminum-containing antacids.

Using Coldrex Lemon Flavor with alcohol

Do not drink alcohol while taking the medicine due to the increased risk of liver damage.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a pharmacist or doctor before taking this medicine.
This medicine should not be used during pregnancy. Administration of phenylephrine hydrochloride during pregnancy may cause congenital malformations and may also cause fetal hypoxia.
During breastfeeding, do not use without consulting a doctor. Phenylephrine may pass into breast milk.
There are no data on the effect of Coldrex Lemon Flavor on fertility.

Driving and using machines

Coldrex Lemon Flavor may cause dizziness. If you experience such symptoms, do not drive or operate machinery.
The medicine contains 2.9 grams of sucrose per dose.This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine.
The medicine contains 121 mg of sodium(the main component of common salt) in each sachet. This corresponds to 6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Coldrex Lemon Flavor

This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor, pharmacist, or nurse. If you are unsure, consult a doctor or pharmacist.

Adults and children over 16 years:

One sachet of Coldrex Lemon Flavor every 4 to 6 hours. Do not take the medicine more often than every 4 hours or take more than 4 sachets per day. Do not exceed the recommended dose.
Always use the lowest effective dose of the medicine.
Children and adolescents
Do not use in children and adolescents under 16 years of age.
Children under 6 years of age should not be given available over-the-counter medicines containing phenylephrine used for colds and coughs.
Elderly patients
Elderly patients, especially the weak or immobile, may require a reduced dose or reduced frequency of administration.
Kidney dysfunction
Patient with diagnosed kidney dysfunction must consult a doctor before taking the medicine. In the case of paracetamol administration to patients with kidney failure, it is recommended to reduce the dose and increase the minimum interval between each administration to at least 6 hours.
Liver dysfunction
Patient with diagnosed liver dysfunction or Gilbert's syndrome must consult a doctor before taking the medicine.

Method of administration

Before administration, the powder should be dissolved in hot water.
Pour the contents of one sachet into a glass, fill with hot water to half, mix well, and drink. If necessary, add cold water or sweeten.
Without consulting a doctor, the medicine should not be used regularly for more than 3 days.
If symptoms persist for more than 3 days or worsen, or if other symptoms occur, treatment should be discontinued and a doctor consulted.
Do not exceed the recommended daily dose or the specified number of doses due to the risk of liver damage.

Using a higher dose of Coldrex Lemon Flavor than recommended

In case of taking more than 4 sachets of the medicine within 24 hours, immediately consult a doctor, even if no side effects occur, due to the risk of delayed, irreversible liver damage.

Missing a dose of Coldrex Lemon Flavor

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects.
Coldrex Lemon Flavor used as recommended is well-tolerated.
Immediately stop taking the medicine and consult a doctor if you experience:

• allergic reaction (hypersensitivity) such as: skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin hypersensitivity reaction such as: sweating, rash, urticaria
• severe skin reaction (acute generalized exanthematous pustulosis, drug rash, Stevens-Johnson syndrome, and toxic epidermal necrolysis) characterized by a rash with pustules all over the body, erosions in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, giant blisters bursting, peeling of large skin flakes, weakness, fever, and joint pain,
• breathing difficulties, if you have experienced similar problems in the past when taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• bruises or bleeding of unknown cause,
• vision loss, which may be caused by excessively high intraocular pressure. This is very rare but possible in patients with glaucoma,
• abnormal rapid heartbeat or irregular heart rhythm,
• difficulty urinating, urinary retention. Urinary retention is most likely in men with prostate enlargement,
• cloudy urine,
• liver dysfunction.

These reactions occur rarely (more often than 1 in 10,000 but less often than 1 in 1,000 patients) or very rarely (less often than 1 in 10,000 patients).
Coldrex Lemon Flavor may also cause the following side effects, the frequency of which is unknown (cannot be estimated from the available data):

• headache,
• dizziness,
• insomnia,
• nervousness,
• increased blood pressure,
• nausea and vomiting
• a serious condition that can cause blood acidification (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

In some individuals, while taking Coldrex Lemon Flavor, other side effects may occur. If you experience other side effects not mentioned in this leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, 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: 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 Coldrex Lemon Flavor

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 stated month.
Store in a dry place.
Medicines should 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 packaging and other information

What Coldrex Lemon Flavor contains

• The active substances of the medicine are: paracetamol, phenylephrine hydrochloride, and ascorbic acid (vitamin C). Each sachet (5 grams of powder) contains 750 mg of paracetamol, 10 mg of phenylephrine hydrochloride, and 60 mg of ascorbic acid.
• The other ingredients are: ethylcellulose, anhydrous citric acid, sodium saccharin, lemon flavor 100% AP05.51, lemon flavor 52293/TP05.51, quinoline yellow (E104), sodium citrate, crystalline sucrose.

What Coldrex Lemon Flavor looks like and what the packaging contains

The medicine is a light yellow powder in sachets.
The packaging contains 5 or 10 sachets.

Marketing authorization holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
tel.: +48 (22) 852 55 51

Manufacturer

SmithKline Beecham S.A.
Ctra. De Ajalvir, Km 2 500
28806 Alcala de Henares
Madrid
Spain

Date of leaflet approval:

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.