vivinox Nerve Calming Dragees

Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets 112.5 mg / 125 mg / 80 mg. Indications: Restlessness and nervous-related sleep disturbances. Warnings: Contains glucose and sucrose.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets 112.5 mg / 125 mg / 80 mg, for restlessness and nervous-related sleep disturbances, for use in children over 12 years and adults.
Active ingredients: Lemon balm leaf dry extract / Valerian root dry extract / Passionflower herb dry extract.

Read the entire package leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after 14 days, consult your doctor.

What this leaflet contains:

1. WHAT ARE VIVINOX NERVEN CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING DRAGEES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VIVINOX NERVE CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING DRAGEES?
3. HOW SHOULD VIVINOX NERVE CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING DRAGEES BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VIVINOX NERVEN CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING DRAGEES BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS VIVINOX NERVE CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING COLOURS AND WHAT IS IT USED FOR? Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated

• if you are allergic to lemon balm, valerian, passionflower or any of the other ingredients of this medicine listed in section 6

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Vivinox Nerve Rest Valerian + Lemon Balm + Passionflower calming tablets.

Children:
There are insufficient studies on the use of Vivinox Nerve Rest Valerian + Lemon Balm + Passionflower calming tablets in children. Therefore, the use of Vivinox Nerve Rest Valerian + Lemon Balm + Passionflower calming tablets is not recommended for children under 12 years of age.

Taking Vivinox Nerve Rest Valerian + Lemon Balm + Passionflower calming tablets with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Studies on interactions between Vivinox Nerve Rest Valerian + Lemon Balm + Passionflower calming tablets and other medicines are not available. No interactions have been reported to date; however, an interaction with synthetic sedatives cannot be ruled out.

Taking Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets with food and drink:
You should avoid drinking alcohol while using this medicine.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. There are no studies on the use of Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets during pregnancy and breastfeeding. Therefore, Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets should not be used during pregnancy or while breastfeeding.

Driving and operating machinery:
Even when used as directed, Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets can impair your ability to react to such an extent that your ability to actively participate in road traffic, operate machinery, or work without a secure footing is affected. This applies to an even greater degree when combined with alcohol. Therefore, driving, operating machinery, or engaging in other hazardous activities should be completely avoided.

Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Dragees contain glucose and sucrose:
Please consult your doctor before taking Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Dragees if you know you have an intolerance to certain sugars.

Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets contain sodium:
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e., it is essentially sodium-free.

3. HOW TO TAKE VIVINOX NERVE CALM VALERIAN + LEMON BALM + PASSION FLOWER CALMING CODLED Tablets?

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage:

Unless otherwise prescribed by your doctor, the usual dose is:
For adults and adolescents over 12 years of age:

• For the treatment of restlessness, take 2 coated tablets 3 times daily.
• For the treatment of nervous-related sleep disturbances, take 2 coated tablets 0.5 to 1 hour before bedtime.

If necessary, you can take an additional 2 coated tablets earlier in the evening. A single dose of 2 coated tablets corresponds to 1.13 g of lemon balm leaves, 1.13 g of valerian root, and 0.96 g of passionflower herb.

Method of administration:
For oral use.

Do not take Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower calming tablets while lying down. Swallow the tablets whole with sufficient liquid (preferably a glass of water).

Duration of use:
There is generally no limit to the duration of use of Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower calming tablets. If symptoms persist for more than 2 weeks or worsen, you must consult a doctor.

Please talk to your doctor or pharmacist if you feel that the effect of Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower calming tablets is too strong or too weak.

Use in children:
Use in children under 12 years of age has not been sufficiently studied and is therefore not recommended.

If you have taken more Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets than you should:
The recommended dose of this medicine is 2-6 tablets per day. If you accidentally take double or triple the intended dose, this usually has no adverse effects. In this case, continue taking the medicine as described in the dosage instructions or as prescribed by your doctor. If you have taken a significant overdose of this medicine, you should consult a doctor.

If you forget to take Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Coated Tablets:
Do not take a double dose to make up for a forgotten dose. Continue taking the medicine as described in this leaflet or as prescribed by your doctor.

If you stop taking Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower Calming Dragees:
No special measures are necessary.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Gastrointestinal problems (e.g., nausea and abdominal cramps) and allergic skin reactions may occur.

If you experience the first signs of a hypersensitivity reaction, do not take this medicine again.

A single case of hypersensitivity reaction (vasculitis), nausea, and tachycardia has been reported following the ingestion of passionflower herb. The frequency is not known (frequency cannot be estimated from the available data).

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

5. HOW TO STORE VIVINOX NERVE CALM VALERIAN + LEMON BALM + PASSIONFLOWER CALMING COLOURS?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of the month indicated.

Never dispose of medicines via wastewater (e.g., down the toilet or sink). Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. Contents of the pack and further information.

The active ingredients are:
Lemon balm leaf dry extract/Valerian root dry extract/Passionflower herb dry extract. One coated tablet contains 112.5 mg dry extract of lemon balm leaves (4-6 :1), extraction solvent methanol 30% (V/V), 125 mg dry extract of valerian root (3-6 :1), extraction solvent ethanol 70% (V/V) and 80 mg dry extract of passionflower herb (5-7 :1), extraction solvent ethanol 50% (V/V).

The other ingredients are:
spray-dried glucose syrup, highly dispersed silicon dioxide, cellulose powder, croscarmellose sodium, maltodextrin, stearic acid, talc, sucrose, calcium carbonate E 170, gum arabic, tragacanth, bleached wax, carnauba wax, shellac, sodium sulfate E 514, colorants: titanium dioxide E 171, quinoline yellow E 104, indigo carmine E 132.

Note for diabetics:
1 coated tablet contains a maximum of 0.02 bread units (BU).

What Vivinox Nerve Calm Valerian + Lemon Balm + Passionflower calming dragees look like and the contents of the pack:
Round dragees.

(Apo) Usually ship out within 3-5 business days