Microsoft word - pil gudobeliu sk ekstr valentis lv_en.doc
PACKAGE LEAFLET: INFORMATION FOR THE USER
HAWTHORN LIQUID EXTRACT VALENTIS
1:1 oral drops, solution
Crataegi extractum fluidum
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Hawthorn
liquid extract Valentis carefully to get the best results from it.
Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after 6 weeks. 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.
In this leaflet
1. What Hawthorn liquid extract Valentis is and what it is used for 2. Before you use Hawthorn liquid extract Valentis 3. How to use Hawthorn liquid extract Valentis 4. Possible side effects 5. How to store Hawthorn liquid extract Valentis 6. Further information
WHAT HAWTHORN LIQUID EXTRACT VALENTIS IS AND WHAT IT IS
Hawthorn liquid extract Valentis is used in case of functional heart disease, as remedy in case
of chronic heart insufficiency (NYHA I, II), arrhythmia (abnormal heartbeat rhythm),
especially in case of paroxysmal tachycardia (abnormally rapid heartbeat), 1. degree arterial
hypertension (increased blood pressure). 2.
BEFORE YOU TAKE HAWTHORN LIQUID EXTRACT VALENTIS
Do not take Hawthorn liquid extract Valentis
if You are allergic (hypersensitive) to plants of the rose family (Rosaceae
); if You have severe renal and/or hepatic insufficiency; if You are pregnant or breast feeding.
Take special care with Hawthorn liquid extract Valentis
if if the chest pain appears and swelling and dyspnoea increase; if the symptoms of coronary heart disease and reduced blood circulation emerge or
symptoms (dyspnoea (shortness of breath), leg swelling, bluish lips and nails, arrhythmic and/or rapid heart beat) do not improve after six weeks of treatment with this preparation, please consult Your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Hawthorn liquid extract can interact with other medicines (for example, cardiac glicosides,
beta blockers and calcium channel blockers) which influence heart function as well as with
hypolipideming drugs (drugs reducing lipid level in blood), thus, they should not be used
concomitantly with Hawthorn liquid extract Valentis.
Hawthorn herb contains tannin and therefore there might be disturbed absorption of iron, and
this should be taken in account in patients with anaemia (deficiency of red blood cells). In
order to avoid this interaction, iron containing medicines should not be used concomitantly
with Hawthorn liquid extract Valentis.
Hawthorn liquid extract Valentis potentate effect of antidepressants (used to treat depression
or anxiety), thus, they should not be used concomitantly.
Hawthorn liquid extract is not advised to be taken concomitantly with disulfiram (used to treat
chronic alcoholism) and metronidazol (antibiotic) as it may cause similar reaction to
disulfiram. Taking Hawthorn liquid extract Valentis with food and drink
Hawthorn liquid extract Valentis should be used before meal. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
It is not advised to use this preparation during pregnancy and lactation.
Driving and using machines
Though the preparation contains ethanol, when it is used at prescribed doses it has no effect
on the ability to drive or to use machines.
Important information about some of the ingredients of Hawthorn liquid extract
This medicinal product contains 55 vol % ethanol (alcohol), i.e. up to 0,32 g per dose,
equivalent to 6,48 ml beer, 2,7 ml wine per dose. Harmful for those suffering from
alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-
risk groups such as patients with liver disease, or epilepsy. 3.
HOW TO TAKE HAWTHORN LIQUID EXTRACT VALENTIS
Always take Hawthorn liquid extract Valentis exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Oral use. Shake before use.
First 3 or 4 days take 20 - 30 drops diluted with water, 3 or 4 times a day; later decrease the
dose to 15-20 drops 2 or 3 times per day. The preparation should be used for 4 – 8 weeks. The use in children:
The use in children under 12 years of age has not been established due to lack of adequate
data therefore is not recomended. Dosage for special patient groups:
There are no special pososlogy recomedations for elderly and standard dossage should be
Patients with renal and/or hepatic impairment should consult their doctor before use. If you take more Hawthorn liquid extract Valentis than you should
If You or somebody else, has taken too much Hawthorn liquid extract Valentis, please consult
Your doctor or go to the nearest emergency department immediately.
If you forget to take Hawthorn liquid extract Valentis
Do not take a double dose to make up for a forgotten dose. If you stop taking Hawthorn liquid extract Valentis
If you have any further questions on the use of this product, ask your doctor or pharmacist. 4.
POSSIBLE SIDE EFFECTS
Like all medicines, Hawthorn liquid extract Valentis can cause side effects, although not
everybody gets them and You may not experience them. Not known (frequency cannot be estimated from the available data)
: nausea, skin rash,
sweating, fatigue, hypotension (decreased blood pressure) and sedation.
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. 5.
HOW TO STORE HAWTHORN LIQUID EXTRACT VALENTIS
Keep out of the reach and sight of children.
Do not store above 25 0C.
Keep the bottle in outer carton.
Keep the bottle tightly closed.
Protect from light.
Do not use Hawthorn liquid extract Valentis after the expiry date which is stated on the
packaging. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
What Hawthorn liquid extract Valentis contains
The active substance is liquid extract from hawthorn berries. 1 ml of solution contains
1 ml of liquid extract from hawthorn berries 1:1 (manufactured with ethanol 70 % (V/V)).
What Hawthorn liquid extract Valentis looks like and contents of the pack
Brownish-red, aromatic, sourish sweet solution. May precipitate during storage.
25 ml of solution in dark glass bottle with plastic closure. The bottle is put in outer carton. Marketing authorization holder and manufacturer:
UAB „Valentis“, Molėtų pl. 11, LT-08409 Vilnius, Lithuania
Tel.: +370 5 2701225
Fax: +370 5 2701223 This leaflet was last revised in:
BIOGRAPHICAL SKETCH (PI) Name : Hideshi Okada Degree(s) : M.D., Ph.D. Position/Title : Postdoctoral Fellow Education/Training : (Begin with entry into college and include postdoctoral training) Medicine, Gifu, Japan Hyogo Prefectural Amagasaki Hospital, Hyogo, Japan Hyogo Prefectural Amagasaki Hospital, Hyogo, Japan Gifu University Hospital, Gifu Institute, La Jolla, CA, USA Vet
List of Publications Original articles, peer-reviewed 1. Steffens S , Thiel H-J, Behrens S-E (1999). The RNA-dependent RNA polymerases of different members of the family Flaviviridae exhibit similar properties in vitro. Journal of General Virology, 80(Pt 10): 2583-90 2. Steffens S , Frank S, Fischer U, Heuser C, Meyer KL, Dobberstein K-U, Rainov NG, Kramm CM (2000). EGFP fusion pr