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Relieves symptoms of the common cold

image descriptionKaloba Pelargonium Cough & Cold Relief Syrup

Pelargonium sidoides root extract

100ml sugar-free cough & cold syrup

Traditionally used for:

  • Common cold
  • Sore throat
  • Cough
  • Runny nose
  • Blocked nose
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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. Suitable for adults and children from 6 years+. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal Active
Pelargonium (Pelargonium sidoides DC.)
Strength
Each 100g (93.985ml) of solution contains 0.2506g of dried root extract
Dose
Adults & children over 12 years: 7.5ml three times daily
Children 6 to 12 years: 5ml three times daily

Kaloba contains Pelargonium sidoides, a member of the geranium family. It has long stalked leaves that are mildly aromatic, heart shaped and velvety.

Adults and children 12+ should take 7.5ml of the syrup three times a day (morning, midday, evening).

Children aged 6-12 years should take 5ml of the syrup three times a day (morning, midday, evening).

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

A licensed herbal medicine means a safe, high quality product

Kaloba Pelargonium Cough & Cold Relief Syrup has been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • Kaloba is a regulated herbal product and meets specific standards of safety and quality
  • Kaloba is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. Kaloba’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that Kaloba has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe for more information about our company.

Find out more about Pelargonium at www.pelargonium-sidoides.com

Also available from…

Boots, Holland & Barrett and other leading independent pharmacies and health food stores nationwide.

As seen on TV!

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About Pelargonium

Pelargonium is a member of the geranium family and has long stalked leaves.

Visit Herbfacts.co.uk

About the common cold

The common cold is an infection that affects the upper respiratory tract – the nose, throat, sinuses, trachea, larynx and bronchial tubes. How can natural remedies help to relieve the common cold?

Kaloba Guide

Download your FREE ‘Family Guide to Coping With Coughs and Colds’.

More about Pelargonium

Find out more about Pelargonium at www.pelargonium-sidoides.com

What this product is and what it is used for

This product is a traditional herbal medicinal product containing Pelargonium sidoides DC root dried extract. 100g (=93.985 ml) syrup contain 0.2506g dried liquid extract from the roots of Pelargonium sidoides DC (EPs® 7630).

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, 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

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

How to take this product

For oral use only. Shake the bottle well before use. Use the measuring cup provided.

Adults and children over 12 years

Take 7.5 ml of the syrup three times daily (morning, midday, evening).

Children aged 6-12 years

Take 5 ml of the syrup three times daily.

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

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, 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 you notice 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.

The product can be stored for up to six months after opening. Store the product in a cool dry place. Keep the product out of the reach and sight of children.

Further information

100g (= 93.985 ml) syrup contain 0.2506 g dried liquid extract from the roots of Pelargonium sidoides DC (1:8-10) (EPs® 7630). Extraction solvent: 11% ethanol (w/w).

Kaloba Pelargonium Cough & Cold Relief syrup is an orange to light brown syrup. However it is a natural product and therefore slight variations in colour and taste may occur.

This product also contains the following ingredients:

Extract: Maltodextrin
Syrup: Xylitol, glycerol 85%, citric acid anhydrous, potassium sorbate, xanthan gum,
purified water.

Each pack contains 100ml syrup.

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 05332/0006

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@kaloba.co.uk

This leaflet was revised 01/2015.

1. Name of the medicinal product

Kaloba Pelargonium Cough and Cold Relief syrup

2. Qualitative and quantitative composition

Active substance:
100 g (= 93.985 ml) syrup contain 0.2506 g dried liquid extract from the roots of Pelargonium sidoides DC (1 : 8 – 10) (EPs® 7630). The extraction agent is 11% ethanol (w/w).

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Syrup

Kaloba is an orange to light brown, viscous syrup.

4. Clinical particulars

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

For oral use

Shake the bottle well before use

Adults, the elderly and adolescents over 12 years of age:
Take 7.5 ml of the syrup three times per day.

Children aged between 6-12 years:
Take 5 ml of the syrup three times per day.

Syrup is to be taken in the morning, midday and evening.

The use in children under 6 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”.)

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

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

  • hypersensitivity to the active substance or to any of the excipients
  • increased tendency to bleeding
  • patients using coagulation-inhibiting drugs
  • severe hepatic and renal diseases due to lack of adequate data

4.4 Special warnings and special precautions for use

In the patient information 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 blood in the sputum.

On theoretical grounds Kaloba should not be used where there is a likelihood of increased tendency to bleeding or use of coagulation-inhibiting drugs.

Kaloba should not be used in case of severe hepatic and renal diseases, due to lack of adequate data.

The use of this product in children or adolescents under 6 years of age is not recommended because data are not sufficient and medical advice should be sought.

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 effect of Kaloba on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin and should not be taken concomitantly with these drugs. (see section 4.3).

4.6 Pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

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

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:
less than 1 out of 10 but more than 1 out of 100 treated persons

Uncommon:
less than 1 out of 100 but more than 1 out of 1000 treated persons

Rare:
less than 1 out of 1000 but more than 1 out of 10 000 treated persons

Very rare:
less than 1 out of 10 000 treated persons including cases with unknown frequency

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 gums 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 occur after the first intake of the product.

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

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

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

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

Pharmacotherapeutic group: cough and cold preparations, ATC code: R 05
Not required as per article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars

6.1 List of excipients

Extract:
Maltodextrin

Syrup:
Xylitol
Glycerol 85%
Citric acid anhydrous
Potassium sorbate
Xanthan gum
Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.
The shelf-life of the syrup after the container has been opened is 6 months.

Note for the patient:
Since Kaloba syrup is a natural product, slight variations in colour and taste may occur.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Amber glass bottles, hydrolytic class III (Ph. Eur.), with pourer as dosage aid (LDPE), screw cap (PP) with seal (PEHD/PELD) and a measuring cup (PP), in pack sizes of 100 ml syrup.

6.6 Special precautions for disposal

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) Ltd
Alexander House
Mere Park
Dedmere Road
Marlow
Buckinghamshire
SL7 1PD

8. Marketing authorisation number(s)

THR 05332/0006

9. Date of first authorisation/renewal of the authorisation

11th June 2010

10 Date of revision of the text

3rd September 2013

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