Kaloba Pelargonium Cough And Cold Relief Oral Drops
5: 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 Return any out-of-date product to your pharmacist who will dispose of it for you.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.
6: 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)\ extraction solvent 11% ethanol (m/m).
This product also contains the following ingredients:
Glycerol 85%
Ethanol
Each pack contains 20 or 50ml oral solution.
Registration holder and manufacturer of this product
Certification
Mark
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 leaflet was revised 01/2015.
’EPs® 7630 is a proprietary extract of Dr Willmar Schwabe GmbH & Co. KG
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Patient Information Leaflet
COUM/ADC
KaLoba@ Pelargonium Cough & Cold Relief Oral Drops, solution
Pelargonium sidoides root extract 8g per 10g
Please read this leaflet carefully before you start taking this oral solution.
It contains some important information about Kaloba Pelargonium Cough & Cold Relief. Keep this leaflet with the oral solution.
You may want to read it again or show it to your doctor, pharmacist or qualified healthcare practitioner.
1: What this product is and what it is used for.................................. page 1
2: Before you take this product..................................................pages 1-2
3: How to take this product......................................................... page 2
4: Possible side-effects...............................................................page 3
5: How to store this product ........................................................page 4
6: Further information............................................................... page 4
1: 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.
2: Before you take this product
DO NOT TAKE this product if you:
• are allergic to any of the ingredients (see section 6)
• suffer from severe liver disease
• are pregnant or breast-feeding
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This product is not suitable for children under the age of 6 years.
Kaloba oral solution contains 12 vo I % ethanol (alcohol).
This corresponds to:
• 125 mg alcohol equivalent to 2.5 ml beer or 1.0 ml of wine per adults' 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 wtih liver disease or epilepsy.
3: 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 as shown
If you take too much of this product (overdose)
If you take more than the recommended dose, speak to your doctor, pharmacist or qualified 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 qualified healthcare practitioner.
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4: 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
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 worsens, or 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.