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Using Kaloba Tablets

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Pelargonium sidoides DC root extract. Each film-coated tablet of this product contains 20 mg of a dry extract from the roots of Pelargonium sidoides DC.

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

Before you take this product

DO NOT TAKE this product if you:

• are allergic to any of the ingredients (see section 6)
• are lactose-intolerant (react badly to lactose or milk)
• suffer from severe liver or kidney disease
• are 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 formulation is not suitable for children under the age of 12 years.

How to take this product

For oral use only

Adults and children over 12 years

Take 1 tablet three times daily (morning, midday, evening).

Swallow the tablet whole with some water. Do not chew the tablet.
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.

This formulation is not suitable for children under the age of 12 years.

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.
 

Tell your doctor or qualified healthcare professional if you notice any other side-effect.

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 blood in the 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 blister pack.

Store the product in a cool dry place.

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

Product description

Each film-coated tablet contains 20 mg of extract (as dry extract) from the roots of
Pelargonium sidoides DC (1: 8–10) (EPs® 7630). Extraction solvent: 11% ethanol (w/w).

This product also contains the following ingredients:

Extract: Maltodextrin

Tablet core: Maltodextrin, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, precipitated silica, magnesium stearate.

Film-coating: Hypromellose 5 mPas, Macrogol 1500, iron oxide yellow E 172, iron oxide red E 172, titanium dioxide E 171, talc, simeticone, methylcellulose, sorbic acid.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each film-coated tablet contains 20mg of lactose.

Each pack contains 21, 30, 42, 60 film-coated tablets.

Not all pack sizes may be marketed.

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 05332/0005

If you would like further information about this product, please contact:
Schwabe Pharma (UK) Ltd
Alexander House, Mere Park
Dedmere Road,
Marlow, Bucks, SL7 1PD
Telephone: 01628 401980
Email: info@kaloba.co.uk
This leaflet was prepared in March 2009