Coldrex Iunior C

Leaflet attached to the packaging: information for the user

Coldrex Junior C

300 mg + 5 mg + 20 mg, powder for oral solution

Paracetamol + Phenylephrine hydrochloride + Ascorbic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, 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, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Coldrex Junior C and what is it used for
• 2. Important information before taking Coldrex Junior C
• 3. How to take Coldrex Junior C
• 4. Possible side effects
• 5. How to store Coldrex Junior C
• 6. Contents of the pack and other information

1. What is Coldrex Junior C and what is it used for

Coldrex Junior C is a medicine with analgesic and antipyretic effects, which constricts the blood vessels of the nasal mucosa and reduces its congestion, thereby relieving nasal congestion. The medicine contains vitamin C.

Coldrex Junior C is used for the short-term, symptomatic treatment of flu or colds, accompanied by fever, chills, headache, sore throat, and runny nose (catarrh) in children aged 6 to 12 years.

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

2. Important information before taking Coldrex Junior C

When not to take Coldrex Junior C

• if the patient is 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 disease,
• in patients with hyperthyroidism,
• in patients with diabetes,
• in patients with pheochromocytoma,
• in patients taking tricyclic antidepressants or beta-blockers simultaneously
• in patients taking antihypertensive drugs (debrisoquine, guanethidine, reserpine, methyldopa) simultaneously
• in patients with angle-closure glaucoma,
• in patients with severe coronary artery disease,
• in patients taking other sympathomimetic drugs (such as nasal decongestants, appetite suppressants, psychostimulants similar to amphetamines) simultaneously
• 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 paracetamol or medicinal products used for colds and flu.

Overdose of paracetamol may lead to irreversible liver damage.

The risk of overdose is higher in patients with alcoholic liver disease without cirrhosis.

Patients with diagnosed liver or kidney dysfunction must consult a doctor before taking the medicinal product.

Taking the medicinal product with paracetamol further increases the risk of liver damage in patients with liver disease.

Read the leaflet before taking the medicine and follow the instructions it contains.

Consult a doctor before taking the medicinein case of:

• liver cell failure (Child-Pugh score <9)
• regular alcohol consumption
• kidney failure
• Gilbert's syndrome (mild jaundice)
• concomitant use of other medicines affecting liver function
• glucose-6-phosphate dehydrogenase deficiency
• hemolytic anemia
• glutathione deficiency
• dehydration
• chronic malnutrition
• elderly, adult, and adolescent patients with a body weight below 50 kg
• urinary retention or prostate enlargement
• thromboembolic disease (e.g., Raynaud's syndrome)

During treatment with Coldrex Junior C, immediately inform a doctor if the patient experiences severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or when the patient is also taking flucloxacillin (an antibiotic).

In these situations, patients have been reported to develop a severe disease called metabolic acidosis (a 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, feeling sick (nausea) and vomiting.

Liver damage is possible in individuals who have ingested more than 10 g of paracetamol at once.

Consuming 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

• Patient taking long-term 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 with possible 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 sight and reach of children.

Children

Do not give the medicine to children under 6 years of age.

Coldrex Junior C and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Consult a doctor when taking the following medicines:

• anticoagulants (e.g., warfarin) in case of a need for long-term use of a painkiller,
• 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-adrenoreceptor blockers and other antihypertensive drugs (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) that require emergency treatment (see section 2).

Concomitant use of paracetamol and drugs 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 taking recommended doses of paracetamol.

Salcylamide prolongs the elimination time of paracetamol.

Caffeine enhances the analgesic effect of paracetamol.

Taking paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).

Phenylephrine may enhance the blood pressure-increasing effect of drugs that accelerate labor.

Ascorbic acid increases iron absorption and increases aluminum absorption from aluminum-containing antacids.

Taking Coldrex Junior C 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 baby, consult a doctor or pharmacist before taking this medicine.

This medicine should not be taken during pregnancy.

Administration of phenylephrine hydrochloride during pregnancy may cause congenital malformations and may also cause fetal hypoxia.

During breastfeeding, do not take the medicine without consulting a doctor.

Phenylephrine may pass into breast milk.

There is no data on the effect of Coldrex Junior C on fertility.

Driving and using machines

Coldrex Junior C may cause dizziness.

If dizziness occurs after taking the medicine, do not drive or operate machinery.

The medicine contains 1.9 g of sucroseand 3.325 g of glucose per dose.

Consider this in patients with diabetes.

If a patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

The medicine contains 56.5 mg of sodium(the main component of common salt) per sachet.

This corresponds to 3% of the maximum recommended daily intake of sodium in the diet for adults.

The medicine contains sulfites.It may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Coldrex Junior C

Always take this medicine exactly as directed by a doctor or pharmacist.

Administration in children aged 6 to 12 years

One sachet, if necessary, after 4 hours, the dose can be repeated, up to 4 times a day.

Do not take more frequently than every 4 hours or more than 4 sachets per day.

Always use the lowest effective dose of the medicine.

Children and adolescents

Administration in children under 6 years of age is contraindicated.

Children under 6 years of age should not be given available over-the-counter medicines containing phenylephrine used to treat colds and coughs.

Elderly patients

Elderly patients, especially the weak or immobile, may require a reduced dose or reduced frequency of administration.

Kidney dysfunction

Patients 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

Patients with diagnosed liver dysfunction or Gilbert's syndrome before taking the medicine must consult a doctor.

Method of administration

Before administration, the powder should be dissolved in hot water.

Pour the contents of one sachet into a glass, add half a glass of hot water, mix well, and drink.

If necessary, add cold water or sweeten.

Do not take the medicine in children under 6 years of age.

Without consulting a doctor, do not take the medicine regularly for more than 3 days.

If symptoms persist for more than 3 days or worsen, or if other symptoms occur, discontinue treatment and consult a doctor.

If the symptoms of the disease persist, consult a doctor.

If you feel that the effect of the medicine is too strong or too weak, consult a doctor.

Do not exceed the recommended daily dose or the specified number of doses due to the risk of liver damage.

Taking a higher dose of Coldrex Junior C than recommended

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

Missing a dose of Coldrex Junior C

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, although not everybody gets them.

Stop taking the medicine and consult a doctor immediately 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 with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis) characterized by a rash with pustules all over the body, ulcers in the mouth, eyes, genitals, and on the skin, red spots on the torso, often with blisters in the center, large blisters bursting, shedding of large skin patches, weakness, fever, and joint pain,
• breathing difficulties, if similar problems have occurred in the past when taking acetylsalicylic acidor other non-steroidal anti-inflammatory drugs,
• bruisesor bleedingof unknown cause,
• vision loss, which may be caused by excessively high intraocular pressure.
• unusual rapid heartbeator feeling of irregular heartbeat,
• difficulty urinating, urinary retention.
• urine with a cloudy color,
• liver dysfunction (which may be indicated by yellowing of the skin and eyes, liver tenderness).

Coldrex Junior C 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 disease taking paracetamol (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Coldrex Junior C

Keep the medicine out of sight and reach of children.

Do not take the medicine after the expiry date stated on the packaging (EXP).

The expiry date refers to the last day of the specified month.

Store in a temperature below 25°C.

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 pack and other information

What Coldrex Junior C contains

• The active substances of the medicine are: paracetamol, phenylephrine hydrochloride, ascorbic acid
• The other ingredients are: sodium saccharin, sodium cyclamate, anhydrous citric acid, sodium citrate, corn starch, sucrose, colloidal anhydrous silica, citrus flavor PHS-163671, coloring agent - curcumin 5% (curcumin E100, glucose).

What Coldrex Junior C looks like and what the pack contains

A carton box 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

Importer:

Omega Pharma International NV

Venecoweg 26

Nazareth, 9810

Belgium

Perrigo Supply Chain International Designated Activity Company

The Sharp Building

Hogan Place

Dublin 2

Dublin, D02 TY74, Ireland

Date of last revision of the leaflet:

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