These cases of lymphadenopathy were usually related to infections and noted to resolve upon appropriate antibiotic therapy. Of these 14 cases, the majority had either a clear etiology or were known to resolve. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, ELIDEL Cream should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Sun Exposure During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while ELIDEL is not on the skin. Because of this concern: A patient should stop ELIDEL Cream when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by the physician.
A patient should contact the physician if: A patient or caregiver should apply a thin layer of ELIDEL Cream only to the affected skin areas, twice a day, as directed by the physician.
This should remove any cream left on the hands. This could wash off the cream. They should be sure to check with the physician first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important they keep up good skin care practices. If a patient needs to be outdoors after applying ELIDEL Cream, the patient should wear loose fitting clothing that protects the treated area from the sun.
The physician should advise the patient about other types of protection from the sun. A patient should not cover the skin being treated with bandages, dressings or wraps. A patient can wear normal clothing. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out.
Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year rat dermal carcinogenicity study using ELIDEL Cream, a statistically significant increase in the incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male animals compared to vehicle and saline control male animals.
However, oral studies may not reflect continuous exposure or the same metabolic profile as by the dermal route.
In a mouse oral gavage carcinogenicity study, a statistically significant increase in the incidence of lymphoma was noted in high dose male and female animals compared to vehicle control male and female animals. In a week dermal photo-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation 40 weeks of treatment followed by 12 weeks of observation with the ELIDEL Cream vehicle alone.
No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, pimecrolimus, to the vehicle cream. How long to apply Elidel Long term treatment should be intermittent and not continuous.
Stop Elidel as soon as signs of eczema have disappeared. Continue using the cream for as long as your doctor advises. Stop the treatment and consult your doctor if no improvement occurs after 6 weeks or if your eczema gets worse. In the long-term treatment of eczema, begin using Elidel as soon as you notice signs and symptoms redness and itch.
This helps to prevent progression to severe flare-ups. If signs and symptoms return you should start treatment again. If you apply more Elidel than you should If you apply more cream to your skin than you needed to, just wipe it off.
If you forget to use Elidel If you forget an application of the cream, apply it as soon as possible and then continue your normal dosing routine. However, if it alsmost time for your next application, skip the missed dose and continue your normal dosing routine.
Do not apply extra cream to make up for a missed dose. If you stop using Elidel cream If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you accidentally swallow some Elidel If you or someone else accidentally swallows Elidel, tell your doctor immediately. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common side effects of Elidel are reactions such as discomfort at the application site.
Some effects could be serious Rare side effects affecting less than 1 in people angioedema - the signs include itching, hives urticaria , red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
Very rare side-effects affecting less than 1 in 10, people anaphylactic reaction: If you experience any of these symptoms soon after using Elidel cream, stop using the cream and tell your doctor immediately.
Common side-effects affecting more than 1 in people Irritation, itching and reddening of the skin where the cream has been applied. Skin infections such as folliculitis. Uncommon side effects affecting less than 1 in every people Skin infections such as impetigo a bacterial skin infection , cold sores herpes simplex , shingles herpes zoster , herpes simplex dermatitis eczema herpeticum , molluscum contagiosum a viral skin infection , warts and furuncles boils.
Application site reactions such as rash, pain, prickling sensation, slight scaling of the skin, dryness, swelling and worsening of eczema symptoms. Rare side effects affecting less than 1 in people Flushing, rash, burning, itching or swelling shortly after drinking alcohol. Changes in the skin color becomes darker or lighter than the surrounding skin. Cases of cancer, including cancer of the lymph glands or skin, have been reported in patients using Elidel.
Cases of enlarged lymph glands have been reported in patients using Elidel. However, a link to the treatment with Elidel cream has not been established. If any of the side effects gets severe, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly via the Yellow Card Scheme www. By reporting side effects you can help provide more information on the safety of this medicine. How to store Elidel cream Keep out of the sight and reach of children. Do not use this medicine after the expiry date shown on the carton and tube. The expiry date refers to the last day of that month. Store in the original package. Keep the tube tightly closed.
Once opened, the tube should be used within 12 months. You may find it helpful to write the date you opened the tube in the space provided on the carton. Do not throw away any medicines via wastewater.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Contents of the pack and other information What Elidel cream contains The active substance is pimecrolimus. The other ingredients are: You should inform your doctor if you are pregnant or breast feeding.
This should be done before starting this medication. If you enter this condition after starting the treatment, inform your doctor immediately. You should also avoid sunlight, tanning beds and sun lamps while undergoing this treatment. You should not use sunscreen on the skin treated with brand or generic Elidel Cream, until or unless it is advised by your doctor.
You should not double dose on this medicine. If you miss a dose of pimecrolimus topical, take it as soon as you remember. However, you should skip the missed dose if you are already near your next dose.
Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. Do not apply extra cream to make up for a missed dose. Symptoms to watch for, which may be indicative of a reaction, include skin rashes, hives, swelling of the face or limbs, trouble breathing, elidel cream price in egypt, and trouble swallowing. Irritation at the egypt or sites of application including stinging, feeling of warmth or burning, runny nose Professional Standards and Safety Customer Safety is our number one priority, that is why CanDrugStore has maintained a cream patient safety record to ensure our customers receive the highest quality medications at the lowest price with the best customer service. Changes in the skin color becomes darker or lighter than the surrounding skin. A patient should not cover the skin being treated with bandages, dressings or wraps. Important information You should not use Elidel if you are allergic to pimecrolimus, or if you have a bacterial or viral skin infection including herpes or price pox. Your doctor may ask you to use an appropriate medicine to treat the infection. An oral peri- and post-natal developmental study was conducted in rats. Do not be alarmed by this list of elidel side effects.
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