CRATAEGUTT

CRATAEGUTT 450 mg Cardiovascular Tablets

Important notes (mandatory information)

Crataegutt 450 mg Cardiovascular Tablets 450 mg, film-coated tablets. Active ingredient: Hawthorn leaf and flower dry extract. Areas of application: to support cardiovascular function.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Crataegutt 450 mg Cardiovascular Tablets 450 mg, film-coated tablets For adults
Active ingredient: Hawthorn leaf and flower dry extract

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Crataegutt 450 mg Cardiovascular Tablets 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 after 2 weeks, you must see a doctor.

What this package leaflet contains

1. WHAT ARE CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS?
3. HOW TO TAKE CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS AND WHAT ARE THEY USED FOR?

Traditional herbal medicinal product to support cardiovascular function. The medicinal product is a traditional herbal medicinal product which is registered exclusively on the basis of long-standing use for the area of application.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS?

Crataegutt 450 mg Cardiovascular Tablets must not be taken if you are allergic to hawthorn or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If symptoms persist or if side effects other than those mentioned in the package leaflet occur, a doctor or other qualified healthcare professional should be consulted. If there is fluid retention in the ankles or legs, pain in the heart area that may radiate to the arms, upper abdomen or neck, or shortness of breath, immediate medical attention is essential.

Children and adolescents

There is insufficient experience with the use of this medicine in this age group. It should therefore not be used in persons under 18 years of age.

Taking Crataegutt 450 mg Cardiovascular Tablets together with other medicines

No interactions are known. Studies on interactions with other medicines have not been performed. Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines

Taking Crataegutt 450 mg Cardiovascular Tablets together with food, drink and alcohol

No special features need to be considered.

Pregnancy and breast-feeding

The safety of the medicinal product during pregnancy and breast-feeding has not been sufficiently studied. As a precaution, taking Crataegutt 450 mg Cardiovascular Tablets should be avoided during pregnancy and breast-feeding.

Driving and using machines

Studies on the ability to drive and use machines have not been performed.

3. HOW TO TAKE CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS?

Always take this medicine exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure. The recommended dose is: 1 film-coated tablet twice a day (corresponding to a daily dose of 900 mg hawthorn extract). The film-coated tablets are taken whole with some liquid. One film-coated tablet is taken in the morning and evening. Crataegutt 450 mg Cardiovascular Tablets can be taken independently of meals. If symptoms occur and persist for more than 2 weeks or worsen, or if any unclear symptoms occur, please consult a doctor. Please also note the warnings under section 2. Patients with impaired liver and kidney function Different dosage recommendations for impaired liver or kidney function cannot be derived from the years of use of this medicinal product. Crataegutt 450 mg Cardiovascular Tablets are not recommended for use in children and adolescents under 18 years of age.

If you have taken more Crataegutt 450 mg Cardiovascular Tablets than you should

Symptoms of overdose have not been reported to date. If you have accidentally taken twice or three times the single dose, this will generally not have any adverse effects. In this case, continue taking the medicine as described in the dosage instructions. If you have taken a significantly larger amount of Crataegutt 450 mg Cardiovascular Tablets than you should, please notify your doctor. He/she can decide on any necessary measures.

If you forget to take Crataegutt 450 mg Cardiovascular Tablets

Do not take double the dose, but continue taking the medicine as before.

If you stop taking Crataegutt 450 mg Cardiovascular Tablets

Interrupting or prematurely terminating treatment is generally harmless.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Crataegutt 450 mg Cardiovascular Tablets can have side effects, although not everybody gets them. Side effects of Crataegutt 450 mg Cardiovascular Tablets are not known.

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 SHOULD CRATAEGUTT 450 MG CARDIOVASCULAR TABLETS BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton or label. Do not store above 30°C!

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Crataegutt 450 mg Cardiovascular Tablets contain

The active ingredient is: Hawthorn leaf and flower dry extract. 1 film-coated tablet contains: Active ingredient: 450 mg dry extract of hawthorn leaves with flowers (4-6.6:1), extraction solvent: Ethanol 45% (m/m). The other ingredients are: Citric acid; Croscarmellose sodium; Highly dispersed silicon dioxide; Hypromellose; Macrogol 400; Macrogol 6000; Magnesium stearate (Ph. Eur.)[vegetable]; Microcrystalline cellulose; Saccharin sodium; Talc; Iron(-III)-oxide E 172; Titanium dioxide E 171.

What Crataegutt 450 mg Cardiovascular Tablets look like and contents of the pack

Crataegutt 450 mg Cardiovascular Tablets are reddish-brown, oval film-coated tablets. Packs of 50, 100 and 200 film-coated tablets are available.

Pharmaceutical entrepreneur and manufacturer

Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Telephone:0800 000 52 58
Telefax:0800 100 9549
www.schwabe.de

This leaflet was last revised in February 2018.

Source: Package leaflet information
Status: 10/2019
Active ingredient: Hawthorn leaf and flower dry extract. Areas of application: to support cardiovascular function.