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ADDITIONAL WARNING STATEMENTS FOR INCLUSION ON
THE LABEL AND/OR IN THE LEAFLET OF CERTAIN
MEDICINES
1. PURPOSE
The purpose of this guidance is to set out the warning statements which should appear on the label and/or in the leaflet of certain medicines. UK legislation foresees the need for certain medicines to include warning statements on the label to enable these to be used safely and to best effect.
Previously, a small number of warning statements were included by statute and appeared in Schedule 5 to the Medicines (Marketing Authorisations etc) Regulations 1994 number 3144 [SI 1994/3144]. These applied principally to a small number of medicines available over-the-counter. Many more warning statements were added to the labelling of other medicines through the marketing authorisation rather than through a legislative provision.
As part of the consolidation of the Medicines Act and in line with the better regulation principals operated under Cabinet Office guidelines, with the exception of warning statements to be applied to all medicines containing paracetamol, warning statements will no longer appear on the face of the legislation. Amending legislation is complex and by setting out those medicines and the associated warnings in guidance flexibility can be applied by Marketing Authorisation Holders (MAH) in how these statements are implemented.
2. STATUS
Although having no legal force it is expected that MAHs will apply these warning statements to the labelling and/or the leaflet as appropriate. It will not be necessary to use the wordings proposed verbatim, but it should be borne in mind that many of these forms of words have already been the subject of user testing and are in use (through the British National Formulary) on dispensing labels applied in pharmacies across the UK. Care should be taken to ensure that any deviation from what is set out below does not cause confusion amongst patients.
The warning statements are divided into general and specific categories and for some medicines warnings from both sections may need to be applied.
3. GENERAL WARNING STATEMENTS
For Pharmacy Only (P) medicines where the product would be prescription only if it contained a higher proportion of the active ingredient unless it is an antihistamine or for external use e.g. ibuprofen, codeine, paracetamol This should be placed adjacent to the directions for use or the recommended
dosage: Warning: Do not take more medicine than the label tells you to.
If the product is for external use only and is and embrocation, liniment, lotion, cream, liquid antiseptic or other liquid preparation or gel. Where the medicine is a Pharmacy Only (P) medicine this statement must appear on the label:
Use this medicine only on your skin.
For medicines which are available as Pharmacy Only. The letter “P” must appear in a box in which there is no other information.
For medicines which are available only on prescription. The letters “POM” must appear in a box in which there is no other information.
CONTROLLED DRUGS Medicines which fall to be considered as controlled drugs under the Misuse of Drugs Act 1971 should include the following next to the declaration of the legal status on the labelling. The letters CD in an inverted triangle.
ALL MEDICINES
In line with Part 13 of the HMRs a warning that users should “keep out of the sight and reach of children” should appear on the label of all medicines.
In line with Part 13 of the HMRs, a statement encouraging patients to report adverse events which they may experience to the competent authority should appear in the patient information leaflet. In the UK the following form of words should be used:
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.
This should appear at the end of section 4.
MEDICINES SUBJECT TO ADDITIONAL MONITORING Medicines which appear on the black triangle list published on the MHRA website should include the inverted black triangle immediately after the name in the patient information leaflet followed by the wording in schedule 27 of Human Medicines Regulation 2012 (as amended).
▼This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Aspirin and aspirin derivatives can cause Reye’s syndrome when given to children. This is a very rare disease but it can be fatal. Do not give this medicine to children under 16 years of age unless your doctor tells you to.
AMINOPHYLLINE
For P medicines and the product is for asthma or bronchial spasm.
Warning: Talk to your doctor before using this medicine
ANTIDEPRESSANTS (ALL CLASSES) Suicidal thoughts/behaviour
Patient Information Leaflet Section 2:
Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this:
- If you have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
ARACHIS (PEANUT) OIL
Label: In the list of ingredients: Arachis oil (peanut oil)
PIL: [product] contains arachis oil (also called peanut oil). If you are allergic to peanuts or soya, do not use/take this medicine
ASPIRIN If the product contains aspirin, unless the product name includes “aspirin” or the product is for external use. These statements must be placed prominently on the packaging:
Contains Aspirin
If you do not get better talk to your doctor
Do not give to children under 16 years of age unless your doctor tells you to.
If the product contains aspirin the following statements must be included on the label where a PIL is NOT separately available:
Aspirin can cause Reye’s syndrome when it is given to children. This is a very rare disease but it can be fatal. Do not give aspirin to children under 16 years of age unless your doctor tells you to.
AZELASTINE For nasal preparations which are available as P for over-the-counter supply for the treatment of seasonal and perennial allergic conjunctivitis: If you need to use this medicine for longer than 4 weeks, stop using the medicine and talk to your doctor.
BENZODIAZEPINE PIL: Secton 1. What this medicine is for This medicine should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependent or of having problems when you stop taking it.
When taking this medicine there is a risk of dependence (a need to keep taking the medicine). The risk increases with the dose and length of treatment period. The risk is greater if you have ever had a history of alcohol or drug abuse.
Section 2. Pregnancy Do not take X if you are pregnant, might become pregnant or breast-feeding. If you and your doctor decide that you should take this medicine towards the end of your pregnancy (or during labour) this may harm your baby. The baby may have a low temperature, be listless, have breathing problems or difficulty in feeding. Also, if you take this medicine regularly during your pregnancy your baby may get withdrawal symptoms.
Section 3. Stopping X and Withdrawal Effects: This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you stop taking the tablets suddenly you may experience the following withdrawal effects:
depression, nervousness,
Change the patch after 72 hours
Back of carton
Add the following text
POM
Read the package leaflet before use
Make a note of the day, date and time that you apply the first patch. Change the patch at the same time of day 72 hours (3 days) later:
Apply Mon Tue Wed Thu Fri Sat Sun Change Thu Fri Sat Sun Mon Tue Wed
Time:
Sufficient space should be provided to accommodate a standard dispensing label of 70 x 35 mm.
PATIENT INFORMATION LEAFLET
Headlines
Headline information should be presented prominently at the beginning of the PIL.
These patches contain a strong pain killer Ensure that old patches are removed before applying a new one Patches must not be cut Do not expose the patches to a heat source (such as a hot water bottle) Do not soak in a hot bath or take a hot shower whilst wearing a patch. If you develop a fever tell your doctor immediately Follow the dosage instructions carefully and only change your patch at the same time of day 72 hours (3 days) later If your breathing becomes shallow and weak take the patch off and seek medical help
Section 2 – Warnings and Precautions
Driving and using machinery
CD
Add the following text
[Product name] can affect your ability to drive 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.
Section 3 – How to use
Add the following text
The following table shows you when to change your patch:
Apply your patch on Change your patch at the same time of day on Monday Thursday Tuesday Friday Wednesday Saturday Thursday Sunday Friday Monday Saturday Tuesday Sunday Wednesday
4 DAY PATCHES
PARTICULARS TO APPEAR ON OUTER PACKAGING
Front of carton
Add the following text - prominently
Change the patch twice a week
Back of carton
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.
Section 3 – How to use
Add the following text
The following table shows you when to change your patch:
Apply/change your patch in morning of
Apply/change your patch in evening of Monday Thursday Tuesday Friday Wednesday Saturday Thursday Sunday Friday Monday Saturday Tuesday Sunday Wednesday
7 DAY PATCHES
PARTICULARS TO APPEAR ON OUTER PACKAGING
Front of carton
Add the following text - prominently
Change the patch after 7 days
Back of carton
Add the following text
POM
Read the package leaflet before use
CD
Make a note of the day, date and time when you apply the first patch. Change the patch on the same day and at the same time 7 days later:
Apply / Change
Mon Tue Wed Thu Fri Sat Sun
Time:
Disposal after use : Keep the sachet after removing the patch inside. Keep it to put your used patch in. As soon as you take the patch off, fold it firmly in half (sticky sides together) and put it back in the sachet. Either discard in the bin with the household rubbish or return to the pharmacy.
Keep out of the sight and reach of children
This medicine can make you feel sleepy. Do not drive while taking this medicine until you know how if makes you feel. See the leaflet inside for more information.
Sufficient space should be provided to accommodate a standard dispensing label of 70 x 35 mm.
PATIENT INFORMATION LEAFLET
Headlines
Headline information should be presented prominently at the beginning of the PIL.
These patches contain a strong pain killer Ensure that old patches are removed before applying a new one Patches must not be cut Do not expose the patches to a heat source (such as a hot water bottle) Do not soak in a hot bath or take a hot shower whilst wearing a patch. If you develop a fever tell your doctor immediately Follow the dosage instructions carefully and only change your patch on the same day and at the same time 7 days later If your breathing becomes shallow and weak take the patch off and seek medical help
Section 2 – Warnings and Precautions
Driving and using machinery
Add the following text
LABELLING
Front of Pack Can cause addiction Contains opioid For three days use only
These requirements are in addition to the normal statutory provisions and should be prominently displayed.
This information will also be included in section 4.4 of the SmPC under the heading “The label will state”.
Back of Pack List of indications as agreed in 4.1 of the SmPC If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist This medicine contains codeine [or dihydrocodeine] which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse
These requirements are in addition to the normal statutory provisions and should be prominently displayed.
This information will also be included in section 4.4 of the SmPC under the heading “The label will state”.
LEAFLET
Headlines section (to be prominently displayed) This medicine can only be used for …….(indications) You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice This medicine contains codeine [or dihydrocodeine] which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it If you take this medicine for headaches for more than three days it can make them worse
Section 1: What the medicine is for Succinct description of the indications from 4.1 of the SmPC
Section 2: Before taking
This medicine contains codeine [or dihydrocodeine] which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it If you take a painkiller for headaches for more than three days it can make them worse
Pregnancy and Breast-feeding (for codeine only) Usually it is safe to take “X” while breast-feeding as the levels of codeine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels of codeine in their breast milk. If any of the following side effects develop in you or your baby stop taking this medicine and speak to your doctor at once: feeling sick, being sick, constipation, poor appetite, feeling tired or sleeping for longer than usual, shallow or slow breathing.
Section 3: Dosage Do not take for more than 3 days. If you need to use this medicine for more than three days you should speak to your doctor or pharmacist This medicine contains codeine [or dihydrocodeine] and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms
Section 4: Side effects Some people may have side-effects when taking this medicine.
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.
NEW SECTION: How do I know if I am addicted? If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor: You need to take the medicine for longer periods of time You need to take more than the recommended dose When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
For medicines which contain codeine or dihydrocodeine and are available on prescription only [POM]
have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you. This leaflet was last updated on xx/xx/xx
Section 1. Benefit Information to be included
Dexamethasone belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as dexamethasone) is an effective way to treat various illnesses involving inflammation in the body. Dexamethasone reduces this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Section 2. Before you take dexamethasone
Check with your doctor first If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while taking steroid medicines like dexamethasone. If any of your close family has had these illnesses. If either of these applies to you, talk to a doctor before taking dexamethasone.
Mental problems while taking dexamethasone Mental health problems can happen while taking steroids like dexamethasone (see also section 4 Possible Side Effects ) These illnesses can be serious Usually they start within a few days or weeks of starting the medicine. They may be more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen, they might need treatment.
Talk to a doctor if you (or someone taking this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide and when doses are being lowered or stopped. In a few cases, mental problems have happened during this time.
Section 4. Possible side effects
Serious effects: tell a doctor straight away Steroids including dexamethasone can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like dexamethasone. Feeling depressed, including thinking about suicide. Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused
and losing your memory. Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone. If you notice any of these problems talk to a doctor straight away.
DIAMORPHINE
See MORPHINE
DICLOFENAC
Prescription Medicines – oral formulations and suppositories
The Patient Information Leaflet (PIL) should be revised. The following wording should be added to the PIL: Section 2 “What you need to know before you take X”
Do not take X if you Have had a heart attack, a stroke, a mini-stroke (TIA), blood clots or had a heart bypass have or have ever had a stomach ulcer, perforation or bleeding are allergic to diclofenac or any other ingredient of the product, aspirin, ibuprofen or other related painkillers are taking other NSAID painkillers, or aspirin are pregnant or breastfeeding
Speak to a pharmacist or your doctor before taking this product if you have asthma, diabetes, high cholesterol, angina, high blood pressure, liver, kidney or bowel problems there is a chance you may be pregnant you smoke
Topical medicines available as P (over the counter)
The label will include: Read the enclosed leaflet before taking this product. Do not use if you are allergic to diclofenac or any other ingredient of the product, aspirin, ibuprofen or other related painkillers are taking other NSAID painkillers, or aspirin are in the last three months of pregnancy
Speak to a pharmacist or your doctor before using this product if have or have ever had a stomach ulcer, perforation or bleeding
you have asthma, diabetes, high cholesterol, angina, high blood pressure, liver, kidney or bowel problems there is a chance you may be pregnant or you are breastfeeding you smoke
This medicine can make you feel very sleepy during the day and can also make you fall asleep suddenly. You should not drive, use tools or operate machines.
- Driving and using machines:
[Product] can make you feel very sleepy during the day and can also make you fall asleep suddenly. You should not drive, use tools or operate machines as you may put yourself or others at risk of serious injury.
- Side effects:
This medicine can make you feel very sleepy and can also make you fall asleep suddenly.
PIL : For medicines which contain apomorphine, α-dihydroergocryptine, lisuride and quinagolide (to treat Parkinson’s disease )
- Warnings and precautions section:
This medicine can make you feel very sleepy during the day. You should not drive, use tools or operate machines.
- Driving and using machines:
[Product] can make you feel very sleepy during the day. You should not drive, use tools or operate machines as you may put yourself or others at risk of serious injury.
- Side effects:
This medicine can make you feel very sleepy
ECONAZOLE
See imidazoles
EPHEDRINE For P medicines and the product is for asthma or bronchial spasm.
Warning: Talk to your doctor before using this medicine.
FAMOTIDINE For medicines available as P for over-the-counter supply: This medicine may be taken for up to 14 days. If you need to take it for longer than 14 days or your symptoms come back stop taking the medicine and talk to your doctor.
FENTANYL
FRONT OF PACK
Can cause addiction Contains opioid For three days use only
These requirements are in addition to the normal statutory provisions and should be prominently displayed.
BACK OF CARTON Read the package leaflet before use
How to use the patches/medicine [Product name] should be worn continuously for 3 days (72 hours). It is important to change your patch on the correct day at the same time that it was applied.
Disposal after use : Keep the pouch after removing the patch inside. Keep it to put your used patch in. As soon as you take the patch off, fold it firmly in half (sticky sides together) and put it back in the pouch. Either discard in the bin with the household rubbish or return to the pharmacy.
Keep out of the reach and sight of children
Sufficient space should be provided to accommodate a standard dispensing label of 70 x 30 mm.
FRONT OF POUCH The front of the pouch should be fully compliant with Article 55(3)
BACK OF POUCH Read the leaflet before use. Dosage: as directed by your doctor.
Remove your old patch before applying a new one on a new area of skin. Apply a new patch every 3 days (72 hours)
Opening instructions [maximum for four bullet points, they should be succinct in content]
Gently tear open the pouch at the tear notch and remove the edge of the pouch completely. Grasp both sides of the opened pouch and pull apart completely. Take out the patch and use it straight away. Never divide or cut the patch. Do not use the patch if it looks damaged.
Disposal after use: Keep the pouch after removing the patch inside. Keep it to put your used patch in. As soon as you take the patch off, fold it firmly in half (sticky sides together) and put it back in the pouch. Either discard in the bin with the household rubbish or return to the pharmacy.
