More about using Fentanyl Lavipharm<\/strong>
<\/p>\n\n\n\nEveryday activities when the patch is used<\/strong><\/p>\n\n\n\n- The patches are water-resistant.<\/li>
- You can shower or bathe while wearing the patch, but do not rub on the patch itself.<\/li>
- If your doctor agrees, you can exercise and participate in sports activities while wearing the patch.<\/li>
- You can also swim while wearing the patch, but:
- Do not bathe in hot tubs.<\/li>
- Do not apply tight or elastic bands over the patch.<\/li><\/ul><\/li>
- 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.<\/li><\/ul>\n\n\n\n
How quickly do the patches take effect?<\/strong><\/p>\n\n\n\n- It may take some time for your first patch to take full effect.<\/li>
- Your doctor may also give you other painkillers for the first day.<\/li>
- 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.<\/li><\/ul>\n\n\n\n
How long will you use the patches?<\/strong><\/p>\n\n\n\n- Fentanyl Lavipharm patches are intended for long-term pain. Your doctor can tell you how long you can expect to use the patches.<\/li><\/ul>\n\n\n\n
If your pain worsens<\/strong><\/p>\n\n\n\n- 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).<\/li>
- If it does not help to increase the strength of the patches, your doctor may stop using the patches.<\/li><\/ul>\n\n\n\n
If you use too many patches or patches with the wrong strength<\/h2>\n\n\n\n
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.
<\/p>\n\n\n\n
If you have applied too many patches or patches with the wrong strength, remove the patches and contact a doctor immediately.
<\/p>\n\n\n\n
Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, lethargy, dizziness, and confusion.<\/p>\n\n\n\n
If you forget to change your patch<\/strong><\/p>\n\n\n\n- 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)<\/strong> as usual.<\/li>
- If you are very late in changing your patch, talk to your doctor, as you may need more painkillers, but do not<\/strong> put on an extra patch.<\/li><\/ul>\n\n\n\n
If a patch comes off<\/strong><\/p>\n\n\n\n- 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:<\/li>
- Your upper body or arm<\/li>
- The upper part of your baby’s back.<\/li>
- Let your doctor know that this has happened and leave the patch on for another 3 days (72 hours), or the time specified by your doctor, before changing to a new patch as usual.<\/li>
- If your patches constantly come off, talk to a doctor, pharmacist, or nurse.<\/li><\/ul>\n\n\n\n
If you want to stop using the patches<\/strong><\/p>\n\n\n\n- Talk to your doctor before stopping using these patches.<\/li>
- 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.<\/li>
- 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.<\/li><\/ul>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, this medicine can cause side effects, although not everybody gets them.
<\/p>\n\n\n\n
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.<\/strong><\/p>\n\n\n\n- Unusual drowsiness, slower or shallower breathing than expected.<\/li>
- 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 Lavipharm or morphine). (Uncommon, may affect up to 1 in 100 people)<\/li>
- Sudden swelling of the face or throat, severe irritation, redness, or blistering of your skin.<\/li>
- This may be a sign of an allergic reaction. (Has been reported (occurs in an unknown number of users))<\/li><\/ul>\n\n\n\n
- Seizures. (Uncommon, may affect up to 1 in 100 people.)<\/li>
- Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people.)<\/li><\/ul>\n\n\n\n
The following <\/strong>side effects<\/strong> have also been reported<\/strong><\/strong>
<\/p>\n\n\n\nVery common (may affect more than 1 in 10 people)<\/strong><\/p>\n\n\n\n- Nausea, vomiting, constipation<\/li>
- Sleepiness ( somnolence )<\/li>
- Dizziness<\/li>
- Headache<\/li><\/ul>\n\n\n\n
Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n- Allergic reaction<\/li>
- Loss of appetite<\/li>
- Difficulty sleeping<\/li>
- Depression<\/li>
- The feeling of anxiety and confusion<\/li>
- To see, feel, hear or smell something that does not exist (hallucinations)<\/li>
- Shaking or muscle twitching<\/li>
- Abnormal sensation in the skin, such as tingling or crawling sensation ( paresthesias )<\/li>
- Dizziness (fraud)<\/li>
- Rapid or irregular heartbeat ( palpitation, tachycardia )<\/li>
- High blood pressure<\/li>
- Shortness of breath ( dyspnoea )<\/li>
- Diarrhea<\/li>
- Dry mouth<\/li>
- Abdominal pain or indigestion<\/li>
- Significantly increased sweating<\/li>
- Itching, rash, or redness of the skin<\/li>
- Inability to urinate or empty bladder properly<\/li>
- Severe fatigue, weakness, or general malaise<\/li>
- To feel frozen<\/li>
- Swollen hands, ankles, or feet (peripheral edema ).<\/li><\/ul>\n\n\n\n
Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n- Feeling anxious or confused<\/li>
- A strong feeling of happiness ( euphoria )<\/li>
- Decreased sensation or sensitivity, especially in the skin ( hypoesthesia )<\/li>
- Memory loss<\/li>
- Dimsyn<\/li>
- Slow heartbeat ( bradycardia ) or low blood pressure<\/li>
- Blue skin caused by low oxygen content in the blood (cyanosis)<\/li>
- Intestinal cramps ( ileus )<\/li>
- Itchy skin rash ( eczema ), an allergic reaction, or other skin conditions where the patch is located<\/li>
- Flu-like illness<\/li>
- The feeling of change in body temperature<\/li>
- Fever<\/li>
- Muscle twitching<\/li>
- Difficulty getting and maintaining an erection ( impotence ) or problems having sex<\/li><\/ul>\n\n\n\n
Rare (may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n- Condensed pupils are ( mios )<\/li>
- Temporary respiratory arrest ( apnea )<\/li><\/ul>\n\n\n\n
No known frequency (cannot be calculated from the available data)<\/strong><\/p>\n\n\n\n- Lack of male sex hormone (androgen deficiency)<\/strong><\/li>
- Delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist, sleep disturbance, nightmares)<\/li><\/ul>\n\n\n\n
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.
<\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
If you switch from another painkiller to Fentanyl Lavipharm or if you suddenly stop using Fentanyl Lavipharm, you may experience withdrawal symptoms such as nausea, diarrhea, anxiety, or shaking. Tell your doctor if you get any of these symptoms.
<\/p>\n\n\n\n
There are also reports of newborns experiencing withdrawal symptoms after their mothers have been using Fentanyl Lavipharm for a long time during pregnancy.
<\/p>\n\n\n\n
5. How to store Fentanyl Lavipharm<\/h2>\n\n\n\n
Storage space<\/strong><\/p>\n\n\n\nKeep all patches (used and unused) out of the reach and sight of children.
<\/p>\n\n\n\n
Storage time<\/strong><\/p>\n\n\n\nUse Fentanyl Lavipharm before the expiry date which is stated on the carton and envelope. The expiration date is the last day of the specified month. If the patches have passed their expiry date, take them to your pharmacist.<\/p>\n\n\n\n
Do not store above 25 \u00b0 C.<\/p>\n\n\n\n
Store in the original package. Moisture sensitive.
<\/p>\n\n\n\n
How to dispose of used patches or patches you no longer need<\/strong><\/p>\n\n\n\nIf a used or unused patch is accidentally stuck on another person, especially a child, it can be fatal.
<\/p>\n\n\n\n
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. Ask your pharmacist how to dispose of medicines no longer required.
<\/p>\n\n\n\n
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n
The active substance is fentanyl.
<\/p>\n\n\n\n
Each Fentanyl Lavipharm 12 microgram \/ hour 5 cm 2 <\/sup>transdermal patch contains 1.375 mg of fentanyl and releases 12.5 micrograms of fentanyl per hour.<\/sup>
<\/p>\n\n\n\nEach Fentanyl Lavipharm 25 microgram \/ hour 10 cm 2 <\/sup>transdermal patch contains 2.75 mg of fentanyl and releases 25 micrograms of fentanyl per hour.<\/sup>
<\/p>\n\n\n\nEach Fentanyl Lavipharm 50 microgram \/ hour 20 cm 2 <\/sup>transdermal patch contains 5.5 mg of fentanyl and releases 50 micrograms of fentanyl per hour.<\/sup>
<\/p>\n\n\n\nEach Fentanyl Lavipharm 75 microgram \/ hour 30 cm 2 <\/sup>transdermal patch contains 8.25 mg of fentanyl and releases 75 micrograms of fentanyl per hour.<\/sup>
<\/p>\n\n\n\nEach Fentanyl Lavipharm 100 microgram \/ hour 40 cm 2 <\/sup>transdermal patch contains 11.0 mg of fentanyl and releases 100 micrograms of fentanyl per hour.<\/sup>
<\/p>\n\n\n\nOther ingredients are:
<\/p>\n\n\n\n
Adhesive (with the active substance and against the skin)
<\/strong>Silicone adhesive (polydimethylsiloxane, silicate resin)<\/p>\n\n\n\nPolydimethylsiloxane
<\/p>\n\n\n\n
Cover and protective film<\/strong><\/p>\n\n\n\nPolyethylene terephthalate film coated with a fluoropolymer
<\/p>\n\n\n\n
Back<\/strong><\/p>\n\n\n\nPigmented polyethylene terephthalate \/ ethylene-vinyl acetate copolymer film
<\/p>\n\n\n\n
Release regulating diaphragm<\/strong><\/p>\n\n\n\nEthylene-vinyl acetate copolymer film
<\/p>\n\n\n\n
Printing ink<\/strong><\/p>\n\n\n\nBeige and orange or red or green or blue or gray.
<\/p>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Fentanyl Lavipharm transdermal patch is rectangular with rounded corners and is marked on the back with:<\/p>\n\n\n\n
- beige, diagonal stripes with a repeat of \u201cFentanyl\u201d in orange font, if every other orange, diagonal stripes with a repeat of \u201c12 \u03bcg \/ h\u201d in beige font or<\/li><\/ul>\n\n\n\n
- beige, diagonal stripes with repetition of ‘Fentanyl’ in red font, if every other red, diagonal stripe with repetition of ’25 \u03bcg \/ he in beige font or<\/li>
- beige, diagonal stripes with repetition of “Fentanyl” in green font, if every other green, diagonal stripes with repetition of “50 \u03bcg \/ h” in beige font or<\/li>
- beige, diagonal stripes with repetition of “Fentanyl” in blue font, if every other blue, diagonal stripe with repetition of “75 \u03bcg \/ h” in beige font or<\/li>
- beige, diagonal stripes with repetition of “Fentanyl” in gray font, if every other gray, diagonal stripe with repetition of “100 \u03bcg \/ h” in the beige font.<\/li><\/ul>\n\n\n\n
Each patch has a sticky back so that it can be attached to the skin. The patch is covered by two larger, transparent protective films, both of which are removed before application.
<\/p>\n\n\n\n
Each transdermal patch is packaged in a child-resistant bag.
<\/p>\n\n\n\n
Fentanyl Lavipharm is available in packs of 1, 3, 5, 10, 16, and 20 transdermal patches.<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Lavipharm SA<\/p>\n\n\n\n
Agias Marinas Street<\/p>\n\n\n\n
190 02 Peania, Attica<\/p>\n\n\n\n
Greece<\/p>\n\n\n\n
Tel: +30 210 6691000
<\/p>\n\n\n\n
This medicine is authorized in the European Economic Area<\/strong><\/p>\n\n\n\nunder the names:<\/strong>
<\/p>\n\n\n\nGermany<\/strong> Fentapon 12, 25, 50, 75, 100 Micrograms \/ Hour transdermal Patches<\/p>\n\n\n\nItalien<\/strong> Alghedon 12, 25, 50, 75, 100 microgrammi \/ ora cerotto transdermico<\/p>\n\n\n\n
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12 micrograms \/ hour, 25 micrograms \/ hour, 50 micrograms \/ hour, 75 micrograms \/ hour, 100 micrograms \/ hour depot
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