Pharmagrip Congestion 600 mg/10 mg granules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Pharmagrip congestion 600mg/10mg granules

Paracetamol/Hydrochloride phenylephrine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided 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 more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, or if fever persists for more than 3 days, or if pain or other symptoms last for more than 5 days.

Contents of the leaflet

1. What Pharmagrip congestion is and what it is used for
2. What you need to know before taking Pharmagrip congestion
3. How to take Pharmagrip congestion
4. Possible side effects
5. How to store Pharmagrip congestion
6. Contents of the pack and other information

1. What Pharmagrip congestion is and what it is used for

Pharmagrip congestion is a medicine containing the active substances paracetamol (an analgesic that reduces pain and fever) and phenylephrine (which acts by reducing nasal congestion).

This medicine is indicated for the relief of symptoms associated with cold or flu-like conditions involving pain (mild or moderate), fever, and nasal congestion in adults and adolescents over 12 years of age.

You should consult a doctor if your condition worsens or does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before taking Pharmagrip congestion

Do not take Pharmagrip congestion

• If you are allergic to phenylephrine, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with beta-blockers (used to treat high blood pressure or heart conditions).
• If you are taking tricyclic antidepressants (medicines used to treat depression).
• If you are being treated with any monoamine oxidase inhibitor (MAOI) medicine (medicines used to treat depression) or have taken them within the last two weeks.
• If you suffer from bronchial asthma.
• If you have a phaeochromocytoma (a tumour of the adrenal glands).
• If you have glaucoma (increased eye pressure, often associated with high blood pressure).
• If you are being treated with sympathomimetic medicines (such as decongestants, appetite suppressants, or amphetamine-like psycho-stimulants).
• If you have severe liver or kidney disease (severe hepatic insufficiency, severe renal insufficiency).
• If you have diabetes.
• If you have any thyroid disease (hyperthyroidism).
• If you have high blood pressure (hypertension), circulatory problems, or heart conditions.
• If you have glucose-6-phosphate dehydrogenase deficiency (an inherited condition causing a decrease in red blood cells).
• If you have severe haemolytic anaemia (abnormal breakdown of blood cells).
• Do not use this medicine in children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Pharmagrip congestion:

• If you are taking any other medicine (see also "Other medicines and Pharmagrip congestion").
• If you have an enlarged prostate.
• If you have vascular occlusive disease (blockage of arteries, e.g., Raynaud's syndrome).
• If you have kidney disease (renal insufficiency).
• If you have liver, heart, or lung diseases.
• If you have anaemia.

If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Do not take Pharmagrip congestion for more than 3 consecutive days without consulting your doctor.

While being treated with Pharmagrip congestion, you should not drink alcoholic beverages.

Do not take this medicine in combination with other medicines containing paracetamol. If paracetamol is taken at high doses, serious adverse reactions may occur, including severe liver disease and changes in the kidneys and blood.

Children and adolescents

Children under 12 years of age must not take this medicine.

Other medicines and Pharmagrip congestion

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose of some of them, separate administration by at least 15 days, or discontinue treatment:

• Medicines that may alter liver function, such as isoniazid, which may increase the harmful effect of paracetamol on the liver.
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for tuberculosis (isoniazid, rifampicin).
• Medicines for seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.
• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics) and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others).
• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin), as high-dose paracetamol may increase the risk of bleeding.
• Medicines used to prevent nausea and vomiting (metoclopramide and domperidone), which may increase the rate of paracetamol absorption.
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines containing beta-blockers, used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias) (propranolol) (see also section "Do not take Pharmagrip congestion").
• Medicines to lower blood cholesterol levels (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other conditions that are monoamine oxidase inhibitors (MAOIs). Administration of Pharmagrip congestion should be separated by at least 15 days after stopping treatment (see also section "Do not take Pharmagrip congestion").
• Medicines used to treat migraine, such as ergotamine and methysergide; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking medicines).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or arterial diseases).
• Medicines for depression containing tricyclic and tetracyclic antidepressants.
• General anaesthetic medicines.
• Antihypertensives (medicines to lower blood pressure).
• Medicines for the heart such as cardiac glycosides (digoxin) and antiarrhythmics.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart conditions and digestive disorders such as atropine sulphate.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disturbance (called metabolic acidosis with high anion gap), which must be treated urgently (see section 2).

Interference with laboratory tests

If you are due to have any laboratory tests (including blood and urine tests), inform your doctor that you are taking/using this medicine, as it may alter test results.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine is not recommended during pregnancy and breastfeeding.

Driving and using machines

Pharmagrip congestion does not affect your ability to drive or operate machinery. However, if you experience dizziness, you should not drive or operate machinery.

Pharmagrip congestion contains sorbitol (E-420), aspartame (E-951), and sodium:

This medicine contains 42 mg of sorbitol per sachet.

This medicine contains 25 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic condition in which phenylalanine accumulates because the body cannot eliminate it properly.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e., essentially "sodium-free".

3. How to take Pharmagrip congestion

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

Adults and children over 12 years of age: 1 sachet every 6–8 hours, up to a maximum of 3 sachets in 24 hours.

Patients with hepatic impairment: consult your doctor before taking this medicine.

These patients may only take 1 sachet every 8–12 hours as needed.

You must take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 3 sachets in 24 hours, divided into 3 doses.

Patients with renal impairment:

These patients must not take this medicine due to the paracetamol dose.

Elderly patients:

Elderly individuals should not use this medicine without consulting their doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the presence of phenylephrine and chlorpheniramine. They are also more likely to experience adverse effects such as sedation, confusion, hypotension, or excitation, and may be more sensitive to effects such as dry mouth and urinary retention.

Use in children

This medicine is contraindicated in children under 12 years of age.

Method of administration

Place the granules directly on the tongue and swallow. Pharmagrip congestion dissolves with saliva, allowing it to be used without water.

Alternatively, you may dissolve the contents of one sachet in a glass of hot (but not boiling) water, stirring with a spoon. If preferred, add cold water to cool it down and add sugar. Once prepared, drink the solution within a few minutes.

Duration of treatment

This medicine should be taken only as long as symptoms are present. Treatment should be discontinued as symptoms subside.

This medicine should be used for a short period only.

Do not take it for more than 3 consecutive days without consulting your doctor.

Consult your doctor if symptoms persist or if you notice any change in their characteristics.

If you take more Pharmagrip congestion than you should

If you or someone else has taken more Pharmagrip congestion than recommended, or if you suspect a child has swallowed the contents of a sachet, go immediately to the nearest hospital or contact a doctor, even if you feel well. Bring this leaflet, any remaining sachets, and the packaging with you. In case of accidental high-dose ingestion, symptoms may include pallor, nausea, vomiting, loss of appetite (anorexia), abdominal pain, altered blood sugar levels (glucose metabolism abnormalities), and accumulation of acids in the body (metabolic acidosis).

In severe poisoning, hepatic failure may progress to brain damage (encephalopathy, cerebral edema), bleeding, low blood glucose (hypoglycemia), and death. Even in the absence of severe liver damage, acute kidney injury may occur, manifesting as kidney damage (acute tubular necrosis), blood in the urine (hematuria), and protein in the urine (proteinuria). Changes in heart rhythm (cardiac arrhythmia) and inflammation of the pancreas (pancreatitis) may also occur.

Other possible symptoms include irritability, headache (cephalalgia), and elevated blood pressure. In more severe cases, confusion, hallucinations, and seizures may occur. High doses of the medicine may cause short-lived watery diarrhea (osmotic diarrhea).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pharmagrip congestion

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking Pharmagrip congestión immediately and consult your doctor or go immediately to hospital if you experience any of the following adverse effects:

• Allergic reactions or hypersensitivity, anaphylactic shock (severe allergic reactions causing difficulty breathing or dizziness).
• Very rare cases of severe skin reactions have been reported: severe rash, skin peeling, or mouth ulcers (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).
• Respiratory problems (bronchospasm) in patients with hypersensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).

During the period of use of paracetamol and phenylephrine, the following adverse effects have been reported, although their frequency has not been accurately established:

• Adverse effects that may occur infrequently (rare) are:

  • Malaise
  • Drop in blood pressure (hypotension)
  • Myocardial infarction, ventricular arrhythmia (irregular heartbeat), and cerebral hemorrhage (at high doses or in sensitive patients).
  • Pulmonary edema (increased fluid volume in the lungs), usually at high doses or in susceptible individuals.
  • Abnormal liver function (elevated liver transaminases).

• Adverse effects that may occur very infrequently (very rare) are:

  • Kidney disorders, cloudy urine.
  • Liver disease (jaundice: yellowing of the skin or eyes).
  • Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, neutropenia, hemolytic anemia, thrombocytopenia), with symptoms such as unusual bleeding, sore throat, or fatigue;
  • Hypoglycemia (low blood sugar).
  • Hypersensitivity, including skin rash, angioedema (sudden swelling of the skin and mucous membranes).
  • Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or over prolonged periods.

-Adverse effects for which the frequency of occurrence is unknown:

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).
• Insomnia (difficulty sleeping), nervousness, anxiety, agitation, confusion, irritability.
• Tremor (trembling), dizziness, headache (at high doses and may be a symptom of hypertension).
• Increase in blood pressure (hypertension, usually with high doses and in sensitive patients), reduction in blood vessel diameter (peripheral vasoconstriction), coldness in the extremities (legs or arms).
• Very slow heart rate (severe bradycardia), reduction in blood vessel diameter (peripheral vasoconstriction), reduced cardiac performance particularly affecting elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, palpitations (with high doses).
• Flushing, feeling of faintness (hypotension).
• Increased blood sugar (hyperglycemia).
• Decreased potassium levels in blood, metabolic acidosis (metabolic disturbance).
• Pallor of the skin, piloerection (goosebumps), increased sweating.
• Breathing difficulty.
• Difficulty urinating (anuria, urinary retention), more likely to occur in individuals with bladder outflow obstruction, such as prostatic hypertrophy.

At high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pharmagrip congestion

Keep this medicine out of the sight and reach of children.

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

It is important to always keep the product information with you. Keep the carton and the package leaflet.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Pharmagrip congestion

The active substances are: paracetamol 600 mg and phenylephrine hydrochloride 10 mg (equivalent to 8.2 mg of phenylephrine).

The other components are: mannitol (E-421), Xylitab 200 (containing xylitol and sodium carboxymethylcellulose), lemon flavour (containing flavouring substances, corn maltodextrin and citric acid), sorbitol (E-420), ascorbic acid, citric acid, colloidal hydrated silica, aspartame (E-951) and sodium saccharin.

Appearance of the product and contents of the pack

Pharmagrip congestion is packed in sachets containing white or almost white granules.

Pharmagrip congestion is available in packs of 10 and 16 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain.

Manufacturer:

E-Pharma Trento S.p.A.

Via Provina 2,

38123 Trento (TN), Italy.

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain.

Date of the most recent revision of this leaflet: January 2025

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) at http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning the QR code included in the package leaflet and outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89542/P_89542.html

QR code to: https://cima.aemps.es/cima/dochtml/p/89542/P_89542.html