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Oftidorix PF 5 ml. View full size

Oftidorix PF 5 ml.

Oftidorix PF contains 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".

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19.00 €


Oftidorix PF 5 ml.

What Oftidorix PF is and what it is used for
Oftidorix PF contains 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".
These drugs lower the pressure in the eye in different ways.
Oftidorix PF is released to reduce elevated intraocular pressure in glaucoma treatment when eye drops containing beta-blocker drugs used alone are not sufficient.
Ophtydrix PF eye drops solution is a sterile solution that does not contain preservatives.

2. What you need to know before using Oftidorix PF
Do not use Oftidorix PF:

if you are allergic to dorzolamide, timolol or any of the other ingredients of this medicine (listed in section 6);
if you have or have had a respiratory problem such as asthma or severe chronic obstructive bronchitis (a severe lung disease that may cause wheezing, difficulty in breathing and / or prolonged cough);
if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeats);
if you have severe kidney disease or problems or previous history of kidney stones;
if you have too high acidity in the blood caused by the accumulation of chloride in the blood (hyperchloraemic acidosis).
If you are not sure if you should use this medicine, contact your doctor or pharmacist.

Warnings and precautions
Talk to your doctor before using Oftidorix PF
Tell your doctor about any medical or ocular problems that you have or have had in the past such as:

coronary heart disease (symptoms may include chest pain or chest tightness, shortness of breath or suffocation), heart failure, low blood pressure;
heart rate disorders such as slow heartbeat;
breathing problems, asthma or chronic obstructive pulmonary disease;
a disease associated with poor circulation (such as Raynaud's disease or Raynaud's syndrome);
diabetes, as timolol can mask the signs and symptoms of low blood sugar;
hyperactivity of the thyroid gland since timolol can mask signs and symptoms.
If you have a history of contact hypersensitivity to silver, you should not use this product.
Tell your doctor before taking any surgery that you are using Ophthirdrix PF as timolol may alter the effects of some medicines used in anesthesia.
Also tell your doctor about all allergies or anaphylactic reactions, including rash, swelling of the face, lips, tongue and / or throat, which may cause shortness of breath or difficulty in swallowing.
Tell your doctor if you have muscle weakness or are diagnosed with myasthenia gravis.
If you develop eye irritation or any new eye problems such as eye redness or swelling of the eyelids, contact your doctor immediately.
If you suspect that Ophthydroxy PF causes an allergic reaction or hypersensitivity (such as skin rash, severe skin reaction or redness and itching in the eye), stop using this medicine and contact your doctor immediately.
Tell your doctor if you develop an eye infection, get eye damage, have eye surgery or develop a reaction, including new or worsening symptoms.
When Optidrix PF is applied to the eye, it can affect the whole body.
OphtyDox PF has not been studied in patients with contact lenses. If you wear soft contact lenses, you should consult your doctor before using this medicine.

Children and adolescents
There is limited experience with dorzolamide / timolol (preservative) in babies and children.

Use in elderly patients
In dorsolamide / timolol (preservative) studies, the effects of dorzolamide / timolol (a preservative form) were similar in both elderly and younger patients.

Use in patients with hepatic impairment
Tell your doctor about any liver problems that you have or have had in the past.
Other medications and Oftidorix PF
Oftidorix PF may affect or be affected by other medicines you are using, including other eye drops to treat glaucoma. Tell your doctor if you are using or intending to use medicines to lower your blood pressure, heart medicines or medicines to treat diabetes.

Tell your doctor or pharmacist if you have recently used or are likely to use other medicines, in particular:

medicines for lowering blood pressure or for treating heart disease (such as calcium channel blockers, beta-blockers or digoxin);
medicines to treat irregular or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin;
other eye drops that contain a beta-blocker;
another carbonic anhydrase inhibitor such as acetazolamide;
monoamine oxidase inhibitors (MAOI);
parasympathomimetic medicine that may be prescribed to help with urination. Parasympathomimetics are also a particular type of medication that is sometimes used to help restore normal bowel movements;
opioids such as morphine used to treat moderate to severe pain;
medicines to treat diabetes;
antidepressants known as fluoxetine and paroxetine;
a drug containing a sulfonamide group;
quinidine (used to treat heart disease and some types of malaria).
Pregnancy and breastfeeding
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Use in pregnancy
You should not use Ophthirdrix PF if you are pregnant unless your doctor thinks it necessary.

Use in breastfeeding
You should not use Oftidorix PF if you are breast-feeding. Timolol can enter the stern.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. There are side effects associated with Ophthirdox PF, such as blurred vision, which may affect the ability to drive and / or operate machinery. Do not drive or operate machinery until you feel good or your vision is clear.

3. How to use Oftidorix PF
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The appropriate dose and duration of treatment will be determined by your doctor.
The recommended dose is one drop in the affected eye (eyes) in the morning and evening.
If you use Oftidorix PF with other eye drops, the drops should be given at least 10 minutes apart.
Do not change the dose of the medicine without consulting your doctor.
If you have difficulty applying eye drops, seek help from a family member or a carer.
Do not let the tip of the multi-dose container touch the eye or the areas around the eye. It can cause injury. The eye drop solution can be contaminated with bacteria that cause eye infections leading to serious damage even to loss of vision.
To avoid possible contamination of the multi-dose container, keep the tip of the multi-dose container out of contact with surfaces.

Instructions for use
Before applying eye drops:

Wash your hands before opening the bottle.
Do not use this medicine if you notice that the sealing of the bottle neck which indicates whether it has been opened is broken before the first use.
On first use, before dropping into the eye, you should exercise using the dropper bottle by squeezing it slowly to release a drop in the air away from the eye.
When you are sure you can apply one drop, you need to take the position most convenient for drops (you can sit, lie on your back or stand in front of the mirror).
1. Hold the bottle directly under the cap and rotate it to open the bottle. Do not touch anything with the tip of the bottle to avoid contamination of the solution.
2. Tilt your head back and hold the bottle over the eye.
3. Pull the lower lid down and look upwards. Squeeze the bottle gently in the middle and let a drop fall into the eye. Keep in mind that there may be a delay of several seconds between corking the bottle and dropping the drop. Do not squeeze too hard.
If you are not sure how to use your medicine, ask your doctor, pharmacist or nurse.
4. Blink a few times so that the drop can spread across the eye.
5. Repeat instructions 2. - 4. to apply a drop to the other eye if your doctor instructs you to do so. Sometimes one eye should only be treated and your doctor will advise you if it is for you and which eye needs treatment.
6. After use and before re-inserting the cap, the bottle should be shaken once in the downward direction without touching the tip
If you forget to use OphtyDorid PF
It is important to use this medicine as prescribed by your doctor.
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and return to your usual schedule.
Do not take a double dose to make up for the missed dose.

If you stop using Ophthyriox PF
If you want to stop using this medicine, talk to your doctor first.

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 everyone gets them.
Normally you can continue to use the drops unless the effects are serious. If you have concerns, talk to a doctor or pharmacist. Do not stop using Ophthirdrix PF without speaking to your doctor.

Generalized allergic reactions, including swelling under the skin in areas such as the face and extremities, may occur and block the airways, which may cause difficulty in swallowing or breathing, hives or itchy rash, localized and generalized rash, pruritus, severe, life-threatening allergic reaction.

The following side effects have been reported with the use of Optidotrix PF or one of its components during clinical trials or during post-marketing experience:
Very common (may affect more than 1 in 10 people):

Burning and stinging in the eyes;
Taste deviation.
Common (may affect up to 1 in 10 people):

Redness in and around the eye (eyes);
Sneezing or itching in the eye (eyes);
Corneal erosion (damage to the front layer of the eyeball), swelling and / or irritation in and around the eye (eyes);
Feeling a foreign body in the eye;
Reduced sensation of the cornea (do not realize that you have a foreign body in the eye and feel no pain);
Pain in the eyes;
Dry eyes;
Blurred vision;
Sinusitis (sensation of nose or nasal congestion);
Weakness / fatigue and fatigue.
Uncommon (may affect up to 1 in 100 people):

Inflammation of the iris;
Visual disturbances, including refractory changes (in some cases due to discontinuation of miotic therapy);
Slow pulse;
Difficulty breathing (dyspnoea);
Kidney stones.
Rare (may affect up to 1 in 1,000 people):

Systemic lupus erythematosus (a disease of the immune system that can cause inflammation of the internal organs);
Numbness or stiffness in the palms or feet;
Memory loss
Increased signs and symptoms of myasthenia gravis (muscle disorder);
Decreased desire for sex;
Temporary myopia, which may resolve when treatment is stopped;
Removing the layer beneath the retina containing blood vessels as a result of a filtration operation that may cause visual disturbances;
Hanging the eyelids (which makes the eye appear half-closed);
Double vision;
Formation of crusts on the eyelids;
Corneal swelling (with symptoms of visual disturbance);
Low eye pressure;
Noise in the ears;
Low blood pressure;
Changes in rhythm or pulse rate;
Congestive heart failure (heart disease with shortness of breath and swelling of the feet and feet due to fluid build-up);
Edema (fluid build-up);
Cerebral ischemia (reduced blood supply to the brain);
Chest pain;
Palpitations (faster and / or irregular heart beat);
Heart attack;
Raynaud's phenomenon, swelling or cold on the palms and feet and decreased blood circulation in the hands and feet;
Cramps and / or walking pain (claudication);
Shortness of breath;
Respiratory failure;
Bleeding from the nose;
Respiratory tract obstruction in the lungs;
Throat irritation;
Dry mouth;
Contact dermatitis;
Hair loss;
Skin rash of silver-white color (psoriasiform rash);
Peyroni's Disease (may cause penis curvature);
Allergic-like reactions such as rash, hives, itching, rarely swelling of the lips, eyes and mouth, wheezing or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Like other medicines administered in the eyes, timolol is absorbed into the blood. This may cause side effects similar to those seen with oral beta-blockers. The incidence of adverse reactions following topical ophthalmic administration is lower than when the medicines are taken, for example, orally, or injected. The listed additional side effects include reactions seen in the beta-blocker class when used to treat eye diseases:

Not known (frequency can not be estimated from the available data):

Low blood sugar levels;
Heart failure;
Type of heart rhythm disturbance;
Stomach ache;
Muscle pain that is not caused by physical exercise;
How to store Oftidorix PF
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
After first opening, the product may be stored for up to 28 days. No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton and the bottle after EXP. The expiry date refers to the last day of that month. Ensure that the container is properly closed.
Do not use this medicine if you notice that the seal is broken the first time you use the container.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What does Oftidorix PF contain
The active substances are dorzolamide and timolol. Each milliliter contains 20 mg dorzolamide (such as dorzolamide hydrochloride) and 5 mg timolol (as timolol maleate 6.83 mg).
The other ingredients are: hydroxyethylcellulose, mannitol, sodium nitrate, sodium hydroxide and water for injections.

What Oftidorix PF looks like and contents of the pack
Oftidorix PF eye drops solution is a 5 ml clear, colorless, slightly viscous solution in a white, opaque bottle of 11 ml of LDPE and a Novelia white HDPE and silicone white nozzle with a white HDPE cap.
Types of packaging: 1 or 3 bottles in a cardboard box.
Not all pack sizes may be marketed.



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Oftidorix PF 5 ml.

Oftidorix PF 5 ml.

Oftidorix PF contains 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".

Write your review