PSEUDOEPHEDRINE FARMALIDER 30 mg MEDICATED CHEWING GUMS

Introduction

Package Leaflet: Information for the User

PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews

Pseudoephedrine Hydrochloride

Read all of this leaflet carefully because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist for more than 5 days, or are accompanied by fever
• you should consult a doctor.
• If you consider that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet are Explained:

1. What PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews are and what they are used for
2. Before taking PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews
3. How to take PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews
4. Possible side effects
5. Storage of PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews
6. Additional information

1. What PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews are and what they are used for

Pseudoephedrine acts as a nasal decongestant.

It is indicated for the temporary relief of nasal congestion associated with rhinitis, common cold, and flu.

2. BEFORE TAKING PSEUDOEPHEDRINE FARMALIDER

Do not take PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews if:

• you are allergic (hypersensitive) to pseudoephedrine, to other nasal decongestants, or to any of the other components of this medicine
• you suffer from severe hypertension or severe heart or artery disease
• you have an inflammatory bowel disease that manifests with frequent diarrhea (ulcerative colitis)
• you are taking or have taken in the last two weeks antidepressant medications of the monoamine oxidase inhibitor type, as an increase in blood pressure may occur
• during the first trimester of pregnancy.
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.

Be careful with PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews

Sudden abdominal pain or rectal bleeding may occur with the use of PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews, due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews and contact your doctor or seek immediate medical attention. See section 4.

• if you take other products that contain nasal decongestants, you should not take this medicine.
• if diarrhea occurs during treatment, stop taking this medicine immediately and consult your doctor.
• you should discontinue treatment at least 24 hours before surgery.
• you should consult your doctor before taking this medicine if you have:

• diabetes cardiovascular disease
• a hormone-producing tumor of the adrenal gland that affects heart rate and blood pressure (pheochromocytoma)
• high eye pressure (glaucoma)
• enlarged prostate (prostatic hypertrophy)
• severe liver disease or disorder with reduced liver function
• moderate or severe kidney disease or disorder with reduced kidney function.

There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of pseudoephedrine-containing medications. PRES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using PSEUDOEPHEDRINE FARMALIDER immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").

Use of other medications

Tell your doctor or pharmacist if you are using, or have recently used, any other medication, including those obtained without a prescription.

In particular, if you are using any of the following medications or substances with pharmacological effects listed below, it may be necessary to modify the dose of one of them or interrupt treatment:

• urinary acidifiers (ammonium chloride)
• urinary alkalizers (sodium bicarbonate)
• inhalation anesthetics.
• antidepressants (tricyclic and monoamine oxidase inhibitors).
• certain medications to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine)
• citrates
• cocaine
• central nervous system stimulants (amphetamines, xanthines)
• digitalis glycosides (used for heart conditions)
• thyroid hormones (used for thyroid diseases)
• levodopa (used for Parkinson's disease treatment)
• linezolid (used as an antibacterial)
• selegiline (used for Parkinson's disease treatment)
• procarbazine (used to treat cancer)
• nitrates (used to treat angina pectoris)

it should not be used with other medications to relieve nasal congestion

Taking PSEUDOEPHEDRINE FARMALIDER with food and beverages

Food may delay the absorption of pseudoephedrine.

It should not be taken with stimulating beverages (coffee, tea, chocolate)

Use in children

Do not use this medication in children under 12 years of age.

Use in people over 65 years of age:

Older people are often more prone to its stimulating effects, so the dose may need to be reduced sometimes. Consult your doctor.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Do not use pseudoephedrine during the first trimester of pregnancy

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and using machines:

Although no effects are expected, you should avoid driving and using machines if you experience dizziness or drowsiness.

Important information about some of the components of PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews:

This medication contains aspartame (E-951) as an excipient. People with phenylketonuria should note that each medicinal chew contains 5.6 mg of phenylalanine.

3. HOW TO TAKE PSEUDOEPHEDRINE FARMALIDER:

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have doubts

The following administration schedule is recommended:

Over 12 years: 1 or 2 chews (30 or 60 mg of pseudoephedrine) every 6 hours, if necessary. The maximum daily dose is 8 chews (240 mg of pseudoephedrine).

Over 65 years: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.

Patients with kidney, liver, or heart disease: may require a dose reduction, so it is necessary to consult a doctor.

PSEUDOEPHEDRINE FARMALIDER is administered orally

Chew 1 or 2 chews together for at least 15 minutes. The chewing rate is the same as for any non-medicinal chewing gum.

If the medication is taken at night, it should be taken one hour before bedtime to reduce the possibility of insomnia in patients with sleep difficulties.

If symptoms worsen or persist for more than 5 days or are accompanied by fever, you should consult a doctor.

Do not exceed the recommended dose. Always use the lowest effective dose.

If you think the effect of PSEUDOEPHEDRINE FARMALIDER is too strong or too weak, tell your doctor or pharmacist.

If you take more PSEUDOEPHEDRINE FARMALIDER than you should:

If you have taken more PSEUDOEPHEDRINE FARMALIDER 30 mg Medicinal Chews than you should, consult your doctor or pharmacist immediately.

The symptoms of overdose include stimulation of the nervous system and heart: rapid breathing, excitement, nervousness, irritability, restlessness, tremors, convulsions, palpitations, increased blood pressure, alteration of heart rhythm (arrhythmias), difficulty urinating. In more severe cases, it can cause: decreased potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone: 91-5620420, indicating the medication and the amount ingested.

If you forget to take PSEUDOEPHEDRINE FARMALIDER

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

Restart treatment as indicated in the section HOW TO TAKE PSEUDOEPHEDRINE FARMALIDER

4. Possible side effects

Like all medications, PSEUDOEPHEDRINE FARMALIDER can have side effects, although not everyone gets them.

During the use of pseudoephedrine, the following side effects have been observed, whose frequency could not be established with precision:

• Severe diseases affecting the blood vessels of the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Heart disorders: alterations in heart rate (tachycardia, bradycardia, and arrhythmias), palpitations, difficulty breathing (dyspnea)
• Nervous system disorders: symptoms of excitement, sleep disorders, restlessness, dizziness, vertigo, headache, convulsions, and hallucinations
• Stomach or intestine disorders: nausea, vomiting, inflammation of the intestine with frequent diarrhea (ulcerative colitis). Inflammation of the colon due to insufficient blood irrigation (ischemic colitis).
• Kidney disorders: urine retention in men, pain or difficulty urinating
• Skin and subcutaneous tissue disorders: skin rashes with or without irritation, itching, skin inflammation (dermatitis)
• Eye disorders: involuntary closure of the eyelids (blepharospasm), fear of light, and tearing
• General disorders: tremors, paleness, weakness, and increased sweating.

Stop taking this medication immediately if convulsions or hallucinations occur.

Stop using PSEUDOEPHEDRINE FARMALIDER immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of PSEUDOEPHEDRINE FARMALIDER

Keep out of the reach and sight of children.

Do not store above 30°C. Store in the original package.

Expiration date

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

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of PSEUDOEPHEDRINE FARMALIDER

Each medicinal chew contains 30 mg of pseudoephedrine hydrochloride as the active ingredient.

The other components (excipients) are: xylitol, aspartame (E-951), potassium acesulfame, magnesium stearate, glycerol distearate type I, medium-chain triglycerides, amorphous silica, peppermint flavor, menthol flavor, cinnamon flavor, and gum base (gum base, sorbitol (E-420), isomaltose, silicon dioxide).

Appearance of the product and packaging content

PSEUDOEPHEDRINE FARMALIDER 30 mg are medicinal chews of circular shape, white-yellowish in color with green speckles. They come in packages of 12 and 24 chews.

Marketing Authorization Holder

Laboratorios Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Manufacturer:

SmithKline Beecham S.A.

Ctra. Ajalvir, Km 2,500.

28806 Alcalá de Henares. Madrid

Spain

This leaflet was approved in: June 2007

Date of the last revision of this leaflet: May 2024

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