Fixapost

Latanoprost, timolol (as maleate).

This medicinal product is presented as an eye drops, solution in single-dose container. The solution is a slightly yellow and opalescent preservative free solution, practically free from particles presented in single-dose containers packed in a sachet of 5 units, each single-dose container holding 0.2 ml of product.
The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
Excipients/Inactive Ingredients: The other ingredients are: macrogolglycerol hydroxystearate, sorbitol, macrogol, carbomer, disodium edetate, sodium hydroxide (for pH-adjustment), water for injections.

Fixapost contains two medicines: latanoprost and timolol.
Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.

Fixapost is used to reduce the pressure in the eye in conditions known as open angle glaucoma or ocular hypertension. Both these conditions are linked to an increase in the pressure within the eye, eventually affecting eyesight. Fixapost is usually prescribed when other medicines have not worked adequately.

Advise patient to always use this medicine exactly as prescribed, and to check with the doctor or pharmacist if not sure.
The recommended dose for adults (including the elderly) is one drop once a day in the affected eye(s).
Do not use Fixapost more than once a day, because the effectiveness of the treatment can be reduced if it is administered more often.
Patient should use Fixapost as instructed until ordered to stop.
Extra checks may be done on heart and circulation if using Fixapost.
Contact lens wearers: If patient is wearing contact lenses, advise to remove them before using Fixapost. After using Fixapost, wait 15 minutes before putting the contact lenses back in.
If using Fixapost with other eye drops: Wait at least 5 minutes between using Fixapost and using the other eye drops.
If Fixapost is swallowed: If Fixapost was accidentally swallowed, patient should contact the doctor for advice. If a lot of Fixapost was swallowed, the patient may feel sick, have stomach pains, feel tired, flushed and dizzy and start to sweat.
If patient forgets to use Fixapost: Carry on with the usual dosage at the usual time. Do not use a double dose to make up to the dose forgotten. Patient should talk to the doctor or pharmacist if unsure.

If the patient put too many drops in the eye, he/she may experience some minor irritation in the eye and the eyes may water and turn red. This should pass but patient should contact the doctor for advice if he/she is worried.

Patient must not use Fixapost: if he/she is allergic (hypersensitive) to latanoprost, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in Description); if he/she has now or has had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough); if he/she has serious heart problems or heart rhythm disorders.

Fixapost can be used in adult men and women (including the elderly), but is not recommended for use if the patient is less than 18 years of age.
Before prescribing Fixapost, be advised if patient has now or has had in the past: coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure, low blood pressure; disturbances of heart rate such as slow heartbeat; breathing problems, asthma or chronic obstructive pulmonary disease; poor blood circulation disease (such as Raynaud's disease or Raynaud's syndrome); diabetes as timolol may mask signs and symptoms of low blood sugar; overactivity of the thyroid gland as timolol may mask signs and symptoms; patient is about to have any kind of eye surgery (including cataract surgery) or has had any kind of eye surgery in the past; patient suffers from eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision); patient suffers from dry eyes; patient wears contact lenses (he/she can still use Fixapost but follow the instructions for contact lens wearers in Dosage & Administration); patient suffers from angina (particularly a type known as Prinzmetal angina); patient suffers from severe allergic reactions that would usually require hospital treatment; patient suffered or is currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
Patient must tell the doctor before having an operation that he/she is using Fixapost as timolol may change effects of some medicines used during anaesthesia.
Fixapost contains macrogolglycerol hydroxystearate (derived from castor oil) which may cause skin reactions.
Driving and using machines: When using Fixapost the vision may become blurred for a short time. If this happens, patient must not drive or use any tools or machines until the vision becomes clear again.

Do not use Fixapost when patient is pregnant or breastfeeding.
Fixapost may get into the milk.
Latanoprost and timolol have been found to have no effect on male or female fertility in animal studies.
Patient should ask the doctor for advice before taking this medicine if she is pregnant or breast feeding, thinks she may be pregnant or is planning to have a baby.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient can usually carry on using the drops, unless the effects are serious. Advise patient to talk to a doctor or pharmacist if he/she is worried. He/she should not stop using Fixapost without speaking to the doctor.
Listed as follows are the known side effects of using Fixapost. The most important side-effect is the possibility of a gradual, permanent change in the eye colour. It is also possible that Fixapost might cause serious changes in the way the heart works. Advise patient to speak to a doctor in case of changes in the heart rate or heart function.
The following are known side effects of using Fixapost: Very common (may affect more than 1 in 10 people): A gradual change in the eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If patient has mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) he/she is more likely to see this change than those with eyes of one colour (blue, grey, green or brown eyes).
Any changes in the eye colour may take years to develop. The colour change may be permanent and may be more noticeable if Fixapost is used in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Fixapost treatment is stopped.
Common (may affect up to 1 in 10 people): Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye) and eye pain.
Uncommon (may affect up to 1 in 100 people): Headache; Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes, inflammation of the eyelids, irritation or disruption of the surface of the eye; Skin rashes or itching (pruritus).
Other side effects: Like other medicines used in the eyes, Fixapost (latanoprost and timolol) is absorbed into the blood. The incidence of side effects after using eye drops is lower than when medicines are, for example, taken by mouth or injected.
Although not seen with Fixapost, the following additional side effects have been seen with the medicines in Fixapost (latanoprost and timolol) and therefore might occur when Fixapost is used. The listed side effects include reactions seen within the class of beta-blockers (e.g. timolol) when used for treating eye conditions: Developing a viral infection of the eye caused by the herpes simplex virus (HSV).
Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.
Low blood glucose levels.
Dizziness.
Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucination.
Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations like pins and needles, and headache.
Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance (deepening of the eye sulcus).
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision.
Darkening of the skin around the eyes, changes to the eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes to the direction of eyelash growth, swelling around the eye, swelling of the coloured part of the eye (iritis/uveitis), scarring of the surface of the eye.
Whistling/ringing in the ears (tinnitus).
Angina, worsening of angina in patients who already have heart disease.
Slow heart rate, chest pain, palpitations (awareness of heart rhythm), oedema (fluid build-up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build-up), a type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, poor blood circulation which makes the fingers and toes numb and pale, cold hands and feet.
Shortness of breath, constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness.
Sexual dysfunction, decreased libido.
Reporting of side effects: Advise patient to talk to the doctor or pharmacist if he/she gets any side effects. This includes any possible side effects not listed in this monograph. By reporting side effects more information on the safety of this medicine can be provided.

Be advised if patient is taking, has recently taken or might take any other medicines, including using eye drops and medicines obtained without a prescription.
Fixapost can affect or be affected by other medicines the patient is using, including other eye drops for the treatment of glaucoma. Be advised if patient is using or intends to use medicines to lower blood pressure, heart medicine or medicines to treat diabetes. In particular, patient should speak to the doctor or pharmacist if he/she is taking any of the following types of medicine: Prostaglandins, prostaglandin analogues or prostaglandin derivatives; Beta-blockers; Epinephrine, Drugs used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics; Quinidine (used to treat heart conditions and some types of malaria); Antidepressants known as fluoxetine and paroxetine.
Fixapost with food and drink: Normal meals, food or drink have no effect on when or how Fixapost is used.

Instructions for use: This medicine is intended to be administered into the eye.
Follow these instructions to use the drops: 1. Wash hands and sit or stand comfortably.
2. Open the sachet containing 5 single-dose containers. Write down the date of first opening on the sachet.
3. Break off one single-dose container from the strip.
4. Twist open the top of the single-dose container. Do not touch the tip after opening the container.
5. Use the finger to gently pull down the lower eyelid of the affected eye.
6. Place the tip of the single-dose container close to, but not touching the eye.
7. Squeeze the single-dose container gently so that only one drop goes into the eye, then release the lower eyelid.
8. Press a finger against the corner of the affected eye by the nose. Hold for 2 minutes while keeping the eye closed.
9. Repeat in the other eye if advised. Each single-dose container contains enough solution for both eyes.
10. Discard the single-dose container after use. Do not keep it to use it again. Since sterility cannot be maintained after the individual single-dose container is opened, a new container must be opened prior to each use.
11. Place the unopened single-dose containers back in the sachet. Place the opened sachet in the carton. The unopened containers must be used within 1 month after opening the sachet.

After first opening of the sachet: use the single-dose containers within 1 month.
Write down the date of first opening on the sachet.
After first opening of the single-dose container: use immediately and discard the single-dose container after use.
Keep the unused single-dose containers in the opened sachet in order to protect them from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help protect the environment.

Antiglaucoma Preparations

S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.

P₁S₁S₃