Systral® 15 mg/g Ointment
Chlorphenoxamine hydrochloride
Package leaflet: Information ofr the user
Systral 15 mg/g ointment
Chlorphenoxamine hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
- What SYSTRAL is and what it is used for
- What you need to know before you use SYSTRAL
- How to use SYSTRAL
- Possible side effects
- How to store SYSTRAL
- Contents of the pack and other information
SYSTRAL is indicated for topical application in insect bites, mild burns, sunburns, chilblain, pruriginous and allergic dermatitis, such as those caused by jellyfish, eczema.
Pharmacotherapeutic group: 13.8.2 (local anaesthetics and antipruritics).
Do not use SYSTRAL:
- If you are allergic (hypersensitive) to the active substance or any of the other ingredients of SYSTRAL.
- If you have specific cutaneous processes (such as syphilis, tuberculosis), chickenpox, post vaccination reactions, mycosis, bacterial cutaneous infections, steroid acne.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using SYSTRAL
- Systral ointment must not be used in large skin areas of breast-feeding children and young children, for example in case of burns or sunburns. In such cases, a doctor should be immediately consulted. The extended use of large amounts or the use on large areas may induce systemic reactions.
Other medicines and Systral
Tell your pharmacist if you are using or have recently used or might use any other medicines.
Systral with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
SYSTRAL must only be used during pregnancy and lactation if considered indispensible by the doctor.
Driving and using machines
Not relevant.
This medicine contains 5 mg benzyl alcohol in each g of ointment. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause mild local irritation.
This medicine contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
This medicine contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Apply several times a day on the affected areas of the skin.
If you use more SYSTRAL than you should
The use of SYSTRAL in extended areas of skin affected by inflammatory changes (burns, sunburns) may cause adverse effects due to the percutaneous absorption of large amount of chlorphenoxamine hydrochloride especially in small children. In very rare cases, restlessness, confusion and pupillary dilation may occur. In adults, adverse effects are mainly fatigue and dry mouth.
If any of the symptoms above mentioned occur, immediately head for the hospital.
If you forget to use SYSTRAL
Not applicable.
If you stop using SYSTRAL
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The extended use may induce cutaneous atrophy and telangiectasias (spider veins).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system through the contacts below. By reporting side effects you can help provide more information on the safety of this medicine.
Website: http://www.infarmed.pt/web/infarmed/submissaoram
(preferably)
or through:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel: +351 21 798 73 73
Medicines hotline: 800222444 (free)
E-mail: farmacovigilancia@infarmed.pt
Do not store above 25º C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What SYSTRAL contains
The active substance is Chlorphenoxamine hydrochloride
The other ingredients are stearic acid, cetyl stearyl alcohol, benzyl alcohol, isopropyl myristate, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, triethanolamine, sorbitol 70%, vaseline, potassium hydroxide and purified water.
What SYSTRAL looks like and contents of the pack
Ointment. Pack sizes: tubes of 20 g or 30 g or 50 g.
Marketing Authorisation Holder and Manufacturer:
SIDEFARMA – Sociedade Industrial de Expansão Farmacêutica, S.A.
Rua da Guiné, n.º 26
2689-514 Prior Velho
Portugal
Tel: 219426100
Fax: 219416205
e-mail: geral@sidefarma.pt
This leaflet was last revised in February 2024.