- fentanyl citrate
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 42924/0013.
Cynril 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg and 1600 mcg Lozenges
Package leaflet: Information for the user
Cynril 200 micrograms compressed lozenges with integral oromucosal applicator
Cynril 400 micrograms compressed lozenges with integral oromucosal applicator
Cynril 600 micrograms compressed lozenges with integral oromucosal applicator
Cynril 800 micrograms compressed lozenges with integral oromucosal applicator
Cynril 1200 micrograms compressed lozenges with integral oromucosal applicator
Cynril 1600 micrograms compressed lozenges with integral oromucosal applicator
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Cynril is and what it is used for.
2. What you need to know before you take Cynril
3. How to take Cynril.
4. Possible side effects
5. How to store Cynril
6. Contents of the pack and other information
1. What Cynril is and what it is used for
Cynril contains the active substance fentanyl which is a strong pain-relieving medicine known as an opioid.
The Cynril unit comes as a lozenge on a stick.
2. What you need to know before you take Cynril
Do not use Cynril:
Do not use Cynril if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Cynril.
Warnings and precautions:
Keep using the opioid pain medicine you take for your persistent (around-the-clock) cancer pain during your Cynril treatment.
Talk to your doctor or pharmacist before taking Cynril if:
Talk to your doctor before using Cynril if you use antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase (MAO) inhibitors; see section 2 under Do not use Cynril and Other medicines and Cynril).
The use of these medicines with Cynril can lead to serotonin syndrome a potentially life-threatening condition (see section 2 under Other medicines and Cynril).
Serious allergic reactions
Serious allergic reactions have been reported with fentanyl (see section 4 under Serious side effects), early symptoms can be difficulty in breathing or dizziness, swelling of the tongue, lip or throat.
Cynril contains approximately 2 grams of sugar and a frequent consumption exposes you to an increased risk of dental decay that may be serious. Thus, it is important to continue to take good care of your mouth and teeth during treatment with Cynril. If you present such serious local effects consult your doctor.
Children and adolescents
This medicine is not recommended for children and adolescents below 16 years of age
Other medicines and Cynril
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines:
Tell your doctor or pharmacist before using Cynril if you are taking or have recently taken or might take any other medicines:
This includes medicines obtained without a prescription, including herbal medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
If you are due to have surgery requiring a general anaesthetic speak with your doctor or nurse
Cynril with food and drink and alcohol
Cynril can be used before or after meals. However, do not use during a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to have a baby, ask your doctor or pharmacist before using this medicine.
Cynril should not be used during pregnancy unless you have discussed this with your doctor. If Cynril is used for a long-time during pregnancy, there is also a risk of the new-born child having withdrawal symptoms which might be life-threatening if not recognized and treated by a doctor. You should not use Cynril during childbirth because fentanyl may cause respiratory depression in the new-born child.
Fentanyl can get into breast milk and may cause side effects in the breast-fed infant. Do not use Cynril if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Cynril.
Driving and using machines
This medicine may affect you being able to drive or use any tools or machines. Talk to your doctor about whether it is safe for you to drive or use any tools or machines in the first few hours after using Cynril.
Do not drive or use any tools or machines if you: feel sleepy or dizzy; have blurred or double vision; have difficulty in concentrating. It is important you know how you react to Cynril before driving or using any tools or machines.
Cynril contains glucose
This medicine contains glucose (as hydrated dextrates). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Glucose containing lozenge of Cynril may be harmful to your teeth. This medicine contains less than 1 mmol (23 mg) per lozenge, that is to say essentially ‘sodium-free’
3. How to use Cynril
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
When you first start using Cynril, your doctor will work with you to find the dose that will relieve your breakthrough pain. It is very important that you use Cynril exactly as the doctor tells you
Do not change doses of Cynril or your other pain medicines on your own. Change in dose must be prescribed and checked by your doctor.If you are not sure about the right dose or if you have questions about using this medicine, talk to your doctor
How the medicine is administered
When you place Cynril in your mouth:
While the right dose is being found
You should start to feel some relief quickly while you are using Cynril. However, while you and the doctor are finding out the dose that controls your breakthrough pain, you may not get enough pain relief up to 30 minutes after starting to use one Cynril unit (15 minutes from when you finish using the Cynril unit). If this happens, your doctor may allow you to use a second Cynril unit of the same strength for that same episode of breakthrough pain. Do not use a second unit unless your doctor tells you to. Never use more than two units to treat a single episode of breakthrough pain.
While the right dose is being found, you may need to have more than one strength of Cynril units at home. However, keep only the strengths of Cynril you need in the house. This is to stop possible confusion or overdose. Talk to your pharmacist about how to dispose of any Cynril units you do not need.
How many units should be used
Once the right dose has been found with your doctor, use 1 unit for an episode of breakthrough pain. Talk to your doctor if your right dose of Cynril does not relieve your breakthrough pain for several episodes of breakthrough pain in a row.
Your doctor will decide if your dose needs to be changed.
You must tell your doctor straight away if you are using Cynril more than four times per day. This is because he may wish to change your medicine for your persistent (around-the- clock) pain. When he has done this, when your persistent pain has been controlled, he may need to change your dose of Cynril. For the most effective relief, tell your doctor about your pain and how Cynril is working for you. This is so that the dose can be changed if needed.
How to take Cynril
Opening the package
Remove the Cynril unit from the blister pack and put the lozenge in your mouth straight away
Using the Cynril unit
How often you should use Cynril Once a dose is found that effectively controls your pain, do not use more than four units of Cynril per day. If you think you might need to use more than four Cynril units per day, talk to your doctor straight away
How many Cynril units you should use
Do not use more than two units to treat any single episode of breakthrough pain.
If you use more Cynril than you should
The most common side effects of using too much Cynril are feeling sleepy, sick or dizzy.
A serious side effect of Cynril is slow and/or shallow breathing. This can occur if your dose of Cynril is too high or if you take too much Cynril. Other serious side effects associated with overdose include altered mental status, loss of consciousness, coma and cardiorespiratory arrest (sudden heart attack).
What to do if a child or adult accidentally takes Cynril
If you think someone has accidentally taken Cynril, get medical help straight away. Try to keep the person awake (by calling their name and shaking their arm or shoulder) until emergency help arrives.
If you forget to use Cynril
If you still have breakthrough pain, you may use Cynril as your doctor has told you. If the breakthrough pain disappears, do not use Cynril until the next breakthrough pain.
If you stop using Cynril
You should normally stop taking Cynril when you no longer have any breakthrough pain. You must however continue to take your usual opioid pain-relieving medicine to treat your persistent cancer pain as advised by your doctor, unless your doctor tells you to stop. You may experience withdrawal symptoms similar to the possible side effects of Cynril when discontinuing Cynril. If you experience withdrawal symptoms or if you are concerned about your pain relief you should contact your doctor. Your doctor will evaluate if you need medicine to reduce or eliminate the withdrawal symptoms
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them. If you notice any of these, contact your doctor. The most serious side effects are shallow breathing, low blood pressure and shock. You or your carer should REMOVE the Cynril unit from your mouth, contact your doctor immediately and call for emergency help if you experience any of the following serious side effects- you may need urgent medical attention:
Becoming very sleepy or having slow and/ or shallow breathing.
Difficulty in breathing or swelling of the tongue, lip or throat which may be early signs of serious allergic reaction.
Note to carers:
If you see that the patient taking Cynril has slow breathing or if you have a hard time waking the person up, take the following steps IMMEDIATELY:
If you feel excessively dizzy, sleepy or otherwise ill while taking Cynril, use the handle to remove the Cynril unit and dispose of it according to the instructions given in this leaflet (see section 5). Then contact your doctor for further directions on using Cynril.
Contact your doctor if you experience a combination of the following symptoms Nausea, vomiting, loss of appetite, tiredness, weakness, dizziness and low blood pressure Together these symptoms may be a sign of a potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Not known (frequency cannot be estimated from the available data):
They have also reported the following side effects with the use of Cynril but how often that can occur is not known:
Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn which can be life-threatening (see section 2)
While using Cynril you may experience irritation, pain and ulcers in the application site and gum bleeding.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cynril
The pain-relieving medicine in Cynril is very strong and could be life-threatening if taken accidentally by a child. Cynril must be kept out of sight and reach of children.
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.
How to dispose of Cynril after use
Partially used units of Cynril may still contain enough medicine to be harmful or life-threatening to a child. Even if there is a little or no medicine left on the handle, the handle itself must be properly disposed of as follows:
6. Contents of the pack and other information
What Cynril contains: The active substance is fentanyl. Each individual lozenge contains either 200, 400, 600, 800, 1200 or 1600 micrograms of fentanyl (as citrate).
The other ingredients are:
Dextrates hydrated, citric acid, disodium hydrogenphosphate, artificial flavour berry (tapioca starch, arabic gum (E-414), magnesium stearate.
Edible glue used to attach the lozenge to the applicator:
Based food starch modified maize, hydrated dextrates, water.
Printing ink: Ethanol, Water, Purified Shellac (E904), Acetone, FD&C Blue No.1 (E133 Brilliant Blue FCF), Ammonium Hydroxide (E527)
What Cynril looks like and contents of the pack
Cynril is a system for administering medication directly through the lining of the mouth. Each unit consists of a white to slightly yellowish cylindrical lozenge attached to a handle for oromucosal application.
The unit is normally white, however, during storage can acquire a slightly mottled appearance. This does not affect in any way the action of the medicine.
Cynril is available in six different doses: 200, 400, 600, 800, 1200 and 1600 micrograms. The dose is marked on the white lozenge in the applicator in the blister and on the carton to ensure that you use the appropriate medication and dosage. Each dose is associated with a specific color.
Each blister package contains one unit of Cynril supplied in boxes of 1, 3, 15 or 30 individual Cynril units.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:
Netherlands - Fentanyl CF 200/ 400/ 600/ 800/ 1200/ 1600 μg, zuigtabletten met integrale applicator voor oromucosaal gebruik
Germany - Fentanyl KSK-Pharma 200/ 400/ 600/ 800/ 1200/ 1600 Mikrogramm Lutschtablette mit integriertem Applikator zur Anwendung in der Mundhöhle
This leaflet was last revised in 05/2019