Konex 1 mg/g cutaneous solution EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
KONEX 1 mg/g cutaneous solution EFG
Read the entire leaflet carefully before you start using this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you consider any of the adverse reactions to be serious or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What KONEX is and what it is used for
- Before you use KONEX
- How to use KONEX
- Possible adverse effects
- How to store KONEX
- Further information
1. What KONEX is and what it is used for
Mometasone furoate belongs to the group of topical glucocorticoids and acts as an anti-inflammatory and antipruritic agent in skin conditions.
KONEX 1 mg/g cutaneous solution is indicated for the relief of inflammatory and pruritic manifestations (with stinging or itching) of dermatoses that respond to treatment with glucocorticoids, such as psoriasis (a skin disease characterized by scaling) and atopic dermatitis (a chronic skin condition characterized by the appearance of scaly rashes accompanied by itching).
2. Before using KONEX
Do not use KONEX:
If you are allergic to mometasone furoate or to any other glucocorticoid, or to any of the components of this medicinal product.
Take special care with KONEX
When treating extensive body surfaces, when using occlusive dressings, during long-term treatment, or when applying to the facial skin or skin folds.
Avoid contact with the eyes. In case of accidental contact, rinse the eyes thoroughly with plenty of water.
Contact your doctor if you experience blurred vision or other visual disturbances.
Use of other medicines:
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medicine.
KONEX should be avoided in pregnant or breastfeeding women, except under medical prescription.
Driving and use of machines:
There are no known data suggesting that the product may affect the ability to drive or operate machinery.
Important information about some of the components of KONEX:
This medicine contains propylene glycol, which may cause skin irritation.
3. How to use KONEX
Follow exactly the administration instructions given by your doctor. Consult your doctor or pharmacist if you have any doubts.
Remember to use your medication.
Your doctor will determine the duration of treatment with Mometasone furoate in cutaneous solution. Do not stop the treatment on your own.
If you consider the effect of Mometasone furoate in cutaneous solution to be too strong or too weak, inform your doctor or pharmacist.
Avoid abrupt discontinuation of treatment.
KONEX is applied to the skin or scalp.
Apply a few drops of KONEX to the affected areas once daily and gently massage until it disappears.
Do not cover or bandage the treated area unless instructed by your doctor.
If you use more KONEX than you should:
If you have used more KONEX than indicated, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount used.
If you forget to use KONEX:
Do not use a double dose to make up for missed doses. Continue with your regular dosing schedule, and if you have missed several doses, consult your doctor or pharmacist immediately.
4. Possible adverse effects
Like all medicines, KONEX can cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported and are classified according to their frequency as:
Very common: affects at least 1 in 10 people
Common: affects at least 1 in 100 people but less than 1 in 10
Uncommon: affects at least 1 in 1,000 people but less than 1 in 100
Rare: affects at least 1 in 10,000 people but less than 1 in 1,000
Very rare: affects less than 1 in 10,000 people.
Skin and subcutaneous tissue disorders:
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Endocrine disorders:
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Eye disorders:
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Reporting of adverse reactions:
If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of KONEX
Keep out of the reach and sight of children.
Storage conditions: No special storage conditions required.
Expiry: Do not use KONEX after the expiry date stated on the label and the carton. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional information
Composition of KONEX:
The active substance is Mometasone furoate. Each gram of solution contains 1 milligram of mometasone furoate.
The other components are: isopropyl alcohol, propylene glycol, hydroxypropyl cellulose, sodium dihydrogen phosphate dihydrate, phosphoric acid, and purified water.
Appearance of the product and contents of the container:
Clear, colourless solution.
KONEX is available in 30 ml and 60 ml bottles.
Marketing Authorization Holder:
Laboratorios Serra Pamies, S.A.
Ctra. Castellvell, 24
43206 Reus (Tarragona)
Manufacturer:
Laboratorio Reig Jofré, S.A.
C/ Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
or
Marketing Authorization Holder and Manufacturer:
Laboratorios Serra Pamies, S.A.
Carretera de Castellvell, nº 24
43206 Reus (Tarragona)
This summary of product characteristics was approved in November 2017.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/