PACKAGE LEAFLET: INFORMATION FOR THE USER
HAWTHORN TINCTURE VALENTIS 1:10 oral drops, solution
Crataegi tinctura
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
tincture 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 tincture Valentis is and what it is used for
2. Before you use Hawthorn tincture Valentis
3. How to use Hawthorn tincture Valentis
4. Possible side effects
5. How to store Hawthorn tincture Valentis
6. Further information
1.
WHAT HAWTHORN TINCTURE VALENTIS IS AND WHAT IT IS USED
FOR
Hawthorn tincture 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 TINCTURE VALENTIS
Do not take Hawthorn tincture 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 tincture 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 tincture 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 tincture Valentis.
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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 tincture Valentis.
Hawthorn tincture potentate effect of antidepressants (used to treat depression or anxiety),
thus, they should not be used concomitantly.
Hawthorn tincture 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 tincture Valentis with food and drink
Hawthorn tincture 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 tincture Valentis
This medicinal product contains 65 vol % ethanol (alcohol), i.e. up to 0,35 g per dose,
equivalent to 7,02 ml beer, 2,92 ml wine per dose. Harmful for those suffering from
alcoholism. To be taken into account in pregnant or breast-feeding women, children and highrisk groups such as patients with liver disease, or epilepsy.
3.
HOW TO TAKE HAWTHORN TINCTURE VALENTIS
Always take Hawthorn tincture 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
used.
Patients with renal and/or hepatic impairment should consult their doctor before use.
If you take more Hawthorn tincture Valentis than you should
If You or somebody else, has taken too much Hawthorn tincture Valentis, please consult Your
doctor or go to the nearest emergency department immediately.
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If you forget to take Hawthorn tincture Valentis
Do not take a double dose to make up for a forgotten dose.
If you stop taking Hawthorn tincture 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 tincture 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 TINCTURE 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 tincture 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
environment.
6.
FURTHER INFORMATION
What Hawthorn tincture Valentis contains
 The active substance is tincture from hawthorn berries. 1 ml of solution contains 1 ml
of tincture from hawthorn berries 1:10 (manufactured with ethanol 70 % (V/V)).
 There are no other ingredients.
What Hawthorn tincture Valentis looks like and contents of the pack
Tawny, clear, sweetish 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: July 2011.
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