HAMETUM

HAMETUM hemorrhoid suppositories

Important notes (mandatory information)

Hametum Haemorrhoid Suppositories 400 mg/suppository. Active ingredient: Hamamelis leaf extract. Areas of application: for the relief of symptoms such as itching, burning, slight bleeding in the early stages of haemorrhoidal disease.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hametum Haemorrhoid Suppositories 400 mg/suppository for adults and adolescents aged 12 and over
Active ingredient: Hamamelis leaf extract
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, Hametum Haemorrhoid Suppositories must be used as directed in order to achieve the best possible treatment results.

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

This package leaflet contains

1. WHAT ARE HAMETUM HAEMORRHOID SUPPOSITORIES AND WHAT ARE THEY USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING HAMETUM HAEMORRHOID SUPPOSITORIES?
3. HOW TO USE HAMETUM HAEMORRHOID SUPPOSITORIES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HAMETUM HAEMORRHOID SUPPOSITORIES?
6. HOW ARE HAMETUM HAEMORRHOID SUPPOSITORIES COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS HAMETUM HAEMORRHOID SUPPOSITORIES?

1. WHAT ARE HAMETUM HAEMORRHOID SUPPOSITORIES AND WHAT ARE THEY USED FOR?

Hametum Haemorrhoid Suppositories are a herbal haemorrhoid remedy. Hametum Haemorrhoid Suppositories are used to relieve symptoms such as itching, burning, slight bleeding in the early stages of haemorrhoidal disease.

2. What do you need to know before using Hametum Haemorrhoid Suppositories?

Hametum Haemorrhoid Suppositories must not be used if you are hypersensitive to Hamamelis or any of the other ingredients of this medicine.

Special care must be taken when using Hametum Haemorrhoid Suppositories

In the following cases, a doctor should be consulted: In case of acute onset of symptoms, if there is no improvement within 7 days, in case of advanced haemorrhoidal disease and other palpable external changes. In particular, blood in the stool or bleeding from the rectum must always be clarified by a doctor. In case of a fungal infection, the additional use of a locally effective agent against fungal infections is necessary. There is no experience with the use of this medicine during pregnancy and breastfeeding. Due to the tannin content, it should only be used after consulting a doctor. The duration of treatment should not exceed 2 weeks. There are no sufficient studies on the use of this medicine in children. Hametum Haemorrhoid Suppositories should therefore not be used in children under 12 years of age.

Interactions with other medicines

None known. Note: When treating with Hametum Haemorrhoid Suppositories, the use of latex condoms at the same time may reduce the tear resistance and thus impair the safety of such condoms due to the auxiliary substance microcrystalline hydrocarbons.

3. HOW TO USE HAMETUM HAEMORRHOID SUPPOSITORIES?

Always use Hametum Haemorrhoid Suppositories exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of application

Rectal use. Unless otherwise prescribed by your doctor, the usual dose is: Hametum Haemorrhoid Suppositories are usually used 2 times a day. In case of more severe symptoms, the suppositories can also be used more frequently for a while.

How and when should you use Hametum Haemorrhoid Suppositories?
The suppositories are inserted deep into the anus every day in the morning and evening, if possible after a bowel movement. Removing the suppository: To use the suppositories, please tear or cut the aluminium foil open from the tip in the direction of the arrow along the suppository far enough so that it can be easily removed. Note: When using ointments and suppositories in the anal area, the laundry may become soiled due to body heat. It is therefore advisable to use an insert.

How long should you use Hametum Haemorrhoid Suppositories?
The duration of treatment depends on the type and severity of the course of the disease and is usually determined by the doctor. In principle, Hametum Haemorrhoid Suppositories can be used until the symptoms subside or for a few days beyond. Self-treatment without consulting a doctor should not exceed a period of 4 weeks. Please also note the information on "Precautions for use and warnings" regarding the duration of treatment.

If you have used more Hametum Haemorrhoid Suppositories than you should

No overdosages are known when Hametum Haemorrhoid Suppositories are used as directed. If Hametum Haemorrhoid Suppositories are accidentally swallowed by a child, for example, no serious poisoning symptoms are to be expected. However, symptoms such as abdominal pain and nausea may occur. In this case, a doctor should be consulted. If you have accidentally used Hametum Haemorrhoid Suppositories more often than intended on one or more occasions, no undesirable side effects are to be expected. In this case, reduce the application to the intended dosage and otherwise follow the treatment plan.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Hametum Haemorrhoid Suppositories can have side effects. The list includes all known side effects under treatment with Hamamelis leaf extract, 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 treated persons in 100
Uncommon:	1 to 10 treated persons in 1,000
Rare:	1 to 10 treated persons in 10,000
Very rare:	less than 1 treated person in 10,000
Not known:	Frequency cannot be estimated from the available data.

When using Hametum Haemorrhoid Suppositories, short-term irritation such as a slight burning sensation often occurs. Very rarely, allergic reactions to Hamamelis-containing medicines may occur when applied locally.

What countermeasures should be taken in case of side effects?
If there are any signs of allergies, such as skin redness combined with itching, please stop using Hametum Haemorrhoid Suppositories and inform your doctor about the side effects that have occurred so that he/she can treat them specifically if necessary. 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 HAEMORRHOID SUPPOSITORIES?

Keep medicines out of the reach of children. Suppositories based on hard fat tend to form a so-called "fat bloom" on their surface during storage. This phenomenon does not affect the use or effectiveness of the suppositories. The expiry date is printed on the folding box and on the container. The product should not be used after the expiry date! Do not store above 25°C!

6. HOW ARE HAMETUM HAEMORRHOID SUPPOSITORIES COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

1 suppository contains: Active ingredient: 400 mg extract from Hamamelis leaves (1:2), extraction agent: Ethanol 60% (V/V). Other ingredients: Glycerol monooleates; hard fat; microcrystalline hydrocarbons (C40-C60); polyglycerol poly(12-hydroxy stearate); highly dispersed silicon dioxide, methylated; alpha-tocopherol (Ph. Eur.).

Hametum Haemorrhoid Suppositories are available in packs of 10 (N1), 25 (N2) suppositories.

7. WHO IS HAMETUM HAEMORRHOID SUPPOSITORIES?

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 April 2014.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Hamamelis leaf extract. Areas of application: for the relief of symptoms such as itching, burning, slight bleeding in the early stages of haemorrhoidal disease.