Using Kaloba

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Pelargonium sidoides root extract. 10g (=9.75ml) of oral solution contain 8g of the liquid extract.

Kaloba is a traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including the common cold, such as sore throat, cough and blocked or runny nose, exclusively based on long standing use as a traditional remedy. Always read the label.

Before you take this product

DO NOT TAKE this product if you are:

• allergic to any of the ingredients (see product description below)
• suffer from severe liver or kidney disease
• pregnant or breast-feeding

If you suffer from an increased tendency to bleeding and/or take anti-coagulating drugs such as warfarin, there is a theoretical risk that taking this product may increase the risk of bleeding.

This product is not suitable for children under the age of 6 years.

Kaloba oral solution contains 12 vol% ethanol (alcohol).

This corresponds to:

• 180mg alcohol equivalent to 3.6ml beer or 1.5ml wine per adult’s single dose (30 drops)
• 120 mg alcohol equivalent to 2.4ml beer or 1.0ml wine per children’s single dose (20 drops).

This is harmful for those suffering from alcoholism. The alcohol content should be taken into consideration when treating children and high-risk groups such as patients with liver disease or epilepsy.

How to take this product

Adults and children over 12 years

Take 30 drops three times daily.

Children aged 6-12 years

Take 20 drops three times daily.

The correct dosage can be taken straight from a spoon or mixed with half a glass of water. The entire contents of the glass should be drunk straightaway. Take one dose in the morning, midday and evening.

After the relief of symptoms, continue treatment for a further 2-3 days to prevent a relapse. However, treatment should not exceed two weeks.

Do not exceed the stated dose.

Hold bottle vertically. If drops come out too quickly, tilt bottle

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to your doctor, pharmacist or healthcare practitioner and take this leaflet with you.

If you forget to take this product

Do not take twice the dose, but continue to take your usual dose at the usual time.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner.

Side-effects

Like all medicines, this product can have side-effects, although not everybody gets them. They are listed below.

Uncommon side-effects (affecting more than 1 in 1,000 but fewer than 1 in 100 people)

• Gastro-intestinal complaints such as stomach pain, heartburn, nausea or diarrhoea.

Rare side-effects (affecting more than 1 in 10,000 but fewer than 1 in 1000 people)

• mild bleeding from the gums or nose
• hypersensitivity reactions, e.g. skin rash, nettle rash or itching of the skin and mucous membranes

Such reactions may occur when this product is first taken.

Very rare side-effects (affecting 1 or fewer in 10,000 people)

• Serious hypersensitivity reactions with swelling of the face, breathlessness and drop in blood pressure

Single cases

Signs indicating changes in liver function have been reported after taking Kaloba; however, the causal relationship between these effects and the use of the product has not been demonstrated.

After taking this product

Consult a doctor immediately if your condition does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or bloody sputum.

Do not use this product after the expiry date. Return any out-of-date product to your pharmacist who will dispose of it for you. The expiry date is printed on the box and also the bottle label.

Store the product in a cool dry place. Do not store the product in a place where the temperature goes above 30°C.

Keep the product out of the reach and sight of children.

Product description

This product is a traditional herbal medicinal product containing Pelargonium sidoides root extract. 10g (= 9.75mL) of oral solution contain 8g extract from the roots of Pelargonium sidoides (1 :8-10) (EPs® 7630)1, extraction solvent 11% ethanol (m/m).

This product also contains the following ingredients:

Glycerol 85% Ethanol

Each pack contains 20, 50 or 100ml oral solution.

Registration holder and manufacturer of this product

Dr Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Germany

Distributor of this product in the UK

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1PD

Traditional herbal registration number: THR 05332/0003