CHOLIGRIP 600 mg + 40 Mg + 10 Mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Choligrip Menthol Active
3. Menthol, honey and lemon flavor
4. 600 mg + 40 mg + 10 mg, powder for oral solution
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Choligrip Menthol Active and what is it used for
6. Important information before using Choligrip Menthol Active
   1. When not to use Choligrip Menthol Active:
   2. Warnings and precautions
   3. The medicine contains paracetamol.
   4. Using Choligrip Menthol Active in children
   5. Choligrip Menthol Active and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Choligrip Menthol Active contains 3755 mg of sucrose in each sachet.
   9. Choligrip Menthol Active contains 118 mg of sodium (the main component of common salt)
7. How to use Choligrip Menthol Active
   1. Use in adults and adolescents over 12 years of age
   2. Use in children
   3. Do not give the medicine to children under 12 years of age.
   4. Using a higher dose of Choligrip Menthol Active than recommended
   5. Missing a dose of Choligrip Menthol Active
8. Possible side effects
   1. You should stop using the medicine and consult a doctor if you experience:
   2. Reporting side effects
9. How to store Choligrip Menthol Active
10. Contents of the packaging and other information
    1. What Choligrip Menthol Active contains
    2. What Choligrip Menthol Active looks like and what the packaging contains
    3. Marketing authorization holder:
    4. Manufacturer:
    5. Other sources of information

Leaflet attached to the packaging: information for the user

Choligrip Menthol Active

Menthol, honey and lemon flavor

600 mg + 40 mg + 10 mg, powder for oral solution

Paracetamol + Ascorbic Acid + Phenylephrine Hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Choligrip Menthol Active and what is it used for
• 2. Important information before using Choligrip Menthol Active
• 3. How to use Choligrip Menthol Active
• 4. Possible side effects
• 5. How to store Choligrip Menthol Active
• 6. Contents of the packaging and other information

1. What is Choligrip Menthol Active and what is it used for

Choligrip Menthol Activeis indicated for short-term, symptomatic treatment of flu or cold, accompanied by fever, chills, headache, sore throat, and nasal congestion (catarrh).
Choligrip Menthol Activecontains 3 active ingredients:

• Paracetamol- has analgesic and antipyretic effects
• Phenylephrine- constricts blood vessels, clears nasal passages and sinuses, making breathing easier
• Vitamin C- a vitamin whose deficiencies may occur in the first days of a cold or flu.

2. Important information before using Choligrip Menthol Active

When not to use Choligrip Menthol Active:

• if the patient is allergicto paracetamol, phenylephrine, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has liver failureor severe kidney failure.
• if the patient has alcoholic disease.
• if the patient is taking zydovudine(used to treat HIV infections).
• if the patient is using a medicine from the group of monoamine oxidase inhibitors(used to treat depression) and for 2 weeks after the last use of this medicine.

Warnings and precautions

The medicine contains paracetamol.

Overdose of paracetamol can lead to severe liver damage.
The medicine should not be used at the same time as other medicines containing paracetamol, such as painkillers, antipyretics, or medicines used to treat flu and cold symptoms.
Do not use other medicines that reduce nasal congestion, appetite suppressants, or psychostimulants with similar effects to amphetamines at the same time.
Before starting to use the medicine, you should discuss it with your doctor, pharmacist, or nurse if you have:

• high blood pressure.
• heart and blood vessel diseases.
• diabetes.
• hyperthyroidism.
• glaucomawith a closed angle of filtration (a severe eye disease usually caused by increased pressure inside the eyeball).
• chromaffin tumor of the adrenal gland(a tumor near the kidneys).
• prostate enlargement.
• vascular diseases with vessel closure(e.g., Raynaud's phenomenoncharacterized by episodic finger pain under the influence of cold or emotions).
• are taking beta-adrenergic receptor blockersand other blood pressure-lowering medicines (debryzoxine, guanethidine, reserpine, methyldopa).
• are taking tricyclic antidepressants(e.g., imipramine or amitriptyline).
• are taking other sympathomimetics (such as nasal decongestants, appetite suppressants, or psychostimulants with similar effects to amphetamines).
• have a deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase.
• have liver or kidney failure. General liver diseases increase the risk of liver damage from paracetamol.
• are underweight or malnourished, suffering from anorexia,
• regularly consume alcohol. Before using the medicine, you should consult a doctor if you have a severe infection that may increase the risk of metabolic acidosis. The symptoms of metabolic acidosis include:
• deep, rapid, and labored breathing,
• nausea, vomiting, and loss of appetite,
• general poor well-being. You should contact your doctor immediately if you experience any of the above symptoms.

In people with liver disease, there is an increased risk of overdose.
During treatment with the medicine, you should not drink alcohol due to the increased risk of liver damage.
Liver damage is possible in people who have consumed more than 10 g of paracetamol at a time.
Consuming 5 g of paracetamol can lead to liver damage in patients with the following risk factors:

• patients taking carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St. John's wort, or other liver enzyme-inducing medicines.
• patients who regularly abuse alcohol.
• patients who may have a glutathione deficiency, e.g., with eating disorders, cystic fibrosis, HIV infection, malnutrition, or exhaustion.

In case of paracetamol overdose, immediate treatment is necessary, despite the lack of early symptoms.
If symptoms persist, you should consult a doctor.
The medicine should be stored in a place invisible and inaccessible to children.

Using Choligrip Menthol Active in children

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

Choligrip Menthol Active and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
You should consult a 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 a need for long-term use of painkillers.
• sedatives, antiepileptics, rifampicin (an antitubercular medicine).
• salicylamide (an anti-inflammatory, antipyretic, and analgesic medicine).
• MAO inhibitors (used in depression) and if it has not been 2 weeks since the last use of these medicines.
• other antidepressant medicines (from the group of tricyclic antidepressants, e.g., amitriptyline).
• nonsteroidal anti-inflammatory medicines (including acetylsalicylic acid).
• ergot alkaloids (used in migraine).
• certain medicines used in heart diseases or high blood pressure (e.g., digoxin, beta-adrenolytics, methyldopa).
• appetite suppressants, nasal decongestants, and psychostimulants (e.g., used in attention deficit hyperactivity disorder).

The use of 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 childbirth.
Caffeine enhances the analgesic effect of paracetamol.
Ascorbic acid increases iron absorption and increases aluminum absorption from products containing it.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.

Driving and using machines

The medicine may cause dizziness. If you experience such symptoms, you should not drive vehicles or operate machines.

Choligrip Menthol Active contains 3755 mg of sucrose in each sachet.

This should be taken into account in patients with diabetes. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Choligrip Menthol Active contains 50 mg of aspartame (E 951)in each sachet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Choligrip Menthol Active contains 118 mg of sodium (the main component of common salt)

in each sachet, which corresponds to 6% of the recommended daily intake of sodium in the diet for adults.
People with reduced kidney function or on a low-sodium diet should take this amount of sodium into account in their diet.
Choligrip Menthol Active containsglucose (a component of maltodextrin). If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains sulfites.The medicine can rarely cause severe hypersensitivity reactions and bronchospasm.
Choligrip Menthol Active contains3.5 mg of benzoic acid in each sachet, which corresponds to 0.7 mg/g.
Choligrip Menthol Active contains sulfites.The medicine can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Choligrip Menthol Active

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If you have any doubts, you should consult a doctor, pharmacist, or nurse.

Use in adults and adolescents over 12 years of age

The recommended dose is one sachet (600 mg of paracetamol, 40 mg of ascorbic acid, and 10 mg of phenylephrine hydrochloride) if necessary, every 4 to 6 hours. For oral use only.
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 use more frequently than every 4 hours.
• Do not use more than 4 sachets (2400 mg of paracetamol, 160 mg of ascorbic acid, and 40 mg of phenylephrine hydrochloride) per day.
• Do not use a higher dose than recommended.
• You should always use the lowest effective dose of the medicine.
• Without a doctor's recommendation, the medicine should not be used for more than 3 days.
• If symptoms worsen or do not improve, you should consult a doctor or pharmacist.

Use in children

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

Using a higher dose of Choligrip Menthol Active than recommended

Overdose of paracetamol can cause delayed severe liver damage, which can result in liver transplantation or death. Overdose of paracetamol can cause nausea, vomiting, excessive sweating, drowsiness, and general weakness within a few or several hours. In every case of taking paracetamol in a dose of 5 g or more, you can provoke vomiting if it has not been more than an hour since ingestion and contact a doctor immediately. Administer 60-100 g of activated charcoal orally, preferably mixed with water. The amount of medicine that can cause severe overdose symptoms of phenylephrine or ascorbic acid would cause severe liver damage from paracetamol. Overdose of phenylephrine can cause nervousness, headache, dizziness, insomnia, increased blood pressure, nausea, vomiting, irritability, restlessness, hypertension, and decreased heart rate. In severe cases, it can cause confusion, hallucinations, and arrhythmia. High doses of ascorbic acid (above 3 g) can cause transient diarrhea and gastrointestinal symptoms such as nausea and discomfort in the abdominal cavity.
In case of taking a higher dose than recommended, you should immediately seek medical advice, even if you feel well. You should take the medicine leaflet with you so that you can show it to your doctor.

Missing a dose of Choligrip Menthol Active

You should 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.

You should stop using the medicine and consult a doctor if you experience:

• an allergic reaction (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 reaction characterized by acute generalized pustular rash or blisters and erosions on the skin, mouth, eyes, and genitals, fever, and joint pain or bursting giant subcutaneous blisters, extensive skin erosion, and fever,
• breathing problems, if you have had similar problems in the past when using acetylsalicylic acid or other nonsteroidal anti-inflammatory medicines.
• bruises or bleeding of unknown cause.
• nausea, sudden weight loss, loss of appetite, and yellowing of the eyes and skin.
• eye pain and redness, vision disturbances, headache, and nausea, which can be symptoms of acute angle-closure glaucoma caused by excessively high intraocular pressure. This is very rare but more likely to occur in people with angle-closure glaucoma.
• abnormal rapid heartbeat or feeling of irregular heartbeat.
• difficulty urinating. The likelihood of this is higher in men with prostate enlargement.

The above symptoms are very rare (less common than 1 in 10,000 patients).
The following side effects may also occur. You should inform your doctor about them:

• increased blood pressure, headache, dizziness, sleep disturbances, nervousness, restlessness, pupil dilation.
• diarrhea or vomiting.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 Choligrip Menthol Active

The medicine should be stored in a place invisible and inaccessible to children.
Do not store above 30°C.
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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Choligrip Menthol Active contains

• The active substances of the medicine are paracetamol, ascorbic acid (vitamin C), and phenylephrine hydrochloride. Each sachet contains 600 mg of paracetamol, 40 mg of ascorbic acid, and 10 mg of phenylephrine hydrochloride.
• The other ingredients are: sodium saccharin (E 954), aspartame (E 951), sucrose, sodium citrate, citric acid (anhydrous), corn starch, menthol flavor E41580, lemon flavor PHS-163671 (contains linalool, geraniol, d-limonene, citronellol, citral, maltodextrin - a source of glucose, butylhydroxyanisole (E 320), sulfites), lemon flavor PHS-050860 (contains maltodextrin - a source of glucose, propylene glycol, sulfites, benzoic acid (E 210)), honey flavor F7624/P, caramel color.

What Choligrip Menthol Active looks like and what the packaging contains

The medicine is a light powder with a honey, lemon, and menthol flavor.
The packaging contains 5, 6, 8, 10, 12, 15, 20, or 24 sachets.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer:

SmithKline Beecham S.A.
Carretera De Ajalvir, km 2.500, 28806 Alcala de Henares
Madrid
Spain
Date of last update of the leaflet:August 2023

Other sources of information

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