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Potters Nodoff Plus Mixture

Document: leaflet MAH BRAND_THR 44893-0026 change

4. POSSIBLE SIDE EFFECTS:

Like all medicines this product can cause side effects, but not everyone gets them.

If any of the following or other side effects occur please consult your doctor or pharmacist:

• Gastrointestinal symptoms such as nausea and abdominal cramps have been reported with Valerian Root.

The frequency is not known.

One case of hypersensitivity (vasculitis) and one case of increased heart beat (tachycardia) have been reported in patients using Passion Flower Herb. The frequency is not known.

Making medicines safer:

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.

5.    HOW TO STORE POTTER'S NODOFF PLUS MIXTURE:

Keep out of the reach and sight of children.

Do not use this product after the expiry date stated on the label and base of the carton.

Return any unused medicine to your pharmacist for safe disposal.

Do not store above 25°C. Store in the original packaging.

6.    FURTHER INFORMATION:

Each 5 ml of oral liquid contains:

0.5 ml Liquid Extract Passion Flower Herb (Passiflom incamata L.) (1:1) (equivalent to 500 mg Passion Flower Herb)

Extraction solvent: Water.

0.5 ml Liquid Extract Jamaica Dogwood Bark (Piscidia erythrina L.) (1:1) (equivalent to 500 mg Jamaica Dogwood Bark)

Extraction solvent: Ethanol 60% v/v.

0.4 ml Liquid Extract Hop Strobile (Humulus lupulus L.) (1:1) (equivalent to 400 mg Hop Strobile)

Extraction solvent: Ethanol 45% v/v.

0.25 ml Liquid Extract Valerian Root (Valeriana officinalis L.) (1:1) (equivalent to 250 mg Valerian Root)

Extraction solvent: Ethanol 45% v/v.

THR


This product also contains:

Ethanol, Glucose Liquid, Syrup (sucrose), Glycerol, Compound Cardamom Tincture (Cochineal E120, Cardamom Oil, Caraway Oil, Cinnamon Bark Oil, glycerol, water), Nutmeg Oil, Clove Oil, Cinnamon Oil, Liquorice Extract (Liquorice Root, Sorbitol, Glucose Liquid Caramel (E150), ethanol, water), Caramel (E150), Water.

Potter's Nodoff Plus Mixture is a dark brown liquid and is available in a 150 ml bottle. Traditional Herbal Registration Holder and Manufacturer:

Potters, Wigan WN5 0JZ

Traditional Herbal Registration number:

THR 44893/0026

Certification Mark

Lor further information, call 01202 449752

If you would like a version of this leaflet in an alternative format, please call 01942 219960

Product code: N0D30LEA4 Leaflet last revised: 24/07/2015

PATIENT INFORMATION LEAFLET


NODOFF PLUS MIXTURE


WITH EXTRACTS OF PASSION FLOWER

(Possifloio), JAMAICA DOGWOOD, HOPS & VALERIAN


PLEASE READ THESE INSTRUCTIONS BEFORE USE

This medicine is available without

prescription. However, you still need

to take Potter's Nodoff Plus Mixture

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 or pharmacist if your symptoms worsen or do not improve after 4 weeks.

•    If you experience any of the side effects listed in the leaflet or if you notice any other side effects, please consult your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Potter's Nodoff Plus Mixture

is and what it is used for

2.    Before you take Potter's Nodoff Plus Mixture

3.    How to take Potter's Nodoff Plus Mixture

4.    Possible side effects

5.    How to store Potter's Nodoff Plus Mixture

6.    Further information

1.    WHAT POTTER'S NODOFF PLUS MIXTURE IS AND WHAT IT IS USED FOR:

A traditional herbal medicinal product used to aid sleep, based on traditional use only. Containing extracts of Passion Flower (,Passiflom), Jamaica Dogwood, Hops & Valerian.

For full details, see Section 6.

2.    BEFORE YOU TAKE POTTER'S NODOFF PLUS MIXTURE:

Do not take Potter's Nodoff Plus Mixture:

•    if you have previously had an allergic reaction to any of the ingredients

in this mixture. See Section 6 for further information

•    if you are already taking medicines for sleep or anxiety, synthetic sedatives e.g. benzodiazepines and/or other medicines known to interact with alcohol e.g. metronidazole

•    if you are pregnant or breastfeeding

•    if you are under 18 years of age.

Taking other medicines:

Please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Driving and using machinery:

This product might cause drowsiness and contains Ethanol (alcohol) therefore if affected, do not drive or operate machinery. Important information about some of the ingredients within Potter's Nodoff Plus Mixture:

The effect of this product may be increased by alcohol. Excessive consumption of alcohol whilst taking this product should therefore be avoided.

This medicine contains 16.5% v/v Ethanol (alcohol), i.e. up to 660 mg per dose (5 ml), equivalent to 16.5 ml beer or 6.9 ml wine per dose. It may be harmful for those suffering from alcoholism and high-risk groups such as pregnant or breastfeeding women, children and patients with liver disease or epilepsy.

It also contains Syrup (sucrose) and Glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE POTTER'S NODOFF PLUS MIXTURE:

It is important that you follow the instructions carefully.

Shake the bottle well before use.

For oral use only.

Adults and the elderly: Take one 5 ml teaspoonful after the last meal of the day, and two 5 ml teaspoonfuls at bedtime.

The use in children and adolescents under 18 years is not recommended.

Do not exceed the stated dose.

For the best results, you may need to take for 2-4 weeks continuously.

If your condition worsens or symptoms persist for more than 4 weeks, consult your doctor or pharmacist.

If you take too much Potter's Nodoff Plus Mixture:

Stop taking the medicine and consult a doctor or pharmacist.

Overdose of this product may result in alcohol intoxication and should be treated accordingly. See Section 2 for more information.

If you forget to take Potter's Nodoff Plus Mixture:

If you miss a dose, take your next dose at the usual time. Do not take two doses at the same time to make up for a missed dose. Always consult your doctor or pharmacist if you need further advice.