ILMODEC FEBBRE E NASO KIUSO 500 mg/60 mg Effervescent tablet

Зміст інструкції

1. Ilmodec febbre e naso chiuso
   1. What is Ilmodec fever and nasal congestion and what is it used for
   2. What you need to know before taking Ilmodec fever and nasal congestion
   3. How to take Ilmodec febbre e naso chiuso
   4. Possible side effects
   5. How to store Ilmodec febbre e naso chiuso
   6. Contents of the pack and other information

Ilmodec febbre e naso chiuso

500 mg + 60 mg effervescent tablets
paracetamol and pseudoephedrine hydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take 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.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after three days.

Contents of this leaflet:

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

1. What is Ilmodec fever and nasal congestion and what is it used for

Ilmodec fever and nasal congestion contains paracetamol, a pain reliever and antipyretic, and pseudoephedrine hydrochloride, a decongestant that clears the nasal passages and facilitates breathing.
Ilmodec fever and nasal congestion is used for fever, especially of influenza origin, accompanied by a cold and nasal congestion.
See a doctor if you do not feel better or if you feel worse after three days.

2. What you need to know before taking Ilmodec fever and nasal congestion

Do not take Ilmodec fever and nasal congestion

• if you are allergic to paracetamol, pseudoephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• if you are under 12 years of age (see “Children and Adolescents”);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension with medication;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you suffer from any of the following diseases:
• severe cardiovascular diseases (severe diseases affecting the heart and/or blood vessels);
• hypertension (high blood pressure);
• hyperthyroidism (a thyroid disorder);
• glaucoma (eye disease due to increased eye pressure);
• prostatic hypertrophy (enlargement of the prostate);
• if you are being treated with:
• medicines that are monoamine oxidase inhibitors (medicines used in mood disorders, anxiety, depression) or with tricyclic antidepressants or if you have stopped this treatment less than two weeks ago;
• anti-inflammatory drugs (see “Other medicines and Ilmodec fever and nasal congestion”);
• if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzymatic deficiency);
• if you suffer from phenylketonuria (the medicine contains aspartame).

One of the active ingredients of Ilmodec fever and nasal congestion, pseudoephedrine, can cause abuse and high doses of pseudoephedrine can be toxic. Continuous use can lead to taking an amount of Ilmodec fever and nasal congestion greater than the recommended dose to obtain the desired effect, resulting in an increased risk of overdose. The maximum recommended dose and duration of treatment must not be exceeded (see section 3).

Warnings and precautions
See your doctor or pharmacist before taking Ilmodec fever and nasal congestion:

• if you suffer from kidney failure
• if you suffer from liver failure
• if you are elderly, as the medicine can occasionally cause spasm (involuntary contraction) of the bladder sphincter with difficulty emptying the urine (urinary retention).

During treatment with Ilmodec fever and nasal congestion, immediately inform your doctor if:
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 if you are malnourished, 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. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Very rare cases of severe skin reactions have been reported. If you experience skin manifestations such as redness, rash, blisters and peeling, stop using the medicine and consult your doctor immediately (see “Possible side effects”).
With products containing pseudoephedrine, a severe form of skin reaction, defined as Acute Generalized Exanthematous Pustulosis, can occur in isolated cases. If symptoms such as fever, erythema or small pustules (widespread) occur, patients should stop treatment and consult a doctor.
High or prolonged doses of the product can cause alterations in the blood, even serious ones (see section “Possible side effects”).
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood flow to the brain. Stop using Ilmodec fever and nasal congestion immediately and seek immediate medical attention if you develop symptoms that may be signs of PRES or RCVS (see section 4 “Possible side effects” for symptoms).
With Ilmodec fever and nasal congestion, a reduction in blood flow to the optic nerve may occur.
If you experience sudden loss of vision, stop taking Ilmodec fever and nasal congestion and consult your doctor or a healthcare facility immediately. See section 4.
With Ilmodec fever and nasal congestion, sudden abdominal pain or rectal bleeding may occur, due to inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, immediately stop treatment with Ilmodec fever and nasal congestion and contact your doctor or seek medical advice. See section 4.
During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, as if paracetamol is taken in high doses, serious adverse reactions can occur.
Also, before combining any other medicine, contact your doctor.

Children and adolescents
This medicine should not be taken by children under 12 years of age.

Other medicines and Ilmodec fever and nasal congestion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Before taking this medicine, tell your doctor if you are taking:

• Medicines that slow down gastric emptying (e.g. propantheline): can reduce the rate of absorption of paracetamol delaying its effect
• Medicines that increase the rate of gastric emptying (e.g. metoclopramide, domperidone): result in an increase in the rate of absorption of paracetamol
• AZT (zidovudine - antiretroviral, against the attack of some viruses): the concomitant use of paracetamol and AZT increases the tendency to a reduction in the white blood cell count (neutropenia)
• Oral anticoagulants (medicines that make the blood more fluid)
• Tropisetron and granisetron (antiemetics, medicines against nausea and vomiting): can completely inhibit the analgesic effect of paracetamol
• Chloramphenicol (antibiotic): paracetamol can increase its half-life (the time required to reduce by half the amount of a medicine in plasma or blood) and therefore, potentially, increase its toxicity
• Lamotrigine (antiepileptic): paracetamol can reduce the effectiveness of lamotrigine
• Rifampicin (antibiotic), cimetidine (medicine against acidity of the stomach) or antiepileptic medicines (glutethimide, phenobarbital, carbamazepine): you must use paracetamol with extreme caution and only under strict medical control
• Decongestants (medicines that clear the stuffy nose), anorectics and amphetamine-like drugs (medicines that decrease the sense of appetite): the use of Ilmodec fever and nasal congestion simultaneously with these medicines should be avoided, as it can cause increases in blood pressure
• Monoamine oxidase inhibitors: the concomitant use of pseudoephedrine and monoamine oxidase inhibitors (medicines used in mood disorders, anxiety, depression) can cause an increase in blood pressure. Do not use medicines based on pseudoephedrine if you have stopped treatment with monoamine oxidase inhibitors less than two weeks ago (see “Do not take Ilmodec fever and nasal congestion”)
• Furazolidone (antibiotic): can cause a progressive inhibition of monoamine oxidase
• Some antihypertensive medicines (e.g. methyldopa, beta-blockers, debrisochine, guanethidine, betanidine and bretylium tosilate): the effect may be partially annulled by Ilmodec fever and nasal congestion
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that needs to be treated urgently (see section 2).

Anti-inflammatory drugs (NSAIDs) and painkillers (opioids): the simultaneous administration with Ilmodec fever and nasal congestion potentiates the analgesic effect.
If you take Ilmodec fever and nasal congestion, the results of tests for uric acid (performed for example in case of gout) and blood sugar (performed for example in case of diabetes) may be affected.
If you take Ilmodec fever and nasal congestion, the values of a liver enzyme (serum alanine-aminotransferase

• ALT) may be elevated.

Ilmodec fever and nasal congestion with alcohol
Avoid drinking alcohol when taking this medicine

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, do not take this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
Be careful when driving vehicles or using machinery, due to the possible occurrence of dizziness or drowsiness.

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may still result in positive doping tests.

Ilmodec fever and nasal congestion contains aspartame, sorbitol and sodium

• This medicine contains 20.0 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful to you if you suffer from phenylketonuria, a rare genetic disease that causes the accumulation of phenylalanine because the body cannot dispose of it properly.
• This medicine contains 260 mg of sodium (the main component of table salt) per tablet. This is equivalent to 13% of the recommended daily intake with the diet of an adult.
• This medicine contains 296 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) 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 (or your child) take this medicine.

3. How to take Ilmodec febbre e naso chiuso

Take this medicine following exactly what is reported in this leaflet or the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults: 1 effervescent tablet up to three times a day. The medicine should be taken for a maximum of 5 days of therapy.
Children over 12 years: 1 effervescent tablet up to three times a day. The medicine should be taken for a maximum of 3 days of therapy (pediatric population 12-18 years).
Dissolve the tablet in a glass of water and drink the resulting solution immediately.
Take the medicine on a full stomach.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in the characteristics of your disorder.

Use in children and adolescents
This medicine is not indicated for children under 12 years of age.

Warning:do not exceed the indicated doses without the advice of your doctor. This recommendation should be taken into particular consideration if you are elderly.
If you suffer from kidney disease
Consult your doctor before taking this medicine, as a modification of the dosage may be necessary. If you have severe kidney disease (creatinine clearance <10 ml/min) the doctor will evaluate whether the risk of using paracetamol is lower than the benefit.
The doctor will evaluate your dose and follow it during intake.

If you suffer from liver disease
Consult your doctor before taking this medicine if you suffer from liver disease (mild to moderate hepatocellular insufficiency including Gilbert's syndrome; severe liver failure Child-Pugh >9; acute hepatitis, concomitant treatment with medicines that alter liver function; glucose-6-phosphate dehydrogenase deficiency; hemolytic anemia), as a modification of the dosage may be necessary.

If you take more Ilmodec febbre e naso chiuso than you should
If you accidentally take an excessive dose of Ilmodec febbre e naso chiuso, immediately inform your doctor or go to the nearest hospital.

If you forget to take Ilmodec febbre e naso chiuso
Do not take a double dose to compensate for forgetting the tablet.
If you have any doubts about the use of Ilmodec febbre e naso chiuso, consult your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequency “not known” (cannot be estimated from the available data):

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2);
• serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Stop taking Ilmodec febbre e naso chiuso immediately and seek urgent medical attention if you develop symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset
• nausea
• vomiting
• confusion
• seizures
• changes in vision

Adverse reactions listed below have been reported with the use of paracetamol and/or pseudoephedrine.
The adverse reactions listed below are derived from spontaneous reports and it is therefore not possible
to organize them by frequency categories.

Blood disorders:
changes in the blood cell counts, such as:

• thrombocytopenia: reduced number of platelets (blood cells) circulating,
• thrombocytopenic purpura (autoimmune disease),
• leukopenia: reduced number of white blood cells (blood cells) circulating,
• anemia,
• agranulocytosis: reduced number of granulocytes (a type of white blood cells) circulating
• pancytopenia: reduction of all cells present in the blood.

Immune system disorders:
hypersensitivity reactions have been reported very rarely, such as:

• allergic edema and angioedema, edema of the larynx (swelling of the throat),
• allergic reactions (anaphylactic reaction, anaphylactic shock),
• asthma,
• sweating,
• nausea,
• hypotension,
• dyspnea (difficulty breathing).

Psychiatric disorders:

• hallucinations.

Nervous system disorders:

• dizziness,
• drowsiness,
• hyperactivity,
• hyperexcitability (increased reaction to physical or mental stimuli),
• insomnia,
• anxiety,
• muscle tremors,
• headache,
• dysgeusia (altered taste).

Cardiac disorders:

• arrhythmias, palpitations,
• tachycardia (fast heartbeat).

Vascular disorders:

• hypertension (high blood pressure),
• hypotension (low blood pressure).

Respiratory disorders:

• breathing difficulties,
• dryness of the nose and throat.

Gastrointestinal disorders:

• nausea,
• vomiting,
• stomach discomfort,
• diarrhea,
• abdominal pain,
• anorexia (loss of appetite).

Liver disorders:

• problems with liver function,
• hepatitis,
• dose-dependent liver failure,
• necrotic liver damage (death of liver tissue) potentially fatal.

Skin disorders:
skin reactions of varying types and severity, including:

• skin rash,
• itching, hives,
• acute generalized pustulosis (appearance of pustules all over the body),
• fixed erythema,
• multiforme erythema,
• Stevens-Johnson syndrome (acute hypersensitivity reaction involving skin and mucous membranes) and toxic epidermal necrolysis (serious toxic reaction of the skin) which can lead to death,
• very rare cases of severe skin reactions have been reported.

Kidney disorders:

• acute renal failure,
• interstitial nephritis (inflammation inside the kidney),
• hematuria (blood in the urine),
• anuria (absence of urine).

Frequency “not known”
Reduced blood flow to the optic nerve (ischemic optic neuropathy).
Inflammation of the colon due to insufficient blood supply (ischemic colitis).
side effects are generally temporary.

Reporting of side effects
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 “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 Ilmodec febbre e naso chiuso

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the product in intact packaging, correctly stored. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Keep the tube tightly closed to protect the medicine from humidity.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ilmodec febbre e naso chiuso contains

• The active ingredients are paracetamol and pseudoephedrine hydrochloride. One tablet contains 500 mg of paracetamol and 60 mg of pseudoephedrine hydrochloride.
• The other ingredients are citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol, lemon flavour, aspartame, sodium saccharin, simeticone, leucine, sodium docusate.

Description of the appearance of Ilmodec febbre e naso chiuso and contents of the pack
Ilmodec febbre e naso chiuso is available in the form of effervescent tablets.
The pack contains 8 divisible effervescent tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia s.r.l.
Via Pinciana 25
00198 Rome

Manufacturer
E-Pharma Trento S.p.A.
Frazione Ravina
Via Provina, 2
38123 Trento (TN)