HAMETUM

HAMETUM wound and healing ointment

Important notes (mandatory information)

Hametum Wound and Healing Ointment. Active ingredient: Hamamelis distillate. Areas of application: for minor skin injuries and for small-scale inflammations of the skin and mucous membranes.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hametum Wound and Healing Ointment 6.25 g/100 g ointment
Active ingredient: Hamamelis distillate
Herbal medicinal product

Read the entire package leaflet/instructions for use carefully, as it contains important information for you. This medicine is also available without a doctor's prescription. However, in order to achieve the best possible treatment results, Hametum Wound and Healing Ointment must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.

This package leaflet contains

1. WHAT IS HAMETUM WOUND AND HEALING OINTMENT AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE USING HAMETUM WOUND AND HEALING OINTMENT?
3. HOW TO USE HAMETUM WOUND AND HEALING OINTMENT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HAMETUM WOUND AND HEALING OINTMENT?
6. HOW IS HAMETUM WOUND AND HEALING OINTMENT COMPOSED AND WHAT PACKAGES ARE AVAILABLE?
7. WHO IS HAMETUM WOUND AND HEALING OINTMENT FROM?

1. WHAT IS HAMETUM WOUND AND HEALING OINTMENT AND WHAT IS IT USED FOR?

Hametum Wound and Healing Ointment is a herbal medicinal product for wound treatment. Hametum Wound and Healing Ointment is used for minor skin injuries and for small-scale inflammations of the skin and mucous membranes. For large-scale or purulent infected wounds, consultation with a doctor is required.

2. WHAT DO YOU NEED TO CONSIDER BEFORE USING HAMETUM WOUND AND HEALING OINTMENT?

Hametum Wound and Healing Ointment must not be used if you are hypersensitive to Hamamelis, wool wax or any of the other ingredients of the medicine.

Special care must be taken when using Hametum Wound and Healing Ointment

What do you need to consider during pregnancy and breastfeeding?
There is no experience with the use of this medicine during pregnancy and breastfeeding. Preparations containing tannins should only be used on a small scale (maximum 2 palm-sized area) during pregnancy. When used in the nipple area during breastfeeding, the skin must be cleaned thoroughly before breastfeeding.

What else do you need to watch out for?
Due to its content of wool wax, butylhydroxytoluene and cetyl stearyl alcohol, this medicine can cause local irritation of the skin (e.g. contact dermatitis) and mucous membranes.

Interactions with other medicines

No interactions with other agents are known to date. Note: When treating with Hametum Wound and Healing Ointment in the genital or anal area, the excipients paraffin and Vaseline can lead to a reduction in the tear resistance of condoms made of latex and thus to an impairment of the safety of condoms.

3. HOW TO USE HAMETUM WOUND AND HEALING OINTMENT?

Always use Hametum Wound and Healing Ointment exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of application

Application to the skin. Unless otherwise prescribed by your doctor, the usual dose is: Hametum Wound and Healing Ointment is applied thinly to the affected skin areas several times a day.

How long should you use Hametum Wound and Healing Ointment?
In principle, Hametum Wound and Healing Ointment can be used until the symptoms subside. However, if there is no improvement in symptoms within one week or even a worsening, we recommend that you consult a doctor. Self-treatment without consulting a doctor should not exceed a period of 4 weeks. Please also refer to the information under "Areas of application" and "Precautions for use and warnings".

If you have used a larger amount of Hametum Wound and Healing Ointment than you should

Hametum Wound and Healing Ointment is very well tolerated. No overdose symptoms have been reported to date.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Hametum Wound and Healing Ointment can have side effects. The list includes all known side effects under treatment with Hamamelis leaves and twigs, including those under higher dosage or long-term therapy.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	Frequency cannot be estimated from the available data.

Very rarely, allergic reactions to Hamamelis-containing medicines can occur when applied locally. Allergic reactions can also occur in case of hypersensitivity to wool wax alcohol.

What countermeasures should be taken in case of side effects?
If you experience any signs, such as skin redness and itching, please stop using Hametum Wound and Healing Ointment and consult your doctor if necessary. If you observe any side effects other than those listed here, please inform your doctor or pharmacist. If you observe any of the above side effects, please inform your doctor so that he/she can decide on the severity and any necessary measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE HAMETUM WOUND AND HEALING OINTMENT?

Keep medicines out of the reach of children. The expiry date is printed on the folding box and the tube. The product should not be used after the expiry date. The shelf life after opening is 6 months. Do not store above 30°C!

6. HOW IS HAMETUM WOUND AND HEALING OINTMENT COMPOSED AND WHAT PACKAGES ARE AVAILABLE?

100 g ointment contain: Active ingredient: 6.25 g distillate from fresh Hamamelis leaves and twigs (1 : 1.12 - 2.08), distillation agent: Ethanol 6% (m/m). Other ingredients: Cetyl stearyl alcohol (Ph. Eur.); Citric acid-glycerol monooleate-glycerol monostearate-L-(+)-6-O-palmitoylascorbic acid-all-rac-a-tocopherol-lecithin (2.5:7.5:20:20:25:25); Sodium edetate (Ph. Eur.); Glycerol(mono/di/tri)[adipate/alkanoat(C6-C20)/isostearate]; Liquid paraffin; Microcrystalline hydrocarbons (C40-C60); Propylene glycol; White Vaseline; Purified water; Wool wax (contains butylhydroxytoluene).

Hametum Wound and Healing Ointment is available in packs of 25 g (N1), 50 g (N2), 100 g (N3), 200 g ointment.

7. WHO IS HAMETUM WOUND AND HEALING OINTMENT FROM?

Pharmaceutical entrepreneur and manufacturer

Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Telephone: 0800 000 52 58
Telefax: 0800 100 95 49
www.schwabe.de

This leaflet was last revised in January 2017.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Hamamelis distillate. Areas of application: for minor skin injuries and for small-scale inflammations of the skin and mucous membranes.