Sedonium® 300 mg
Product Characteristics
Read all of this leaflet carefully because it contains important information for you.This medicine is available without prescription. However, you still need to take Sedonium® 300mg 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 2 weeks.
Sedonium® 300mg
Active substance: The active pharmaceutical ingredient is a dry extract of valerian root.
One coated tablet contains:
300 mg dry extract of valerian root at a drug-to-extract ratio of 3-6 : 1. The extraction solvent is ethanol 70% (v/v).
The other ingredients are:
Glucose solution (dry substance), highly dispersed silicon dioxide, lactose monohydrate, cellulose, magnesium stearate, hypromellose, castor oil, macrogol 6000, sucrose (saccharose), talcum, gelatine, titanium dioxide (E 171), povidone K 25, Carnauba wax, highly dispersed silicon dioxide (methylated).
Sedonium® 300 mg coated tablets do not interfere with sugar metabolism; they are thus safe for diabetics. One coated tablet is equivalent to 0.03 carbohydrate exchanges.
Sedonium® 300 mg is available in original packs of 50 coated tablets or 100 coated tablets.
Furthermore, hospital packs of 1,000 coated tablets are available for use in a hospital setting.
1. WHAT Sedonium® 300mg IS AND WHAT IT IS USED FOR
1.1 Sedonium® 300 mg is a herbal sedative.
1.2 From: Cassella-med GmbH & Co. KG, Gereonsmühlengasse 1, 50670 Cologne.
Manufacturer:
Klosterfrau Berlin GmbH, Motzener Straße 41, 12277 Berlin, Germany
1.3 Sedonium® 300mg is used for
episodes of restlessness and difficulty falling asleep due to nervous conditions.
If these complaints persist for more than 2 weeks or become worse, you must by all means see a doctor.
2. BEFORE YOU TAKE Sedonium® 300mg
2.1 Do not take Sedonium® 300mg
if you are allergic (hypersensitive) to the active substance, to soybean meal, or to any of the other ingredients.
2.2 Take special care with Sedonium® 300mg
a) in children:
No adequate studies have been conducted on the use of this medicine in children. It should therefore not be used by children under 6 years of age.
b) during pregnancy and breast-feeding
From the common and widespread use of valerian root as a medicine, there has as yet been no evidence of risks during pregnancy and breast-feeding; however, results from experimental studies are not available. Therefore, you should not use this medicine while you are pregnant or breast-feeding.
c) Driving and using machines
For up to 2 hours after taking this medicine, you should not operate a motor vehicle or any machine, nor do any work under unsafe conditions, as your mental alertness may be impaired even when you use your medicine exactly as directed. This is particularly important if you drink alcohol during your treatment.
2.3 Taking other medicines
No interactions with other medicines are known.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
2.4 Taking Sedonium® 300 mg with food and drink
If possible, you should not drink any alcohol while using this medicine.
3. HOW TO TAKE Sedonium® 300 mg
Always take Sedonium® 300 mg exactly as directed in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
3.1 Method of administration
For oral use.
3.2 The usual dose is
for adults and adolescents from 12 years of age:
- for treating episodes of restlessness: 2 coated tablets up to 3 times per day.
- for treating difficulty falling asleep due to nervous conditions: 2 coated tablets taken 1/2 - 1 hour before bedtime. If necessary, you may take 2 more coated tablets earlier in the evening. One individual dose is equivalent to 2-3 g of valerian root
for children from 6-12 years of age:
- for treating episodes of restlessness and difficulty falling asleep due to nervous conditions: 1-2 coated tablets per day.
The coated tablets should not be taken while lying down.
Please swallow the coated tablets whole with a sufficient amount of liquid (preferably a glass of plain drinking water).
Please consult your doctor or pharmacist if you feel that the effect of this medicine is too strong or too weak.
How long to take Sedonium® 300 mg
The duration of treatment with this medicine is not generally limited. If your complaints persist for more than 2 weeks or get worse, you should consult a doctor.
3.3 If you take more Sedonium® 300 mg than you should
If you accidentally take 1 or 2 tablets more than you should at any time, this will usually have no negative consequences. If this happens, just continue taking your medicine as described in the dosage instructions, or as your doctor has prescribed.
If you have taken a substantial overdose of this medicine, you should consult a doctor.
3.4 If you forget to take Sedonium® 300 mg
Do not take a double dose to make up for a forgotten dose, but continue taking your medicine as described in this package leaflet, or as your doctor has told you.
4. POSSIBLE SIDE EFFECTS
No side effects are known.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Sedonium® 300 mg
Keep out of the reach and sight of children.
Do not use Sedonium® 300 mg after the expiry date which is stated on the carton/container.
Storage:
Do not store above 25°C.
This leaflet was last approved in:
August 2006.
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