Fendermal Patch

FENDERMAL belongs to a group of strong painkillers called opioids. The painkiller, fentanyl, slowly passes from the patch, through the skin and into the body.

FENDERMAL relieves severe long-lasting pain, which can only adequately be managed with strong painkillers (opioids).

Do not use FENDERMAL:

• If you are hypersensitive (allergic) to fentanyl, or any of the other ingredients of FENDERMAL (listed in section 6).
• If you suffer from pain which lasts only for a short period (e.g. after a surgical procedure) or if the pain is mild and can be managed with less potent painkillers.
• If you have difficulty breathing.
• If you have a slow heartbeat and a disturbance in your heart rhythm.
• If you are pregnant, planning to become pregnant or breastfeeding your baby (see “Pregnancy, breastfeeding and fertility”).
• FENDERMAL transdermal patches may not be used on children less than 12 years of age.
• If you have severe or uncontrolled asthma.
• If your central nervous system is severely impaired, e.g., by brain injury.

Certain medicines can cause undesired effects when used together with FENDERMAL. Such medicines have the potential to affect your breathing, blood pressure, and may lead to coma. These include medicines used to treat allergies, medicines used to treat muscle pain (muscle relaxants), medicines used for the treatment of sleeplessness as well as alcoholic beverages and other medicines as listed in the section “Other medicines and FENDERMAL”.

Warnings and precautions

FENDERMAL can have life-threatening side effects in people who are not already regularly using prescribed opioid medicines (strong painkillers like morphine), even at the lowest dose.

FENDERMAL is a medicine that could be life-threatening to children, even if the patches have been used. Bear in mind that a sticky patch (unused or used) could be tempting to a child and if it sticks to a child’s skin or they put it in their mouth, the result may be fatal.

Do not share medicines prescribed for you with any other person.

Always use FENDERMAL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide which dose of FENDERMAL is most suitable for you, depending on the severity of your pain, your general condition and the type of pain treatment that you have received so far. The usual starting dose is 25 μg/h.

According to your reaction the dose of the patch or the number of patches may need to be adjusted. The effect is reached within 24 hours after the first patch has been applied and its effects lessen gradually after the patch is removed. Do not discontinue treatment without consulting your doctor.

Your first patch will start to work slowly; this may take as long as one day. Your doctor may give you extra painkillers until your FENDERMAL transdermal patch starts working completely. After this, FENDERMAL should help to relieve pain continuously and you should be able to stop taking these extra painkillers. However sometimes you may still need extra painkillers.

How to apply FENDERMAL:

1. Find a flat part of your upper body (trunk) or upper arm, where the skin is without hair, cuts, spots or other skin blemishes. The area must not have been treated with radiotherapy. Carefully check correct adhesion of the patch and if necessary, additionally fix the patch in place.
2. If the skin is hairy, cut the hair as close to the skin as possible, with scissors or clippers. Do not shave, as shaving irritates the skin. If the skin needs washing, wash with water. Do not use soap, oil, lotions, alcohol or other cleansers that may irritate the skin. The skin must be completely dry before applying the patch.
3. Apply the patch immediately after opening the package. When the release liner has been removed, apply the patch by pressing it firmly onto the skin with the palm of the hand for approximately 30 seconds to make sure that the patch sticks well to the skin. Make sure that the patch sticks properly at the edges.
4. FENDERMAL is usually used for 72 hours (3 days).
5. Do not expose the patch application site to heat from external sources (see Warnings and Precautions).
6. As FENDERMAL is protected by an outer waterproof backing film, you can also wear it while showering.

How to change FENDERMAL:

• Remove the patch after the period your doctor has told you. In most cases this is after 72 hours (3 days), in some patients after 48 hours (2 days). The patch does not come off by itself. If traces of the transdermal patch remain on the skin after its removal, you can clean them off using plenty of soap and water. Do not use alcohol or any other solvent.
• Fold the used patch in half with the sticky sides together. Put used patches back in the outer package and discard safely or whenever possible give it to your pharmacist.
• Apply a new patch as described above, but on another part of the skin. At least 7 days should elapse before the same area is used again.

FENDERMAL can have side effects. Not all side effects reported for FENDERMAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using FENDERMAL, please consult your healthcare provider for advice.

Stop using FENDERMAL and seek medical help immediately if you have any of these signs of an allergic reaction:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat, severe irritation, reddening or blistering of your skin.

If any of the following happens, stop taking FENDERMAL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Feeling unusually drowsy, breathing that is more slow or shallow than expected. Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible. Very rarely these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (like FENDERMAL or morphine) before.
• Fits (seizures).
• Reduced consciousness or loss of consciousness.

These are all very serious side effects. If you have them, you may have had a serious reaction to FENDERMAL. You may need urgent medical attention or hospitalisation.

Consult your doctor if any of the following side effects continue or are bothersome and occur frequently:

• Allergic reaction
• Loss of appetite
• Difficulties in sleeping
• Hallucinations (seeing or hearing things that are not there)
• Depression
• Feeling anxious or confused
• Sleepiness, nervousness, weight loss
• Headache
• Feeling dizzy
• Pins and needles (paraesthesia)
• Muscle tremors
• Spinning sensation (vertigo)
• Heartbeat feels fast or uneven (palpitations, tachycardia)
• High blood pressure
• Difficulties in breathing, shortness of breath
• Nausea, vomiting, constipation, dry mouth, heartburn
• Diarrhoea
• Stomach pain
• Increased sweating, itching (itching will usually disappear within one day after the patch has been removed)
• Skin rash, skin reddening
• Muscle spasms
• Difficulties in passing urine
• Swollen hands, ankles or feet (peripheral oedema)
• Feeling very tired, weak or generally unwell
• Feeling cold

Less frequent side effects that may occur include the following:

• An exaggerated feeling of well-being (feeling “high”), memory loss
• Feeling agitated or disoriented
• Speech disorders, excessive anxiety or fear
• Convulsions (fits)
• Being uncertain about your surroundings, becoming unconscious
• Decreased feeling or sensitivity, especially in the skin (hypoesthesia)
• Fall in blood pressure
• Dilation of the blood vessels (you may notice reddening of the skin)
• Slow heart rate
• Blue colour to the skin caused by low oxygen in the blood (cyanosis)
• Breathing problems, including asthma
• Being unable to breath
• Stopping breathing from time to time (apnoea)
• Severe spasmodic pain owing to the lack of movement of the intestines (ileus)
• Skin condition with itching, redness and a burning feeling (eczema) or other skin disorders including dermatitis
• Skin reactions at the attachment site
• Muscle twitching
• Disturbances in vision
• Blurred vision
• Constricted pupils (miosis)
• Difficulty getting and keeping an erection (impotence) or problems having sex
• Flu-like illness
• Feeling of body temperature change
• Fever
• Abdominal pain, including inflamed and irritated pancreas

Side effects that have been reported with frequency unknown:

• Lack of male sex hormones (androgen deficiency)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares)
• Loss of coordination
• Reduced vision in one eye (lazy eye)
• Irregular heartbeat (dysrhythmia)
• Abnormally slow breathing rate
• Hiccups
• Pain when passing wind
• Passing less urine than normal
• Pain in the bladder
• Tolerance (a condition that occurs when the body gets used to the medicine so that either more medicine is needed, or different medicine is needed)
• You can become dependent on FENDERMAL

FENDERMAL with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. FENDERMAL may interact with these medicines and you may experience changes to mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not there (hallucinations) and other effects such as changing blood pressure, fast heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhoea.

If you have been using FENDERMAL for some time, it might happen that FENDERMAL will become less effective for you so that a dose adjustment will be necessary (tolerance may develop). Physical and psychological dependence may develop as well and you might experience withdrawal symptoms, if you do suddenly stop using the patches. Withdrawal symptoms may be nausea, vomiting, diarrhoea, anxiety and shivering. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FENDERMAL.

• Store in sealed sachet at or below 25 °C.
• Do not remove from outer carton until required for use.
• STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN BEFORE AND AFTER USE.
• Do not use after the expiry date printed on the label or carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).