Leaflet: information for the user

Grippostad with paracetamol/cafeína hard capsules

Paracetamol/ cafeína/ hydrochloride of phenylephrine

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 3 days of treatment.

1. What isGrippostad with paracetamol/cafeínaand what it is used for

2. What you need to know before starting to takeGrippostad with paracetamol/cafeína

3. How to takeGrippostad with paracetamol/cafeína

4. Possible side effects

5. Storage ofGrippostad with paracetamol/cafeína

6. Contents of the pack and additional information

Grippostad with paracetamol/cafeína contains three active principles that help to treat symptoms:

• Paracetamol, which is analgesic (relieves pain) and antipyretic (reduces fever).
• Fenilefrina, which is a substance from the sympathomimetic group. It acts as a decongestant by unblocking nasal passages. This helps to breathe more easily.
• Cafeína, which acts by helping the effectiveness of paracetamol.

Grippostad paracetamol/cafeína is indicated for symptomatic relief of colds and flu that are accompanied by fever, mild and moderate pain, sore throat, and nasal congestion.

This medication is indicated for treatment in adults and children aged 12 years and above.

Do not take Grippostad with paracetamol/caffeine

• If you areallergicto paracetamol, caffeine, phenylephrine hydrochloride or any of the other components of this medication (listed in section 6),
• If you have a rare genetic disorder known asglucose-6-phosphate dehydrogenase deficiency (G6PD). G6PD deficiency is an enzyme deficiency and can lead to anemia (a lack of red blood cells),
• If you have a tumor of the adrenal glandscalled pheochromocytoma. The adrenal glands are triangular in shape and are located at the top of the kidneys,
• If you havesevere kidney problems,
• If you havehigh blood pressure,
• If you havean overactive thyroid gland,
• If you havediabetes,
• If you haveheart disease,
• If you havehigh eye pressure (glaucoma),
• If you are taking any medication from the group ofbeta-blockers,
• If you are taking any medication for depression from the group oftricyclic antidepressants,
• If you are taking or have taken any medication for depression from the group ofmonoamine oxidase inhibitors (MAOIs)in the last two weeks.

Warnings and precautions

Consult your doctor or pharmacist before taking Grippostad with paracetamol/caffeine:

• If you haveprostate enlargement. Symptoms of prostate enlargement include difficulty urinating, painful urination or urinating more frequently.
• If you haveRaynaud's phenomenon(fingertip discoloration caused by a circulation deficit).
• If you haveheart or circulation problems.
• If you haveliver or kidney problems, including alcoholic liver disease.
• If you havelow body weight(less than 50 kg) or are malnourished.
• If you consume large amounts of alcohol regularly (alcoholism).
• If you suffer fromsevere dehydration.
• If you are taking medications thataffect your liver.
• If you are asenior citizen.
• If you haveglutathione deficiency(a metabolic disorder that can cause difficulties in paracetamol degradation).
• If you have an enzyme deficiency calledglucose-6-phosphate dehydrogenase deficiency.
• If you havehemolytic anemia(abnormal breakdown of red blood cells).

If you find yourself in any of the above situations, you may need to reduce the amount of Grippostad with paracetamol/caffeine you take or avoid taking this medication altogether.

You should not take Grippostad with paracetamol/caffeine if you are taking other sympathomimetic medications (stimulants or appetite suppressants and medications used to treat congestion and asthma).

You should not take a lot of caffeine (for example, coffee, tea, and some canned beverages) while taking Grippostad with paracetamol/caffeine.

Do not take other medications that contain paracetamol. Taking too much paracetamol can lead to severe liver problems that can even be fatal. You should be especially careful if you have any liver or kidney disease. The risk of overdose increases in alcoholics.

You should visit your doctor if:

• A high fever appears.
• Signs of another infection appear, such as feeling unwell, night sweats, fatigue, pain, or inflammation.
• The symptoms have not improved after three days.

During treatment with Grippostad with paracetamol/caffeine, report immediately to your doctor if:

If you have severe diseases, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing damage to organs), or if you are malnourished, have chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disorder called metabolic acidosis (a blood and fluid anomaly) 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. Symptoms of metabolic acidosis may include: severe respiratory difficulties with rapid and deep breathing, drowsiness, feeling unwell (nausea) and discomfort (vomiting).

Use of Grippostad with paracetamol/caffeine and other medications

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

The following medications may affect or be affected by Grippostad with paracetamol/caffeine.

You should not take Grippostad with paracetamol/caffeine with any of the following medications without first speaking with your doctor:

• Monoamine oxidase inhibitors (MAOIs), including moclobemide
• Sympathomimetic medications (stimulants or appetite suppressants and medications used to treat congestion and asthma)
• Beta-blockers and other anti-hypertensive medications (used to treat high blood pressure), including debrisoquine, guanethidine, reserpine, and methyldopa
• Tricyclic antidepressants, for example amitriptyline
• Cardiac glycosides (used to control heart rate or contractions), for example digoxin
• Ergot alkaloids (medications used to treat migraine), for example ergotamine and methysergide
• Anticoagulants (medications used to thin the blood, such as warfarin)
• Propantelina (used to treat gastrointestinal disturbances, enuresis, and excessive sweating (hyperhidrosis))
• Pentazocine and petidina (analgesics)
• Metoclopramide or domperidone (used to treat nausea and vomiting)
• Colestiramine (used to lower blood cholesterol levels)
• Carbamazepine, phenobarbital, phenytoin, and primidone (used to treat epilepsy)
• Rifampicin (antibiotic)
• St. John's Wort (used to treat depression)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (metabolic acidosis) that must be treated urgently (see section 2).

Do not take Grippostad with paracetamol/caffeine with other medications that contain paracetamol

Grippostad with paracetamol/caffeine and alcoholic beverages

Do not take alcoholic beverages(wine, beer,alcoholic drinks…) while taking this medication.

Pregnancy and breastfeeding

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

This medication is not recommended during pregnancy or breastfeeding.

Driving and operating machines

You should be careful when driving. Grippostad with paracetamol/caffeine may affect your ability to react, especially:

• At the beginning of treatment
• After increasing the dose
• When changing medication
• If you take alcohol

Do not operate any tools or machines, or drive if your reactions are affected.

Important information about some of the ingredients of Grippostad with paracetamol/caffeine

• Warning:

Grippostad with paracetamol/caffeine contains paracetamol and an active ingredient to reduce nasal congestion (decongestant). Do not take with other medications for cold or flu relief, or with other products that contain paracetamol.

Grippostad with paracetamol/caffeine contains sodium

This medication contains less than 1 ml of sodium (23 mg) per capsule, which is essentially sodium-free.

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

Always take the lowest effective dose for the shortest duration necessary to relieve your symptoms.

The recommended dose is:

Adults (including elderly patients):

Take 2 capsules up to 4 times a day if necessary. Do not take more than 8 capsules in 24 hours. Leave at least 4 hours between each dose.

Children between 12 and 18 years of age

Take 2 capsules up to 3 times a day if necessary. Do not take more than 6 capsules in 24 hours. Leave at least 4 hours between each dose.

Children under 12 years

This medication is contraindicated in children under 12 years.

Special populations

Adults and elderly patients with special conditions

Do not take more than 6 capsules a day in the following situations, unless your doctor tells you to:

• Body weight less than 50 kg
• Regular consumption of large amounts of alcohol (alcoholism)
• Dehydration
• Malnutrition

Use in renal or hepatic insufficiency

If you have been diagnosed with kidney or liver problems, consult your doctor or pharmacist. You may need to take a lower dose or increase the time between doses.

Do not take a higher dose than recommended without first talking to your doctor.

It is recommended to use Grippostad with paracetamol/cafeína during the day, as it contains caffeine, which can cause insomnia.

How to take Grippostad with paracetamol/cafeína

This medication is taken orally.

The capsules should be swallowed whole with water. Do not chew.

For how long should you take Grippostad with paracetamol/cafeína

If symptoms do not improve after three days, consult your doctor. Prolonged use, except under medical supervision, may be harmful.

You are at higher risk of overdose if:

• You have been taking any of the following medications for a continuous period:
• • Carbamazepine, phenobarbital, phenytoin, and primidone (used to treat epilepsy)
  • Rifampicin (antibiotic)
  • St. John's Wort (used in the treatment of depression)
• You regularly consume high doses of alcohol
• You have a deficiency of a protein called glutathione. This can be due to:
• • A disorder such as loss of appetite or weight loss (anorexia)
  • Malnutrition, or if you lose weight even when eating normally (weight loss called cachexia)
  • Cystic fibrosis (hereditary alteration that causes respiratory difficulties)
  • HIV infection (AIDS)

The symptoms of overdose in the first 24 hours are:

• Pallor
• Nausea
• Vomiting
• Loss of appetite (anorexia)
• Abdominal pain (dyspepsia)

Other symptoms are:

• Metabolic problems with glucose
• Elevated acid levels in the body (metabolic acidosis)

Severe overdose can be fatal and lead to:

• Liver failure
• Cerebral damage (encephalopathy)
• Bleeding (hemorrhage)
• Low blood sugar (hypoglycemia)
• Cerebral edema (inflammation)
• Renal insufficiency with lumbar pain (acute tubular necrosis)
• Blood in the urine (hematuria)
• Protein in the urine (proteinuria)
• Irregular heartbeat (arrhythmia)
• Pancreatitis (inflammation of the pancreas)
• Upper abdominal pain (epigastric pain)
• Vomiting
• Increased urine production (diuresis)
• Fast heart rate (tachycardia)
• Stimulation of the nervous system, including:
• • Difficulty sleeping (insomnia)
  • Anxiety (agitation)
  • Excitement
  • Restlessness and frustration
  • Uncontrolled tremors
  • Seizures
• Other effects similar to those described in section 4 "Possible adverse effects", of this leaflet.
• High blood pressure (hypertension)
• Slow heart rate (bradycardia)
• Confusion
• Seeing or feeling things that are not there (hallucinations)

If you forget to take Grippostad with paracetamol/cafeína

Do not double the dose to compensate for the missed capsules.

Make sure to take the next dose at least four hours after the previous dose.

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

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

If you experience any of the following side effects, stop taking the medicine and seek help quickly

• Allergic reactions:
• • Swelling of the skin, face, and lips, tongue, or throat (angioedema)
  • Difficulty breathing (dyspnea)
  • Sweating
  • Nausea
  • Decreased blood pressure (hypotension) leading to "shock"
  • Severe allergic reactions (anaphylaxis)

If you experience any of the following side effects, stop taking the medicine and talk to your doctor

• Allergic reactions on the skin (cutaneous hypersensitivity reactions) including:
• • Rashes
  • Stevens-Johnson syndrome (a severe skin disease with blistering of the skin, mouth, eyes, and genitals)
  • Toxic epidermal necrolysis (severe blistering and peeling of the skin)
• Allergic reactions, for example: rash, urticaria, skin inflammation (allergic dermatitis)
• Allergic reactions (hypersensitivity). If you have had a previous allergic reaction with another sympathomimetic medication (such as pseudoephedrine), you are more likely to have an allergic reaction (cross-sensitivity)

Very rare (may affect up to 1 in 10,000 patients):

• Very rare cases of severe skin reactions
• Liver problems (hepatic dysfunction)

Unknown (cannot be estimated with the available data):

• Decreased number of platelets (thrombocytopenia)
• Decreased number of white blood cells (leucopenia)
• Severe deficiency of white blood cells (agranulocytosis)
• Decreased number of red and white blood cells (pancytopenia)
• Fatigue
• Headache
• Dizziness
• Difficulty sleeping (insomnia)
• Anxiety
• Nervousness
• Irritability
• Restlessness
• Excitability
• Worsening of pre-existing narrow-angle glaucoma (see section 2, "Do not take Grippostad with paracetamol/caffeine")
• Dilated pupils (mydriasis)
• Sudden increase in eye pressure (acute angle-closure glaucoma)
• High blood pressure (hypertension)
• Palpitations
• Tachycardia
• Bronchospasm
• Dry mouth
• Nausea
• Vomiting
• Diarrhea
• Loss of appetite (anorexia)
• Kidney problems (renal dysfunction)
• Difficulty urinating (dysuria) or inability to urinate (urinary retention). This is more likely to occur if your bladder is blocked, for example if you have benign prostatic hyperplasia. See also section 2 "Warnings and precautions"
• A severe condition that can make the blood more acidic (metabolic acidosis), in patients with severe diseases who use paracetamol (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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after the letters «CAD». The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Grippostad with paracetamol/caffeine

The active principles are:

• Paracetamol
• Caffeine
• Hydrochloride of phenylephrine

Each capsule contains:

• 300 mg of paracetamol
• 25 mg of caffeine
• 5 mg of hydrochloride of phenylephrine

The other components are:

• Sodium lauryl sulfate
• Anhydrous colloidal silica
• Magnesium stearate

Other ingredients in the capsule coating:

• Gelatin
• Titanium dioxide (E 171)
• Yellow iron oxide (E 172)

Appearance of the product and contents of the package

Grippostad with paracetamol/caffeine are hard capsules of size 1 with a white body and a yellow cap. Filled with white to yellow powder.

Grippostad with paracetamol/caffeine is available in:

• OPA/Alu/PVC-glassine paper/Alu/PVC/PVAC blister
• PVC-PVDC / Aluminum blister

The blister is packaged in cardboard boxes.

Package size of 10, 12, 20, and 24 capsules.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18

67778 Bad Vilbel

Germany

Or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co.Tipperary

Ireland

This medicine is authorized in the Member States of the European Economic Area with the following names:

SpainGrippostad with paracetamol/caffeine hard capsules

IrelandParalief Cold & Flu hard capsules, Paracetamol 300 mg Caffeine 25 mg Phenylephrine hydrochloride 5 mg

RomaniaGrippostad Zi capsule

Last review date of this prospectus: December 2024

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