HAMETUM

HAMETUM Hemorrhoid Ointment

Important notes (mandatory information)

Hametum Haemorrhoid Ointment. Active ingredient: Hamamelis leaf and twig distillate. Areas of application: for improving symptoms in the early stages of haemorrhoidal disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hametum Haemorrhoid Ointment 62.5mg/1 g ointment
Active ingredient: Hamamelis leaf and twig distillate
Herbal haemorrhoid remedy

Read the entire package leaflet/instructions for use carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Hametum Haemorrhoid 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 HAEMORRHOID OINTMENT AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING HAMETUM HAEMORRHOID OINTMENT?
3. HOW TO USE HAMETUM HAEMORRHOID OINTMENT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HAMETUM HAEMORRHOID OINTMENT?
6. HOW IS HAMETUM HAEMORRHOID OINTMENT COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS HAMETUM HAEMORRHOID OINTMENT FROM?

1. WHAT IS HAMETUM HAEMORRHOID OINTMENT AND WHAT IS IT USED FOR?

Hametum Haemorrhoid Ointment is a herbal haemorrhoid remedy. Hametum Haemorrhoid Ointment is used to improve symptoms in the early stages of haemorrhoidal disorders. Note: Blood in the stool or bleeding from the intestinal-anal area must always be clarified by a doctor.

2. WHAT YOU NEED TO KNOW BEFORE USING HAMETUM HAEMORRHOID OINTMENT?

Hametum Haemorrhoid 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 Haemorrhoid Ointment

In the case of advanced haemorrhoidal disorders and other palpable external changes in the anal region (anal area), a doctor must be consulted. Hametum Haemorrhoid Ointment contains substances that can cause allergies if used in the anal area for a long period of time. Therefore, pay particular attention to the new onset or worsening of itching, redness and swelling in the treated area. If you notice such signs, please stop using Hametum Haemorrhoid Ointment and consult your doctor.

What you need to consider during pregnancy and breastfeeding
There is no experience with the use of this medicine during pregnancy and breastfeeding. The treatment of haemorrhoidal disorders with tannin-containing preparations should only be carried out during pregnancy and breastfeeding after consulting a doctor for a maximum of 2 weeks.

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 localised skin irritation (e.g. contact dermatitis) and irritation of the mucous membranes. Interactions with other medicines No interactions with other medicines are known to date. Note: When treating with Hametum Haemorrhoid Ointment in the genital or anal area, the auxiliary substances 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 HAEMORRHOID OINTMENT?

Always use Hametum Haemorrhoid 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 or rectal application. Unless otherwise prescribed by your doctor, the usual dose is: Hametum Haemorrhoid Ointment is applied thinly to the affected skin areas several times a day. The anal area should be cleaned and dried thoroughly before use. Hametum Haemorrhoid Ointment can be applied thinly with your finger or with the enclosed applicator. To do this, screw the applicator firmly onto the tube and remove the cap. By pressing on the tube, the ointment is pressed into the applicator until it emerges from the side openings. The applicator is then carefully inserted into the anus until it stops. The lubricity can be increased by coating the applicator with a little ointment. The ointment is distributed sufficiently by carefully turning the tube. The applicator is best cleaned after use by unscrewing it and cleaning it with warm water. After cleaning and drying the applicator, put the cap back on it. Once you have removed the applicator, please close the tube with the original screw cap to prevent it from drying out.

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

If you have used more Hametum Haemorrhoid Ointment than you should

Hametum Haemorrhoid Ointment is very well tolerated. No overdose symptoms have been reported to date.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Hametum Haemorrhoid 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 assess 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 the event of side effects?
If you experience any signs, such as skin redness and itching, please stop using Hametum Haemorrhoid Ointment and consult your doctor if necessary. If you notice any side effects not listed here, please inform your doctor or pharmacist. If you notice any of the side effects listed above, 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 HAEMORRHOID 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 HAEMORRHOID OINTMENT COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

1 g ointment contains: Active ingredient: 62.5mg 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-alpha-tocopherol-lecithin (2.5:7.5:20:20:25:25); Sodium edetate (Ph. Eur.); Glycerol(mono/di/tri)[adipate/alkanoate(C6-C20)/isostearate]; Thick liquid paraffin; Microcrystalline hydrocarbons (C40-C60); Propylene glycol; White Vaseline; Purified water; Wool wax (contains butylhydroxytoluene).

Hametum Haemorrhoid Ointment is a slightly yellowish, homogeneous ointment. Hametum Haemorrhoid Ointment is available in packs of 25 g (N1), 50 g ointment.

7. WHO IS HAMETUM HAEMORRHOID 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 package leaflet was last revised in January 2017.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Hamamelis leaf and twig distillate. Areas of application: for improving symptoms in the early stages of haemorrhoidal disorders.