IlviGrip Expectorant powder for oral solution , 10 sachets

IlviGrip Expectorant powder for oral solution , 10 sachets

Leaflet: information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for taking the medicine exactly as given in this leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.

If you need advice or further information, ask your pharmacist.

If you experience side effects, please tell your doctor, even if they are not listed in this leaflet. See section 4.

You should consult a doctor if you get worse or if you do not improve after 3 days.

Contents of the package leaflet:

What ilviGrip Expectorant is and what it is used for 2.

2.   What you need to know before you start using ilviGrip Expectorant

3.   How to take ilviGrip Expectorant

4.   Possible side effects

5.   Storage of ilviGrip Expectorant

6.   Contents of the pack and additional information

1. What ilviGrip Expectorant is and what it is used for

ilviGrip Expectorant is indicated for the symptomatic relief of catarrhal and flu-like conditions.

It contains three active ingredients:

Paracetamol is well known for its ability to eliminate pain (analgesic). It is effective against headaches and sore throats and can also reduce fever (antipyretic).

Guaifenesin (an expectorant) liquefies phlegm, helping to clear mucus.

Phenylephrine hydrochloride (a nasal decongestant) reduces inflammation of the nasal passages, relieving nasal congestion.

You should only use ilviGrip Expectorant if you have mild to moderate pain, fever, nasal congestion and phlegm.

Consult your doctor if you do not improve or if it gets worse after 3 days.

2. What you need to know before you start taking ilviGrip Expectorant

Do not take ilviGrip Expectorant:

If you are allergic (hypersensitive) to paracetamol, guaifenesin, phenylephrine hydrochloride, or any of the ingredients (see section 6 composition of ilviGrip Expectorant).

If you have heart disease.

If you have high blood pressure (hypertension).

If you have liver disease or severe kidney disease.

If you have an overactive thyroid.

If you are diabetic.

If you have narrow-angle glaucoma (increased pressure in the eye).

If you have porphyria, which is an inherited disorder characterised by excessive amounts of pigments in the urine.

If you are taking tricyclic antidepressants.

If you are taking beta-blockers.

If you are taking monoamine oxidase inhibitors (MAOIs) - used in the treatment of depression or Parkinson's disease - or have taken them within the last 14 days.

If you are taking medicines to lower blood pressure or to treat angina pectoris.

Warnings and precautions

Important: Contains Paracetamol. Do not take with other medicines containing paracetamol.

In case of overdose you should consult your doctor immediately, even if you feel well, because of the delayed risk of serious liver damage. Do not take this medicine with other medicines for flu, cold or nasal congestion.

Talk to your doctor or pharmacist before taking ilviGrip Expectorant:

If you have any liver problems.

If you are a man and have an enlarged prostate, making it more difficult for you to pass urine.

If you have circulation problems (including Raynaud's syndrome).

If you have a chronic or persistent cough such as occurs with asthma, chronic bronchitis or emphysema.

If you have severe haemolytic anaemia, glucose-6-dehydrogenase deficiency, chronic nutritional disorder or if you are dehydrated.

Children and adolescents

Do not use ilviGrip Expectorant in children under 12 years of age.

Use of ilviGrip Expectorant with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Tell your doctor if you are taking

medicines containing paracetamol or other decongestants for colds and flu. If you are taking them, do not take ilviGrip Expectorant.

flucloxacillin (antiobiotic), because of a serious risk of blood and fluid disturbance (metabolic acidosis with high anion imbalance) which must be treated urgently and which can occur particularly in case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood resulting in organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used.

monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson's disease. Do not take ilviGrip Expectorant if you have been treated with MAOIs within the last 14 days.

tricyclic antidepressants for depression, such as amitriptyline or imipramine.

medicines for high blood pressure (antihypertensives), including beta-blockers, or to improve heart function or correct abnormal heart rhythms (digoxin, lanoxin, digitoxin).

phenothiazines (also used as antipsychotic drugs to treat conditions such as schizophrenia or paranoia, or to prevent nausea and vomiting.

medicines for nausea and vomiting (such as metoclopramide or domperidone).

medicines to thin the blood (anticoagulants), such as warfarin or other coumarins.

medicines for high cholesterol (such as cholestyramine).

sedatives (barbiturates).

probenecid or AZT (zidovudine).

Isoniazid (used to treat or prevent tuberculosis).

Taking ilviGrip Expectorant with food, drinks and alcohol.

Do not take this product with alcoholic drinks.

Pregnancy, breast-feeding and fertility

Taking ilviGrip Expectorant during pregnancy and breast-feeding should only be used if recommended by your doctor or pharmacist. 

.

If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. If necessary and only if recommended by a doctor or pharmacist, ilviGrip Expectorant may be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest possible time. Contact your doctor if your pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

This medicine may cause dizziness or confusion. Do not drive or operate machinery if you feel drowsy or dizzy.

ilviGrip Expectorant contains aspartame, sucrose and sodium:

Aspartame: This medicine contains 6 mg of aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot properly eliminate it.

Sucrose. If you have been told by your doctor that you have an intolerance to certain sugars, check with your doctor before taking this medicine.

Sodium: This medicine contains 157 mg of sodium (main component of cooking/table salt) in each sachet. This is 7.85% of the maximum recommended daily intake of sodium for an adult. Talk to your doctor or pharmacist if you need 3 or more sachets per day for a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet.

3. How to take ilviGrip Expectorant

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you are in any doubt.

The recommended dose is:

Adults and children over 12 years of age:

1 sachet every 4-6 hours as needed, up to a maximum of 4 sachets in 24 hours.

Do not exceed the stated dose.

Do not take this medicine with alcoholic drinks.

Use in children and adolescents

Do not use in children under 12 years of age.

Method of administration

This medicine is a powder to be dissolved in water and taken warm.

Dissolve the contents of one sachet in a cup of hot, but not boiling water (approx. 250 ml). Allow to cool to drinking temperature.

Duration of treatment

Long-term use of the product is not recommended.

If symptoms worsen or persist for more than 3 days, consult your doctor.

If you take more ilviGrip Expectorant than you should

Consult a doctor immediately if you accidentally take more than you should or give a child more than recommended, even if you/the child feels well, because of the delayed risk of serious liver damage.

In case of overdose or accidental ingestion, seek medical advice immediately, or call the Servicio de Información Toxicologica, telephone 91 562 04 20, stating the medicine and the amount taken.

If you have any other questions about the use of this product, ask your pharmacist.

If you forget to take ilviGrip Expectorant

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, stop taking the medicine immediately and seek emergency medical help.

- Very rare cases of serious skin reactions have been reported. Severe allergic reactions (anaphylaxis), wheezing or difficulty breathing may occur in rare cases.

(Rare: affecting less than 1 in 1,000 people, but more than 1 in 10,000; Very rare: affecting less than 1 in 10,000 people).

- Certain blood cell disorders and pancreatitis (inflammation of the pancreas) may occur very rarely with paracetamol (affects less than 1 in 10,000 people).

Other side effects

Frequency

Adverse effects

Frequent (may affect up to 1 in 10 people)

Loss of appetite, nausea or vomiting

Rare (may affect up to 1 in 1,000 people)

Mild allergic reactions ( such as skin rash or hives)

Stomach pain, diarrhoea

Headache, dizziness

Rapid heartbeat (palpitations), High blood pressure, Difficulty sleeping (insomnia), nervousness, tremor (shaking), irritability, restlessness, confusion or anxiety.

Abnormal liver blood tests.

Reporting of side effects:

If you experience any side effects, please contact your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: http;//www.notificaram.es. By reporting adverse effects you can help to provide more information on the safety of this medicine.

5. Storage of ilviGrip Expectorant

Keep out of the sight and reach of children.

Do not store above 25 ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.

Shelf life after reconstitution: The reconstituted solution is stable for 90 minutes.

Medicines should not be disposed of down the drain or in the trash. Please dispose of containers and unneeded medicines at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help to protect the environment.

6. Package contents and additional information

Composition of GripaVicks

The active substances are paracetamol, guaifenesin and phenylephrine hydrochloride. Each sachet of this medicine provides a single dose containing the following active substances: 500 mg paracetamol, 200 mg guaifenesin and 10 mg phenylephrine hydrochloride.

The other ingredients (excipients) are: sucrose, citric acid, tartaric acid, sodium cyclamate, sodium citrate, aspartame (E951), acesulfame potassium (E950), menthol powder flavouring, lemon flavouring, lemon juice flavouring, quinoline yellow (E104).

Appearance of the product and contents of the package

GripaVicks is an almost white powder packed in single-dose sachets in cardboard boxes. The cartons may contain 5 and 10 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturing Authorisation Holder

Marketing Authorisation Holder

Laboratorios Vicks, S.L.

Avda. de Bruselas, 24, 28108, Alcobendas, Madrid

Spain

Responsible for the manufacture

Procter & Gamble Manufacturing GmbH

Procter & Gamble Strasse 1

64521 Gross-Gerau, Hessen

Germany

Local representative

Procter & Gamble España, S.A.U.

Avenida de Bruselas, 24, 28108 Alcobendas, Madrid

Date of last revision of this package leaflet: June 2022

"Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/."