Coldrex with lemon flavour

Coldrex o smaku cytrynowym
(750 mg + 10 mg + 60 mg)/sachet, powder for oral solution
Paracetamolum + Phenylephrini hydrochloridum + Acidum ascorbicum
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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if the patient feels worse, consult a doctor.

Table of contents:

1. What Coldrex o smaku cytrynowym is and what it is used for
2. Important information before taking Coldrex o smaku cytrynowym
3. How to take Coldrex o smaku cytrynowym
4. Possible side effects
5. How to store Coldrex o smaku cytrynowym
6. Further information

1. What Coldrex o smaku cytrynowym is and what it is used for

Coldrex o smaku cytrynowym is a medicine with analgesic and antipyretic properties, which constricts blood vessels in the nasal mucosa, reduces mucosal congestion, and thereby helps clear nasal passages and sinuses. The medicine contains vitamin C (ascorbic acid).
Coldrex o smaku cytrynowym is indicated for the relief of symptoms of influenza and colds, such as headache, chills, sore throat, nasal congestion, and sinus pain.

2. Important information before using Coldrex o smaku cytrynowym

When not to use Coldrex o smaku cytrynowym:

• 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 (MAO inhibitors) 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 concurrently taking tricyclic antidepressants or beta-blockers (see section 4.5),
• in patients concurrently taking antihypertensive drugs (debrisoquine, guanethidine, reserpine, methyldopa),
• in patients with narrow-angle glaucoma,
• in patients with severe ischemic heart disease,
• in patients concurrently taking other sympathomimetic drugs (such as nasal decongestants, appetite suppressants, psychostimulants similar to amphetamines),
• in patients with hepatic insufficiency or severe renal insufficiency,
• in patients with alcoholic liver disease,
• in patients taking zidovudine,
• in children under 6 years of age.

Warnings and precautions
The medicine contains paracetamol.
Do not use together with other medicinal products containing paracetamol or products used for cold and flu, such as pain-relieving and antipyretic medicines.
Paracetamol overdose may lead to irreversible liver damage.
The risk of overdose is higher in patients with alcoholic liver disease without cirrhosis.
Patients diagnosed with impaired liver or kidney function must consult a physician before taking this medicine. The use of paracetamol-containing medicinal products further increases the risk of liver damage in patients with liver disease.
Before using this medicine, consult a doctor if:

• hepatic parenchymal insufficiency (Child-Pugh score < 9),
• regular alcohol consumption,
• renal insufficiency,
• Gilbert's syndrome (mild jaundice),
• concurrent use of other drugs affecting liver function,
• glucose-6-phosphate dehydrogenase deficiency,
• hemolytic anemia,
• glutathione deficiency,
• dehydration,
• chronic malnutrition,
• elderly patients, adults and adolescents with body weight below 50 kg,
• urinary retention or prostate enlargement,
• thromboembolic disorders (e.g. Raynaud's syndrome).
  Particular caution is required in the above cases.

During treatment with Coldrex o smaku cytrynowym, immediately inform the doctor if the patient has severe illnesses, including severe renal dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). In these situations, patients have been reported to develop a serious condition called metabolic acidosis (abnormality in blood and body fluids) when taking paracetamol at regular doses over a prolonged period or when taking paracetamol together 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 taken a single dose of 10 g or more of paracetamol.
Ingestion of 5 g of paracetamol may lead to liver damage in patients with the following risk factors:

• Patients chronically taking carbamazepine, phenobarbital, phenytoin, primidone (medicines used e.g. in epilepsy), rifampicin (medicines used e.g. in tuberculosis), St. John's wort (used e.g. in depression), or other drugs inducing liver enzymes.
• Patients who regularly abuse alcohol.
• Patients in whom glutathione deficiency may occur, e.g. due to eating disorders, cystic fibrosis, HIV infection, malnutrition, or cachexia.
  Chronic use of various types of painkillers for headache may lead to worsening of headache. If this situation occurs or is suspected, consult a doctor and discontinue treatment.

Caution is advised in patients with asthma who are also taking acetylsalicylic acid, as mild bronchospasm associated with paracetamol use (cross-reaction) has been observed.
Keep the medicine out of sight and reach of children.
Children
Do not give this medicine to children under 16 years of age.
Coldrex o smaku cytrynowym and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Consult a doctor if taking the following medicines:

• anticoagulants (e.g. warfarin), especially if long-term pain relief is needed,
• cholestyramine (used to reduce high blood cholesterol levels), 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-adrenolytics and other antihypertensive drugs (including debrisoquine, guanethidine, reserpine, methyldopa),
• tricyclic antidepressants (e.g. amitriptyline),
• ergot alkaloids (e.g. ergotamine and methysergide),
• flucloxacillin (antibiotic), due to serious risk of blood and body fluid disorders (called metabolic acidosis), which require urgent treatment (see section 2).

Concomitant use of paracetamol and drugs enhancing hepatic 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 recommended doses of paracetamol are used.
Salicylamide prolongs the elimination time of paracetamol.
Caffeine enhances the analgesic effect of paracetamol.
Paracetamol use may cause false results in certain laboratory tests (e.g. blood glucose measurement).
Phenylephrine may enhance the blood pressure-raising effect of drugs used to accelerate labor.
Ascorbic acid increases iron absorption and enhances aluminum absorption from aluminum-containing antacid preparations.
Use of Coldrex o smaku cytrynowym with alcohol
Do not drink alcohol while taking this medicine due to increased risk of liver damage.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a pharmacist or doctor before using this medicine.
This medicine should not be used during pregnancy. Administration of phenylephrine hydrochloride during pregnancy may cause congenital developmental defects and may also lead to 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 o smaku cytrynowym on fertility.
Driving and operating machinery
Coldrex o smaku cytrynowym may cause dizziness. If such symptoms occur, do not drive or operate machinery.
The medicine contains 2.9 g of sucrose per dose. This should be taken into account in patients with diabetes. If a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
The medicine contains 121 mg of sodium (main component of table salt) per sachet. This corresponds to 6% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Coldrex o smaku cytrynowym

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

Adults and adolescents aged 16 years and over:
One sachet of Coldrex o smaku cytrynowym every 4 to 6 hours. Do not take the medicine more frequently than every 4 hours or exceed 4 sachets per day. Do not exceed the recommended dose.

Always use the lowest effective dose.

Children and adolescents
Do not use in children and adolescents under 16 years of age.
Over-the-counter medicines containing phenylephrine used to treat colds and cough should not be given to children under 6 years of age.

Elderly patients
Elderly patients, especially frail or immobile individuals, may require a reduced dose or less frequent administration.

Renal impairment
Patients diagnosed with impaired kidney function should seek medical advice before taking this medicine. When administering paracetamol to patients with renal impairment, it is recommended to reduce the dose and increase the minimum interval between doses to at least 6 hours.

Hepatic impairment
Patients diagnosed with impaired liver function or Gilbert's syndrome should seek medical advice before taking this medicine.

Method of administration
Dissolve the powder in hot water before use.
Empty the contents of one sachet into a glass, add half a glass of hot water, stir well, and drink. If necessary, add cold water or sweeten to taste.

Do not use this medicine regularly for more than 3 days without consulting a doctor.
If symptoms persist for more than 3 days, worsen, or new symptoms occur, discontinue treatment and consult a doctor.
Do not exceed the recommended daily dose or the specified number of doses due to the risk of liver damage.

Taking more than the recommended dose of Coldrex o smaku cytrynowym
If more than 4 sachets are taken within 24 hours, seek immediate medical attention, even if no adverse symptoms are present, due to the risk of delayed, irreversible liver damage.

Missed dose of Coldrex o smaku cytrynowym
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions.
Coldrex o smaku cytrynowym, when used as recommended, is well tolerated.
You should stop taking the medicine immediately and consult a doctor if any of the following occur:

• allergic reactions (hypersensitivity) such as: skin rash or itching, sometimes associated with difficulty in breathing or swelling of the lips, tongue, throat or face,
• skin hypersensitivity reactions such as: sweating, purpura, urticaria,
• severe skin reactions (acute generalized exanthematous pustulosis, drug-induced dermatitis, bullous erythema multiforme (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome)) manifested by blistering rash over the entire body, erosions in the oral cavity, eyes, genital organs and on the skin, red spots on the trunk, often with blisters in the center, rupturing of giant blisters, peeling of large sheets of epidermis, weakness, fever and joint pain,
• breathing difficulties, especially if similar problems occurred previously during use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• bruises or bleeding of unknown cause,
• loss of vision, which may be caused by abnormally high intraocular pressure. This is very rare, but there is a possibility of such an event in patients with glaucoma,
• unusually rapid heartbeat or sensation of irregular heart rhythm,
• difficulty in urination, urinary retention. Urinary retention is most likely in men with benign prostatic hyperplasia,
• cloudy urine,
• liver function disorders.

The above reactions occur rarely (more than 1 in 10,000 but less than 1 in 1,000 patients) or very rarely (less than 1 in 10,000 patients).
Coldrex o smaku cytrynowym may also cause the following adverse reactions, for which the frequency is unknown (cannot be estimated from available data):

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

In some individuals, other adverse reactions may occur during treatment with Coldrex o smaku cytrynowym. If any adverse symptoms not listed in this leaflet occur, they should be reported to a doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any 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 at 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Coldrex o smaku cytrynowym

Keep this medicine out of the reach and sight 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Coldrex o smaku cytrynowym contains

• The active substances in this medicine are: paracetamol, phenylephrine hydrochloride and ascorbic acid (vitamin C). Each sachet (5 g of powder) contains 750 mg of paracetamol, 10 mg of phenylephrine hydrochloride and 60 mg of ascorbic acid.
• Other ingredients are: ethylcellulose, anhydrous citric acid, sodium saccharin, lemon flavour 100% AP05.51, lemon flavour 52293/TP05.51, quinoline yellow 14031 (E104), sodium citrate, crystalline sucrose.

What Coldrex o smaku cytrynowym looks like and contents of the pack
The medicine is in the form of a light yellow powder contained in sachets.
The pack contains 5 or 10 sachets.
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warszawa
tel.: +48 (22) 852 55 51
Manufacturer
SmithKline Beecham S.A.
Ctra. De Ajalvir, Km 2 500
28806 Alcala de Henares
Madrid
Spain
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.