CRATAE-LOGES

CRATAE-LOGES 450 mg hawthorn film-coated tablets

Important notes (mandatory information)

cratae-Loges 450 mg Hawthorn Film-coated Tablets. Active ingredient: Dry extract from hawthorn leaves with flowers.

Indications

Decreased cardiac performance corresponding to stage II according to NYHA.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

cratae-Loges 450 mg Hawthorn Film-coated Tablets for use in adolescents aged 12 years and over and adults
Active ingredient: Dry extract from hawthorn leaves with flowers

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without prescription. However, cratae-Loges 450 mg Hawthorn must be taken as directed in order to be effective.

• 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS CRATAE-LOGES 450 MG HAWTHORN AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING CRATAE-LOGES 450 MG HAWTHORN?
3. HOW TO TAKE CRATAE-LOGES 450 MG HAWTHORN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CRATAE-LOGES 450 MG HAWTHORN?
6. FURTHER INFORMATION

1. WHAT IS CRATAE-LOGES 450 MG HAWTHORN AND WHAT IS IT USED FOR?

cratae-Loges 450 mg Hawthorn is a herbal medicine for heart disease.

Indications

Decreased cardiac performance corresponding to stage II according to NYHA.

2. WHAT DO YOU NEED TO KNOW BEFORE TAKING CRATAE-LOGES 450 MG HAWTHORN?

If the symptoms of the disease persist unchanged for more than 6 weeks or if there is a build-up of water in the legs, it is advisable to consult a doctor. In the event of pain in the heart region, which may radiate into the arms, upper abdomen or neck area, or in the event of shortness of breath, immediate medical clarification is essential. cratae-Loges 450 mg Hawthorn must not be taken if you are hypersensitive (allergic) to the active substance or any of the other ingredients of cratae-Loges 450 mg Hawthorn.

Special care must be taken when taking cratae-Loges 450 mg Hawthorn

In children

There are no adequate studies on the use of this medicine in children. It should therefore not be taken by children under 12 years of age.

When taking cratae-Loges 450 mg Hawthorn with other medicines

Interactions of cratae-Loges 450 mg Hawthorn with other medicines have not been investigated to date. Therefore, an increase or decrease in the effect of other medicines cannot be ruled out. However, no interactions have been reported to date. Please consult your doctor. Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even those not prescribed.

Pregnancy and breast-feeding

There is no evidence from the widespread use of hawthorn as a medicine to suggest any risks or side effects during pregnancy and breast-feeding. However, the results of experimental studies are not available. The medicine should therefore not be used during pregnancy and breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

There is no experience with regard to impairment of driving ability and the ability to operate machines.

3. HOW TO TAKE CRATAE-LOGES 450 MG HAWTHORN?

Always take cratae-Loges 450 mg Hawthorn exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adults and adolescents aged 12 years and over should take 1 film-coated tablet twice a day.

Method of administration

Do not take film-coated tablets while lying down. Please take the film-coated tablets whole with sufficient liquid (preferably 1 glass of drinking water [200 ml]).

Duration of use

It is recommended to take the medicine for at least 6 weeks and for a maximum of 6 months. The attending physician should then determine the further duration of use.

Please talk to your doctor or pharmacist if you have the impression that the effect of cratae-Loges 450 mg Hawthorn is too strong or too weak.

If you have taken more cratae-Loges 450 mg Hawthorn than you should

If you have accidentally taken twice or three times the single dose (equivalent to 2 - 3 film-coated tablets of this medicine), this will generally not have any adverse effects. In this case, continue taking the medicine as described in the dosage instructions or as prescribed by your doctor. If you have significantly overdosed on this medicine, the side effects may occur more frequently (see "Side effects"). In this case, you should consult a doctor.

If you forget to take cratae-Loges 450 mg Hawthorn

Do not take a double dose to make up for a forgotten dose, but continue taking the medicine as described in the package leaflet or as prescribed by your doctor.

If you stop taking cratae-Loges 450 mg Hawthorn

Interrupting or prematurely terminating treatment is generally harmless. If in doubt, please consult your doctor or pharmacist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, cratae-Loges 450 mg Hawthorn can have side effects, although not everybody gets them.

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

Possible side effects

The list includes all known side effects under treatment with preparations of hawthorn leaves with flowers, including those under higher dosage or long-term therapy. Rarely, gastrointestinal complaints, m weakness or skin rash may occur. These symptoms usually subside within a few days after discontinuation of the medicine. If side effects persist, consult a doctor who will decide on any necessary measures. At the first signs of a hypersensitivity reaction (e.g. skin rash), the medicine should not be taken any further.

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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CRATAE-LOGES 450 MG HAWTHORN?

Keep out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton/blister after "Use by".

Storage conditions

Do not store above 25°C.

6. FURTHER INFORMATION

What cratae-Loges 450 mg Hawthorn contains

1 film-coated tablet contains the active substance Dry extract from hawthorn leaves with flowers [4-7:1] 450 mg Extraction agent: Ethanol 45% (V/V). The other ingredients are: Maltodextrin, highly dispersed silicon dioxide, purified water, microcrystalline cellulose, hydrogenated castor oil, sodium carboxymethyl starch (type A), stearic acid, hypromellose, talc, macrogol 6000, titanium dioxide E 171, iron(III) oxide E 172.

Note for diabetics

The amount of carbohydrates ingested with 1 daily dose (= 2 film-coated tablets) corresponds to 0.34 BE.

What cratae-Loges 450 mg Hawthorn looks like and contents of the pack

Original packs of 50, 100 and 200 salmon-coloured film-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Dr. Loges + Co. GmbH
Schützenstraße 5
21423 Winsen (Luhe)
Telephone: 04171 707-0
Telefax: 04171 707-100
E-mail: info@loges.de

This package leaflet was last revised in November 2021.

Source: Package leaflet information
Version: 02/2023
Active ingredient: Dry extract from hawthorn leaves with flowers. Indications: Decreased cardiac performance corresponding to stage II according to NYHA.