ACTIFED 2.5 mg/60 mg Coated tablet

Зміст інструкції

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

ACTIFED 2.5 mg + 60 mg tablets
ACTIFED 2.5 mg/10 ml + 60 mg/10 ml syrup
triprolidina hydrochloride; 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 to.

• 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 your symptoms do not improve or get worse after 7 days of treatment.

Contents of this leaflet:

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

1. What is ACTIFED and what is it used for

ACTIFED contains pseudoephedrine hydrochloride, a nasal decongestant and triprolidine
hydrochloride, an antihistamine that reduces nasal secretions.
ACTIFED is a medicine used to relieve symptoms of nasal congestion due to the
common cold.
See 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 you take ACTIFED

Do not use ACTIFED:

• if you are allergic to the active ingredients or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to other antihistamines;
• if you are taking or have taken in the last 2 weeks monoamine oxidase inhibitors (MAOIs) drugs for depression, because the use of these drugs with ACTIFED can cause an increase in blood pressure;
• if you are taking medicines used for breathing problems, such as medicines to treat asthma, because the use of these medicines with ACTIFED can cause an increase in blood pressure;
• if you have heart problems;
• 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, bladder, urethra or ureters;
• if your thyroid gland is overactive (hyperthyroidism);
• 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;
• if you are under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking ACTIFED if:

• you have breathing problems, emphysema or chronic bronchitis or acute or chronic bronchial asthma;
• you have serious liver problems;
• you have reduced kidney function;
• you are elderly, as you are more likely to develop adverse events with this medicine;
• you have an intolerance to certain sugars (see “Excipients with known undesirable effects”).

Contact your doctor if the use of ACTIFED does not improve your symptoms, if your symptoms worsen or if
new symptoms appear, if you develop a high fever or notice other undesirable effects.

Stopusing ACTIFED and consult your doctorif you experience:

• sudden severe headaches, nausea, vomiting, confusion, convulsions, visual disturbances: severe sudden headaches, nausea, vomiting, confusion, convulsions, visual disturbances, symptoms of reversible posterior encephalopathy syndrome(PRES/RCVS) may occur with ACTIFED.
• sudden abdominal pain, blood in the stool: sudden abdominal pain or rectal bleeding may occur with ACTIFED due to inflammation of the colon (ischemic colitis).
• a widespread feverish rash associated with pustules: severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with products containing pseudoephedrine. This acute pustular rash 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, a reduction in blood flow to the optic nerve may occur.
If you experience sudden loss of vision, stop taking ACTIFED and
immediately consult your doctor or a healthcare facility. See
section 4.

If you experience any of these symptoms, stop using ACTIFED and contact your doctor or seek
immediate medical assistance. (see section “4. Possible side effects”).
Other medicines and ACTIFED
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine
Do not use ACTIFED if you are taking:

• medicines for depression, monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks, as this may cause an increase, even sudden, in blood pressure;
• medicines used for breathing problems, such as for the treatment of asthma, as this may cause an increase, even sudden, in blood pressure;
• anticholinergic medicines, used for example for urinary incontinence, for Parkinson's disease or for stomach or intestinal disorders;
• medicines that slow down blood clotting (anticoagulants);
• medicines used to lower high blood pressure (antihypertensives), such as methyldopa, alpha and beta blockers, debrisochine, guanethidine, betanidine and bretylium;
• medicines against depression called tricyclic antidepressants;
• hypnotic, sedative or tranquilizing medicines;
• other medicines that reduce nasal congestion;
• medicines that cause a decrease in appetite and a lowering of body weight (anorexigenics and amphetamine-like drugs);
• antibiotics that cause problems with the ear;
• furazolidone, an antibiotic.

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not use ACTIFED if you are pregnant or if you are breastfeeding.

Driving and using machines
ACTIFED can cause drowsiness. Make sure you do not suffer from this side effect before
driving vehicles or using machines.

ACTIFED syrup contains:

• sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine;
• methyl parahydroxybenzoate. May cause allergic reactions (also delayed);
• yellow sunset (E110). May cause allergic reactions;
• 10 mg of sodium benzoate per dose (10 ml of syrup).
• less than 1 mmol (23 mg) of sodium per dose (10 ml of syrup), i.e. essentially ‘sodium-free’.

ACTIFED tablets contains:

• lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

For athletes: the use of the drug without therapeutic necessity constitutes doping and may
anyway result in positive anti-doping tests.

3. How to take ACTIFED

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.

• Do not exceed the recommended doses.
• Take ACTIFED tablets with some water.
• Take ACTIFED syrup using the measuring device with markings at 5 and 10 ml.

Children under 12 years of age
ACTIFED should not be used in children under 12 years of age.

Adults and children over 12 years of age
one tablet or one 10 ml dose of syrup 2 - 3 times a day.

If you take more ACTIFED than you should, you may experience:

• drowsiness, deep sleep (lethargy), respiratory depression, high blood pressure (hypertension), increased body temperature (hyperthermia), dilated pupils (mydriasis), flushing, fever, dry mouth,

urinary retention, reduced intestinal motility (reduced bowel sounds), increased heart rate (tachycardia), low blood pressure (hypotension), nausea, vomiting, agitation, confused state,
hallucinations, psychosis, seizures, heart rhythm disturbances (arrhythmias);

• Patients experiencing prolonged agitation, coma, or seizures may rarely develop severe muscle damage (rhabdomyolysis) and reduced kidney function (renal failure);
• insomnia, irritability, anxiety, awareness of heartbeat (palpitations), decreased heart rate (bradycardia);
• intracerebral hemorrhage, myocardial infarction, reduced blood calcium levels (hypocalcemia), intestinal infarction.
• In children, tremors, insomnia, hyperactivity and seizures and drowsiness may occur.

If you take a high dose of ACTIFED, inform your doctor immediately or go to the nearest
hospital.
Keep this medicine out of the reach of children. In case of overdose, seek medical help
or contact a poison control center immediately.

If you forget to take ACTIFED
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects(may affect up to 1 in 10 people)

• dry mouth, nausea;
• dizziness, difficulty falling asleep (insomnia) and nervousness.

Very rare side effects(may affect up to 1 in 10,000 people)

• anxiety, euphoric mood, hallucination including visual, restlessness;
• headache, changes in sensation (paresthesia), psychomotor hyperactivity, drowsiness, muscle tremors;
• changes in heart rate (arrhythmia, extrasystoles), perception of heartbeat (palpitations), increased heart rate (tachycardia);
• weakness (asthenia);
• nosebleeds (epistaxis);
• vomiting, stomach and intestinal disorders;
• itching, skin rash, hives;
• severe skin rash characterized by the formation of pustules (acute generalized exanthematous pustulosis AGEP) (See section 2 “Warnings and precautions”)*;
• swelling of the face, eyes, lips and throat with possible difficulty breathing (angioedema);
• difficulty in passing urine (dysuria), urinary retention;
• increased blood pressure;
• allergic reactions (hypersensitivity).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• skin reactions after exposure to light (photosensitivity);
• thickening of bronchial secretions;
• diarrhea;
• alteration of certain blood values;
• lowering of blood pressure (especially in the elderly),
• stroke (cerebrovascular accidents)
• heart attack, reduced blood supply to the heart that can cause discomfort or pain at the level of the chest, neck, back, jaw, shoulders or arms (known as angina);
• severe headache, confusion, convulsions, visual disturbances (See section 2 “Warnings and precautions”).
• inflammation of the colon due to insufficient blood flow (ischemic colitis) (See section 2 “Warnings and precautions”).
• Reduced blood flow to the optic nerve (ischemic optic neuropathy).

*The sudden onset of fever, skin redness or numerous small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis – AGEP) may occur within the first two days of treatment with ACTIFED.
Stop using ACTIFED if you develop these symptoms and contact your doctor and/or seek immediate medical attention

Side effects in children and adolescents

• psychomotor hyperactivity that manifests with excessive motor activity such as walking back and forth, being unable to stay still while seated, being restless, wringing hands, incessantly manipulating clothes or other objects. This side effect is very rare.

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

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. The expiry date refers to the last day of that month.
ACTIFED syrup: store this medicine protected from light.
ACTIFED tablets: store at a temperature not exceeding 25°C and in a dry place.
Do not dispose of any medicine in wastewater 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 ACTIFED tablets contain
The active ingredients are: triprolidine hydrochloride and pseudoephedrine hydrochloride.
The other ingredients are: lactose, corn starch, povidone, magnesium stearate.

What ACTIFED syrup contains
The active ingredients are: triprolidine hydrochloride and pseudoephedrine hydrochloride.
The other ingredients are: glycerol, sucrose, methyl parahydroxybenzoate, sodium benzoate, yellow
quinoline (E104), sunset yellow (E110), purified water.

Description of the appearance of ACTIFED and contents of the pack
ACTIFED tablets are available in packs of 12 tablets.
ACTIFED syrup is available in 100 ml bottles, with a measuring cup with markings at 5 and 10 ml.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071Santa Palomba - Pomezia (Roma)

Manufacturer
ACTIFED tablets
Janssen-Cilag, Domaine de Maigremont F27100 Val de Reuil, France
ACTIFED syrup
Famar Orléans – 5, Avenue de Concyr – 45071 Orlèans Cedex 2 (France)
Detailed and updated information on this medicine is available by scanning the QR Code
present on the outer packaging with a smartphone. The information is also available
(https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/).