Prospecto:Information for the Patient

Termalgin Cold 500 mg/30 mg Powder for Oral Solution

For adults and adolescents 15 years of age and older

Paracetamol/Hydrochloride of Pseudoephedrine

Read this prospect carefully before starting to take thismedicine, because it contains important informationfor you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• Ifyou experience adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improveafter 3 days of treatment.

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

2. What you need to know before starting to take Termalgin Cold

3. How to take Termalgin Cold

4. Possible adverse effects

5. Storage of Termalgin Cold

6. Contents of the package and additional information

Termalgin Resfriado contains 2 active principles:

• paracetamol is an analgesic that reduces pain and fever.

• hydrochloride of pseudoephedrine is a nasal decongestant. It decongests a blocked nose and helps to breathe more easily by reducing nasal mucosa inflammation. It also relieves sinus pressure.

Termalgin Resfriado is indicated for the relief of symptoms of colds and flu that are accompanied by pain, fever, and nasal congestion in adults and adolescents 15 years of age and older.

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

If you only suffer from one of the mentioned symptoms, it would be more convenient to take a medication that contains only one of the active principles.

Do not take Termalgin Resfriado:

• if you are allergic to paracetamol, hydrochloride of pseudoephedrine, menthol, or any of the other components of this medication (listed in section 6);
• if you are allergic to peanuts or soy, as this medication contains soy lecithin (E322);
• if you have kidney failure, unless your doctor tells you to;
• if you have a severe, acute (sudden), or chronic (long-term) kidney disease, 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 closed-angle glaucoma (elevated intraocular pressure);
• if you have urinary retention;
• if you have a phaeochromocytoma (a type of adrenal gland tumor);
• if you are taking or have taken in the last 2 weeks monoamine oxidase inhibitors (medications used to treat depression or Parkinson's disease);
• if you are taking tricyclic antidepressants;
• if you are taking beta-blockers (medications used to treat hypertension or heart problems);
• if you are taking other sympathomimetic medications such as decongestants, appetite suppressants, and psychostimulants like amphetamine;
• 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 medications that contain paracetamol. Do not take more than the recommended dose, as it may cause severe liver damage.

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

Abdominal pain or rectal bleeding may occur with the use of Termalgin Resfriado, due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Termalgin Resfriado and seek medical attention immediately. See section 4.

Pseudoephedrine causes 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 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 radiate from your chest to your arms, jaw, neck, back, or abdomen. You may also feel dizzy or lightheaded, sweat, or experience shortness of breath while at rest. Stop using Termalgin Resfriado immediately and seek medical attention if you develop symptoms that may be signs of ACS.

Reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. RPLS and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Termalgin Resfriado immediately and seek medical attention if you present symptoms that may be signs of RPLS or RCVS (see section 4 "Possible side effects").

The incorrect use, high doses, and long-term use of analgesics may cause headaches that should not be treated with higher doses of analgesics.

General administration of analgesics, 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 Resfriado and seek medical attention immediately. See section 4.

Pseudoephedrine causes 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 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 radiate from your chest to your arms, jaw, neck, back, or abdomen. You may also feel dizzy or lightheaded, sweat, or experience shortness of breath while at rest. Stop using Termalgin Resfriado immediately and seek medical attention if you develop symptoms that may be signs of ACS.

Reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of medications containing pseudoephedrine. RPLS and RCVS are rare diseases that may involve a reduction in blood flow to the brain. Stop using Termalgin Resfriado immediately and seek medical attention if you present symptoms that may be signs of RPLS or RCVS (see section 4 "Possible side effects").

The discontinuation of analgesics after a long-term treatment, with high doses, or after 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 analgesics and do not restart treatment without medical advice.

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

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

Do not consume alcoholic beverages while using this medication.

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

• you have kidney problems;
• you have a severe infection, severe malnutrition, are severely underweight, or are a chronic alcohol consumer 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 circulation problems (such as Raynaud's syndrome);
• if you have mild jaundice (Gilbert's syndrome);
• if you have dehydration;
• if you have psychosis;
• if you are over 60 years old.

During treatment with TERMALGIN RESFRIADO, immediately inform your doctor 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). Metabolic acidosis, a severe disease, has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

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

Older 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 control.

Termalgin Resfriado with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, particularly:

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

Inform your doctor that you are taking this medication if you need to undergo glucose blood or urine tests.

Termalgin Resfriado with food, drinks, and alcohol

Do not consume alcoholic beverages while taking this medication.

This medication can be taken with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

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

You should avoid using this medication during lactation.

Driving and operating machines

This medication may cause dizziness. If you experience dizziness during treatment with this medication, avoid driving vehicles or operating machines.

Termalgin Resfriado contains saccharose, Aspartamo (E951), sodium, red allura (E-129), and yellow orange S

• This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 6.9 g of saccharose per dose.

This medication may cause tooth decay.

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

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

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

The recommended dose is:

Adults and adolescents 15 years and older:

1 tablet every 4 to 6 hours, as needed. Do not take more than 4 tablets 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 needed to treat symptoms and use the medication for the shortest period necessary.

Do not exceed the indicated dose.

Patients with liver disease

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

Use in children and adolescents

Do not administer in children under 15 years.

How to Take Termalgin Cold

Oral administration.

Dissolve the contents of one tablet in a standard-sized cup (approximately 250 ml) containing hot water, without boiling. Drink when it has cooled to a temperature considered 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. 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, Telephone 91 562 04 20, indicating themedicationand theamountused.

If you forget to take Termalgin Cold

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

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

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

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

Possible side effects of paracetamol:

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

• allergic reactions, including shortness of breath, difficulty breathing, facial or mouth swelling, lips, tongue, throat, or eyes;
• skin rash (including hives, itching), skin redness;
• skin peeling, blisters, mouth ulcers;
• 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 side effects may occur in rare occasions (may affect up to 1 in 1,000 people). If you experience any of the following side effects, consult your doctor:

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

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

Possible side effects of pseudoephedrine:

Unknown frequency: cannot be estimated from available data

- severe diseases affecting the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS)

Stop using Termalgin Resfriado immediately and seek urgent medical assistance if you experience symptoms that may be signs of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden and severe headache

• discomfort

• vomiting

• confusion

• convulsions

• vision changes

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

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

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

• dry mouth.

Unknown frequency

• sudden onset of fever, skin redness, or many small pustules (possible symptoms of generalized acute pustular psoriasis - GAPP) that may occur in 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
• reduction of 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication 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 above25°C.

Medicines should not be disposed of through drains or inthe trash. Askyour pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Termalgin Cold

The active principles are: paracetamol and hydrochloride of pseudoephedrine.

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

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

Appearance of the product and contents of the package

Termalgin Cold 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 Cold powder for oral 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.

C/ de Severo Ochoa, 2

28760 Tres Cantos, Madrid - Spain

Responsible for manufacturing

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:

Last review date of this leaflet: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.