Pinex Jordgubb
Package leaflet: Information for the user
/.../ 500 mg granules in sachets
Paracetamol
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 3 days
What is in this leaflet:
1. What /.../ is and what it is used for
2. What you need to know before you take /.../
3. How to take /.../
4. Possible side effects
6. Contents of the pack and other information
1. What /.../ is and what it is used for
Paracetamol belongs to the pharmacotherapeutic group of analgesics (painreducing agents) which are acting simultaneously as antipyretics (feverreducing agents) with weak antiinflammatory effects.
/.../ is used to reduce fever and for the relief of mild to moderate pain.
2. What you need to know before you take/.../
Do not take /.../
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you have severe kidney problems
- if you have hepatitis
- if you are taking other paracetamol containing medicines, as it may severely damage your liver
- if you have alcohol problems
Warnings and precautions
Talk to your doctor or pharmacist before taking/.../
- if you suffer from liver or kidney disease
- if you have glucose-6-phosphatedehydrogenase deficiency (an enzyme)
- if you have haemolytic anaemia (abnormal reduction of red blood cells)
- if you have Gilbert’s syndrome(familial non-haemolytic jaundice)
- if you are asthmatic and at the same time sensitive to acetylsalicylic acid
Prolonged or frequent use is discouraged. You should not take other paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur. However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful.
In the case of high fever, or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of treatment should be made.
Paracetamol should be used with caution in cases of dehydration and chronic malnutrition. The total dose of paracetamol should not exceed 3 g daily for adults and children weighing 50kg and more .
If your symptoms worsen or do not improve after 3 days, or with high fever you must contact a doctor.
Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or liver damage and do not use paracetamol together with alcohol. Paracetamol does not potentiate the effect of alcohol.
The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Caution should be exercised in cases of chronic alcoholism.
If you are concomitantly taking other pain medication containing paracetamol do not use of /.../ without first speaking to your doctor or a pharmacist.
Never take more of /.../than recommended. A higher dose does not increase pain relief; instead it can cause serious liver damage. The symptoms of liver damage occur first after a few days. It is therefore very important that you contact your doctor as soon as possible if you have taken more /.../then recommended in this leaflet.
In long-term, high-dose, incorrect use of painkillers, headaches may occur which may not be treated with higher doses of the medicine.
In general, habitual intake of painkillers, particularly a combination of several analgesic substances, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).
Abrupt discontinuation following long-term, high-dose, incorrect use of painkillers may lead to headaches, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until this time, avoid further intake of painkillers and do not restart them without medical advice.
You should not take /.../for long periods or at high doses without talking to your doctor or dentist.
Other medicines and /.../
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines that can affect the effects of /.../:
- alcohol
- probenecid (a medicine used to treat gout)
- possibly liver-damaging medicines e.g. phenobarbital (sleeping tablets) phenytoin, carbamazepine, primidone (medicines used to treat epilepsy) isoniazid, rifampicin (medicines used to treat tuberculosis) St John’s wort (a herbal remedy to treat depression). Simultaneous use of these medicines and paracetamol can cause liver damage
- metoclopramide and domperidone (medicines used to treat nausea). These can increase the absorption and onset of effect of paracetamol.
- medicines that slow emptying of the stomach. These can delay the absorption and onset of effect of paracetamol.
- colestyramine (a medicine to reduce raised serum lipid levels). These can decrease the absorption and onset of effect of paracetamol. Therefore you should not take Colestyramine within an hour following paracetamol administration.
- blood-thinning medicines (oral anticoagulants, particularly warfarin). Repeated paracetamol intake for longer than one week enhances the bleeding tendency. Therefore long-term administration of paracetamol should only take place under medical supervision. Occasional paracetamol intake has no significant effects on bleeding tendency
Simultaneous use of paracetamol and zidovudine (a medicine used to treat HIV infections) increases the tendency to a reduction in the white blood cells (neutropenia). This can affect the immune system and increase the risk for infections./.../ should therefore be used simultaneously with zidovudine only on medical advice.
Effect of the intake of paracetamol on laboratory tests
Tests for uric acid and blood sugar can be affected.
/…/ with alcohol
Concurrent use of /…/ and consuption of alcohol should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, paracetamol should not be taken for long periods, at high doses or in combination with other medicinal products.
Recommended doses of paracetamol may be used during pregnancy or breast-feeding.
Driving and using machines
The use of /.../ has no influence on the ability to drive or use machines.
/.../ contains sorbitol:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take /.../
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The dose depends on the data in the following table. The dose of /.../ is based upon age and body weight.
The respective dose interval depends on the symptoms and the maximum total daily dose.
A dosing interval of at least 6 hours must be maintained, that means an administration of maximum 4 times per day.
If symptoms persist longer than 3 days, a doctor should be contacted.
500mg sachets
|
Body weight (age) |
single dose [sachet] |
max. daily dose [sachets] |
|
26 kg – 40 kg (8 years -12 years) |
500 mg Paracetamol (1 sachet) |
1500 mg Paracetamol (3 sachets) |
|
over 40 kg (children over 12 years and adults) |
500 - 1000 mg Paracetamol (1 – 2 sachets) |
3000 mg Paracetamol ( 6 sachets of 500 mg) |
Method / Route of administration
/.../ is for oral use only.
Do not take /.../ at fed state.
The granules should be taken directly into the mouth onto the tongue and should be swallowed without water.
Special groups of patients
Impaired liver or kidney function
In patients with impaired liver or kidney function, the dose must be reduced or the dosing interval prolonged. Ask your doctor or pharmacist for advice.
Chronic alcoholism
Chronic alcohol consumption may lower the paracetamol toxicity threshold. In these patients, the length of time between two doses should be a minimum of 8 hours. Do not exceed 2 g paracetamol per day.
Elderly patients
Dose adjustment is not required in the elderly.
Children and adolescents with small body weight
/…/ 500 mg is not suitable for children under 8 years of age and under 26 kg body weight respectively, since the dose strength for this age group is not suitable. For this patient group, other formulations and dose strength are available.
If you take more /.../ than you should
In the case of an overdose with /.../ please inform your doctor or emergency roomOverdosing has very serious consequences and can even lead to death.
An immediate treatment is essential, even if you feel well, because of the risk of delayed serious liverdamage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdoseor the risk of organ damage.
If you forget to take /.../
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using /.../and immediately contact a doctor if you experience any of the following symptoms (angiooedema).Rare side effect (may affect up to 1 in 1,000 people):
swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties.
Other possible side effects are listed below:
Rare side effects (may affect up to 1 in 1,000 people):
- Blood platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cells in bone marrow).
- Allergic reactions.
- Depression, confusion, hallucinations.
- Tremor, headache.
- Disturbed vision.
- Oedema (abnormal accumulation of fluid under the skin).
- Abdominal pain, stomach or intestinal bleeding, diarrhoea, nausea, vomiting.
- Abnormal liver function, liver failure, jaundice (with symptoms like yellowing of the skin and eyes), hepatic necrosis (death of liver cells).
- Dizziness, generally feeling unwell (malaise), fever, sedation, interactions with medicines.
- Overdose and poisoning.
Very rare side effects (may affect up to 1 in 10,000 people):
- Blood disorders (reduction in platelets, white blood cells and neutrophils in the blood, haemolytic anaemia (abnormal breakdown of red blood cells).
- Low level of blood glucose in the blood.
- Hepatotoxicity (damage caused to the liver due to chemicals).
- Cloudy urine and kidney disorders.
- Severe allergic reactions requiring discontinuation of treatment.
Very rare cases of serious skin reactions have been reported.
Side effects of unknown frequency (frequency cannot be estimated from the available data):
Erythema multiforme (allergic reaction or infection of skin), accumulation of fluid in the larynx, anaphylactic shock (severe allergic reaction), anaemia (decrease in red blood cells), hepatitis (liver inflammation), severe kidney impairment, blood in urine, inability to urinate, disorder of stomach and intestine, vertigo.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via <to be completed nationally>. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store /.../
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What /.../ contains
The active substance is:
paracetamol
1 sachet contains 500 mg paracetamol
The other ingredients are:
Sorbitol, Talc, Basic butylated methacrylate polymer, Magnesium oxide light, Hypromellose, Carmellose sodium, Stearic acid, Sodium laurilsulfate, Magnesium stearate (Ph.Eur.), Titanium dioxide (E 171), Sucralose, Simeticone, Cappuccino flavour (contains Maltrodextrin, Gum arabic (E414), Natural & Nature Identical Flavouring substances, Triacetin (E1518), N,2,3-Trimethyl-2-(propan-2-yl)butanamid)
What /.../ looks like and contents of the pack
Aluminium sachet with white or almost white granules.
/.../ is available in packages with
10, 20 sachets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
To be completed nationally
This leaflet was last revised in {MM/YYYY}
To be completed nationally
2016-11-03
This medicinal product is authorised in the Member States of the EEA under the following names:
BG: ParacetaMax 500mg
FI: Pinex strawberry/vanilla 500mg rakeet
IT: SINEBRIV analgesico e antipiretico
MT: Pinex 500 mg granules (strawberry-vanilla flavoured)
NO: Pinex 500 mg granulat med jordbærsmak
SE: Pinex Jordgubb 500 mg granulat i dospåse