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Medicinal Products Not Subject to Medical Prescription | Systral
Package leaflet: Information for the patient
Systral, 15 mg/g ointment
Chlorphenoxamine hydrochloride

This leaflet contains important information for you. Read it carefully.
This medicine is available without prescription. However, it is necessary to use SYSTRAL carefully to get the best results.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must talk to a doctor if you do not feel better or if you feel worse.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is in this leaflet
1. What SYSTRAL is and what it is used for
2. What you need to know before you use SYSTRAL
3. How to use SYSTRAL
4. Possible side effects
5. How to store SYSTRAL
6. Other information

1. What SYSTRAL is and what it is used for
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 anti-pruriginous)

2. What you need to know before you use SYSTRAL
Do not use SYSTRAL:
- if you are allergic to (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.

Take special care with 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 physician 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 doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without prescription.

Systral with food, drink and alcohol
Not applicable.

Pregnancy and breast-feeding
SYSTRAL must only be used during pregnancy and lactation if considered indispensible by the physician.
Talk to your pharmacist before using any medicine.

Driving and using machines
Not relevant.

Important information about some of the ingredients of SYSTRAL
This medicine contains stearic acid, cetyl stearyl alcohol, benzil alcohol, perfume, isopropyl myristate, sodic nipagin, sodic nipazol, triethanolamine, sorbitol 70%, vaseline, potassium hydroxide and purified water.

3. How to use SYSTRAL
Apply several times a day on the affected areas of the skin.
Talk to your pharmacist if you have any doubts.

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 pharmacist.

4. Possible side effects
Like all medicines, Systral can cause side effects, although not everybody gets them.

The extended use may induce cutaneous atrophy and telangiectasias (spider veins).
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your pharmacist.

5. How to store SYSTRAL
Do not store above 25º C.

Keep this medicine out of the sight and reach of children.

Do not use SYSTRAL after the expiry date printed on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Other information
What Systral contains
- The active substance is Chlorphenoxamine hydrochloride
- The other ingredients are stearic acid, cetyl stearyl alcohol, benzil alcohol, perfume, isopropyl myristate, sodic nipagin, sodic nipazol, triethanolamine, sorbitol 70%, vaseline, potassium hydroxide and purified water.

Marketing Authorisation Holder and Manufacturer
SIDEFARMA - Sociedade Industrial de Expansão Farmacêutica, S.A.
Rua da Guiné, n.º 26 - 2689-514 Prior Velho.

This leaflet was last revised in May 2006

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