In this manual :
1. WHAT IS DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, TABLET AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, TABLET
3. HOW DO I TAKE DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, TABLET?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, Tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, 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 (doxylamine).
DECONGESTANTS FOR SYSTEMIC USE.
This medicine is indicated for the treatment of colds in adults and adolescents over the age of 15:
- of blocked nose sensations,
- of clear nasal discharge,
- headaches and/or fever.
2. WHAT YOU SHOULD KNOW BEFORE TAKING DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, TABLET
List of information needed before taking the medicine
If your doctor has told you that you are intolerant to certain sugars, contact him or her before taking this medicine.
Do not take DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE tablets 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 potentially fatal hyperthermia.
- In combination with other indirectly acting sympathomimetics: vasoconstrictors for nasal decongestion, whether oral or nasal (phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine), and methylphenidate, because of the risk of vasoconstriction and/or hypertensive flare-ups.
- 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], due to 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 DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, tablet:
Special Warnings
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
- It is imperative that the dosage, the 4-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 PHYSICIAN 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 4 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.
Do not drink alcoholic beverages or take any medication containing alcohol while taking this medication.
Report taking this medication if your doctor orders a blood uric acid test.
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To avoid the adverse effects of overdose,
DO NOT take other drugs containing vasoconstrictors, paracetamol or antihistamines 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
This medicinal product may cause alcohol-induced drowsiness: it is preferable to start the treatment in the evening and to abstain from alcoholic beverages during the treatment (see Taking or using other medications).
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 ability to drive vehicles or use machines
Driving and use of machines:
Due to the presence of doxylamine in the night tablet:
- attention is drawn, particularly in drivers of vehicles and users of machines, to the risk of drowsiness or reduced vigilance associated with the use of this medicine.
This phenomenon is accentuated by the intake of alcoholic beverages or medicines containing alcohol.
List of excipients with a known effect
Important information about some of the ingredients of DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, tablet:
This medicine contains wheat starch (gluten) and lactose.
3. HOW TO TAKE DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, 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.
During the day: 1 oblong tablet, to be repeated if necessary after a minimum of 4 hours, without exceeding 3 tablets per day (e.g. 1 tablet in the morning, 1 at lunchtime if necessary and 1 at dinner if necessary).
In the evening at bedtime: 1 round tablet if necessary.
Do not exceed 3 tablets per day and 1 night tablet per 24 hours.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Method of administration
Take by mouth.
The tablet is to be swallowed with a large glass of water.
Frequency of administration
Repeat if necessary after at least 4 hours.
In case of severe kidney disease (severe renal insufficiency), interval the doses by at least 8 hours.
Duration of treatment
The duration of use is limited to 4 days. If there is no improvement or if the symptoms persist beyond 4 days of treatment, do not continue the treatment and seek medical advice.
Symptoms and instructions in case of overdose
If you have taken more DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE tablets than you should have, contact your doctor:
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 DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, 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, DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, Tablet is likely to have side effects, although not everyone is likely to experience them.
Due to thepresence of pseudoephedrine, this drug 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, STOP THE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.
- May also occur:
o allergic reactions,
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 drop in blood pressure when moving to a standing position, which may be accompanied by dizziness,
o exceptionally, hemorrhagic strokes have been reported in patients treated with vasoconstrictor-containing drugs, particularly in cases of overdose, failure to follow contraindications or warnings and/or in patients with vascular risk factors (see "Never use DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, Tablet in the following situations" and See "Use caution with DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, Tablet").
IN THESE CASES, DISCONTINUE USE AND CONTACT YOUR DOCTOR IMMEDIATELY.
Due to thepresence 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.
Due to thepresence of doxylamine:
- constipation, dry mouth, visual disturbances (accommodation disorders), heart palpitations and drowsiness.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, Tablet
Keep out of the reach and sight of children.
Do not use DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE 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 DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE, tablet contain?
The active ingredients are:
Daytime tablet
Paracetamol .................................................................................................................................... 500 mg
Pseudoephedrine hydrochloride ........................................................................................................ 30 mg
For one oblong tablet.
Night tablet
Paracetamol .................................................................................................................................... 500 mg
Doxylamine hydrogen succinate .................................................................................................... 7.5 mg
For one round tablet.
Other components are:
Oblong daytime tablet: wheat starch, pregelatinized potato starch, sodium carboxymethyl starch (type A), lactose monohydrate, magnesium stearate.
Round night tablet: lactose monohydrate, sodium carboxymethyl starch (type A), pregelatinised maize and potato starch, talc, magnesium stearate.
Pharmaceutical form and content
What DOLIRHUMEPRO PARACETAMOL, PSEUDOEPHEDRINE AND DOXYLAMINE is and what it contains
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
Français
English
