THERAFLU 500 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Theraflu GRIP Forest Fruits
3. 500 mg, powder for oral solution
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Theraflu GRIP Forest Fruits and what is it used for
   1. In case of pain lasting more than 5 days or fever lasting more than 3 days or worsening of these symptoms, you should contact your doctor.
5. Important information before taking Theraflu GRIP Forest Fruits
   1. When not to take Theraflu GRIP Forest Fruits
   2. When to be extra careful
   3. Before taking the medicine, consult your doctor if you have:
   4. Warnings and precautions
   5. Do not take any other products containing paracetamol at the same time
   6. Do not drink alcohol while taking this medicine.
   7. Children
   8. Other medicines and Theraflu GRIP Forest Fruits
   9. Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.
   10. Theraflu GRIP Forest Fruits with food, drinks, and alcohol
   11. Do not drink alcohol while taking this medicine.
   12. Pregnancy and breastfeeding
   13. Driving and using machines
   14. Important information about some ingredients of this medicine
6. How to take Theraflu GRIP Forest Fruits
   1. Adults
   2. Children and adolescents
   3. Do not exceed the recommended doses.
   4. Patients with kidney or liver function disorders
   5. How to take Theraflu GRIP Forest Fruits
   6. How long to take Theraflu GRIP Forest Fruits
   7. Taking a higher dose of Theraflu GRIP Forest Fruits than recommended
   8. Missing a dose of Theraflu GRIP Forest Fruits
   9. Possible side effects
   10. If you experience any of the following symptoms, STOP taking this medicine and contact your doctor or pharmacist immediately:
   11. If you experience any side effects, including any possible side effects not listed in this leaflet, contact your doctor or pharmacist.
   12. Reporting side effects
7. How to store Theraflu GRIP Forest Fruits
   1. Keep the medicine out of sight and reach of children and adolescents.
8. Package contents and other information
   1. What Theraflu GRIP Forest Fruits contains
   2. What Theraflu GRIP Forest Fruits looks like and what the package contains
   3. Responsible entity:
   4. Importer:

Leaflet attached to the packaging: information for the user

Theraflu GRIP Forest Fruits

500 mg, powder for oral solution

Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
• If after 5 days for pain or 3 days for fever, there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Theraflu GRIP Forest Fruits and what is it used for
• 2. Important information before taking Theraflu GRIP Forest Fruits
• 3. How to take Theraflu GRIP Forest Fruits
• 4. Possible side effects
• 5. How to store Theraflu GRIP Forest Fruits
• 6. Package contents and other information

1. What is Theraflu GRIP Forest Fruits and what is it used for

Theraflu GRIP Forest Fruits is a powder in sachets for making a hot solution. The active substance of the medicine is paracetamol, which has analgesic and antipyretic effects. Theraflu GRIP Forest Fruits is used for short-term treatment of mild or moderate pain and fever in colds and flu, headache, muscle and joint pain, toothache, and menstrual pain. 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 more than 5 days or fever lasting more than 3 days or worsening of these symptoms, you should contact your doctor.

2. Important information before taking Theraflu GRIP Forest Fruits

When not to take Theraflu GRIP Forest Fruits

When to be extra careful

Before taking the medicine, consult your doctor if you have:

• 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,
• if you are taking other medicines containing paracetamol.

Warnings and precautions

Do not exceed the recommended daily dose of the medicine.Higher doses than recommended do not ensure stronger analgesic effects, but may cause very severe liver damage. In case of overdose, contact your doctor immediately.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 Forest Fruits, before taking other medicines, 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. Theraflu GRIP Forest Fruits should not be used 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 Forest Fruits

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to take.

In particular, before taking Theraflu GRIP Forest Fruits, tell your doctor about taking:

• blood thinners (anticoagulants), such as warfarin or other coumarin derivatives
• medicines containing paracetamol (see section 2 - Warnings and precautions)
• medicines for nausea and vomiting, 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 Forest Fruits.
• 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 Forest Fruits with food, drinks, and alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

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

Driving and using machines

Theraflu GRIP Forest Fruits does not affect the ability to drive or use machines.

Important information about some ingredients of this medicine

Theraflu GRIP Forest Fruits contains:

• aspartame (E951), a source of phenylalanine, which may be harmful to people with phenylketonuria (an enzyme deficiency that affects phenylalanine metabolism).
• sodium(38 mg/sachet): sodium content should be taken into account in the case of a low-sodium diet.
• sucrose(5.4 g/sachet). If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The sucrose content should also be considered in patients with diabetes.
• soy lecithin (E322). If you are allergic to peanuts or soy, do not take this medicine.

3. How to take Theraflu GRIP Forest Fruits

This medicine should always be taken as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult your 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. Do not take more than 6 sachets (3000 mg) in 24 hours. 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. Do not take more than 4 sachets (2000 mg) in 24 hours. 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 or liver function disorders

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

How to take Theraflu GRIP Forest Fruits

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

How long to take Theraflu GRIP Forest Fruits

In case of pain lasting more than 5 days, fever lasting more than 3 days, or worsening of these symptoms, consult your doctor.

Taking a higher dose of Theraflu GRIP Forest Fruits than recommended

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

Missing a dose of Theraflu GRIP Forest Fruits

If you miss a dose, take the medicine as soon as possible, unless it is almost time for the next dose. Then continue treatment as recommended. Always maintain at least a 4-hour interval between doses. Do 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.

If you experience any of the following symptoms, STOP taking this medicine and contact your doctor or pharmacist immediately:

• allergic reaction, including difficulty breathing, 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 affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people). Very rare cases of severe skin reactions have been reported. Other side effects that may occur rarely(in up to 1 in 1,000 people):
• 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. A very rare side effect that may also occur(in up to 1 in 10,000 people):
• low blood sugar levels (hypoglycemia).

If you experience any side effects, including any possible side effects not listed in this leaflet, contact your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Theraflu GRIP Forest Fruits

Keep the medicine out of sight and reach of children and adolescents.

Do not use Theraflu GRIP Forest Fruits after the expiration date stated on the packaging. There are no special precautions for storing the medicine. Store in the original packaging. Do not use this medicine if you notice signs of spoilage. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Theraflu GRIP Forest Fruits 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), forest fruit flavor (contains soy lecithin), raspberry flavor (contains soy lecithin), cranberry flavor (contains soy lecithin), menthol flavor (contains soy lecithin), green tea flavor (contains soy lecithin). (More information about some ingredients - see section 2).

What Theraflu GRIP Forest Fruits looks like and what the package contains

Theraflu GRIP Forest Fruits is a white to light yellow powder with brown granules, packaged in sachets. Theraflu GRIP Forest Fruits 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. 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. For more detailed information about the medicine and its names in individual EU member states, contact the responsible entity. Date of last update of the leaflet:August 2024