OFTIDORIX 5ml.

What is Oftidorix and what is it used?
Oftidorix is a combination of the two drugs: dorzolamide and timolol.
• Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers".
Oftidoriks prescribed for lowering elevated intraocular pressure in glaucoma treatment when used alone eye drops containing beta-blockers are not enough.

2. What you should know before using Oftidorix?
Do not use Oftidorix:
if you are allergic to dorzolamide, timolol, beta-blockers or any of the ingredients of this medicine (listed in section 6);
if you currently have or have ever had breathing problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheezing, difficulty in breathing and / or lasting cough)
if you have severe kidney problems or have had kidney stones if you have a violation of pH (acid-alkaline balance) of blood if you have a slow heartbeat, abnormal heart rhythm (irregular heart rate) or heart failure.
If any of the above applies to you, tell your doctor before using Oftidorix.
Warnings and Precautions
Before using this medication, tell your doctor if you currently have or have ever had:
- Coronary heart disease - symptoms may include pain or chest tightness, shortness of breath or choking, heart failure, low blood pressure (hypotension);

- Breathing problems, asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheezing, difficulty in breathing and / or lasting cough);

- A disease associated with poor blood circulation (peripheral arterial 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 the signs and symptoms
If you have a history of heart disease, your doctor may wish to monitor your pulse rate and other signs of this disease while using Oftidoriks.
Tell your doctor if you have or have had liver problems, if you have muscle weakness or been diagnosed with myasthenia gravis.
If develop conjunctivitis (redness and irritation of the eye [eyes]), swelling of the eyes and eyelids, skin rashes or itching in and around the eye contact your doctor. These symptoms may be due to an allergic reaction or may have side effects of Oftidoriks (see "Possible side effects").
Tell your doctor if you develop an eye infection, receive trauma to the eye, you made eye surgery, develop other reactions or worsening of symptoms.
If you wear soft contact lenses, it is important before using your eye drops to remove the lens and not put them back up to 15 minutes after using the drops as possible preservative benzalkonium chloride can discolour your contact lenses.
Tell your doctor before you operate it using Oftidoriks as timolol may change effects of some drugs used in anesthesia.

Use in Elderly
In studies the effects of Dorzolamide / Timolol eye drops solution were similar in elderly and younger patients.

Children and adolescents
There is limited experience with Oftidorix in children and adolescents. Other medicines and Oftidorix
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Oftidoriks can affect or be affected by other medicines you use, including other eye drops for treating glaucoma.
Tell your doctor if you are taking or plan to take:
? drugs for lowering blood pressure (calcium channel blockers, beta-blockers, guanethidine);
? heart medication (antiaritmititsi amiodarone or quinidine (used in the treatment of certain types of myalgia) or digoxin);
? drugs for the treatment of diabetes;
- Another carbonic anhydrase inhibitor such as acetazolamide. You may take this type of medicine by mouth, as eye drops, or otherwise medicines to treat depression or other psychiatric illness (fluoxetine, paroxetine, MAO inhibitors)
- Parasimpatomimetik, medicine that can be prescribed to help you urinate or to help restore normal bowel transit narcotics such as morphine used for moderate to severe pain, high doses of aspirin.

Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine. Oftidoriks Do not use if you are pregnant unless your doctor considers it necessary.
Do not use Oftidoriks if you are breastfeeding. Dorzolamide and timolol can pass into breast milk.
Driving and using machines
Oftidoriks can cause side effects such as blurred vision in some patients. Do not drive or use any tools or machines until symptoms subside.
Oftidoriks contain the preservative benzalkonium chloride.
• benzalkonium chloride may cause eye irritation.
• It is known that benzalkonium chloride discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before applying the drops and wait at least 15 minutes before putting them back.

3. How to use Oftidorix?
Always use this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose and duration of treatment.
The recommended dose is one drop in the affected eye (s) twice a day, as morning and evening.
After using Oftidorix, press your finger into the corner of the eye to the nose (Figure 1) for 2 minutes. This helps non-active substance in other parts of the body.
If you use Oftidoriks concomitantly with other eye drops, wait at least 10 minutes between putting in Oftidoriks and other medicine.
Do not change the dose of the drug without consulting your doctor. If you need to stop treatment, immediately contact your doctor.
Do not let the tip of the bottle touch the eye or eye area. This can lead to its contamination by bacteria, which can cause infections, leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the bottle, keep the top of the container from contact with any surface.
To ensure proper dosing hole on top of the dropper should not be expanded.

Instructions for Use
It is advisable to wash your hands before putting drops in the eye. You may be easier to apply eye drops in front of the mirror.
1. Before the first use of the product, make sure that the protective tape on the bottle neck is not broken. It is normal to exist a gap between the bottle and the cap in a closed bottle.
2. Remove the bottle cap.
3. Tilt your head back and pull the lower eyelid down to form a small pocket between the eyelid and your eye.
4. Turn the bottle upside down and squeeze it until the eye gets a drop, as you explained your doctor. Do not touch your eye or eyelid with the tip of the dropper.
5. Repeat step 3 and 4 with the other eye if your doctor prescribes it.
6. Replace the cap and close the bottle immediately after you have used it.

If you use more than the amount Oftidoriks
It is important to stick to the dose prescribed by your doctor. If you put too many drops in your eye or swallow the contents of the bottle, you may feel unwell, for example, can make you feel faint, have difficulty breathing, or feel that your heart rate has slowed. Seek immediate medical attention if you experience any of the above effects.

If you forget to use Oftidorix
It is important to use Oftidorix as prescribed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Do not use a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue using the drops, unless the effects are serious. If you're worried, talk to your doctor or pharmacist. Do not stop taking Oftidoriks without talking to your doctor.
If allergic reactions including wheezing, swelling of the face, lips, tongue and / or throat that may cause difficulty in breathing or swallowing, you should stop applying Oftidoriks and immediately consult your doctor.
The following side effects may occur with Oftidoriks:
Very common (affecting more than 1 in 10 patients): Burning and stinging in the eyes, unusual taste
Common (affects 1 to 10 of 100 patients): Redness and / or swelling in and around the eye (s), watery or itchy eyes (eye) irritation and / or itching in and around the eye (s), foreign body sensation the eye (corneal erosion), decreased sensitivity of the cornea (lack of sensation and pain when there is something in the eye), dry eyes, blurred vision, headache, sinusitis (feeling of tension or heaviness in the nose), nausea and fatigue.

Uncommon (affects 1 to 10 of 1000 patients): Dizziness, fainting, depression, inflammation of the iris, blurred vision after discontinuation of the pupil of the eye, slow heartbeat, shortness of breath, indigestion and kidney stones (often marked by a sudden onset of excruciating pain and spasms in the lower back and / or side, groin or abdomen)

Rare (affects ot_1 to 10 of 10 000 patients): Systemic lupus erythematosus (a disease of the immune system, which can cause inflammation of internal organs), tingling or numbness in the arms or legs, sleep disorders, nightmares, memory loss, increase in signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, temporary myopia, which can fade after stopping treatment, eye pain, accumulation of fluid under the retina (detachment of the choroid following filtration surgery), drooping eyelids, double vision, crusts on the eyelids, swelling of the cornea (with symptoms of visual disturbances), low intraocular pressure, tinnitus, low blood pressure, irregular heartbeat, chest pain, palpitations (rapid or irregular heart beat), edema heart attack (cardiac arrest), stroke, decreased blood flow to the brain (cerebral ischemia), swelling or cold hands and feet and reduced circulation in the hands and feet, cramps and / or leg pain when walking (claudication), changes in ECG (atrioventricular block), cardiac or respiratory failure (with symptoms such as shortness of breath, shortness of breath), runny or stuffy nose, nose bleed, bronchospasm (difficulty breathing), cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, psoriasis such as rash or worsening of psoriasis, Peyronie's disease (which can lead to curvature of the penis), allergic-type reactions such as rash, hives, itching, in rare cases, swelling of the face, lips, eyes and mouth , tongue or throat that may cause difficulty in swallowing or breathing (angioedema and anaphylaxis), wheezing.

Not known (frequency can not be estimated): Low blood sugar (hypoglycemia), changes in taste sensations, abdominal pain, ^ vomiting, muscle pain that is not caused by loading (myalgia), sexual dysfunction .
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible effects not listed in this leaflet. In particular, tell your doctor or pharmacist, especially if you have any changes / visual disturbance when using Oftidoriks after eye surgery.

5. How to store Oftidorix?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require special storage temperature.
Oftidoriks must be used within 28 days after first opening. Therefore, you must throw away the bottle 4 weeks after first opening, even if remaining solution. To help you remember, write the date you opened it on the carton.