Sobrepin cough influenza cold

Package leaflet: Information for the patient

SOBREPIN COUGH COLD AND FLU 650 mg/20 mg/4 mg granules for

oral solution
Paracetamol/Dextromethorphan hydrobromide /Chlorpheniramine maleate
Equivalent medicine
Please 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 to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days (3 days in case of fever and in adolescents).

Contents of this leaflet

1. What SOBREPIN COUGH COLD AND FLU is and what it is used for
2. What you need to know before taking SOBREPIN COUGH COLD AND FLU
3. How to take SOBREPIN COUGH COLD AND FLU
4. Possible side effects
5. How to store SOBREPIN COUGH COLD AND FLU
6. Contents of the pack and other information

1. What SOBREPIN COUGH FLU COLD is and what it is used for

SOBREPIN COUGH FLU COLD 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 cold and flu symptoms with mild to moderate pain, such as headache, fever, dry cough (irritative cough, nervous cough), and nasal congestion.
Consult a doctor if symptoms worsen or persist for more than 5 days in adults or for 3 days in adolescents, or if fever persists for more than 3 days.

2. What you should know before taking SOBREPIN COUGH FLU COLD

COLD
Do not take SOBREPIN COUGH FLU COLD if:

• You are allergic (hypersensitive) to the active substances or to any of the other ingredients of this medicine listed in section 6.
• You suffer from respiratory insufficiency, asthmatic cough, or productive cough (with phlegm).
• You have severe kidney or liver problems.
• You are taking or have taken within the last two weeks a class of medicines called monoamine oxidase inhibitors (MAOIs).
• You are currently taking or have recently taken other medicines such as antidepressants, medicines for Parkinson’s disease, treatments based on linezolid (an antibiotic), or procarbazine (for cancer treatment) (see section "Other medicines and SOBREPIN COUGH FLU COLD").
• Children under 14 years of age must not take this medicine due to the dosage of its active ingredients.

Warnings and precautions
Talk to your doctor or pharmacist before taking SOBREPIN COUGH FLU COLD.
Do not take a higher dose than recommended in section 3 "How to take SOBREPIN COUGH FLU COLD". Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, consult a doctor immediately. Immediate medical advice is essential both in adults and children, even if no signs or symptoms are observed.
People who regularly consume large amounts of alcoholic beverages should ask their doctor whether they can take paracetamol or other painkillers or antipyretics and should 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 lead to a paracetamol overdose, possibly causing liver damage. Do not take more than one medicine containing paracetamol without consulting a doctor.
Before starting to take SOBREPIN COUGH FLU COLD, consult a doctor or pharmacist if:

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

This medicine may cause drowsiness. Avoid drinking alcohol and taking certain medicines while using this medicine, as they may increase drowsiness.
Read the sections "Other medicines and SOBREPIN COUGH FLU COLD" and "SOBREPIN COUGH FLU COLD with food, drinks and alcohol".
Sedated, debilitated, or bedridden individuals must not take this medicine.
In rare cases, severe skin reactions such as redness, rash, or eruptions may occur. If you notice any of these symptoms, stop taking the medicine and consult a doctor.
This medicine may cause dependence; therefore, it should be taken only for short periods.

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

Other medicines and SOBREPIN COUGH FLU COLD
Inform 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, dosage adjustment or discontinuation may be necessary:

• Medicines for epilepsy (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines that prevent blood clotting (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 causing potassium loss (such as those used for treating hypertension or other conditions).
• Medicines for preventing nausea and vomiting (metoclopramide and domperidone).
• Medicines for gout (probenecid).
• Medicines for high blood pressure (hypertension), such as propranolol, and for cardiac arrhythmias, such as amiodarone or quinidine.
• Medicines to lower cholesterol levels (cholestyramine).
• Take SOBREPIN COUGH FLU COLD only if at least 14 days have passed since stopping treatment with certain antidepressants (moclobemide, tranylcypromine, fluoxetine, paroxetine, bupropion); medicines for Parkinson’s disease (selegiline); and medicines for other diseases such as cancer (procarbazine) and infections (linezolid, furazolidone).
• Antidepressant medicines 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 adverse effects include ear damage (ototoxic).
• Medicines whose adverse events include light sensitivity (photosensitizing).
• Medicines for treating pain and inflammation (celecoxib, parecoxib, valdecoxib).
• Medicines to increase mucus secretion.

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

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

SOBREPIN COUGH FLU COLD 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 COUGH FLU COLD) 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 must not be taken with grapefruit juice or bitter orange juice, as this could increase the effects of one of its ingredients, namely dextromethorphan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Taking medicines during pregnancy may pose risks to the embryo or fetus and must be monitored by a doctor.
This medicine must not be taken during pregnancy unless your doctor considers it strictly necessary.
The active ingredients of this medicine are excreted in breast milk; therefore, breastfeeding women must not take SOBREPIN COUGH FLU COLD.

Driving and using machines
SOBREPIN COUGH FLU COLD may cause drowsiness, thereby affecting mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

SOBREPIN COUGH FLU COLD contains sodium:
This medicine contains 26.3 mg of sodium (a main component of table salt) per sachet. This corresponds to 1.18% of the maximum recommended dietary intake for an adult.

SOBREPIN COUGH FLU COLD contains sucrose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains 4.4 g of sucrose (sugar) per dose. This should be taken into account in patients with diabetes mellitus.

SOBREPIN COUGH FLU COLD contains sunset yellow (E-110):
This medicine may cause allergic reactions as it contains sunset yellow FCF (E110).

How to take SOBREPIN COUGH FLU COLD
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
SOBREPIN COUGH FLU COLD 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 may add sugar or honey, according to your preference. At night, it is advisable to take it before going to bed.
The recommended dose is:
Adults and adolescents aged 14 years and over: one sachet every 6–8 hours (3 or 4 times daily), as needed. It is recommended to take one sachet before going to sleep. Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. See section “Warnings and precautions”.
Patients with hepatic impairment: one sachet every 8 hours. Do not take more than 3 sachets (equivalent to 1.95 g of paracetamol) per day. Consult a doctor.
Patients with renal impairment: do not take this medicine due to the paracetamol dosage of 650 mg.
Always take the lowest effective dose. Start treatment as soon as symptoms appear and stop when symptoms resolve. Consult a doctor if there is no improvement or if symptoms worsen after 5 consecutive days of treatment (3 days in case of fever or in adolescents). (See section 1. "What SOBREPIN COUGH FLU COLD is and what it is used for").

If you take more SOBREPIN COUGH FLU COLD than you should
Seek immediate medical attention, even if you have no symptoms, as symptoms often appear only three days after ingestion of an excessive dose, even in cases of severe poisoning.
The most serious effect of overdose is liver damage caused by paracetamol. Symptoms may include 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 altered gait.
There have been cases of abuse of medicines containing dextromethorphan in adolescents, which may cause serious adverse events such as agitation, behavioural disturbances, ataxia (incoordinated movements), coma, altered consciousness, dysarthria (difficulty articulating words), apathy, nystagmus (involuntary, uncontrolled eye movements), seizures, serotonin syndrome, tremor, depression and excitation of the central nervous system, miosis and mydriasis (pupil constriction and dilation), respiratory depression, and urinary retention.
Symptoms of chlorpheniramine overdose may include: central nervous system depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, reduced bowel 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 drug ingestion. Patients taking barbiturates or chronic alcoholics may be more susceptible to toxicity following paracetamol overdose.
In case of overdose or accidental ingestion, contact a doctor or Poison Control Centre immediately, specifying the medicine ingested and the amount.

If you forget to take SOBREPIN COUGH FLU COLD:
Do not take a double dose to make up for the forgotten dose.

If you stop taking SOBREPIN COUGH FLU COLD
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects were reported in one subject out of 100 during clinical trials conducted with chlorphenamine: drowsiness, dry mouth, dizziness, restlessness, pharyngitis and dyspepsia.

The following adverse reactions have been reported with unknown frequency: anaphylactic shock, hypersensitivity, insomnia, nervousness and restlessness (motor hyperactivity), abdominal pain, diarrhoea, nausea, vomiting, angioedema (swelling of certain areas of the skin), pruritus, urticaria, rash and skin lesions following administration of the medicine (drug-induced fixed eruption), as well as increased transaminases.

Concomitant consumption of alcohol during treatment may intensify adverse events. Do not consume alcoholic beverages during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 COUGH COLD AND FLU

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SOBREPIN COUGH COLD FLU contains

• The active substances are: paracetamol 650 mg, chlorpheniramine maleate 4 mg and dextromethorphan hydrobromide 20 mg.
• The other components (excipients) are: sucrose, sodium cyclamate, sodium citrate, orange yellow 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 COUGH COLD FLU and
contents of the pack
Yellow granules with lemon flavour 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 under the
following names:
Italy: SOBREPIN COUGH COLD FLU
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/)