Fotil 5 mg / ml + 20 mg / ml and Fotil forte 5 mg / ml + 40 mg / ml eye drops , solution
Timolol maleate / pilocarpine hydrochloride

1. What Fotil and Fotil forte are and what they are used for

Timolol is a beta-blocker that lowers the pressure in the eye by reducing the inflow of aqueous humor, ie. the fluid in the anterior chamber of the eye. Pilocarpine lowers the pressure in the eye by facilitating the outflow of ventricular fluid from the anterior ventricle.

Fotil and Fotil forte used for high pressure in the eye by chronic glaucoma ( glaucoma ), in which chamber angle is open and the combination treatment is recommended.

Timolol and pilocarpine found in Fotil and Fotil forte may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Fotil or Fotil forte

Do not use Fotil or Fotil forte

  • if you are allergic to timolol, beta-blockers, pilocarpine, or any of the other ingredients of this medicine (listed in section 6)
  • if you currently have or have previously had respiratory problems, e.g. asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or prolonged cough)
  • if you have a low heart rate, heart failure, or heart rhythm disturbances (organ-bound heart rhythm)
  • if you have any disease that makes it inappropriate for a contraction of the pupil one, e.g. iritis ( inflammation in the eye’s iris ).

Warnings and cautions

Talk to your doctor before using Fotil or Fotil forte if you currently have or have had

  • the disease of the coronary arteries of the heart (with symptoms such as chest pain or pressure over the chest, shortness of breath or shortness of breath), heart failure, low blood pressure, disturbances in the heart rhythm, e.g. slow heart rate
  • respiratory problems, asthma, or chronic obstructive pulmonary disease (COPD)
  • a disease that impairs blood circulation (eg Raynaud’s disease or Raynaud’s syndrome)
  • diabetes, because timolol can mask the signs and symptoms of low blood sugar
  • the overactive thyroid gland, as timolol can mask symptoms of illness
  • atopy or severe anaphylactic (allergic) reaction, as timolol may affect the effectiveness of adrenaline (used to treat anaphylactic reaction )
  • the disease of the cornea (anterior layer of the eyeball), as beta-blockers can cause dry eyes

If you are going to have an operation, tell your doctor that you are using Fotil or Fotil forte, as timolol maleate may affect the effectiveness of certain medicines used in anesthesia.

Other drugs and Fotil and Fotil forte

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Fotil and Fotil forte eye drops can affect or be affected by other medicines you use, including other eye drops for glaucoma.

Tell your doctor if you use or intend to use

  • drugs that lower blood pressure et
  • heart medicine
  • drugs against diabetes
  • quinidine (used in heart disease and to treat certain types of malaria )
  • antidepressants containing fluoxetine or paroxetine
  • cortisone or other corticosteroid preparations for a long time
  • allergy medicines
  • medicines for asthma or chronic obstructive pulmonary disease.

Pregnancy and breastfeeding

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.

Do not use Fotil or Fotil forte if you are pregnant, unless your doctor considers it necessary. There is a risk that the fetus is affected.

Do not use Fotil or Fotil forte if you are breast-feeding. Timolol can be transferred to breast milk. If you are breast-feeding, ask your doctor for advice before taking any medicine.

Driving and using machines

Fotil and Fotil forte can in some cases cause visual disturbances, including refraction disorders (refractive errors), double vision, the fallout of the upper eyelids, often appearing mild and transient blurred vision, and occasional cases of dizziness or fatigue, eye irritation, and impaired night vision. Caution should therefore be exercised when driving, especially in the dark.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Fotil and Fotil forte contain benzalkonium chloride

Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with it

the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.

3. How to use Fotil and Fotil forte

Always use this medicine exactly as your doctor has told you. Dose one is determined by the doctor who adjusts it individually for you. The recommended dose is 1 drop in the eye morning and evening. Ask your doctor or pharmacist if you are unsure.

After applying Fotil or Fotil forte, press with a finger in the corner of the eye closest to the nose (fig. 4) and hold the finger there for 2 minutes. This prevents timolol from reaching other parts of the body.

Instructions for use

The eye drop bottle is personal. Never use a cloudy solution.

Before use:

Wash your hands. Choose the position that feels most natural to you (eg sitting down, lying on your back, or standing in front of the mirror).

Application:

1. Open the bottle. Avoid touching anything with the tip of the bottle so that the contents are not contaminated.

2. Tilt your head back and hold the bottle above your eye.

Picture 1

3. Pull the lower eyelid down, look up, and squeeze a drop into the eye.

Picture 2

4. Close the eye and press with the index finger in the inner corner of the eye for 2 minutes. This way you avoid the eye medicine running down into the tear duct. Close the bottle.

Picture 3

A tip: Feel free to have the bottle on the bedside table and drip morning and evening in connection with you getting up / going to bed.

If you have used too much Fotil or Fotil forte

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Fotil or Fotil forte

Do not take a double dose to make up for a forgotten dose.

If you stop using Fotil or Fotil forte

Do not stop treatment with Fotil or Fotil forte without first talking to a doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You can usually continue to use the drops unless the side effects are severe. Talk to your doctor or pharmacist if you are worried. Do not stop treatment with Fotil or Fotil forte without first talking to a doctor.

Common side effects (in more than 1 in 100 users): headache, eye pain, increased tear flow, eye irritation, visual disturbances such as refraction disorders (refractive errors), blurred vision, myopia, impaired night vision.

Uncommon (in 1 to 10 users in 1,000): inflammation of the conjunctiva or cornea (front layer of the eyeball), fatigue, fainting, dizziness, slow heartbeat, depression, nausea, difficulty breathing.

Rare (less than 1 in 1000 users) :

Drooping eyelids (which keep the eye half closed), double vision, lens clouding with long-term use, dry eyes, inflammation of the eyelids, decreased sensitivity of the cornea, retinal detachment especially in younger myopic patients, chest pain, low blood pressure, changes in heart rate or heart rhythm, atrioventricular block (a type of arrhythmia), the impaired blood supply to the brain, heart failure, cardiac arrest, skin rash, hives, effects on the unconscious nervous system (cholinergic nervous system), narrowing of the lungs’ airways (mainly in patients with pre-existing disease), shortness of breath.

As with other ophthalmic drugs, timolol is absorbed into the bloodstream. This can cause side effects similar to those that can be seen with beta-blockers taken by mouth (orally) or given by injection. The incidence of side effects after the drug has been dropped into the eye is lower than when the drug is taken by mouth or by injection. The listed adverse reactions include the following reactions seen in the beta-blocker group for use in the eyes:

  • Allergic reactions that affect the whole body including subcutaneous swelling, e.g. face or arms and legs, and which may cause narrowing of the airways so that it may be difficult to swallow or breathe ( angioedema ), hives, local or generalized rash, itching, sudden severe life-threatening allergic reaction.
  • Low blood sugar level.
  • Difficulty sleeping (insomnia), nightmares, memory loss, hallucinations.
  • Stroke, increased symptoms and signs of myasthenia gravis (muscle disease), abnormal sensations such as tingling or ant crawling.
  • Signs and symptoms of eye irritation (eg burning or stinging sensation, itching, watery eyes, red eyes), loosening of the blood vessel-containing membrane under the retina after filtration surgery, which may cause visual disturbances, corneal erosion (damage to the anterior layer of the eyeball).
  • Edema (fluid retention), chronic heart failure (heart disease with shortness of breath, swollen feet, and legs due to fluid retention), heart attack.
  • Raynaud’s phenomenon, cold hands, and feet.
  • Cough.
  • Taste disorders, digestive problems, diarrheadry mouth, abdominal pain, vomiting.
  • Hair loss, white/silver (psoriasis-like) skin rash or worsening psoriasis, other forms of skin rash.
  • Muscle pain that is not exercise-related.
  • Impaired sexual function, decreased sex drive.
  • Muscle weakness, muscle fatigue.
  • Systemic lupus erythematosus (a disease in which the immune system attacks various organs in the body. Common symptoms are joint pain, rash, fever, fatigue, sun sensitivity, and hair loss).

Stop taking Fotil or Fotil forte and contact your doctor immediately if swelling occurs in e.g. face, tongue, and/or throat or if you suffer from hives or shortness of breath or have difficulty swallowing.

5. How to store Fotil and Fotil forte

Keep this medicine out of the sight and reach of children.

Store the bottle in the outer carton. Sensitive to light.

Unopened packaging is stored in a refrigerator (2 ° C – 8 ° C).

Opened packaging can be stored at a maximum of 25 ° C.

Opened drip bottle is durable for four weeks.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Do not use this medicine if you notice signs of change, e.g. if the solution has become cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are

  • Armchair: timolol maleate equivalent to timolol 5 mg / ml, pilocarpine hydrochloride 20 mg / ml
  • Fotil forte: timolol maleate corresponding to timolol 5 mg / ml, pilocarpine hydrochloride 40 mg / ml

The other ingredients are citric acid, sodium citrate, hypromellose, water for injections, benzalkonium chloride 0.1 mg/ml.

What the medicine looks like and the contents of the pack

The 5 ml bottle is made of low-density polyethylene (LDPE) with a screw cap of high-density polyethylene (HDPE).

Pack sizes:

Plastic bottle: 5 ml and 3 x 5 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

Manufacturer

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Muhammad Nadeem

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