Sedacur forte 50 coated tablets

Sedacur forte 50 coated tablets

Sedacur forte 50 coated tablets - 75 mg dry extract of valerian roots, 23 mg dry extract of hop strobiles, 45 mg dry extract of balm leaves;

Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, you still need to take Sedacur® forte 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 14 days.

- 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 Sedacur® forte is and what it is used for

2. Before you take Sedacur® forte

3. How to take Sedacur® forte

4. Possible side effects

5. How to store Sedacur® forte

6. Further information

1. What Sedacur® forte is and what it is used for

Sedacur® forte is a herbal medicine for sedation. Sedacur® forte is used in case of restlessness and difficulties in falling asleep.

2. Before you take Sedacur® forte

2.1 Do not take Sedacur® forte if you are allergic (hypersensitive) to the active ingredients valerian root, hop strobile, balm leaves or any of the other ingredients (see under 6. “Further information”) of Sedacur® forte.

2.2 Take special care with Sedacur® forte, if your complaints persist for more than 2 weeks or worsen. Then you should consult a doctor in any case.

2.3 Children

No sufficient data are available on the use of this medicine in children. Therefore, the use of this medicine is not recommended in children younger than 12 years of age.

2.4 Taking other medicines

As of now, no interactions of other medicines with Sedacur® forte are known. Nevertheless, please, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

2.5 Taking Sedacur® forte with foods and drinks

During the intake of this medicine you should not drink alcohol, if possible.

2.6 Pregnancy and breast-feeding

The common use of valerian root, hop strobile, melissa leaves as a medicine has shown no indications regarding risks during pregnancy and lactation. However, results of experimental testing are not available. Therefore, you should not take Sedacur® forte during pregnancy and breast-feeding.

2.7 Driving and operate machines

Up to 2 hours after the intake of this medicine you should not drive or operate machinery, since your alertness can be influenced, even if taken as directed. This effect may be enhanced, especially by consumption of alcohol.

2.8 Important information about some of the other ingredients of Sedacur® forte

This medicine contains the sugars glucose and sucrose. Please only take Sedacur® forte after talking to your doctor, if you know that you suffer from an intolerance to certain sugars.

3. How to take Sedacur® forte

Always take Sedacur® forte exactly as directed in this package leaflet. Please check with your doctor or pharmacist if you are not sure.

3.1 Unless otherwise prescribed by a doctor, the usual dose is:

For adults and adolescents over 12 years of age

• for the treatment of restlessness - 2 to 3 times daily x 2 Sedacur® forte

• for the treatment of difficulties in falling asleep x 2 Sedacur® forte, ½ to 1 hour before bedtime. Do not take Sedacur® forte while lying down. Please take Sedacur® forte unchewed with sufficient liquid (preferably a glass of drinking water).

3.2 Duration of use

The duration of use of this medicine is not limited in principle. However, please consider the note under item 2.2. Please ask your doctor or pharmacist if you have the impression that the effect of Sedacur® forte is too strong or too weak.

3.3 If you take more Sedacur® forte than you should

If you have inadvertently taken the double or triple dosage than the one described (corresponds to 4 – 6 Sedacur® forte), this normally has no adverse consequences. In this case continue the intake as described in the dosage instruction or as prescribed by your doctor. If you have taken extremely high doses of Sedacur® forte, you should contact a doctor.

3.4 If you forget to take Sedacur® forte:

Do not take a double dose, but continue the intake at the usual time. If you have any further questions on the use of the medicinal product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sedacur® forte can cause side effects, although not everybody gets them. The listing includes all known side effects under the treatment with the active ingredients hop strobile and balm leaves, even those caused by higher dosage or long-term therapy.

Assessment of side effects is based on the following frequency rates:

Very common: more than 1 treated patient of 10

Common: 1 to 10 treated patients of 100

Uncommon: 1 to 10 treated patients of 1,000

Rare: 1 to 10 treated patients of 10,000

Very rare: less than 1 treated patient of 10,000

Unknown: frequency not assessable on the basis of the available data

Possible side effects: Rare: gastro-intestinal complaints. Very rare: allergic skin reactions. In general, the side effects disappear after discontinuing the medication. If first signs of a hypersensitivity reaction occur, this medicine should not be taken again. Please inform your doctor or pharmacist if any of the listed side effects considerably impairs you, or if you notice any side effects not listed in this leaflet.

5. How to store Sedacur® forte

Keep out of the reach and sight of children. You should not use Sedacur® forte after the expiry date printed on the side of this pack. The expiry date refers to the last day of that month. Do not store above 30°C. This is the English version of the German package leaflet.

6. Further information

What Sedacur® forte contains:

Active substances: 1 coated tablet contains 75 mg dry extract of valerian roots in a drug to extract ratio of 5-6:1, the extractant is ethanol 70% (V/V); 23 mg dry extract of hop strobiles in a drug to extract ratio of 4-8:1, the extractant is methanol 40% (V/V); 45 mg dry extract of balm leaves in a drug to extract ratio of 4-6:1, the extractant is water.

The other ingredients are: maltodextrin, colloidal anhydrous silica, microcrystalline cellulose, stearic palmitic acid, talc, povidone, copovidone, sucrose (saccharose), titanium dioxide E 171, maize starch, glucose syrup, carnauba wax, bleached wax, shellac, carboxymethylcellulose sodium, polysorbate 80, indigotine E132.

What Sedacur® forte looks like and contents of the pack:

The coated tablets are round with light blue glossy coating. Sedacur® forte is available in packs containing 60 and 100 coated tablets.

Marketing authorisation holder and manufacturer - Schaper & Brümmer GmbH & Co.