EFFERAMOL 1000 mg Effervescent Tablet

Зміст інструкції

1. EFFERAMOL 1000 mg effervescent tablets
   1. What is Efferamol and what is it used for
   2. What you need to know before taking Efferamol
   3. How to take Efferamol
   4. Possible side effects
   5. How to store Efferamol
   6. Contents of the pack and other information

EFFERAMOL 1000 mg effervescent tablets

paracetamol
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Efferamol and what is it used for

Efferamol contains paracetamol which works by relieving pain and reducing fever.
Efferamol is used in adultsand adolescents over 15 years of agefor the symptomatic treatment
of all types of pain (for example, headache, joint pain, stiff neck, back pain,
toothache, menstrual pain, minor surgical procedures).
See your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Efferamol

Do not take Efferamol

• if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
• if you are under 15 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Efferamol.
In particular, tell your doctor:

• if you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause a blood disease);
• if you suffer from hemolytic anemia (destruction of red blood cells);
• if you suffer from liver diseases that reduce its functionality (mild/moderate hepatic insufficiency, Gilbert's syndrome, severe hepatocellular insufficiency, acute hepatitis) or if you are undergoing concomitant treatment with medicines that alter liver function;
• if you suffer from reduced kidney function (mild/moderate renal insufficiency);
• if you are undergoing concomitant treatment with any other medicine (see “Other medicines and Efferamol”). Use with caution in case of chronic alcoholism, excessive alcohol consumption (3 or more alcoholic beverages per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.

During treatment with Efferamol always keep in mind that:
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• before taking any other medicine, you should check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur. Always inform your doctor before taking any other medicine (see “Other medicines and Efferamol”).

During treatment with Efferamol, immediately inform your doctor:
If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins
circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking
flucloxacillin (an antibiotic). In patients in these situations, a serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. The symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.

Use of high doses and/or for prolonged periods
The use of high doses and/or prolonged use of this medicine can cause liver disorders (hepatopathy) and
alterations even serious to the kidney and blood.
Before taking this medicine, informyour doctor if the person who is going to take the medicine suffers from a
kidney or liver disease.

Children and adolescents
Donot give Efferamol to children and adolescents under 15 years of age (see section “Do not take
Efferamol”).

Other medicines and Efferamol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
In particular, tell your doctor if you are taking:

• medicines that contain paracetamol. During treatment with paracetamol, before taking any other medicine, check that it does not contain paracetamol, as if paracetamol is taken in high doses, serious side effects can occur;
• medicines that slow down gastric emptying(e.g. anticholinergics, opioids), as these medicines delay the effect of Efferamol;
• medicines that speed up gastric emptying(e.g. prokinetics). As these medicines speed up the effect of Efferamol;
• cholestyramine(medicine used to reduce cholesterol levels in the blood), as it reduces the effect of paracetamol;
• chloramphenicol(an antibiotic), as it may increase the risk of side effects;
• rifampicin(an antibiotic);
• cimetidine(a medicine used in the treatment of stomach ulcers);
• antiepileptics(medicines used to treat epilepsy), such as glutethimide, phenobarbital, carbamazepine;
• zidovudine(medicine for the treatment of HIV);
• oral anticoagulants(medicines used to make the blood more fluid). In the case of high-dose treatments with paracetamol (4 g per day for at least 4 days), take Efferamol only under strict medical supervision;
• flucloxacillin(antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis with high anion gap) which needs to be treated urgently (see section 2). Interference with blood tests
• If the person taking the medicine needs to undergo blood tests, keep in mind that the administration of paracetamol may interfere with the determination of uricemia and glycemia.

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Efferamol with alcohol
Take Efferamol with caution and only under strict medical supervision if you abuse alcohol (see section
“Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.
If necessary, Efferamol can be used during pregnancy. It is advisable to use the lowest possible dose that
relieves pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or
fever does not decrease or if you need to take the medicine more often.

This medicine can be taken during breastfeeding only if absolutely necessary and under the
control of the doctor.

Driving and operating machinery
Efferamol does not impair the ability to drive vehicles or operate machinery.

Efferamol contains sodium, sorbitol and benzoate
Sodium: this medicine contains 498.21 mg of sodium (the main component of table salt) per
tablet. This is equivalent to 25.5% of the recommended daily intake with the diet of an
adult. Talk to your doctor or pharmacist if you need more doses per day for a prolonged period,
especially if you have been advised to follow a low-sodium diet.

Sorbitol: this medicine contains 563 mg of sorbitol per tablet, equivalent to 24mg/kg/day
considering the maximum daily dose of 3 tablets/day. Sorbitol is a source of fructose. If your doctor has
told you that you are intolerant to some sugars, or if you have a diagnosis of hereditary fructose intolerance, a
rare genetic disease in which patients cannot transform fructose, talk to your doctor before
you take this medicine.

Benzoate: this medicine contains 50 mg of sodium benzoate per tablet. Sodium benzoate may
increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to take Efferamol

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Adults and adolescents over 15 years of age
The recommended dose is 1 effervescent tablet up to 3 times a day.
The interval between different administrations must not be less than four hours.
Dissolve the effervescent tablets in a glass of water.

Renal insufficiency
In case of renal insufficiency, the dose must be reduced:

• creatinine clearance less than 10-50 ml/min dose of 500 mg every 6 hours
• creatinine clearance less than 10 ml/min dose 500 mg every 8 hours.

Use in children
Efferamol must not be used in children under 15 years of age.

If you take more Efferamol than you should
In case of accidental intake of an excessive dose of Efferamol, stop taking it and immediately inform
your doctor or go to the nearest hospital.
Symptoms
In case of accidental intake of very high doses of paracetamol, the symptoms that you may generally
experience within the first 12-48 hours include:
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• loss or reduction of appetite (anorexia), nausea and vomiting followed by a profound deterioration of general conditions;
• alterations in blood laboratory values (increased bilirubin in the blood, lactic dehydrogenase, liver transaminase levels, reduced prothrombin levels in the blood);
• liver damage that can lead to coma and death. Treatment The doctor, based on the nature and severity of the symptoms, will carry out the appropriate supportive therapy.

There is a risk of poisoning, especially in patients with liver disease, in case of chronic alcoholism,
in patients suffering from chronic malnutrition and in patients receiving enzyme inducers. In
these cases, overdose may be fatal.

If you forget to use Efferamol
Do not use a double dose to make up for a missed dose.

If you stop taking Efferamol
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects STOPtreatment with this medicine and contact

immediatelyyour doctor:

• allergic reactions with:
• skin rashes with skin irritation (erythema) and skin redness accompanied by itching (urticaria)
• swelling of the throat (laryngeal edema)
• swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema)
• severe allergic reaction (anaphylactic shock).

In addition, people taking the medicine may experience the following side effects with unknown frequency
(frequency cannot be defined based on available data).

• reduction in the number of platelets in the blood (thrombocytopenia)
• reduction in the number of white blood cells in the blood (leukopenia/agranulocytosis)
• reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia)
• dizziness
• stomach and intestinal disorders
• abnormal liver function
• liver inflammation (hepatitis)
• red spots, blistering lesions with areas of skin detachment, blisters, skin rashes (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis)
• rapid reduction in kidney function (acute renal failure)
• kidney inflammation (interstitial nephritis)
• blood in the urine (hematuria)
• cessation or reduction of urine production (anuria)
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2).

Very rare cases of severe skin reactions have been reported.

Reporting of side effects
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If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting
side effects you can help provide more information on the safety of this medicine.

5. How to store Efferamol

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the label after “Exp.”.
The expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
After first opening of the tube, the product should be used within 3 months (only for the tube packaging).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Efferamol contains
The active ingredient is paracetamol.
Each effervescent tablet contains 1000 mg of paracetamol.
The other ingredients are: sodium hydrogen carbonate, anhydrous sodium carbonate, anhydrous citric acid, sorbitol,
sodium docusate, sodium benzoate, simeticone, orange aroma, sucralose.

Description of the appearance of Efferamol and contents of the pack
Round effervescent tablets and white to off-white in colour.
Efferamol is available in:
Pack containing 12 effervescent tablets in blisters
Pack containing 12 effervescent tablets in a tube

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (RM) – Italy

MANUFACTURER
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy
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