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LEMOCALM DRY COUGH 10 MG / 5ML ORAL SOLUTION - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - LEMOCALM DRY COUGH 10 MG / 5ML ORAL SOLUTION

LemoCalm® Dry Cough 10 mg/5 ml Oral Solution

Dextromethorphan Hydrobromide

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

  • – Keep this leaflet. You 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 or pharmacist. 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.

What is in this leaflet:

  • 1. What LemoCalm® Dry Cough is and what it is used for

  • 2. What you need to know before you take LemoCalm®

Dry Coughs

  • 3. How to take LemoCalm® Dry Cough

  • 4. Possible side effects

  • 5. How to store LemoCalm® Dry Cough

  • 6. Contents of the pack and other information

The name of your medicine is LemoCalm® Dry Cough 10 mg/5 ml Oral Solution, but is referred as ‘LemoCalm® Dry Cough’ throughout the leaflet.

1. what lemocalm® dry cough is and what it is used for

LemoCalm® Dry Cough acts as a cough suppressant which acts to reduce coughing.

It can be used to relieve of persistent dry irritant coughs. Dry coughs do not produce phlegm or mucus on the chest.

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

This medicine can lead to dependence. Therefore the treatment should be of short duration.

2. what you need to know before you take lemocalm® dry cough

Do not take this medicine

  • If you are allergic to this medicine or any of the other ingredients of this medicine (listed in Section 6);
  • If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), used to treat depression or have taken this medicine in the last 14 days;
  • If you are currently taking a selective serotonin reuptake inhibitor (SSRI), used to treat depression and anxiety or have taken this medicine in the last 14 days;
  • If you are currently taking any other medication for depression, psychiatric, or emotional conditions, or Parkinson’s di­sease;
  • If you suffer from lung disease (including asthma or any other lung or breathing problems);
  • with any other cough or cold medicine.

If any of these apply to you, get advice from a doctor or pharmacist without using LemoCalm® Dry Cough.

Warnings and Precautions

Talk to your doctor or pharmacist before taking LemoCalm® Dry Cough:

  • If you suffer from liver or kidney problems;
  • If you have a persistent cough (if your cough lasts more than 7 days) such as occurs with smoking, asthma or produces a lot of mucus (phlegm);
  • are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
  • have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

If you are taking medicines such as certain antidepressants or antipsychotics LemoCalm® Dry Cough may interact with these medicines and you may experience mental status changes (e.g agitation, hallucinations, coma), and other effects such as body temperature above 380C, increase in heart rate, unstable blood pressure, and exaggeration of reflexes, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g nausea, vomiting, diarrhoea).

Taking this medicine regularly, particularly for a long time, can lead to addiction. Only use this medicine as described in the leaflet.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Speak to your doctor if you experience withdrawal symptoms.

Other medicines and LemoCalm® Dry Cough

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

  • Antipsychotics (haloperidol, thioridazine drugs used to treat mood disorders);
  • Amiodarone, propafenone and quinidine (used to treat an irregular heart beat).

Pregnancy, Breast-feeding and Fertility

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.

LemoCalm® Dry Cough with food drink and alcohol

You should not drink alcohol whilst you are on this medicine.

Driving and using machines

LemoCalm® Dry Cough can affect your ability to drive or operate machinery as it may make you sleepy or dizzy.

  • Do not drive while taking this medicine until you know how it affects you.
  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence if:

  • – The medicine has been prescribed to treat a medical or dental problem and

  • – You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

  • – It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

This medicine contains Malitol, Napthol Red and Propylene glycol If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Naphthol red may cause allergic reactions.

This medicine contains 129.5 mg propylene glycol in each 5 mL.

|       3. How to take LemoCalm

® Dry Cough |

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

For oral use only.

Do not take more than the stated dose shown below.

155mm


SAME SIZE ARTWORK 250 × 155 mm

Front


The recommended dose is:

Age

Dose

Adults and children aged 12 years and over:

Take one or two 5 ml spoonfuls every 4 – 6 hours.
  • Do not exceed a maximum of eight 5 ml spoonfuls per day. If symptoms persist, talk to your doctor or pharmacist.

Children under 12 years

Do not give to children under 12 years of age.

If you take more LemoCalm® Dry Cough than you should

If anyone has too much, contact your nearest Hospital Casualty/ Accident and Emergency Department take this medication in its original packaging with you.

If you take more LemoCalm® Dry Cough than you should, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, somnolence, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (rapid heart beating), coordination disorders, psychosis with visual hallucinations, and hyperexcitability. Other symptoms in case of massive overdose may be : coma, severe breathing problems, and convulsions.

Contact your doctor or hospital straight away if you experience any of the above symptoms.

If you forget to take this medicine

You should only take this medicine as required following the dosage instructions above carefully.

If you forget to take a dose, take the next dose when needed. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking and seek immediate medical help if you experience any of the following:

  • Fits
  • Swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing

Mild effects that may occur include:

Not known (frequency cannot be estimated from the available data)

  • Pruritis (Itching)
  • Rash
  • Urticaria (hives)
  • Difficulty sleeping
  • Confusion
  • Dizziness
  • Restlessness
  • Drowsiness
  • Shallow breathing
  • Diarrhoea
  • Upset stomach
  • Nausea and Vomiting
  • Stomach pain
  • Dependence and addiction (see section “How do I know if I am addicted?”).

Drug Withdrawal:

When you stop taking LemoCalm® DryCough, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking LemoCalm® Dry Cough, it could be a sign that you have become addicted.

  • – You need to take the medicine for longer than advised

  • – You feel you need to use more than the recommended dose

  • – You are using the medicine for reasons other than those indicated – When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your doctor or pharmacist.

Reporting of side effects

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 can also report side effects directly via the Yellow Card Scheme at: , or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store lemocalm® dry cough

  • Keep this medicine out of the sight and reach of children.
  • Do not store above 25°C. Store in the original container. Keep the container tightly closed.
  • Do not use this medicine after the expiry date printed on the pack. The expiry date refers to the last day of that month.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat lemocalm® dry cough contains the active substance in lemocalm®dry cough is dextromethorphan hydrobromide.

  • Each 5 ml of LemoCalm®Dry Cough contains 10 mg of Dextromethorphan Hydrobromide. The other ingredients are: Sodium Benzoate, Anhydrous citric acid, Liquid maltitol, Saccharin sodium, Propylene glycol, Strawberry flavour (containing propylene glycol and alphatocopherol), Contramarum flavouring (containing propylene glycol and benzyl alcohol), Naphthol red.

What LemoCalm® Dry Cough looks like and contents of the pack

  • LemoCalm®Dry Cough is a limpid red solution for oral administration, packed into amber coloured polyethylene terephthalate (PET) bottle, closed by a high density polyethylene (HDPE) white coloured closure. 1.25, 2.5 and 5 ml polypropylene doubled spoon with EC mark are provided as administration device.
  • LemoCalm®Dry Cough is available in bottles of 150 ml.

Sources: Original (products.mhra.gov.uk)