GELENCIUM EXTRACT

GELENCIUM EXTRACT herbal film-coated tablets

Important notes (mandatory information)

Gelencium Extract herbal film-coated tablets 600 mg. Active ingredient: 600 mg devil's claw root dry extract. Areas of application: For the supportive treatment of degenerative diseases of the musculoskeletal system. Warning: Contains lactose and sucrose

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Gelencium Extract herbal film-coated tablets 600 mg, for use in adults
Active ingredient: 600 mg devil's claw root dry extract

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

This package leaflet contains

1. WHAT IS GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?
3. HOW TO TAKE GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS AND WHAT IS IT USED FOR?

Gelencium Extract Herbal Film-Coated Tablets is a herbal medicine for diseases of the musculoskeletal system.

Area of application

For the supportive treatment of degenerative diseases of the musculoskeletal system.

In acute conditions, which are accompanied by e.g. redness, swelling or overheating of joints, as well as persistent complaints, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?

Gelencium Extract Herbal Film-Coated Tablets must not be used:

• if you are allergic to devil's claw or any of the other ingredients of this medicine listed in section 6.1.
• in gastric and duodenal ulcers.

Warnings and precautions

In case of gallstone disease, the medicine should only be taken after consultation with a doctor.

Children and adolescents

There are no adequate studies on the use of Gelencium Extract Herbal Film-Coated Tablets in children and adolescents under 18 years of age. Gelencium Extract Herbal Film-Coated Tablets should therefore not be used in children and adolescents under 18 years of age.

Taking Gelencium Extract Herbal Film-Coated Tablets with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interactions with other medicines are not known in the dosage range indicated here. There are no studies available.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are no adequate studies on the use of the medicine during pregnancy and breast-feeding. Therefore, you should not use the medicine during pregnancy and breast-feeding. It should be noted that use in women of childbearing potential who are not using contraception must also be carefully considered, as a possible pregnancy may not yet be known.

Driving and using machines

No special precautions are required.

Gelencium Extract Herbal Film-Coated Tablets contains lactose and sucrose

Please only take Gelencium Extract Herbal Film-Coated Tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

Gelencium Extract Herbal Film-Coated Tablets contains sodium carboxymethyl starch (type A) (Ph.Eur.)

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. it is essentially "sodium-free".

3. HOW TO TAKE GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?

Always take Gelencium Extract Herbal Film-Coated Tablets exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Adults over 18 years of age take 2 film-coated tablets (2400 mg dry extract; equivalent to 4.8 g of drug) twice a day.

Type of application

For oral use. Please take Gelencium Extract Herbal Film-Coated Tablets unchewed with some liquid in the morning and evening after meals.

Duration of use

The use of Gelencium Extract Herbal Film-Coated Tablets is not limited in time. However, please note the information under Areas of application.

If you have taken more Gelencium Extract Herbal Film-Coated Tablets than you should

No risks are to be expected from accidental overdose, so that no special measures are necessary.

If you forget to take Gelencium Extract Herbal Film-Coated Tablets

If you forget to take a dose, do not take it, but continue with the next dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

Possible side effects

In rare cases, diarrhoea, nausea, vomiting, abdominal pain, dizziness and headache have been observed. Hypersensitivity reactions (skin rashes, hives, facial oedema up to circulatory collapse (anaphylactic shock)) have been described very rarely. In very rare cases, an increase in blood sugar has been observed in insulin-dependent diabetes mellitus, which decreased after discontinuation.

Reporting of side effects

If you experience 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 GELENCIUM EXTRACT HERBAL FILM-COATED TABLETS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Gelencium Extract Herbal Film-Coated Tablets contains

The active ingredient is: Dry extract of devil's claw root. 1 film-coated tablet contains: 600 mg dry extract of devil's claw root (1.5-2.5:1), extraction solvent: water. The other ingredients are: cellulose powder, highly dispersed silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate (vegetable) (Ph.Eur.), sodium carboxymethyl starch (type A) (Ph. Eur.), microcrystalline cellulose, sucrose, stearic acid (Ph.Eur.), titanium dioxide (E171)

Note for diabetics

1 film-coated tablet contains 0.018 bread units (BE).

What Gelencium Extract Herbal Film-Coated Tablets looks like and contents of the pack

Gelencium Extract Herbal Film-Coated Tablets are white, oblong film-coated tablets. Gelencium Extract Herbal Film-Coated Tablets is available in packs of 75, 150 and 300 (2 x 150) film-coated tablets.

Pharmaceutical entrepreneur and manufacturer

Heilpflanzenwohl GmbH
Alt-Moabit 101 D
10559 Berlin
Phone: + 49 30 209 66 97 81
Fax: + 49 30 209 66 97 89
E-mail: hpw@heilpflanzenwohl.com

This package leaflet was last revised in April 2022.

Source: Information from the package leaflet
Status: 04/2023
Active ingredient: 600 mg devil's claw root dry extract. Areas of application: For the supportive treatment of degenerative diseases of the musculoskeletal system. Warning: Contains lactose and sucrose