Dextromethorphan hydrobromide, 10mg/5ml syrup

Dextromethorphan hydrobromide monohydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.

-    Keep this leaflet. Y ou may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

- You must talk to a doctor if you do not feel better or if you feel worse after 3-5 days.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. Y ou may need to read it again.

-    If you have any further questions, ask your your doctor or pharmacist

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Dextromethorphan hydrobromide 10mg/5ml syrup is and what it is used for

2.    Before you take Dextromethorphan hydrobromide 10mg/5ml syrup

3.    How to take Dextromethorphan hydrobromide 10mg/5ml syrup

4.    Possible side effects

5.    How to store Dextromethorphan hydrobromide 10mg/5ml syrup

6.    Contents of the pack and further information

1. What Dextromethorphan hydrobromide 10mg/5ml syrup is and what it is used for

Pharmacotherapeutic group: Cough and cold preparations

Dextromethorphan hydrobromide 10mg/5ml syrup is used to help relieve dry, irritating coughs.

It contains the active ingredient dextromethorphan hydrobromide which belongs to a group of medicines called cough suppressants that help provide relief from dry coughs.

The medicine is for use in adults and children aged 12 years and over.

2. What you need to know before you take Dextromethorphan hydrobromide 10mg/5ml syrup

Do not take Dextromethorphan hydrobromide 10mg/5ml syrup

-    if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6)

-    if you have a long-term cough or acute symptoms from respiratory conditions such as asthma, Chronic obstructive pulmonary disease (COPD), pneumonia.

-    if you are less than 12 years old

if you are taking or have taken in the last two weeks medicines for depression known as Monoamine Oxidase inhibitors (MAO’Is). If you are uncertain as to whether you are taking such medication, talk to your doctor or pharmacist

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Dextromethorphan hydrobromide

-    Dextromethorphan hydrobromide may cause dependency when used over longer periods of time (i.e. exceeding the recommended treatment period) or by people with a tendency towards abuse

- If you are taking or have recently been taking certain medicines e.g. for depression, such as SSRI or tricyclic antidepressives

- If you suffer from liver or renal problems

- If you have persistent cough or cough associated with considerable mucus production (phlegm), (e.g. patients with conditions such as bronchiectasis and cystic fibrosis) or in patients with neurological illness associated with a markedly reduced cough reflex (such as stroke, Parkinson’s disease and dementia)

- If you are intolerant to some sugars

- If you are diagnosed to have mastocytosis

Children

Dextromethorphan hydrobromide should not be used in children under 12 years of age Other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenon, thioridazine, cimetidine, ritonavir, berberine, bupropion, cinacalcet, flecainide and terbinafine or mucolytics (medicines which loosen phlegm or serotonergic medicines. Serotonergic medicines are e.g certain antidepressives such as MAO-inhibitors, selective serotonin reuptake inhibitors (SSRI) (e.g. fluoxetine, paroxetine) or tricyclic antidepressives. Dextromethorphan may increase the risk of serotonin syndrome. Symptoms of serotonin syndrome include agitation, increased heart and breath rate, restlessness, muscle spasms and twitching, high body temperature, excessive sweating, shivering, and tremor. Dextromethorphan hydrobromide with alcohol

Some side effects can be more likely when alcohol is consumed along with Dextromethorphan hydrobromide .

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine may make you feel drowsy or dizzy. If you are affected do not drive or use machines. The risk of these effects is increased with alcohol and some other medicines.

Dextromethorphan hydrobromide contains:

Malititol 89(kcal/g)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

May have a mild laxative effect

Calorific value 2.3kcal/g maltitol

2.8 g of propylene glycol

Methylhydroxybenzoate (E219)

May cause allergic reactions (possibly delayed)

3. How to take Dextromethorphan hydrobromide 10mg/5ml syrup

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children aged 12 years and over.

15 ml of syrup up to 3 times daily, every 6 - 8 h as required.

Do not exceed the maximum total daily dose of 45 ml of syrup (3 intakes).

Use the measuring device included in the package.

When self-medicating, do not use for more than 3-5 days.

The syrup does not contain sugar (sucrose) and thus may be taken by diabetics.

If you take more Dextromethorphan hydrobromide 10mg/5ml syrup than you should

If you take too much of this medicine, consult your doctor or hospital immediately.

Bring any remaining medicine to show the doctor.

If you forget to take Dextromethorphan hydrobromide 10mg/5ml syrup do not take a double dose to make up for a forgotten dose.

Take the next dose when needed.

4. Possible side effects

Like all medicines, Dextromethorphan hydrobromide 10mg/5ml syrup can cause side effects, although not everybody gets them.

Allergic reactions

■    which may be serious include the following symptoms: difficulty in breathing or dizziness, swelling of the face or the throat, severe itching or hives (urticaria), skin rash, redness of the skin (erythema), fixed drug eruption

■    If you get any of these symptoms, stop using the medicine and get medical help at once.

Other possible side effects

■    Common (affects less than 1 in 10 people)

o dizziness, vomiting, upset stomach, nausea, exhaustion

■    Very rare (affects less than 1 in 10,000 people)

o hallucinations, addiction, sleepiness

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V*.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dextromethorphan hydrobromide 10mg/5ml syrup

Store in the original packaging in order to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label carton and bottle. The expiry date refers to the last date of the month.

After first opening: 12 months

Do not use this medicine if you notice any signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Dextromethorphan hydrobromide 10mg/5ml syrup contains

-The active substance is dextromethorphan hydrobromide monohydrate.

-The other excipients are:

Saccharin sodium Maltitol liquid (E965)

Propylene glycol Apricot flavour Vanilla flavour

Methyl parahydroxybenzoat (E218)

Purified water

What Dextromethorphan hydrobromide 10mg/5ml syrup looks like and contents of the pack

5 ml contains 10 mg of dextromethorphan hydrobromide monohydrate (equivalent to 7.35mg of dextromethorphan).

Dextromethorphan hydrobromide 10mg/5ml syrup is a clear, colourless to slightly yellow syrup available in a type III amber glass bottle and plastic cap.

Pack-sizes:

1 x 190ml bottle and 1 measuring device

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder <[To be completed nationally]>

Manufacturer

DELPHARM REIMS

10 rue Colonel Charbonneaux, 51100 REIMS France

<This medicines product is authorised in the Member States of the EEA under the following names:>

This leaflet was last approved in {MM/YYYY} <To be completed nationally>

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