Label:information for the user

SERRAGRIP 650 mg/ 10 mg/ 4 mgoral powder for solution

paracetamol / hydrochloride of phenylephrine / maleate of chlorphenamine

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

- Keep this label, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

- You should consult a doctor if you worsen or do not improve after 5 days or if the fever persists for more than 3 days.

1. What is Serragrip and for what it is used

2. What you need to know before starting to take Serragrip

3. How to take Serragrip

4. Possible adverse effects

5. Conservation of Serragrip

6. Contents of the package and additional information

Serragrip is an association of paracetamol, chlorphenamine and phenylephrine.

Paracetamol is an analgesic 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 symptomatic relief of catarrhal and flu-like processes that are accompanied by fever, mild or moderate pain and nasal congestion.

You should consult a doctor if symptoms worsen or do not improve after 5 days and fever does not subside after 3 days of treatment.

Do not take Serragrip:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have any liver disease, or thyroid disease (such as hyperthyroidism), or any serious heart or artery disease (such as angina pectoris and severe coronary disease) or phaeochromocytoma.
• If you are taking any antidepressant (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 old cannot take this medication.

Warnings and precautions

• Do not take more medication than recommended in section 3. How to take Serragrip.
• Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In chronic alcoholics, be careful not to take more than 3 packets per day (2 g/day) of paracetamol.
• In patients with kidney disease, or lung disease, in patients with anemia, urethral obstruction, glaucoma of the closed angle, prostate hypertrophy, urinary retention, high blood pressure (hypertension) and diabetes mellitus, consult your doctor before taking this medication, as taking it may worsen these conditions.
• Older patients should not take this medication as they are more prone to adverse effects even at the usual adult dose.

Paracetamol should be administered with caution in the following situations:

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

During treatment with Serragrip, inform your doctor immediately 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 if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Use in children

This medication is contraindicated in children under 12 years old.

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 above 2 g/day together 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 severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with diagnostic tests

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

Taking Serragrip with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

The use of medications during pregnancy may be hazardous to the embryo or fetus, and should be monitored by your doctor.

In case of need, Serragrip may be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor, midwife if the pain or fever do not decrease or if you need to take the medication more frequently.

Breastfeeding

Women in the lactation period should not take this medication without consulting their doctor, as paracetamol and chlorphenamine pass into breast milk.

Driving and operating machinery

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

Avoid driving vehicles or operating hazardous machinery while the effects of this treatment last.

Serragrip contains saccharose

This medication contains saccharose.If your doctor has indicated 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 saccharose per tablet.

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.

Serragrip sachets are administered orally.

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

The recommended dose is:

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

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

Always use the lowest effective dose.

The administration of the preparation is subject to the appearance of pain or fever. As these disappear, this medication should be discontinued.

Use in children

Do not administer to children under 12 years.

If you take moreSerragrip than you should

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

Due to paracetamol:

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

In children, somnolence and alterations in gait may appear, which can help identify the overdose.

If an overdose has been ingested, you should go quickly to a medical center, even if there are no symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

If you forgot to take Serragrip

Do not take a double dose to compensate for the missed doses.

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

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

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

Common side effects:

• Due to the content ofchlorphenamine, in sensitive patients drowsiness may occur.
• Due to the content ofphenylephrine, headache may occur.

Rare side effects:

• Due to the content ofparacetamol, the following may occur:

Renal effects, cloudy urine, allergic dermatitis, jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia) and hypoglycemia (low blood sugar). Paracetamol may damage the liver when taken at high doses or for prolonged periods.

• Due to the content ofchlorphenamine, the following may occur:

Skin eruptions, increased skin sensitivity 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 to occur). Other side effects include anticholinergic effects (dry mouth, nose, and throat, blurred vision, urinary retention, constipation), especially at the beginning of treatment. Confusion and euphoria may also occur.

• Due to the content ofphenylephrine, the following may occur:

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

If you experience any of these or any other adverse reaction not listed above, consult your doctor or pharmacist.

Very rare side effects:

• Due to the content ofparacetamol,very rarely severe skin reactions have been reported.

Side effects of unknown frequency::

• Due to the content ofparacetamol, the following may occur:

A severe disease that may make the blood more acidic (metabolic acidosis) in patients with severe disease 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 Pharmacovigilance of Medicines for Human Use:https://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.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Serragrip

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

Appearance of the product and content of the packaging

Oral solution powder, white and with orange flavor.

It is presented in packaging containing 10 sachets.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

LABORATORIOS SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for the manufacture:

LABORATORIOS ALCALÁ FARMA, S.L.

Avda. de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last review of thisleaflet: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/).