Actifed

Package leaflet: Information for the patient

ACTIFED 2.5 mg + 60 mg tablets, 2.5 mg/10 ml + 60 mg/10 ml syrup

triprolidine hydrochloride; pseudoephedrine hydrochloride
Please 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 instructed you.

• 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, contact your doctor, pharmacist, or nurse. See section 4.
• Contact 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 is and what it is used for
2. What you need to know before taking 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 ACTIFED is and what it is used for

ACTIFED contains pseudoephedrine hydrochloride, a nasal mucosa decongestant, and triprolidine hydrochloride, an antihistamine that reduces nasal secretions.
ACTIFED is a medicine used to relieve symptoms of nasal congestion caused by the common cold.
Consult your doctor if you do not feel better or feel worse after 7 days of treatment.

2. What you need to know before taking ACTIFED

Do not use ACTIFED:

• if you are allergic to the active substances 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 within the last 2 weeks monoamine oxidase inhibitors (MAOIs), medicines for depression, because using these medicines with ACTIFED may cause an increase in blood pressure;
• if you are taking medicines used for respiratory problems, for example medicines to treat asthma, because using these medicines with ACTIFED may 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 have glaucoma (increased eye pressure with possible worsening of vision);
• if you have 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 frequent need to urinate);
• if you suffer from epilepsy;
• if you have diabetes;
• if you are under 12 years of age.

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

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

Contact your doctor if use of ACTIFED does not improve your symptoms, if your symptoms worsen or new symptoms appear, if you develop high fever or notice other adverse effects.
Stop using ACTIFED and contact your doctor if you experience:

• sudden severe headache, nausea, vomiting, confusion, seizures, visual disturbances: with ACTIFED, serious sudden headaches, nausea, vomiting, confusion, seizures, visual disturbances, symptoms of posterior reversible encephalopathy syndrome (PRES/RCVS), may occur.
• sudden abdominal pain, presence of blood in stools: with ACTIFED, sudden abdominal pain or rectal bleeding due to inflammation of the colon (ischaemic colitis) may occur.
• generalized febrile erythema associated with pustules: severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported with products containing pseudoephedrine. This acute pustular eruption may occur within the first 2 days of treatment, with fever and numerous small, mostly non-follicular pustules arising from a widespread edematous erythema, mainly localized in skin folds, trunk, and upper limbs.

With ACTIFED, a reduction in blood flow to the optic nerve may occur.
If sudden vision loss occurs, stop taking ACTIFED and contact your doctor or a healthcare facility immediately. See section 4.
If you experience any of these symptoms, stop using ACTIFED and contact your doctor or seek immediate medical help. (See section “4. Possible side effects”).
Other medicines and ACTIFED
Inform 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:

• antidepressant medicines called monoamine oxidase inhibitors (MAOIs) or have taken them within the last 2 weeks, as this may cause an increase, even sudden, in blood pressure;
• medicines used for respiratory problems, for example to treat asthma, as this may cause an increase, even sudden, in blood pressure;
• anticholinergic medicines, used for example for urinary incontinence, Parkinson's disease, or stomach or intestinal disorders;
• medicines that delay blood clotting (anticoagulants);
• medicines used to lower high blood pressure (antihypertensives), such as methyldopa, alpha and beta blockers, debrisoquine, guanethidine, betanidine, and bretylium;
• antidepressant medicines called tricyclic antidepressants;
• hypnotics, sedatives, or tranquilizers;
• other medicines that reduce nasal congestion;
• medicines that cause decreased appetite and weight loss (anorectics and amphetamine-like substances);
• antibiotics that cause ear problems;
• furazolidone, an antibiotic.

ACTIFED and alcohol
Do not drink alcohol while 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 may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use ACTIFED if you are pregnant or breastfeeding.
Driving and using machines
ACTIFED may cause drowsiness. Make sure you do not experience this side effect before driving or operating machinery.
ACTIFED syrup contains:

• sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• methyl parahydroxybenzoate. May cause allergic reactions (including delayed ones);
• sunset yellow (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 contain:

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

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

3. How to take ACTIFED

Take this medicine exactly as stated in this leaflet or as directed 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 a glass of water.
• Take ACTIFED syrup using the dosing cup marked with graduations at 5 and 10 ml.

Children under 12 years of age
ACTIFED must 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 daily.

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, confusion,
hallucinations, psychosis, seizures, heart rhythm disorders (arrhythmias);

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

If you take a large dose of ACTIFED, contact 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 centre immediately.
If you forget to take ACTIFED
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 everybody gets them.

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

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

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

• anxiety, elevated mood, visual hallucinations, restlessness;
• headache, altered sensation (paraesthesia), psychomotor hyperactivity, drowsiness, muscle tremors;
• changes in heart rhythm (arrhythmia, extrasystoles), awareness of heartbeat (palpitations), increased heart rate (tachycardia);
• weakness (asthenia);
• nosebleeds (epistaxis);
• vomiting, stomach and intestinal disturbances;
• itching, rash, urticaria;
• 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, possibly causing breathing difficulties (angioedema);
• difficulty passing urine (dysuria), urinary retention;
• increased blood pressure;
• allergic reactions (hypersensitivity).

Side effects with unknown frequency (cannot be estimated from the available data)

• skin reactions after exposure to light (photosensitivity);
• thickening of bronchial secretions;
• diarrhoea;
• changes in certain blood test values;
• drop in blood pressure (especially in the elderly);
• stroke (cerebrovascular accidents);
• heart attack, reduced blood flow to the heart which may cause discomfort or pain in the chest, neck, back, jaw, shoulders or arms (known as angina);
• severe headache, confusion, seizures, visual disturbances (See section 2 “ Warnings and precautions”);
• inflammation of the colon due to insufficient blood supply (ischaemic colitis) (See section 2 “ Warnings and precautions”);
• reduced blood flow to the optic nerve (ischaemic optic neuropathy).

*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 assistance.

Side effects in children and adolescents

• psychomotor hyperactivity, manifesting as excessive motor activity such as walking back and forth, inability to sit still, restlessness, hand-wringing, or incessant manipulation of clothes or other objects. This side effect occurs very rarely.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 below 25°C and in a dry place.
Do not dispose of any medicine 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 tablets contain
The active substances are: triprolidine hydrochloride and pseudoephedrine hydrochloride.
The other components are: lactose, maize starch, povidone, magnesium stearate.

What ACTIFED syrup contains
The active substances are: triprolidine hydrochloride and pseudoephedrine hydrochloride.
The other components are: glycerol, sucrose, methyl 4-hydroxybenzoate, sodium benzoate, quinoline yellow (E104), sunset yellow (E110), purified water.

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia (Rome)

Manufacturer
ACTIFED tablets
Janssen-Cilag, Domaine de Maigremont F27100 Val de Reuil, France
ACTIFED syrup
Famar Orléans – 5, Avenue de Concyr – 45071 Orléans Cedex 2 (France)

Detailed and updated information on this medicinal product is available by scanning the QR code on the outer packaging with a smartphone. Information is also available at (https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/).