SOBREPIN 650 mg/20 mg /4 Mg Granulki Do Sporządzania Roztworu

Treść ulotki

1. SOBREPIN TOSSE INFLUENZA RAFFREDDORE 650 mg/20 mg/4 mg granules for
   1. What is SOBREPIN TOSSE INFLUENZA RAFFREDDORE and what is it used for
   2. What you need to know before taking SOBREPIN TOSSE INFLUENZA
   3. Possible side effects
   4. How to store SOBREPIN TOSSE INFLUENZA RAFFREDDORE
   5. Contents of the pack and other information

SOBREPIN TOSSE INFLUENZA RAFFREDDORE 650 mg/20 mg/4 mg granules for

oral solution
Paracetamol/Dextromethorphan bromhydrate /Chlorphenamine maleate
Generic medicine

Read this leaflet carefully before taking this medicine because
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 want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if your symptoms do not improve or worsen after 5 days (3 days in case of fever and in adolescents).
• 1. What is SOBREPIN TOSSE INFLUENZA RAFFREDDORE and what it is used for
• 2. What you need to know before you take SOBREPIN TOSSE INFLUENZA RAFFREDDORE
• 3. How to take SOBREPIN TOSSE INFLUENZA RAFFREDDORE
• 4. Possible side effects
• 5. How to store SOBREPIN TOSSE INFLUENZA RAFFREDDORE
• 6. Contents of the pack and other information

1. What is SOBREPIN TOSSE INFLUENZA RAFFREDDORE and what is it used for

SOBREPIN TOSSE INFLUENZA RAFFREDDORE is a medicine containing three
active ingredients in combination: paracetamol which reduces fever and relieves pain, dextromethorphan which acts on cough and chlorphenamine for nasal congestion.
The medicine is indicated in adults and adolescents from 14 years of age, for the treatment of
symptoms of cold and flu with mild to moderate pain, such as headache, fever,
dry cough (irritative cough, nervous cough) and nasal congestion.
Consult your doctor if symptoms worsen or persist for more than 5 days in adults or
for 3 days in adolescents or if the fever persists for more than 3 days.

2. What you need to know before taking SOBREPIN TOSSE INFLUENZA

COLD
Do not take SOBREPIN TOSSE INFLUENZA if:

• You are allergic (hypersensitive) to the active ingredients or to any of the other ingredients of this medicine, listed in paragraph 6.
• You suffer from respiratory failure, asthmatic cough and productive cough (with phlegm).
• You have serious problems with your kidneys or liver,
• You are taking a category of medicines called monoamine oxidase inhibitors (MAOIs) or have taken them in the last two weeks.
• You are taking or have recently taken other medicines such as, for example: antidepressants, medicines for Parkinson's disease, therapies based on linezolid (an antibiotic) or procarbazine (for the treatment of cancer) (see paragraph "Other medicines and SOBREPIN TOSSE INFLUENZA RAFFREDDORE”).
• Children under 14 years of age cannot take this medicine, given the dosage of the active ingredients contained.

Warnings and precautions
Consult your doctor or pharmacist before taking SOBREPIN TOSSE INFLUENZA
RAFFREDDORE.
Do not take a dose higher than that recommended in paragraph 3 " How to take

SOBREPIN TOSSE INFLUENZA RAFFREDDORE". A dose higher than that
recommended (overdose) could cause liver damage. In case of overdose,
consult a doctor immediately. Immediate medical attention is essential in both
adults and children, even if you do not notice any signs or symptoms.
Those who constantly consume large amounts of alcoholic beverages should ask their doctor if
they can take paracetamol or other pain relievers or antipyretics and must also limit themselves to a
maximum of 3 sachets per day (2 g of paracetamol).
Do not take other medicines containing paracetamol while taking this medicine, as
this could cause an overdose of paracetamol, with possible liver damage. Do not
take more than one medicine containing paracetamol without consulting a doctor.
Before starting to take SOBREPIN TOSSE INFLUENZA RAFFREDDORE, consult a
doctor or pharmacist if:

• You suffer from kidney, heart or lung disease,
• You suffer from anemia,
• You suffer from liver disease (with or without hepatic insufficiency) or viral hepatitis, as the medicine increases the risk of hepatotoxicity,
• You suffer from asthma or are sensitive to acetylsalicylic acid,
• You are sensitive (allergic) to an antihistamine, as you may be sensitive to other antihistamines, such as chlorphenamine.
• You suffer from hypertension (high blood pressure), glaucoma (high eye pressure), hyperthyroidism, obstruction of the bladder neck, prostatic hyperplasia with urine formation. Elderly patients may be more sensitive to the side effects of this medicine.
• You suffer from atopic dermatitis
• You are a slow CYP2D6 metabolizer or are taking CYP2D6 inhibitors.
• You suffer from chronic respiratory problems, such as emphysema, chronic bronchitis, bronchial asthma or cough accompanied by excessive secretions, glaucoma or difficulty urinating caused by prostatic hyperplasia.

This medicine can cause drowsiness. Avoid drinking alcohol and taking certain
medicines while taking this medicine as they may increase drowsiness.
Read the paragraphs " Other medicines and SOBREPIN TOSSE INFLUENZA RAFFREDDORE” and
" SOBREPIN TOSSE INFLUENZA RAFFREDDORE with food, drinks and alcohol".
People who are sedated, debilitated or bedridden should not take this medicine.
In rare cases, severe skin reactions with redness, rash or eruptions may occur. If
you notice any of these symptoms, stop taking the medicine and consult a doctor.
This medicine can cause dependence, therefore, it must be taken for short
periods.

Children and adolescents
This medicine is contraindicated in children under 14 years of age, given the dosage of the
active ingredients.

Other medicines and SOBREPIN TOSSE INFLUENZA RAFFREDDORE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
If you are taking any of the following medicines, it may be necessary to
modify the dosage or stop taking them:

• Medicines for epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines that prevent blood clots (oral anticoagulants), such as acenocoumarol, warfarin.
• Medicines to increase urine production (loop diuretics, such as those belonging to the furosemide group or other diuretics), and other diuretics that cause potassium loss (such as diuretics for the treatment of hypertension or other conditions).
• Medicines for the prevention of nausea and vomiting (metoclopramide and domperidone).
• Medicines for gout (probenecid).
• Medicines for high blood pressure (hypertension), such as propranolol and for heart arrhythmias, such as amiodarone or quinidine.
• Medicines to lower cholesterol levels (cholestyramine).
• Take SOBREPIN TOSSE INFLUENZA RAFFREDDORE only if at least 14 days have passed since the end of therapy with certain antidepressants (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medicines for Parkinson's disease (selegiline) and medicines for the treatment of other diseases, such as cancer (procarbazine) and infections (linezolid, furazolidone).
• Medicines for depression, called tricyclics, and tetracyclic antidepressants (such as maprotiline).
• Medicines for schizophrenia (such as haloperidol).
• Medicines that depress the central nervous system, such as those used to treat insomnia, anxiety, Parkinson's disease or allergies.
• Medicines whose side effects involve damage to the ears (ototoxic)
• Medicines whose adverse events involve light allergy (photosensitizing).
• Medicines for the treatment of pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines to increase mucus secretion.

Consult your doctor or pharmacist before taking SOBREPIN TOSSE INFLUENZA
RAFFREDDORE:
If you are taking other medicines, such as antidepressants or antipsychotics, SOBREPIN TOSSE
INFLUENZA RAFFREDDORE may interact with these medicines and you may
experience changes in mental status (such as agitation, hallucinations, coma) and other
effects, such as a temperature above 38°C, increased heart rate, high blood pressure and excessive reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (such as nausea, vomiting and diarrhea).

Interference with clinical tests
If you are about to undergo any clinical tests (such as blood, urine or
skin tests with allergens, etc.) tell your doctor that you are taking this medicine,
as it may alter the results.

SOBREPIN TOSSE INFLUENZA RAFFREDDORE with food, drinks and alcohol
Do not drink alcohol when taking this medicine, as this may increase its side
effects.
Taking medicines containing paracetamol (such as SOBREPIN TOSSE INFLUENZA
RAFFREDDORE) by patients who regularly consume alcoholic beverages (three or
more alcoholic drinks, such as beer, wine or spirits, per day) may cause liver damage.
This medicine should not be taken with grapefruit or bitter orange juice, as
this may increase the effects of one of its ingredients, namely dextromethorphan.

Pregnancy, breastfeeding and fertility.
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Taking medicines during pregnancy can put the embryo or fetus at risk and must be
monitored by a doctor.
This medicine should not be taken during pregnancy unless your doctor considers it strictly necessary.
The active ingredients of this medicine are excreted in breast milk; therefore, women who are
breastfeeding should not take SOBREPIN TOSSE INFLUENZA
RAFFREDDORE.

Driving and operating machinery
SOBREPIN TOSSE INFLUENZA RAFFREDDORE can cause drowsiness,
resulting in effects on mental and/or physical abilities. If you notice these effects, avoid driving
vehicles or operating machinery.

SOBREPIN TOSSE INFLUENZA RAFFREDDORE contains sodium:
This medicine contains 26.3 mg of sodium (the main component of table salt) per
sachet. This is equivalent to 1.18% of the recommended maximum intake with the diet of an
adult.

SOBREPIN TOSSE INFLUENZA RAFFREDDORE contains sucrose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.
This medicine contains 4.4 g of sucrose (sugar) per dose. To be taken
into consideration in people with diabetes mellitus.

SOBREPIN TOSSE INFLUENZA RAFFREDDORE contains yellow orange (E-110):
This medicine may cause allergic reactions as it contains Yellow Orange S (E110).

How to take SOBREPIN TOSSE INFLUENZA RAFFREDDORE
Use this medicine following exactly the instructions in the leaflet or as indicated by your doctor or pharmacist. If you have doubts, consult your doctor or
pharmacist.
SOBREPIN TOSSE INFLUENZA RAFFREDDORE is a medicine for oral use. Pour
the contents of one sachet into half a glass of water and stir until the product
is completely dissolved. You can add sugar or honey, depending on your
preferences. In the evening, it is advisable to take it before going to bed.
The recommended dose is:

Adults and adolescents from 14 years: one sachet every 6 - 8 hours (3 or 4 times a day), depending
on needs. It is recommended to take one sachet before going to bed. Do not
take more than 4 sachets (equal to 2.6 g of paracetamol) per day. See the paragraph
“Warnings and precautions”.

Patients with hepatic insufficiency: one sachet every 8 hours. Do not take more than 3 sachets (equal to
1.95 g of paracetamol) per day. Consult a doctor.

Patients with renal insufficiency: do not take this medicine, given the dosage of the
paracetamol 650 mg.
Always take the lowest effective dose. Start treatment as soon as symptoms appear and stop when symptoms disappear. Consult a doctor if you do not notice
an improvement or in case of worsening after 5 consecutive days of treatment (3 in
case of fever or in adolescents). (Read paragraph 1. " What is SOBREPIN TOSSE

INFLUENZA RAFFREDDORE and what it is used for").

If you take more SOBREPIN TOSSE INFLUENZA RAFFREDDORE than you should
Seek immediate medical attention, even if you do not experience symptoms, as symptoms often
appear only three days after ingestion of the excess dose of the drug,
even in case of severe poisoning.
The most serious effect of an overdose is liver damage caused by paracetamol. You may experience dizziness, confusion, excitability, restlessness, nervousness, irritability, vision problems,
loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain and shortness of breath; in children, drowsiness and gait disturbances.
There have been cases of abuse of medicines containing dextromethorphan in adolescents, which
can cause serious adverse events such as agitation, behavioral disorders, ataxia
(uncoordinated movements), coma, altered state of consciousness, dysarthria (difficulty articulating
words), apathy, nystagmus (involuntary and uncontrollable eye movements),
seizures, serotonin syndrome, tremor, depression and excitation of the central nervous system,
miosis and mydriasis (contraction and dilation of the pupil), respiratory depression and
urinary retention.
The symptoms of chlorphenamine overdose may include: depression of the central nervous
system, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, reduced intestinal sounds), tachycardia, hypotension,
hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures or
arrhythmias. In rare cases, patients with agitation, coma or prolonged seizures may
develop rhabdomyolysis and renal failure.
Treatment of overdose is most effective when started within 4 hours of ingestion of the
drug. Patients taking barbiturates or chronic alcoholics may be more
susceptible to the toxicity resulting from paracetamol overdose.
In case of overdose or accidental ingestion, seek immediate medical attention or
the Poison Control Center, specifying the medicine taken and its quantity.

If you forget to take SOBREPIN TOSSE INFLUENZA RAFFREDDORE:
Do not take a double dose to make up for the missed dose.

If you stop taking SOBREPIN TOSSE INFLUENZA RAFFREDDORE
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been reported in one in 100 people during clinical trials conducted with chlorphenamine: drowsiness, dry mouth, dizziness,
restlessness, pharyngitis and dyspepsia.
The following adverse reactions have occurred with an unknown incidence: anaphylactic shock,
hypersensitivity, insomnia, nervousness and restlessness (motor hyperactivity), abdominal pain,
diarrhea, nausea, vomiting, angioedema (swelling of some areas of the skin), itching, urticaria,
rash and skin lesions after taking the medicine (fixed drug eruption), and also
increased transaminases.
Simultaneous consumption of alcohol during treatment may accentuate adverse events. Do not
consume alcoholic beverages during treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects via
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 SOBREPIN TOSSE INFLUENZA RAFFREDDORE

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack, after
“Expiry Date”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOBREPIN TOSSE INFLUENZA RAFFREDDORE contains

• The active ingredients are: paracetamol 650 mg, chlorphenamine maleate 4 mg and dextromethorphan hydrobromide 20 mg.
• The other ingredients (excipients) are: sucrose, sodium cyclamate, sodium citrate, Yellow Orange S (E-110), sodium saccharin, anhydrous citric acid, polysorbate 80, povidone K 30, titanium dioxide (E-171), lemon flavour, Quinoline Yellow (E-104).

Description of the appearance of SOBREPIN TOSSE INFLUENZA RAFFREDDORE and
contents of the pack
Yellow granules, lemon flavoured, for oral solution. Each pack contains 10 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharm@idea S.r.l.
Via del Commercio 5
25039 Travagliato (Brescia)

Manufacturer
Farmasierra Manufacturing SL
Ctra de Irún km 26,200
San Sebastián de los Reyes 28709 Madrid, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy: SOBREPIN TOSSE INFLUENZA RAFFREDDORE
Spain Remidol

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (https://www.aifa.gov.it/)