Theraflu grip forest fruits

Package leaflet: Information for the user

Theraflu Grip Owoce Leśne
500 mg, effervescent powder for oral solution
Paracetamolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken according to the instructions in this patient leaflet or as directed by
your doctor or pharmacist.

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

Leaflet contents:

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

1. What Theraflu Grip Owoce Leśne is and what it is used for

Theraflu Grip Owoce Leśne is an effervescent powder in sachets for preparing a hot drink.
The active substance in this medicine is paracetamol, which has analgesic (pain-relieving) and antipyretic (fever-reducing) effects.
Theraflu Grip Owoce Leśne is used for the short-term treatment of mild to moderate pain and fever associated with colds and flu, headache, muscle and joint pain, toothache, and menstrual pain.
This medicine is intended for use in adults and adolescents over 12 years of age.
This medicine may be used by people with sensitive stomachs.
If pain persists for more than 5 days or fever lasts longer than 3 days, or if these symptoms worsen,
you should consult your doctor.

2. Information before using Theraflu GRIP Owoce Leśne

When not to use Theraflu GRIP Owoce Leśne

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6). When to be cautious Before using the medicine, consult a doctor if any of the following conditions apply:
• kidney disease,
• liver disease, including disorders caused by alcohol abuse,
• Gilbert's syndrome (a mild form of jaundice),
• glucose-6-phosphate dehydrogenase deficiency (enzyme deficiency),
• haemolytic anaemia (abnormal breakdown of red blood cells),
• dehydration or prolonged malnutrition,
• when taking other medicines containing paracetamol.

Warnings and precautions
Do not exceed the daily dose of the medicine stated in section 3. Doses higher than recommended
do not provide stronger pain relief, but may cause severe
liver damage. In case of overdose, contact a doctor immediately. Symptoms of liver damage usually appear within a few days.
Do not take any other products containing paracetamol simultaneously,
due to the risk of exceeding the maximum daily dose of paracetamol. When
using Theraflu GRIP Owoce Leśne, check the composition of any other medicines before taking them.
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. Do not use Theraflu GRIP Owoce Leśne simultaneously with
alcohol consumption. Taking paracetamol does not intensify the effects of alcohol, but alcohol may
intensify the toxic effects of paracetamol on the liver.
Children
This medicine should not be used in children under 12 years of age or weighing less than 41 kg.
Other medicines and Theraflu GRIP Owoce Leśne
Tell your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines you plan to take.
In particular, before using Theraflu GRIP Owoce Leśne, inform your doctor if you are taking:

• blood-thinning medicines (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 gastric emptying, such as exenatide,
• cholestyramine, used to reduce blood cholesterol levels. Wait at least one hour between taking cholestyramine and Theraflu GRIP Owoce Leśne.
• medicines used to treat tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol),
• probenecid, used in the treatment of gout,
• medicines used to treat epilepsy, e.g. phenytoin, phenobarbital and carbamazepine,
• St. John's wort (an ingredient in some herbal medicines).

Theraflu GRIP Owoce Leśne with food, drink and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant, consult your doctor or
pharmacist before using this medicine.
Paracetamol passes into breast milk in small amounts. Despite this, breastfeeding women may use this medicine. Do not exceed the daily dose or duration of treatment
recommended in this leaflet.
Driving and using machines
Theraflu GRIP Owoce Leśne does not affect the ability to drive or operate
machinery.
Important information about certain ingredients of this medicine
Theraflu GRIP Owoce Leśne contains:

• aspartame (E951), a source of phenylalanine, which may be harmful to people with phenylketonuria (an enzyme deficiency responsible for phenylalanine metabolism).
• sodium (38 mg per sachet): sodium content should be considered in a low-sodium diet.
• sucrose (5.4 g per sachet). If a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine. Sucrose content should also be considered in patients with diabetes.
• soy lecithin (E322). This medicine should not be used in case of allergy to peanuts or soy.

3. How to use Theraflu GRIP Owoce Leśne
This medicine should always be taken according to the instructions in the patient leaflet or as directed by
a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Adults
Take 1 or 2 sachets (500 to 1000 mg) every 4–6 hours as needed, up to 4
times a day.
Usually, one sachet per dose is sufficient. Do not take more than
6 sachets (3000 mg) within 24 hours.
Wait 4–6 hours between successive doses.
Children and adolescents

• Children under 12 years of age or weighing less than 41 kg: this medicine should not be used in children under 12 years of age or weighing less than 41 kg.
• Adolescents aged 12 to 15 years weighing 41 to 50 kg: one sachet per dose, every 4–6 hours as needed, up to four times a day. Do not take more than 4 sachets (2000 mg) within 24 hours. Wait 4–6 hours between successive doses.
• Adolescents aged 16 to 18 years weighing more than 50 kg: same as adults. Do not exceed the recommended doses. In adolescents and adults weighing less than 50 kg, the total daily dose of paracetamol should not exceed 60 mg/kg body weight/day. Patients with impaired kidney or liver function In patients with impaired liver or kidney function, the dose should be reduced or the intervals between doses extended. Consult a doctor before using this medicine. How to take Theraflu GRIP Owoce Leśne Dissolve the contents of one or two sachets in a standard-sized cup of hot, but not boiling, water (approximately 250 ml). If two sachets are used, more water may be added, depending on taste preference. Drink after cooling to a suitable temperature. How long to take Theraflu GRIP Owoce Leśne If pain persists for more than 5 days, fever lasts longer than 3 days, or symptoms worsen, consult a doctor. Taking more than the recommended dose of Theraflu GRIP Owoce Leśne In case of overdose or accidental ingestion, contact a doctor immediately or go directly to a hospital or poison control centre. Immediate medical assistance is crucial, even if the patient feels well, due to the risk of severe liver damage. Missed dose of Theraflu GRIP Owoce Leśne If a dose is missed, take the medicine as soon as possible, unless it is almost time for the next dose. In that case, 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 product may cause side effects, although not everyone will experience them. If any of the symptoms listed below occur, STOP using
this medicine and contact a doctor or pharmacist immediately:

• allergic reaction, including shortness of breath, swelling of the face, lips, tongue or throat,
• skin rash (including hives, itching), redness of the skin,
• skin peeling, blisters, erosions, mouth ulcers,
• blood disorders, including unusual bleeding or bruising,
• any changes in the appearance or amount of urine, including cloudy urine, presence of blood in urine, difficulty urinating, which are symptoms of kidney dysfunction,
• yellowing of the skin or whites of the eyes (jaundice). These are symptoms of liver dysfunction. Changes in laboratory test results for liver function may also occur. The above-mentioned side effects are rare (may occur in 1 out of 1000 people) or very rare (may occur in 1 out of 10,000 people). In very rare cases, severe skin reactions have been reported. Other side effects that may occur rarely (in 1 out of 1000 people). If any of the following symptoms occur, inform your doctor:
• nausea, abdominal pain, vomiting, diarrhoea,
• depression, disorientation, perception of non-existent sensory sensations (hallucinations),
• tremors, headache, dizziness, nervousness, disorientation,
• vision disturbances,
• abnormal accumulation of fluid in subcutaneous tissue (oedema),
• balance disorders, general fatigue and malaise, fever, drowsiness,
• excessive sweating. The following side effect may also occur very rarely (in 1 out of 10,000 people). If it occurs, consult a doctor:
• low blood glucose levels (hypoglycaemia). If any side effects occur, including any possible side effects not listed in the leaflet,
  consult a doctor or pharmacist.

Reporting side effects
If any side effects occur, including any side effects
not listed in the leaflet, inform your doctor, pharmacist or nurse.
Side effects 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, e-mail: [email protected]
Reporting side effects helps to collect more information on the safety of the medicine.

5. How to store Theraflu Grip Owoce Leśne

Keep this medicine out of sight and reach of children and adolescents.
Do not use Theraflu Grip Owoce Leśne after the expiry date stated on the packaging.
No special storage conditions are required.
Store in the original packaging. Do not use this medicine if signs of deterioration are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Theraflu GRIP Owoce Leśne contains
The active substance is paracetamol (500 mg/packet).
The other ingredients are:
ascorbic acid (vitamin C), potassium acesulfame, aspartame (E951), calcium phosphate, citric acid, maltodextrin, colloidal hydrated silica, sodium citrate, sucrose, quinoline yellow (E104), berry flavour (containing soya lecithin), raspberry flavour (containing soya lecithin), cranberry flavour (containing soya lecithin), menthol flavour (containing soya lecithin), green tea flavour (containing soya lecithin). (More information on certain ingredients – see section 2).

What Theraflu GRIP Owoce Leśne looks like and contents of the pack
Theraflu GRIP Owoce Leśne is a white to pale yellow powder with brown granules, packed in sachets.
Theraflu GRIP Owoce Leśne is available in packs containing 6, 8, 10 or 12 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:
Delpharm Orleans
5 avenue de Concyr
Orleans cedex 2, 45071
France

Importer:
Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany

For further information about this medicinal product and its names in the individual countries of the European Economic Area, please contact the Marketing Authorisation Holder.