Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Tears Naturale
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hypromellose, Dextran 70 may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR
TEARS NATURALE is a slightly viscous solution that acts as an artificial tear. It is used to treat dry eyes caused by a lack of tears in the eye(s). Replacement of the missing natural tears with an artificial tear helps to soothe and lubricate your eyes and provide relief from irritation. 2 BEFORE YOU USE TEARS NATURALE Do not use TEARS NATURALE… If you are allergic to dextran 70, hypromellose or any of the other ingredients listed in section 6 If any of these apply, ask your doctor for advice. Take special care … Only use TEARS NATURALE in your eye(s).
If you experience eye pain, headaches, changes in vision, persistent redness or irritation of your eyes, or if your condition worsens or does not improve within 3 days, stop using TEARS NATURALE and consult a doctor. This medicine is available without a prescription. However, you still need to use TEARS NATURALE carefully to get the best results from it. Pregnancy and breast‐feeding If you are pregnant or might get pregnant, or if you are breast‐feeding a baby, talk to your doctor before you use TEARS NATURALE. TEARS NATURALE can be used during pregnancy or breast‐feeding. Driving and using machines You may experience blurred vision after using TEARS NATURALE. Do not drive or use any machines unless your vision is clear. Using other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are using more than one type of eye medicine, the medicines must be used at least 5 minutes apart. Eye ointments should be used last. Important information if you wear Contact Lenses Do not use the drops while wearing contact lenses. Wait at least 15 minutes after use before putting your lenses back in. There is a preservative in TEARS NATURALE (benzalkonium chloride) that can cause eye irritation and is also know to discolour soft contact lenses. 3
HOW TO USE TEARS NATURALE
The usual dose The usual dose is 1 or 2 drops in your eye (s) as often as you require to relieve the irritation.
Remove the loose collar from the cap when the bottle is first opened. Always use TEARS NATURALE exactly as recommended. You should check with your doctor or pharmacist if you are not sure. Only use TEARS NATURALE for dropping in your eye(s). Continued over > Continued over
HOW TO USE TEARS NATURALE (continued)
How to take it
Wash your hands before you start. Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers. Tilt your head back. Pull down your lower eyelid with a finger, until there is a 'pocket' between the eyelid and your eye. The drop will go in here (picture 1). Bring the bottle tip close to the eye. Do this in front of a mirror if it helps. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops. Gently press on the base of the bottle to release one drop at a time (picture 2). Do not squeeze the bottle, only a gentle press on the bottom is needed. If you use drops in both eyes, repeat the steps for your other eye. Put the bottle cap firmly back on immediately after use.
If a drop misses your eye, try again. If you use more TEARS NATURALE than you should do not worry as it will not cause you any harm. If necessary TEARS NATURALE can be washed out of your eye with warm water. Do not put in any more drops until it is time for your next regular dose. If you swallow TEARS NATURALE do not worry, it will not harm you. If you forget to use TEARS NATURALE, continue with the next dose as planned. Do not use a double dose to make up.
If you have any further questions on the use of TEARS NATURALE, ask your doctor or pharmacist. 4
POSSIBLE SIDE EFFECTS
Like all medicines, TEARS NATURALE can cause side effects, although not everybody gets them.
You may experience some or all of the following effects in your eye(s) :
Very common (affects more than 1 user in 10): blurred vision Common (affects 1 to 10 users in 100): dryness, discomfort, abnormal sensation, feeling of something in the eye, eyelid problem Uncommon (affects 1 to 10 users in 1,000) : sensitivity to light, decreased sensation, itching, irritation, redness
Not known (cannot be estimated from the available data): pain, swelling, discharge, eyelid redness or crusting, increased tear production
- You may also experience effects in other areas of your body including : Uncommon: headache, discomfort (skin) Not known: hypersensitivity Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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 it
TEARS NATURALE
6
Keep out of the reach and sight of children. Do not refrigerate or store above 25 °C. Keep the bottle tightly closed. Do not use the drops after the expiry date (marked 'Exp') on the bottle and the carton. The expiry date refers to the last day of that month. Stop using the bottle 4 weeks after first opening, to prevent infections. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. FURTHER INFORMATION
What TEARS NATURALE contains The active substances are dextran 70 1 mg /ml and hypromellose 3 mg /ml. The other ingredients are disodium edetate, sodium chloride, potassium chloride, benzalkonium chloride, hydrochloric acid and /or sodium hydroxide (to adjust pH) and purified water. What TEARS NATURALE looks like and contents of the pack TEARS NATURALE is a clear, colourless liquid supplied in a pack containing a 15 ml plastic bottle with a screw cap. Marketing authorisation holder: Alcon Eye Care UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey, GU15 3YL
United Kingdom Manufacturer: Alcon Laboratories Belgium Lichterveld 3 2870 Puurs‐Sint‐Amands Belgium This leaflet was last revised in 01/2020 Alcon
Frequently asked questions about Tears Naturale
What is the active substance in Tears Naturale?
The active substance in Tears Naturale is hypromellose, dextran 70.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Tears Naturale, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Tears Naturale without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hypromellose, dextran 70
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
As a lubricant and artificial tear in dry eye and other ocular irritation syndromes associated with deficient tear or mucous secretion.
4.2. Posology and method of administration
Adults, children and the elderly:
One or two drops as required or directed instilled into the conjunctival sac.
Method of administration
For ocular use
Patients must not use this product if the solution becomes cloudy or changes colour. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
4.3. Contraindications
Hypersensitivity to dextran 70, hypromellose or to any of the excipients.
4.4. Special warnings and precautions for use
• For ocular use only. Not for injection or ingestion.
• Tears Naturale contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided. Patients should be advised to remove their contact lenses prior to the application of Tears Natural and wait at least 15 minutes before reinsertion.
• If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness, or if the condition worsens or persists for more than 3 days, they are to discontinue use and consult their doctor.
4.5. Interaction with other medicinal products and other forms of interaction
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
4.6. Fertility, pregnancy and lactation
Fertility
There is no adequate data regarding the impact of Tears Naturale on fertility. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating. Therefore, no effects on fertility are anticipated.
Pregnancy
There is no adequate data from the use of Tears Naturale in pregnant women. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating; therefore, no adverse effects during pregnancy are anticipated. These components are not expected to be absorbed systemically, to demonstrate any systemic toxicity or to have any effect on reproduction or embryofetal development. Tears Naturale can be used during pregnancy.
Breast-feeding
There is no adequate data regarding the impact of Tears Naturale Eye drops, Solution on lactation. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating therefore, no adverse effects during breast-feeding are anticipated. It is unknown whether dextran 70, hypromellose or any of the components are excreted in human milk. Nonetheless, discontinuation of product use during breast-feeding is not considered necessary.
4.7. Effects on ability to drive and use machines
Tears Naturale has no or negligible influence on the ability to drive or use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
4.8. Undesirable effects
a. Summary of the safety profile
The most frequently occurring adverse reaction during clinical trials was vision blurred.
b. Tabulated list of adverse reactions
The following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post marketing spontaneous reports.
System Organ Classification
MedDRA Preferred Term (v.19.0)
Immune system disorders
Not known: hypersensitivity
Nervous system disorders
Uncommon: headache
Eye disorders
Very common: vision blurred
Common: dry eye (residual), eyelid disorder, abnormal sensation in eye, foreign body sensation in eyes, ocular discomfort.
Uncommon: photophobia, hypoaesthesia eye, eye pruritus, eye irritation, ocular hyperaemia.
Not known: erythema of eyelid, eye swelling, eye pain, eye discharge, eyelid margin crusting, lacrimation increased.
General disorders and administration site conditions
Uncommon: discomfort (skin)
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 case of overdose has been reported.
• An overdose of Tears Naturale can easily be washed out of the eye with lukewarm tap water.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Hypromellose, Dextran 70. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- DEXTRAN 40, 100g/l in solutie de CLORURA DE SODIU 9 g/l prescription partial — not the same combinationDEXTRANUM · injection / infusion
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Tears Naturale IIDextranum + Hypromellosum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Tears Naturale. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.