Ashwagandha KSM-66 PIL

ASHWAGANDHA KSM-66 INFORMATION LEAFLET

SCHEDULING STATUS

 

Category D: Complementary Medicine

Classification: Discipline Specific Traditional Claims.

Discipline: 33.8 Other Herbal

This unregistered medicine has not been evaluated by the SAHPRA for its

quality, safety or intended use.

 

ASHWAGANDHA KSM – 66 (Vegetable capsule)

 

Sugar free

 

Read all of this leaflet carefully because it contains important information for you

 

Ashwagandha KSM- 66  is available without a doctor’s prescription, for you to maintain your health. Nevertheless, you still need to use Ashwagandha KSM- 66  carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Do not share Ashwagandha KSM- 66  with any other person.

Ask your health care provider or pharmacist if you need more information or advice.

 

 

WHAT IS ASHWAGANDHA KSM- 66  AND WHAT IT IS USED FOR

May improve an individual’s resistance towards stress and thereby

improves self-assessed quality of life.

May assist with enhancing both immediate and general memory in

people with mild cognitive impairment.

Can assist in improving executive function, attention and information

processing speed.

May assist with improving quality of sleep.

May enhance cardiorespiratory endurance and improve the quality of life

in healthy athletic adults.

May improve female sexual health in otherwise healthy women who do not

have any hormonal disturbances.

Ashwagandha root extract may be utilized to aid in the enhancement of

male sexual function.

Ashwagandha supplementation may increase muscle mass and strength

and may be useful in conjunction with a resistance training program.

 

WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASGWAGANDHA KSM -66

Do not take Ashwagandha KSM- 66            

If you are hypersensitive to the active substance or to any of the excipients or

residues from the manufacturing process in which case, discontinue use.

 

WARNINGS AND PRECAUTIONS

Consult a health care provider, doctor, pharmacist or nurse

prior to use if you are pregnant or breastfeeding.

Consult a health care provider, doctor, pharmacist or nurse

 if sleeplessness persists for more than 4 weeks (chronic insomnia).

Some people may experience drowsiness. Exercise caution if operating

Heavy machinery, driving a motor vehicle or involved in activities requiring

mental alertness.

Avoid taking with alcohol or products that cause drowsiness

 

Children

Not suitable for children under the age of 18 years.

 

Pregnancy, breastfeeding and fertility

If you are pregnant or breast feeding your baby please consult your doctor,

pharmacist or other relevant health care provider for advice before taking

this medicine.

 

 

Ashwagandha KSM-66 contains magnesium stearate.

 

  1. HOW TO TAKE ASHWAGANDHA KSM-66

Do not share medicines prescribed for you with any other person.

Always take Ashwagandha KSM- 66  exactly as described in this leaflet or as your doctor, or

pharmacist have told you. Check with your doctor or pharmacist if you are not

sure.

 

It is recommended that adults take 1 vegetable capsules daily of Ashwagandha KSM-66 with or without a meal.

Do not exceed daily dose without consulting a relevant health care provider.

 

If you take more Ashwagandha KSM- 66  than you should

In overdose, side effects can be precipitated and/or be of increased severity.

Symptoms of overdose, drowsiness, insomnia and nausea

Some people may experience drowsiness. Exercise caution if operating

heavy machinery, driving a motor vehicle or involved in activities requiring

mental alertness.

 

 

If you forget to take Ashwagandha KSM- 66  

Do not take a double dose to make up for forgotten individual doses.

 

  1. POSSIBLE SIDE EFFECTS

Ashwagandha KSM- 66  can have side effects.

Less Frequent side effects: (Occurs in less than 1 in 100 users)

Nervous system disorders

Drowsiness

 

Not all side effects reported for Ashwagandha KSM- 66  are included in this leaflet. Should

your general health worsen or if you experience any untoward effects while

taking Ashwagandha KSM- 66  , please consult your health care provider for advice.

If you notice any side effects not mentioned in this leaflet, please inform your

doctor or pharmacist.

 

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also

report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting

Form”, found online under AHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you

can help provide more information on the safety of Ashwagandha KSM- 66.

 

  1. HOW TO STORE Ashwagandha KSM- 66,

Store all medicines out of reach of children.

Store in the airtight container, protected from light at or below 25 ˚C.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

 

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ashwagandha KSM- 66 contains

The active substances are:

 

Active Ingredients:

mg per serving size (1 x veg capsules)

Withania somnifera (Ashwagandh KSM 66 ®)

[root: full spectrum standardized to 5% withanolides]

500  

 

 

 

 

 

 

 

 

 

The other ingredients are:

Ashwagandha KSM-66 contains magnesium stearate.

 

Sugar free.

 

What Ashwagandha KSM- 66 looks like and contents of the pack

Ashwagandha KSM- 66 250 ml Polyethylene Terephthalate (PET) black bottle with black screw lid and aluminium seal containing 30 white vegetable capsules.

 

Holder of Certificate of Registration

MC Pharma (Pty) Ltd

62 Constantia Avenue

Mnandi

Centurion

0157

South Africa

 

This leaflet was last revised in

23 August 2023

 

Registration number

To be allocated

 

Access to the corresponding Professional Information

Refer to QR Code on the Label to access the Professional Information.