Consumer medicine information

Sudafed Sinus and Nasal Decongestant Tablets

Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Sudafed Sinus and Nasal Decongestant

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sudafed Sinus and Nasal Decongestant Tablets.

FULL CMI

SUDAFED Sinus and Nasal Decongestant

Active ingredient: Pseudoephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sudafed Sinus and Nasal Decongestant. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sudafed Sinus and Nasal Decongestant.

Where to find information in this leaflet:

1. Why am I using Sudafed Sinus and Nasal Decongestant?
2. What should I know before I use Sudafed Sinus and Nasal Decongestant?
3. What if I am taking other medicines?
4. How do I use Sudafed Sinus and Nasal Decongestant?
5. What should I know while using Sudafed Sinus and Nasal Decongestant?
6. Are there any side effects?
7. Product details

1. Why am I using Sudafed Sinus and Nasal Decongestant?

Sudafed Sinus and Nasal Decongestant contains the active ingredient Pseudoephedrine hydrochloride. Pseudoephedrine hydrochloride belongs to a group of medicines called sympathomimetic decongestants. It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, and making it easier to breathe.

Sudafed Sinus and Nasal Decongestant is used for the symptomatic relief of sinus and nasal congestion due to allergic (seasonal) rhinitis, vasomotor (perennial) rhinitis, sinusitis, the common cold and flu.

2. What should I know before I use Sudafed Sinus and Nasal Decongestant?

Warnings

Do not use Sudafed Sinus and Nasal Decongestant if:

  • you are allergic to Pseudoephedrine hydrochloride or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • you are younger than 12 years
  • have very high blood pressure
  • have severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
  • have taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days.

Check with your doctor or pharmacist if you:

  • have any other medical conditions
    - high blood pressure
    - overactive thyroid gland
    - diabetes
    - heart disease and poor blood flow in the blood vessels of the heart
    - glaucoma (high pressure in the eyes)
    - prostate problems
    - liver or kidney disease
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Small amounts of pseudoephedrine pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Sudafed Sinus and Nasal Decongestant and affect how it works.

These include

  • medicines used to treat depression especially monoamine oxidase inhibitors and tricyclic antidepressants
  • medicines used to treat heart conditions
  • medicines used to treat high blood pressure
  • medicines used to treat urinary tract infections and bladder problems
  • medicines used to treat behavioral disorders
  • phenylephrine, a medicine used to treat congestion
  • appetite suppressants

You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sudafed Sinus and Nasal Decongestant.

4. How do I use Sudafed Sinus and Nasal Decongestant?

How much to take

  • The recommended dose of Sudafed Sinus and Nasal Decongestant for adults and children over 12 years is
    1 tablet 3-4 times a day, as necessary.
  • Follow the instructions provided with the medicine.
  • Do not exceed 4 day tablets in 24 hours.
  • Do not exceed the recommended dosage.

When to take Sudafed Sinus and Nasal Decongestant

  • Sudafed Sinus and Nasal Decongestant should be taken 3-4 times a day, as necessary.

How to take Sudafed Sinus and Nasal Decongestant

  • Swallow the tablets whole.
  • Do not use for more than 7 days at a time except on medical advice.
  • Follow all directions given to you by your pharmacist or doctor carefully. This may differ from the information contained in this leaflet.
  • If you forget to take it and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, you may take a dose as soon as you remember if you think you need it. Do not take a double dose to make up for the dose that you missed.
  • If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.

If you use too much Sudafed Sinus and Nasal Decongestant

If you think that you have used too much Sudafed Sinus and Nasal Decongestant, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Sudafed Sinus and Nasal Decongestant?

Things you should do

Stop use and talk to your doctor or pharmacist if your symptoms persist, worsen, or if new symptoms occur. Your doctor or pharmacist will assess your condition and decide if you should continue to take the medicine.

Remind any doctor, dentist or pharmacist you visit that you are using Sudafed Sinus and Nasal Decongestant.

Things you should not do

  • Do not take Sudafed Sinus and Nasal Decongestant to treat any other complaints unless your pharmacist or doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sudafed Sinus and Nasal Decongestant affects you.

Sudafed Sinus and Nasal Decongestant may cause dizziness in some people.

If this happens, do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take.
  • Keep your medicine in a cool dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effectsWhat to do
  • headache
  • drowsiness
  • dizziness
  • difficulty sleeping
  • nervousness
  • excitability
  • feeling of extreme happiness
  • restlessness
  • fear or anxiety
  • change in heart rate
  • rapid or irregular heart beat
  • raised blood pressure
  • tremor
  • headache
  • hallucinations
  • dry mouth
  • nausea
  • vomiting
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • urine retention
  • pain when passing urine
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, or other parts of the body
  • rash, itching or hives on the skin
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people. Children and people over 65 years if age may have an increased chance of getting side effects.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What Sudafed Sinus and Nasal Decongestant contains

Active ingredient
(main ingredient)		Pseudoephedrine hydrochloride
Other ingredients
(inactive ingredients)		Lactose monohydrate
Magnesium stearate
Maize starch
Povidone

Do not take this medicine if you are allergic to any of these ingredients.

What Sudafed Sinus and Nasal Decongestant looks like

White, biconvex round tablet, embossed with 'S7A' and scored on the upper face. Bottom face plain.

(Aust R 11003).

Who distributes Sudafed Sinus and Nasal Decongestant

Johnson & Johnson Pacific
45 Jones Street
Ultimo NSW 2007
Australia
Phone: 1800 029979

This leaflet was prepared in May 2022.

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Sudafed Sinus and Nasal Decongestant

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

1 Name of Medicine

Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Sudafed Sinus and Nasal Decongestant tablets contain pseudoephedrine hydrochloride 60 mg.
Sudafed Sinus and Nasal Decongestant also contains lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sudafed Sinus and Nasal Decongestant tablets are white, biconvex, round and uncoated. They are embossed with 'S7A' and scored on the upper face, and the bottom face is plain.

4 Clinical Particulars

4.1 Therapeutic Indications

Sudafed Sinus and Nasal Decongestant provides symptomatic relief of sinus and nasal congestion due to allergic (seasonal) rhinitis, vasomotor (perennial) rhinitis, sinusitis, the common cold and flu.

4.2 Dose and Method of Administration

The recommended dose of Sudafed Sinus and Nasal Decongestant for adults and children 12 years and over is 1 tablet 3 to 4 times a day.
Sudafed Sinus and Nasal Decongestant should not be used for children under 12 years.
No more than 4 tablets should be taken in 24 hours.
Sudafed Sinus and Nasal Decongestant should not be used for more than 7 days except on medical advice.

4.3 Contraindications

Pseudoephedrine is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine;
with known hypersensitivity or idiosyncratic reaction to any of the other ingredients in the product;
with severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Pseudoephedrine should be used with caution in patients with: hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy.
Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
If signs and symptoms such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with pseudoephedrine should be discontinued and a physician should be consulted.

Use in hepatic impairment.

Pseudoephedrine should be used with caution in patients with severe hepatic dysfunction.

Use in renal impairment.

Pseudoephedrine should be used with caution in patients with severe renal dysfunction.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with pseudoephedrine have been noted.
Antidepressant medication e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) - may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers - may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.
Pseudoephedrine should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
 Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours. Therefore, pseudoephedrine is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse effects include:
cardiovascular stimulation - elevated blood pressure, palpitations, tachycardia or arrhythmias;
CNS stimulation - headache, restlessness, feeling jittery, insomnia, anxiety, euphoric mood, tremor and (rarely) hallucinations;
psychomotor hyperactivity (in the paediatric population);
skin rashes, dysuria and urinary retention;
hypersensitivity.
Children and the elderly are more likely to experience adverse effects than other age groups.

Post-marketing data.

Additional adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1. The frequencies are provided according to the following convention:
Very common: ≥ 1/10; Common: ≥ 1/100, < 1/10; Uncommon ≥ 1/1,000, < 1/100; Rare: ≥ 1/10,000, < 1/1,000; Very rare < 1/10,000.
In Table 1, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported Company AEs under given PT or medical concept and the denominator represents exposure data calculated from sales data.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia). In New Zealand call 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pseudoephedrine has direct- and indirect-sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.
Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

Clinical trials.

The safety of pseudoephedrine from clinical trial data is based on data from 6 randomized, placebo-controlled single dose clinical trials and 6 randomized, placebo-controlled multiple dose clinical trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/ infection after a natural cold.
Table 2 includes adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.

5.2 Pharmacokinetic Properties

Absorption.

Pseudoephedrine is readily absorbed from the gastrointestinal tract.

Distribution.

Small amounts are distributed into breast milk.

Metabolism.

It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine.

Excretion.

It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sudafed Sinus and Nasal Decongestant contains lactose, magnesium stearate, povidone, maize starch.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Keep dry.

6.5 Nature and Contents of Container

Sudafed Sinus and Nasal Decongestant blister packs (PVC/PVDC) come in the following sizes: 4 tablets; 12 tablets#.
#Marketed.
AUST R 11003.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

CAS Registry Number: 345-78-8.

7 Medicine Schedule (Poisons Standard)

S3.

Summary Table of Changes