SUDAFED 60 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Sudafed, 60 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Sudafed and what is it used for
4. Important information before taking Sudafed
   1. When not to take Sudafed:
   2. Warnings and precautions
   3. Stop taking Sudafed and contact your doctor or seek medical help immediately if you experience:
   4. Sudafed and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sudafed contains lactose
5. How to take Sudafed
   1. Dosage for adults and children over 12 years of age
   2. Dosage for elderly patients
   3. Dosage for patients with liver failure
   4. Dosage for patients with kidney failure
   5. Taking a higher dose of Sudafed than recommended
   6. Missing a dose of Sudafed
6. Possible side effects
   1. Common (less than 1 in 10 patients) side effects include:
   2. Very rare (less than 1 in 10,000 patients) side effects include:
   3. Frequency not known (frequency cannot be estimated from the available data)
   4. Reporting side effects
7. How to store Sudafed
8. Contents of the pack and other information
   1. What Sudafed contains
   2. What Sudafed looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Leaflet attached to the packaging: patient information

Sudafed, 60 mg, coated tablets

Pseudoephedrine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Sudafed and what is it used for
• 2. Important information before taking Sudafed
• 3. How to take Sudafed
• 4. Possible side effects
• 5. How to store Sudafed
• 6. Contents of the pack and other information

1. What is Sudafed and what is it used for

Sudafed reduces the swelling of the mucous membrane of the upper respiratory tract, especially the nasal mucosa and paranasal sinuses, leading to a reduction in swelling and discharge, and relief of nasal congestion.
Sudafed is used for symptomatic treatment of nasal and paranasal sinus mucosa inflammation (cold, runny nose) in the course of:

• common cold,
• flu,
• allergic nasal mucosa inflammation. The medicine is intended for adults and children over 12 years of age.

2. Important information before taking Sudafed

When not to take Sudafed:

• if you are allergic to pseudoephedrine or any of the other ingredients of this medicine (listed in section 6);
• if you have severe coronary artery disease;
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension;
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in depression). Concomitant use of Sudafed with these medicines may sometimes lead to increased blood pressure or hypertensive crisis.

if you are taking furazolidone. The antibacterial furazolidone has dose-dependent monoamine oxidase inhibiting properties. Although there are no reports of hypertensive crisis caused by concomitant administration of Sudafed and furazolidone, these medicines should not be used at the same time.

• if you are taking furazolidone. The antibacterial furazolidone has dose-dependent monoamine oxidase inhibiting properties. Although there are no reports of hypertensive crisis caused by concomitant administration of Sudafed and furazolidone, these medicines should not be used at the same time.

Warnings and precautions

Before starting to take Sudafed, discuss it with your doctor:

• if you have hypertension, heart disease,
• if you have diabetes, hyperthyroidism, increased intraocular pressure, or prostate enlargement,
• if you have liver or kidney function disorders.

Stop taking Sudafed and contact your doctor or seek medical help immediately if you experience:

• sudden abdominal pain, rectal bleeding, or other symptoms of developing colitis,
• fever with generalized skin redness and pustular rash (see section 4).

During treatment with Sudafed, a decrease in blood flow in the optic nerve may occur. If you experience sudden vision loss, stop taking Sudafed and contact your doctor or seek medical help immediately. See section 4.
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported. PRES and RCVS are rare conditions that can be associated with reduced blood flow to the brain.
If symptoms occur that may be symptoms of PRES or RCVS, stop taking Sudafed immediately and seek medical help immediately (symptoms, see section 4 "Possible side effects").
If after 3 days the symptoms do not improve, worsen, or new symptoms appear, stop taking the medicine and consult a doctor.
Avoid taking Sudafed and alcohol at the same time.

Sudafed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Sudafed with the following medicines:

• monoamine oxidase inhibitors (MAOIs) (medicines used, among others, in depression). Concomitant use of Sudafed with these medicines may sometimes lead to increased blood pressure or hypertensive crisis.
• furazolidone (an antibacterial medicine), which has dose-dependent monoamine oxidase inhibiting properties.

Before taking Sudafed, consult your doctor if you are taking:

• tricyclic antidepressants,
• medicines that reduce nasal congestion,
• appetite suppressants,
• psychotropic medicines with amphetamine-like effects,
• blood pressure lowering medicines, such as bretylium, betanidine, guanethidine, debrisoquine, methyldopa, and alpha- and beta-adrenergic receptor blockers. Sudafed may weaken the effect of these medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Sudafed may be used during pregnancy and breastfeeding only in cases where, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus or breastfed child.
In pregnant or breastfeeding women, the medicine should only be used after consulting a doctor.

Driving and using machines

It is not known whether the medicine affects the ability to drive or use machines.

Sudafed contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Sudafed

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The medicine is taken orally.

Dosage for adults and children over 12 years of age

One tablet 3 to 4 times a day, in children for a maximum of 4 days.

Dosage for elderly patients

No specific studies have been conducted on the effect of Sudafed in elderly patients. It is recommended to use the same dosage as for adults and to pay special attention to liver and kidney function (see below "Dosage for patients with liver failure" and "Dosage for patients with kidney failure").

Dosage for patients with liver failure

Caution should be exercised when taking the medicine in patients with severe liver function disorders.

Dosage for patients with kidney failure

Caution should be exercised when taking the medicine in patients with moderate kidney function disorders. In case of severe kidney function disorders, Sudafed should not be taken.

Taking a higher dose of Sudafed than recommended

Symptoms of overdose are: nausea, vomiting, insomnia, tremors, dilated pupils, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension, reflex bradycardia, arrhythmias, hypertensive crisis, intracranial hemorrhage, myocardial infarction, psychosis, muscle damage, low potassium levels in the blood, and intestinal ischemia. In case of overdose in children, drowsiness has been reported.
Keep out of reach of children. In case of overdose, seek medical help immediately. The doctor will take appropriate actions, such as supporting breathing and administering anticonvulsant medicines if necessary. In justified cases, gastric lavage and catheterization of the urinary bladder may be necessary. If the doctor considers it appropriate, pseudoephedrine elimination can be accelerated by administering urine acidifying medicines or by dialysis.

Missing a dose of Sudafed

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sudafed can cause side effects, although not everybody gets them.

Common (less than 1 in 10 patients) side effects include:

• dry mouth, nausea,
• dizziness,
• insomnia, nervousness.

Very rare (less than 1 in 10,000 patients) side effects include:

• arrhythmias, myocardial infarction, palpitations, tachycardia,
• allergic reactions,
• rash, itching, sudden onset of limited skin and/or mucous membrane edema, which can cause difficulty breathing or swallowing,
• increased blood pressure,
• stroke, headache, paresthesia, excessive psychomotor activity, drowsiness, tremors,
• anxiety, euphoria, hallucinations, visual hallucinations, restlessness,
• ischemic colitis (see section Warnings and precautions), vomiting,
• painful urination, urinary retention.

Frequency not known (frequency cannot be estimated from the available data)

• Severe conditions affecting the blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Stop taking Sudafed immediately and seek medical help immediately if symptoms of PRES or RCVS occur. These include:
• sudden severe headache,
• nausea,
• vomiting,
• confusion,
• seizures,
• vision changes.
• Decreased blood flow in the optic nerve (ischemic optic neuropathy).
• Sudden fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Sudafed. See section 2.

If such symptoms occur, stop taking Sudafed and contact your doctor or seek medical help immediately.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sudafed

Store the medicine below 30°C, protect from moisture.
Store the medicine out of sight and reach of children.
Do not use Sudafed after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sudafed contains

• The active substance is pseudoephedrine hydrochloride. One tablet contains 60 mg of pseudoephedrine hydrochloride.
• The other ingredients are: lactose, microcrystalline cellulose, maize starch, colloidal silica, magnesium stearate; the composition of the Opadry OY-S-9473 coating: red iron oxide, hypromellose, talc, macrogol 400.

What Sudafed looks like and contents of the pack

Sudafed is a round, biconvex, film-coated tablet with a brown-red color, with "SUDAFED" printed on one side.
The pack contains 1 blister pack of 12 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer

JNTL Consumer Health (France) SAS
Domaine de Maigremont
27100 Val de Reuil
France
For more information, contact:
email: [email protected]
Date of last revision of the leaflet:March 2024