FULL CMI

Bisolvon^® Dry Pastilles

Active ingredient: Dextromethorphan hydrobromide monohydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Bisolvon Dry Pastilles.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 Bisolvon Dry Pastilles.

Where to find information in this leaflet:

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

1. Why am I using Bisolvon Dry Pastilles?

Bisolvon Dry Pastilles are used for the treatment of dry, irritating coughs.

Bisolvon Dry Pastilles contains the active ingredient dextromethorphan hydrobromide, a cough suppressant that acts on the cough centre in the brain to suppress a dry cough.

Bisolvon Dry Pastilles also helps soothe sore throats.

Bisolvon Dry Pastilles does not have any pain-relieving (analgesic) properties.

2. What should I know before I use Bisolvon Dry Pastilles?

Warnings

Do not use Bisolvon Dry Pastilles if:

You are allergic to dextromethorphan hydrobromide (active ingredient), or any of the ingredients listed at the end of this leaflet.

• Some of the symptoms of an allergic reaction may include:
  - 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
• Do not take Bisolvon Dry Pastilles if you have the following medical conditions:
  - asthma
  - a lung condition called chronic obstructive airways disease (COAD or COPD)
  - respiratory failure
  - pneumonia
  - shallow breathing (respiratory depression)
  - fructose intolerance
  - mastocytosis
• Do not take this medicine if you are taking, or have taken in the previous 14 days a monoamine oxidase inhibitor (MAOI) used to treat depression and Parkinson's disease.
• Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
• If it has expired or is damaged, return it to your pharmacist for disposal.
• If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

• Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
• Your doctor can discuss with you the risks and benefits involved.
• Tell your doctor or pharmacist if you have developed a chesty, mucus-producing (productive) cough.
• Tell your doctor if your irritant, dry cough has lasted for more than 5 days.
• This could be a symptom of a condition that requires treatment by your doctor.
• Tell your doctor or pharmacist if you have impaired liver or kidney function.
• Bisolvon Dry Pastilles should also be used with caution in patients with impaired liver or kidney function.
• If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Bisolvon Dry Pastilles.

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

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor can discuss with you the risks and benefits involved.

Do not take this medicine if you are breastfeeding, or intend to breastfeed.

The active ingredient in Bisolvon Dry Pastilles may pass into breast milk and there is a possibility that your baby may be affected.

Children

• Do not use Bisolvon Dry Pastilles in children under 6 years of age.
• Use in children 6 – 11 years only on the advice of a doctor, pharmacist or nurse practitioner.

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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Bisolvon Dry Pastilles.

Some medicines and Bisolvon Dry Pastilles may interfere with each other. These include:

• monoamine oxidase inhibitors (MAOIs), medicines used to treat depression
• medicines used to treat mental disorders, such as haloperidol
• medicines used to treat depression such as SSRI (selective serotonin reuptake inhibitors) used to treat depression and anxiety e.g. fluoxetine or paroxetine or tricyclic antidepressants e.g. clomipramine and imipramine
• medicines with a sedative or suppressant effect on the body
• medicines containing alcohol
• antiarrhythmics, medicines used to treat irregular heartbeats e.g. quinidine, amiodarone, flecainide
• berberine, an antioxidant medicine
• bupropion, a medicine used for smoking cessation
• cinacalcet, a medicine used to treat an over active thyroid
• terbinafine, a medicine used to treat fungal infections
• cimetidine, a medicine used to treat reflux and ulcers
• ritonavir, a medicine used to treat HIV infections

These medicines may be affected by Bisolvon Dry Pastilles or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

4. How do I use Bisolvon Dry Pastilles?

How much and when to take

The recommended doses for Bisolvon Dry Pastilles in adults and children are stated below:

Bisolvon Dry Pastilles should be taken according to the following dosage directions:

Children 6 – 11 years:

• Slowly suck 1 pastille every 4 to 6 hours when necessary.
• Do not exceed 6 pastilles in a 24 hour period.

Adults and children 12 years and over:

• Slowly suck 1 - 3 pastilles every 4 to 6 hours when necessary.

Do not exceed 12 pastilles in a 24 hour period.

Ask your doctor or pharmacist for more information if you have been advised to take a different dose.

Bisolvon Dry Pastilles starts to act within an hour after being taken and is effective for approximately 3-6 hours.

Serious adverse events, including neurological disorders, may occur in children in case of overdose.

Caregivers should not exceed the recommended dose.

How long to take it

If the cough persists for more than 5 days, seek medical advice before continuing to take this medicine. The active ingredient dextromethorphan has minor addictive potential.

If you forget to take it

If it is almost time for your next dose and you think you need it, skip the dose you missed and take your next dose.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect. Your next dose should be taken in 4 to 6 hours if you think you need it.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too many Bisolvon Dry Pastilles

If you think that you have used too many Bisolvon Dry Pastilles, 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.

Signs of an overdose with Bisolvon Dry Pastilles include:

• nausea
• vomiting
• impaired vision
• lack of muscle coordination
• dizziness/sleepiness
• inability to pass urine
• impaired consciousness
• shallow breathing
• hallucinations
• disorientation
• delusions
• confused/paranoid state
• fast heartbeat
• clumsiness and lack of coordination
• slurred speech
• uncontrollable muscle spasms affecting the eyes, head, neck and body
• visual disturbance
• convulsions

5. What should I know while using Bisolvon Dry Pastilles?

Avoid drinking alcohol while you are taking this medicine.

If you drink alcohol, dizziness or drowsiness may be worse.

Driving or using machines

Be careful driving or operating machinery until you know how Bisolvon Dry Pastilles affects you.

This medicine may cause dizziness or drowsiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Things you should do

If your symptoms persist, you should contact your doctor or pharmacist for further advice.

Your doctor or pharmacist will assess your condition and decide if you should continue to take Bisolvon Dry Pastilles or if a new treatment plan is needed.

Remind any doctor, dentist or pharmacist you visit that you are using Bisolvon Dry Pastilles.

Looking after your medicine

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

• Keep Bisolvon Dry Pastilles in a cool dry place, where the temperature stays below 25°C.

Store 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

Heat and dampness can destroy some medicines.

Keep Bisolvon Dry Pastilles where children cannot reach it.

A locked cupboard at least one-and-one-half metres above the ground is a good place to store medicines.

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?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Bisolvon Dry Pastilles.

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.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects from taking Bisolvon Dry Pastilles.

In general, side effects from Bisolvon Dry Pastilles are rare. The most common side effects include:

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell, during or after taking Bisolvon Dry Pastilles.

Other side effects not listed above may also occur in some people.

Cases of dextromethorphan abuse and dependency have been reported. Your doctor can provide you with more information about this.

Bisolvon Dry Pastilles contain 10.2 g of maltitol and 0.8 g of sorbitol per maximum adult daily dose of 12 pastilles. Products containing maltitol and sorbitol may have a laxative effect or cause diarrhoea.

This is more likely if several products containing maltitol, sorbitol or other related substances are consumed at the same time.

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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

Bisolvon Dry Pastilles is the brand name of your medicine.

What Bisolvon Dry Pastilles contains

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

What Bisolvon Dry Pastilles look like

Bisolvon Dry Pastilles is a yellow, round pastille with a honey lime flavour. It is available in blisters containing 20 pastilles enclosed in a carton.

Bisolvon Dry Pastilles are available from your local pharmacy without a prescription.

Who distributes Bisolvon Dry Pastilles

Bisolvon Dry Pastilles are supplied in Australia by:

Sanofi Consumer Healthcare,
87 Yarraman Place, Virginia,
Qld 4014 Australia.
Toll-free: 1800 818 806

Bisolvon Dry Pastilles are supplied in New Zealand by:

Sanofi-Aventis New Zealand Limited,
Auckland, New Zealand.
Toll-free: 0800 283 684.

Registration No AUST R 191459

Date of preparation: 25 March 2021

bisolvondrypas-ccds5-cmiv06-25mar2021

Published by MIMS May 2021

1 Name of Medicine

Dextromethorphan hydrobromide monohydrate.

2 Qualitative and Quantitative Composition

Each 5 mL of Bisolvon Dry Oral Liquid contains dextromethorphan hydrobromide monohydrate 10 mg.

Excipients with known effect.

Excipients with known effect.

3 Pharmaceutical Form

Bisolvon Dry Oral Liquid is a clear, colourless, syrupy liquid with an aroma of apricot and vanilla.
Bisolvon Dry Pastille is a yellow, round pastilles with a honey lime flavour.

4 Clinical Particulars

4.1 Therapeutic Indications

Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs. Bisolvon Dry Pastilles also helps soothe the throat.

4.2 Dose and Method of Administration

Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are preparations for oral administration.
The following dosage regimen is recommended:
In the case of self treatment, the maximum duration of treatment is 5 days.

Bisolvon Dry Oral Liquid.

Adults and children 12 years and over.

Children 6-11 years.

Bisolvon Dry Pastilles.

Adults and children 12 years and over.

Children 6 to 11 years.

4.3 Contraindications

Dextromethorphan is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to dextromethorphan (or any other ingredients in the product, see Section 4.8 Adverse Effects (Undesirable Effects) for effects of maltitol and sorbitol).
Patients with fructose intolerance should not take Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles.
Children below 6 years of age.
Patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks.
Bronchial asthma.
Chronic obstructive pulmonary disease.
Pneumonia.
Respiratory depression.
Respiratory insufficiency.
Breastfeeding.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Avoid drinking alcoholic beverages while using dextromethorphan. Dextromethorphan potentiates the inhibitory effect of alcohol on the central nervous system.
Dextromethorphan should not be used for chronic persistent cough accompanying a disease state, or for cough associated with excessive secretions.
In cases of productive cough with considerable mucus production (e.g. patients with conditions such as bronchiectasis, cystic fibrosis) or in patients with neurological illness associated with a markedly reduced cough reflex (such as stroke, Parkinson's disease and dementia) antitussive treatment should be administered with particular caution and only after careful benefit-risk assessment (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Dextromethorphan should not be given to patients with or at risk of developing respiratory failure, e.g. asthma, chronic obstructive airways disease and pneumonia. Caution is needed in patients with a history of asthma and it should not be given during an acute attack.
Dextromethorphan should be used with caution in patients receiving serotonergic drugs (other than MAO - inhibitors) such as selective serotonin re-uptake inhibitors (SSRI) e.g. fluoxetine, paroxetine or tricyclic antidepressives (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Due to potential histamine release dextromethorphan should be avoided in patients with the rare disease of mastocytosis. Dextromethorphan can activate mast cells resulting in possible histamine release with associated clinical manifestations.

Use in patients with hepatic or renal impairment.

CYP2D6 inhibitors.

Drug tolerance.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Dextromethorphan possesses weak serotonergic properties. Thereby dextromethorphan may increase the risk of serotonin toxicity (serotonin syndrome) particularly if taken with other serotonergic agents, such as MAO-inhibitors or SSRIs. Especially pre-treatment or concomitant treatment with drugs that impair metabolism of serotonin, such as antidepressants of the MAO inhibitor type, may result in the development of a serotonin syndrome (see Section 4.3 Contraindications, MAO-inhibitors; Section 4.4 Special Warnings and Precautions for Use).
Dextromethorphan should not be used in patients taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. The use of dextromethorphan with, or within two weeks of taking MAOIs, may increase the risk of serious side effects such as hypertensive crisis, hyperpyrexia and convulsions.
Dextromethorphan when used with SSRI's (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine) may result in a "serotonin syndrome" with changes in mental status (e.g. agitation, excitement, confusion), hypertension, restlessness, myoclonus, hyperreflexia, diaphoresis, shivering and tremor.
Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Serum levels of dextromethorphan may be increased to levels multifold higher than normal by the concomitant use of potent inhibitors of cytochrome P450 2D6, such as the antiarrhythmics quinidine and amiodarone, antidepressants such as fluoxetine and paroxetine, or other drugs which inhibit cytochrome P450 2D6 such as haloperidol, cimetidine, ritonavir, berberine, bupropion, cinacalcet, flecainide and terbinafine. This increases the patient's risk for toxic effects of dextromethorphan. This effect may occur if any of these medicines have been administered recently, even if they are no longer being taken.
Concomitant use of dextromethorphan and other CNS depressants (e.g. alcohol, narcotic analgesics and tranquillizers) may increase the CNS depressant effects of these drugs.
If dextromethorphan is used in combination with secretolytics in patients with pre-existing chest disease such as cystic fibrosis and bronchiectasis who are affected by mucus hypersecretion reduced cough reflex can lead to serious accumulation of mucus (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Even when used as recommended this medication may cause mild drowsiness and alter reaction times to the extent that the ability to drive or to operate machinery is impaired. The risk is increased when it is taken in combination with alcohol or with medications that can impair reaction times (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.8 Adverse Effects (Undesirable Effects)

Side effects with usual doses are uncommon but may include mild drowsiness, fatigue, dystonias, dizziness and gastrointestinal disturbances (nausea or vomiting, stomach discomfort or constipation).
Side effects that may occur with high doses (overdosage) include excitation, confusion, psychosis, nervousness, irritability, restlessness, "serotonin syndrome", severe nausea and vomiting and respiratory depression.
Cases of dextromethorphan abuse and dependency have been reported (see Section 4.4 Special Warnings and Precautions for Use).
The maximum adult dose of 60 mL of Bisolvon Dry Oral Liquid contains 28.6 g of maltitol and 4.2 g of sorbitol. The maximum adult dose of Bisolvon Dry Pastilles (12 pastilles) contains 10.2 g of maltitol and 0.8 g of sorbitol. Products containing maltitol and sorbitol may have a laxative effect or cause diarrhea. This is more likely if several products containing maltitol, sorbitol or other related substances are consumed simultaneously.
Patients with the rare hereditary condition of fructose intolerance should not take this medicine as it may cause severe abdominal pain, vomiting and hypoglycaemia due to presence of maltitol and sorbitol.
The frequency of undesirable effects is based on the following categories: 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; not known: cannot be estimated from the data available.

Psychiatric disorders.

Nervous system disorders.

Skin and subcutaneous tissue disorders.

Immune system disorder.

Gastrointestinal disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

Symptoms.

Management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism.

Elimination.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Bisolvon Dry Oral Liquid contains methyl hydroxybenzoate, saccharin sodium, maltitol solution, propylene glycol, Vanilla Aroma 33 P 080, apricot aroma 653460 and purified water.
Bisolvon Dry Pastilles contain betadex, acacia, sodium cyclamate, saccharin sodium, quinoline yellow, citric acid, Honey Flavour 8366/001 Wild product number 3-183660001, Limette Flavour 18635/02 Wild product number 3-186350002, menthol, maltitol solution, light liquid paraffin, beeswax white.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Bisolvon Dry Oral Liquid should be stored below 25°C and protected from direct sunlight.
Bisolvon Dry Pastilles should be stored below 25°C.

6.5 Nature and Contents of Container

Bisolvon Dry Oral Liquid available in amber glass type III coloured bottles containing 200 mL.
Bisolvon Dry Pastilles available in PVC/PVDC/Al blister packs containing 10, 20, 30 and 40 pastilles.
Not all pack sizes are distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Dextromethorphan hydrobromide monohydrate is a white or almost white crystalline powder, soluble in alcohol and chloroform, sparingly soluble in water and practically insoluble in ether.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S2 - Pharmacy Medicine.

Summary Table of Changes