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.
Pilocarpine Eye Drops BP 2.0% w/v (Tubilux)
⚠ 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 Pilocarpine hydrochloride 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 Pilocarpine Hydrochloride belongs to a group of medicines called miotics, these medicines affect muscles in the eye causing the pupil of the eye to get smaller. Pilocarpine Eye Drops are used to treat certain forms of glaucoma (an increase in the pressure within the eye) and to reverse the effect of drugs that cause the pupil of the eye to get bigger.
What you need to know before you take it
e Pilocarpine Eye Drops Do not use Pilocarpine Eye Drops if:
- you are allergic (hypersensitive) to Pilocarpine or any of the other ingredients in this medicine, which are listed in section 6 of this leaflet.
- you are suffering from inflammation of the coloured part of the eye (acute iritis or anterior uveitis).
- you are suffering from eye disorders such as narrow angle glaucoma or secondary glaucoma.
- you are wearing soft contact lenses. Warnings and precautions: Talk to your doctor or pharmacists before taking Pilocarpine eye drops if
- you are suffering from any heart problems.
- you have asthma.
- you have Parkinson's disease.
- you have problems in passing urine.
- you have high blood pressure.
- you have a stomach ulcer.
- you are pregnant or are breast-feeding. If you are unsure about how to use Pilocarpine Eye Drops talk to your doctor or pharmacist. Children Pilocarpine should be given at the lowest available dose at the start of the treatment for children under 18 years of age. Eye tests Your doctor may want to check your eyes before and during your therapy particularly if you have had any eye disorders. If you have not had your eyes checked recently, tell your doctor. Other medicines and Pilocarpine Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines can interfere with your treatment. Tell your doctor if you are taking any of the following:
- antihistamines (medicines used to treat allergies).
- anticholinesterases, (such as neostigmine) which are medicines that affect the muscles and are used to treat diseases like myasthenia gravis.
- medicines used to make the pupil larger and dry up the saliva in your mouth, such as atropine and phenylephrine.
- medicines used to treat Parkinson's disease, anticholinergic drugs such as orphenadrine, procyclidine and trihexyphenidyl.
- antidepressants including tricyclic antidepressants (such as amitriptyline) and monoamine oxidase inhibitors (MAOI's), a type of medicine used to treat severe depression.
- phenothiazines (medicines used to treat serious mental disorders) e.g. chlorpromazine.
- medicines used to treat high blood pressure (adrenergic blockers) such as guanethidine. If you have any doubts about whether you should use this medicine talk to your doctor or pharmacist. Pilocarpine Eye Drops with food,drink and alcohol You are advised not to drink alcohol during your treatment with Pilocarpine Eye Drops.
Adults (including the elderly) The usual dose is two drops three times daily. Use in children Lowest available dose and concentration should be used at the start of the treatment for children under 18 years of age. Your doctor might increase the dose up to the maximum recommended adult dosage of the 2 % Pilocarpine eye drops depending on the response and tolerability. If you use more Pilocarpine Eye Drops than you should If you are at all concerned that you have used or been given too much of this medicine please tell your doctor. If you swallow any Pilocarpine Eye Drops Pilocarpine Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Pilocarpine Eye Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container and this leaflet with you if possible, even if empty. If you forget to take Pilocarpine Eye Drops
Pregnancy, breast-feeding and fertility 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 taking this medicine.
If you miss a dose of Pilocarpine Eye Drops, use them as soon as you remember unless it is nearly time for the next dose, then carry on using it as before. Do not take a double dose to make up for one you have missed.
Driving and using machines Pilocarpine Eye Drops can cause difficulty in adapting to the dark. You should not drive or use machinery in poor light. The eye drops may also cause blurred vision. If this happens, you should not drive or operate machinery until you can see clearly.
If you stop using Pilocarpine Eye Drops
Pilocarpine eye drops contains benzalkonium This medicine contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Soft contact lenses must not be worn during treatment with Pilocarpine Eye Drops.
How to take it
Pilocarpine Eye Drops Always use Pilocarpine Eye Drops exactly as your doctor has told you. Always complete a course of treatment. Do not stop because you feel better. Pilocarpine Eye Drops are for external use only. Instructions for use 1. Before opening a new bottle of Pilocarpine Eye Drops, please check that the safety strip on the front of the bottle is unbroken. 2. Tear off the safety strip to break the seal. 3. Wash your hands well before use. 4. Remove the outer cap. If you are putting in the eye drops yourself, you should use a mirror. 5. Tilt your head back and look up at the ceiling. 6. Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye. 7. Hold the container between the thumb and middle finger of the other hand, turn the bottle upside down near to the eye, try not to touch the eye with the nozzle. 8. Apply enough pressure to the bottle to release one to two drops, as directed by your doctor. 9. Blink your eye a few times. 10. If you think that you have missed your eye, then insert another drop. 11. Repeat steps 5-10 above for your other eye if you have been told to use Pilocarpine Eye Drops in both eyes. 12. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the eye or your fingers. 13. Wash your hands. Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide how much you need based on the severity of your condition and your response to treatment. Continued overleaf
You should keep using Pilocarpine Eye Drops for as long as your doctor has asked. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this. If you have any further questions on the use of the medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. Common side effects (may affect 1 and 10 in every 100 patients):
- itching, smarting and a burning sensation around the eye
- a red skin rash with itching (urticaria)
- swelling, redness or soreness of the eyelid
- swelling of the front of the eye (conjunctiva)
- temporarily blurred vision
- temporary short sightedness
- difficulty in seeing in poor light
- enlargement of the veins in the eye
- headache and brow ache (especially in young patients at the beginning of treatment).
- bleeding within the front of the eye
- detachment of the retina (the inner surface of the eye)
How to store it
Pilocarpine Eye Drops Keep this medicine out of the sight and reach of children Make sure the container is properly closed after each use. Store Pilocarpine Eye Drops in their original container to protect from moisture and away from direct light. Store below 25°C. Do not use Pilocarpine Eye Drops after the expiry date which is printed on the label. The expiry date refers to the last day of that month. Dispose of this medicine 28 days after opening. 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.
Contents of the pack and other information
What Pilocarpine Eye Drops contain The active substance is Pilocarpine hydrochloride 1.0%, 2.0% or 4.0% w/v The other ingredients are benzalkonium chloride and purified water. What Pilocarpine Eye Drops look like and contents of the pack Pilocarpine Eye Drops are a clear, colourless and sterile solution supplied in a plastic dropper bottle. Each bottle contains 10ml of the solution. Marketing Authorisation Holder: Martindale Pharmaceuticals Ltd T/a Martindale Pharma Bampton Road Harold Hill Romford Essex RM3 8UG UK Manufacturers: Tubilux Pharma S.p.A. Via Costarica 20/22 00071 Pomezia (RM) ITALY Marketing Authorisation numbers: Pilocarpine Eye Drops 1.0% w/v PL 00156/0079 Pilocarpine Eye Drops 2.0% w/v PL 00156/0080 Pilocarpine Eye Drops 4.0% w/v PL 00156/0078 This leaflet was last revised in:04/2016
Rare may affect up to 1 in 1,000 people:
- feeling sick (nausea)
- being sick (vomiting)
- diarrhoea
- increase in saliva
- increased flow of tears
- trembling or shaking
- wheezing and breathing difficulties
- change in blood pressure or changes in the way your heart beats With long term use it is possible that the lens of your eye may change shape resulting in changes to your vision. You may not know if you have some of the side effects. Your doctor will detect them during examinations. Reporting of side effects 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 Website: http:// www.mhra.gov.uk/yellowcard.
D03227
PACKAGE LEAFLET: INFORMATION FOR THE USER
3227-C
100mm Measurement Verification Bar
Frequently asked questions about Pilocarpine Eye Drops BP 2.0% w/v (Tubilux)
How do I take Pilocarpine Eye Drops BP 2.0% w/v (Tubilux)?
Pilocarpine Eye Drops BP 2.0% w/v (Tubilux) comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pilocarpine Eye Drops BP 2.0% w/v (Tubilux)?
The active substance in Pilocarpine Eye Drops BP 2.0% w/v (Tubilux) is pilocarpine hydrochloride.
Are there equivalent medicines to Pilocarpine Eye Drops BP 2.0% w/v (Tubilux)?
Medicines with the same active substance, strength and form include: Pilocarpine Eye Drops BP 1.0% w/v, Pilocarpine Eye Drops BP 1.0% w/v (Tubilux), Pilocarpine Eye Drops BP 2.0% w/v. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pilocarpine Eye Drops BP 2.0% w/v (Tubilux), 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 Pilocarpine Eye Drops BP 2.0% w/v (Tubilux) 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: pilocarpine hydrochloride
- 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
Pilocarpine is a direct acting miotic indicated for:• chronic simple glaucoma.• acute (closed angle) glaucoma alone, or in conjunction with other agents to decrease intra-ocular pressure prior to surgical treatment. • miosis - to counteract the effects of cycloplegic or mydriatic eye drops.
4.2. Posology and method of administration
Posology Adults and the elderly
a) In the treatment of open angle glaucoma, the dosage is one or two drops every six hours or as prescribed by the physician.The strength of the preparation and the frequency of use are determined by the severity of the condition and the response to treatment.b) When used prior to surgery for acute attacks of closed-angle glaucoma, the dosage is one drop every five minutes until miosis is obtained or as directed by the physician.c) To overcome weaker mydriatics, the normal dosage is one drop every five minutes until the effect is counteracted or as directed by the physician. Paediatric population
Based on the infrequency of reports of adverse events in children, and the extensive experience of use of pilocarpine in childhood glaucoma, concentrations of up to 2% may be safely used in children. Currently available data are described in section 5.1 but no recommendation on a posology can be made.Treatment should be started with the lowest available dose and concentration in patients under 18 years of age. Depending on clinical response and tolerability, the dose may be increased up to the maximum recommended adult dosage of the 2% pilocarpine eye drop solution. Directly after administration of any dose, the lacrimal punctum should be occluded for one minute with a finger to limit systemic exposure. Method of administration
Eye drops for topical administration into the conjunctival sac.
4.3. Contraindications
• Hypersensitivity to any component.• Acute iritis• Anterior uveitis• Some forms of secondary glaucoma Soft contact lenses.Hypersensitivity to the active substances(s) or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Although rare, the possibility of systemic absorption should be considered especially in the treatment of acute closed-angle glaucoma where higher doses are administered. It should be used with caution in patients with bronchial asthma, peptic ulceration, urinary tract obstruction, Parkinson's disease, acute heart failure and hypertension.Fundus examination is advised in all patients before starting pilocarpine therapy since retinal detachment has been associated with the use of miotics in susceptible individuals and those with pre-existing retinal disease.Regular monitoring of visual fields and intra-ocular pressure should be carried out in patients on long term therapy with pilocarpine for chronic simple glaucoma.
4.5. Interaction with other medicinal products and other forms of interaction
If systemic absorption occurs, pilocarpine may enhance the effects of alcohol and anticholinesterases and diminish the effects of anticholinergics. The effects of pilocarpine may be enhanced by anticholinesterases, MAOI's, phenothiazines, antihistamines and tricyclic antidepressants. Adrenergic blockers may decrease the effects of pilocarpine. Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
Safety of pilocarpine for use during pregnancy has not been established. Ophthalmic pilocarpine may be systemically absorbed and mothers using the drug may give birth to infants with signs mimicking neonatal meningitis such as restlessness, convulsions, diaphoresis and hypothermia. Pilocarpine should therefore only be used during pregnancy when essential Breast-feeding
Safety of pilocarpine for use during lactation has not been established and it should therefore only be used when clearly indicated. It is not known whether pilocarpine is excreted in breast milk. The possibility of systemic absorption however, should be borne in mind.
4.7. Effects on ability to drive and use machines
The miotic effects of pilocarpine cause difficulty in adapting to the dark. Caution is therefore necessary if driving or operating machinery in poorly lit conditions. Pilocarpine impairs accommodation by paralysis or spasm and patients should not drive or operate machinery if they experience blurred vision.
4.8. Undesirable effects
Adverse drug reactions from clinical trials are listed by MedDRA system organ class. Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse drug reaction is based on 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), not known (cannot be estimated from the available data). System Organ Class Frequency Undesirable effect
Eye disorders Common decreased visual acuity in poor illumination (frequently experienced by older individuals and in those patients with lens opacity), itching, smarting (discomfort) and burning, sensitisation of the lids and conjunctival vascular congestion, superficial keratitis, ciliary spasm, blurred vision, induced myopia, transient myopia, lens changes with chronic use, increased pupillary block,vitreous haemorrhages,retinal detachments.
rare lacrimation
Nervous system disorder Common Headache and browache(especially in younger patients who have recently initiated therapy),
rare sweating, increased salivation, tremor
Cardiac disorders rare changes in cardiac rhythm
Vascular disorders rare changes in blood pressure
Respiratory, thoracic and mediastinal disorders rare bronchial spasm, pulmonary oedema
Gastrointestinal disorders rare nausea, vomiting and diarrhoea
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 Website: http://www.mhra.gov.uk/yellowcard.
4.9. Overdose
If pilocarpine is accidentally ingested, emesis should be induced or gastric lavage performed. The patient should be monitored for signs of pilocarpine toxicity such as increased salivation and sweating, lacrimation, nausea, vomiting and diarrhoea. If these occur, therapy with an anticholinergic such as atropine may be required.
💬 Ask about this leaflet
Ask anything about Pilocarpine Eye Drops BP 2.0% w/v (Tubilux). 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.