GRIPPOSTAD WITH PARACETAMOL/CAFFEINE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Grippostad with Paracetamol/Caffeine Hard Capsules

Paracetamol/Caffeine/Phenylephrine Hydrochloride

Read all of 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 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, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days of treatment.

Contents of the Package Leaflet

1. What Grippostad with Paracetamol/Caffeine is and what it is used for
2. What you need to know before you take Grippostad with Paracetamol/Caffeine
3. How to take Grippostad with Paracetamol/Caffeine
4. Possible side effects
5. Storage of Grippostad with Paracetamol/Caffeine
6. Contents of the pack and further information

1. What Grippostad with Paracetamol/Caffeine is and what it is used for

Grippostad with Paracetamol/Caffeine contains three active ingredients that help treat symptoms:

• Paracetamol, which is an analgesic (relieves pain) and antipyretic (reduces fever).
• Phenylephrine, which is a substance from the group of sympathomimetics. It acts as a decongestant by unblocking nasal passages. This helps you breathe more easily.
• Caffeine, which helps increase the effectiveness of paracetamol.

Grippostad Paracetamol/Caffeine is indicated for the symptomatic relief of colds and flu that come with fever, mild and moderate pain, sore throat, and nasal congestion.

This medicine is indicated for treatment in adults and children from 12 years old.

2. What you need to know before you take Grippostad with Paracetamol/Caffeine

Do not take Grippostad with Paracetamol/Caffeine

• If you are allergicto paracetamol, caffeine, phenylephrine hydrochloride, or any of the other components of this medicine (listed in section 6),
• If you have a rare hereditary disease known as glucose-6-phosphate dehydrogenase deficiency (G6PD). G6PD deficiency is an enzyme deficiency and can lead to anemia (red blood cell deficiency),
• If you have an adrenal gland tumorcalled pheochromocytoma. The adrenal glands are triangular in shape and are located on top of the kidneys,
• If you have severe kidney problems,
• If you have high blood pressure,
• If you have an overactive thyroid gland,
• If you have diabetes,
• If you have heart disease,
• If you have high eye pressure (glaucoma),
• If you are taking any beta-blockermedication,
• If you are taking any tricyclic antidepressantmedication for depression,
• If you are taking or have taken any monoamine oxidase inhibitor (iMAO)medication for depression in the last two weeks.

Warnings and precautions

Consult your doctor or pharmacist before taking Grippostad with Paracetamol/Caffeine if:

• You have prostate enlargement. Symptoms of prostate enlargement include difficulty urinating, pain while urinating, or urinating more frequently.
• You have Raynaud's phenomenon(discoloration of the fingers caused by a lack of circulation).
• You have heart or circulation problems.
• You have liver or kidney problems, including alcoholic liver disease.
• You have low weight(less than 50 kg) or are malnourished.
• You regularly consume large amounts of alcohol (alcoholism).
• You suffer from severe dehydration.
• You are taking medications that affect your liver.
• You are an elderly patient.
• You have a glutathione deficiency(a metabolic disorder that can cause difficulties in paracetamol degradation).
• You have an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency.
• You have hemolytic 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 medicine 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 too much caffeine (e.g., coffee, tea, and some canned drinks) while taking Grippostad with Paracetamol/Caffeine.

Do not take other medications that contain paracetamol. Taking too much paracetamol can lead to serious liver problems that can 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 very high fever appears.
• Signs of another infection appear, such as feeling unwell, night sweats, fatigue, pain, or inflammation.
• Symptoms have not improved after three days.

During treatment with Grippostad with Paracetamol/Caffeine, inform your doctor immediately if:

If you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or if you 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 breathing difficulties with rapid and deep breathing, drowsiness, feeling unwell (nausea) and discomfort (vomiting).

Using Grippostad with Paracetamol/Caffeine and other medications

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

The following medications may affect or be affected by Grippostad with Paracetamol/Caffeine.

Do not take Grippostad with Paracetamol/Caffeine with any of the following medications without talking to your doctor first:

• Monoamine oxidase inhibitors (iMAO), including moclobemide
• Sympathomimetic medications (stimulants or appetite suppressants and medications used to treat nasal 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 migraines), for example, ergotamine and methysergide
• Anticoagulants (medications used to thin the blood, such as warfarin)
• Propantheline (used to treat gastrointestinal disorders, enuresis, and excessive sweating (hyperhidrosis))
• Pethidine and pentazocine (pain relievers)
• Metoclopramide or domperidone (used to treat nausea and vomiting)
• Colestyramine (used to lower blood cholesterol levels)
• Carbamazepine, phenobarbital, phenytoin, and primidone (used in the treatment of epilepsy)
• Rifampicin (antibiotic)
• St. John's Wort (used in the treatment of depression)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (called metabolic acidosis) that should 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 drink alcoholic beverages(wine, beer, alcoholic drinks...) while taking this medicine.

Pregnancy and breastfeeding

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

This medicine is not recommended during pregnancy or breastfeeding.

Driving and using machines

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

• At the start of treatment
• After increasing the dose
• When changing medication
• If you drink alcohol

Do not operate any tool or machinery, 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, flu, or nasal congestion relief, or with other products that contain paracetamol.

Grippostad with Paracetamol/Caffeine contains sodium

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

3. How to take Grippostad with Paracetamol/Caffeine

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.

Always take the lowest effective dose for the shortest necessary time 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 old

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 old

This medicine is contraindicated in children under 12 years old.

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 indicates otherwise:

• 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/Caffeine during the day, as it contains caffeine, which can cause insomnia.

How to take Grippostad with Paracetamol/Caffeine

This medicine is taken orally.

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

For how long should you take Grippostad with Paracetamol/Caffeine

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

You have a 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 dietary disorder such as lack or loss of appetite
  • Starvation, or if you lose weight even when eating normally (weight loss called cachexia).
  • Cystic fibrosis (a hereditary disorder that causes respiratory difficulties)
  • HIV infection (AIDS)

The symptoms of overdose in the first 24 hours are:

• Pallor
• Nausea
• Vomiting
• Lack of appetite (anorexia)
• Abdominal pain

Other symptoms are:

• Glucose metabolism problems
• High acid levels in the body (metabolic acidosis)

Severe overdose can be fatal and lead to:

• Liver failure
• Brain damage (encephalopathy)
• Bleeding (hemorrhage)
• Low blood sugar levels (hypoglycemia)
• Brain inflammation (cerebral edema)
• Kidney failure with back pain (acute tubular necrosis)
• Blood in the urine (hematuria)
• Protein in the urine (proteinuria)
• Irregular heartbeat (cardiac arrhythmia)
• Pancreas inflammation (pancreatitis)
• Pain in the upper abdomen (epigastric pain)
• Vomiting
• Increased urine production (diuresis)
• Rapid heartbeat (tachycardia)
• Nervous system stimulation, including:
• • Difficulty sleeping (insomnia)
  • Restlessness
  • Excitement
  • Anxiety (agitation)
  • Irritability and frustration
  • Uncontrolled tremors
  • Seizures
• Other similar effects described in section 4 "Possible side effects" of this leaflet.
• High blood pressure (hypertension)
• Slow heart rate (reflex bradycardia)
• Confusion
• Seeing or feeling things that are not there (hallucinations)

If you forget to take Grippostad with Paracetamol/Caffeine

Do not double the dose to make up for forgotten capsules.

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

If you have any questions 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.

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

• Allergic reactions:
• • Skin inflammation, face and lip swelling, tongue or throat swelling (angioedema)
  • Difficulty breathing (dyspnea)
  • Sweating
  • Nausea
  • Decreased blood pressure (hypotension) leading to "shock"
  • Severe allergic reactions (anaphylaxis)

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

• Allergic skin reactions (cutaneous hypersensitivity reactions) including:
• • Skin rashes
  • Stevens-Johnson syndrome (a severe skin disease with blistering of the skin, mouth, eyes, and genitals)
  • Toxic epidermal necrosis (severe skin blistering and peeling)
• Allergic reactions, for example: rash, hives, skin inflammation (allergic dermatitis)
• Allergic reactions (hypersensitivity). If you have previously had an allergic reaction to another sympathomimetic medicine (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 (liver dysfunction)

Unknown (cannot be estimated from the available data):

• Decrease in the number of blood cells called platelets or thrombocytes (thrombocytopenia)
• Decrease in the number of white blood cells called leukocytes (leukopenia)
• Severe deficiency of white blood cells (agranulocytosis)
• Decrease in the number of red and white blood cells (pancytopenia)
• Fatigue
• Headache
• Dizziness
• Difficulty sleeping (insomnia)
• Anxiety
• Nervousness
• Irritability
• Restlessness
• Excitability
• Worsening of elevated eye pressure (pre-existing narrow-angle glaucoma) (see section 2, "Do not take Grippostad with paracetamol/caffeine")
• Dilated pupils (mydriasis)
• Sudden increase in eye pressure (acute narrow-angle 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 prostate hypertrophy. See also section 2 "Warnings and precautions"
• A serious condition that can cause the blood to become more acidic (called metabolic acidosis), in patients with severe diseases using paracetamol (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 is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Grippostad with Paracetamol/Caffeine

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

Do not use this medicine after the expiration date stated on the packaging after the letters "CAD". The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Grippostad with Paracetamol/Caffeine

The active ingredients are:

• Paracetamol
• Caffeine
• Phenylephrine hydrochloride

Each capsule contains:

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

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 Package Contents

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 or
• PVC-PVDC/Aluminum blister

Blister packs are packaged in cardboard boxes.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

Manufacturer

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:

Spain Grippostad with paracetamol/caffeine hard capsules

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

Romania Grippostad Zi capsule

Date of the last revision of this prospectus: December 2024

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