Actifed Cold 15 tablets

1. WHAT IS ACTIFED RHUME, tablet AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

This medicine combines three active ingredients: an analgesic (paracetamol), a nasal decongestant vasoconstrictor (pseudoephedrine) and an antihistamine (triprolidine).

DECONGESTANTS FOR SYSTEMIC USE.

Therapeutic indications

This medication is indicated for the treatment of colds in adults and adolescents over the age of 15:

• - blocked nose,
• - clear nasal discharge,
• - headaches and/or fever.

2. WHAT DO I NEED TO KNOW BEFORE TAKING ACTIFED RHUME, tablet?

List of information required before taking the medicine

Not applicable.

Contraindications

Never take ACTIFED RHUME, tablet in the following cases:

• - If you have a history of allergy to any component of this product.
• - Children under 15 years of age.
• - If you have had a stroke.
• - Severe hypertension or poorly controlled hypertension.
• - Severe heart disease (coronary insufficiency).
• - If you have certain forms of glaucoma (increased pressure in the eye).
• - If you have difficulty in urinating due to prostatic or other problems.
• - If you have had convulsions recently or in the past.
• - In case of serious liver or kidney disease due to the presence of paracetamol.
• - If you are breast-feeding.
• - In association with non-selective MAOIs, due to the risk of paroxysmal hypertension and life-threatening hyperthermia.
• - In association with other indirect-acting sympathomimetics: vasoconstrictors designed to relieve nasal congestion, whether administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine] and methylphenidate, due to the risk of vasoconstriction and/or hypertensive flare-ups.
• - In association with alpha sympathomimetics: vasoconstrictors designed to decongest the nose, whether administered orally or nasally [etilefrin, midodrine, naphazoline, oxymetazoline, phenylephrine (aka neosynephrine), synephrine, tetryzoline, tuaminoheptane, tymazoline], due to the risk of vasoconstriction and/or hypertensive flare-ups.

Unless otherwise advised by your doctor, you should not use this medication during pregnancy.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Be careful with ACTIFED RHUME, tablet:

Special warnings

KEEP OUT OF REACH OF CHILDREN.

• - Strict adherence to dosage, 5-day treatment period and contraindications is imperative.
• - In the event of overdose, or if you take too high a dose by mistake, consult your doctor immediately.

• - During treatment, in the event of a sensation of accelerated heartbeat, palpitations, appearance or increase in headaches, appearance of nausea, behavioural disorders, stop treatment and contact your doctor immediately.

PREVENT YOUR PHYSICIAN if you suffer from:

• - high blood pressure,
• - heart disease, hyperthyroidism (hyperfunction of the thyroid gland),
• - personality disorders,
• - diabetes.

PREVENT YOUR DOCTOR if you are taking:

• - a selective MAOI (moclobemide, toloxatone),
• - treatment containing ergot alkaloids:

o dopaminergic, such as bromocriptine, cabergoline, lisuride or pergolide,
(e.g. an antiparkinsonian)

o vasoconstrictor, such as dihydroergotamine, ergotamine, methylergometrine, methysergide),
(e.g. an antimigraine agent)

• - linezolid.

Precautions for use

• - In the event of purulent nasal discharge, persistent fever or failure to improve after 5 days of treatment, CONSULT YOUR PHYSICIAN.
• - In the event of serious liver or kidney disease, consult your doctor before taking this medicine (due to the presence of paracetamol).
• - Elderly people or those prone to constipation, dizziness or urinary disorders.
• - This drug may cause alcohol-induced drowsiness: it is preferable to start treatment in the evening and to abstain from alcoholic beverages or drugs containing alcohol for the duration of treatment.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other drugs

Taking or using other medicines:

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

This medicine contains a vasoconstrictor, pseudoephedrine.

This drug should not be used in combination with:

• - other oral or nasal vasoconstrictors (phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine, methylphenidate, etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline);
• - a non-selective MAOI (iproniazid).

This drug should not be used if you are already being treated:

• - with a selective A-AMI, prescribed for certain depressive states;
• - and/or other dopaminergic or vasoconstrictor drugs such as bromocriptine, cabergoline, lisuride, pergolide or dihydroergotamine, ergotamine, methylergometrine, methysergide, prescribed to treat certain neurological or endocrine disorders or migraine headaches;
• - linezolid.

Do not take alcoholic beverages or any medication containing alcohol during treatment.

If your doctor prescribes a uric acid or blood sugar test, tell him/her that you are taking this medicine.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and breast-feeding

Pregnancy and breast-feeding

Pregnancy

The use of this drug is generally not recommended during pregnancy.

Breast-feeding

Due to possible adverse effects on infants, this drug is contraindicated if you are breast-feeding.

Sportsmen

Sportsmen

Caution: this product contains an active ingredient (pseudoephedrine) which may induce a positive reaction in anti-doping tests.

Effects on ability to drive and use machines

Driving vehicles and using machines:

Drivers of vehicles and users of machines in particular should be aware of the risk of drowsiness or reduced vigilance associated with the use of this drug.

This phenomenon is accentuated by the consumption of alcoholic beverages or medicines containing alcohol.

List of excipients

Not applicable.

3. HOW TO TAKE ACTIFED RHUME, tablet?

Instructions for proper use

Not applicable.

Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment

Dosage

FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OF AGE.

1 tablet, repeated if necessary after 6 hours, not to exceed 3 tablets per day.

IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Method of administration

Oral administration.

The tablet should be swallowed whole with a drink (e.g. water, milk, fruit juice).

Frequency of administration

Repeat if necessary after at least 4 hours.

In cases of severe kidney disease (severe renal failure), take at least 8 hours apart.

Duration of treatment

Use is limited to 5 days. If symptoms do not improve or persist beyond 5 days, seek medical advice.

If symptoms persist, discontinue treatment and seek medical advice.

Symptoms and instructions in case of overdose

If you have taken more ACTIFED RHUME, tablet than you should have:

In case of accidental overdose or intoxication, STOP THE TREATMENT AND CONSULT YOUR PHYSICIAN IMMEDIATELY.

Instructions in case of missed dose(s)

If you forget to take ACTIFED RHUME, tablet:

Do not take a double dose to make up for the one you forgot to take.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, ACTIFED RHUME, tablet is likely to have undesirable effects, although not everyone is subject to them.

Due to thepresence of pseudoephedrine, this drug may cause:

• - General effects such as:

o headaches, strokes,

o palpitations, hypertension, myocardial infarction, sweating, behavioral disturbances, nausea, vomiting,

o the triggering of an acute glaucoma attack in predisposed subjects, resulting in a red, painful eye,

IN SUCH CASES, DISCONTINUE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.

• - The following may also occur

o allergic reactions,

o urinary disorders (significant decrease in urine output, difficulty urinating),

o dry mouth,

o convulsions, hallucinations, agitation, behavioral disorders and insomnia have been described, particularly in children,

o memory or concentration disorders, confusion, dizziness (more frequent in the elderly),

o motor incoordination, tremors,

o drowsiness and reduced alertness, more marked at the start of treatment,

o allergic reactions:

§ skin rash (redness, itching, urticaria, eczema),

§ angioedema (sudden swelling of the face and neck, leading to breathing difficulties),

§ anaphylactic shock (violent, very severe allergic reaction),

o drop in blood pressure when standing, which may be accompanied by dizziness,

o exceptionally, haemorrhagic strokes have been reported in patients treated with drugs containing vasoconstrictors, particularly in cases of overdose, failure to observe contraindications or warnings, or in patients with vascular risk factors (see 2. WHAT YOU SHOULD KNOW BEFORE TAKING ACTIFED RHUME, Tablet, subheadings: "Never take ACTIFED RHUME, Tablet in the following situations", "Be careful with ACTIFED RHUME, Tablet").

IN THESE CASES, DISCONTINUE USE AND CONTACT YOUR DOCTOR IMMEDIATELY.

Due to the presence of paracetamol:

• - In rare cases, a rash or reddening of the skin may occur, or an allergic reaction may manifest itself as sudden swelling of the face and neck, or sudden malaise with a drop in blood pressure. Treatment must be stopped immediately, your doctor must be informed and you must never take paracetamol-containing drugs again.
• - In exceptional cases, biological changes requiring a blood test may be observed: abnormally low levels of certain blood elements (platelets) may lead to nose or gum bleeding. In this case, consult a doctor.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

5. HOW TO USE ACTIFED RHUME, tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use ACTIFED RHUME, comprimé after the expiration date stated on the box. The expiry date refers to the last day of the month.

Storage conditions

Store at a temperature not exceeding 25°C.

If necessary, warnings against certain visible signs of deterioration

Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What does ACTIFED RHUME, tablet contain?

The active ingredients are

Paracetamol ................................................................................................................................ 500.00 mg

Pseudoephedrine hydrochloride ................................................................................................... 60.00 mg

Triprolidine hydrochloride ............................................................................................................. 25.00 mg

For one tablet.

The other components are:

Pregelatinized corn starch, povidone, crospovidone, stearic acid, microcrystalline cellulose, colloidal silica, magnesium stearate.

Pharmaceutical form and contents

What is ACTIFED RHUME, tablet and what does it contain?

This medicine comes in tablet form. Box of 15 tablets.

Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different

Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1 RUE CAMILLE DESMOULINS

92130 ISSY LES MOULINEAUX