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Relieves symptoms of the common cold

image descriptionKaloba Pelargonium Cough & Cold Relief Tablets

Pelargonium sidoides root extract 20mg

16 and 30 film-coated tablets

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. 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
20mg of dried root extract
Dose
Adults & children over 12 years: One tablet 3 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.

Each pharmaceutical grade coated tablet is foiled blister packed to retain its freshness and maintain its potency.

Adults and children 12+ should take one tablet three times a day (morning, midday, evening). Tablets should be swallowed whole with a little water. The tablets should not be chewed.

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 Tablets have 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 other leading independent pharmacies and health food stores nationwide.

As seen on TV!

About Pelargonium

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

Visit vitfacts.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 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 upper respiratory 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.

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.

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.

You can help to make medicines safer by reporting any side-effects tothe Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call Freephone 0808 100 3352 (available 10am–2pm Monday –Friday).

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 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 revised 05/2013

1 Name of the medicinal product

  • Kaloba Pelargonium Cough & Cold Relief tablets
  • Higher Nature Pelargonium Cold Relief film-coated tablets
  • Healthspan Pelargonium Cold Relief tablets

2 Qualitative and quantitative composition

1 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).

Excipient:

One film-coated tablet contains 20 mg lactose monohydrate.

For a full list of excipients, see section 6.1.

3 Pharmaceutical form

Film-coated tablet

Round, reddish-brown, smooth surface film coating without ruptures.

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

Adults and adolescents over 12 years of age:
Take 1 tablet three times daily (morning, midday, evening).

Tablets should be swallowed whole with a little water. The tablets should not be chewed.

The use in children under 12 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

Kaloba is not to be used in the following cases:

  • 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.

One film-coated tablet contains 20 mg lactose monohydrate.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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.

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

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, the use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machine

No studies on the effect 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:
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 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 reactions 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 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

Not required.

5.2 Pharmacokinetic properties

Not required.

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

Tablet core:

  • Maltodextrin
  • Microcrystalline cellulose
  • Lactose monohydrate
  • Croscarmellose sodium,
  • Precipitated silica
  • Magnesium stearate

Film-coating:

  • Hypromellose 5 mPas
  • Macrogol 1500
  • Iron oxide yellow E172
  • Iron oxide red E172
  • Titanium dioxide E171
  • Talc
  • Simeticone
  • Methylcellulose
  • Sorbic acid.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

4 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Original packages containing 16, 21 or 30 film coated tablets (Kaloba Pelargonium Cough & Cold Relief tablets) or 30 (Healthspan Pelargonium Cold Relief tablets) or 21 (Higher Nature Pelargonium Cold Relief film-coated tablets).

The tablets are packed in PVC/ PVDC aluminium blisters and inserted into a carton together with the package leaflet.

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

8 Marketing authorisation number(s)

THR 05332/0005

9. Date of first authorisation/renewal of the authorisation

31st March 2009

10 Date of revision of the text

12th July 2013

3 reviews for Kaloba Pelargonium Cough & Cold Relief Tablets

  1. 5 out of 5

    :

    Antihistamines do absolutely nothing to help my hayfever. In fact they exacerbate it.
    But I’ve found Kaloba to be an excellent & very natural feeling remedy.

  2. 5 out of 5

    :

    I always take Kaloba when I’m coming down with a cold – it usually goes within 2-3 days. Great stuff!!

  3. 5 out of 5

    :

    I find Kaloba Tablets a very convenient way to treat my cold with Pelargonium.

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