Patient leaflet - Lemocalm dry Cough 10 mg / 5 ml oral solution
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 chronic bronchitis, emphysema or asthma or have had a cough for a few weeks or a cough with a lot of mucus (phlegm).
- If you are taking any other cough and cold medicines.
- If your child is prone to developing certain allergic reactions (e.g. atopic reactions). • 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 have been told by your doctor that you are a slow metabolizer of CYP2D6. • If you are taking medicines such as certain antidepressants or antipsychotics this medicine 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.
- Certain drugs for depression such as norepinephrine-dopamine reuptake inhibitors (NDRI), which include bupropion.
- Antipsychotics (drugs used to treat mood disorders such as haloperidol, thioridazine, perphenazine). • Anti-arrhythmic agents (drugs used to treat an irregular heartbeat such as amiodarone, propafenone, quinidine and flecainide).
Calcimimetic agents (drugs used to treat secondary hyperparathyroidism, elevated parathyroid hormone levels such as cinacalcet).
- Antifungals (terbinafine).
- Opioid analgesics (drugs used to relieve pain e.g. codeine, tramadol, morphine, methadone) • Antihistamines (drugs used to treat the symptoms of allergic reactions).
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 Propylene glycol and Sodium Benzoate
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.
Sodium benzoate: This medicine contains 5 mg in each 5 ml which is equivalent to 1mg/ml. Information on sodium content
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that is to say essentially ‘sodium-free’.
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.
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Do not take more than the stated dose shown below.
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
If you experience any of the following stop using the medicine and talk to your doctor:
- Itching, rash, hives.
Other effects which may occur but it is not known how often, include:
- Dependence and addiction (see section ‘How do I know if I am addicted?’).
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- Dizziness or drowsiness.
- Nausea, vomiting or diarrhoea.
- Upset stomach or stomach pain.
- Difficulty sleeping or feeling agitated, jittery, restless or confused.
- Shallow breathing.
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 Website: www.mhra.gov.uk/yellowcard, 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 information
What 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.
Marketing Authorisation Holder and Manufacturer
Name and Address:
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
LemoCalm® Dry Cough 10 mg/5 ml Oral Solution: PL 17907/0314
This leaflet was last revised in May 2022
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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