Theraflu Grip Miud i Citrina

Leaflet attached to the packaging: information for the user

Theraflu GRIP Honey and Lemon

500 mg, powder for oral solution

Paracetamol

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

This medicine should always be taken in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
• If after 5 days in the case of pain or 3 days in the case of fever, there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

• 1. What is Theraflu GRIP Honey and Lemon and what is it used for
• 2. Important information before taking Theraflu GRIP Honey and Lemon
• 3. How to take Theraflu GRIP Honey and Lemon
• 4. Possible side effects
• 5. How to store Theraflu GRIP Honey and Lemon
• 6. Contents of the packaging and other information

1. What is Theraflu GRIP Honey and Lemon and what is it used for

Theraflu GRIP Honey and Lemon is a powder in sachets for the preparation of a hot solution.
The active substance of the medicine is paracetamol, which has analgesic (reduces pain) and
antipyretic (reduces body temperature) effects.
Theraflu GRIP Honey and Lemon is used for the short-term treatment of mild or moderate pain and
fever in the course of colds and flu, headache, muscle and joint pain, toothache, and menstrual cramps.
The medicine is intended for use in adults and adolescents over 12 years of age.
The medicine can be used by people with sensitive stomachs.

In case of pain lasting for more than 5 days or fever lasting for more than 3 days or worsening of these symptoms, you should contact a doctor.

2. Important information before taking Theraflu GRIP Honey and Lemon

When not to take Theraflu GRIP Honey and Lemon

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

When to exercise special caution

Before taking the medicine, you should consult a doctor in case of:

• kidney disease,
• liver disease, including disorders resulting from alcohol abuse
• Gilbert's syndrome (a mild form of jaundice),
• glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency),
• hemolytic anemia (abnormal breakdown of red blood cells),
• dehydration or prolonged malnutrition,
• in case of taking other medicines containing paracetamol.

Warnings and precautions

Do not exceed the daily dose of the medicine given in point 3.Higher doses than recommended
do not ensure stronger analgesic effects, but may cause very severe liver damage. In case of overdose, you should immediately contact
a doctor.Symptoms of liver damage usually appear within a few days.

Do not take any other products containing paracetamol at the same time

due to the risk of exceeding the maximum daily dose of paracetamol.When taking Theraflu GRIP Honey and Lemon, before taking other medicines, you should check their composition.

Do not drink alcohol while taking this medicine.

Without a doctor's recommendation, patients who abuse alcohol or have liver damage should not take this medicine. You should not take Theraflu GRIP Honey and Lemon at the same time as consuming alcohol. Taking paracetamol does not enhance the effects of alcohol, but alcohol may enhance the toxic effects of paracetamol on the liver.

Children

The medicine should not be used in children under 12 years of age or with a body weight of less than 41 kg.

Other medicines and Theraflu GRIP Honey and Lemon

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

In particular, before taking Theraflu GRIP Honey and Lemon, you should tell your doctor about taking:

• blood thinners (anticoagulants), such as warfarin or other coumarin derivatives
• medicines containing paracetamol (see section 2 - Warnings and precautions)
• anti-nausea and anti-vomiting medicines, such as metoclopramide or domperidone.
• medicines that slow down gastric emptying, such as exenatide
• cholestyramine, used to reduce blood cholesterol levels. You should wait at least one hour between taking cholestyramine and taking Theraflu GRIP Honey and Lemon.
• medicines used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol).
• probenecid, used to treat gout
• medicines used to treat epilepsy, such as phenytoin, phenobarbital, and carbamazepine
• St. John's wort (an ingredient in some herbal medicines).

Theraflu GRIP Honey and Lemon with food, drinks, and alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant, you should consult a doctor or pharmacist before taking this medicine.
Paracetamol passes into breast milk in small amounts. Nevertheless, breastfeeding women can take this medicine. You should not exceed the daily dose or treatment period recommended in this leaflet.

Driving and using machines

Theraflu GRIP Honey and Lemon does not affect the ability to drive and use machines.

Important information about some ingredients of this medicine

Theraflu GRIP Honey and Lemon contains:

• aspartame (E951), a source of phenylalanine, which may be harmful to people with phenylketonuria (a deficiency of the enzyme responsible for phenylalanine metabolism).
• sodium(38 mg/sachet): the sodium content should be taken into account in the case of a low-sodium diet.
• sucrose(5.3 g/sachet). If you have previously been diagnosed with intolerance to some sugars, you should consult a doctor before taking the medicine. The sucrose content should also be considered in patients with diabetes.
• Allura Red AC (E129)0.09 mg/sachet: an azo dye, may cause allergic reactions
• soy lecithin (E322). If you are allergic to peanuts or soy, you should not take this medicine.

3. How to take Theraflu GRIP Honey and Lemon

This medicine should always be taken in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The recommended dose is:

Adults

Take 1 or 2 sachets (500 to 1000 mg) every 4-6 hours as needed, up to a maximum of 4 times a day.
Usually, one sachet per dose is sufficient. You should not take more than 6 sachets (3000 mg) in 24 hours.
You should wait 4-6 hours between doses.

Children and adolescents

• Children under 12 years of age or with a body weight of less than 41 kg:the medicine should not be used in children under 12 years of age or with a body weight of less than 41 kg.
• Adolescents from 12 to 15 years of age with a body weight of 41 to 50 kg:one sachet per dose, every 4-6 hours as needed, up to a maximum of 4 times a day. You should not take more than 4 sachets (2000 mg) in 24 hours.

You should wait 4-6 hours between doses.

• Adolescents from 16 to 18 years of age with a body weight over 50 kg:as adults.

Do not exceed the recommended doses.

In adolescents and adults with a body weight of less than 50 kg, the total dose of paracetamol should not exceed 60 mg/kg body weight/day.

Patients with kidney and liver function disorders

In patients with liver or kidney function disorders, the dose should be reduced or the intervals between doses prolonged. You should consult a doctor before taking this medicine.

How to take Theraflu GRIP Honey and Lemon

The contents of one or two sachets should be dissolved in a standard-sized cup of hot, but not boiling water (about 250 ml). In the case of using two sachets, you can add more water, depending on taste. Drink after cooling to a suitable temperature.

How long to take Theraflu GRIP Honey and Lemon

In case of pain lasting for more than 5 days, fever lasting for more than 3 days, or worsening of these symptoms, you should consult a doctor.

Taking a higher dose of Theraflu GRIP Honey and Lemon than recommended

In case of overdose or accidental ingestion of the medicine, you should immediately contact a doctor or go directly to a hospital or poison control center.
Immediate medical attention is essential, even if the patient feels well, due to the risk of severe liver damage.

Missing a dose of Theraflu GRIP Honey and Lemon

In case of missing a dose, you should take the medicine as soon as possible, unless there is little time left before the next dose. In this case, you should continue treatment as recommended. You should always maintain a 4-hour interval between doses. 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.

In case of experiencing any of the following symptoms, you should STOP taking this medicine and immediately consult a doctor or pharmacist:

• allergic reaction, including shortness of breath, swelling of the face, lips, tongue, or throat.
• skin rash (including hives, itching), redness of the skin.
• peeling of the skin, blisters, ulcers, mouth sores.
• blood disorders, including unusual bleeding or bruising.
• any changes in the appearance or amount of urine, including cloudiness of urine, presence of blood in urine, difficulty urinating, which are symptoms of kidney function disorders.
• yellowing of the skin or whites of the eyes (jaundice). These are symptoms of liver function disorders. Changes in liver function test results may also occur. The above side effects are rare (may occur in 1 in 1000 people) or very rare (may occur in 1 in 10,000 people). In very rare cases, severe skin reactions have been reported

Other side effects that may occur rarely(in 1 in 1000 people). In case of experiencing any of the following symptoms, you should tell your doctor:

• nausea, abdominal pain, vomiting, diarrhea;
• depression, disorientation, perception of non-existent sensory impressions (hallucinations);
• tremors, headache, dizziness, nervousness, disorientation;
• vision disorders;
• abnormal accumulation of fluid in the subcutaneous tissue (edema);
• balance disorders, general malaise, and poor well-being, fever, drowsiness;
• increased sweating. Very rarely, the following side effect may also occur(in 1 in 10,000 people). In case of its occurrence, you should consult a doctor:
• low blood sugar levels (hypoglycemia).

If you experience any side effects, including any possible side effects not listed in the leaflet, you should consult a doctor or pharmacist.

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, 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, e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Theraflu GRIP Honey and Lemon

The medicine should be stored in a place invisible and inaccessible to children and adolescents.

You should not take Theraflu GRIP Honey and Lemon after the expiry date stated on the packaging.
There are no special precautions for storing the medicine.
You should store it in the original packaging. You should not use this medicine if you notice signs of spoilage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Theraflu GRIP Honey and Lemon contains

The active substance of the medicine is paracetamol (500 mg/sachet).
The other ingredients are:
ascorbic acid (vitamin C), acesulfame potassium, aspartame (E951), calcium phosphate, citric acid, maltodextrin, colloidal silica, sodium citrate, sucrose, quinoline yellow (E104), brilliant blue FCF (E133), Allura Red AC (E129), lemon flavor (contains soy lecithin), chamomile flavor (contains soy lecithin), honey flavor (contains soy lecithin), white tea flavor. (More information about some ingredients - see section 2).

What Theraflu GRIP Honey and Lemon looks like and what the packaging contains

Theraflu GRIP Honey and Lemon is a white to light yellow powder in the form of granules, packaged in sachets.
Theraflu GRIP Honey and Lemon is available in packages containing 6, 8, 10, or 12 sachets.
Not all pack sizes may be marketed.

Responsible entity:

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

Manufacturer:

Delpharm Orleans
5 avenue de Concyr
Orleans cedex 2, 45071
France

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
In order to obtain more detailed information about the medicine and its names in individual EU member states, you should contact the responsible entity.
Date of last update of the leaflet:August 2024