Document: leaflet MAH BRAND_PL 00240-0345 change

• leaflet MAH BRAND 2_PL 00240-0137
• leaflet MAH BRAND 2_PL 00240-0345
• leaflet MAH BRAND_PL 00240-0137
• leaflet MAH BRAND_PL 00240-0345

---

Patient Information

23279110 Qj]

A topical lotion for the eradication of head lice.

You can use this medicine to treat adults and children over 6 months old without seeing a doctor, but use it carefully to get the best results.

Read all this leaflet carefully before you start using this medicine.

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

•    Ask your pharmacist for further advice if live lice are detected after the second treatment with Hedrin®, or if head lice are a persistent or recurring problem.

•    If you have any other questions, ask your doctor or pharmacist.

•    If you notice any side effects or any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.

In this leaflet

1    What is Hedrin® Lotion and what does it do?

2    Before using Hedrin®

3    How to use Hedrin®

4    Possible side effects

5    Storing Hedrin®

6    Further information

1 What is Hedrin® Lotion and what does it do?

The name of your medicine is Hedrin® 4%

Lotion. It is a cutaneous solution which is highly effective against head lice.

2 Before using Hedrin®

Do not use Hedrin®:

•    If you are allergic to either of the ingredients listed.

Take special care with Hedrin® Lotion:

•    For external use only.

•    Avoid contact of the lotion with your eyes. If it accidentally comes into contact with your eyes, flush with water.

If you accidentally swallow some

• If you accidentally swallow some of the solution, you should consult a doctor as soon as possible. Take the pack with you to show which medicine you have swallowed. If you get an allergic reaction e.g. rash, swelling or weals on the skin, or breathing difficulties (see section 4), shampoo off the product straight away and get medical advice immediately.

Use in pregnancy and breastfeeding:

Hedrin® Lotion may be used during pregnancy and breastfeeding.

Use in infants under 6 months:

Children under 6 months should only be treated under medical supervision.

Driving and using machines:

Hedrin® Lotion does not affect your ability to drive or operate machinery.

3 How to use Hedrin®

Hedrin® is suitable for adults and children aged 6 months and over.

Please note:

If a member of the family has live head lice, check the other family members and treat all other cases of live head lice which are discovered, at the same time.

Hedrin® is for external use only.

MHRA Header Box

Product Title	Hedrin 4% Lotion UK P pack	Colours Used		Fonts Used
		■	PANTONE 280C	Frutiger
Component	Leaflet	■	PANTONE 326 C+60%+l 5%	Frutiger LT
Pack Size	150ml	□	Keyline (Does not print)
IG Code	23279110
Dimensions	210x 148mm flat (27x 148mm folded)
Proof No.	2 Date 21.08.2014

Hedrin

4% Lotion dimeticone

A topical lotion for the eradication of head lice.

You can use this medicine to treat adults and children over 6 months old without seeing a doctor, but use it carefully to get the best results.

Read all this leaflet carefully before you start using this medicine.

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

•    Ask your pharmacist for further advice if live lice are detected after the second treatment with Hedrin®, or if head lice are a persistent or recurring problem.

•    If you have any other questions, ask your doctor or pharmacist.

•    If you notice any side effects or any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.

In this leaflet

1    What is Hedrin® Lotion and what does it do?

2    Before using Hedrin®

3    How to use Hedrin®

4    Possible side effects

5    Storing Hedrin®

6    Further information

1 What is Hedrin® Lotion and what does it do?

The name of your medicine is Hedrin® 4%

Lotion. It is a cutaneous solution which is highly effective against head lice.

2 Before using Hedrin®

Do not use Hedrin®:

•    If you are allergic to either of the ingredients listed.

Take special care with Hedrin® Lotion:

•    For external use only.

•    Avoid contact of the lotion with your eyes. If it accidentally comes into contact with your eyes, flush with water.

•    Do not breathe the spray.

If you accidentally swallow some

• If you accidentally swallow some of the solution, you should consult a doctor as soon as possible. Take the pack with you to show which medicine you have swallowed.

If you get an allergic reaction e.g. rash, swelling or weals on the skin, or breathing difficulties (see section 4), shampoo off the product straight away and get medical advice immediately.

Use in pregnancy and breastfeeding:

Hedrin® Lotion may be used during pregnancy and breastfeeding.

Use in infants under 6 months:

Children under 6 months should only be treated under medical supervision.

Driving and using machines:

Hedrin® Lotion does not affect your ability to drive or operate machinery.

3 How to use Hedrin®

Hedrin® is suitable for adults and children aged 6 months and over.

Please note:

If a member of the family has live head lice, check the other family members and treat all other cases of live head lice which are discovered, at the same time.

Hedrin® is for external use only.

MHRA Header Box

Product Title	Hedrin 4% Lotion Spray UK	Colours Used		Fonts Used
		■	PANTONE 280 C	Frutiger
Component	Leaflet	■	PANTONE 326 C	Frutiger LT
Pack Size	120ml	□	Keylines (non-printing)
IG Code	23604507
Dimensions	21 Ox 148mm flat (27x 148mm folded)
Proof No.	2 Date 21.08.2014

Directions

The spray comes ready assembled. Before use,

unlock the trigger by twisting the plastic lock.

Lock after use.

•    Cover the shoulders with a towel.

•    Be careful not to spray into the eyes and face, and do not breathe the spray.

•    Holding the spray approximately 10cm from the hair carefully spray sufficient solution evenly over DRY HAIR to ensure that the scalp and hair are fully covered, and the hair is saturated.

•    Work into the hair with fingers or an ordinary comb spreading the liquid evenly from the roots to tips. Allow the hair to dry naturally.

•    Leave on the hair for at least 8 hours or overnight.

•    Wash the hair with normal shampoo, rinse thoroughly with water and dry.

Duration of treatment

•    It is important that Hedrin® is applied again after seven days to deal with any lice which may hatch in that time. Failure to repeat the treatment may result in the return of a louse infestation.

4 Possible side effects

Important side effects

If you experience any of the following, stop using Hedrin® immediately (shampoo off) and talk to a doctor or pharmacist.

•    Allergic reactions such as rash, swelling or

weals on the skin.

•    Breathing difficulties Other side effects

When using Hedrin® on broken skin, slight irritation may occur. Sometimes application may cause flaking of the scalp, itching, irritation around the eyes and hair loss.

If you notice any of these or other side effects, stop using the product and talk to a doctor or pharmacist.

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 Storing Hedrin®

•    Keep out of the sight and reach of children.

•    This product does not require any other special storage conditions. • Do not use after the expiry date shown on the pack. • Care should be taken if Hedrin® is spilled as it may cause a slip hazard.

6 Further information

What Hedrin® Lotion contains The active substance is Dimeticone 4% w/w. Dimeticone is not a chemical poison. It works by a physical process which effectively covers and drowns the louse.

The other ingredient is Cyclomethicone 5.

What Hedrin® looks like

It is a clear colourless solution.

Hedrin® is available in 120ml spray pack format. Marketing Authorisation Holder and Manufacturer Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. This leaflet was prepared in September 2014

Hedrin® is a registered Trade Mark of Thornton & Ross Ltd.

About head lice

•    Head lice vary in size according to their age. From the size of a printed full stop.... ©

....to the size of a sesame seed (§)

Head lice can be difficult to spot because they can match their colour to that of the environment.

•    Lice live close to the scalp where they feed on blood and this can cause the scalp to itch.

•    Head lice cannot jump, fly or swim and can only be acquired by direct head to head contact. This is why lice are commonly found on the heads of children and those in close contact with children and why it is important to check the heads of all the family members when head lice are found.

•    Head lice only live on humans and have no preference for clean or dirty hair.

•    The female louse will lay between 3 and 5 eggs per day and these hatch after 7 days. This is why it is important to repeat this treatment after 7 days to ensure that any lice which have hatched after the first treatment are killed.

•    Once the louse has hatched, the empty case (known as a nit) will remain glued to the hair shaft. Nits are completely harmless and can be removed with the fingers or a fine-toothed comb.

23604507