Actifed Composto

Package leaflet: Information for the patient

ACTIFED COMPOUND syrup

Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide
Please read all of this leaflet carefully before you start 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 do.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
• Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

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

1. What ACTIFED COMPOSTO is and what it is used for

ACTIFED COMPOSTO contains pseudoephedrine hydrochloride, a decongestant that relieves nasal and upper airway congestion, triprolidine hydrochloride, an antihistamine that reduces sneezing and nasal secretions, and dextromethorphan hydrobromide, a cough suppressant.
ACTIFED COMPOSTO is a medicine used to relieve symptoms of nasal and upper airway congestion, particularly due to allergy.
This medicine should only be used by adults and children over 12 years of age.
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

2. What you need to know before taking ACTIFED COMPOUND

Do not take ACTIFED COMPOUND:

• if you are allergic to triprolidine hydrochloride, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, other antihistamines, or any of the other ingredients of this medicine (listed in section 6);
• in children under 12 years of age;
• if you are taking or have taken within the last 2 weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs) (see "Other medicines and ACTIFED COMPOUND");
• if you are taking medicines used for respiratory problems, including medicines to treat asthma (see "Warnings and precautions");
• if you have or are at risk of severe respiratory problems (respiratory failure);
• if you have pre-existing cardiovascular diseases or coronary artery diseases;
• if you suffer from high blood pressure (hypertension);
• if you are pregnant or breastfeeding;
• if you have glaucoma (increased pressure in the eye with possible worsening of vision);
• if you have narrowing (stenosis) of the stomach or intestine, bladder (bladder neck obstruction), urethra, or ureters;
• if you have thyroid problems;
• if you have an enlarged prostate (prostatic hypertrophy, causing problems such as difficulty urinating or frequent need to urinate);
• if you suffer from epilepsy;
• if you have diabetes.

Warnings and precautions
Talk to your doctor or pharmacist before taking ACTIFED COMPOUND if:

• you have respiratory problems not treated with medication, such as emphysema, chronic bronchitis, or asthma (see "Do not use ACTIFED COMPOUND");
• you have a persistent or long-lasting (chronic) cough, or a cough with abundant mucus production;
• you have severe liver problems;
• you have reduced kidney function;
• you are elderly, due to increased sensitivity to antihistamines and pseudoephedrine;
• you have an intolerance to certain sugars (see "ACTIFED COMPOUND contains");
• you are taking medicines such as certain antidepressants or antipsychotics: ACTIFED COMPOUND may interact with these medicines and cause changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).

This medicine may lead to dependence. Therefore, treatment should be short-term.
Discontinue treatment and contact your doctor or seek immediate medical attention if, while using
ACTIFED COMPOUND:

• your symptoms do not improve, persist or worsen, or if new symptoms appear, including high fever, or you notice other adverse effects;
• you develop a generalized feverish erythema associated with pustules (see section "4. Possible side effects"). Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine. This acute pustular rash may appear within the first 2 days of treatment, with fever and numerous small pustules, mostly non-follicular, arising from a widespread edematous erythema, mainly localized in skin folds, trunk, and upper limbs.

With ACTIFED COMPOUND, sudden:

• abdominal pain or rectal bleeding due to inflammation of the colon (ischemic colitis) may occur. If you experience these gastrointestinal symptoms, stop using ACTIFED COMPOUND and contact your doctor or seek immediate medical attention (see section "4. Possible side effects").
• reduction in blood flow to the optic nerve. If sudden vision loss occurs, stop taking ACTIFED COMPOUND and contact your doctor or seek immediate medical attention immediately. See section 4.

Other medicines and ACTIFED COMPOUND
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, or if you have been told that you are a slow metabolizer of CYP2D6.
Do not use ACTIFED COMPOUND if you are taking:

• medicines for depression known as monoamine oxidase inhibitors (MAOIs), or have taken them within the last 2 weeks, as this may cause an increase in blood pressure, even sudden, and/or a hypertensive crisis (see "Do not take ACTIFED COMPOUND");
• medicines used for respiratory problems, for example to treat asthma (see "Do not use ACTIFED COMPOUND").

Inform your doctor or pharmacist if you are taking, have recently taken, or might take the following medicines:

• anticholinergic medicines, used for example for urinary incontinence, Parkinson's disease, or stomach or intestinal disorders;
• oral anticoagulants (taken by mouth), used to thin the blood, such as warfarin;
• antihypertensive medicines, used to treat high blood pressure, such as methyldopa, alpha and beta blockers, debrisochine, guanethidine, betanidine, and bretylium;
• medicines for depression such as fluoxetine, paroxetine, sertraline, and bupropion (see section 2. "Do not take...");
• medicines with a depressant effect on the central nervous system, such as hypnotics, sedatives, or tranquillizers;
• medicines for psychiatric disorders (haloperidol, perphenazine, and thioridazine);
• other medicines that reduce nasal congestion (decongestants);
• medicines that cause loss of appetite and weight reduction (anorectics and amphetamine-like substances);
• medicines for heart rhythm disorders (quinidine, amiodarone, propafenone);
• medicines for cardiac arrhythmias (flecainide);
• antibiotics that cause ear damage (ototoxic);
• medicines to reduce calcium levels in the blood and treat dysfunction due to reduced secretion of the hormone regulating these levels (hyperparathyroidism), such as cinacalcet;
• medicines used to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines used to prevent fungal growth (terbinafine);
• furazolidone, an antibacterial agent.

ACTIFED COMPOUND and alcohol
Do not drink alcohol while using ACTIFED COMPOUND, as it may interfere with your treatment and/or increase the risk of adverse effects, such as drowsiness.
Pregnancy and breastfeeding
Do not use ACTIFED COMPOUND if you are pregnant or breastfeeding (see section "Do not take ACTIFED COMPOUND").
Driving and using machines
Exercise caution when driving or operating machinery.
ACTIFED COMPOUND may cause sedation and drowsiness. Make sure you do not experience this adverse effect before driving or using machinery.
ACTIFED COMPOUND contains:

• sorbitol. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which patients cannot metabolize fructose, talk to your doctor before taking this medicine;
• 5.6 g of sucrose (sugar) per single dose (10 ml of syrup). If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine. This should be considered in patients with diabetes mellitus.
• 10 mg of sodium benzoate per single dose (10 ml of syrup), equivalent to 0.1429 mg/kg/ml.
• less than 1 mmol (23 mg) of sodium per single dose (10 ml of syrup), i.e., essentially 'sodium-free'.
• methyl 4-hydroxybenzoate. May cause allergic reactions (including delayed reactions);
• Ponceau 4R. May cause allergic reactions;
• ethanol. This medicine contains 439.88 mg of alcohol (ethanol) in each single dose (10 ml of syrup), equivalent to 11 ml of beer or 4.40 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take ACTIFED COMPOUND

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children over 12 years of age:
The recommended dose is 10 ml of syrup taken 2–3 times daily.
Children under 12 years of age
ACTIFED COMPOUND must not be used in children under 12 years of age (see section “Do not take ACTIFED COMPOUND”).
Contact your doctor if you do not feel better or if you feel worse after 7 days of treatment.
Method of administration

• ACTIFED COMPOUND is a medicine for oral use.
• Do not exceed the recommended doses.
• Take this medicine for the shortest possible time and use the lowest dose needed to control your symptoms.
• The bottle is closed with a safety cap: to open, press down and turn the cap at the same time; to close, screw the cap tightly.

• Take ACTIFED COMPOUND using the dosing spoon (supplied) shaped like a double spoon, where the smaller part corresponds to 2.5 ml and the larger part to 5 ml. 5 ml 2.5 ml

• If you take more ACTIFED COMPOUND than you should, the following symptoms may occur: drowsiness, irritability, deep sleep (lethargy), severe breathing problems (respiratory depression), increased blood pressure (hypertension), seizures;
• in children, difficulty sleeping (insomnia), hyperactivity, seizures, muscle tremors.
• nausea and vomiting, ischemic colitis, involuntary muscle contractions, agitation, confusion, involuntary neurological symptoms (conversion disorder), drowsiness, cognitive disturbances, involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat), coordination problems, decreased level of consciousness, motor speech disorder (dysarthria), serotonin syndrome, psychosis with visual hallucinations and hyperexcitability, pupil constriction (miosis), pupil dilation (mydriasis), urinary retention. Additional symptoms in cases of massive overdose may include: coma, severe respiratory problems, and seizures.

Bromide intoxication has been observed with concomitant use of over-the-counter medicines containing bromide or with overdose of hydrobromide of dextromethorphan. Symptoms may include: headache, tremor, irritability, speech disorders, confusion, drowsiness, memory disturbances, eating disorders, hallucinations, psychosis, movement disorders, and in severe cases, stupor and coma.
Seek immediate medical attention from your doctor or hospital if any of the above symptoms occur.
If you take a large dose of ACTIFED COMPOUND, inform your doctor immediately or go to the nearest hospital.
If you forget to take ACTIFED COMPOUND
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult 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 during post-marketing experience (frequency cannot be estimated from the available data):

• anxiety, hallucinations including visual hallucinations, restlessness, irritability, agitation;
• disturbances in sensation (paraesthesia), hyperactivity;
• stroke (cerebrovascular accidents);
• sensation of pounding heartbeat (palpitations);
• heart attack (myocardial infarction);
• nosebleed (epistaxis);
• abdominal discomfort or pain, ischaemic colitis (see section 2);
• Reduced blood flow to the optic nerve (ischaemic optic neuropathy);
• itching, hives, erythema;
• severe skin rash characterised by pustule formation (generalised exanthematous pustulosis) (see section 2);
• difficulty in passing urine (dysuria);
• increase in blood pressure;
• decreased appetite.

Stop taking ACTIFED COMPOSTO and contact your doctor immediately if you notice:

• Allergic reactions (hypersensitivity), presenting as more or less sudden appearance of skin lesions, even severe, such as discoloured spots or widespread rash, appearance of blisters or skin peeling, itching, swelling (angioedema) of the face, eyes, lips, throat with breathing difficulties, increased heart rate and sudden drop in blood pressure.
• Inflammation of the colon due to inadequate blood supply (ischaemic colitis) (see section “2 Warnings and precautions”).
• Sudden onset of fever, skin redness or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP), which may occur within the first two days of treatment with ACTIFED COMPOSTO (see section “2 Warnings and precautions”).

Inform your doctor if you experience any other side effects during treatment with ACTIFED COMPOSTO:

• dry mouth, nausea, vomiting, diarrhoea;
• dizziness, difficulty falling asleep (insomnia), and nervousness;
• euphoric mood;
• headache, drowsiness, muscle tremors, vertigo;
• changes in heart rhythm (arrhythmia), increased heart rate (tachycardia);
• feeling of malaise (fatigue);
• skin rashes;
• difficulty urinating (urinary retention);
• changes in blood parameters;
• drop in blood pressure;
• skin reactions after exposure to light (photosensitisation);
• increased bronchial secretions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via 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 ACTIFED COMPOSTO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “EXP.”.
The expiry date refers to the last day of that month.
Store below 25°C and protect from light.
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 ACTIFED COMPOUND contains
The active substances are: triprolidine hydrochloride, pseudoephedrine hydrochloride and dextromethorphan hydrobromide.
100 ml of syrup contain: 0.025 g of triprolidine hydrochloride, 0.600 g of pseudoephedrine hydrochloride and 0.200 g of dextromethorphan hydrobromide.
The other components are: sorbitol (70%) non-crystallizable, sucrose, sodium benzoate, methyl parahydroxybenzoate, ponceau 4R (E124), ethanol, blackberry flavour, menthol, vanillin, purified water.
Description of the appearance of ACTIFED COMPOUND and package contents
ACTIFED COMPOUND is available in a 100 ml glass bottle with a child-resistant cap. A dosing spoon shaped like a double spoon, corresponding to a dose of 2.5 or 5 ml, is included in the package.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia ROMA
Manufacturer
Delpharm Orléans – 5, Avenue de Concyr – 45071 Orlèans Cedex 2 (France)