Kaloba - Direkt Granulat im Beutel

Kaloba is a herbal medicine made from the root of the Pelargonium plant (Pelargonii radix) (Cape Pelargonium) for the symptomatic treatment of acute bronchial infections with cough and mucus production. This medicine is used in adults, adolescents and children from 6 years of age and is practical for on the go as a direct granulate. If you do not feel better or even worse after 7 days, contact your doctor.

Application

Kaloba Direkt is a granulate for oral use.

The recommended dose is Adults and adolescents over 12 years: 1 sachet 3 times a day (morning, noon, evening) 

Children from 6 to 11 years: 1 sachet 2 times a day (morning, evening) 

Kaloba Direkt is not suitable for children under 6 years of age due to the dosage form. Kaloba drops for oral use or Kaloba syrup are also available for children from 1 year of age.

If the symptoms worsen or do not improve after 7 days, a doctor must be consulted. The duration of treatment should not exceed 3 weeks.

Ingredients

The active ingredient is: Dry extract of Pelargonium root (Pelargonii radix) (drug extract ratio (DEV) 4 - 25: 1) (EPs® 7630). The extraction agent is ethanol 11% (m/m). 1 sachet with 800 mg granulate contains 20 mg dry extract of Pelargonium root (Pelargonii radix) as active ingredient. 

The other ingredients are: Maltodextrin, xylitol, highly dispersed silicon dioxide.

What should you consider before taking it?

What should you consider before taking Kaloba?

Kaloba must not be taken,
- if you are allergic (hypersensitive) to Pelargonium or any of the other ingredients of this medicine listed in section 6.
- if you have severe liver disease.

Warnings and Precautions
Please talk to your doctor or pharmacist before taking Kaloba.

If fever, shortness of breath or bloody sputum occurs or if you notice signs of liver dysfunction (e.g. yellowing of the whites of the eyes or skin), you must see a doctor.

Children:

Kaloba Direkt is not suitable for children under 6 years of age due to the dosage form

Taking Kaloba Direkt with other medicines:

 Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. No interactions have been reported to date. 

Pregnancy and breast-feeding:

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is no or very limited experience with the use of this medicine in pregnant and breast-feeding women. As a precaution, Kaloba Direkt should be avoided during pregnancy and breast-feeding.

Driving and using machines:

No studies on the effects on the ability to drive and use machines have been performed

How to take the medicine?

How to take Kaloba?

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

1). Hold the bag by the arrows and shake briefly to settle the contents.

2). Tear open the bag along the arrows.

3). Place the granules directly in the mouth. It dissolves in saliva and can be swallowed directly. If desired, some liquid can be drunk afterwards.

If you have taken more Kaloba Direkt than you should No cases of overdose are known. 

If you forget to take Kaloba Direkt Do not take a double dose to make up for a forgotten dose. 

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

What side effects are possible?

What side effects are possible?

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

The list includes all known side effects under treatment with Kaloba, including those under higher dosage or long-term therapy.

The following frequency information is used to assess side effects:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people

Very rare: may affect up to 1 in 10,000 people

Not known: frequency cannot be estimated from the available data

When using Kaloba, gastrointestinal complaints such as stomach pain, heartburn, nausea or diarrhea occasionally occur.
In rare cases, slight bleeding of the gums or nose may occur.

In addition, allergic reactions (skin rash, hives, itching of the skin and mucous membranes) have been described in rare cases. Such reactions can occur even when the medicine is taken for the first time.

In very rare cases, severe allergic reactions with facial swelling, shortness of breath and a drop in blood pressure can occur.

Cases of elevated liver enzymes and hepatitis (inflammation of the liver) have been reported in connection with taking Pelargonium-containing medicines. The frequency is not known.

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system:

Federal Office for Safety in Health Care

Traisengasse 5
1200 VIENNA
AUSTRIA
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/

By reporting side effects, you can help provide more information about the safety of this medicine.

Special storage instructions

How to store Kaloba?

This medicine does not require any special storage conditions. Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special notes on the content

Contents of the pack and further information

What Kaloba Direkt contains

The active ingredient is: Liquid extract of Pelargonium root (Pelargonii radix) (drug extract ratio (DEV) 1: 8 - 10) (EPs® 7630). The extraction agent is ethanol 11% (m/m).

1 sachet with 800 mg granulate contains 20 mg dry extract of Pelargonium root (Pelargonii radix) as active ingredient.

What Kaloba looks like and contents of the pack

Kaloba Direkt is a beige-brown granulate sealed in sachets made of PET/aluminum/PE film. Kaloba Direkt is available in packs of 21 sachets. Kaloba Direkt is a natural product in which slight variations in appearance and taste can occur, which do not affect its quality.