SERRAGRIP 650 mg / 10 mg / 4 mg ORAL SOLUTION POWDER

Introduction

Leaflet:information for the user

SERRAGRIP 650 mg/ 10 mg/ 4 mgpowder for oral solution

paracetamol / phenylephrine hydrochloride / chlorphenamine maleate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days or if the fever persists for more than 3 days.

Contents of the leaflet

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

1. What is Serragrip and what is it used for

Serragrip is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is a pain reliever that reduces pain and fever.

Chlorphenamine is an antihistamine that reduces nasal secretion.

Phenylephrine is a sympathomimetic that acts by reducing nasal congestion.

This medication is indicated for the symptomatic relief of catarrhal and flu-like processes that occur with fever, mild or moderate pain, and nasal congestion.

You should consult a doctor if your condition worsens or does not improve after 5 days and the fever after 3 days of treatment.

2. What you need to know before taking Serragrip

Do not take Serragrip:

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have any liver disease, thyroid disease (such as hyperthyroidism), or severe heart or artery disease (such as angina pectoris and severe coronary artery disease) or pheochromocytoma.
• If you are taking any antidepressant medication (monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants) or any antiparkinsonian medication (such as methyldopa). You should wait 15 days between taking these medications and Serragrip.
• Children under 12 years of age cannot take this medication.

Warnings and precautions

• Do not take more medication than recommended in section 3. How to take Serragrip
• You should avoid taking this medication simultaneously with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In chronic alcoholics, you should be cautious not to take more than 3 sachets per day (2 g/day) of paracetamol.
• In patients with kidney or lung disease, in patients with anemia, obstruction of the vesical neck, closed-angle glaucoma, prostate hypertrophy, urinary retention, high blood pressure (hypertension), and diabetes mellitus, you should consult your doctor before taking this medication, as taking it may worsen these diseases.
• Elderly patients should not take this medication, as they are more prone to experiencing side effects even at the usual dose for adults.

Paracetamol should be administered with caution in the following situations:

• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (may cause hemolytic anemia)

During treatment with Serragrip, inform your doctor immediately if:

• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Use in children

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

Use of Serragrip with other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

The chronic administration of paracetamol doses higher than 2 g/day along with medications for circulation (oral anticoagulants) may cause an increase in the effects of these medications.

Serragrip may interact with other medications or substances that act on the central nervous system, such as alcohol, antidepressants (especially MAOIs and tricyclics), barbiturates, and anesthetics.

It may also interact with digitalis medications (heart medications), zidovudine, anticholinergic medications, beta-blockers (such as propranolol), lamotrigine, and antiparkinsonian medications (such as methyldopa).

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion imbalance) that should be treated urgently (see section 2).

Interference with diagnostic tests

You should consult your doctor or pharmacist if you need to undergo a blood test, urine test, or skin tests that use allergens. It is recommended to suspend the medication at least 3 days before starting the tests and inform the doctor.

Taking Serragrip with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day) may cause liver damage.

Pregnancy and breastfeeding

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

Pregnancy

Taking medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

If necessary, Serragrip can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Women who are breastfeeding should not take this medication without consulting their doctor, as paracetamol and chlorphenamine pass into breast milk.

Driving and using machines

This medication can cause drowsiness and sedation, which may affect your reaction time.

You should avoid driving vehicles or operating hazardous machinery while the effects of this treatment last.

Serragrip contains sucrose

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

Patients with diabetes mellitus should note that this medication contains 3.994 g of sucrose per sachet.

3. How to take Serragrip

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

Serragrip sachets are administered orally.

The contents of the sachet should be taken dissolved completely in a little liquid, preferably in half a glass of water.

The recommended dose is:

• Adults and children over 12 years of age: 1 sachet (650 mg of paracetamol) every 6-8 hours. Do not take more than 4 sachets every 24 hours. Do not take more than 3 g of paracetamol every 24 hours (see "Warnings and precautions" section).

• Patient with kidney or liver failure: should consult their doctor (see section 2).

Always use the lowest effective dose.

Administration of the preparation is subject to the appearance of pain or fever. As they disappear, this medication should be discontinued.

Use in children

Do not administer to children under 12 years of age.

If you take more Serragrip than you should

You may experience dizziness, vomiting, loss of appetite, confusion, restlessness, excitability, yellowing of the skin and eyes (jaundice), and abdominal pain.

Due to paracetamol:

• Overdose can also cause: coagulation disorders (blood clots and bleeding).

In children, drowsiness and changes in gait may appear, signs that can help identify overdose.

If you have taken an overdose, you should go to a medical center immediately, even if you have no symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medication.

Patients taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount taken.

If you forget to take Serragrip

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The assessment of side effects is based on the following frequency table:

Common side effects:

• Due to the content of chlorphenamine, in sensitive patients, drowsiness may occur.
• Due to the content of phenylephrine, headache may occur.

Rare side effects:

• Due to the content of paracetamol, the following may occur:

Kidney effects, cloudy urine, allergic dermatitis, jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, thrombocytopenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or for prolonged periods.

• Due to the content of chlorphenamine, the following may occur:

Skin rashes, increased sensitivity of the skin to the sun, increased sweating, loss of appetite, drowsiness, dizziness, paradoxical reaction (nightmares, excitement, nervousness, more likely in children and elderly patients, in whom confusion is also more likely). Other side effects include anticholinergic effects (dry mouth, nose, and throat, blurred vision, urinary retention, constipation), especially at the beginning of treatment. Mental confusion and euphoria may also occur.

• Due to the content of phenylephrine, the following may occur:

Nervousness, insomnia, dizziness, headache, high blood pressure (hypertension).

If you observe these or any other adverse reaction not described above, consult your doctor or pharmacist.

Very rare side effects:

• Due to the content of paracetamol, very rare cases of severe skin reactions have been reported.

Side effects of unknown frequency:

• Due to the content of paracetamol, the following may occur:

A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting 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 Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Serragrip

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

No special storage conditions are required.

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

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Serragrip

• Each sachet contains as active ingredients: 650 mg of paracetamol, 10 mg of phenylephrine hydrochloride, and 4 mg of chlorphenamine maleate.
• The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, orange flavor.

Appearance of the product and package contents

Oral powder solution, white and orange-flavored.

It is presented in packages containing 10 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

LABORATORIOS SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer:

LABORATORIOS ALCALÁ FARMA, S.L.

Avda. de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last revision of this leaflet:February 2025

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