Dorzolamide/Timolol Stulln PF 20 mg/mL + 5 mg/mL Eye Drops in Single Dose Containers

Introduction

Package Leaflet: Information for the User

Dorzolamida/Timolol Stulln PF 20 mg/ml + 5 mg/ml eye drops, solution in single-dose container

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Dorzolamida/Timolol Stulln PF and what is it used for
2. What you need to know before using Dorzolamida/Timolol Stulln PF
3. How to use Dorzolamida/Timolol Stulln PF
4. Possible side effects
5. Storage of Dorzolamida/Timolol Stulln PF
6. Contents of the pack and further information

1. What is Dorzolamida/Timolol Stulln PF and what is it used for

Dorzolamida/Timolol Stulln PF contains two active substances: dorzolamida and timolol.

• Dorzolamida belongs to a group of medicines called "carbonic anhydrase inhibitors".
• Timolol belongs to a group of medicines called "beta-blockers".

These medicines reduce pressure in the eye in different ways.

This medicine is prescribed to reduce high pressure in the eye in the treatment of glaucoma when the use of a single beta-blocker eye drop is not adequate.

2. What you need to know before using Dorzolamida/Timolol Stulln PF

Do not use Dorzolamida/Timolol Stulln PF

• if you are allergic to dorzolamida hydrochloride, timolol maleate or any of the other ingredients of this medicine (listed in section 6).
• if you have now or have had in the past respiratory problems, such as asthma or severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing and/or persistent cough over a long time).
• if you have a slow heart rate, heart failure or irregular heart rhythm (irregular heartbeats).
• if you suffer from severe kidney disease or disorders, or have a history of kidney stones.
• if you have excess acidity of the blood caused by an accumulation of chlorides in the blood (hyperchloremic acidosis).

If you are not sure whether you should use this medicine, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before starting to use this medicine if you have or have had in the past:

• coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing or shortness of breath), heart failure, low blood pressure.
• irregular heart rhythms such as slow heart rate.
• respiratory problems, asthma or chronic obstructive pulmonary disease.
• poor circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask signs and symptoms of low blood sugar.
• overactive thyroid gland, as timolol may mask signs and symptoms.

Tell your doctor before having surgery that you are using this medicine, as timolol may affect the effects of some medicines used during anesthesia.

Also, tell your doctor about any allergies or allergic reactions, including hives, swelling of the face, lips, tongue and/or throat that can cause difficulty breathing or swallowing.

Tell your doctor if you have muscle weakness or if you have been diagnosed with severe myasthenia gravis.

If you develop any other eye irritation or new problems in the eyes, such as redness of the eyes or swelling of the eyelids, consult your doctor immediately.

If you suspect that this medicine is causing an allergic reaction or hypersensitivity (e.g., skin rash, severe skin reaction, or redness and itching of the eyes), stop using this medicine and consult your doctor immediately.

Tell your doctor if you get an eye infection, if you suffer an eye injury, if you have eye surgery, or if you develop a reaction that includes new symptoms or worsening of existing ones.

When this medicine is instilled in the eye, it can affect the whole body.

This medicine has not been studied in patients who use contact lenses.

If you wear soft contact lenses, you should consult your doctor before using this medicine.

Use in children

There is limited experience with dorzolamida/timolol eye drops, solution (preservative-containing formulation) in infants and children.

Use in elderly patients

In studies with dorzolamida/timolol eye drops, solution (preservative-containing formulation), the effects were similar in both elderly and younger patients.

Use in patients with liver impairment

Tell your doctor if you have or have had liver problems.

Use in athletes

This medicine contains timolol, which may produce a positive result in doping tests.

Use of Dorzolamida/Timolol Stulln PF with other medicines

This medicine may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, or medicines to treat diabetes. Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine. This is especially important if you are:

• taking medicines to lower blood pressure or to treat heart diseases, such as calcium channel blockers, beta-blockers, or digoxin.
• taking medicines to treat irregular heart rhythms, such as calcium channel blockers, beta-blockers, or digoxin.
• using another eye drop that contains beta-blockers.
• taking another carbonic anhydrase inhibitor, such as acetazolamide.
• taking monoamine oxidase inhibitors (MAOIs).
• taking a parasympathomimetic drug that may have been prescribed to help you urinate. Parasympathomimetics are also a type of medicine that is sometimes used to help restore normal movement through the intestines.
• taking narcotics, such as morphine used to treat moderate to severe pain.
• taking medicines to treat diabetes.
• taking antidepressants known as fluoxetine and paroxetine.
• taking a sulfonamide.
• taking quinidine (used to treat heart disorders and some types of malaria).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

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

Breastfeeding

Do not use this medicine if you are breastfeeding your child. Timolol may pass into breast milk. Ask your doctor for advice before taking any medicine during breastfeeding.

Driving and using machines

No studies have been conducted on the effects of this medicine on the ability to drive or use machines. There are side effects associated with this medicine, such as blurred vision, that may affect your ability to drive and/or operate machines. Do not drive or operate machines until you feel well or your vision is clear.

3. How to use Dorzolamida/Timolol Stulln PF

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again. The appropriate dosage and duration of treatment will be determined by your doctor.

The recommended dose is one drop in the affected eye(s) in the morning and at night.

If you are using this medicine at the same time as another eye drop, the drops should be instilled at least 10 minutes apart.

Do not change the dose of the medicine without consulting your doctor.

If you have difficulty administering the drops, seek help from a family member or caregiver.

Do not let the tip of the single-dose container touch the eyes or the surrounding areas. This could cause eye injury. It may be contaminated with bacteria that can cause eye infections that can lead to serious damage to the eyes, including loss of vision. To avoid possible contamination of the single-dose container, wash your hands before using this medicine and avoid letting the tip of the container come into contact with any surface. The single-dose container should be opened immediately before use. If your doctor has instructed you to use the eye drops in both eyes, one single-dose container contains enough solution for both eyes.

Discard the container once opened immediately after use with its remaining contents

Instructions for use

1. Wash your hands.
2. Open the aluminum pouch and remove a strip of single-dose containers.
3. Separate a single-dose container from the strip (Fig. 1).
4. Open the single-dose container by twisting the tip. Do not touch the tip after opening the container (Fig. 2).
5. Tilt your head back (Fig. 3).
6. Pull the lower eyelid down with your finger and hold the single-dose container with the other hand. Squeeze the container to release one drop into the eye (Fig. 4).
7. Close your eye and press the inner corner of the eye with your finger for about two minutes. This helps prevent the medicine from reaching the rest of the body (Fig. 5). If necessary, repeat steps 5 to 7 with your other eye.
8. Discard the single-dose container after use.
9. Put the remaining single-dose containers back in the pouch and fold the edge of the pouch. Put the pouch in the box. If there are single-dose containers left 3 months after opening the pouch, they should be discarded properly and a new pouch opened. It is important to continue using the eye drops as prescribed by your doctor.

Fig. 1 Fig. 2 Fig. 3 Fig. 4 Fig. 5

If you use more Dorzolamida/Timolol Stulln PF than you should

If you apply too many drops in the eye or swallow some of the contents of the container, among other effects, you may feel dizziness, have difficulty breathing, or notice that your heart beats more slowly. Contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Dorzolamida/Timolol Stulln PF

It is important to use this medicine as your doctor has prescribed.

If you forget to apply a dose, you should apply it as soon as possible. However, if it is almost time for the next dose, do not apply the missed dose and continue with the scheduled dosing program as usual.

Do not use a double dose to make up for missed doses.

If you stop using Dorzolamida/Timolol Stulln PF

If you want to stop treatment with this medicine, consult your doctor first.

If you have any other questions about 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.

Usually, you can continue using the drops, unless the effects are severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using this medicine without talking to your doctor.

Generalized allergic reactions may occur, including swelling under the skin in areas such as the face and limbs, and may obstruct the airways, causing difficulty swallowing or breathing, hives or skin rash with itching, generalized and localized rash, itching, severe allergic reaction that can be life-threatening.

The following adverse reactions have been reported with dorzolamida/timolol eye drops, solution (preservative-free formulation) or with 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, alteration of taste.

Common (may affect up to 1 in 10 people)

Redness in and around the eye(s), tearing or itching in the eye(s), corneal erosion (damage to the front layer of the eyeball), inflammation and/or irritation in and around the eye(s), sensation of a foreign body in the eye (sensation that something is in the eye), decreased sensitivity of the cornea (does not appreciate that something is in the eye and does not feel pain), eye pain, dry eyes, blurred vision, headache, sinusitis (feeling of tension or congestion in the nose), nausea, weakness/fatigue and tiredness.

Uncommon (may affect up to 1 in 100 people)

Dizziness, depression, inflammation of the iris, changes in vision including modifications of refraction (in some cases due to the suppression of miotic therapy), decreased heart rate, fainting, difficulty breathing (dyspnea), indigestion, kidney stones (often marked by a sudden onset of severe pain and cramps in the lower back and/or sides, groin, or abdomen).

Rare (may affect up to 1 in 1,000 people)

Systemic lupus erythematosus (an immune disease that can cause inflammation of internal organs), tingling or numbness of hands or feet, insomnia, nightmares, memory loss, increased signs and symptoms of myasthenia gravis (muscle disorder), decreased sexual desire, stroke, transient myopia that resolves upon cessation of therapy, detachment of the layer under the retina that contains blood vessels after filtration surgery, which can cause visual disturbances, drooping eyelid (making the eye stay half-closed), double vision, crusts on the eyelid, swelling of the cornea (with symptoms of visual disturbances), low eye pressure, ringing in the ears, low blood pressure, changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), edema (fluid accumulation), cerebral ischemia (reduced blood flow to the brain), chest pain, strong and/or irregular heartbeats (palpitations), heart attack, Raynaud's phenomenon, swollen and/or cold hands and feet, and decreased circulation in arms and legs, leg cramps and/or leg pain when walking (claudication), difficulty breathing, respiratory failure, rhinitis, nosebleeds, constriction of airways in the lungs, cough, throat irritation, dry mouth, diarrhea, contact dermatitis, hair loss, skin rash with a silvery white appearance (psoriasiform rash), Peyronie's disease (which can cause curvature of the penis), allergic reactions such as skin rash, hives, itching, and in rare cases, possible swelling of the lips, eyes, and mouth, wheezing, or severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

As with other eye medicines, timolol is absorbed into the bloodstream. This can cause side effects similar to those seen with oral or injected beta-blockers. The incidence of side effects after topical ophthalmic administration is lower than when, for example, medicines are administered orally or injected. The following side effects were observed with beta-blocker medicines for the treatment of eye disorders:

Not known (frequency cannot be estimated from available data)

Low blood sugar levels, hallucinations, heart failure, a type of heart rhythm disorder, increased heart rate, increased blood pressure, abdominal pain, vomiting, muscle pain not caused by exercise, sexual dysfunction.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dorzolamida/Timolol Stulln PF

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

Do not store above 30°C.

Keep in the original packaging to protect from light.

Do not use more than 3 months after the first opening of the aluminum pouch.

This medicine does not contain preservatives. Once opened, the contents of the single-dose container should be used immediately and cannot be stored. The remaining solution in the single-dose container should be discarded after application.

Do not use this medicine after the expiration date stated on the carton, the pouch, and the single-dose container after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the containers and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition ofDorzolamida/Timolol Stulln PF

• The active ingredients are dorzolamida and timolol.

Each ml contains 20 mg of dorzolamida (as 22.26 mg of dorzolamida hydrochloride) and 5 mg of timolol (as 6.83 mg of timolol maleate).

• The other components are hydroxyethylcellulose (4000 - 5000 mPa·s), mannitol, sodium citrate, sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance and Packaging of the Product

Dorzolamida/Timolol Stulln PF is a clear, almost colorless, slightly viscous solution, practically free of visible particles. A single-dose container contains 0.2 ml or 0.3 ml.

Dorzolamida/Timolol Stulln PF is available in packs of 10, 20, 30, 50, 60, 100, or 120 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharma Stulln GmbH

Werksstrasse 3

92551 Stulln

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Dorzolamid + Timolol Stulln sine 20 mg/ml + 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

Germany: Dorzocomp-Stulln sine 20 mg/ml + 5 mg/ml Augentropfen, Lösung im Einzeldosisbehältnis

France: DORTIRUS 20 mg/ml + 5 mg/ml collyre en solution en récipient unidose

Greece: DORZYLEA 20 mg/ml + 5 mg/ml Οφθαλμικ?ς σταγ?νες, δι?λυμα σε περι?κτη μ?ας δ?σης

Netherlands: Dorzolamide + Timolol Stulln zonder conserveermiddel 20 mg/ml + 5 mg/ml oogdruppels, oplossing in verpakking voor éénmalig gebruik

Poland: Dorzolamidum + Timololum Stulln

Spain: Dorzolamida/Timolol Stulln PF 20 mg/ml + 5 mg/ml colirio en solución en envase unidosis

Date of Last Revision of this Leaflet:November 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)