Relieves symptoms of the common cold

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 Pelargonium Cough & Cold Relief 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, based on traditional use only.

Before you take this product

DO NOT TAKE this product if you:

• are allergic to any of the ingredients (see further information below)
• suffer from severe liver 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 product is not suitable for children under the age of 6 years.

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

This corresponds to:

• 125 mg alcohol equivalent to 2.5 ml beer or 1.0 ml wine per adult’s single dose (30 drops)
• 84 mg alcohol equivalent to 1.7 ml beer or 0.7 ml 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.

Possible 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, vomiting, difficulty
  swallowing (dysphagia) 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 decrease in blood pressure

Liver problems including hepatitis have been reported when taking this product. However, a causal relationship has not been established. The frequency is not known.

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.

Liver problems including hepatitis have been reported when taking this product. However, a causal relationship has not been established. The frequency is not known. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness, loss of appetite), stop taking immediately and seek medical advice.

Tell your doctor or pharmacist if any of the above side-effects becomes serious or if younotice any other side-effects not listed above.

Reporting of side effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not listed in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

How to store this product

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.

Further information

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 or 50 ml 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 1FX

Traditional herbal registration number: THR 05332/0003

If you would like further information about this product, please contact:

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park, Dedmere Road, Marlow, Bucks, SL7 1FX
Telephone: 01628 401980
Email: info@schwabepharma.co.uk

This information was revised 01/2015.

1 Name of the medicinal product

• Kaloba Pelargonium Cough and Cold Relief oral drops

2 Qualitative and quantitative composition

Active substance:

10 g (= 9.75 mL) of oral solution contains 8.0 g extract from the roots of Pelargonium sidoides DC (1 : 8 – 10) (EPs® 7630).

Extraction solvent: 11% ethanol (w/w).

1 ml (approximately 20 drops) of Kaloba Oral Drops, solution contains 120 mg ethanol (alcohol) equivalent to 2.4 ml beer or 1.0 ml of wine.

For a full list of excipients, see section 6.1.

3 Pharmaceutical form

Oral drops, solution. Light brown to reddish brown solution

4 Clinical particulars

4.1 Therapeutic indications

Traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including common cold, such as sore throat, cough and blocked or runny nose, based on traditional use only.

4.2 Posology and method of administration

Adults and adolescents over the age of 12:
Take 30 drops three times per day.

Children aged between 6-12 years:
Take 20 drops three times per day.

The necessary amount of drops may be taken directly from a spoon or, if preferred, can be mixed with half a glass of water and the contents of the entire glass should be drunk straightaway.

The dose should be taken in the morning, at midday and in the evening.

20 drops is equivalent to approximately 1ml

30 drops is equivalent to approximately 1.5ml.

Duration of application

After relief of symptoms, continuation of treatment for further 2 – 3 days is recommended in order to prevent a relapse, however treatment duration should not exceed 2 weeks.

4.3 Contraindications

Kaloba is not to be used in the following cases:

• hypersensitivity to the active substance or to the excipient,
• increased tendency to bleeding and application of coagulation-inhibiting drugs,
• severe hepatic and renal diseases, as no adequate data are available in these areas,
• pregnancy and lactation
• children < 6 years.

4.4 Special warnings and precautions for use

In the package leaflet, the patient is advised to consult a doctor immediately if his or her 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.

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

This corresponds to:
180 mg alcohol equivalent to 3.6 ml beer or 1.5 ml wine per adults´single dose (30 drops)
120 mg alcohol equivalent to 2.4 ml beer or 1.0 ml wine per children’s single dose (20 drops).

Harmful for those suffering from alcoholism. To be taken into account in children and high-risk groups such as patients with liver disease, or epilepsy.

4.5 Interaction with other medicinal products and other forms of interaction

Drug interactions have not been reported to date.

However, due to the potential influence of Kaloba on coagulation parameters, the possibility that this product enhances the effect of coagulation-inhibiting drugs such as warfarin in cases of simultaneous intake cannot be excluded (see section 4.3).

4.6 Pregnancy and lactation

This product should not be used in women who are pregnant or breast-feeding, as there are no data available for these patient groups.

4.7 Effects on ability to drive and use machines

Kaloba has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

The evaluation of adverse reactions is based on the following information on frequency:

Very common:
more than 1 out of 10 treated persons

Common:
more than 1 out of 100 treated persons

Uncommon:
more than 1 out of 1000 treated persons

Rare:
more than 1 out of 10 000 treated persons

Very rare:
1 or less out of 10 000 treated persons including single cases

Gastro-intestinal complaints such as stomach pain, heartburn, nausea or diarrhoea may occur uncommonly (≥ 1/1,000 to < 1/100) during treatment with Kaloba.

In rare cases (≥1/10,000 to ≤ 1/1,000), mild bleeding from the gingiva or nose may occur. Furthermore, hypersensitivity reactions (e.g. exanthema, urticaria, pruritus of skin and mucous membranes) have been described in rare cases. Such reactions may already occur at the first intake of the pharmaceutical product.

In very rare cases (≤ 1/10,000), serious hypersensitivity reactions with swelling of the face, dyspnea and drop of blood pressure may occur.

In single cases, signs indicating disturbances of liver function have been reported after intake of Kaloba; the causal relationship between this effect and the application of the product has not been demonstrated.

4.9 Overdose

The effects of overdose are unknown.

Although there are no data on cases of overdose, overdose is likely to increase side effects. Thus, treatment should be symptomatic and as clinically indicated.

5 Pharmacological properties

5.1 Pharmacodynamic properties

Not required.

5.2 Pharmacokinetic properties

Not required.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

6 Pharmaceutical particulars

6.1 List of excipients

Glycerol 85%, Ethanol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Unopened: 2 years

In-use: for bottles with 20 ml and 50 ml: 3 months

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Brown glass bottles, hydrolytic class III (Ph. Eur.), with dropper tip and screw cap (PP/PE), in pack sizes of 20 ml, 50 ml oral solution.

6.6 Special precautions for disposal and other handling

No special requirements.

7 Marketing authorisation holder

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

Distributed in the UK by:

Schwabe Pharma (UK) Limited
Alexander House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1PD

8 Marketing authorisation number(s)

THR 05332/0003

9 Date of first authorisation/renewal of the authorisation

26th March 2008

10 Date of revision of the text

3rd September 2013