Fentanyl transdermal patch 100 mcg. 5 patch

Fentanyl transdermal patch 100 mcg. 5 patch
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Fentanyl belongs to a group of strong painkillers called opioids. Analgesic efficacy is achieved after fetanil pass slowly from the patch through the skin and from there into the body.

Fentanyl transdermal patch is used for treatment of severe and persistent pain, which can be influenced only by adequately powerful analgesics (opioid analgesics).

Fentanyl is used for long-term treatment of severe and persistent pain in children older than 2 years who have previously been treated with other strong painkillers.

2. BEFORE YOU USE Fentanyl
Do not use Fentanyl:
if you are hypersensitive (allergic) to fentanyl or any of the other ingredients of the product;
if you suffer from pain which lasts only for a short period of time, eg. pain after the surgical procedure;
if your central nervous system is severely impaired (brain and spinal cord), for example from craniocerebral trauma.
Take special care with Fentanyl
Fentanyl is a medicinal product that can be dangerous to children's lives.
This applies even when the transdermal patches are already used.
Keep in mind that the design of this product may be interesting for the child.
Fentanyl is possible to cause life-threatening side-effects in persons that are not regularly used opioid products.
Your doctor will use Fentanyl as part of a comprehensive treatment of pain and will monitor regularly how you respond to treatment with Fentanyl.
Before starting to use Fentanyl should inform your doctor if you suffer from any of the following diseases. With their risk of adverse drug reactions following administration of Fentanyl is high and / or may need Your doctor may prescribe a lower dose:
asthma, respiratory depression or any lung disease;
low blood pressure;
impaired liver function;
impaired renal function;
if you had a head injury, brain tumor, signs of increased intracranial pressure (eg headache, visual disturbances), changes in the state of consciousness, loss of consciousness or coma;
delayed and irregular heartbeat (bradyarrhythmias)
myasthenia gravis (a disease causing tiredness and weakness of the muscles).
Tell your doctor if you have fever during treatment, as at elevated temperature through the skin in your body can pass too much of the drug. For the same reason you should avoid exposing the patch placed on the skin to direct heat such as heating pads, electric blankets, heated water beds, heat lamps and tanning (solarium), intensive sunbathing, hot water bottles, sauna , long hot baths or spa treatments in the pool with warm water. Is allowed to be exposed to sunlight, but in hot summer days the patch should be protected with part of your clothing. Fentanyl transdermal patch contains metal. Before carrying out the nuclear magnetic resonance it is necessary to remove the patch, since during the procedure, it is possible to heat up strongly and burn the skin surface.
Prolonged use of Fentanyl can lead to onset of tolerance to the drug, physical and psychological dependence observed in rare cases in the treatment of pain caused by cancer.
If you are very old or very bad physical condition (and weak) Your doctor will closely monitor you and may need to prescribe a treatment with low doses.
The patches should not be cut into smaller parts, because the quality, efficacy and safety of the divided patches have not been demonstrated.

Use in children and adolescents
Fentanyl should only be used in children and adolescents aged 2 years who have previously been treated with other strong painkillers (eg. Morphine). Fentanyl should not be used in infants and toddlers under 2 years of age.
To protect children from accidental ingestion necessary place for the application of Fentanyl transdermal patch is selected carefully (see section 3. "How to use Fentanyl") and monitored regularly that the patch is tightly adhered to the skin.

Taking other medicines
Please tell your doctor if you use barbiturates (used for treating sleep disorders), buprenorphine, nalbuphine or pentazocine (other strong painkillers). Concomitant use of these drugs Fentanyl is not recommended.
Please tell your doctor if you are taking or have taken within the last 14 days MAO inhibitors (eg. Moclobemide against depression or selegiline against Parkinson's disease). If these products are taken with Fentanyl may increase their toxicity.
If you take Fentanyl with drugs that affect brain function there is a greater chance that you may experience adverse effects, especially breathing difficulties. This applies for example to:
Medicines used for treating anxiety (tranquillizers)
Medicines used to treat psychiatric disorders (neuroleptics)
Anesthetics; if you are having procedures, applying anesthetic, tell the doctor or dentist that you are using Fentanyl;
Medicines used to treat sleep disorders (hypnotics, sedatives);
Medicines used for treating allergies or travel sickness (antihistamines / antiemetics);
Other strong-acting painkillers (opioids);
Some drugs for the treatment of back pain or other conditions of the musculo-skeletal system, passing with pain (musculoskeletal relaxants);
You should not take the following medicines with Fentanyl, except in the event that your doctor carefully monitored.
These medicines may increase the effects and side effects of Fentanyl. This applies for example to:
ritonavir (used to treat AIDS);
ketoconazole, itraconazole (used for the treatment of diseases caused by fungi);
diltiazem (to treat heart disease);
cimetidine (used to treat gastrointestinal diseases);
macrolide antibiotics (used to treat infections).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Use of Fentanyl with food and drink
Concomitant use of Fentanyl alcohol increases the risk of serious side effects and can cause difficulty breathing, decreased blood pressure, profound sedation (very calming and relaxing) and coma. During treatment with Fentanyl should not drink alcohol.

Pregnancy and lactation
Ask your doctor or pharmacist before uses any other medicine.
Do not use Fentanyl during childbirth and in the perinatal period (including caesarean section) because fetanil crosses the placental barrier and can suppress respiration in the newborn child. If you become pregnant during treatment with Fentanyl, consult your doctor. Fentanyl should not be used during pregnancy and lactation, unless strictly necessary. Safe use during pregnancy has not been established. Fentanyl passes into breast milk and may cause adverse reactions in nursing infants, such as sedation (excessive sedation) and respiratory depression. Breast milk produced during treatment or within 72 hours after removal of the last patch should be discarded.

Driving and using machines
Fentanyl has a major influence on the ability to drive and use machines especially at the beginning of treatment, at any change of dosage as well as ingestion of alcohol or tranquilizers. If you are using a constant dose of Fentanyl for an extended period of time, your doctor may resolve whether to drive or operate hazardous machinery. While taking Fentanyl should not drive or operate dangerous machines if your doctor is allowed.

3. HOW TO USE Fentanyl
Always use Fentanyl exactly as your doctor has prescribed. If you are unsure, ask your doctor or pharmacist.
Your doctor will evaluate your general condition, the severity of your pain and healing that you have been until now, and will decide on the most appropriate concentration for you.
Depending on how you respond to treatment may be required strength of the patch and the number of patches to be changed. Effect of pain relief was achieved within 24 hours of placing the first patch and fall gradually after removal. Do not stop treatment without consulting your doctor.
The action of the first patch occurs slowly and may take a day. While fentanyl transdermal patch starts working completely, your doctor may order additional other painkillers. After Fentanyl relieve pain permanently, you can stop the additional intake of painkillers. Sometimes you may need additional application of painkillers.

Use in children and adolescents
Fentanyl should only be used in children and adolescents aged 2 years who have previously been treated with other strong painkillers (eg. Morphine). Fentanyl should not be used in infants and toddlers under 2 years of age.

How to apply Fentanyl
Find a flat, non-inflamed area in the upper part of your body or upper arm, where the skin is without hair, cuts, spots or other skin blemishes.
If the skin is hairy cut the hair with scissors. Do not shave place 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 the patch.
Before applying the patch should be inspected. Patches that are cut, broken or damaged should not be applied.
To remove the protective bag Fentanyl first stumbles near the end of arrow on the label on the bag, then gently away. If using scissors to open the pouch it must be done near the sealed portion, so as not to damage the inner surface.
The patch should be affixed immediately after opening the package. After the release strip is removed, the patch is applied to the skin and pressed firmly with the palm of the hand for about 30 seconds to ensure that the patch is adhered well to the skin. Take special care that the patch is close fitting at the ends.
Fentanyl transdermal patch is used for a period of 72 hours (3 days). On the outside of the package you can write the date and time that you applied the patch. This may help you remember when to replace your patch.
Application site of the patch should not be exposed to heat from external sources (See "special measures required in application of Fentanyl).
The transdermal patch is protected by a waterproof outer layer and can be worn while you take a shower.
In children, it is preferable to apply the patch to the skin of the upper back, in order to prevent the possibility of removal.
How to replace the transdermal patch
The patch is removed after the time which is determined by your doctor. In most cases this is after 72 hours (3 days), but in some patients after 48 hours (2 days). Usually the patch does not fall by itself. If the traces left on the skin by transdermal patch, they can be washed thoroughly with soap and water.
Fold the used patch in half so that its ends from the adhesive surface to adhere to each other. Put back used patches in the outer package and hand in to your pharmacist.
Apply a new patch as described above, but a different area of ​​skin. Must pass at least 7 days before the same place can be used again.
If you take more dose of Fentanyl
If you're stuck on more patches than prescribed, remove the patches and contact your doctor or hospital to assess the possible risk.
The most common sign of overdose is reduced ability to breathe. The patient's symptoms are slow or shallow breathing. If this occurs - the patches are removed and seek immediate medical attention. While waiting for the doctor, the patient is kept awake through conversation or shaking.
Other signs and symptoms of overdose are drowsiness, low body temperature, slow heart rate, decreased muscle tone, hypotension, profound sedation, loss of muscle co-ordination, constriction of the pupils and convulsions.

If you forget to use Fentanyl
Under no circumstances use a double dose.
You should change your patch at the same time of day every three days (72 hours), unless otherwise prescribed by your doctor. If you forget, then change your patch as soon as you remember. If you are very late changing your patch then you should contact your doctor because it may need extra painkillers.

If you stop using Fentanyl
If you wish to interrupt or stop treatment, you surely should consult with your doctor about the reasons for the termination and how to continue your treatment.
Prolonged use of Fentanyl can lead to physical dependence. If you stop using Fentanyl transdermal patch may become unwell. Never stop treatment with Fentanyl transdermal patch at your discretion, first consult your doctor. Upon abrupt cessation of treatment the risk of occurrence of withdrawal symptoms it (nausea, vomiting, diarrhea, irritability and muscle tremor) is higher.

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

Like all medicines, Fentanyl can cause side effects, although not everybody gets them.
Adverse reactions are classified according to the following frequency data:
Very common: Affects more than 1 in 10 patients;
Common: affects less than 1 in 10 but more than 1 in 100 patients;
Uncommon: affects less than 1 in 100 but more than 1 in 1000 patients;
Rare: affects less than 1 in 1000 but more than 1 in 10,000 patients;
Very rare: affects less than 1 in 10,000 patients, including isolated cases.
If you experience any of the following serious, but very rare side effects you should discontinue treatment immediately and contact your doctor or visit a hospital: severe respiratory depression (severe breathlessness, wheezing with breathing) or complete violation of the function of the digestive tract (convulsive pain, vomiting, flatulence).

Other adverse reactions:
Very common: somnolence, headache, dizziness, nausea, vomiting, constipation.

Common: redness of the eyes, loss of appetite, sedation (calming), sleep disorders, depression, generalized anxiety, confusional state, hallucinations, nervousness, involuntary twitching, numbness and tingling with pins and needles, dizziness of heights uncomfortable feeling or highly irregular heartbeat, increased blood pressure, difficulty breathing, diarrhea, dry mouth, decreased salivation or absence of saliva, stomach pain, indigestion, excessive sweating, skin reactions at the injection site, itching, rash, redness (erythema), muscle spasms, difficulty urinating, unusual lethargy or fatigue (depressant effect on brain function), loss of physical strength, general discomfort (malaise), feeling cold.

Uncommon: agitation, disorientation, euphoric mood, memory loss, decreased sensitivity, particularly of the skin, convulsions (incl. Clonic and type "grand mal"), speech disorders, decreased blood pressure and decreased heart rate, bluish skin, disordered breathing (respiratory depression), blockage, eczema, dermatitis. Rash, redness and itching of the skin that usually disappear within one day after the removal of the patch. Muscle twitching, impotence in men, sexual dysfunction, skin reactions at the injection site, flu-like illness, withdrawal symptoms, sense of body temperature.

Rare: contraction of the pupil of the eye, irregular heart beat, dilation of blood vessels, stopping breathing (apnea), too shallow or too slow breathing, which does not meet the needs of the body (hypoventilation), hiccups, complete dysfunction of the digestive tract .
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