PACKAGE LEAFLET: INFORMATION FOR THE USER LINDOFLUID®

(Cutaneous Solution)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1.    What Lindofluid® is and what it is used for

2.    What you need to know before you use Lindofluid®

3.    How to use Lindofluid®

4.    Possible side effects

5.    How to store Lindofluid®

6.    Contents of the pack and other information

1.    What Lindofluid® is and what it is used for

The name of your medicine is Lindofluid®. It is a topical solution (to be used only on the skin).

Lindofluid® is used for the symptomatic relief of the following:

•    Muscular pain and stiffness

•    Backache including mild to severe low back pain (lumbago)

•    Pain or inflammation of the muscle and bones, tendons and joints (fibrositis)

•    Cramps

•    Bruises

2.    What you need to know before you use Lindofluid®

Do not use Lindofluid®:

•    If you are allergic to Lindofluid® or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Lindofluid® if:

•    You have any cuts, grazes or any other areas of broken skin where you want to apply Lindofluid®.

•    Lindofluid® comes into contact with the eyes, nose, mouth or any other sensitive areas.

•    You are pregnant or breast-feeding (see “Pregnancy and breast-feeding” section)

Other medicines and Lindofluid®

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

There are no medicines which are known to interact with or be affected by Lindofluid®.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

There is no evidence of the safety of Lindofluid® in pregnancy but it has been widely used for many years and no adverse events have been reported.

Breast-feeding

There is no evidence of the safety of Lindofluid® in breast-feeding but it has been widely used for many years and no adverse events have been reported.

Driving and using machines

Lindofluid® does not affect the ability to drive or operate machinery.

Lindofluid® contains the following colouring agents:

•    Sunset yellow (E110)

•    Ponceau 4R red (E124) which may cause allergic reactions.

3.    How to use Lindofluid®

Always use Lindofluid® exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Lindofluid® is for external use only.

•    Apply a little Lindofluid® to the painful area. Rub in gently if necessary.

Adults

•    It is recommended that you should use Lindofluid® four times a day, leaving a few hours between each application.

•    If symptoms persist, consult your doctor.

Use in children

•    Children under 6 years old should not use Lindofluid®.

If you accidentally swallow Lindofluid®

If you accidentally swallow Lindofluid®, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take the Lindofluid® bottle and carton with you.

If you forget to use your Lindofluid®

Use it as soon as you remember, unless it is nearly time for your next application. If you miss an application, do not apply double the amount to make up for a forgotten application.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines, Lindofluid® can cause side effects, although not everybody gets them.

Seek medical advice immediately if you develop the following symptoms:

•    Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness

Other Side Effects

•    Irritant skin reactions may occur in the presence of turpentine oil.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Lindofluid®

•    Keep all medicines out of the sight and reach of children.

•    Do not use Lindofluid® after the expiry date is stated on the carton/label after EXP. The expiry date refers to the last day of that month..

•    Do not store above 25°C. Lindofluid® is flammable and should not be stored or used near naked flames, including lighted cigarettes. Do not incinerate.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6) Contents of the pack and other information

What Lindofluid® contains:

Lindofluid® contains bornyl acetate 0.29% w/w, alpha-pinene 0.47% and arnica liquid extract 0.50mg (isopropyl alcohol 50%(1:20)) as active ingredients.

The other ingredients are: 48% isopropyl alcohol and diisopropyl adipate, lemon oil, spruce needle oil, isobornyl acetate, purified water, mountain pine oil, alpha-terpineol, eucalyptus oil, melissa extract, aniseed aldehyde, coumarin, lavandin, camphor, menthol, aldehyde C 12 laurin, rosemary oil and a colouring agent.

This colouring agent contains quinoline yellow (E104), sunset yellow (E110), ponceau 4R red (E124), patent blue (E103).

What Lindofluid® looks like and the contents of the pack:

Clear, pale green liquid with an aromatic odour.

Lindofluid® is available in:

The bottles contain either 100mls or 250mls of Lindofluid®.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots Cambridgeshire PE19 8ET UK

Product Licence Number:

PL 11311/0532

This leaflet was last revised in July 2016

Till-Ver.1s