Patient Information Leaflet

Sudafed, 60 mg, coated tablets
Pseudoephedrini hydrochloridum
Please read this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

What Sudafed is and what it is used for
What you should know before taking Sudafed
How to take Sudafed
Possible side effects
How to store Sudafed
Contents of the pack and other information

1. What Sudafed is and what it is used for

Sudafed reduces congestion of the mucous membranes of the upper respiratory tract, especially the nasal mucosa and paranasal sinuses, thereby reducing swelling and mucus secretion and helping to clear nasal passages.
Sudafed is used for symptomatic treatment of rhinitis and sinusitis (nasal congestion, stuffy nose) associated with:

the common cold,
influenza,
allergic rhinitis.

This medicine is intended for adults and children over 12 years of age.

2. Important information before using Sudafed

When not to use Sudafed:

if the patient is allergic to pseudoephedrine or to any of the other ingredients of this medicine (listed in section 6);
if the patient has severe coronary heart disease;
if the patient has very high blood pressure (severe hypertension) or hypertension that cannot be controlled with medication;
if the patient has severe acute or chronic kidney disease or renal failure;
if the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (medicines used e.g. for depression). Concomitant use of Sudafed with such medicines may sometimes lead to increased blood pressure or hypertensive crisis;
if the patient is taking furazolidone. The antibacterial agent furazolidone exhibits dose-dependent inhibition of monoamine oxidase activity. Although there have been no reports of hypertensive crisis due to concomitant use of Sudafed and furazolidone, these medicines should not be used together.

Warnings and precautions
Before starting Sudafed, discuss with your doctor:

if the patient has hypertension, heart disease,
if the patient has diabetes, hyperthyroidism, increased intraocular pressure, or benign prostatic hyperplasia,
if the patient has impaired liver function and/or kidney function.

The patient should stop taking Sudafed and immediately contact a doctor or
seek medical help if:

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

During treatment with Sudafed, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, the patient should stop taking Sudafed immediately and contact a doctor or seek medical help without delay. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, Sudafed should be discontinued immediately and medical help should be sought immediately (symptoms, see section 4 "Possible side effects").
If symptoms do not improve after 3 days, worsen, or new symptoms appear, the patient should stop taking the medicine and consult a doctor.
Concomitant use of Sudafed and alcohol should be avoided.

Sudafed with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Do not take Sudafed with the following medicines:

monoamine oxidase inhibitors (MAOIs) (medicines used e.g. for depression). Concomitant use of Sudafed with such medicines may sometimes lead to increased blood pressure or hypertensive crisis.
furazolidone (an antibacterial medicine) which exhibits dose-dependent inhibition of monoamine oxidase activity.

Consult a doctor before taking Sudafed if the patient is taking:

tricyclic antidepressants,
decongestants,
appetite suppressants,
psychotropic medicines with amphetamine-like effects,
antihypertensive medicines such as bretylium, betanidine, guanethidine, debrisoquin, methyldopa, and medicines blocking α- and β-adrenergic receptors. Sudafed may reduce the effectiveness of these medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Sudafed may be used during pregnancy and breastfeeding only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus or breastfed child.
In women who are pregnant or breastfeeding, the medicine should be used only after consultation with a doctor.

Driving and operating machinery
It is unknown whether the medicine affects the ability to drive or operate machinery.

Sudafed contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Sudafed

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Dosage for adults and children over 12 years of age
One tablet 3 to 4 times daily. In children, treatment should not exceed 4 days.
Dosage for elderly patients
No detailed studies on the effects of Sudafed in elderly patients have been conducted. It is recommended to use the adult dosage and pay special attention to kidney and liver function (see sections below: “Dosage in patients with hepatic impairment”, “Dosage in patients with renal impairment”).
Dosage in patients with hepatic impairment
Caution is advised when administering this medicine to patients with severe liver function disorders.
Dosage in patients with renal impairment
Caution is advised when administering this medicine to patients with moderate renal function disorders. Sudafed should not be used in patients with severe renal impairment.
Overdose of Sudafed
Symptoms of overdose include: nausea, vomiting, insomnia, tremor, pupil dilation, restlessness, excitement, hallucinations, seizures, palpitations, tachycardia (rapid heartbeat), hypertension, reflex bradycardia (slowed heart rate), cardiac arrhythmias, hypertensive crisis, intracranial hemorrhage, myocardial infarction, psychosis, muscle damage, hypokalemia (low blood potassium levels), and ischemic bowel infarction. In children, drowsiness has been reported in cases of overdose.
Keep out of reach of children. In case of overdose, seek immediate medical help. The doctor will take appropriate measures, such as respiratory support and administration of anticonvulsant medication if necessary. In justified cases, gastric lavage and urinary catheterization may be required. If deemed appropriate by the doctor, elimination of pseudoephedrine can be enhanced by administering urinary acidifying agents or by subjecting the patient to dialysis.
Missed dose of Sudafed
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (reported in up to 1 in 10 patients):

Dryness of the mouth, nausea,
Dizziness,
Insomnia, nervousness.

Very rare (reported in up to 1 in 10,000 patients):

Heart rhythm disorders, myocardial infarction, palpitations, tachycardia,
Allergic reactions,
Rash, itching, sudden onset of localized swelling of the skin and (or) mucous membranes which may cause difficulty in breathing or swallowing,
Increased blood pressure,
Stroke, headache, paraesthesia (unpleasant sensations, most commonly tingling, numbness or changes in skin temperature), excessive psychomotor activity, drowsiness, tremor,
Restlessness, euphoria, hallucinations, visual hallucinations, motor restlessness,
Ischaemic 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 blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Treatment with Sudafed should be stopped immediately and medical help should be sought immediately if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:
- sudden, severe headache,
- nausea,
- vomiting,
- confusion,
- seizures,
- visual disturbances.
Reduced blood flow in the optic nerve (ischaemic 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 any of these symptoms occur, treatment with Sudafed should be stopped and a doctor should be contacted or immediate medical help sought.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sudafed

The medicine should be stored at a temperature below 30°C and protected from moisture.
The medicine should be kept out of the 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 stated month.
Medicines must 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 packaging and other information

What Sudafed contains

The active substance is pseudoephedrine hydrochloride. One tablet contains 60 mg of pseudoephedrine hydrochloride.
Other ingredients are: lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal silicon dioxide, magnesium stearate; coating composition Opadry OY-S-9473: red iron oxide, hypromellose, talc, polyethylene glycol 400.

What Sudafed looks like and contents of the pack
Sudafed is a brownish-red, round, biconvex coated tablet with the inscription "SUDAFED" on one side.
Pack: 1 blister containing 12 tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Manufacturer
McNeil Healthcare (Ireland) Limited JNTL Consumer Health (France) SAS
Office 5, 6 & 7, Block 5 Domaine de Maigremont
High Street, Tallaght 27100 Val de Reuil
Dublin 24, D24 YK8N France
Ireland
For further information, please contact:
email: [email protected]