Active ingredient
- dihydrocodeine tartrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00156/0093 .
DF118 FORTE 40mg tablets (Dihydrocodeine Tartrate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
DF118 FORTE 40mg Tablet
Dihydrocodeine Tartrate
This medicine contains dihydrocodeine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start using DF118 FORTE because it contains important information for you.
What is in this leaflet:
1. What DF1 18 FORTE is and what it is used for
2. What you need to know before you take DF118 FORTE
3. How to take DF118 FORTE
4. Possible side effects
5. How to store DF118 FORTE
6. Contents of the pack and other information
1. What DF118 FORTE is and what it is used for
This medicine has been prescribed for you for the relief of severe and long lasting pain including the pain of sciatica (nerve pain of the leg/back), joint and bone pain (osteoarthritis, rheumatoid arthritis of the spine), nerve pain, pain following blood vessel disease, cancer or after operations.
It contains dihydrocodeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
2. What you need to know before you take DF118 FORTE
Do not take DF118 FORTE if:
Warning and Precautions
Talk to your prescriber before taking DF118 FORTE:
Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.
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. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction.
Overuse and misuse can lead to overdose and/or death.
Other medicines and DF118 FORTE
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without prescription. DF118 FORTE must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them. These drugs are known as Monoamine Oxidase Inhibitors (MAOl’s).
Other medicines which may interact with DF118 FORTE include:
Concomitant use of Dihydrocodeine Tartrate 40mg Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
Because of this, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor does prescribe Dihydrocodeine Tartrate 40mg Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
DF118 FORTE with food and drink
DF118 FORTE should be taken with or after food.
You are advised not to drink alcohol while being treated with Dihydrocodeine.
Pregnancy, breast-feeding and fertility
Do not take DF118 FORTE if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use DF118 FORTE during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take DF118 FORTE while you are breastfeeding as dihydrocodeine passes into breast milk and will affect your baby.
Driving and using machines
This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery if you feel drowsy or cannot think clearly.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
DF118 FORTE contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicinal product.
3. How to take DF118 FORTE
Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
This medicine is for oral use.
Adults and elderly and children over 12 years:
One or two tablets three times daily taken with or after food up to a maximum of 6 tablets per day.
Children under 12 years: Not recommended.
If you forget to take DF118 FORTE
If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not take a double dose to make up for a forgotten dose.
If you take more DF118 FORTE than you should
If you take too much of your medicine seek immediate medical advice from your doctor or your nearest hospital.
Symptoms of an overdose include sudden or unexpected difficulty in breathing, pin-point pupils or a drop in blood pressure. In the case of children they may suffer fits.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
If you stop taking DF118 FORTE
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
4. Possible side effects
Like all medicines, DF118 FORTE can cause side effects, although not everybody gets them.
If you experience any of the following side effects stop taking the tablets and contact your doctor or go to the casualty/emergency department of your nearest hospital immediately.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Drug Withdrawal
When you stop taking DF118 FORTE, you may experience withdrawal symptoms, which include restlessness, dissiculty 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 DF118 FORTE, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber
Reporting of side effects
If you get any side effects, talk to your doctor or 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 at: 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 DF118 FORTE
Keep all medicines out of the sight and reach of children.
Do not use DF118 FORTE after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not store above 25°C in a dry place. Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other Information
What DF118 FORTE contains:
Active ingredient: Dihydrocodeine Tartrate 40 mg per tablet
Other ingredients: lactose, maize starch, pregelatinised maize starch and magnesium stearate.
What DF118 FORTE looks like and contents of the pack:
DF118 FORTE is a white, circular tablet supplied either in a plastic container or in plastic blister packs. Each pack contains 10, 28, 56, 100 or 500 tablets.
Marketing Authorisation Holder:
Manufacturer:
Product licence numbers: PL 0156/0093
Leaflet revised: February 2020
Building A2, Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, UK
+44 (0) 1277 266 600