In this manual :
1. WHAT IS DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg TABLET AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, Tablet
3. HOW DO I TAKE DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg TABLET AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
DECONGESTANTS FOR SYSTEMIC USE.
This medicine contains a nasal decongestant vasoconstrictor (pseudoephedrine) and an analgesic (paracetamol).
This medicine is indicated for the treatment of colds in adults and adolescents over 15 years of age:
- of blocked nose sensations,
- headaches and/or fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Never take DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet in the following cases:
- If you have a history of allergy to any of the components of the product.
- Children under 15 years of age.
- If you have had a stroke.
- If you have severe or poorly controlled high blood pressure.
- If you have severe heart disease (coronary artery disease).
- If you have certain forms of glaucoma (increased pressure in the eye).
- If you have difficulty in urinating due to prostatic or other causes.
- If you have had a seizure in the past or recently.
- If you have severe liver or kidney disease due to the presence of paracetamol.
- If you are breast-feeding.
- If you are allergic (hypersensitive) to wheat, due to the presence of wheat starch.
- In combination with non-selective MAOIs because of the risk of paroxysmal hypertension and life-threatening hyperthermia.
- In combination with other indirectly acting sympathomimetics: vasoconstrictors intended to decongest the nose, whether orally or nasally administered [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine] and methylphenidate, because of the risk of vasoconstriction and/or hypertensive flares.
- In combination with alpha sympathomimetics: vasoconstrictors intended to decongest the nose, whether administered orally or nasally [etilefrin, midodrine, naphazoline, oxymetazoline, phenylephrine (a.k.a. neosynephrine), synephrine, tetryzoline, tuaminoheptane, tymazoline], because of the risk of vasoconstriction and/or hypertensive flare-ups
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The combination of two decongestants is contraindicated, regardless of the route of administration (oral and/or nasal): such a combination is useless and dangerous and corresponds to misuse.
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You should not generally use this medicine during pregnancy, unless your doctor advises otherwise.
IF IN DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take caution with DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet:
Special Warnings
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
- It is imperative that the dosage, the 5-day treatment period, and the contraindications be strictly observed.
- In case of overdose or if you take too much by mistake, consult your doctor immediately.
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This medicine contains paracetamol. Other medicines contain paracetamol. Do not take them together, so that you do not exceed the recommended daily dose (see chapter on dosage).
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- During treatment, in the event of a sensation of accelerated heartbeat, palpitations, appearance or increase in headaches, appearance of nausea, behavioural problems, stop the treatment and contact your doctor immediately.
PREVENT YOUR DOCTOR if you suffer from:
- high blood pressure,
- heart disease, hyperthyroidism (hyperfunction of the thyroid gland),
- personality disorders,
- diabetes.
NOTIFY YOUR DOCTOR if you are taking:
- a selective MAOI (moclobemide, toloxatone),
- a treatment containing an ergot alkaloid:
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 drug)
- linezolid.
Related to excipients
The use of this medicinal product is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
This medication may be used in celiac disease. Wheat starch may contain gluten, but only in trace amounts, and is therefore considered safe for people with celiac disease.
Precautions for use
- In case of purulent nasal discharge, persistent fever, lack of improvement after 5 days of treatment, CONSULT YOUR DOCTOR.
- In case of serious liver or kidney disease, it is necessary to consult your doctor before taking this medicine (because of the presence of paracetamol).
- In the elderly or in persons prone to constipation, dizziness and urinary disorders.
- This medicine may cause drowsiness increased by alcohol: it is preferable to start the treatment in the evening and to abstain from alcoholic beverages or medicines containing alcohol during the treatment.
- If you have to undergo anaesthesia, stop treatment with this medicine beforehand and inform the anaesthetist.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medication, including medication 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 vasoconstrictors whether orally or nasally administered (phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine, methylphenidate, etilefrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, tymazoline);
- a non-selective MAOI (iproniazid).
It is not recommended to use this medication if you are already being treated:
- with a selective A-AMI drug, a drug prescribed for certain depressive states;
- and/or other dopaminergic or vasoconstrictor drugs such as bromocriptine, cabergoline, lisuride, pergolide or dihydroergotamine, ergotamine, methylergometrine, methysergide, drugs prescribed for certain neurological or endocrine disorders or migraine headaches
- with linezolid.
Report taking this medication if your doctor orders a blood uric acid test.
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To avoid the harmful effects of an overdose,
DO NOT take other drugs containing vasoconstrictors or paracetamol WITHOUT MEDICAL ADVICE.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
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Ask your doctor or pharmacist for advice before taking any medicine.
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Pregnancy
The use of this medicine is generally not recommended during pregnancy.
Breastfeeding
Due to possible adverse effects on infants, this medicine should not be taken if you are breastfeeding.
Sportsmen
Warning: this medicine contains an active substance (pseudoephedrine) which may cause a positive reaction in tests carried out during doping controls.
Effects on the ability to drive vehicles or use machines
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet:
This medicine contains wheat starch (gluten) and lactose.
3. HOW TO TAKE DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet: This medicine contains wheat starch (gluten) and lactose
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OF AGE.
1 to 2 tablets 3 times a day. The interval between doses should be at least 4 hours.
Do not exceed 6 tablets per day. The maximum daily dosage is 3 g of paracetamol and 180 mg of pseudoephedrine.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Method and route of administration
Oral use.
The tablets should be swallowed as they are with a glass of water.
Frequency of administration
Repeat if necessary after at least 4 hours.
In case of severe kidney disease (severe renal failure), take at least 8 hours apart.
Duration of treatment
The duration of use is limited to 5 days. In the absence of improvement as well as in the event of persistence of symptoms beyond 5 days of treatment, do not continue the treatment and seek medical advice.
If the symptoms do not subside, seek medical advice.
Symptoms and instructions in case of overdose
If you have taken more DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg tablets than you should have
In case of accidental overdose or intoxication, STOP THE TREATMENT AND CONSULT YOUR DOCTOR IMMEDIATELY.
Instructions in case of missed dose(s)
If you forget to take DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet:
Do not take a double dose to make up for the single dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg tablets may cause side effects, although not everyone is likely to experience them.
Due to thepresence of pseudoephedrine, this medicine may cause:
- General effects such as:
o headaches, strokes,
o palpitations, high blood pressure, myocardial infarction, sweating, behavioural disturbances, nausea, vomiting,
o the onset of acute glaucoma in susceptible individuals which may result in a red and painful eye.
IN THESE CASES, DISCONTINUE USE AND CONTACT YOUR DOCTOR IMMEDIATELY.
- May also occur:
o allergic manifestations,
o urinary disorders (significant decrease in urine output, difficulty in urinating),
o dry mouth,
o inflammation of the large intestine due to insufficient blood supply,
o anxiety,
o convulsions, hallucinations, agitation, behavioural disturbances and insomnia have been described particularly in children,
o exceptionally, haemorrhagic strokes have been reported in patients treated with medicines containing a vasoconstrictor, particularly in cases of overdose, failure to observe contraindications or warnings and/or in patients with vascular risk factors (see "Do not take DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg tablets in the following cases" and "Be careful with DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet).
IN THESE CASES, DISCONTINUE USE AND CONTACT YOUR DOCTOR IMMEDIATELY.
Due to the presence of paracetamol:
- In rare cases, a rash or redness of the skin or an allergic reaction may occur, which may include sudden swelling of the face and neck or sudden discomfort with a fall in blood pressure. Treatment must be stopped immediately, your doctor must be informed and you must not take any other medication containing paracetamol.
- In exceptional cases, biological changes requiring a blood test have been observed: abnormally low levels of certain blood elements (platelets) which may result in nose or gum bleeding. In this case, consult a doctor.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet
Keep out of the reach and sight of children.
Do not use DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg tablets after the expiry date stated on the box. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg tablet contain?
The active ingredients are
Paracetamol ................................................................................................................................ 500.00 mg
Pseudoephedrine hydrochloride ................................................................................................... 30.00 mg
Quantity corresponding to pseudoephedrine base .............................................................................. 24.57 mg
For one tablet.
Other components are:
Wheat starch, potato starch, sodium carboxymethyl starch, lactose, magnesium stearate.
Pharmaceutical form and content
What is DOLIRHUME PARACETAMOL AND PSEUDOEPHEDRINE 500 mg/30 mg, tablet and what does it contain?
This medicine is in tablet form.
Box of 16 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
1-13 BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
AVENTIS INTERCONTINENTAL
ZI NORD EST
RUE EDOUARD BRANLY
14104 LISIEUX CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH ADVICE/EDUCATION
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