CHOLIGRIP 750 mg/10 mg /60 Mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Choligrip
   1. Read the leaflet carefully before taking the medicine, as it
   2. Table of Contents of the Leaflet
3. What is Choligrip and what is it used for
4. Important information before taking Choligrip
   1. When not to take Choligrip:
   2. Warnings and precautions
   3. The medicine contains paracetamol.
   4. Children
   5. Choligrip and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. What Choligrip contains
5. How to take Choligrip
   1. Administration in adults and children over 12 years of age
   2. Method of administration
   3. In case of overdose of Choligrip
6. Possible side effects
   1. The patient should stop taking the medicine and consult their doctor immediately if they experience:
   2. Reporting side effects
7. How to store Choligrip
8. Contents of the pack and other information
   1. What Choligrip contains
   2. What Choligrip looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the User

Choligrip

(750 mg + 10 mg + 60 mg)/sachet, 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 the patient leaflet
or as directed by a doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Choligrip and what is it 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 is Choligrip and what is it used for

Choligrip is a medicine with analgesic and antipyretic effects, constricting
the blood vessels of the nasal mucosa and reducing its swelling, thereby
clearing the nose and sinuses. The medicine contains vitamin C.
Choligrip is indicated for the treatment of flu and cold symptoms such as:
headaches, chills, sore throats, nasal and sinus congestion accompanied by pain.

2. Important information before taking Choligrip

When not to take 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 or severe kidney failure,
• in patients with alcoholism,
• in patients taking zidovudine (used to treat HIV infections),
• in patients taking monoamine oxidase inhibitors (MAOIs) and within 2 weeks of their last use. Do not give to children under 12 years of age.

Warnings and precautions

The medicine contains paracetamol.

Paracetamol overdose can lead to severe liver damage.
The medicine should not be taken at the same time as other medicines containing paracetamol,
such as painkillers, antipyretics used to treat flu and cold symptoms or as a sleep aid.
Do not take with other medicines containingsympathomimetics (such as nasal decongestants, appetite suppressants, and psychostimulants similar to amphetamines) or medicines used for colds and flu.
Patients should read the leaflet before taking the medicine and follow the instructions.
Before taking the medicine, patients should consult their doctor if they have:

• liver or kidney disease,
• are underweight or malnourished, suffering from anorexia,
• regularly consume alcohol.
• severe infection, which may increase the risk of metabolic acidosis characterized by:
• deep, rapid, and labored breathing,
• nausea, vomiting, and (or) loss of appetite
• general poor well-being. Patients should immediately contact their doctor if they experience the above symptoms.
• high blood pressure, heart disease, vascular diseases such as Raynaud's syndrome (characterized by episodic finger pain caused by cold or emotions),
• diabetes,
• hyperthyroidism,
• glaucoma (a disease characterized by progressive eye damage and consequent vision impairment or loss),
• chromaffin tumor of the adrenal gland,
• prostate enlargement,
• deficiency of certain enzymes (glucose-6-phosphate dehydrogenase and methemoglobin reductase). During treatment with the medicine, patients should not drink alcohol due to the increased risk of liver damage. Liver damage is possible in patients who have consumed 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 in epilepsy), rifampicin (medicines used in tuberculosis), St. John's Wort (used in depression), or other liver enzyme-inducing medicines.
• Patient regularly abusing alcohol.
• Patient with possible glutathione deficiency, e.g., with eating disorders, cystic fibrosis, HIV infection, starvation, or malnutrition. In patients with liver disease, there is an increased risk of overdose.

Children

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

Choligrip and other medicines

Patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Patient should consult their doctor when taking the following medicines:

• metoclopramide, domperidone (used against nausea and vomiting),
• cholestyramine (used to reduce high cholesterol levels in the blood),
• anticoagulant medicines (e.g., warfarin) in case of prolonged use of painkillers,
• sleeping pills, antiepileptic drugs, rifampicin (an antitubercular medicine),
• MAOIs (used in depression) and other antidepressant medicines (tricyclic antidepressants),
• nonsteroidal anti-inflammatory medicines (e.g., acetylsalicylic acid),
• ergot alkaloids (used in migraine),
• certain heart or high blood pressure medicines (e.g., digoxin, beta-blockers, methyldopa).
• appetite suppressants, nasal decongestants, and psychostimulants derived from amphetamines (e.g., used in attention deficit hyperactivity disorder).

Paracetamol may cause false results in some laboratory tests (e.g., blood glucose measurement).
Phenylephrine may enhance the blood pressure-increasing effect of medicines that accelerate labor.
Caffeine increases the analgesic effect of paracetamol.
Ascorbic acid increases iron absorption, increases aluminum absorption from antacids, and increases the absorption of certain medicines.

Pregnancy, breastfeeding, and fertility

Do not take the medicine during pregnancy or breastfeeding, or if pregnancy is suspected, without consulting a doctor.
If the patient plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The medicine may cause dizziness. If such symptoms occur, the patient should not drive or operate machinery.

What Choligrip contains

The medicine contains 135 mg of sodium (the main component of common salt) per sachet.
This corresponds to 6.7% of the maximum recommended daily intake of sodium in the diet for adults.
Patients with reduced kidney function and those on a low-sodium diet should be aware of this.
The medicine contains 2.47 g of sucrose per sachet. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 50 mg of aspartame (E 951) per sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion. The medicine contains glucose (a component of maltodextrin). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains sulfites. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains 5.25 mg of benzoic acid per sachet, corresponding to 1.05 mg/g.

3. How to take Choligrip

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.

Administration in adults and children over 12 years of age

One sachet of Choligrip every 4 to 6 hours. Do not take more than 4 sachets in 24 hours. Do not exceed the recommended dose.

Method of administration

For oral use only.
Before administration, the powder should be dissolved in warm water.
Pour the contents of one sachet into a glass, add half a glass of warm water, mix well, and drink. If necessary, add cold water or sweeten.
Do not take more than every 4 hours.
Without consulting a doctor, the medicine should not be taken regularly for more than 3 days.
If the symptoms persist, the patient should consult their doctor.
Do not give to children under 12 years of age.
Always use the lowest effective dose of the medicine.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

In case of overdose of Choligrip

In case of taking more than 4 sachets of the medicine within 24 hours, the patient should immediately consult their doctor, even if no side effects occur, 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 a few or several hours. In case of taking more than 5 g of paracetamol at once, the patient may induce vomiting if it has been less than an hour since ingestion and immediately consult their doctor. The patient should take 60-100 g of activated charcoal orally, preferably mixed with water. The amount of the medicine that may cause severe overdose symptoms of phenylephrine or ascorbic acid would cause severe liver damage due to paracetamol. Phenylephrine overdose may cause nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, irritability, restlessness, hypertension, and decreased heart rate. In severe cases, it may cause confusion, hallucinations, and arrhythmia. High doses of ascorbic acid (above 3 g) may cause transient diarrhea and gastrointestinal symptoms such as nausea and discomfort in the abdominal cavity.

4. Possible side effects

Like all medicines, Choligrip can cause side effects, although not everybody gets them.

The patient should stop taking the medicine and consult their doctor immediately if they experience:

• allergic reactions (hypersensitivity) such as skin rash or itching, sometimes accompanied by difficulty breathing or swelling of the lips, tongue, throat, or face,
• skin rash or severe skin reactions, characterized by acute generalized pustular rash or blisters and ulcers on the skin, mouth, eyes, and genitals, fever, and joint pain or large blisters under the skin, widespread skin peeling, and fever,
• breathing problems, especially if the patient has had similar problems in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory medicines,
• 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 heart rhythm or feeling of irregular heartbeat,
• difficulty urinating. This is more likely in men with prostate enlargement,
• liver function disorders. The above 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).

Choligrip may also cause the following side effects:
very rarely
(affecting less than 1 in 10,000 patients)

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

In some patients, other side effects may occur during treatment with Choligrip. If other side effects occur that are not listed in this leaflet, the patient should inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Choligrip

The medicine should be stored 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 month stated.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Choligrip contains

The active substances of the 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.
The other ingredients are anhydrous citric acid, sodium saccharin, sodium citrate, lemon flavor 610399E (contains linalool, geraniol, d-limonene, citronellol, citral, maltodextrin - a source of glucose, butylhydroxyanisole (E 320), sulfites), honey flavor PFW PHS - 050860 (contains maltodextrin - a source of glucose, propylene glycol, sulfites, benzoic acid (E 210)), honey flavor Felton F7624P, caramel color 626, cornstarch, aspartame, sucrose.

• source of glucose

What Choligrip looks like and contents of the pack

The medicine is a beige to light brown powder in sachets.
The pack contains 5, 8, or 10 sachets.
Not all pack sizes may be marketed.

Marketing authorization 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
Date of last revision of the leaflet:August 2023
Detailed information about this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.