What Torzkom is and what it is used for
Torzkom contains two medicinal substances: dorzolamide and timolol .
- Dorzolamide belongs to a group of drugs called carbonic anhydrase inhibitors.
- Timolol belongs to a group of medicines called beta blockers.
These medicinal substances lower the pressure in the eye in different ways.
Torzkom is used to lower an elevated pressure in the eye in glaucoma ( glaucoma ) when treatment with eye drops containing only beta-blockers is not sufficient.
Dorzolamide and timolol found in Torzkom may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Torzkom
Do not use Torzkom
- if you are allergic to dorzolamide hydrochloride, timolol maleate, or any of the other ingredients of this medicine (listed in section 6)
- if you now have or have previously had respiratory problems such as asthma or severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing)
- if you have a low heart rate, heart failure, or heart rhythm disturbances (irregular heartbeats)
- if you have severely impaired kidney function
- if the acidity of your blood is increased due to increased chloride levels in the blood (hyperchloraemic acidosis ).
Warnings and precautions
Talk to your doctor before using Torzkom.
Tell your doctor about any medical or eye problems you have or have had in the past:
- coronary heart disease (symptoms may be chest pain or pressure on the chest, shortness of breath, or feeling of suffocation), heart failure, low blood pressure
- heart rhythm disturbances such as low heart rate
- breathing problems, asthma, or chronic obstructive pulmonary disease (COPD)
- disease involving poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome)
- diabetes, as timolol may mask signs and symptoms of low blood sugar
- an overactive thyroid, such as timolol, can mask the signs and symptoms of this.
Tell your doctor before an operation that you are taking Torzkom, as timolol can change the effect of some medicines used during anesthesia. Also tell your doctor about an allergy or hypersensitivity reaction with fever, rash, edema, and drop in blood pressure (anaphylactic reactions).
Also, tell your doctor if you have muscle weakness or have been diagnosed with myasthenia gravis.
If you feel irritation of any kind in the eye or get other eye problems, such as red eyes or swollen eyelids, you should contact your doctor as soon as possible.
If you suspect that Torzkom is causing an allergic reaction or hypersensitivity (e.g. skin rash, severe skin reaction, or redness and itching of the eye), discontinue treatment and consult a doctor as soon as possible.
Tell your doctor if you develop an eye infection, have an eye injury, undergo eye surgery, or develop a reaction with symptoms that worsen or that you have not previously experienced.
Torzkom eye drops can affect the whole body.
Torzkom has not been studied in patients who wear contact lenses. If you wear soft contact lenses, consult your doctor before using this medicine.
Use in children
Experience in the treatment of infants and children with Torzkom is limited.
Use in the elderly
In studies of dorzolamide/timolol (containing preservatives ), the effect was comparable in older and younger patients.
Use in patients with impaired liver function
Other medicines and Torzkom
Torzkom can affect or be affected by other medicines that you use, including other eye drops for the treatment of glaucoma. Tell your doctor if you use or intend to use medicines that lower blood pressure, heart medicines, or medicines for diabetes. Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This is especially important if you:
- are using medicines that lower blood pressure et or treat heart disease (such as calcium blockers, beta-blockers, or digoxin )
- use medicines to treat irregular heart rhythms such as calcium blockers, beta-blockers, or digoxin
- using other eye drops that contain a beta blocker
- using another carbonic anhydrase inhibitor such as acetazolamide
- using monoamine oxidase inhibitors ( MAOIs )
- are using medicines that you have been given for, for example, vomiting (parasympathomimetics). Parasympathomimetics are a type of drug that is sometimes also used to restore normal bowel movements.
- use certain strong pain-relieving narcotic drugs such as morphine
- use drugs to treat diabetes
- using antidepressants called fluoxetine and paroxetine
- use drugs that contain sulfonamides
- using quinidine (used to treat heart conditions and some types of malaria ).
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Torzkom if you are pregnant unless your doctor considers it necessary.
Do not use Torzkom if you are breastfeeding. Timolol can pass into your breast milk. Ask your doctor for advice before taking medicine while you are breastfeeding.
Driving ability and use of machinery
No studies regarding effects on the ability to drive and use machines have been performed. Torzkom can cause side effects such as blurred vision, which can affect your ability to drive or use machinery. Wait to drive or use machines until you feel well or your vision is clear. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Description of these effects and side effects are found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor, nurse, or pharmacist if you are not sure.
How to use Torzkom
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The appropriate dose and duration of treatment are determined by the doctor.
The recommended dose is one drop morning and evening in the eye(s) to be treated.
If Torzkom is used together with other eye drops, the eye drops should be taken at least 10 minutes apart.
Do not change the dosage without consulting a doctor.
If you have difficulty taking your eye drops, ask a family member or caregiver for help.
Make sure that the single-dose container does not touch the eye or the area around the eye. It can damage your eye. It can also lead to contamination with bacteria, which can cause eye infections. Such an infection can lead to serious eye damage, even loss of vision. To avoid contamination of the single-dose container, hands should be washed before using this medicine and the tip should not touch other surfaces. A new single-dose container must be opened immediately before each use. The contents of one single-dose container are enough for both eyes if the doctor has told you to use the drops in both eyes.
Discard opened container with any remaining contents immediately after use.
Instructions for use
Open the envelope containing a strip of 5 single-dose containers. Record the date of the first opening on the envelope.
Every time you use Torzkom
- Wash your hands.
- Take a strip of the single-dose container from the envelope.
- Break off a single-dose container from the strip.
- Put the rest of the strip back in the envelope and close the envelope by folding the edge.
- Open the single-dose container by twisting off the tab.
- Hold the single-dose container between your thumb and forefinger.
- Tilt your head back or lie down. Look up and pull the lower eyelid down with the other hand. Do not allow any part of the container to touch the eye or the area around the eye. Gently press the container and let a drop fall into the space between the eyelid and the eye. Do not blink while instilling drops in the eye. The contents of one single-dose container are enough for both eyes.
- Close the eye and press a finger on the inner corner of the eye for about two minutes. This prevents the medicine from getting out into the rest of the body.
- Wipe off any solution that may have ended up on the skin around the eye.
Repeat steps 7-9 for the other eye if your doctor has told you to use the eye drops in both eyes.
To avoid contamination of the solution, which does not contain preservatives, the single-dose container, and any remaining solution should be thrown away after use.
Store the remaining single-dose containers in the envelope. The single dose containers must be used within 7 days of opening the envelope. If after 7 days there are single-dose containers left in the envelope, these are thrown away safely and a new envelope is opened. You must continue to use the eye drops according to your doctor’s instructions.
If you are not sure how to use your medicine, ask your doctor, pharmacist, or nurse.
If you have taken too much Torzkom
If you have taken too much medicine or if, for example, a child has swallowed the medicine, contact a doctor or hospital for an assessment of the risk and advice. If you put too many drops in the eye or have swallowed some of the contents of the single-dose container, you may, among other things, become dizzy, have difficulty breathing, or feel that your heart beats more slowly.
If you forget to take Torzkom
It is important to take this medicine as directed by your doctor. If you forget to take a dose, take it as soon as possible. If, on the other hand, it is time to take the next dose, then skip the forgotten dose and then follow your usual dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop using Torzkom
If you want to stop treatment with the medicine, consult your doctor first.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue taking the drops unless the side effects are severe. If you are worried, talk to your doctor or pharmacist. Do not stop using Torzkom without talking to your doctor.
General allergic reactions include swelling under the skin which may appear on areas such as the face, arms, and legs, and may block the airways which may cause difficulty in swallowing or breathing, hives or itchy rash, localized or generalized rash, itching, sudden severe life-threatening allergic reaction.
The following side effects have been reported with Torzkom or any of its ingredients, either in clinical trials or after the medicine has been sold:
Very common (may affect more than 1 in 10 users)
Burning and stinging sensation in the eyes, changes in taste.
Common (may affect up to 1 in 10 users)
Redness in and around the eye(s), increased tearing or itching in the eye(s), damage to the cornea (damage to the outer layer of the eye), swelling and/or irritation in or around the eye(s), the sensation of getting something in the eye, decreased sensitivity in the cornea (doesn’t notice that you got something in your eye and doesn’t feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (pressure or fullness in the nose), nausea, weakness/fatigue.
Uncommon (may affect up to 1 in 100 users)
Dizziness, depression, inflammation of the iris, visual disturbances including refractive errors (sometimes as a result of discontinued treatment with pupil constrictors), low heart rate, fainting, difficulty breathing ( dyspnoea ), indigestion, and kidney stones.
Rare (may affect up to 1 in 1,000 users)
Systemic lupus erythematosus ( SLE , an immune disease that can cause inflammation of internal organs) , tingling or numbness in the hands or feet, trouble falling asleep, nightmares, memory loss, worsening signs and symptoms of myasthenia gravis (muscle disease), decreased sex drive, stroke, temporary nearsightedness which may disappear when treatment is stopped, detachment of the blood vessel-containing membrane under the retina after filtration surgery which can cause visual disturbances, drooping eyelids (which causes the eye to be half closed), double vision, crusting of the eyelids, swelling of the cornea (with symptoms of visual disturbances ), low pressure in the eye, ringing in the ears, low blood pressure, change in the rhythm or speed of the heartbeat, chronic heart failure (heart disease with shortness of breath, swollen feet and legs due to fluid retention), edema (fluid retention), cerebral ischaemia (reduced blood supply to the brain), chest pain, heart attack, Raynaud’s phenomenon, swelling or cold hands and feet and reduced blood circulation in the arms and legs, leg cramps and/or pain in the legs when walking (claudication), shortness of breath, shortness of breath, runny or stuffy nose, nosebleeds, constriction of the airways in the lungs, cough, throat irritation, dry mouth , diarrhoea, contact dermatitis(skin inflammation), hair loss, rash with a silvery white appearance (psoriasis-like rash), Peyronie’s disease (which can cause a bending of the penis), allergic-type reactions eg skin rash, hives , itching , in rare cases possible swelling of the lips, eyes and mouth, wheezing or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis ).
Has been reported (occurring in an unknown number of users):
Shortness of breath, the sensation of having a foreign object in the eye, and strong heartbeats that may be fast or irregular (palpitations).
Like other drugs given in the eye, timolol is absorbed into the blood. This can cause side effects similar to those seen with beta-blockers taken by mouth. The occurrence of side effects when giving medicine locally in the eye is lower than when the medicine is taken by mouth or injected, for example. Additional side effects noted are reactions observed for the class of beta-blockers in the treatment of eye diseases:
Has been reported (occurring in an unknown number of users)
Low blood sugar levels, heart failure, a type of heart rhythm disorder, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction, and hallucination.
How to store Torzkom
Keep this medicine out of the sight and reach of children.
Do not use unopened envelopes with Torzkom after the expiration date on the carton and envelope. The first two digits indicate the month and the last four indicate the year. The expiration date refers to the last day of that month.
Store at a maximum of 25 °C.
Store protected from cold. Do not freeze.
Store in the original packaging. Light sensitive.
Torzkom can be used for 7 days after opening the envelope for the first time.
Throw away the remaining unused single-dose containers after this period.
Discard opened single-dose container with any remaining contents immediately after first use.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substances are dorzolamide and timolol.
- One ml contains 20 mg dorzolamide (as 22.26 mg dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg timolol maleate).
- Other ingredients are hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection.
Appearance and package sizes of the medicine
Torzkom is a clear and colorless or slightly yellow viscous solution, practically free of particles. In each envelope, there are 5 single-dose containers made of polyethylene (LDPE) containing 0.166 ml of solution.
30 x 0.166 ml (6 envelopes with 5 single-dose containers )
60 x 0.166 ml (12 envelopes with 5 single-dose containers )
120 x 0.166 ml (24 envelopes with 5 single-dose containers )
Marketing Authorisation Holder
Blumont Ofta Trading Ltd
103 Stuart Street
Gzira GZR1054, Malta
84084 Fisciano (SA)