KYTTA SEDATIVUM

KYTTA SEDATIVUM Coated Tablets

Important notes (mandatory information)

Kytta-Sedativum Dragees, coated tablets. Areas of application: for use in states of agitation and nervous sleep disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Kytta-Sedativum Dragees, coated tablets for oral administration for adults and children aged 3 years and over
Active ingredients: valerian root dry extract, hop cone dry extract, passion flower herb dry extract
Herbal medicinal product

Dear patient! Please read the entire package leaflet carefully, as it contains important information for you. This medicine is also available without a prescription. However, in order to achieve the best possible treatment success, Kytta-Sedativum Dragees must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need any further information or advice.
• If your symptoms worsen or do not improve after 14 days, you must consult a doctor.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE KYTTA-SEDATIVUM DRAGEES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KYTTA-SEDATIVUM DRAGEES?
3. HOW SHOULD KYTTA-SEDATIVUM DRAGEES BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD KYTTA-SEDATIVUM DRAGEES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE KYTTA-SEDATIVUM DRAGEES AND WHAT ARE THEY USED FOR?

Kytta-Sedativum Dragees are a herbal medicinal product for use in states of agitation and nervous sleep disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING KYTTA-SEDATIVUM DRAGEES?

Kytta-Sedativum Dragees must not be taken if you are hypersensitive (allergic) to valerian, hops, passion flower or any of the other ingredients of Kytta-Sedativum Dragees.

Special care should be taken when taking Kytta-Sedativum Dragees:

• in children under 3 years of age, as there are no sufficient studies available. It should therefore not be used in children under 3 years of age.
• in persons suffering from kidney or liver disease (see section 3).

When taking Kytta-Sedativum Dragees with other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. No studies have been conducted on possible interactions with Kytta-Sedativum Dragees. There is only limited data on pharmacological interactions of valerian, hop and passion flower herb preparations with other medicines. The combination with synthetic sedatives requires a medical diagnosis and monitoring.

When taking Kytta-Sedativum Dragees with food and drink

You should avoid drinking alcohol while using this medicine. Medicines with a sleep-inducing effect can generally, even when used as intended, alter reactions; this applies to an even greater extent in combination with alcohol. Pregnancy and breastfeeding The safety during pregnancy and breastfeeding has not been sufficiently investigated. Kytta-Sedativum Dragees are not recommended for pregnant and breastfeeding women.

Driving and operating machinery

Kytta-Sedativum Dragees can impair the ability to drive and operate machinery, even when used as intended. In this case, you must not drive, operate machinery or perform other hazardous activities. This applies to an even greater extent in combination with alcohol.

Important information about certain other ingredients of Kytta-Sedativum Dragees

This medicine contains glucose, lactose and sucrose (saccharose). Please only take Kytta-Sedativum Dragees after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW SHOULD KYTTA-SEDATIVUM DRAGEES BE TAKEN?

Always take Kytta-Sedativum Dragees exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: For the treatment of states of agitation: Children aged 3 years and over take 1 Kytta-Sedativum Dragee 1 - 2 times a day, adults and children over 12 years of age take up to 1 Kytta-Sedativum Dragee 3 times a day. For the treatment of nervous sleep disorders: Children aged 3 years and over and adults take 1 Kytta-Sedativum Dragee 1/2 to 1 hour before going to bed. If necessary, an additional 1 Kytta-Sedativum Dragee can be taken earlier in the evening. Use in children under 3 years of age is not intended.

For persons suffering from kidney or liver disease

There is insufficient data for specific dosage recommendations in the case of impaired renal/hepatic function.

How and when should you take Kytta-Sedativum Dragees?
Kytta-Sedativum Dragees are taken unchewed with plenty of liquid (preferably a glass of drinking water).

How long should you take Kytta-Sedativum Dragees?
Due to the gradual onset of action, Kytta-Sedativum Dragees are not suitable for the acute treatment of states of agitation and sleep disorders. In order to achieve an optimal treatment success, it is recommended to take the medicine continuously for 2-4 weeks.

If the symptoms do not improve or even worsen after two weeks of continuous use of the medicine, a doctor should be consulted.

If you have taken more Kytta-Sedativum Dragees than you should

If you have accidentally taken 1 or 2 Kytta-Sedativum Dragees more than intended, this will generally not have any adverse effects. In this case, continue taking the medicine as described in the dosage instructions or as prescribed by your doctor. If you have significantly overdosed on this medicine, you should consult a doctor. In one individual case, taking valerian root in a dosage of over 20 g led to the following symptoms: fatigue, abdominal cramps, tightness in the chest, emptiness in the head, trembling of the hands and dilation of the pupils.

If you forget to take Kytta-Sedativum Dragees

Do not take double the dose if you have forgotten to take the previous dose, but continue with the next dose.

If you stop taking Kytta-Sedativum Dragees

An interruption or premature termination of treatment is harmless.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Kytta-Sedativum Dragees can have side effects, although not everybody gets them. The list includes all known side effects under treatment with valerian root, hop cones and passion flower herb, including those under higher dosage or long-term therapy.

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

Since the following possible side effects are based on spontaneous reports from extensive use after market launch, a precise estimation of the frequency is not possible. Therefore, the frequency is classified as "not known". Significant side effects or signs to watch out for, and measures to be taken if you are affected: If you are affected by any of the following side effects, stop taking Kytta-Sedativum Dragees and see your doctor as soon as possible. As with all oral medicines, systemic hypersensitivity reactions can occur. These can manifest themselves, for example, in the form of skin reactions (e.g. skin redness, rashes, hives, itching), hypersensitivity reactions of the gastrointestinal tract (e.g. abdominal pain, vomiting), of the cardiovascular system (e.g. blood pressure fluctuations, rapid heartbeat) or of the respiratory tract (e.g. shortness of breath).

Gastrointestinal disorders

Frequency not known: After taking valerian root preparations, gastrointestinal complaints (e.g. nausea, abdominal cramps) may occur. Other possible side effects Dizziness, headache, inner restlessness, nervousness, restlessness.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD KYTTA-SEDATIVUM DRAGEES BE STORED?

Keep medicines out of the reach of children. The expiry date of this pack is printed on the side flap of the folding box and on the blister. Do not use this pack after the stated date! Storage conditions: Do not store above 25°C.

6. FURTHER INFORMATION

What Kytta-Sedativum Dragees contain

The active ingredients are: 1 coated tablet contains 150 mg dry extract from valerian roots (3 - 6:1), extraction solvent: ethanol 70 % (VA/), 30 mg dry extract from hop cones (4 -8:1), extraction solvent: ethanol 40 % (VA/), 80 mg dry extract from passion flower herb (4 - 7:1), extraction solvent: ethanol 50 % (VA/). The other ingredients are: maltodextrin, lactose monohydrate, highly dispersed silicon dioxide, glucose syrup solids, cellulose powder, povidone 25, magnesium stearate (vegetable), hypromellose, microcrystalline cellulose, stearic acid, talc, sucrose (saccharose), calcium carbonate, titanium dioxide (E171), white clay, gum arabic, macrogol 6000, glycerol 85%, indigo carmine (El32), montanglycol wax.

What Kytta-Sedativum Dragees look like and contents of the pack

Packs of 40 and 100 blue, coated tablets.

Pharmaceutical entrepreneur

Merck Selbstmedikation GmbH
Frankfurter Str. 250,
64293 Darmstadt
Tel. no.: 0 61 51/8 56-22 60
Fax no.: 0 61 51/8 56-22 03
www.merckselbstmedikation.de

Manufacturer

Merck Kommanditgesellschaft auf Aktien & Co
Werk Spittal
A-9800 Spittal/Drau

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 11/2017
Areas of application: for use in states of agitation and nervous sleep disorders.