ACTIFED 100 ML Syrup

Зміст інструкції

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

ACTIFED COMPOSTO syrup

Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide

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 want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

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

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

ACTIFED COMPOSTO contains pseudoephedrine hydrochloride, a decongestant that provides relief from
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 allergies.
This medicine should only be used by adults and children over 12 years of age.
See a 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 COMPOSTO

Do not take ACTIFED COMPOSTO:

• if you are allergic to triprolidine hydrochloride, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, to other antihistamines or to 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 in the last 2 weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs) (see “Other medicines and ACTIFED COMPOSTO”);
• if you are taking medicines used for breathing problems, including medicines to treat asthma (see “Warnings and precautions”);
• if you have or are at risk of having serious breathing problems (respiratory failure);
• if you have pre-existing cardiovascular diseases, coronary heart disease;
• if you suffer from high blood pressure (hypertension);
• if you are pregnant or breastfeeding;
• if you suffer from glaucoma (increased pressure in the eye with possible worsening of vision);
• if you have a narrowing (stenosis) of the stomach or intestine, of the bladder (bladder neck obstruction), of the urethra or ureters;
• if you have problems with the thyroid gland;
• if you have an enlarged prostate (prostatic hypertrophy, which causes problems such as difficulty urinating or needing to urinate frequently);
• if you suffer from epilepsy;
• if you have diabetes.

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

• you have breathing problems that are not treated with medicines such as: emphysema or chronic bronchitis or asthma (see “Do not use ACTIFED COMPOSTO”);
• you have a persistent or long-lasting cough (chronic) or if you have a cough with a lot of mucus;
• you have serious liver problems;
• you have decreased kidney function;
• you are elderly, due to the greater sensitivity to antihistamines and to pseudoephedrine;
• you have an intolerance to certain sugars (see “ACTIFED COMPOSTO contains”).
• you are taking medicines such as some antidepressants or antipsychotics: ACTIFED COMPOSTO may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as a body temperature greater than 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur.

This medicine can lead to dependence. Therefore, treatment should be of short duration.
Stop treatment and contact your doctor or seek immediate medical attention if with the use of
ACTIFED COMPOSTO

• your symptoms do not improve, if symptoms persist or worsen or if new symptoms appear, high fever or notice other side effects,
• you develop a widespread feverish rash 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 eruption may occur within the first 2 days of treatment, with fever and numerous, small pustules, mostly non-follicular, arising from a very widespread edematous erythema and located mainly in the skin folds, on the trunk and upper limbs.

With ACTIFED COMPOSTO, 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 COMPOSTO and contact your doctor or seek immediate medical attention (see section “4. Possible side effects”).
• a reduction in blood flow to the optic nerve may occur. If you experience sudden vision loss, stop taking ACTIFED COMPOSTO and contact your doctor immediately or seek immediate medical attention. See paragraph 4.

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

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

Tell 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, for Parkinson's disease or for 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, debrisoquine, guanethidine, betanidine and bretylium;
• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see paragraph 2. “Do not take…”);
• medicines that have a depressive effect on the nervous system such as hypnotics, sedatives or tranquilizers;
• medicines to treat mental illnesses (haloperidol, perphenazine and thioridazine);
• other medicines that reduce nasal congestion (decongestants);
• medicines that cause a decrease in appetite and a decrease in body weight (anorectics and amphetamine-like drugs);
• medicines to treat heart rhythm disorders (quinidine, amiodarone, propafenone);
• medicines to treat cardiac rhythm abnormalities (flecainide);
• antibiotics that cause damage to the ear (ototoxic);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the organism due to a reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of addiction (methadone);
• medicines used to prevent the development of fungi (mycetes) (terbinafine);
• furazolidone, an antibacterial agent.

ACTIFED COMPOSTO with alcohol
Do not drink alcohol if you are using ACTIFED COMPOSTO as it may interfere with your treatment and/or
increase the risk of side effects, such as drowsiness.

Pregnancy and breastfeeding
Do not use ACTIFED COMPOSTO if you are pregnant or if you are breastfeeding (see paragraph
“Do not take ACTIFED COMPOSTO”).

Driving and using machines
You need to be careful when driving vehicles and using machines.
ACTIFED COMPOSTO can cause sedation and drowsiness. Make sure you do not suffer from this effect
before driving vehicles or using machines.

ACTIFED COMPOSTO 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 a diagnosis of 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 an intolerance to certain sugars, contact him before taking this medicine. This should be considered in people with diabetes mellitus.
• 10 mg of sodium benzoateper single dose (10 ml of syrup) equivalent to 0.1429 mg/kg/ml.
• less than 1 mmol (23 mg) of sodiumper single dose (10 ml of syrup), i.e. it is essentially ‘sodium-free’.
• methyl parahydroxybenzoate. 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 4.40 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

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

3. How to take ACTIFED COMPOSTO

Take this medicine following exactly as indicated 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 2 - 3 times a day.

Children under 12 years of age
ACTIFED COMPOSTO should not be used in children under 12 years of age (see the
section “Do not take ACTIFED COMPOSTO”).
See a doctor if you do not feel better or if you feel worse after 7 days of treatment.
Method of administration

• ACTIFED COMPOSTO is a medicine for oral use.
• Do not exceed the recommended doses.
• Take this medicine for the shortest possible time and using the lowest dose necessary to control the symptoms.
• The bottle is closed with a safety cap: to open, press and simultaneously turn the cap; to close, screw the cap on tightly.
• Take ACTIFED COMPOSTO using the dosing spoon (supplied) in the shape of a double

spoon corresponding to a dose of 2.5 (smaller part of the spoon) and 5 ml (larger part of the
spoon).
5 ml 2.5 ml

• If you take more ACTIFED COMPOSTO than you should, you may experience the following symptoms:

drowsiness, irritability, deep sleep (lethargy), severe breathing problems (respiratory depression),
increased blood pressure (hypertension), convulsions;

• in children, difficulty falling asleep (insomnia), hyperactivity, convulsions, muscle tremors.
• nausea and vomiting, ischemic colitis, involuntary muscle contractions, agitation, confusion, involuntary neurological symptoms (conversion disorder), drowsiness, cognitive impairment, involuntary and rapid eye movements, heart disorders (fast heartbeat), coordination disorders, decreased level of consciousness, speech disorder (dysarthria), serotonin syndrome, psychosis with visual hallucinations and hyperexcitability, pupillary constriction (miosis), pupillary dilation (mydriasis), urinary retention. Other symptoms in case of massive overdose may be: coma, severe breathing problems and convulsions.

Bromide intoxication has been observed with the concomitant use of over-the-counter medicines containing
bromide or with an overdose of dextromethorphan hydrobromide. Symptoms may include: headache,
tremor, irritability, speech disorders, confusion, drowsiness, memory disorders, eating disorders, hallucinations, psychosis, movement disorders, in severe cases dizziness and coma.
Contact your doctor or hospital immediately if you experience any of the aforementioned symptoms.
If you take a high dose of ACTIFED COMPOSTO, inform your doctor immediately or go to the nearest
hospital.

If you forget to take ACTIFED COMPOSTO
Do not take a double dose to make up for a missed dose.
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.
manifest.

The following are side effects that have been identified during post-marketing experience(the frequency cannot be defined based on available data):

• anxiety, hallucinations including visual ones, restlessness, irritability, agitation;
• alterations of sensitivity (paresthesia), hyperactivity,
• stroke (cerebrovascular accidents);
• sensation of heart racing (palpitations),
• heart attack (myocardial infarction);
• nose bleeding (epistaxis);
• discomfort or pain in the abdomen, ischemic colitis (See section 2);
• Reduction of blood flow to the optic nerve (ischemic optic neuropathy)
• itching, hives, erythema;
• severe skin rash characterized by the formation of pustules (acute generalized exanthematous pustulosis) (See section 2);
• difficulty in passing urine (dysuria);
• increase in blood pressure;
• decreased appetite

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

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

Tell your doctor if you experience any other side effects during therapy with ACTIFED COMPOSTO:

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

Reporting of side effects
If you get any side effects, even those 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 ACTIFED COMPOSTO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP.”. The
expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C and protect from light.
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 ACTIFEDCOMPOSTOcontains
The active ingredients are: triprolidine hydrochloride, pseudoephedrine hydrochloride and dextromethorphan hydrobromide.
100 ml of syrup contains: 0.025 g of triprolidine hydrochloride, 0.600 g of pseudoephedrine hydrochloride and
0.200 g dextromethorphan hydrobromide.
The other ingredients are: non-crystallizable sorbitol (70%), sucrose, sodium benzoate, methyl para-
hydroxybenzoate, ponceau 4R (E124), ethanol, blackberry flavour, menthol, vanillin, purified water.

Description of the appearance of ACTIFED COMPOSTO and contents of the pack
ACTIFED COMPOSTO is available in a 100 ml glass bottle equipped with a safety cap. The pack contains a
measuring device in the form of a double spoon corresponding to a dose of 2.5 or 5 ml.

Marketing Authorisation 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)