CRATAEGUS AL

CRATAEGUS AL 450 mg film-coated tablets

Important notes (mandatory information)

Crataegus AL 450 mg Film-coated tablets. Active ingredient: Hawthorn leaf and flower dry extract 450 mg per film-coated tablet. Areas of application: for reduced cardiac performance corresponding to stage II according to NYHA.

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


Patient information: Information for the user
Crataegus AL 450 mg Film-coated tablets
Active ingredients: Hawthorn leaf and flower dry extract 450 mg per film-coated tablet

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, to achieve the best possible treatment results, Crataegus AL 450 mg film-coated tablets must be used as directed.

• Keep this 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 listed here affect you significantly or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

1. WHAT ARE CRATAEGUS AL 450 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING CRATAEGUS AL 450 MG FILM-COATED TABLETS?
3. HOW SHOULD CRATAEGUS AL 450 MG FILM-COATED TABLETS BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CRATAEGUS AL 450 MG FILM-COATED TABLETS BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE CRATAEGUS AL 450 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
Crataegus AL 450 mg film-coated tablets is a herbal medicine for heart conditions. Crataegus AL 450 mg film-coated tablets are used for reduced cardiac performance corresponding to stage II according to NYHA. Please also note the additional information under "Special care must be taken when taking Crataegus AL 450 mg film-coated tablets".

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING CRATAEGUS AL 450 MG FILM-COATED TABLETS?
Crataegus AL 450 mg film-coated tablets must not be taken if you are hypersensitive (allergic) to hawthorn or any of the other ingredients of Crataegus AL 450 mg film-coated tablets.

Special care must be taken when taking Crataegus AL 450 mg film-coated tablets
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 region of the heart, which may radiate into the arms, upper abdomen or neck, or in the event of shortness of breath, immediate medical clarification is essential.
There are no adequate studies on the use of this medicine in children. Crataegus AL 450 mg film-coated tablets should therefore not be used in children under 12 years of age.

Taking Crataegus AL 450 mg film-coated tablets with other medicines
Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. No interactions are known.

Taking Crataegus AL 450 mg film-coated tablets with food and drink
No studies have been conducted on interactions between Crataegus AL 450 mg film-coated tablets and food or drink.

Pregnancy and breast-feeding
To date, no evidence of risks during pregnancy and breast-feeding has emerged from the widespread use of hawthorn as a medicine. The results of experimental studies are not available. Therefore, Crataegus AL 450 mg film-coated tablets should not be taken during pregnancy and breast-feeding. Ask your doctor or pharmacist for advice before taking/using any medicines.

Driving and using machines
There are no data on the effects on driving and using machines.

3. HOW SHOULD CRATAEGUS AL 450 MG FILM-COATED TABLETS BE TAKEN?
Always take Crataegus AL 450 mg film-coated tablets exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is: Unless otherwise prescribed, adults and children over 12 years of age take 1 film-coated tablet of Crataegus AL 450 mg twice a day with plenty of liquid.

Method of administration
The film-coated tablets are taken whole with plenty of liquid at mealtimes.

Duration of use
It is recommended to take Crataegus AL 450 mg film-coated tablets for at least 6 weeks and no longer than 6 months. The attending physician should then determine the further duration of use. Please also note the additional information under "Special care must be taken when taking Crataegus AL 450 mg film-coated tablets".
Please talk to your doctor or pharmacist if you have the impression that the effect of Crataegus AL 450 mg film-coated tablets is too strong or too weak.

If you have taken more Crataegus AL 450 mg film-coated tablets than you should
As this is a mild medicine, immediate measures are generally not necessary. However, always inform your doctor.

If you forget to take Crataegus AL 450 mg film-coated tablets
The application should be continued according to the dosage instructions, i.e. without additional intake.

If you stop taking Crataegus AL 450 mg film-coated tablets
An interruption or premature termination of treatment is generally harmless. In case of doubt, consult your doctor or pharmacist.
If you have any further questions about taking this medicine, ask your doctor or pharmacist

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Crataegus AL 450 mg film-coated tablets can have side effects, although not everybody gets them. The following categories are used as the basis for the frequency of side effects

The following categories are used as the basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Side effects
Gastrointestinal complaints, weakness or skin rash may occur rarely. These symptoms usually subside within a few days after discontinuation of the medicine.

What countermeasures should be taken in the event of side effects?
If side effects occur, the medicine should be discontinued and a doctor consulted. Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet.

5. HOW SHOULD CRATAEGUS AL 450 MG FILM-COATED TABLETS BE STORED?
Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister pack after "Use by". The expiry date refers to the last day of the month. Store in the original package to protect from moisture. Do not store above + 25°C.

6. FURTHER INFORMATION
What Crataegus AL 450 mg film-coated tablets contain
The active ingredient is a hawthorn leaf and flower dry extract. 1 film-coated tablet contains 450 mg dry extract from hawthorn leaves with flowers (4-7:1). Extraction agent: Ethanol 45% (V/V). The other ingredients are: Maltodextrin, highly dispersed silicon dioxide, microcrystalline cellulose, croscarmellose sodium, magnesium stearate (Ph. Eur.), hypromellose, macrogol, talc, titanium dioxide (E 171).

What Crataegus AL 450 mg film-coated tablets look like and contents of the pack
White oblong film-coated tablet with a break notch on both sides.
Crataegus AL 450 mg film-coated tablets are available in packs of 30, 50 and 100 film-coated tablets.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
E-mail: info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This leaflet was last revised in May 2012.

Source: Information from the package leaflet
Status: 12/2012
Active ingredient: Hawthorn leaf and flower dry extract 450 mg per film-coated tablet. Areas of application: for reduced cardiac performance corresponding to stage II according to NYHA.