Theraflu grip honey and lemon

Patient Information Leaflet: Instructions for Use

Theraflu Grip Honey and Lemon
500 mg, effervescent powder for oral solution
Paracetamolum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken in accordance with the instructions provided in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 5 days of treatment for pain or 3 days for fever, or if symptoms worsen, consult a physician.

Table of Contents:

1. What Theraflu Grip Honey and Lemon is and what it is 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 package and other information

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

Theraflu Grip Honey and Lemon is an effervescent powder in sachets intended for preparation of a hot drink.
The active substance is paracetamol, which has analgesic (pain-relieving) and antipyretic (fever-reducing) effects.
Theraflu Grip Honey and Lemon is used for short-term relief 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 product may be used by individuals with sensitive stomachs.
If pain persists for more than 5 days or fever lasts longer than 3 days, or if symptoms worsen,
a physician should be consulted.

2. Important information before using Theraflu GRIP Honey and Lemon

When not to use 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 be cautious Before using the medicine, consult a doctor if any of the following conditions are present:
• 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),
• 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 simultaneously take any other products containing paracetamol due to the risk of exceeding the maximum daily dose of paracetamol. When using Theraflu GRIP Honey and Lemon, check the composition of any other medicines before taking them.
Do not drink alcohol while using this medicine.
Without medical advice, patients who abuse alcohol or have liver damage should not take this medicine. Theraflu GRIP Honey and Lemon should not be used at the same time as alcohol consumption. Taking paracetamol does not intensify the effects of alcohol; however, alcohol may enhance the toxic effect of paracetamol on the liver.
Children
This medicine should not be used in children under 12 years of age or with body weight less than 41 kg.
Other medicines and Theraflu GRIP Honey and Lemon
Tell your doctor or pharmacist about all medicines currently being taken, recently taken, or planned for use.
In particular, before using Theraflu GRIP Honey and Lemon, 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),
• anti-nausea and anti-vomiting medicines, such as metoclopramide or domperidone,
• medicines that slow gastric emptying, such as exenatide,
• cholestyramine, used to reduce blood cholesterol levels. At least one hour should be waited between taking cholestyramine and Theraflu GRIP Honey and Lemon.
• medicines used in the treatment of tuberculosis (rifampicin and isoniazid) and bacterial infections (chloramphenicol),
• probenecid, used in the treatment of gout,
• medicines used in the treatment of epilepsy, e.g. phenytoin, phenobarbital and carbamazepine,
• St. John's wort (an ingredient in some herbal medicines).

Theraflu GRIP Honey and Lemon with food, drink and alcohol
Do not drink alcohol while using this medicine.
Pregnancy and breastfeeding
If the patient is pregnant, consult a doctor or pharmacist before using this medicine.
Paracetamol passes into breast milk in small amounts. Nevertheless, breastfeeding women may use this medicine. Do not exceed the recommended daily dose or treatment duration stated in this leaflet.
Driving and operating machinery
Theraflu GRIP Honey and Lemon does not affect the ability to drive or operate machinery.
Important information about certain ingredients of this medicine
Theraflu GRIP Honey and Lemon 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/sachet): sodium content should be considered in a low-sodium diet.
• sucrose (5.3 g/sachet). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine. 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.
• soya lecithin (E322). This medicine should not be used in case of allergy to peanuts or soya.

3. How to use Theraflu GRIP Honey and Lemon
This medicine should always be taken according to the instructions in this 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 doses.
Children and adolescents

• Children under 12 years of age or with body weight less than 41 kg: This medicine should not be used in children under 12 years of age or with body weight less than 41 kg.
• Adolescents aged 12 to 15 years with body weight between 41 and 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 doses.

• Adolescents aged 16 to 18 years with body weight over 50 kg: same as adults. Do not exceed the recommended doses. In adolescents and adults with body weight 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 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 use Theraflu GRIP Honey and Lemon Dissolve the contents of one or two sachets in a cup of hot, but not boiling, water (approximately 250 ml). If two sachets are used, more water may be added depending on taste preference. Allow to cool before drinking. How long to use Theraflu GRIP Honey and Lemon If pain persists for more than 5 days, fever lasts more than 3 days, or symptoms worsen, consult a doctor. Taking more than the recommended dose of Theraflu GRIP Honey and Lemon In case of overdose or accidental ingestion, contact a doctor immediately or go directly to a hospital or poison treatment 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 Honey and Lemon If a dose is missed, take it 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 following symptoms occur, STOP using this medicine and contact a doctor or pharmacist immediately:
• allergic reaction, including breathlessness, swelling of the face, lips, tongue or throat.
• skin rash (including urticaria, itching), redness of the skin.
• skin peeling, blisters, erosions, mouth ulcers.
• blood disorders, including unusual bleeding or bruising.
• any changes in appearance or amount of urine, including cloudy urine, blood in urine, difficulty passing urine – symptoms of kidney function disorders.
• yellowing of the skin or whites of the eyes (jaundice). These are symptoms of liver function disorders. Changes in laboratory test results for liver function may also occur. The above 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 impressions (hallucinations);
• tremors, headache, dizziness, nervousness, disorientation;
• visual disturbances;
• abnormal accumulation of fluid in subcutaneous tissue (oedema);
• loss of balance, general weakness and malaise, fever, drowsiness;
• excessive sweating. Very rarely, the following side effect may also occur (in 1 out of 10,000 people). If it occurs, consult a doctor:
• low blood glucose levels (hypoglycaemia). If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 adverse effects helps to collect more information on the safety of the medicine.

5. How to store Theraflu Grip Miód i Cytryna

Keep the medicine out of the sight and reach of children and adolescents.
Do not use Theraflu Grip Miód i Cytryna after the expiry date stated on the packaging.
There are no special storage instructions for this medicine.
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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Theraflu GRIP Honey and Lemon contains
The active substance is paracetamol (500 mg/sachet).
The other ingredients are:
ascorbic acid (vitamin C), potassium acesulfame, aspartame (E951), calcium phosphate, citric acid, maltodextrin, colloidal anhydrous silica, sodium citrate, sucrose, quinoline yellow (E104), brilliant blue FCF (E133), Allura red AC (E129), lemon flavour (contains soya lecithin), chamomile flavour (contains soya lecithin), honey flavour (contains soya lecithin), white tea flavour. (For more information on some of the ingredients, see section 2).

What Theraflu GRIP Honey and Lemon looks like and contents of the pack
Theraflu GRIP Honey and Lemon is a white to pale yellow granular powder packed in sachets.
Theraflu GRIP Honey and Lemon 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 the medicinal product and its names in the individual countries of the European Economic Area, please contact the Marketing Authorisation Holder.