Choligrip

Package leaflet: Information for the user

Choligrip
(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, because
it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet
or as directed by the doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days or if you feel worse, contact your doctor.

Table of contents

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

1. What Choligrip is and what it is used for

Choligrip is a medicine with analgesic and antipyretic properties, which constricts
the blood vessels of the nasal mucosa, reduces congestion, and consequently clears
the nasal passages and sinuses. The medicine contains vitamin C.
Choligrip is indicated for the treatment of symptoms of influenza and common cold, such as:
headache, chills, sore throat, nasal and sinus congestion accompanied by pain.

2. Important information before using Choligrip

When not to use Choligrip:

• 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 with liver failure or severe renal failure,
• in patients with alcoholic liver disease,
• in patients taking zidovudine (used in the treatment of HIV infection),
• in patients taking monoamine oxidase inhibitors (MAO inhibitors) and within 2 weeks after their last dose.

Do not administer to children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol. Paracetamol overdose can lead to severe liver damage. Do not take this medicine simultaneously with other medicines containing paracetamol, such as painkillers, antipyretics, medicines used to treat flu and cold symptoms, or sleep aids. Do not take with other medicines containing sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with amphetamine-like effects) or medicines used for colds and flu.

Read the package leaflet carefully before use and follow the instructions provided.

Consult a doctor before using the medicine if:

• the patient has liver or kidney disease,
• the patient is underweight or malnourished due to anorexia,
• the patient regularly consumes alcohol,
• the patient has a severe infection, which may increase the risk of metabolic acidosis, manifested by:
  • deep, rapid, and labored breathing,
  • nausea, vomiting and/or loss of appetite,
  • general malaise. Seek immediate medical advice if the patient develops any of the above symptoms.
• hypertension, heart disease, or vascular disorders such as Raynaud's syndrome (characterized by episodic finger pain triggered by cold or stress),
• diabetes,
• hyperthyroidism,
• glaucoma (a condition characterized by progressive damage to the eye leading to impaired or lost vision),
• pheochromocytoma,
• benign prostatic hyperplasia,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase).

Do not drink alcohol while taking this medicine, as it increases the risk of liver damage. Liver damage may occur in individuals who have taken 10 g or more of paracetamol in a single dose. A dose of 5 g of paracetamol may cause liver damage in patients with the following risk factors:

• Patients taking long-term carbamazepine, phenobarbital, phenytoin, primidone (medicines used e.g. in epilepsy), rifampicin (used e.g. in tuberculosis), St. John's wort (used e.g. in depression), or other medicines that induce liver enzymes.
• Patients who regularly abuse alcohol.
• Patients who may have glutathione deficiency, e.g. those with eating disorders, cystic fibrosis, HIV infection, or those who are fasting or severely debilitated.

Patients with liver disease are at increased risk of overdose.

Children

Do not give this medicine to children under 12 years of age.

Choligrip and other medicines

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

Consult your doctor if you are taking any of the following medicines:

• metoclopramide, domperidone (used to treat nausea and vomiting),
• cholestyramine (used to reduce high blood cholesterol levels),
• anticoagulants (e.g. warfarin), especially if long-term pain relief is needed,
• sedatives, antiepileptic drugs, rifampicin (an anti-tuberculosis drug),
• MAO inhibitors (used e.g. in depression) and other antidepressants (tricyclic antidepressants),
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid),
• ergot alkaloids (used e.g. in migraine),
• certain medicines used for heart conditions or hypertension (e.g. digoxin, beta-blockers, methyldopa),
• appetite suppressants, nasal decongestants, and psychostimulant amphetamine derivatives (e.g. used in attention deficit hyperactivity disorder).

Paracetamol may interfere with certain laboratory tests (e.g. blood glucose measurement), leading to false results.

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

Caffeine enhances the analgesic effect of paracetamol.

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

Pregnancy, breastfeeding, and fertility

Do not use this medicine during pregnancy or if you suspect you may be pregnant, or during breastfeeding, unless advised by a doctor.

If you are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

This medicine may cause dizziness. If this occurs, do not drive or operate machinery.

Choligrip contains:

This medicine contains 135 mg of sodium (the main component of table salt) per sachet. This corresponds to 6.7% of the maximum recommended daily dietary intake of sodium for adults. This should be taken into account in patients with impaired kidney function and in patients on a sodium-restricted diet.

The medicine contains 2.47 g of sucrose per sachet. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

The medicine contains 50 mg of aspartame (E 951) per sachet. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria—a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

The medicine contains glucose (a component of maltodextrin). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

The medicine contains sulfites. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

The medicine contains 5.25 mg of benzoic acid per sachet, equivalent to 1.05 mg/g.

3. How to use Choligrip

This medicine should always be taken exactly as described in the patient information leaflet or
as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Use in adults and adolescents over 12 years of age
One sachet of Choligrip every 4 to 6 hours. Do not take the medicine more frequently than every
4 hours, and do not use more than 4 sachets per day. Do not exceed the recommended dose.
Method of administration
For oral use only.
Before administration, the powder must be dissolved in warm water.
Empty the contents of one sachet into a glass, add half a glass of warm water, stir well, and drink.
If necessary, add cold water or sweeten to taste.
Do not use more frequently than every 4 hours.
Without consulting a doctor, do not use this medicine regularly for more than 3 days.
If symptoms persist, consult a doctor.
Do not use in children under 12 years of age.
Always use the lowest effective dose of the medicine.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
In case of taking more than the recommended dose of Choligrip
If more than 4 sachets of Choligrip are taken within 24 hours, seek immediate medical advice,
even if no adverse symptoms are present, due to the risk of delayed, severe liver damage, which
may result in liver transplantation or death. Paracetamol overdose may cause nausea, vomiting,
excessive sweating, drowsiness, and general weakness within several or up to several dozen hours.
In any case of single-dose paracetamol intake of 5 g or more, if less than one hour has passed since
ingestion, vomiting should be induced and immediate contact with a doctor is required. Administer
60–100 g of activated charcoal orally, preferably mixed with water. The amount of drug that would
cause severe symptoms of phenylephrine or ascorbic acid overdose would already cause severe liver
damage due to paracetamol. Phenylephrine overdose may cause nervousness, headache, dizziness,
insomnia, increased blood pressure, nausea, vomiting, irritability, psychomotor agitation,
hypertension, and decreased heart rate. In severe cases, confusion, hallucinations, and arrhythmia
may occur. High doses of ascorbic acid (above 3 g) may cause transient diarrhoea and gastrointestinal
symptoms such as nausea and abdominal discomfort.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone will experience them.
Stop taking the medicine immediately and consult a doctor if any of the following occur:

• allergic reaction (hypersensitivity) such as skin rash or itching, sometimes associated with difficulty breathing or swelling of the lips, tongue, throat or face,
• skin rash or severe skin reaction, manifesting as acute generalized pustular rash or blisters and erosions on the skin, in the mouth, eyes and genital organs, fever and joint pain, or rupturing large subcutaneous blisters, extensive skin erosions, shedding of large sheets of epidermis, and fever,
• breathing difficulties, especially if similar problems occurred previously during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,
• bruising 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,
• unusual rapid heartbeat or sensation of irregular heart rhythm,
• difficulty in urination. This is more likely in men with benign prostatic hyperplasia,
• liver function disorders. The above reactions occur rarely (more than 1 in 10,000 but less than 0.1 in 1,000 patients) or very rarely (less than 1 in 10,000 patients).

Choligrip may also cause the following adverse reactions:
very rare
(affecting less than 1 in 10,000 patients)

• headache,
• dizziness,
• insomnia,
• nervousness,
• increased blood pressure,
• nausea and vomiting.

Other adverse reactions may occur in some individuals during treatment with Choligrip. If any other adverse symptoms not listed in this leaflet occur, inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of 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, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Choligrip

Keep this 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.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Choligrip contains
The active substances 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.
The other ingredients are: anhydrous citric acid, sodium saccharin, sodium citrate, lemon flavour 610399E (containing linalool, geraniol, d-limonene, citronellol, citral, maltodextrin - source of glucose, butylated hydroxyanisole (E 320), sulphites), honey flavour PFW PHS - 050860 (containing maltodextrin - source of glucose, propylene glycol, sulphites, benzoic acid (E 210)), honey flavour Felton F7624P, caramel colouring 626, maize starch, aspartame, sucrose.

What Choligrip looks like and contents of the pack
Choligrip is a beige to light brown powder contained in sachets.
The pack contains 5, 8 or 10 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
SmithKline Beecham S.A.
Ctra. De Ajalvir, Km 2 500
28806 Alcala de Henares
Madrid
Spain
Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.