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EFFERALGAN EFFERVESCENT TBL 500MG N16

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
EFFERALGAN-drug/medicine -tablets aproximate price on "EFFERALGAN EFFERVESCENT TBL 500MG N16" in Riga city, Latvia is:
  • 3.28€  3.55$  2.81£  379Rub  37.7SEK  14PLN  12.98₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  EFFERALGAN EFFERVESCENT TBL 500MG N16     Recheck

Reģ. Nr.: 99-0141

ATC codeN02BE01 

Active substances: Paracetamolum

 


Vendor, principal: Bristol-Myers Squibb
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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EFFERALGAN 500 mg putojošās tabletes, 16 gab.

 .

EFFERALGAN 500MG N16

Package leaflet: Information for the user

EFFERALGAN, 500 mg effervescent tablets paracetamol

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

Always use this medicine exactly 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. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after three days.

What is in this leaflet

1.   What Efferalgan is and what it is used for
2.   What you need to know before you take Efferalgan
3.   How to use Efferalgan
4.   Possible side effects
5.   How to store Efferalgan
6.   Contents of the pack and other information

1.   What Efferalgan is and what it is used for

Efferalgan is a medicine indicated for the treatment of mild pain and/or fever. It is meant for alleviating fever and/or pain for example in case of headache, colds, toothache, muscle pain and menstrual pain.

2. What you need to know before you take Efferalgan

Do

not use Efferalgan

if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
if you have severe liver disease.

Warnings and precautions

Talk to your doctor before taking Efferalgan.
■   If you have severe renal disease, consult with a doctor before using paracetamol or giving it to a child;
■   if you have any liver disease, consult with a doctor before using paracetamol or giving it to a child;
■   if you are using alcohol;
■   if you    have Gilbert's syndrome (familial hyperbilirubinaemia);
■   if you    have anorexia, bulimia, cachexia or chronic malnutrition;
■   if you    have significant weight loss (dehydration, hypovolemia) or you weigh less than    50 kg;
■   if the doctor has ordered tests to determine uric acid or sugar content in blood, inform    him/her
that you are using this medicine.

Other medicines and Efferalgan

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Concurrent use with medicines that activate specifically the function of hepatic cells like certain hypnotics and anticonvulsives (phenobarbital, phenytoin, carbamazepine) and antibiotics (isoniazid, rifampicin) or alcohol may cause liver damage at otherwise harmless paracetamol doses.
In case of concurrent administration of paracetamol and chloramphenicol the excretion of chloramphenicol may decrease significantly and its toxicity may increase.
Concurrent use of paracetamol and zidovudine (AZT) increases the risk of serious blood change (neutropenia). Therefore, paracetamol should be used concurrently with zidovudine only by a doctor’s recommendation.
Continuous and regular use of paracetamol with oral anticoagulants (warfarin) may increase the risk of haemorrhaging. It is recommended to check blood coagulation values more often.
Cholestyramine decreases, and metoclopramide and domperodone increase paracetamol absorption.
Do not use Efferalgan with other paracetamol-containing medicines to avoid exceeding the recommended daily dose. Simultaneous use of paracetamol with other painkillers is not recommended.

Efferalgan with food and drink

This medicine may be taken with and without food.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine.
Paracetamol may be used during pregnancy and breast-feeding. Nonetheless a small amount of paracetamol is excreted into the breast milk and may affect the infant.

Driving and using machines

No effects on ability to drive or use machines have been observed.

Efferalgan contains sorbitol and sodium.

This medicine contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
One effervescent tablet contains 412.4 mg of sodium, which should be taken into account in patients on diet with controlled sodium content.

3. How to use Efferalgan

This medicine is suitable for adults and children with body weight over 13 kg (starting from about 2 years old). Tablets should not be chewed or swallowed. Dissolve the effervescent tablet in a glass of water and drink immediately. The recommended doses are given below.

Use in adults and adolescents with at least 50 kg body weight (about 15 years old and older)

1-2 effervescent tablets, the dose may be repeated in 4 hours if required, not exceeding 6 effervescent tablets (3 g of paracetamol) a day.

Use in children

The recommended daily dose is 60 mg/kg/day. There should be a recommended 6-hour, but not less than 4-hour interval between administrations. The approximate age corresponding to body weight may be variable.
Body weight
(approximate age)
13-20 kg
(2-7 years)
21-25 kg
(6-10 years)
26-40 kg
(8-13
years)
41-50 kg
(12-15
years)
Single dose, number of effervescent tablets
y2
lA
1
1
Highest number of effervescent tablets per day
2
(4 x '/2 tablets)
3
(6 x / tablets)
4
6

Renal failure

In case of severe renal failure there should be an at least 8-hour interval between administrations.
Do not exceed the highest permitted daily dose of 60 mg/kg.

Hepatic failure

Paracetamol should not be used in case of severe hepatic failure. In case of liver impairment the dose should be decreased or dosage interval prolonged. It should be observed that the highest permitted daily dose would not exceed 60 mg/kg/day or 2 g/day if:
■   your body weight is less than 50 kg;
■   you have chronic or compensated active liver disease, above all with mild to moderate liver failure;
■   you have Gilbert's syndrome (familial hyperbilirubinaemia);
■   you have chronic alcoholism;
■   you have chronic malnutrition;
■   you have dehydration.

If you take more Efferalgan than you should

In case of overdose or unintended administration of too large dose consult a doctor immediately or call emergency number.
In case of overdose in the beginning (during the first day) nausea, vomiting, loss of appetite, sweating, sleepiness and general malaise may occur. Despite possible improvement on the second day the liver damage may continuously and irreversibly worsen.

If you forget to take Efferalgan

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely (1 patient out of 1,000-10,000) the following side effects may occur with paracetamol:
•   diarrhoea, abdominal pain;
•   increase or decrease of blood coagulation indicator INR;
•   changes in blood analysis (increase of the activity of transaminases or hepatic enzymes). Usually these changes are mild, reversible and do not require treatment discontinuation.
Very rarely (less than 1 patient out of 10 thousand) the following side effects have been described:
•   skin rashes (urticaria, erythema) and allergic reactions like angioedema or anaphylaxis;
•   also abnormally low counts of blood cells (leukocytes, platelets) have been reported. This may
cause epistaxis or gum bleeding or recurrence of fever or infection signs. If this occurs, stop treatment immediately and inform your doctor.

Reporting 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 www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Efferalgan

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and strip after “EXP”. The expiry date refers to the last day of that month.
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 Efferalgan contains

■   The active substance is paracetamol.
■   The other ingredients are citric acid anhydrous, sodium carbonate anhydrous, sodium bicarbonate, sorbitol, soluble saccharin, sodium docusate, povidone, sodium benzoate.

What Efferalgan looks like and contents of the pack

Tablets are white, with scoring line. The tablet may be divided into equal doses. 16 effervescent tablets in four aluminium-polyethylene strips in a carton.

Marketing Authorisation Holder

Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lövöhaz u. 39 1024, Budapest Hungary

Manufacturer

UPSA SAS
304, avenue du Docteur Jean Bru
47000 Agen
France
UPSA SAS
979 Avenue des Pyrenees 47520 Le Passage France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Amicus Pharma OÜ tel.: 640 1030
e-mail: [email protected]

This leaflet was last revised in August 2016.

4





  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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