TERMALGIN COLD 500 mg/30 mg ORAL SOLUTION POWDER

Introduction

Leaflet:information for the patient

Termalgin Cold 500 mg/30 mg powder for oral solution

For adults and adolescents from 15 years old

Paracetamol/Pseudoephedrine Hydrochloride

Read all of this leaflet carefullybefore you start taking thismedicine,because it contains important informationfor you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Contents of the leaflet

1. What Termalgin Cold is and what it is used for
2. What you need to know before taking Termalgin Cold
3. How to take Termalgin Cold
4. Possible side effects
5. Storage of Termalgin Cold
6. Package contents and additional information

1. What Termalgin Cold is and what it is used for

Termalgin Cold contains 2 active ingredients:

• Paracetamol is a pain reliever that reduces pain and fever.
• Pseudoephedrine hydrochloride is a nasal decongestant. It decongests the stuffed nose and helps to breathe more easily by reducing the inflammation of the nasal passages. It also relieves sinus pressure.

Termalgin Cold is indicated for the relief of symptoms of colds and flu that involve pain, fever, and nasal congestion in adults and adolescents from 15 years old.

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

If you only have one of the aforementioned symptoms, it would be more convenient to take a medicine that contains only one of the active ingredients.

2. What you need to know before taking Termalgin Cold

Do not take Termalgin Cold:

• if you are allergic to paracetamol, pseudoephedrine hydrochloride, menthol, or any of the other components of this medicine (listed in section 6);
• if you are allergic to peanuts or soy, as this medicine contains soy lecithin (E322);
• if you have kidney failure, unless your doctor indicates it;
• if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure;
• if you have a severe heart or artery disease such as coronary disease or high blood pressure (hypertension);
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have hyperthyroidism;
• if you have narrow-angle glaucoma (high eye pressure);
• if you have urinary retention;
• if you have pheochromocytoma (a type of tumor of the adrenal glands near the kidneys);
• if you are taking or have taken in the last 2 weeks monoamine oxidase inhibitors (medicines used to treat depression or Parkinson's disease);
• if you are taking tricyclic antidepressants;
• if you are taking beta-blockers (medicines used to treat high blood pressure or heart problems);
• if you are taking other sympathomimetic medicines such as decongestants, appetite suppressants, and psychostimulants like amphetamines;
• if you are taking certain antibiotics called furazolidone or linezolid;
• if you are in the first three months of pregnancy.

Warnings and precautions

Contains paracetamol.Do not administer with other medicines that contain paracetamol. Do not take more than the recommended dose, as it may cause severe liver damage.

There is a possibility that one of the active ingredients in Termalgin Cold, pseudoephedrine, may be abused. High doses of pseudoephedrine can be toxic. Continuous use may lead to tolerance and cause you to take more Termalgin Cold than the recommended dose to achieve the desired effect, which could increase the risk of overdose. Do not exceed the maximum recommended dose or treatment duration (see section 3).

Abdominal pain or rectal bleeding may occur with the use of Termalgin Cold due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Termalgin Cold and contact your doctor or seek medical attention immediately. See section 4.

Pseudoephedrine causes blood vessel constriction (vasoconstriction). This action may be associated with the onset of the following medical conditions. These conditions require immediate medical attention:

Acute Coronary Syndrome (ACS): This includes conditions such as a heart attack or unstable angina. Both are associated with a type of severe chest pain caused by the blockage of blood supply to parts of the heart. Sudden chest pain or discomfort (a feeling of pressure or tension) may spread from your chest to your arms, jaw, neck, back, or abdomen. You may also feel dizzy or faint, be sweating, or experience shortness of breath while at rest. Stop using Termalgin Cold immediately and seek immediate medical attention if you develop symptoms that may be signs of ACS.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medicines containing pseudoephedrine. PRES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using Termalgin Cold immediately and seek immediate medical attention if you present symptoms that may be signs of PRES or RCVS (to know the symptoms, see section 4 "Possible side effects").

Incorrect use, high doses, and long-term use of pain relievers may cause headaches that should not be treated with higher doses of pain relievers.

In general, the habitual administration of pain relievers, particularly combinations of several analgesic substances, may trigger permanent kidney damage with a risk of liver failure.

If you develop a generalized febrile rash associated with pustules, stop taking Termalgin Cold and contact your doctor or seek medical attention immediately. See section 4.

With Termalgin Cold, a reduction in blood flow to your optic nerve may occur. If you experience sudden vision loss, stop taking Termalgin Cold and contact your doctor or seek medical attention immediately. See section 4.

The abrupt discontinuation of pain relievers after long-term treatment, high doses, or incorrect use may trigger headaches, fatigue, muscle pain, nervousness, or autonomic symptoms. These withdrawal symptoms resolve in a few days. Until then, avoid any additional intake of pain relievers and do not restart treatment without medical advice.

It is recommended to suspend treatment at least 24 hours before undergoing surgery.

Do not take this medicine with other medicines indicated for the treatment of flu, cold, or congestion.

Do not consume alcoholic beverages while taking this medicine.

Consult your doctor or pharmacist before starting to take Termalgin Coldif:

• you have kidney problems;
• you have a severe infection, severe malnutrition, are severely underweight, or are a chronic consumer of alcohol in significant amounts, as this may increase the risk of metabolic acidosis.
• you have liver problems;
• you have diabetes;
• if you have prostate problems, as you may have urinary retention;
• if you have blood circulation problems (such as Raynaud's syndrome);
• if you have mild jaundice (Gilbert's syndrome);
• if you are dehydrated;
• if you have psychosis;
• if you are over 60 years old.

During treatment with TERMALGIN COLD, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

Do not administer this medicine to children and adolescents under 15 years old.

Elderly patients

These patients may be particularly sensitive to the effects of pseudoephedrine.

Warning related to doping control

Pseudoephedrine may induce positive analytical results in a doping test.

Taking Termalgin Coldwithother medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, in particular:

• monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease: if you are taking or have taken MAOIs during the last 14 days, do not use Termalgin Cold;
• tricyclic antidepressants used to treat depression;
• medicines used to treat high blood pressure (hypertension), such as beta-blockers;
• medicines used to treat heart failure or altered heart rhythm (digoxin and other cardiac glycosides);
• medicines to prevent blood clots (anticoagulants, such as warfarin and other coumarins);
• medicines to prevent nausea and vomiting, such as metoclopramide or domperidone;
• medicines to treat tuberculosis (rifampicin and isoniazid), bacterial infections (chloramphenicol, furazolidone, linezolid);
• medicines to treat seizures, such as lamotrigine, phenytoin, phenobarbital, and carbamazepine;
• cholestyramine, used to decrease cholesterol levels in the blood;
• zidovudine (AZT), used to treat HIV infections (AIDS);
• probenecid used in the treatment of gout;
• ergotamine and methysergide, used to treat migraines;
• medicines that contain paracetamol or decongestants for colds and flu;
• medicines used to treat fever or moderate pain (acetylsalicylic acid, salicylates);
• halogenated anesthetics used in pre-surgical anesthesia.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Tell your doctor that you are taking this medicine if you need to undergo blood glucose tests or urinalysis.

Taking Termalgin Coldwithfood, drinks, and alcohol

Do not consume alcoholic beverages while taking this medicine.

This medicine can be taken with or without food.

Pregnancyandbreastfeeding

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

Do not take this medicine if you are in the first three months of pregnancy.

It is not recommended to use this medicine during the last six months of pregnancy.

You should avoid using this medicine during breastfeeding.

Driving and using machines

This medicine may cause dizziness. If you feel dizzy while taking this medicine, avoid driving vehicles or using machines.

Termalgin Cold contains sucrose,Aspartame (E951),sodium, Allura Red AC (E-129), and Orange Yellow S

• This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 6.9 g of sucrose per sachet.

It may cause cavities.

• This medicine contains 38 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• This medicine contains 35 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 0.7% of the maximum recommended daily sodium intake for an adult.
• This medicine may cause allergic reactions because it contains Allura Red AC(E129) and Orange Yellow S(E110), azoic dyes.

It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Termalgin Cold

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 15 years old:

1 sachet every 4 to 6 hours, as needed. Do not take more than 4 sachets in 24 hours (corresponding to 2 g of paracetamol and 120 mg of pseudoephedrine). Do not take more frequently than every four hours. Use the smallest dose necessary to treat the symptoms and use the medicine for the shortest duration necessary.

Do not exceed the indicated dose.

Patient with liver disease

In patients with liver disease, the dose should be reduced or the intake interval increased. Consult your doctor before taking this medicine.

Use in children and adolescents

Do not administer to children under 15 years old.

How to take Termalgin Cold

Oral route.

Dissolve the contents of one sachet in a standard-sized cup (approximately 250 ml) containing hot water, without boiling. Drink when it cools to a temperature you consider acceptable.

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

If you take more Termalgin Cold than you should

If you accidentally took more Termalgin Cold than you should, seek medical attention (from a doctor) immediately, even if you feel well, due to the risk of severe delayed liver damage. The symptoms of overdose include irritability, restlessness, excitement, tremors, convulsions, palpitations, and difficulty urinating.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, Phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Termalgin Cold

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

If you forgot to take a dose, take it as soon as you remember, unless it is almost time for the next dose. Then, follow the treatment as recommended. Always leave an interval of at least 4 hours between two doses.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Possible Adverse Effects of Paracetamol:

Stop treatment with this medicine and consult your doctor or pharmacist immediately if you experience:

• allergic reactions, including shortness of breath, difficulty breathing, swelling of the face or mouth, lips, tongue, throat, or eyes;
• skin rash (including hives, itching), redness of the skin;
• skin peeling, blisters, sores, ulcers in the mouth;
• blood problems, including unusual bleeding or bruising.

The above side effects are rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people). In particular, severe skin reactions are very rare (may affect up to 1 in 10,000 people).

Other adverse effects may occur in rare cases (may affect up to 1 in 1,000 people). If you experience any of the following adverse effects, consult your doctor:

• liver problems (liver disorders). In rare cases, altered values of liver function test parameters may be observed;
• stomach pain or sudden discomfort (diarrhea, nausea, and vomiting) or blood in your stool;
• sudden and severe headache accompanied by nausea or vision changes.

Frequency not known (cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Possible Adverse Effects of Pseudoephedrine:

Frequency not known: cannot be estimated from available data

• serious diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Termalgin Resfriado immediately and seek urgent medical attention if you present symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• intense headache of sudden onset
• discomfort
• vomiting
• confusion
• seizures
• vision changes

Stop treatment with this medicine and consult your doctor or pharmacist immediately if you experience:

• high blood pressure, palpitations (rapid heartbeat);
• sleep disturbances, agitation, nervousness, irritability, confusion, perception of unreal things (hallucinations), especially in children;
• skin rash (including hives, itching), redness of the skin;
• difficulty urinating. This is more likely to occur in men with an enlarged prostate.

Other side effects may occur in rare cases (may affect up to 1 in 1,000 people). If you experience any of the following side effects, consult your doctor:

• dry mouth.

Frequency "not known"

• sudden onset of fever, skin redness, or many small blisters (possible symptoms of acute generalized exanthematous pustulosis - AGEP) that may occur within the first 2 days of treatment with Termalgin Resfriado. See section 2;
• inflammation of the colon due to insufficient blood supply (ischemic colitis);
• anxiety;
• headache, tremor
• reduced blood flow to the optic nerve (ischemic optic neuropathy).

Stop taking Termalgin Resfriado if these symptoms appear and contact your doctor or seek immediate medical attention. See section 2.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing information on the safety of this medicine.

5. Conservation of Termalgin Resfriado

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Termalgin Resfriado

The active ingredients are: paracetamol and pseudoephedrine hydrochloride.

Each sachet contains 500 mg of paracetamol and 30 mg of pseudoephedrine hydrochloride.

The other components (excipients) are: sucrose, aspartame (E951), blueberry flavor (contains soy lecithin), raspberry flavor (contains soy lecithin), redcurrant flavor (contains soy lecithin), menthol flavor (contains soy lecithin), green tea flavor (contains soy lecithin), anhydrous citric acid, sodium citrate (E331), sodium edetate, acesulfame potassium, maltodextrin, colloidal hydrated silica, orange yellow S (E110), Allura Red AC (E129), and brilliant blue FCF (E133).

Appearance of the Product and Package Contents

Termalgin Resfriado is a granulated powder for oral solution composed of a free-flowing white or off-white powder that may contain brown granules, packaged in individual sachets containing 9.2 grams of the medicine.

Termalgin Resfriado oral powder for solution is marketed in packages of 6, 8, 10, 12, and 14 sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor,

28046 Madrid, Spain

Manufacturer

Delpharm Orleans

5, avenue de Concyr

45071 Orleans cedex 2, France

Or

Haleon Germany GmbH

Barthstrasse, 4 - 80339

Munich (Germany)

This medicine is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus: February 2025

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