12, 25, 37.5, 50, 75, 100 micrograms / hour transdermal patch fentanyl

What Fentanyl Sandoz is and what it is used for

The name of your medicine is Fentanyl Sandoz.

The patches relieve very severely and long-lasting pain:

  • in adults who need continuous pain treatment
  • in children over 2 years of age who are already using opioid medicines and need continuous pain treatment.

Fentanyl Sandoz contains a medicine called fentanyl . It belongs to a group of strong painkillers called opioids.

Fentanyl contained in Fentanyl Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Fentanyl Sandoz

Do not use Fentanyl Sandoz

  • if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6)
  • if you suffer from pain that lasts only a short period of time, such as sudden pain or pain after a surgical procedure
  • if you have difficulty breathing with slow or shallow breathing.

Do not use this medicine if any of the above apply to you or your child. If you have any further questions, ask your doctor or pharmacist before taking Fentanyl Sandoz. 

Warnings and cautions

  • Fentanyl Sandoz can cause life-threatening side effects in people who do not already regularly take prescription opioid medicines.
  • Fentanyl Sandoz is a drug that can be life-threatening for children. This also applies to used patches. Keep in mind that a self-adhesive patch (unused or used) can be attractive to a child and if the patch sticks to the child’s skin or if the child puts it in his mouth, it can be fatal.

Depot patches that have adhered to another person

The patch should only be used on the skin of the person prescribed by the doctor. There are reported cases where a patch was accidentally stuck to a family member during close physical contact or when a bed was shared with the wearer of the patch. A patch that has adhered to another person (especially a child) can cause drugs to pass through the other person’s skin and cause serious side effects such as difficulty breathing with slow and shallow breathing, which can be fatal. If the patch has adhered to another person’s skin, remove the patch immediately and consult a physician.

Take special care with Fentanyl Sandoz

Talk to your doctor or pharmacist before using this medicine if any of the following apply to you – your doctor may need to examine you more carefully about:

  • Have you ever had problems with your lungs or breathing?
  • Have you ever had problems with your heart, liver, kidneys, or had low blood pressure?
  • You’ve ever had a brain tumor
  • Have you ever had a prolonged headache or a head injury
  • You are older – you may be more sensitive to the effects of this medicine
  • You have a disease called myasthenia gravis when the muscles become weak and tired quickly
  • Have you ever abused or been addicted to alcohol, prescription drugs, or illegal drugs.

If any of the above apply to you (or you feel unsure), talk to your doctor or pharmacist before using Fentanyl Sandoz.

Adverse event s and Fentanyl Sandoz

  • Fentanyl Sandoz may make you unusually sleepy and cause you to breathe more slowly and shallowly. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Fentanyl Sandoz or morphine). If you or your partner or caregiver notice that the person wearing the patch is unusually sleepy and is breathing slowly or shallowly:
    • Remove the patch
    • Call a doctor or go to the nearest hospital immediately
    • Make sure the person is moving and talking as much as possible
  • If you get a fever while using Fentanyl Sandoz, tell your doctor – it may cause an increased amount of medicine to pass through your skin.
  • Fentanyl Sandoz can cause constipation. Consult a doctor or pharmacist for help in preventing or treating constipation.
  • Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it. See section 4 for a complete list of possible side effects.

When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths, bathe or take hot whirlpool baths. If you do this, you may get an increased amount of medication from the patch.

Other medicines and Fentanyl Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. You should also tell your pharmacist that you are taking Fentanyl Sandoz if you buy any medicines at the pharmacy.

Your doctor will know which medicines are safe to take with Fentanyl Sandoz. If you are taking any of the types of medicines listed below or if you stop taking any of these, you may need to be closely monitored as it may affect the dose of FentanylSandoz you need.

Above all, tell your doctor or pharmacist if you are taking:

  • Other painkillers, such as opioid painkillers (such as buprenorphine, nalbuphine, or pentazocine)
  • Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem)
  • Medicines that make you feel calmer (sedatives such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental problems (antipsychotics such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines)
  • Muscle relaxants (such as cyclobenzaprine or diazepam ) 
  • Some medicines used to treat depression, called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine ) – see below for more information
  • Some medicines for depression or Parkinson’s disease called MAO inhibitors(such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not take Fentanyl Sandoz within 14 days of stopping these medicines – see below for more information
  • Some antihistamines, especially those that make you sleepy (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine) 
  • Some antibiotics used for infection (such as erythromycin or clarithromycin)
  • Medicines for fungal infections (such as itraconazole, ketoconazole , fluconazoleor voriconazole)
  • Drugs for HIV – infection’s (such as ritonavir)
  • Drugs for irregular heartbeat (such as amiodarone, diltiazem, or verapamil)
  • Medicines for tuberculosis (such as rifampicin)
  • Some medicines for epilepsy (such as carbamazepine, phenobarbital, or phenytoin)
  • Some medicines for nausea or motion sickness (such as phenothiazines)
  • Some medicines for heartburn or stomach ulcers (such as cimetidine)
  • Some medicines for angina (chest pain) or high blood pressure (such as nicardipine)
  • Some medicines are used to treat blood cancer (such as idelalisib).

Fentanyl Sandoz with antidepressants

The risk of side effects is increased if you take medicines such as certain medicines for depression. Fentanyl Sandoz may interact with these medicines and you may find that your mental status changes so that you, for example, feel anxious or see, feel, hear or smell something that does not exist (hallucinations) and experience other effects such as altered blood pressure, fast heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

Use with drugs that suppress the central nervous system, e.g. benzodiazepines, alcohol, and certain narcotic drugs 

Tell your doctor if you are taking any other medicines that suppress your central nervous system ( CNS depressant medicines). CNS antidepressants are, for example, medicines that make you sleepy, alleviate anxiety, or reduce attention (see also Other medicines and Fentanyl Sandoz). Alcohol and certain narcotic drugs also suppress the central nervous system. Taking such medicines with Fentanyl Sandoz can lead to drowsiness, diminished attention, difficulty breathing with slow or shallow breathing, coma, or death. Due to this, concomitant use should only be considered when other treatment options are not possible.

If your doctor still prescribes Fentanyl Sandoz together with sedatives, your doctor should limit the dose and the duration of treatment. Follow your doctor’s recommendation carefully. It may be a good idea to inform friends or relatives that they should be aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Do not drink alcohol while taking Fentanyl Sandoz unless you have first consulted your doctor.

Operations

If you think you may be taking anesthesia, tell your doctor or dentist that you are using Fentanyl Sandoz.

Pregnancy and breastfeeding

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. 

Fentanyl Sandoz should not be used during pregnancy unless you have first discussed this with your doctor.

Fentanyl Sandoz should not be used during childbirth, as it may affect the breathing of the newborn baby. 

Do not use Fentanyl Sandoz if you are breast-feeding. You should not breast-feed for 3 days after removing Fentanyl Sandoz transdermal patches. The reason for this is that the drug can pass into breast milk.

Driving and using machines

Fentanyl Sandoz can affect your ability to drive and use machines or tools as it may make you drowsy or dizzy. If this happens, do not drive or use any tools or machines. Do not drive while using this medicine until you know how it affects you.

If you are not sure if it is safe for you to drive a vehicle while you are taking this medicine, talk to your doctor or pharmacist.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Fentanyl Sandoz

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide which strength of Fentanyl Sandoz is most suitable for you. The doctor bases his assessment on how severe your pain is, your general condition, and the type of pain treatment you have received so far. 

Use and change patches

  • There is enough medicine in each patch to last for 3 days (72 hours).
  • You should change your patch every three days unless your doctor has told you otherwise.
  • Always remove the old patch before applying the new one.
  • Always change patches at the same time of day every three days (72 hours).
  • If you use more than one patch, change all patches at once.
  • Write down the day, date, and time for when you apply the patch, so that you know when you need to change your patch.
  • The following table shows you when it is time to change patches:
Put on your patch at Change your patch on
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday
Friday Monday
Saturday Tuesday
Sunday Wednesday

Here you put on the patch

Adults

  • Apply the patch on a flat part of your upper body or arm (not over a joint).

Children 

  • Always put the patch on the upper back so that the child does not have access to or remove the patch.
  • Check from time to time if the patch remains on the skin.
  • Your child mustn’t take the patch and put it in his mouth as it can be life-threatening and even fatal.
  • Observe your child very closely for 48 hours after:
    • The first patch has been applied
    • A higher dose patch has been applied.
  • It may take some time for the patch to take full effect. Therefore, your child may also need to take other painkillers before the patches take effect. Your doctor will talk to you about this.

Adults and children:

Do not attach the patch

  • The same place twice in a row
  • Skin surfaces that move a lot (joints), skin that is irritated or has sores
  • Skin with a lot of hair. If there is hair, do not shave it off (shaving irritates the skin). Instead, cut the hair as close to the skin as possible.

Put on a patch

Step 1: Prepare the skin

  • Make sure the skin is completely dry, clean, and cool before applying the patch.
  • If you need to clean your skin, use only cold water.
  • Do not use soap or other detergents, creams, moisturizing lotions, oils, or talcum powder before applying the patch.
  • Do not apply a patch immediately after a hot bath or shower.

Step 2: Open the envelope

  • Each patch is enclosed in a separate envelope.
  • Tear open the envelope in the notch indicated by the arrow.
  • Carefully tear off the edge of the envelope completely.
  • Hold both sides of the opened envelope and pull them apart.
  • Take out the patch and apply it immediately.
  • Save the empty envelope so that you can put your used patch in the latter when the patch is to be thrown away.
  • Each patch should only be used once.
  • Do not remove the patch from the envelope until you are ready to use it.
  • Check that the patch is not damaged.
  • Do not use the patch if it has been split, cut, or looks damaged.
  • Never divide or cut the patch.

Step 3: Pull off and press firmly

  • Make sure that the patch will be covered by loose clothing and that it will not sit under a tight or elastic band.
  • Carefully pull one-half of the glossy protective film away from the center of the patch. Avoid touching the adhesive side of the patch.
  • Press the adhesive side of the patch onto the skin.
  • Remove the second protective film and press the entire patch onto the skin using the palm of your hand.
  • Press for at least 30 seconds. Make sure it fits well, especially at the edges.

Step 4: Discard the patch

  • As soon as you remove the patch, fold it carefully in the middle so that the adhesive side sticks together.
  • Put it back in its original envelope and discard the envelope according to the pharmacist’s instructions.
  • Keep used patches out of the reach and sight of children – even used patches contain some medicines that can harm children and can even be fatal.

Step 5: Wash

  • Always wash your hands with clean water only after handling the patch.

More about using Fentanyl Sandoz

Everyday activities when the patch is used

  • The patches are water-resistant.
  • You can shower or bathe while wearing the patch, but do not rub on the patch itself.
  • If your doctor agrees, you can exercise and participate in sports activities while wearing the patch.
  • You can also swim while wearing the patch, but:
    • Do not bathe in hot tubs.
    • Do not apply tight or elastic bands over the patch.
  • When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or sun lamps. You should not sunbathe, take long hot baths or take a sauna. If you do this, you may get an increased amount of medication from the patch.

How quickly do the patches take effect?

  • It may take some time for your first patch to take full effect.
  • Your doctor may also give you other painkillers for the first day.
  • After that, the patch should relieve the pain continuously so that you can stop taking other painkillers, but your doctor may prescribe other painkillers from time to time.

How long will you use the patches?

  • Fentanyl Sandoz patches are intended for long-term pain. Your doctor can tell you how long you can expect to use the patches.

If your pain worsens

  • If your pain worsens while you use the patches, your doctor may try to give you patches with higher strength or additional painkillers (or both).
  • If it does not help to increase the strength of the patches, your doctor may stop using the patches.

If you use too many patches or patches with the wrong strength

If you have applied too many patches or patches with the wrong strength, remove the patches and contact a doctor immediately. 

Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, lethargy, dizziness, and confusion.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to change your patch

  • If you forget to change your patch, do it as soon as you can and write down the day and time.
  • Change the patch again after 3 days (72 hours) as usual.
  • If you are very late in changing your patch, talk to your doctor, as you may need more painkillers, but do not put on an extra patch.

If a patch comes off

  • If a patch comes off before it is time to change, immediately apply a new one and write down the day and time. Apply a new skin surface on:
    • Your upper body or arm
    • The upper part of your baby’s back.
  • Let your doctor know that this has happened and leave the patch on for another 3 days (72 hours), or the time your doctor specifies before changing to a new patch as usual.
  • If your patches constantly come off, talk to a doctor, pharmacist, or nurse.

If you want to stop using the patches

  • Talk to your doctor before stopping using these patches.
  • If you have been using them for a long time, your body may have become accustomed to them. If you suddenly quit, you may start to feel unwell.
  • If you stop using the patches, do not start again without first asking your doctor. You may need a different strength of the patches when you start again.

If you have any further questions on the use of this product, ask your doctor or pharmacist. 

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you or your partner or caregiver notice any of the following in the person using the patch, remove the patch and call a physician or go to the nearest hospital immediately. The person may need immediate medical attention.

  • Unusual drowsiness, slower or shallower breathing than expected. Follow the advice above and make sure the person who used the patch moves and talks as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have never used strong painkillers with opioids (such as Fentanyl Sandoz or morphine). (Uncommon, may affect up to 1 in 100 people.)
  • Sudden swelling of the face or throat, severe irritation, redness, or blistering of your skin. This may be a sign of a severe allergic reaction. (Has been reported, occurs in an unknown number of users.)
  • Seizures. (Uncommon, may affect up to 1 in 100 people.)
  • Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people.)

The following side effects have also been reported

Very common (may affect more than 1 user in 10)

  • Nausea, vomiting, constipation
  • Sleepiness ( somnolence )
  • Dizziness
  • Headache

Common (may affect up to 1 in 10 people)

  • Allergic reaction
  • Loss of appetite
  • Difficulty sleeping
  • Depression
  • The feeling of anxiety and confusion
  • To see, feel, hear or smell something that does not exist (hallucinations)
  • Shaking or muscle twitching
  • Abnormal sensation in the skin, such as tingling or crawling sensation ( paresthesias )
  • Dizziness (fraud)
  • Rapid or irregular heartbeat ( palpitation, tachycardia )
  • High blood pressure
  • Shortness of breath ( dyspnoea )
  • Diarrhea
  • Dry mouth
  • Abdominal pain or indigestion
  • Significantly increased sweating
  • Itching , rash, or redness of the skin
  • Inability to urinate or empty bladder properly
  • Severe fatigue, weakness, or general malaise
  • To feel frozen
  • Swollen hands, ankles, or feet (peripheral edema ).

Uncommon (may affect up to 1 in 100 people)

  • Feeling anxious or confused
  • A strong feeling of happiness ( euphoria )
  • Decreased sensation or sensitivity, especially in the skin ( hypoesthesia )
  • Memory loss
  • Dimsyn
  • Slow heartbeat ( bradycardia ) or low blood pressure
  • Blue skin caused by low oxygen content in the blood (cyanosis)
  • Intestinal cramps ( ileus )
  • Itchy skin rash ( eczema ), an allergic reaction, or other skin conditions where the patch is located
  • Flu-like illness
  • The feeling of change in body temperature 
  • Fever
  • Muscle twitching
  • Difficulty getting and maintaining an erection ( impotence ) or problems having sex

Rare side effects are (may affect up to 1 in 1000 users)

  • Condensed pupils are ( mios )
  • Temporary respiratory arrest ( apnea )

No known frequency (cannot be calculated from the available data)

  • Lack of male sex hormone (androgen deficiency)
  • Delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist, sleep disturbance, nightmares)

You may notice a rash, redness, or slight itching in the skin where the patch is located. This is usually mild and disappears once you have removed the patch. If it does not disappear or if the patch irritates the skin very much, tell your doctor.

Repeated, long-term treatment with the patches may make the medicine less effective (you will become “tolerant” of it) or make you addicted to it. 

If you switch from another painkiller to Fentanyl Sandoz or if you suddenly stop using Fentanyl Sandoz, you may experience withdrawal symptoms such as vomiting, nausea, diarrhea, anxiety, or shaking. Tell your doctor if you get any of these symptoms.

There are also reports of newborns experiencing withdrawal symptoms after their mothers have been using Fentanyl Sandoz for a long time during pregnancy.

5. How to store Fentanyl Sandoz

Keep all patches (used and unused) out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton and envelope after EXP. or EXP. The expiration date is the last day of the specified month. If the patches have passed their expiry date, take them to your pharmacist.

Store in the original package.

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.

If a used or unused patch is accidentally stuck on another person, especially a child, it can be fatal.

Used patches should be folded so that the adhesive side of the patch is glued together. It should then be put back in the original envelope and kept out of sight and reach of other persons, especially children until it is disposed of safely.

6. Contents of the packaging and other information

Content declaration

The active substance is fentanyl.

Fentanyl Sandoz 12 micrograms / hour transdermal patch 
A transdermal patch releases 12.5 micrograms of fentanyl per hour. A5.25 cm 2transdermal patch contains 2.1 mg of fentanyl .

Fentanyl Sandoz 25 micrograms / hour transdermal patch
One transdermal patch releases 25 micrograms of fentanyl per hour. A10.5 cm 2transdermal patch contains 4.2 mg of fentanyl .

Fentanyl Sandoz 37.5 micrograms / hour transdermal patch 
A transdermal patch releases 37.5 micrograms of fentanyl per hour. A15.75 cm 2transdermal patch contains 6.3 mg of fentanyl .

Fentanyl Sandoz 50 micrograms / hour transdermal patch
A transdermal patch releases 50 micrograms of fentanyl per hour. A21 cm 2transdermal patch contains 8.4 mg of fentanyl .

Fentanyl Sandoz 75 micrograms / hour transdermal patch
A transdermal patch releases 75 micrograms of fentanyl per hour. A transdermal patch of 31.5 cm 2 contains 12.6 mg of fentanyl .

Fentanyl Sandoz 100 micrograms / hour transdermal patch
A transdermal patch releases 100 micrograms of fentanyl per hour. A transdermal patch of 42 cm 2 contains 16.8 mg of fentanyl .

The other ingredients are 
Protective film (removed before applying the patch to the skin): 
Polyethylene terephthalate foil, siliconized 
Adhesive matrix layer: 
Acrylic ‑ vinyl acetate copolymer 
Outer plastic film: 
Polyethylene terephthalate 
foil Printing ink

What the medicine looks like and the contents of the pack

Fentanyl Sandoz is a transparent, rounded, elongated patch with a print that has a self-adhesive matrix layer and is protected with a protective film (must be removed before the patch is attached) so that the patch can be attached to the skin.

Fentanyl Sandoz is available in packs of 1, 2, 3, 4, 5, 7, 8, 10, 14, 16, and 20 transdermal patches. Hospital packaging with 5 transdermal patches.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

Manufacturer

HEXAL AG

Industriestr. 25

83607 Holzkirchen

Germany

Muhammad Nadeem

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