ZEEL COMP N. TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Zeel comp. N tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet (301.5 mg) contains:

Contains lactose monohydrate.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablets

Zeel comp N tablets are white to yellow-white, round, flat with beveled edges.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of rheumatic pain and joint stiffness.

4.2 Posology and method of administration

For Oral Use Only

Adults, elderly and children aged 12 years and above:

Take 1 tablet 3 times daily

Adults, elderly and children aged 12 years and above:

If needed, 1 tablet can be taken every 4 to1 hr., up to 12 times for the first 24 hours.

Then continue with 1 tablet 3 times daily.

The tablets should be allowed to dissolve in the mouth at least 30 minutes before meals.

Duration of use

If the condition worsens or if symptoms do not improve within 7 days, consult a doctor or qualified healthcare practitioner.

This product is not recommended for use in children under 12 years of age (See

Section 4.4. special warnings and precautions for use’)

4.3 Contraindications

Hypersensitivity to Rhus toxicodendron (poison ivy) and Arnica montana (arnica) or other plants of the daisy family (Asteraceae/Com­positae), or plants of the cashew family or any of the other ingredients in the product.

4.4 Special warnings and precautions for use

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

This product is not recommended for use in children under 12 years of age due to a lack of data on safety and medical advice should be sought.

You must consult a doctor if joint pain is experienced and accompanied by swelling of the joint, redness or fever.

Do not exceed the stated dose.

If the condition worsens or if symptoms do not improve within 7 days, consult a doctor or qualified healthcare practitioner.

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Fertility, pregnancy and lactation

No studies on the safety of this product during pregnancy and lactation have been performed. Therefore the use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines None known.

4.8 Undesirable effects

There have been a small number of post-marketing reports of hypersensitivity reactions with symptoms of allergic skin reactions such as pruritus and erythema, and gastric pain.

The frequency is not known.

If other adverse effects are experienced a doctor or qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No cases of overdose have been reported. Symptomatic and supportive measures should be taken as appropriate.

5.1

Not applicable.

5.2

5.3

Not applicable.

Preclinical safety data Not applicable.

6.1 List of excipients

Lactose monohydrate

Magnesium stearate

6.2 Incompatibilities

None known

6.3 Shelf life

5 years.

Shelf-life after first opening: 12 months

6.4 Special precautions for storage

Do not store above 30 °C

Store in original package

6.5 Nature and contents of container

Polypropylene container with tamper-evident polypropylene cap, in a cardboard box Pack size: 50 or 100 tablets

6.6 Special precautions for disposal

There are no special precautions.

7 MARKETING AUTHORISATION HOLDER

Biologische Heilmittel Heel GmbH

Dr. Reckeweg Strasse 2–4

D – 76532 – Baden Baden

Tel : 00 49 72 21 501 00

Fax : 00 49 72 21 501 210

e-mail : info@heel.de

8 MARKETING AUTHORISATION NUMBER(S)

NR 08927/0016

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

09/02/2012