FULL CMI

SUDAFED^® Sinus + Pain Relief

Active ingredient(s): Paracetamol and Pseudoephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using SUDAFED Sinus + Pain Relief. 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 + Pain Relief.

Where to find information in this leaflet:

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

1. Why am I using SUDAFED Sinus + Pain Relief?

SUDAFED Sinus + Pain Relief contains the active ingredients Paracetamol and Pseudoephedrine hydrochloride. Paracetamol is an analgesic. It works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever. 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 + Pain Relief is used for the effective relief from sinus pain and congestion.

2. What should I know before I use SUDAFED Sinus + Pain Relief?

Warnings

Do not use SUDAFED Sinus + Pain Relief if:

• you are allergic to Paracetamol, 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 other products containing paracetamol
• 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
  - alcohol dependence
• 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 + Pain Relief 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 behavioural disorders
• phenylephrine, a medicine used to treat congestion
• appetite suppressants
• warfarin, a medicine used to prevent blood clots
• metoclopramide, a medicine used to control nausea and vomiting
• medicines used to treat epilepsy or fits
• chloramphenicol, an antibiotic used to treat ear and eye infections
• alcohol
• flucloxacillin, an antibiotic used to treat skin infections.

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 + Pain Relief.

4. How do I use SUDAFED Sinus + Pain Relief?

How much to take

• The recommended dose of SUDAFED Sinus + Pain Relief for adults and children over 12 years is 1 to 2 tablets, 3 to 4 times a day, as required.
• Follow the instructions provided with the medicine.
• Do not exceed 8 tablets in 24 hours.
• Do not exceed the recommended dosage.

When to take SUDAFED Sinus + Pain Relief

• SUDAFED Sinus + Pain Relief should be used 3 to 4 times a day, as required.

How to take SUDAFED Sinus + Pain Relief

• Swallow the tablets whole.
• Do not use for more than a few 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 + Pain Relief

If you think that you have used too much SUDAFED Sinus + Pain Relief, 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 + Pain Relief?

Things you should do

Stop use an 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 + Pain Relief.

Things you should not do

• Do not take SUDAFED Sinus + Pain Relief 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 + Pain Relief affects you.

SUDAFED Sinus + Pain Relief 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

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 + Pain Relief contains

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

What SUDAFED Sinus + Pain Relief looks like

Sudafed Sinus + Pain Relief is a white, round, flat tablet coded “P3F”. (Aust R 63230).

Who distributes SUDAFED Sinus + Pain Relief

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

This leaflet was prepared in January 2022.

Published by MIMS June 2022

1 Name of Medicine

Paracetamol, pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Sudafed Sinus + Pain Relief tablets contain pseudoephedrine hydrochloride 30 mg and paracetamol 500 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sudafed Sinus + Pain Relief tablets are white, flat, round and uncoated. They are scored and coded 'P3F' on one face, and the other face is plain.

4 Clinical Particulars

4.1 Therapeutic Indications

Sudafed Sinus + Pain Relief provides effective relief from sinus pain and congestion.

4.2 Dose and Method of Administration

The recommended dosage of Sudafed Sinus + Pain Relief for adults and children 12 years and over is 1 to 2 tablets 3 to 4 times a day. Do not exceed 8 tablets in 24 hours.
Sudafed Sinus + Pain Relief should not be taken by children under 12 years of age without medical advice.

Use in adults.

Use in children.

4.3 Contraindications

Pseudoephedrine is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or 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.
Paracetamol is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol (or any of the other ingredients in the product).
Discontinue use and see a doctor at the first sign of a skin rash or any other sign of hypersensitivity.
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 or thyroid disease, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy, severe hepatic or renal dysfunction.
Some cases of ischaemic colitis have been reported with pseudoephedrine.
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.
Paracetamol should be used with caution in patients with impaired hepatic function, impaired renal function, chronic alcoholism.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

Use in hepatic impairment.

Use in renal impairment.

Use in elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions with the 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.
The following interactions with the paracetamol have been noted:
anticoagulant drugs (warfarin) - dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time;
paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide;
paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties and narcotic analgesics;
paracetamol may increase chloramphenicol concentrations;
the risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as alcohol and anticonvulsant agents;
paracetamol excretion may be affected and plasma concentrations altered when given with probenecid;
colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol;
high anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) has been reported with concomitant use of therapeutic doses of paracetamol and flucloxacillin. Patients reported to be most at risk are elderly females with underlying disease such as sepsis, renal function abnormality, and malnutrition.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No data available.

4.8 Adverse Effects (Undesirable Effects)

Children and the elderly are more likely to experience adverse effects than other age groups.
The safety of pseudoephedrine, paracetamol from clinical trial data is based on data from a randomized, placebo-controlled multi-dose clinical trial in the management of symptoms attributed to the paranasal sinus associated with the common cold.
Table 1 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. A dash represents an incidence of less than 1%.
The following additional adverse events were reported by ≥ 1% of subjects in randomized, placebo-controlled trials with single ingredient pseudoephedrine: dry mouth, nausea, dizziness, and insomnia.
Adverse drug reactions identified during postmarketing experience with paracetamol, pseudoephedrine HCl or the combination appear in Table 2 The frequency category was estimated from spontaneous reporting rates according to the following convention: Very common 1/10; common 1/100 and < 1/10; uncommon 1/1,000 and < 1/100; rare 1/10,000 and < 1/1,000; very rare < 1/10,000; not known (cannot be estimated from the available data).

Reporting suspected adverse effects.

4.9 Overdose

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand call 0800 764 766) for advice, or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage, and rarely, acute renal tubular necrosis.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione; however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sudafed Sinus + Pain Relief tablets contain the excipients: microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, sodium starch glycollate, pregelatinised wheat starch, stearic acid.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 30°C. Keep in a dry, dark place.

6.5 Nature and Contents of Container

Sudafed Sinus + Pain Relief tablets are available in blister packs of the following sizes:
4 tablets (S3) Pharmacist Only Medicine;
24 tablets^# (S3) Pharmacist Only Medicine;
^# Marketed.

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.

Paracetamol.

Pseudoephedrine hydrochloride.

7 Medicine Schedule (Poisons Standard)

Schedule 3.

Summary Table of Changes