150 mg vagitorium. Econazole nitrate
What Pevaryl Depot is and what it is used for
Pevaryl Depot is used to treat fungal infections of the vagina.
For self-care of fungal infections, Pevaryl Depot can be sold without a prescription to women who have previously been treated by a doctor against genital fungus and who have now developed the same symptoms.
Econazole nitrate contained in Pevaryl Depot may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
You must talk to your doctor if your symptoms worsen or do not improve within 7 days.
What you need to know before using Pevaryl Depot
Do not use Pevaryl Depot
If you are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Pevaryl Depot contains an oil-based component that can affect and reduce the effectiveness of latex diaphragms and condoms. Therefore, Pevaryl Depot should not be used with pessaries or latex condoms.
Pevaryl Depot can inactivate spermicides, therefore consult a physician when using spermicides.
Pevaryl Depot should not be used with other treatments in or on the genitals.
If signs of irritation or hypersensitivity occur, treatment should be discontinued.
Stop using Pevaryl Depot and contact your doctor immediately if you get any of the following symptoms ( angioedema )
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
Contact a doctor if:
- no improvement occurs or if symptoms worsen within 3 days of starting treatment,
- the symptoms do not completely disappear within 7 days after starting treatment,
- the symptoms return more than 2 times within 6 months.
Other medicines and Pevaryl Depot
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The treatment effect may be affected if Pevaryl Depot is used at the same time as certain other medicines.
Therefore, you should not use Pevaryl Depot at the same time as the following medicines without first consulting your doctor or pharmacist:
- blood-thinning drugs ( warfarin, acenocoumarol).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Pevaryl Depot should only be used during the first trimester of pregnancy on the advice of a doctor. Pevaryl Depot can be used during the second and third trimesters if the potential benefit to the mother outweighs the potential risks to the fetus.
Breast-feeding
It is not known if Pevaryl Depot passes into breast milk. Talk to your doctor before using Pevaryl Depot while breast-feeding.
Driving and using machines
Pevaryl Depot has no known effect on the ability to drive or perform precision work.
How to use Pevaryl Depot
Always use Pevaryl Depot exactly as described in this leaflet or as directed by your doctor, pharmacist or nurse. If you are not sure, talk to your doctor, pharmacist or nurse.
Insert the vagitorium deep into the vagina (with the pointed end first) at bedtime.
The vaginal mass in Pevaryl Depot, after melting, forms a gel structure, from which the active substance is released.
Pregnant women should wash their hands thoroughly before using the vaginas (see section on Pregnancy above for further recommendations, including restrictions on use during pregnancy).
Pevaryl Depot does not stain clothes and can be washed off with soap and water.
If you use more Pevaryl Depot than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If you use more Pevaryl Depot than you should, you may experience the same side effects as mentioned in section 4. If you get Pevaryl Depot in your eyes, wash with clean water or saline solution and see a doctor if symptoms persist.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, Pevaryl Depot can cause side effects, although not everybody gets them.
Common (affects more than 1 user in 100): Itching, burning.
Uncommon (affects less than 1 user in 100): Rash, burning of the skin and mucous membranes at the application site.
Rare (affects less than 1 user in 1,000): Reddening of the skin.
Has been reported (occurs in unknown numbers of users): Swelling of the face, tongue or throat, difficulty swallowing or hives and difficulty breathing ( angioedema ). Hypersensitivity, hives, contact dermatitis, skin flaking. Local reactions in the skin and mucous membranes at the application site such as pain, irritation and swelling.
How to store Pevaryl Depot
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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.
Contents of the pack and other information
Content declaration
The active substance is econazole nitrate.
The other ingredients are polygel, silica, hard fat, stearyl heptanoate.
What the medicine looks like and contents of the pack
Pevaryl Depot 150 mg vagitorium is off-white with a faint odor and is supplied in 1 blister packs.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Trimb Healthcare AB
Box 16184
103 24 Stockholm
Tel: 08-12135200
Email: medical@trimb.se
Manufacturer
Janssen Pharmaceutica NV, 30 Turnhoutseweg, B-2340 Beerse, Belgium.
Lusomedicamenta – Sociedade Técnica Pharmacêutica, SA
Estrada Consiglieri Pedroso 69 B, Queluz de Baixo, 2730-055 Barcarena, Portugal