Fotil Forte (Timolol & Pilocarpine)

What Is Fotil Forte and What Is It Used For?

Fotil Forte is a fixed-dose combination ophthalmic solution developed by Santen Oy for the management of elevated intraocular pressure (IOP). It is primarily prescribed for patients with chronic open-angle glaucoma — the most common form of glaucoma — where the drainage angle of the eye remains open but does not function efficiently, leading to a gradual buildup of pressure that can damage the optic nerve and cause irreversible vision loss if left untreated.

The medication contains two well-established active ingredients that have been used in glaucoma management for decades. Timolol maleate, equivalent to timolol 5 mg/ml, is a non-selective beta-adrenergic receptor antagonist (beta-blocker). In the eye, timolol reduces intraocular pressure by decreasing the production of aqueous humor — the clear fluid that fills the anterior (front) chamber of the eye. By blocking beta-adrenergic receptors in the ciliary body, timolol slows the rate at which this fluid is secreted, thereby lowering the overall pressure within the eye.

Pilocarpine hydrochloride (40 mg/ml in Fotil Forte; 20 mg/ml in the regular Fotil formulation) is a direct-acting parasympathomimetic agent, also known as a cholinergic agonist or miotic. Pilocarpine lowers intraocular pressure through a different mechanism: it contracts the ciliary muscle, which in turn pulls on the scleral spur and opens the trabecular meshwork. This action facilitates the outflow of aqueous humor from the anterior chamber, effectively lowering pressure by improving drainage rather than reducing production.

The rationale for combining these two agents in a single formulation is well supported by clinical evidence. Because timolol and pilocarpine act through complementary mechanisms — one reducing aqueous humor inflow and the other increasing outflow — their combined effect on IOP is additive. Multiple randomized controlled trials have demonstrated that the timolol-pilocarpine combination achieves a greater and more sustained IOP reduction than either agent used alone, making it a valuable option when monotherapy is insufficient to reach the target pressure.

Fotil Forte is available in two strengths, differing only in pilocarpine concentration. The standard Fotil formulation contains timolol 5 mg/ml with pilocarpine 20 mg/ml (2%), while Fotil Forte contains timolol 5 mg/ml with pilocarpine 40 mg/ml (4%). The choice between the two is made by the prescribing physician based on the degree of IOP reduction needed, the patient's response, and tolerance of side effects. Fotil Forte is typically prescribed when a stronger pilocarpine effect is required for adequate pressure control.

What Should You Know Before Using Fotil Forte?

Contraindications

Fotil Forte must not be used in the following situations. If any of these apply to you, inform your doctor immediately so an alternative treatment can be chosen:

• Allergy to the active substances or excipients: Do not use Fotil Forte if you are allergic to timolol, beta-blockers as a class, pilocarpine, or any of the other ingredients (listed in the composition section), including the preservative benzalkonium chloride.
• Respiratory conditions: This medication is contraindicated in patients with current or previous reactive airway disease, including bronchial asthma, severe chronic obstructive pulmonary disease (COPD), or any condition causing wheezing, breathlessness, or persistent cough. Timolol, even when applied topically to the eye, can be absorbed into the bloodstream and may trigger bronchospasm.
• Cardiac conditions: Do not use if you have sinus bradycardia (resting heart rate below 50 beats per minute), second- or third-degree atrioventricular (AV) block, uncontrolled heart failure, or cardiogenic shock. Timolol's beta-blocking effect can worsen these conditions.
• Conditions prohibiting pupil constriction: Pilocarpine causes miosis (pupil constriction). Do not use Fotil Forte if you have iritis (inflammation of the iris), or any other condition in which pupil constriction could be harmful, such as certain forms of secondary glaucoma where miosis may worsen the condition.

Warnings and Precautions

Speak with your ophthalmologist or prescribing physician before using Fotil Forte if you currently have or have previously had any of the following conditions. In many cases, the medication may still be used under careful medical supervision, but your doctor needs to weigh the benefits against potential risks:

• Coronary heart disease: Symptoms such as chest pain, chest tightness, shortness of breath, or exertional dyspnoea may indicate coronary artery disease. Beta-blockers, including topical timolol, can affect cardiac function.
• Heart failure or low blood pressure: Timolol may further reduce heart rate and blood pressure, potentially worsening these conditions.
• Heart rhythm disturbances: Including first-degree AV block or other conduction abnormalities that have not progressed to a complete contraindication.
• Breathing problems: Even mild asthma, reactive airway disease, or mild-to-moderate COPD may be aggravated by topical beta-blockers.
• Peripheral circulatory disorders: Conditions such as Raynaud's disease or Raynaud's syndrome (episodes of reduced blood flow to the fingers and toes, causing them to turn white or blue) may be worsened by beta-blockers.
• Diabetes mellitus: Timolol can mask the signs and symptoms of hypoglycaemia (low blood sugar), particularly tachycardia (rapid heartbeat) and tremor. Patients with diabetes who use Fotil Forte should monitor their blood glucose closely and be aware that the usual warning signals of low blood sugar may be blunted.
• Thyroid disorders: Beta-blockers can mask the clinical signs of hyperthyroidism (overactive thyroid), particularly elevated heart rate. If you have or suspect thyroid disease, inform your doctor.
• Severe allergic history or atopy: Patients with a history of severe allergic reactions (anaphylaxis) or atopic conditions should be aware that timolol may reduce the effectiveness of epinephrine (adrenaline) used to treat anaphylactic reactions.
• Corneal disease: Beta-blockers applied topically to the eye may cause dry eyes. If you have conditions affecting the cornea (the clear front surface of the eye), discuss this with your doctor, as reduced tear production may worsen corneal integrity.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, think you may be pregnant, or are breastfeeding, consult your doctor before using Fotil Forte. This medication should generally be avoided during pregnancy and breastfeeding unless your doctor explicitly determines that the benefit outweighs the potential risks.

Pregnancy: Timolol and pilocarpine have not been adequately studied in pregnant women. Animal studies with timolol have shown potential adverse effects on the fetus when administered at doses significantly higher than therapeutic ophthalmic doses. While topical ophthalmic application results in much lower systemic exposure than oral administration, there is still a theoretical risk that timolol absorbed into the maternal circulation could cross the placenta and affect fetal heart rate and development. As a precaution, Fotil Forte should not be used during pregnancy unless your physician has determined it to be essential.

Breastfeeding: Timolol is excreted into human breast milk after topical ophthalmic administration. Even though the amounts reaching breast milk from eye drops are small, beta-blockers can potentially cause serious adverse effects in nursing infants, including bradycardia and hypoglycaemia. Therefore, Fotil Forte should not be used while breastfeeding. If treatment with Fotil Forte is essential, your doctor may advise you to discontinue breastfeeding or choose an alternative medication.

Driving and Operating Machinery

Fotil Forte can cause visual disturbances that may affect your ability to drive or operate machinery safely. Pilocarpine causes miosis (pupil constriction), which significantly reduces the amount of light entering the eye and impairs adaptation to darkness. Additional visual effects may include refraction changes (altered focusing ability), transient blurred vision (typically lasting 20–30 minutes after instillation), double vision (diplopia), and drooping of the upper eyelid (ptosis).

Timolol may occasionally cause dizziness or fatigue. Exercise particular caution when driving at night or in low-light conditions, as the miotic effect of pilocarpine significantly reduces night vision. You are responsible for assessing your own fitness to drive. Do not drive or operate dangerous machinery until you are certain that your vision and alertness are not impaired.

Benzalkonium Chloride Preservative

Fotil Forte contains benzalkonium chloride (approximately 0.003 mg per drop, equivalent to 0.1 mg/ml) as a preservative. Benzalkonium chloride may irritate the eyes, particularly in patients with dry eye syndrome or those with pre-existing corneal conditions. If you experience irritation, stinging, or pain in the eye after applying the drops, contact your doctor.

Contact lens wearers: Benzalkonium chloride can be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before applying Fotil Forte and wait at least 15 minutes before reinserting them. This precaution helps prevent both irritation and lens damage.

How Does Fotil Forte Interact with Other Drugs?

Like all medications, Fotil Forte can interact with other drugs, potentially altering their effects or increasing the risk of side effects. The timolol component is the primary source of drug interactions because, despite being applied to the eye, it is absorbed into the systemic circulation in sufficient quantities to produce pharmacological effects beyond the eye. Always inform your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take — including prescription medications, over-the-counter products, and herbal supplements.

Fotil Forte eye drops may also interact with other topical ophthalmic medications. If you are using other eye drops for glaucoma or other eye conditions, inform your doctor, as the combined effects of multiple eye medications may require dose adjustments or altered scheduling.

What Is the Correct Dosage of Fotil Forte?

Always use Fotil Forte exactly as prescribed by your doctor. The dosage is individualized by your physician based on your specific condition, the degree of intraocular pressure elevation, and your response to treatment. Do not alter the dosage or frequency without consulting your doctor. If you are unsure about any aspect of your treatment, ask your doctor or pharmacist for guidance.

Adults

Consistency in timing is important for maintaining stable intraocular pressure throughout the day. Many patients find it helpful to associate their drops with daily routines — for example, upon waking and before bedtime. Keep the bottle on your bedside table as a reminder.

Children

Elderly Patients

How to Apply Fotil Forte Eye Drops

Proper application technique is crucial for both effectiveness and safety. Follow these steps carefully each time you administer the drops:

1. Wash your hands thoroughly before handling the eye drop bottle. Choose a comfortable position — sitting down, lying on your back, or standing in front of a mirror.
2. Open the bottle and avoid touching the dropper tip with your fingers, the eye, or any other surface to prevent contamination of the solution.
3. Tilt your head back and hold the bottle above the eye. Gently pull down the lower eyelid with one finger to create a small pocket.
4. Look upward and squeeze one drop into the pocket formed by the lower eyelid. Avoid blinking immediately.
5. Close your eye gently and press your index finger firmly against the inner corner of the eye (near the nose) for at least 2 minutes. This technique, called nasolacrimal occlusion, prevents the medication from draining into the nasal passage and being absorbed into the general circulation, significantly reducing the risk of systemic side effects from timolol.
6. Recap the bottle securely after use.

Missed Dose

If you forget to apply a dose of Fotil Forte, apply it as soon as you remember — unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a forgotten one. Doubling the dose increases the risk of side effects without providing additional therapeutic benefit.

Overdose

If you accidentally apply too many drops to the eye or if someone (especially a child) swallows the eye drops, contact a poison control centre or seek medical attention immediately. Symptoms of timolol overdose may include severe bradycardia (very slow heart rate), hypotension (low blood pressure), bronchospasm, and heart failure. Pilocarpine overdose can cause excessive sweating, salivation, nausea, and breathing difficulties.

What Are the Side Effects of Fotil Forte?

Like all medicines, Fotil Forte can cause side effects, although not everyone experiences them. Most side effects are related to the local ocular effects of the medication or to the systemic absorption of timolol. In most cases, you can continue using the drops unless the side effects are severe. Do not stop treatment without consulting your doctor first.

Because timolol is absorbed into the bloodstream even when applied to the eye, some side effects may resemble those seen with oral or injectable beta-blocker medications. However, the frequency and severity of systemic side effects from ophthalmic timolol are generally lower than from systemic administration.

Additional Side Effects Reported with Ophthalmic Beta-Blockers

As timolol is a beta-blocker and is absorbed into the bloodstream after ocular application, the following side effects have been reported within the broader class of ophthalmic beta-blockers. While many are rare, awareness is important for informed patient care:

• Allergic reactions: Generalised allergic reactions including angioedema (swelling of the face, lips, tongue, or throat), urticaria (hives), localised or widespread rash, itching, and in very rare cases, anaphylaxis (severe life-threatening allergic reaction).
• Metabolic: Low blood sugar (hypoglycaemia), particularly relevant for patients with diabetes.
• Neurological and psychiatric: Insomnia, nightmares, memory loss, hallucinations, worsening of myasthenia gravis symptoms, paraesthesia (tingling or pins-and-needles sensation), and stroke.
• Ocular: Signs of eye irritation (burning, stinging, itching, watery eyes, redness), choroidal detachment following filtration surgery, and corneal erosion.
• Cardiovascular: Peripheral oedema (fluid retention), congestive heart failure, myocardial infarction (heart attack), Raynaud's phenomenon, and cold hands and feet.
• Respiratory: Cough.
• Gastrointestinal: Taste disturbances, digestive problems, diarrhoea, dry mouth, abdominal pain, and vomiting.
• Dermatological: Hair loss, psoriasiform rash (resembling psoriasis), or worsening of existing psoriasis.
• Musculoskeletal: Muscle pain not related to exercise, muscle weakness, muscle fatigue.
• Other: Reduced sexual function, decreased libido, and systemic lupus erythematosus (an autoimmune condition).

How Should You Store Fotil Forte?

Proper storage of Fotil Forte is essential to maintain the medication's efficacy and safety throughout its use. The eye drop solution is sensitive to light and temperature, and incorrect storage can lead to degradation of the active ingredients or microbial contamination.

• Before opening: Store the unopened bottle in a refrigerator at 2°C to 8°C. Keep the bottle in its original outer carton to protect it from light.
• After opening: Once opened, the bottle may be stored at room temperature, not exceeding 25°C. There is no need to refrigerate the opened bottle.
• Shelf life after opening: An opened bottle of Fotil Forte must be used within four weeks. After four weeks, discard any remaining solution even if the bottle still contains liquid, as the preservative may no longer adequately prevent microbial growth.
• Expiry date: Do not use the medication after the expiry date printed on the packaging. The expiry date refers to the last day of the stated month.
• Visual inspection: Before each use, briefly inspect the solution. Do not use it if it has become cloudy, discoloured, or contains visible particles.
• Child safety: Keep the bottle out of the sight and reach of children at all times.
• Disposal: Do not dispose of unused medication via household waste or down the drain. Return unused or expired eye drops to a pharmacy for safe disposal to protect the environment.

What Does Fotil Forte Contain?

Active Ingredients

Fotil Forte contains two pharmacologically active substances that work together to lower intraocular pressure:

Inactive Ingredients (Excipients)

The following inactive ingredients serve as the vehicle, stabilizer, and preservative for the eye drop solution:

• Citric acid – pH adjustment and buffering agent
• Sodium citrate – buffering agent to maintain stable solution pH
• Hypromellose – viscosity-increasing agent that helps the solution remain on the eye surface longer
• Water for injections – pharmaceutical-grade solvent
• Benzalkonium chloride 0.1 mg/ml – antimicrobial preservative

Packaging and Presentation

Fotil Forte is supplied in 5 ml low-density polyethylene (LDPE) bottles with high-density polyethylene (HDPE) screw caps. It is available as a single 5 ml bottle or in packs of 3 × 5 ml bottles. Not all pack sizes may be marketed in all countries. The bottle is designed for personal use only — do not share your eye drops with others, as this risks cross-contamination and infection.

Fotil Forte is manufactured by Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland. The marketing authorisation holder is Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland.

References

This article is based on peer-reviewed medical literature, international clinical guidelines, and official product information. All medical claims reflect Evidence Level 1A where available.

1. European Medicines Agency (EMA). Summary of Product Characteristics: Timolol/Pilocarpine combination ophthalmic solutions. EMA product database. Accessed January 2026.
2. European Glaucoma Society (EGS). Terminology and Guidelines for Glaucoma, 5th Edition (2020). European Glaucoma Society.
3. American Academy of Ophthalmology (AAO). Preferred Practice Pattern: Primary Open-Angle Glaucoma. Ophthalmology. 2020;127(1):P183–P227.
4. World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Geneva: World Health Organization.
5. British National Formulary (BNF). Timolol maleate – eye. BNF. National Institute for Health and Care Excellence (NICE). Accessed January 2026.
6. Khouri AS, Realini T, Fechtner RD. Use of fixed-dose combination drugs for the treatment of glaucoma. Drugs & Aging. 2007;24(12):1007–1016.
7. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Archives of Ophthalmology. 1984;102(4):551–553.
8. Li T, Lindsley K, Rouse B, et al. Comparative effectiveness of first-line medications for primary open-angle glaucoma: A systematic review and network meta-analysis. Ophthalmology. 2016;123(1):129–140.
9. National Institute for Health and Care Excellence (NICE). Glaucoma: diagnosis and management. NICE guideline [NG81]. Updated January 2022.
10. Santen Oy. Fotil Forte Product Information. Package leaflet. Last revised 2020.

About the Medical Editorial Team