Rhinadvil 20 tablets

In this manual :

1. WHAT IS RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE TAKING RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet

3. HOW DO I TAKE RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, Coated Tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet AND WHAT IS IT USED FOR?

This medicine contains a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties, ibuprofen and a vasoconstrictor, pseudoephedrine hydrochloride.

It is indicated for the treatment of colds in adolescents (15-17 years of age) and adults, for the symptomatic treatment of a blocked nose accompanied by headache and/or fever.

2. WHAT YOU SHOULD KNOW BEFORE TAKING RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet

Not applicable.

Do not take RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, coated tablet:

Children and adolescents under 15 years of age.

- From the 6th month of pregnancy.

- Patients with a history of allergy or asthma triggered by this or related drugs, including other non-steroidal anti-inflammatory drugs, aspirin, or a history of allergy to other components of the tablet.

- Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy or a history of recurrent peptic ulcer disease or bleeding.

- Severe liver disease.

- Severe kidney disease.

- Severe heart failure.

- Severe or poorly controlled high blood pressure.

- Gastrointestinal bleeding or other red blood cell abnormalities.

- If you have had a stroke.

- Severe heart disease (coronary artery disease).

- Some forms of glaucoma (increased pressure in the eye).

- Difficulty urinating due to prostate or other causes.

- Old or recent seizures.

- history of myocardial infarction

- Systemic lupus erythematosus.

- If you are being treated with:

o other vasoconstrictor drugs, intended to decongest the nose whether administered orally or nasally (phenylpropanolamine, phenylephrine, ephedrine...) or methylphenidate,

o non-selective MAOIs (iproniazid), which are prescribed for certain depressive states.

- If you are breast-feeding.

You should not generally use this medicine unless your doctor tells you to:

- until the 5th month of pregnancy,

- in combination with:

o oral anticoagulants,

o anti-platelet agents,

o other non-steroidal anti-inflammatory drugs (including aspirin and other high dose salicylates),

o corticosteroids,

o heparin injection in curative doses or in the elderly,

o lithium,

o selective serotonin reuptake inhibitors,

o methotrexate (used at doses greater than 20* mg per week).

Use caution with RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet:

At high doses, higher than 6 tablets per day (1200 mg/day of ibuprofen and 180 mg/day of pseudoephedrine), this medicine has anti-inflammatory properties and can cause sometimes serious inconveniences which are those observed with anti-inflammatory medicines.

KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.

In case of overdose or if you take too much by mistake, contact a doctor immediately.

It is imperative to strictly adhere to the dosage, the 5-day treatment period, and the contraindications.

Medicines such as RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke; the risk is more likely with higher doses and longer duration of treatment; do not exceed the dose or duration of treatment (5 days)

If you have heart problems, have had a stroke, or think you may be at risk (e.g. high blood pressure, diabetes, high cholesterol, or if you smoke), you should talk to your doctor or pharmacist before taking this medicine.

BEFORE USING THIS MEDICINE, CONSULT YOUR DOCTOR IF YOU HAVE ANY MEDICAL CONDITIONS:

- A history of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose; administration of this medicine may cause an asthma attack, especially in some people who are allergic to aspirin or a non-steroidal anti-inflammatory drug (see section 2, What you should know before taking RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE..);

- Taking anticoagulant therapy. This drug may cause serious gastrointestinal manifestations;

- A history of gastrointestinal problems (hiatal hernia, gastrointestinal bleeding, previous stomach or duodenal ulcer);

- Heart, liver, kidney disease;

- High blood pressure;

- Heart disease, hyperthyroidism (hyperfunction of the thyroid gland);

- Personality disorders or diabetes;

- If you are taking medication to treat migraine (including ergot-derived alkaloids);

- If you are taking the following drugs: cyclosporine, tacrolimus, trimethoprim.

DURING TREATMENT, IN CASE OF:

- If your eyesight is impaired, DO NOT take this medication without telling your doctor;

- Sensation of accelerated heartbeat, palpitations, appearance or increase in headaches, appearance of nausea, behavioural problems;

- Gastrointestinal haemorrhage (discharge of blood through the mouth or in the stool, black stool);

- Signs of allergy to this medication, including asthma attack or angioedema (see section 4 "What are the possible side effects of RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet?).

STOP TREATMENT AND CONTACT A DOCTOR OR EMERGENCY MEDICAL SERVICE IMMEDIATELY

Due to the presence of sucrose, this medicine should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).

Due to the presence of methyl and propyl parahydroxybenzoates (preservatives), possible allergic reactions or even delayed allergic reaction may occur.

In case of:

Purulent nasal discharge

Persistence of fever

No improvement after 5 days of treatment

CONSULT YOUR DOCTOR

If you have to undergo anaesthesia, stop the treatment beforehand and tell the anaesthetist.

This medicine contains a non-steroidal anti-inflammatory drug, ibuprofen and a vasoconstrictor, pseudoephedrine hydrochloride.

You should not take other medicines containing non-steroidal anti-inflammatory drugs and/or aspirin and/or pseudoephedrine at the same time as this medicine.

Read the package inserts of other medicines you are taking carefully to make sure they do not contain non-steroidal anti-inflammatory drugs and/or aspirin and/or pseudoephedrine.

Taking or using other medications

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including

- antiplatelet agents and oral anticoagulants,

- other non-steroidal anti-inflammatory drugs including aspirin and its derivatives in high doses,

- corticosteroids,

- injectable heparin,

- lithium,

- selective serotonin reuptake inhibitors,

- high-dose methotrexate (greater than 20* mg per week),

- ticlopidine,

- ciclosporin, tacrolimus, trimethoprim,

- drugs for high blood pressure,
even if obtained without a prescription.

Also, this medication contains the vasoconstrictor pseudoephedrine hydrochloride, which should NOT be used in combination with other vasoconstrictor medications:

- with other vasoconstrictor drugs intended to decongest the nose whether administered orally or nasally (phenylpropanolamine, phenylephrine, ephedrine...) and with methylphenidate,

- to drugs prescribed for certain depressive states: non-selective MAOIs (iproniazid).

Also, it is not recommended to combine this medication:

- to selective MAOIs,

- to linezolid,

- to dopaminergic or vasoconstrictor ergot alkaloids such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine, dihydroergotamine.

In case of doubt, do not hesitate to ask your doctor or pharmacist for advice

Not applicable.

Not applicable.

Pregnancy and lactation

Pregnancy

The use of this medicine is not recommended up to and including the 5th month of pregnancy and is contraindicated from the 6th month of pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding

Due to possible adverse effects on infants, this medicine should not be taken if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medication.

Athletes

Pseudoephedrine hydrochloride may cause a positive reaction in doping control tests.

Driving and using machines

In rare cases, dizziness and blurred vision may occur when taking this medicinal product.

List of excipients with a notable effect:sucrose, methyl and propyl parahydroxybenzoates.

3. HOW TO TAKE RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet

Not applicable.

Dosage

FOR ADULTS (15-17 years) AND ADULTS

1 tablet (200 mg ibuprofen / 30 mg pseudoephedrine hydrochloride) per dose, repeated if necessary after 6 hours.

In case of more intense symptoms, 2 tablets (400 mg ibuprofen / 60 mg pseudoephedrine hydrochloride) per dose, to be repeated if necessary after 6 hours, without exceeding 6 tablets (1200 mg ibuprofen / 180 mg pseudoephedrine hydrochloride) per day.

In all cases, never exceed the maximum dosage of 6 tablets per day (i.e. 1200 mg ibuprofen and 180 mg pseudoephedrine hydrochloride per day).

Method of administration

Oral administration.

The tablets should be swallowed as they are with a large glass of water, preferably with meals.

Frequency of administration

The tablets should be taken at least 6 hours apart.

If you feel that the effect of RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, coated tablet, is not as effective as you expected, consult your doctor or pharmacist.

Duration of treatment

The maximum duration of treatment is 5 days.

If you have taken more RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, coated tablet than you should have, contact your doctor:

Check with your doctor.

If you forget to take RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, Coated Tablets:

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

If you stop taking RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, Coated Tablets:

If you have any further questions about using this medicine, ask your doctor or pharmacist for more information.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE coated tablets may have side effects, although not everyone is susceptible.

Some medicines, such as RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, may be associated with a slight increase in the risk of myocardial infarction or stroke.

Tell your doctor or pharmacist if you experience gastrointestinal upset (such as pain or heartburn) at the start of treatment, or if you have experienced upset on previous treatments with anti-inflammatory drugs, especially if you are elderly.

Stop your treatment immediately if you notice any damage to the skin, mucous membranes (e.g. inside the mouth) or signs of allergy.

RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE Coated Tablet may cause the following side effects:

- Sensation of increased heartbeat, palpitations, appearance or increase in headache, appearance of nausea, behavioural disturbances (related to the presence of pseudoephedrine hydrochloride).

- Gastrointestinal haemorrhage (discharge of blood from the mouth or stool, black stool) in rare cases; the higher the dosage used, the more frequent it is (related to the presence of ibuprofen).

- Signs suggestive of allergy to this drug, including asthma attack, angioedema (sudden swelling of the face and neck with difficulty breathing), or skin allergies (skin rash, itching, swelling, worsening of chronic urticaria, erythema)

- Bullous manifestations of the skin or mucous membranes, (burning sensations accompanied by redness with bullae, blisters, ulcerations).

IN THESE CASES, STOP THE TREATMENT AND CONTACT A DOCTOR OR AN EMERGENCY MEDICAL SERVICE IMMEDIATELY.

In addition, the following effects may occur during treatment:

- Digestive disorders: stomach upset, vomiting, nausea, diarrhea, constipation;

- The possibility of triggering an acute glaucoma attack in predisposed subjects;

- Urinary disorders (significant decrease in urine output, difficulty in urinating), particularly in cases of urethral or prostate abnormalities or renal insufficiency;

- Dry mouth, palpitations;

- Convulsions, hallucinations, agitation, anxiety, insomnia, especially in children.

Your doctor should be informed.

Exceptionally, the following may occur

- Headaches accompanied by nausea, vomiting and stiff neck;

- Changes in the liver or blood count (decrease in white or red blood cells) which may be serious have been observed;

- Visual disturbances;

- Hemorrhagic strokes have been reported in patients treated with pseudoephedrine-containing drugs, particularly when contraindications or warnings are not followed (see section 2 "INFORMATION REQUIRED BEFORE TAKING RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, Coated Tablet").

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 DO I USE RHINADVIL RHUME IBUPROFEN/PSEUDOEPHEDRINE, Coated Tablet?

Keep out of the reach and sight of children.

Do not use after the expiry date on the box.

The expiry date refers to the last day of the month.

Store at a temperature not exceeding +20°C.

Medicines should not be disposed of in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.

6. ADDITIONAL INFORMATION

What does RHINADVIL RHUME IBUPROFENE/PSEUDOEPHEDRINE, coated tablet contain?

The active ingredients are

Ibuprofen .................................................................................................................................. 200.00 mg

Pseudoephedrine hydrochloride ................................................................................................. 30.00 mg