Patient leaflet - Codimaz 20 mg / ml + 5 mg / ml eye drops solution
1. What Codimaz is and what it is used for
- 2. What do you need to know before you use Codimaz
- 3. How to use Codimaz
- 4. Possible side effects
- 5. How to store Codimaz
- 6. Contents of the pack and other information
- 1. What Codimaz is and what it is used for
Codimaz is preservative-free ophthalmological medicine in a form of sterile drops, contains two active ingredients: dorzolamide and timolol.
- Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”.
- Timolol belongs to a group of medicines called “beta blockers”.
Together these medicines lower pressure in the eye in different ways.
Codimaz is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eye drop medicine used alone is not adequate.
2. What do you need to know before you use Codimaz
Do not use Codimaz
- if you are allergic to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6)
- if you have now or had in the past respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long standing cough)
- if you have certain heart diseases, including some types of heart rhythm disturbances producing an abnormally slow heart rate or severe heart failure
- if you have severe kidney disease or problems, or a prior history of kidney stones
if you have excess acidity of the blood caused by a build up of chloride in the blood
(hyperchloremic acidosis).
If you are not sure whether you should use Codimaz, contact your doctor or pharmacist.
Warning and precautions
Talk to your doctor before using Codimaz.
Tell your doctor about any medical or eye problems you have now or have had in the past, especially if you have:
- lung problems and breathing problems, asthma or chronic obstructive pulmonary disease
- heart problems such as 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 heart beat
- circulatory problems (such as Raynaud’s disease or Raynaud’s syndrome)
- diabetes as timolol may mask signs and symptoms of low blood sugar
- thyroid problems i.e. overactivity of the thyroid gland as timolol may mask signs and symptoms
- liver problems
- any allergies or allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
- muscle weakness or have been diagnosed as having myasthenia gravis.
If you experience any of the below stop using the eye drops and contact your doctor straight away:
- any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your doctor immediately
- symptoms of an allergic reaction. See section 4 “Possible side effects” (for example, skin rash, or redness and itching of the eye).
If you have a history of contact hypersensitivity to silver, you should not use this medicine as dispensed drops may contain traces of silver from a bottle.
Inform your doctor if you have an eye injury or going to have an eye surgery as timolol may change effects of some medicines used during anaesthesia.
When Codimaz is instilled into the eye it may affect the entire body.
Codimaz has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using Codimaz.
Children
There is limited experience with dorzolamide hydrochloride and timolol maleate in infants and children.
Elderly
In studies with dorzolamide hydrochloride and timolol maleate in preserved formulation the effects were similar in both elderly and younger patients.
Other medicines and Codimaz
Codimaz can affect or be affected by other medicines.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including other eye drops or medicines obtained without a prescription. This is particularly important if you are taking:
- medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin)
- medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin
- monoamine oxidase inhibitors (MAOIs) which are used to treat depression
parasympathomimetic medicine which may have been prescribed to help you pass urine
Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel.
- opioids such as morphine used to treat moderate to severe pain
- medicines to treat diabetes
- medicines to treat depression known as fluoxetine and paroxetine
- a sulfa medicine
- taking quinidine (used to treat heart conditions and some types of malaria)
- other eye drops which also contain a beta-blocker or other carbonic anhydrase inhibitors such as acetazolamide.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Codimaz during pregnancy. Tell your doctor if you are pregnant or intend to become pregnant.
Breast-feeding
Timolol may get into human milk. If treatment with Codimaz is required, breast-feeding is not recommended. Tell your doctor if you are breast-feeding or intend to breast-feed.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed. There are side effects associated with Codimaz, such as blurred vision, which may affect your ability to drive and/or operate machinery. Do not drive or operate machinery until you feel well or your vision is clear.
3. How to use Codimaz
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The appropriate dosage and duration of treatment will be established by your doctor.
The recommended dose is one drop in the affected eye (eyes) in the morning and in the evening.
If you are using Codimaz with another eye drop, the drops should be instilled at least 10 minutes apart. Eye ointments should be administered last.
Do not change the dose of the medicine without consulting your doctor.
The solution from the multi-dose container can be used for up to 28 days after first opening for administration to the affected eye(s).
Patients should wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures.
Ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Before instillation of the eye drops
- Users should be instructed to wash their hands before opening the bottle.
- Users should also be instructed to not use this medicine if they notice that the tamperproof seal on the bottle neck is broken before they first use it.
- When used for the first time, before delivering a drop to the eye, the patient should practice using the dropper bottle by squeezing it slowly to deliver one drop away from the eye.
- When the patient is confident they can deliver one drop at a time, the patient should adopt a position that is the most comfortable for the instillation of the drops (the patient can sit down, lie on their back, or stand in front of a mirror).
Instructions of use:
- 1.
The bottle should be held directly below the cap and the cap should be turned to open the bottle
(Picture 1).To avoid contamination of the solution, the tip of the bottle must not touch anything.
- 2. The patient should tilt their head backwards and hold the bottle above their eye.
- 3. Pull the lower eyelid down and look up (Picture 2). Squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard (Picture 3.). Patients should be instructed to seek advice from their doctor, pharmacist or nurse if they are not sure how to administer their medicine.
- 4.
Close your eye and press the inner corner of the eye with your finger for about two minutes.
This helps to stop the medicine from getting into the rest of the body.
- 5. Repeat instructions 2-4 to deliver a drop into the other eye, if your doctor has instructed you to do this. Sometimes only one eye needs to be treated and your doctor will advise if this applies to you and which eye needs treatment.
- 6.
After each use and prior to recapping (Picture 4.), the bottle should be shaken once in a downwards direction, without touching the dropper tip, in order to remove any residual liquid from the tip.
This is necessary in order to ensure delivery of subsequent drops.
- 7. Wipe off any excess solution from the skin around the eye.
- 8. The medicine should be used within 28 days after the bottle is first opened. Therefore, you must
throw away the bottle 28 days after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton. 
Picture 1. Picture 2. Picture 3. Picture 4.
If you use more Codimaz than you should
If you put too many drops in your eye or swallow any of the contents of the bottle you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your doctor immediately.
If you forget to use Codimaz
It is important to use Codimaz as prescribed by your doctor.
If you miss a dose, use it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.
If you stop using Codimaz
If you want to stop using this medicine talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop allergic reactions including hives or itchy rash, localised and generalised rash, itchiness, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing or chest pain, shortness of breath, sweating, feeling of anxiety, nausea (symptoms of heart attack) you should stop using Codimaz and talk to your doctor immediately.
The following side effects have been reported with dorzolamide hydrochloride and timolol maleate in preservative free formulation or one of its components either during clinical trials or during post-marketing experience:
Very common (may affect more than 1 in 10 people)
- burning and stinging of the eyes, taste perversion.
Common (may affect up to 1 in 10 people)
- redness in and around the eye(s), watering or itching of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the eye, decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), feeling sick, also called nausea, weakness/tiredness, fatigue.
Uncommon (may affect up to 1 in 100 people)
- dizziness, depression, inflammation of the iris, visual disturbances including refractive changes (due to withdrawal of miotic therapy in some cases), difficulty breathing (dyspnoea), slow heartbeat, fainting, indigestion, kidney stones (often marked by a sudden onset of excruciating, cramping pain in low back and/or side, groin, or abdomen).
Rare (may affect up to 1 in 1,000 people)
- systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping (insomnia), nightmares, memory loss, weakening of the muscles (an increase in signs and symptoms of myasthenia gravis - muscle disorder), decreased sex drive, stroke, temporary short-sightedness which may resolve when treatment is stopped, detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances, drooping of the eyelids (making the eye stay half closed), double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in your ear, low blood pressure, irregular heartbeat (changes in the rhythm or speed of the heartbeat), congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build up), oedema (fluid build up), cerebral ischaemia (reduced blood supply to the brain), chest pain, palpitations (a quicker and/or irregular heartbeat), heart attack, Raynaud's phenomenon, swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), shortness of breath, feeling out of breath, runny or stuffed nose, nose bleed, difficulty in breathing (respiratory failure), constriction of the airways in the lungs, cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, psoriasis or worsening of psoriasis (skin rash with white silvery coloured appearance), Peyronie’s disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the lips, eyes and mouth, wheezing, or severe skin reactions (Stevens Johnsons syndrome, toxic epidermal necrolysis).
Like other medicines applied into your eyes, timolol is absorbed into the blood. This may cause similar side effects as seen with oral beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed additional side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:
Not known: frequency cannot be estimated from the available data
Low blood glucose levels, heart failure, a type of heart rhythm disorder, forceful heartbeat that may be rapid or irregular (palpitations), increased heart rate, increased blood pressure, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, shortness of breath, hallucination, foreign body sensation in eye (feeling that there is something in your eye), abnormal sensitivity of the eyes to light.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to Yellow Card Scheme via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Codimaz
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Once opened, do not store above 25°C.
Codimaz should be used within 28 days after the bottle is first opened. Therefore, you must throw away the bottle 28 days after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.
Do not use this medicine after the expiry date (EXP) which is stated on the carton and label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Codimaz contains
The active substances are dorzolamide and timolol. Each ml contains 20 mg of dorzolamide (in the form of dorzolamide hydrochloride 22.26 mg) and 5 mg of timolol (in the form of timolol maleate 6.83 mg).
Each drop (about 35 µl) contains 0.70 mg of dorzolamide and 0.18 mg of timolol.
- The other ingredients are hydroxyethylcellulose, mannitol (E421), sodium citrate (E331), sodium hydroxide (E524) (for pH adjustment), water for injections.
What Codimaz looks like and contents of the pack
Codimaz is colourless, clear, viscous liquid.
This medicine is available in white LDPE bottles with multidose HDPE dropper applicator that prevents content back contamination thanks to a silicon valve system and filtering air return into the bottle and tamper-proof HDPE screw-cap and carton box.
Pack sizes:
1 x 5 ml bottle (one bottle)
3 x 5 ml bottle (three bottles)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmaceutical Works POLPHARMA S.A.
19 Pelplińska Street, 83-200 Starogard Gdański, Poland
Manufacturer
Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece