Diacold Tablets
DiaCold tablets - THR 42340/0017
May 2013
Page 5/9
1.3 - Product Information
1.3.1 - Labelling
Module 1.3.1 Package Leaflet
Patient Information Leaflet DiaCold tablets
Pelargonium root dry extract 20 mg
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take DiaCold carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after one week.
- If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
What is in this leaflet
1. What DiaCold is and what it is used for
2. Before you take DiaCold
3. How to take DiaCold
4. Possible side effects
5. How to store DiaCold
6. Further information
1. What DiaCold is and what it is used for
DiaCold is a traditional herbal medicinal product containing a dry extract from the roots of Pelargonium.
It is a 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.
2. Before you take DiaCold
Do not take DiaCold:
• if you are allergic (hypersensitive) to any of the ingredients of DiaCold film-coated tablets (see section 6)
• if you suffer from severe liver or kidney disease
• if you are pregnant or breast-feeding
Children:
DiaCold is not suitable for children under the age of age of 12 years.
Taking other medicines
Please tell your doctor, pharmacist or healthcare practitioner if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you suffer from an increased tendency to bleed and/or take anti-coagulation drugs such as warfarin, there is a theoretical risk that taking DiaCold may increase your risk of bleeding.
Pregnancy and breast-feeding
Do not take DiaCold if you are pregnant or breast-feeding.
Driving and using machines
DiaCold has no known effect on your ability to drive or use machines. Make sure you know how it affects you before you drive or use machinery. If affected do not drive.
3. How to take DiaCold
Always take DiaCold exactly according to the instructions in this package leaflet. You should check with your doctor or pharmacist if you are not sure.
Adults and children over 12 years
Take 1 film-coated tablet 3 times daily (morning, midday, evening).
Swallow the film-coated tablet whole with some water. Do not chew.
Continue treatment for a further 2-3 days after your symptoms have improved, to prevent a relapse. However, treatment should not exceed two weeks.
Consult a doctor if your condition does not improve within one week, in cases of fever lasting for several days or in case of shortness of breath or blood in your saliva.
Do not exceed the stated dose.
DiaCold is not suitable for children under the age of 12 years.
If you take more DiaCold than you should (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 DiaCold
Do not take a double dose to make up for a forgotten dose, but continue to take your usual dose at the usual time.
If you have any further questions on the use of DiaCold, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.
4. Possible side effects
Like all medicines, DiaCold can cause side effects, although not everybody gets them. They are listed below.
Uncommon side-effects
Gastro-intestinal complaints such as stomach pain, heartburn, nausea or diarrhoea._
Rare side-effects
• 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
Serious hypersensitivity reactions with swelling of the face, breathlessness and drop in
blood pressure._
Frequency not known
Signs indicating changes in liver function have been reported after taking DiaCold; however the causal relationship between these effects and the use of the product has not been demonstrated.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or qualified healthcare professional.
Consult a doctor 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 your saliva.
5. How to store DiaCold
Do not use DiaCold after the expiry date which is stated on the carton and also on the blister pack.. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Do not store above 25° C.
Keep the product out of the reach and sight of children.
6. Further information
What DiaCold contains:
Each film-coated tablet contains 20 mg of extract (as dry extract) from Pelargonium root (Pelargonium sidoides DC and/or Pelargonium reniforme Curt. (4-7:1)
Extraction solvent: Ethanol 14% (v/v).
The other ingredients are:
Extract:
Cellulose powder Silica, colloidal anhydrous
Tablet core:
Cellulose, microcrystalline Silica, colloidal anhydrous Magnesium stearate
Film coating:
Hydroxypropyl methyl cellulose (= hypromellose)
Macrogol, type 6000 Iron oxide yellow E172 Iron oxide red E172 Titanium dioxide E171 Talc
What DiaCold looks like and contents of the pack
DiaCold are red-brown, round film-coated tablets packed in binary blisters made of PVC/PVDC-aluminium.
Each pack contains 30, 50, 60, 90 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Registration holder and Manufacturer
Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany
Traditional herbal registration number: THR 42340/0017
Certification Mark
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG
Wurzburger StraBe 3
26121 Oldenburg
Germany
Telephone: + (49) 441-98344-0 Email: info@diapharm.de
This leaflet was prepared in May 2011.
You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP’s surgery or pharmacy, or call free phone 0808 100 3352 (available 10am-2pm Monday - Friday).