2 mg / ml + 5 mg / ml eye drops , brimonidine tartrate solution 
and timolol

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What COMBIGAN is and what it is used for 
2. What you need to know before you use COMBIGAN 
3. How to use COMBIGAN 
4. Possible side effects 
5. How to store COMBIGAN 6. Contents of the pack 
and other ingredients information

1. What COMBIGAN is and what it is used for

COMBIGAN are eye drops used to treat glaucoma ( glaucoma ). It contains two different drugs (brimonidine and timolol ) that both lower elevated fluid pressure in the eye. Brimonidine belongs to a group of medicines called alpha-2 agonists. Timolol belongs to a group of medicines called beta-blockers. COMBIGAN is used to lower the pressure in the eye when beta-blockers alone do not provide sufficient effect.

Your eyes contain a clear, watery liquid that nourishes the inside of the eye. The fluid is continuously drained out through the eye and new fluid is formed to replace it. If the fluid cannot be drained out of the eye quickly enough, the pressure in the eye builds up and can eventually damage your vision. COMBIGAN works by reducing the production of liquid and increasing the drainage of liquid. In this way, the pressure in the eye is lowered while the eye is still supplied with nutrition.

Brimonidine tartrate and timolol contained in COMBIGAN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using COMBIGAN

Do not use COMBIGAN eye drops, solution:

  • if you are allergic to brimonidine tartrate, timolol, beta-blockers, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include swelling of the face, lips or throat, wheezing, fainting, shortness of breath, itching, or redness around the eyes.
  • if you have or have ever had respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease that may cause wheezing, difficulty breathing, and/or prolonged coughing).
  • if you have heart problems, such as low heart rate, heart failure, disturbances in the heart rhythm (does not apply if you have a pacemaker).
  • if you are using monoamine oxidase (MAO) inhibitors or certain other antidepressants.

If you think any of the above apply to you, do not use COMBIGAN without talking to your doctor.

Warnings and cautions

Talk to your doctor before using COMBIGAN

  • if you have or have had:
    • coronary heart disease (symptoms may include chest pain or tightness in the chest, shortness of breath, or suffocation), heart failure, low blood pressure
    • heart rate disorders such as slow heartbeat
    • respiratory problems, asthma, or chronic obstructive pulmonary disease(COPD)
    • disease with poor blood circulation (eg Raynaud’s disease or Raynaud’s syndrome)
    • diabetes because timolol can mask the signs and symptoms of low blood sugar
    • overactive thyroid gland because timolol can mask signs and symptoms
    • kidney or liver problems
    • tumor of the adrenal glands
    • surgical procedures in the eye to reduce the pressure in the eyes
  • If you have or have had any allergies (eg hay fever, eczema ) or a severe allergic reaction, you should be aware that a higher dose of adrenaline than normal may be required to control a severe reaction.
  • Tell your doctor before undergoing surgery that you are using COMBIGAN, as timolol may alter the effects of certain medicines used under anesthesia.
    Children and young peopleCOMBIGAN should not be used in children under 2 years of age and should not normally be used in children between 2 and 17 years of age.

Other medicines and COMBIGAN

COMBIGAN can affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to medicines for other diseases, even if there is no connection with your eye disease.

Some medicines may affect or be affected by treatment with COMBIGAN. You must tell your doctor if you are using:

  • painkillers.
  • sleeping pills or anti-anxiety drugs.
  • medicines for high blood pressure ( hypertension ).
  • medicines for heart disease (eg abnormal heart rhythm), such as beta-blockers, digoxin, or quinidine (used to treat heart disease and certain types of malaria ).
  • drugs to treat diabetes or high blood sugar.
  • antidepressants, e.g. fluoxetine and paroxetine.
  • other eye drops to lower the pressure in the eye ( glaucoma ).
  • drugs to treat severe allergic reactions.
  • Drugs that affect certain hormones in your body, such as adrenaline and dopamine.
  • drugs that affect the muscles of the blood vessels.
  • drugs to treat heartburn or stomach ulcers.

Tell your doctor if the dose of any of your medicines changes or if you regularly consume alcohol.

If you need to be put to sleep, tell your doctor or dentist that you are using COMBIGAN.

Pregnancy and breastfeeding

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.

Do not use COMBIGAN if you are pregnant, unless your doctor considers it necessary.

Do not use COMBIGAN if you are breast-feeding. Timolol may pass into breast milk. Consult a doctor before taking any medicine while breast-feeding.

Driving and using machines

COMBIGAN may cause drowsiness, fatigue, or blurred vision in some patients. Do not drive or use machines until symptoms have resolved. Tell your doctor if you have any problems.

COMBIGAN contains benzalkonium chloride

This medicine contains 0.25 mg of benzalkonium chloride per 5 ml of solution corresponding to 0.05 mg/ml.

  • Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.
  • 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.

COMBIGAN contains phosphate

This medicine contains 52.9 mg phosphate per 5 ml solution corresponding to 10.58 mg/ml.

If you suffer from severe damage to the transparent layer on the front of the eye (cornea), phosphate er can in very rare cases cause cloudy streaks on the cornea due to calcium accumulation during treatment,

3. How to use COMBIGAN

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. COMBIGAN should not be used in children under 2 years of age. COMBIGAN is not normally used in children and adolescents (from 2 to 17 years of age).

The recommended dose is one drop of COMBIGAN, twice daily at approximately 12-hour intervals. You should not change the dose or stop taking COMBIGAN without consulting your doctor.

If you are taking COMBIGAN with other ophthalmic medicines, allow at least 5 minutes between the use of COMBIGAN and other eye medicines.

Instructions for use

Do not use the bottle if the seal on the neck of the bottle is broken before you start using it.

Wash your hands before opening the bottle. Tilt your head back and look at the ceiling.

Instruction
  1. Carefully pull down the lower eyelid to form a small pocket.
  2. Turn the bottle upside down and push until there is a drop in each eye that needs treatment.
  3. Release the lower eyelid and close your eyes.
  4. Press the finger against the inner corner of the eye (the side of the eye closest to the nose) for 2 minutes. This helps prevent COMBIGAN from spreading to the rest of the body.

If the drop does not get in the eye, try again.

To prevent infection, avoid the tip of the bottle coming into contact with the eye or anything else. Replace the screw cap and close the bottle immediately after use.

If you use more COMBIGAN than you should

Adults

If you use more COMBIGAN than you should it is unlikely to harm you. Take the next dose at the usual time. If you have any further questions, ask your doctor or pharmacist.

Infants and children

Several cases of overdose have been reported in children receiving brimonidine (one of the ingredients in COMBIGAN) as part of their treatment for glaucoma. Symptoms include drowsiness, lethargy, low body temperature, pallor, and difficulty breathing. Contact a doctor immediately if this should happen.

Adults and children

If you accidentally drink COMBIGAN, contact your doctor immediately.

If you forget to take COMBIGAN

If you forget to take COMBIGAN, drip a drop into each eye that needs treatment as soon as you remember, and then return to your normal routine. Do not take a double dose to make up for a forgotten dose.

If you stop using COMBIGAN:

COMBIGAN should be used every day for the medicine to work properly.

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 everybody gets them.

If you experience any of the following symptoms, contact your doctor immediately:

  • Heart problems (eg chest pain) or irregular heart rate
  • Increased or decreased heart rate or low blood pressure

Impact on the eye

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

  • red eyes, burning sensation

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

  • stinging sensation or pain in the eye
  • allergic reaction in the eye or the skin around the eyes
  • small damage to the surface of the eye (with or without inflammation )
  • swelling, redness, or inflammation of the eyelid
  • irritation or a feeling of something in the eye
  • itching in the eye and eyelid
  • blisters or white spots in the transparent layer that covers the surface of the eye
  • visual impairment
  • tear formation
  • dry eyes
  • sticky eyes

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

  • difficulty seeing clearly
  • swelling or inflammation of the transparent layer covering the surface of the eye
  • tired eyes
  • photosensitivity
  • pain in the eyelid
  • whitening of the transparent layer covering the surface of the eyes
  • swelling or areas of inflammation below the surface of the eye
  • fly sight (moving dots in the field of view )

No known frequency (occurs in an unknown number of users):

  • Tamsyn

Impact on the body:

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

  • high blood pressure
  • Depression
  • somnolence
  • headache
  • dry mouth
  • general weakness

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

  • heart failure
  • irregular heart rate
  • dizziness
  • fainting
  • dry nose
  • taste disorder
  • nausea
  • diarrhea

No known frequency (occurs in an unknown number of users):

  • increased or decreased heart rate
  • low blood pressure
  • flushing

Some of these effects may be due to an allergy to one of the ingredients.

Additional side effects have been observed with brimonidine or timolol and may therefore occur with COMBIGAN.

The following additional side effects have been observed with the use of brimonidine

  • inflammation of the eye, pupil reduction, difficulty sleeping, cold-like symptoms, shortness of breath, symptoms affecting the stomach and digestion, general allergic reactions, skin reactions, including redness, facial swelling, itchy rash and dilated blood vessels

Like other medicines applied to the eyes, COMBIGAN (brimonidine/timolol) is absorbed into the bloodstream. Absorption of timolol, a beta-blocker component of COMBIGAN, may cause similar side effects that occur with “intravenous” and/or “oral” beta-blockers. The incidence of side effects after local administration in the eyes is lower than when, for example, medicines are taken by mouth or injected.

The listed side effects include reactions observed in the beta-blocker class when used to treat conditions in the eyes:

  • general allergic reactions, including swelling under the skin (which may occur in areas such as the face and arms or legs and may obstruct the airways, which may cause difficulty in swallowing or breathing), hives (itchy rash), local and general rash, itching, severe sudden life-threatening allergic reaction
  • low blood sugar levels
  • difficulty sleeping (insomnia), nightmares, memory loss, hallucinations
  • stroke, decreased blood supply to the brain, increased signs and symptoms of myasthenia gravis (muscle disease), unusual sensations (such as tingling)
  • inflammation of the cornea, loosening of the layer under the blood vessel-containing retina after filtration surgery (to lower the pressure in the eye), which can cause visual disturbances, decreased corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), drooping upper eyelids (so that the eye is half closed), double vision
  • chest pain, edema (fluid retention), change in heart rate or rate, type of heart rhythm disorder, heart attack, heart failure
  • Raynaud’s phenomenon, cold hands, and feet
  • contraction of the lung airways (especially in patients with pre-existing disease), difficulty breathing, coughing
  • stomach upset, abdominal pain, vomiting
  • hair loss, skin rash with white, silvery appearance (psoriasis-like rash) or worsening of psoriasis, skin rash
  • muscle pain not caused by exercise
  • sexual dysfunction decreased sex drive
  • muscle weakness/fatigue

Other side effects have been reported with eye drops containing phosphate:

This medicine contains 52.9 mg phosphate per 5 ml solution corresponding to 10.58 mg/ml.

In very rare cases, some patients with severe damage to the clear surface of the front of the eye (cornea) have developed cloudy spots on the cornea due to limescale deposits during treatment.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store COMBIGAN

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

Store the bottle in the outer carton. Sensitive to light.

Use only one bottle at a time.

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

You must discard the bottle four weeks after first opening it, even if there are still a few drops left. This prevents infection. To help you remember, write down the date you opened the bottle in the box on the box.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substances are brimonidine tartrate and timolol maleate.
  • One milliliter solution contains 2 milligrams of brimonidine tartrate and timolol maleate equivalent to 5 mg timolol.
  • The other ingredients are benzalkonium chloride ( preservative ), sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, and purified water. Small amounts of hydrochloric acid or sodium hydroxide may be added to give the solution the correct pH (a measure of the acidity of the solution).

What the medicine looks like and the contents of the pack:

COMBIGAN is a clear, greenish-yellow eye drop solution in a plastic bottle with a screw cap. Each bottle is approximately half full and contains 5 ml of solution. COMBIGAN is available in pack sizes of 1 or 3 bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co Mayo

Ireland

This medicinal product is authorized under the European Economic Area under the names: Show larger

Austria Combigan 2 mg / ml + 5 mg / ml eye drops
Belgium Combigan 2 mg / ml + 5 mg / ml eye drops, solution
Bulgaria Combigan 2 mg / ml + 5 mg / ml caps for hair, razor
Czech Republic COMBIGAN 2mg / ml + 5 mg / ml eye caps, tablets
Croatia Combigan 2 mg / ml + 5 mg / ml capi oko, otopina
Denmark Combigan 2 mg / ml + 5 mg / ml eye drops, solution
Estonia Combigan, 2 mg / 5 mg / ml silmatilgad, lahus
Finland Combigan 2 mg / ml + 5 mg / ml silmatipat, liuos
France COMBIGAN 2 mg / ml + 5 mg / ml, collyre and solution
Germany Combigan 2 mg / ml + 5 mg / ml eye drops
Greece COMBIGAN OVERHEAD STOCK, DIALUM (0.2 + 0.5)%
Hungary COMBIGAN 2 mg / ml + 5 mg / ml oldatos szemcsepp
Iceland Combigan 2 mg / ml + 5 mg / ml eye drops, solution
Ireland Combigan 2 mg / ml + 5 mg / ml eye drops, solution
Italy COMBIGAN 2 mg / ml + 5 mg / ml collirio, solution
Latvia Combigan 2 mg / 5 mg / ml acu pilieni, šķīdums
Lithuania Combigan 2 mg / 5 mg / ml akių lašai (tirpalas)
Luxembourg Combigan 2 mg / ml + 5 mg / ml, collyre in solution
Netherlands Combigan 2 mg / ml + 5 mg / ml, eye drops, solution
Norway Combigan 2 mg / ml + 5 mg / ml eye drops, solution
Poland Combigan crop with ox, roztwór, 2 mg / ml + 5 mg / ml
Portugal Combigan 2 mg / ml + 5 mg / ml color, solution
Romania Combigan 2 mg / ml + 5 mg / ml ophthalmic pills, solution
Slovakia COMBIGAN® 2 mg / ml + 5 mg / ml ointment roztoková instilácia
Slovenia COMBIGAN® 2 mg / ml + 5 mg / ml capsules for oco, raztopina
Spain Combigan 2mg / ml + 5 mg / ml colirio in solution
UK Combigan 2 mg / ml + 5 mg / ml eye drops, solution

Muhammad Nadeem

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