50 micrograms / ml and 5 mg / ml eye drops , solution
latanoprost / timolol

What Latacomp is and what it is used for

Latacomp contains two medicines: latanoprost and timolol .

Latanoprost belongs to the group of drugs prostaglandin analogs. Timolol belongs to the group of medicines beta-blockers. Latanoprost increases the natural outflow of aqueous humor inside the eye to the bloodstream. Timolol reduces the formation of fluid inside the eye.

Lazy Comp is used to reduce pressure in the eye if you have glaucoma or ocular hypertension ( glaucoma ). Both of these diseases cause an elevated pressure in the eye that can eventually affect vision. Your doctor will usually prescribe Latacomp when other medicines do not have enough effect.

Latanoprost and timolol contained in Latacomp may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Latacomp

Latacomp can be used by adults (including the elderly) but is not recommended if you are under 18 years of age.

Do not use Latacomp:

  • if you are allergic to latanoprost or timolol or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have previously had breathing problems such as asthma or severe chronic bronchitis (severe lung disease that may cause wheezing, difficulty breathing and / or prolonged cough)
  • if you have severe heart problems or arrhythmias.

Warnings and cautions

Talk to your doctor or pharmacist before using Latacomp if you:

  • have or have previously had disease of the coronary arteries of the heart (symptoms may include chest pain, chest tightness, shortness of breath or suffocation), heart failure , low blood pressure
  • have or have previously had heart rhythm disorders such as slow heartbeat
  • have or have previously had problems with breathing, asthma or chronic obstructive pulmonary disease (COPD)
  • have or have had a disease with poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
  • have diabetes , as timolol can mask the symptoms of low blood sugar
  • have or have previously had an overactive thyroid gland because timolol can mask symptoms of illness
  • has undergone some type of eye surgery (including cataract surgery )
  • have or have previously had eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision)
  • have or have previously had dry eyes
  • wears contact lenses. You can still use Latacomp, but follow the instructions for contact lens wearers in section 3
  • have or have previously had angina (especially of the type Prinzmetal angina)
  • have ever had more severe allergic reactions that usually require hospital treatment
  • have suffered or are suffering from a viral infection in the eye caused by the herpes simplex virus ( HSV ).

Before using surgery, tell your doctor that you are using Latacomp as timolol may alter the effects of medicines used under anesthesia.

Other medicines and Latacomp

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including the use of eye drops or over-the-counter medicines.

Latacomp may be affected or affected by other medicines you are taking, including other eye drops for glaucoma. Tell your doctor if you are taking or plan to take medicines that lower your blood pressure, heart medicines, or medicines for diabetes.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • prostaglandin is, prostaglandin analog is or prostaglandin derivative
  • beta blockers (for high blood pressure )
  • adrenaline
  • drugs that treat high blood pressure such as oral calcium channel blockers, guanetidine
  • antiarrhythmics , digitalis glycosides (medicines used to treat heart failure to treat irregular heartbeat, eg digoxin )
  • parasympatomimetics (to treat glaucoma )
  • quinidine (used in heart disease and certain types of malaria )
  • antidepressants containing fluoxetine and paroxetine .

Latacomp together with food and drink

Normal meals, food, and drink do not affect how and when to use Latacomp.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use Latacomp if you are pregnant.

Breast-feeding
Do not use Latacomp if you are breastfeeding. Latacomp can be transferred to breast milk.

Fertility
Latanoprost and timolol have not been shown to have any effect on male or female fertility in animal studies.

Driving and using machines

When you take Latacomp, your vision may become cloudy for a short while. If this happens to you, do not drive or use any tools or machines until you see them again.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Latacomp contains benzalkonium chloride and phosphates

Latacomp contains benzalkonium chloride

This medicine contains 0.2 mg of benzalkonium chloride per milliliter. Benzalkonium chloride can be absorbed by soft contact lenses and may discolor the contact lenses. Remove contact lenses before using the medicine and wait 15 minutes before re-inserting the contact lenses (see section 3 “How to use Latacomp”).

Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with 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.

Lazy Comp contains phosphate s

This medicine contains 6.4 mg of phosphate in each milliliter. If you have severely damaged cornea, phosphate can in very rare cases cause cloudy spots on the cornea due to accumulation of calcium during treatment.

How to use Latacomp

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults (including the elderly) is one drop daily in the diseased eye (s).

Do not use Latacomp more than once a day, as the effect of treatment may be impaired if your dose is more often.

Use Latacomp exactly as your doctor advised and until your doctor tells you to stop treatment.

Your doctor may want to do extra checks on your heart and circulation during treatment with Latacomp.

For you who wear contact lenses

If you wear contact lenses, remove them before dosing with Latacomp. After taking Latacomp, wait 15 minutes before inserting contact lenses into the eyes.

Instructions for use

  1. Wash your hands and sit or stand comfortably.
  2. Unscrew the outer protective cap from the bottle.
  3. With one finger, pull down the lower eyelid of the eye to be treated.
  4. Place the tip of the bottle close to the eye but avoid contact with the eye. Gently press on the bottle so that only one drop comes into contact with the eye. Make sure that you do not squeeze the bottle too hard, so that no more than one drop gets into the sick eye.
  5. Release the eyelid
  6. After using Latacomp, keep one finger out of the corner of the eye, at the nose for 2 minutes.
  7. It prevents latanoprost / timolol from reaching other parts of the body. Repeat dosing one in the other eye if your doctor prescribes this. If the drop does not end up in the eye, add a new drop.
  8. Close the bottle.

If you use Latacomp and other eye drops

Wait at least 5 minutes between dosing one with Latacomp and another eye drop treatment

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. If you are concerned, talk to your doctor or pharmacist. Do not stop using Latacomp without talking to your doctor.

Below is a list of known side effects of treatment with Latacomp. The most important side effect is the risk of a gradual and permanent change in your eye color. It is also possible that the beer Latacomp can cause serious effects on your heart activity. If you notice a change in heart rhythm or heart function, contact a doctor and tell them that you have used Latacomp.

The following are known side effects of Latacomp:

Very common (may affect more than 1 user in 10):

  • A gradual change in eye color due to an increasing amount of brown pigment in the colored part of the eye called the iris . If you have a mottled eye color (blue-brown, gray-brown, yellow-brown or green-brown), the color change is more likely to occur than if you have monochromatic eyes (blue, gray, green, or brown eyes). The change in eye color can take several years to develop. The color change may be permanent and may become more obvious if you use Latacomp in only one of the eyes. No eye problems could be detected due to the color change. The change in eye color does not continue after discontinuation of Latacomp.

Common (may affect up to 1 in 10 people):

  • Eye irritation (a burning sensation, feeling of gravel in the eyes, itchy feeling, stinging sensation or feeling of debris in the eye) or eye pain.

Uncommon (may affect up to 1 in 100 people):

  • Headache
  • Red eyes, eye infection ( conjunctivitis ), blurred vision, watery eyes, inflammation of the eyelids, irritation or changes in the surface of the eye.
  • Skin rash or itching ( pruritus ).

Other side effects are

Like other eye medicines, Latacomp is absorbed into the bloodstream. The frequency of side effects after using eye drops is lower than if the medicine is taken orally or by injection, for example.

Even if the following side effects have not been seen in connection with treatment with Latacomp, they may occur for the medicines included in Latacomp (latanoprost and timolol ) and thus they may occur in connection with treatment with Latacomp. The side effects listed below are those seen with the drug class beta-blockers (eg timolol ) when used to treat eye diseases:

  • Development of viral infection in the eye caused by herpes simplex virus ( HSV ).
  • Allergic reactions that affect the whole body with swelling under the skin that can occur on the face, arms and legs, and can lead to difficulty swallowing or breathing, hives or itchy rash, local and widespread rash, itching , sudden severe life-threatening allergic reaction .
  • Low blood sugar.
  • Dizziness
  • Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
  • Fainting, stroke , decreased blood supply to the brain, worsening signs and symptoms of myasthenia gravis (muscle disease), abnormal sensations (tingling or ant crawling in the skin) and headaches.
  • Swelling of the back of the eye (macular edema), fluid-filled cyst within the colored part of the eye (iris cyst), photosensitivity ( photophobia ), sunken eyes (deepening of the orbit).
  • Signs and symptoms of eye irritation (eg burning, stinging, itchy sensation, tearing, red eyes), eyelid inflammation, corneal inflammation, blurred vision and discharge after filtration surgery of the blood vessel-containing membrane located under the retina which may cause visual disturbance, decreased corneal sensitivity dry eyes, damage to the cornea (damage to the outer layer of the eye), drooping upper eyelids (which cause the eye to be half-closed at all times), double vision.
  • Darkening of the skin around the eyes, change of the eyelashes and fine hair around the eye (increased number, length and thickness and darker color), changes of the direction of the eyelashes, swelling around the eye, swelling of the colored part of the eye (iritis / uveitis), scarring on the surface of the eye.
  • Whistling / ringing sounds in the ears ( tinnitus ).
  • Angina pectoris, worsening angina pectoris in patients who already have heart problems.
  • Slow heartbeat, chest pain, palpitations (which you feel), edema (fluid retention), changes in heart rate or rhythm, chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid retention), a type of heart rhythm disorder, heart attack heart failure .
  • Low blood pressure , poor blood circulation that makes fingers and toes stiff and pale, cold hands and feet.
  • Shortness of breath, narrowing of the airways in the lungs (especially in patients with pre-existing disease), difficulty breathing, cough, asthma , worsening of asthma .
  • Taste changes, nausea, indigestion, diarrhea, dry mouth , abdominal pain, vomiting.
  • Hair loss, rash with white to silvery appearance (psoriasis-like rash) or worsening psoriasis , skin rash.
  • Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
  • Impaired sexual function, decreased sex drive.

Latacomp contains phosphates. In very rare cases, some patients with severe damage to the thin, clear membrane on the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium storage during treatment with phosphate-containing eye drops.

How to store Latacomp

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

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

Observe the following storage instructions:

Unopened bottle: Store in a refrigerator (2-8 ° C).

After the first opening: Do not store above 25 ° C.

Once the bottle has been opened, it should be used within 4 weeks and then discarded with the remaining contents. Otherwise, there is a risk of an eye infection

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.

Contents of the pack and other information

Content declaration

  • The active substances are latanoprost and timolol maleate.
    1 ml of eye drops contains 50 micrograms latanoprost and 6.8 mg timolol maleate equivalent to 5.0 mg timolol .
  • The other ingredients are:
    Sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, purified water, sodium hydroxide for pH adjustment , hydrochloric acid for pH adjustment

What the medicine looks like and contents of the pack

Latacomp is a clear, colorless liquid packaged in a transparent dropper bottle with a screw cap.

Latacomp is available in the following pack sizes:

1 dropper bottle containing 2.5 ml eye drops.
3 droplets, each containing 2.5 ml of eye drops.
6 droplets, each containing 2.5 ml of eye drops.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer
S.C. ROMPHARM COMPANY SRL
Eroilor Street, no. 1A
Otopeni 075100, Ilfov district
Romania

Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren-Weiler
Germany

Muhammad Nadeem

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