Document: Therimin Skogsbär powder for oral solution ENG PL change

• Therimin Skogsbär powder for oral solution PL
• Therimin Skogsbär powder for oral solution ENG PL

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Package leaflet: Information for the user

Therimin Skogsbär 500 mg Powder for Oral Solution

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicineexactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

• If pain persists for more than 5 days or fever lasts for more than 3 days, or worsen, you should contact a doctor.

What is in this leaflet

1. What Therimin Skogsbär 500 mg powder for oral solution is and what it is used for

Therimin Skogsbär500 mg is a powder for a hot liquid medicine available in sachets. It contains the active ingredient paracetamol which is an analgesic (pain killer) and fever reducer (decreases body temperature).

Therimin Skogsbär is used for the short-term treatment of mild to moderate pain and fever associated with colds and flu, headache, muscles and joints pains, toothache and menstrual pain.

This medicine is recommended in adults and adolescents aged 12 years and above.

It can be used by people with a sensitive stomach.

If pain persists for more than 5 days or fever lasts for more than 3 days, or worsen, you should contact a doctor.

Do not take Therimin Skogsbär if you

Take special care

Tell your doctor before taking this medicineif you

• are suffering from kidney problems,

• are suffering from liver problems including liver problems due to excessive alcohol consumption

• have Gilbert’s syndrome (mild jaundice),

• suffer from glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency),

• have haemolytic anaemia (abnormal breakdown of red blood cells),

• are suffering from dehydration or chronic malnutrition,

• are taking other paracetamol containing medicines,

Warnings and precautions

Do not exceed the daily dose stated in section 3. Higher doses than recommended do not give better pain relief, instead it can result in very severe liver damage. You must contact a doctor straight away if you have taken an overdose. The symptoms of liver damage are normally visible within a few days.

Do not take any other paracetamol-containing products at the same time as there is a risk of exceeding the maximum daily dose of paracetamol. Check the ingredients of other medicines before taking them when you are using Therimin Skogsbär.

Do not drink alcohol while taking this medicine.

Do not take this medicine unless prescribed by your doctor if you have a drinking problem or liver damage. Do not use Therimin Skogsbär together with alcohol. The effect of alcohol will not be enhanced by the addition of paracetamol, but alcohol may increase the toxic effects of paracetamol on your liver.

Children

Do not give this medicine to children under 12 years of age or under 41 kg body weight.

Other medicines and Therimin Skogsbär

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor before using Therimin Skogsbär if you are taking:

• Medicines for thinning the blood (anticoagulants), such as warfarin or other coumarins.

• Paracetamol containing medicines (see “Section 2 - Warnings and precautions).

• Medicines for nausea and vomiting, such as metoclopramide or domperidone.

• Medicines that slow gastric emptying, such as exenatid.

• Cholestyramine, used to lower blood cholesterol. There should be an interval of at least one hour between cholestyramine and Therimin Skogsbär.

• Medicines used to treat tuberculosis (rifampicin and isoniazid), for bacterial infections (chloramphenicol).

• Probenecid used to treat gout.

• Medicines used to treat seizures, such as phenytoin, phenobarbital and carbamazepine.

• St. John’s wort (ingredient in certain herbal medicines).

Therimin Skogsbär with food and drink and alcohol

Do not drink alcohol while using this medicine.

Pregnancy and breast-feeding

If you are pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Paracetamol passes in small amounts into breast milk. This medicine may nevertheless be taken if you are breast-feeding. Do not exceed the daily dose and treatment duration recommended in this leaflet.

Driving and using machines

Therimin Skogsbärdoes not affect the ability to drive or use machines.

Important information about some of the ingredients in this medicine

Therimin Skogsbär contains:

• aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria (enzyme deficiency to breakdown phenylalanine).

• sodium 38 mg per sachet: to be taken into account if you are on a low sodium diet.

• sucrose 5.4 g per sachet. If you have been told by your doctor that you have intolerance to some sugars, ask your doctor before use. This should also be taken into account if you suffer from diabetes.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults

Take 1 to 2 sachets (500 to 1000 mg) every 4 to 6 hours as needed, up to a maximum of four times a day.

Usually one sachet per dose is sufficient. Do not take more than 6 sachets (3000 mg) in 24 hours.

Leave an interval of 4 to 6 hours between two doses

Children and adolescents

• Children below 12 years of age or weighing less than 41 kg: do not give to children under 12 years of age or weighing less than 41 kg.

• Adolescents of 12 to 15 years and weighing 41 to 50 kg:

One sachet per dose, every four to six hours as needed, up to a maximum of four times a day.

Do not use more than 4 sachets (2000 mg) in 24 hours.

Leave an interval of 4 to 6 hours between two doses.

Do not exceed the stated dose.

The total dose of paracetamol should not exceed 60 mg/kg/day for adolescent and adults weighing less than 50 kg.

Patients with hepatic and renal disease

In patients with impaired liver or kidney function, the dose must be reduced or the dosing interval prolonged. Ask your doctor for advice before using this medicine.

How to take Therimin Skogsbär

The contents of 1 or 2 sachets should be dissolved in a standard mug of hot, but not boiling, water (approximately 250 ml). When 2 sachets are used, more water can be added according to taste. Drink when cooled to an acceptable temperature.

How long to take Therimin Skogsbär

If pain persists for more than 5 days or fever lasts for more than 3 days, or worsen, you should contact a doctor.

If you take more Therimin Skogsbär than you should

In the event of an overdose, or accidental intake, contact a doctor, hospital or a Poison Control Centre immediately. Prompt medical attention is critical even if you feel well, because of the risk of serious liver damage.

If you forget to take Therimin Skogsbär

If you forget a dose, take it as soon as you remember unless it is almost time for your next dose. Then continue treatment as recommended. Always leave an interval of at least 4 hours between two doses. Never take a double dose to make up for a forgotten dose.

4 Possible side effects

Like all medicines, Therimin Skogsbär can cause side effects, although not everybody gets them.

STOP taking this medicine and tell a doctor or pharmacist immediately if you experience:

• allergic reaction including shortness of breath, swelling of the face, mouth, tongue or throat.

• skin rash (including hives, itching), redness of the skin.

• skin peeling, blisters, sores, mouth ulcers.

• blood problems, including unusual bleeding or bruising.

• any change in the appearance or amount of urine, including cloudy urine, blood in urine, inability to urinate. These are signs of kidney problems.

• yellowing of the skin or eyes (jaundice). These are signs of liver problems. Abnormal liver laboratory tests may also be observed.

The above side effectsare 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 serious skin reactions have been reported.

Other side effects may occur in rare cases(may affect up to 1 in 1,000 people). If you experience any of the following, tell your doctor:

• nausea, stomach ache, vomiting, diarrhoea.

• depression, confusion, sensing unreal things (hallucinations).

• tremor, headache, dizziness, vertigo, nervousness, , confusion, .

• abnormal vision.

• abnormal accumulation of fluid under the skin (oedema).

• dizziness, feeling of general discomfort or uneasiness (malaise), fever, drowsiness.

• sweating

The following side effect may also occur in very rare cases(may affect up to 1 in 10,000 people). If you experience it, tell your doctor:

If you get any side effects which worry you, even side effects not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Therimin Skogsbär 500 mg powder for oral solution

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

Do not use Therimin Skogsbär after the expiry date which is stated on the pack.

This medicine does not require any special temperature storage conditions.

Store in the original pack. Do not use the product if you notice any visible sign of deterioration.

Do not dispose of medicines via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Therimin Skogsbär contains

The active ingredient is paracetamol 500 mg per sachet.

The other ingredient(s) are:

ascorbic acid (Vitamin C), acesulfame potassium, aspartame (E951), calcium phosphate, citric acid, maltodextrin, silica colloidal hydrated, sodium citrate, sucrose, quinoline yellow (E104), blueberry flavour (contains lecithin soya), raspberry flavour (contains lecithin soya), cranberry flavour (contains lecithin soya), menthol flavour (contains lecithin soya), green tea flavour (contains lecithin soya). (See end of section 2 for further information on some of the ingredients).

What Therimin Skogsbär looks like and contents of the pack

Therimin Skogsbär is a white to off-white, pale yellow granular powder with brown granules packed in individual sachets.

Therimin Skogsbär is available in packs of 6, 8, 10 or 12 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

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Manufacturer

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This medicinal product is authorised in the Member States of the EEA under the following names:

Finland	Theramin Metsämarja 500 mg jauhe oraaliliuosta varten (to be confirmed)
Iceland	Theramin Wildberries (to be confirmed)
Norway	Theramin pulver i dosepose med skogsbærsmak (to be confirmed)
Poland	Theraflu Grip Owoce leśne
Sweden	Thermin Skogsbär

This leaflet was last approved in {MM/YYYY}

2015-07-10